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EPA-HQ-OPP-2002-0280-0002

Supporting & Related Material

Page 1 of 14 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 31, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: November 13, 2001 and December 18, 2001 Meeting of the IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert ingredients associated with the "weathered materials" grouping. Page 2 of 14 INERT INGREDIENT FOCUS GROUP MEETING November 13, 2001 and December 18, 2001 Chemical Name: Several, see below. Category: Weathered materials. CAS Reg. No.: Several, see below. PC Code: Several, see below. Introduction: There were two meetings of the Inert Ingredient Focus Group to discuss the "weathered materials" grouping. The first was held on November 13, 2001, and the second on December 18, 2001. Focus Group members in attendance at both meetings were: Kathryn Boyle (RD), Kerry Leifer (RD), Michael Doherty (HED), Pauline Wagner (HED), Diana Locke (HED), Sid Abel (EFED), and Mark Perry (SRRD). Robert Forrest (RD), Tom Brennan (HED), Henry Craven (EFED), and Larry Schnaubelt (SRRD) were present for the November 13 meeting only. Kelly O'Rourke (HED) attended only the December 18 meeting. The presenters were: Kathryn Boyle (RD) and Sid Abel (EFED). The Executive Secretary for the November 13 meeting was Linda Gerber (RD). Also in attendance at the November 13 meeting were: John Redden (RD), Jeanie McAndrew (RD), Christina Jarvis (RD), and Carol Christensen (HED). Jeanie McAndrew also attended the December 18 meeting. At both meetings the available information on various weathered materials were discussed to determine if sufficient information were available to make tolerance reassessment decisions assessment on the various materials and to make the determination as to whether the various materials should be classified as List 4A or List 4B substances. The available information consisted of information retrieved from various websites, such as, °EPA( www. epa. gov), °CDC( www. atsdr. cdc. gov/ toxprofiles/), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng0000.html) and (www. cdc. gov/ niosh/ npg/ npg. html) ° TOXNET ( www. toxnet. nlm. nih. gov.), Page 3 of 14 °NTP( ntp­ server. niehs. nih. gov.), °Firstgov( www. firstgov. gov/), °IARC( www. iarc. fr/) Additional information included parts of the FDA GRAS assessment of sodium silicoaluminate.. Also, SAR (structure­ activity­ relationship) assessments as performed by OPPT were available for some of the oxides and silicates. Three handouts were provided at the meeting on the 13th: (1) a listing of the substances for which there are existing tolerance exemptions; (2) a short summary dividing the substances into 15 groups for discussion purposes; and (3) the following description/ explanation of weathered materials. Description of Weathered Materials Weathered materials is the term that the Agency is using to describe a group of substances that could also be referred to as rocks and minerals. Generally, weathered materials are decayed or weathered rocks that are mostly unrefined, i. e., not altered or manufactured by man. When referring to weathered materials as mostly unrefined, the Agency is including the mechanical grinding of larger rocks into smaller pieces that are essentially the same, but not the chemical or physical alteration of the rock into a different substance. A mineral is a naturally­ occurring, inorganic solid substance characterized by a definite chemical composition or a range of chemical compositions and by a specific, regular architecture of the atoms that make it up. Simply put, minerals are chemicals arranged in an orderly regular pattern to form a substance that cannot be separated mechanically, i. e., by crushing, into different substances. Quartz, a very common mineral, is made of the basic elements silicon and oxygen. By simply crushing the quartz, silicon and oxygen cannot be separated; but crushed finely, quartz is a major component of the sand found at the beach or in the soil around our homes. Some minerals can be seen with the naked eye especially in coarse grain rocks, but others need magnifying glasses or powerful microscopes to be seen. There are several thousand minerals, each with characteristic chemical and physical properties. Minerals are the building blocks of rocks. Minerals can be combined, aggregated, in a great variety of patterns just as bricks may make up a walkway in an infinite array of schemes. Rocks are not as uniquely defined by their properties as minerals because of the immense number of ways the thousands of minerals can be combined. The major divisions of rocks are igneous (formed from cooling magmas), sedimentary (formed from the settling, cementing and compacting of eroding igneous and metamorphic rock), and metamorphic (igneous or sedimentary rock that has undergone change due to heat and pressure). Weathered materials are derived from these major groups. Rocks are "weathered" by a twofold process, mechanical weathering (the physical Page 4 of 14 breakdown, grinding, of the rocks into smaller pieces), and chemical weathering (the breaking of the chemical bonds between elements). Both processes operate together, each assisting the other in the slow progress of decomposing the rock to materials such as sands and clays or dissolving the rock altogether as happens when water flows over limestone. The smaller the rock pieces, the greater the surface area, the faster the breakdown. Over great periods of time, the weathering of rocks may become the great deposits of weathered minerals that are mined or become part of the soils in the gardens that are around our homes. The conditions (climate) under which this weathering occurs can determine the minerals formed. Feldspar of granite (an igneous rock) may decay to form kaolinite, a common mineral and in its pure form, a raw material for everyday pottery and china. Under certain climatic conditions, kaolinite will dissolve leaving a solid residue called gibbsite. Gibbsite makes up the great deposits of bauxite, the earthy ore known as the major source of extractable aluminum. Phosphate rocks (marine shale and limestones enriched in phosphate – both sedimentary rocks) are the major raw materials of the fertilizer industry, but are also components of the natural soils along the coastal plain of the major continents. The remnants of rock are all around us in our daily life: they are the materials in and of the earth. We are exposed to them in a variety of ways every day. It is the decay and weathering of rocks that give us the soils in which we grow our food and the ore deposits that provide the materials of everyday life. Ecotoxicity, and Environmental Fate and Effects: This presentation was performed by Sid Abel. EFED's hazard characterization was based on the fact that all of these substances are naturally occurring. Since these are naturally occurring substances, no adverse environmental effects are anticipated. Toxicology Data This presentation was performed by Kathryn Boyle (RD) based on the information contained in the previously mentioned websites. A brief summation of the available information( see below) was given for each of the groups. If available, the CAS Reg. No. is given in parenthesis. Comments made during the discussion that pertained only to a specific group are in italics below. Current List classification is also in (italics). 1. Calcium carbonate (471­ 34­ 1) (4A): The weathered materials would be: chalk, marble, calcite (13397­ 26­ 7), limestone (1317­ 65­ 3)( 4A), magnesium­ lime, and could even include oyster shells and calcareous shale. Also includes dolomite (16389­ 88­ 1)( 4A) which is calcium magnesium carbonate. ­ No concerns identified Page 5 of 14 2. Carbon in various forms: Includes carbon, graphite (7782­ 42­ 5)( 4A), and activated charcoal (7440­ 44­ 0). ­ Activated charcoal is not pure carbon. It is not absorbed, but can adsorb other drugs and chemicals on its surface ­ Carbon RED 1991 examined carbon and graphite, but did not include activated charcoal. 3. Gypsum also referred to as natural calcium sulfate (13397­ 24­ 5) (4A), plaster of paris which is hydrated calcium sulfate (26499­ 65­ 0), and calcium sulfate (7778­ 18­ 9) (10101­ 41­ 4)( 4B): ­ Ingestion of plaster of paris per se with little water may result in obstruction with resultant surgical removal It was determined that this type of ingestion is probably not a concern for pesticide products. ­ Irritant ­ Calcium sulfate is the most common of the naturally occurring sulfates and is FDA GRAS ­ Gypsum is used to treat alkali soils Plaster of Paris (total dust), calcium sulfate (total dust), and gypsum (total dust) Chemical Sampling Information Cards described the threshold limit value for all three chemicals as particulate matter containing no asbestos and less than 1% crystalline silica. 4. Lime (12001­ 27­ 3)( 4A), which is calcium oxide (1305­ 78­ 8)( 4B): ­ Dust is irritating to nose and throat ­ Some inhalation concerns ­ CaO is a food additive (GRAS with no limitations) Can be purchased for non­ pesticidal home use 5. Vermiculite (hydrated laminar magnesium­ aluminum­ iron­ silicate) (1318­ 00­ 9)( 4A) There can be asbestos contamination: Discussion focused on ways to define asbestos­ free vermiculite. After the first meeting, information was obtained from the Schindler Company website (www. schundler. com) and the Agency's Asbestos­ Contaminated Vermiculite Fact Sheet. Vermiculite (a hydrated laminar magnesium­ aluminum­ iron­ silicate), like most other naturallyoccurring materials, often contain a range of other minerals including, in some cases, asbestos. However, it is known that only a few vermiculite deposits contain more than trace amounts of asbestos. (Example: Libby) EPA has tested samples of vermiculite to determine the amounts of asbestos present. Most samples were non­ detect (no detectable levels of asbestos) using a quantifiable level of 0.1 percent by weight. The vermiculite industry has also tested various vermiculite ores with similar results. 6. Bentonite (1302­ 78­ 9)( 4A) or Montmorillonite Clay (1318­ 93­ 0)( 4A): Page 6 of 14 ­ Practically non­ toxic ­ Biologically inert when ingested ­ Some lung irritation (not silicosis) after years of exposure ­ aka Fuller's earth (8031­ 18­ 3) (claylike material composed primarily of montmorillonite); low/ moderate concern (SAR) 7. Attapulgite­ clay (12174­ 11­ 7)( 4A) (complex metallic (magnesium aluminum) silicate), also known as palygorskite: ­ Long fibers are carcinogenic (> 5 um) when inhaled ­ Short fibers are not carcinogenic (< 5 um) ­ Medical Uses (activated attapulgite) ­ Absorbent in pet litter ­ Not absorbed from GI tract ­ has colloidal and sorptive properties Discussion focused on ways to check the fiber size 8. Kaolin (1332­ 58­ 7)( 4A) which are aluminum silicates. ­ Inert after oral administration ­ Medicinal uses ­ Some inhalation concerns, kaolinosis ­ Kaolin RED Kaolin Chemical Sampling Information Card described kaolin as not classifiable as to carcinogenicity, with the comment for particulate matter containing no asbestos and less than 1% crystalline silica (respirable fraction). 9. Silicon dioxide: includes crystalline forms: silica/ quartz (14808­ 60­ 7), cristobalite (14464­ 46­ 1)( 3), tridymite (15468­ 32­ 3), tripoli (1317­ 95­ 9); includes amorphous silica (112926­ 00­ 8, 76313­ 69­ 5, 7631­ 86­ 9), sand (3), diatomaceous earth (61790­ 53­ 2)( 4B), granite, vitreous silica (60676­ 86­ 0)( 4B) and silica gel (63231­ 67­ 4, 112926­ 00­ 8)( 4B). ­ Considered to be inert when ingested ­ Crystalline forms are carcinogenic when inhaled from occupational sources ­ Cristobalite is moderate concern (SAR) ­ Silicosis occurs by prolonged and extensive exposure to respirable free crystalline silica. ­ Food additive/ feed additive Information was also obtained from the 9 th Report on Carcinogens (revised January 2001): "Inhalation of excessive levels of crystalline silica is best known as a cause of pneumoconiosis, an occupational lung disease. It is unclear whether the carcinogenic risk of crystalline silica is because it is a traditional carcinogen that interacts with nuclear macromolecules or because of an epigenetic process associated with cell damage and healing." Page 7 of 14 10. Talc (14807­ 96­ 6)( 3) is a finely powdered magnesium silicate hydroxide, also known as steatite: ­ The nonasbestiform cosmetic grade was determined to be carcinogenic. ­ Talc pneumoconiosis ­ Soapstone (1343­ 90­ 4)( 4A) is a granular form of talc. ­ Pyrophyllite (12269­ 78­ 2)( 4B) is a hydrous aluminum silicate with a structure similar to that of talc; it is a color additive mixture for drugs and cosmetics exempt from certification Both forms of talc (asbestiform and non­ asbestiform) have been proposed for review for listing in the 10 th Report on Carcinogens. Additional information was found on the NIOSH Sampling Guide which described talc as "containing no asbestos and less than 1% quartz". OSHA Chemical Sampling Information Cards have two descriptions of talc "containing asbestos" and "containing no asbestos". While the CAS Reg. Nos. are the same, the descriptors are different, with the first being described as carcinogenic, and the second being described as not classifiable as to carcinogenicity, with the comment for particulate matter containing no asbestos and less than 1% crystalline silica (respirable fraction). The International Chemical Safety Card refers to "Talc (exempt de silice et de fibres)" 11. Mica (12003­ 38­ 2)( 4A) (hydrated potassium aluminum silicate) and feldspar (potassium aluminum silicate)( 68476­ 25­ 5), low/ moderate concern (SAR) ­ Pneumconiosis The OSHA Chemical Sampling Information Card referred to a value for particulate matter containing no asbestos and less than 1% crystalline silica (respirable fraction). Also, a different CAS Reg. No. was referenced: 12001­ 26­ 2 12. Zeolites (3) Zeolites are crystalline alumino­ silicate minerals with cage­ like crystal structures. This is probably the most extensive family of minerals in the earth's crust. (1318­ 02­ 1, 12173­ 10­ 3, 12271­ 42­ 0, 67240­ 23­ 7, 12173­ 98­ 7, 12445­ 20­ 4, 66732­ 10­ 3, 68652­ 75­ 5, 12174­ 18­ 4, 61027­ 84­ 7, 66733­ 09­ 3, 68989­ 22­ 0, 68989­ 23­ 1, and 79982­ 98­ 2) There are both naturallyoccurring and synthetic versions of zeolites. Both can be fibrous or non­ fibrous. Terms used to describe zeolites include clinoptilolite, mordenite, and phillipsite. The SAR assessment performed by OPPT indicated moderate concern for the 68989­ 22­ 0 form of zeolite. One form, erionite (66733­ 21­ 9), was determined to be carcinogenic, by IARC (8 th Annual Report on Carcinogens). Erionite consists of crystals, and is not know to occur in other than fibrous form. When administered by inhalation erionite induces plural mesotheliomas. Natural erionite has been replaced by synthetic non­ fibrous zeolites. Erionite is not known to be currently in use in the US. Page 8 of 14 13. Refined silicates Refined silicates (both hydrous and anhydrous forms) are not the naturally occurring forms of silicate, but the more refined chemicals that are either derived from the naturally occurring forms or manufactured specifically through the reaction of other chemicals for selling in commerce. According to information in the FDA's GRAS assessment of silicates, there are at least 30 to 40 silicate compounds that could be consumed by humans. Most silicon compounds (except potassium and sodium) are insoluble or only slightly soluble in water: ­ Sodium (1344­ 09­ 8, 6834­ 92­ 0, and 10213­ 79­ 3)( 4B) forms a gelatinous (very alkaline) mixture in water, corrosive, extreme eye irritant; also a sodium metasilicate (10213­ 79­ 3, 13870­ 28­ 5, and 15593­ 82­ 5) which is more caustic than sodium ­ Calcium (1344­ 95­ 2)( 4B) is GRAS with limitations, in pharmaceuticals; also a tricalcium form which is used in cement; occurs naturally as wollastonite (13983­ 17­ 0) moderate concern (SAR) ­ Magnesium (14987­ 04­ 3, 1343­ 88­ 0, 13776­ 74­ 4, and 1343­ 90­ 4)( 4B) is classified as practically non­ toxic; low/ moderate concern (SAR) ­ Sodium aluminum (12003­ 51­ 9 and 1344­ 00­ 9) has low ecotoxicity, negative for mutagenicity, silicon excreted in rats; it was the predominate silicate added to foods in the US in 1979; low/ moderate concern (SAR) ­ Potassium aluminum (1327­ 44­ 2) is moderate concern (SAR) ­ Potassium (1312­ 76­ 1)( 3) ­ Sodium potassium aluminum (12736­ 96­ 8, 37244­ 96­ 5)( 3) ­ Aluminum (1327­ 36­ 2) is low/ moderate concern (SAR); hydrated (1335­ 30­ 4)( 3) ­ Aluminum calcium silicate ­ Aluminum magnesium silicate (1327­ 43­ 1)( 3) ­ Perlite (93763­ 70­ 3) (a naturally occurring polysilicate/ glass) 14. Refined Oxides: ­ Metal fume fever: produced by inhalation of metal ions at high temperatures from occupational exposures such as cutting and welding Fumes are only produced at high temperatures. Therefore, should not be a concern when used in a pesticide product. ­ Zinc (1314­ 13­ 2)( 4B) is also known as C. I. pigment white 4; no concerns identified in SAR; used in sunscreen products and calamine lotion; positive mutagenicity results were reported in two studies; no evidence of carcinogenicity was found in feeding zinc oxide at 34.4 mg zinc per day to rats for 29 weeks; in rats growth is retarded at 1% zinc oxide and developmental impacts occurred at 4000 ppm; used as an animal feed nutritional supplement; Zinc Salts RED indicated that people are usually not exposed to such large amounts of zinc through the diet ­ Aluminum (1344­ 28­ 1)( 4B) is low/ moderate (SAR) for health, high for Page 9 of 14 ecotoxicity (this was the only 3) ­ Magnesium (1309­ 48­ 4)( 4B) is low concern (SAR), mutagenicity studies were negative ­ Iron also known as rust (1345­ 25­ 1, 1309­ 37­ 1, 1317­ 61­ 9 and 12259­ 21­ 1)( 4B) is low concern (SAR); inhalation if iron oxide can cause siderosis which is a benign condition (takes 6 to10 years to get and can be slowly cleared from rat lungs; IARC monograph ­ not classifiable (Group 3) ­ Iron magnesium oxide (12068­ 86­ 9)( 3) ­ Zinc iron oxide (12063­ 19­ 3)( 3) 15. Sulfur (7704­ 34­ 9) (3): ­ Used as a fertilizer or soil amendment ­ 1991 RED ­ low toxicity ­ EPA designation under 40 CFR 180.2 ­ MSDS indicates airborne exposure limits have not been established. Discussion By consensus, the group determined that these materials are generally, with some exceptions, low toxicity substances. There would be no concerns for ecotoxicity, or for most dietary or dermal human exposure. All existing tolerance exemptions can be reassessed. However, there are inhalation concerns for some of these substances. Several of these substances have suspected or documented chronic inhalation exposure/ risk issues including carcinogenicity, silicosis or pneumoconiosis. At the November 13 meeting, the IIFG did not come to a complete conclusion for these inhalation concerns. In response to these concerns, Tom Brennan (HED) researched how these inhalation exposure/ risk concerns, that are of concern in industrial settings, might translate to exposure/ risk concerns of these same materials used as an inert ingredients in pesticides. His analysis is summarized in the paragraph below: Generally mining, processing, packaging and transporting weathered materials are full time industrial occupations that may lead to daily exposures over the course of many years. These industrial activities will create exposures to the raw (extracted) product as well as more refined products. It is very likely that routine worker activities will create the possibility of routine exposure to respirable­ sized particles. By contrast, mixing/ loading and applying granular or dust pesticide products that have these same weathered materials will not have the same level or types of exposures. The first major difference is the time and duration of exposure. For most cases the pesticide applicators will not be exposed on a daily basis. In fact, it is much more likely that pesticide applicators, both professional operators and homeowners, will have only short­ term exposures (i. e., those occurring for 1 day to a month – over a year's time). Additionally, the applicator's exposure to the inert ingredient is in a formulated product – not the raw weathered material. Page 10 of 14 Classification of an inert ingredient to List 4A means that the inert can be used in 25( b) deregulated products, without the need for acute end­ product toxicity testing for the Agency to determine the appropriate labeling language. Thus, List 4A reclassification requires consideration of other routes of exposure for the pesticide product. The List 4A classification would depend not only on the dietary exposure, but also on the likelihood of dermal and/ or inhalation concerns. There is various information from OSHA/ NIOSH (Occupational Safety and Health Administration/ National Institute for Occupational Safety and Health), such as that on a Chemical Sampling Information Card or an International Safety Card. A threshold limit value (TLV) s is a limit on inhalation exposure in the workplace (40 years, usually 8 hours per day). Generally a level of 10 mg/ m 3 is considered to be a nuisance level dust standard, which implies for inhalation concerns, that the chemical is non­ toxic, not irritating. TLVs are developed exclusively for occupational settings, assuming healthy workers. It is possible that the general public could be more susceptible. IIFG believes that TLVs are sufficient for use as benchmarks. TLVs and other endpoints such as NIOSH RELs (recommended exposure limits) or OSHA PELs (permissible exposure limits) were obtained from various sources such as the Chemical Sampling Information Cards. All units are mg/ m 3 . The TWA (time­ weighted average) is usually for 8 hours. If information were available for both the total dust and the respirable dust, then the total dust was used. (See below) attapulgite not established bentonite 10 OSHA PEL: 15 calcium carbonate 10 (TWA) NIOSH REL: 10 (TWA) calcium oxide 2 NIOSH REL: 2 calcium silicate NIOSH REL: 10 (TWA) calcium sulfate 10 (TWA) NIOSH REL: 10 graphite, natural 2 (TWA) NIOSH REL: 2. 5 (TWA) graphite, synthetic 15 (TWA) gypsum 10 (TWA) NIOSH REL: 10 (TWA) iron oxide not established kaolin 10 (TWA) limestone 10 (TWA) NIOSH REL: 10 (TWA) magnesium oxide 10 (TWA fume) marble 10 (TWA) NIOSH REL: 10 (TWA) mica 3 (TWA) NIOSH REL: 3 (TWA) montmorillonite not established perlite 10 (TWA) sand 0.05 (TWA) silica, amorphous 10 silica, amorphous, NIOSH REL: 6 (TWA) diatomaceous earth silica, amorphous, NIOSH REL: 6 (TWA) Page 11 of 14 precipitated and gel silica, crystalline cristobalite 0. 05 (TWA) NIOSH REL: 0. 05 (TWA) silica, crystalline quartz 0. 1 (TWA) NIOSH REL: 0. 05 (TWA) silica, crystalline tripoli 0. 1 (TWA) NIOSH REL: 0. 05 (TWA) silica, crystalline tridymite 0. 05 (TWA) NIOSH REL: 0. 05 (TWA) silica, fused 0. 1 (TWA) NIOSH REL: 0. 05 (TWA) silica, quartz NIOSH REL: 0.05 (TWA) soapstone 6 (TWA) NIOSH REL: 6 (TWA) sodium metasilicate none listed sulfur none listed talc (asbestos free) 2 (TWA) NIOSH REL: 2 (TWA) talc 0. 1 fiber/ cc (100 min TWA) vermiculite not established zinc oxide 10 (TWA) NIOSH REL: 5 (TWA) At the December 18 meeting the group discussed using information such as TLVs to perform a screen level inhalation assessment. Kelly O'Rourke (HED) developed such an inhalation screen for residential exposures for comparison with TLVs. Weathered materials are oftentimes used as solid carriers or diluents. Therefore, for these screening level exposure assessments it was assumed the product was a granular formulation and that the weathered material comprised 100% of the formulation. Two scenarios were considered: broadcast treatment of half an acre taking approximately 1 hour, and spot treatment of 1000 square feet taking approximately half an hour. The point estimate for broadcast treatment is 0. 18 mg/ m 3 and for spot treatment is 0.6 mg/ m 3 . It was necessary to convert these point estimates to a time weighted average over 8 hours for comparison to time weighted averages such as TLVs. The weighted average is 0. 023 mg/ m 3 for broadcast and 0.038 mg/ m 3 for spot treatment. For most of the substances the estimated weighted averages are less than the TLVs by at least two orders of magnitude. However, for some substances for which there was already information indicative of inhalation concerns, the lowest TLVs (0. 05 mg/ m 3 and 0. 01 mg/ m 3 for sand and various crystalline silicas) are in the range of the estimated weighted averages. Such substances would not be considered for List 4A classification. There was also a concern for the use of aluminum oxide due to aquatic ecotoxicty. According to the OPPT Chemical Categories Report, soluble salts of aluminum are known to be highly toxic to green algae and moderately toxic to fish and aquatic invertebrates. A screening level assessment was performed to determine the maximum application rate for aluminum oxide to avoid exceeding estimated toxicity endpoints for aquatic organisms. This assessment assumed the direct application of a pesticide containing aluminum oxide to either a farm pond or to a shallow waterbody or wetland. The lowest application rate that would not exceed a level of concern was 2. 1 pounds of aluminum oxide per acre. Aluminum oxide will be classified as List 4B. IIFG Recommendations Page 12 of 14 By consensus there were no objections to the following: All existing tolerance exemptions can be reassessed. In 40 CFR 180.2 lime and sulfur. In 40 CFR 180.1001( c): aluminum oxide , attapulgite­ type clay; bentonite; calcareous shale; calcite; calcium carbonate; calcium oxide; calcium silicate; charcoal, activated; diatomite (diatomaceous earth); dolomite, granite, graphite, gypsum, iron oxide; kaolinite­ type clay; magnesium lime; magnesium oxide; magnesium silicate; mica; montmorillonite­ type clay; potassium aluminum silicate; pyrophyllite; sand; silica, hydrated; soapstone; sodium aluminum silicate; sodium metasilicate; sodium silicate; talc; vermiculite; zeolite (hydrated alkali aluminum silicate); and zinc oxide. In 40 CFR 180.1001( d): graphite. In 40 CFR 180.1001( e): attapulgite­ type clay; calcium carbonate; calcium silicate, hydrated calcium silicate; calcium sulfate; diatomite (diatomaceous earth); graphite; iron oxide; kaolinite­ type clay; magnesium silicate, hydrated magnesium silicate; montmorillonite­ type clay; silica, hydrated silica; silica aerogel (finely powdered microcellular silica foam having a minimum silica content of 89. 5 %); soapstone; sulfur; talc; and zinc oxide. Also 40 CFR 180.1017. Tolerance exemptions maybe established for those chemicals evaluated for which there is not currently an existing exemption. By consensus the following List classifications have been determined: 1. Calcium carbonate, chalk, marble, calcite, limestone, magnesium lime, and dolomite: List 4A based on the fact that no concerns were identified. 2. Activated charcoal: List 4B given its adsorptive properties. Carbon and graphite: List 4A given the properties of and lack of toxicity of carbon. 3. Gypsum, plaster of paris, and calcium sulfate: List 4A with the following specification: (no asbestos, less than 1% crystalline silica). 4. Lime: List 4A since agricultural lime is prepared by calcining materials consisting largely of calcium carbonate such as limestone, or oyster, clam or fossil shells. Carbon dioxide is driven off. Thus, agricultural lime contains the original impurities in the starting materials. This material is openly available for purchase in lawn and garden centers. Calcium oxide: List 4B given the liberation of heat and dehydration of tissues possible from this more refined material. 5. Vermiculite: List 4A with the following specification: no asbestos, less than 1% crystalline silica 6. Bentonite, Montmorillonite clay, and Fuller's earth : List 4A based on the fact that no concerns were identified. Page 13 of 14 7. Attapulgite clay: Reclassified to List 4B based on carcinogenic concerns for fibers greater in length than 5 um. 8. Kaolin: List 4A based on the RED, with the following specification: (no asbestos, less than 1% crystalline silica ( respirable fraction)) 9. Crystalline forms of silica/ quartz including cristobalite, tridymite, and tripoli: List 4B based on concerns for carcinogenicity when inhaled. Granite: List 4B based on the fact that it contains 25 to 30% quartz. Silica sand and flours: List 4B based on the many forms and varieties available which contain crystalline quartz in various amounts Amorphous silica, vitreous silica, and silica gel: List 4A given that there are no carcinogenic concerns for non­ crystalline forms of silica/ quartz. Diatomaceous earth: List 4A when specified as silica, amorphous, diatomaceous earth (less than 1% crystalline silica) 10. Talc: List 4B based on concerns for carcinogenicity in the NTP study which was performed with non asbestiform cosmetic grade talc, with the following specification (no asbestos, less than 1% crystalline silica ( respirable fraction)) Soapstone: List 4A given that it is a granular form of talc. Pyrophillite: List 4B given its similarities to talc, and the lack of information on its carcinogenicity. 11. Mica: List 4A with the following specification (no asbestos, less than 1% crystalline silica ( respirable fraction)). 12. Natural and synthetic zeolites: List 4A with an exclusion for erionite due to concerns for carcinogenicity. 13. Sodium silicate and sodium metasilicate: List 4B given the corrosive, caustic nature of the chemical. Potassium silicate: List 4B given its similarities to sodium silicate. Calcium silicate: List 4A given the SAR assessment, the low ecotoxicity, and the role of calcium in bone­ formation. Magnesium silicate: List 4A given the SAR assessment, the low ecotoxicity, and that magnesium is an essential nutrient. Aluminum silicate: List 4A given the SAR assessment and the low ecotoxicity. Sodium aluminum silicate: List 4A given its low ecotoxicity and the SAR assessment. Potassium aluminum silicate: List 4A given the SAR assessment and its similarities to sodium aluminum silicate. Sodium potassium aluminum silicate: List 4A given the above assessments. Aluminum calcium silicate: List 4A based on the assessments for aluminum and calcium. Aluminum magnesium silicate: List 4A based on the assessments for aluminum and Page 14 of 14 magnesium. Perlite: List 4A with the following specification: (no asbestos, less than 1% crystalline silica ( respirable fraction)). 14. Zinc oxide: List 4A given the SAR assessment, the RED, and that zinc is an essential nutrient. Aluminum oxide: List 4B given that the SAR assessment is low/ moderate for health and high for ecotoxicity (this was the only 3) Magnesium oxide: List 4A given the SAR assessment and that magnesium is an essential nutrient Iron oxide: List 4A given the low concern in the SAR assessment Iron magnesium oxide: List 4A based on the assessments for iron oxide and magnesium oxide. Zinc iron oxide: List 4A based on the assessments for iron oxide and zinc oxide. 15. Sulfur: List 4A based on the low toxicity, the fact that it is metabolized in the body, and the RED.

epa

2024-06-07T20:31:44.085813

regulations

EPA-HQ-OPP-2002-0280-0003

Supporting & Related Material

Page 1 of 8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 28, 2002 MEMORANDUM SUBJECT: Tolerance Review of Compounds of the Citric Acid Cycle (Kreb's Cycle) as Inert Ingredients in Terrestrial and/ or Aquatic Agricultural and Non­ Agricultural Uses FROM: Sid Abel, Senior Environmental Scientist Environmental Fate and Effects Division (7507C) TO: Kathryn Boyle, Inerts Team Lead Registration Division (7505C) This memorandum transmits the Environmental Fate and Effects Division's (EFED) exposure and risk assessment of compounds of the Citric Acid Cycle (also known as the Kreb's Cycle). The assessment is based on readily available information from the Agency and peer reviewed public literature sources. Information contained in these sources permits EFED to conduct a qualitative assessment of environmental exposures and risks. If you should have any questions concerning the information within, please contact me at 305­ 7346. Page 2 of 8 Conclusions A review of the readily available information on the compounds that make up the Citric Acid Cycle (also known as the Kreb's Cycle) is sufficient to conduct a qualitative assessment of the potential exposures and risks associated with their use as pesticide inert ingredients. Environmental loadings are attributable to natural (plants and animal materials) and anthropogenic (food additives, drugs, and related products) sources. Available data indicate that they rapidly dissociate in the aquatic environment at environmentally relevant pH's to the corresponding acid (anion) and its respective cation (H + ,Ca + ,K + ,Na + ,NH4 + ,Mg 2+ , among others). Anions of the respective compounds undergo aerobically mediated mineralization in days to weeks; mineralization is complete degradation to CO2 and water. Half­ lives are anticipated to be shorter. Under anaerobic conditions, the anions are expected to mineralize in a matter of weeks. These compounds are expected to be predominantly found in the non­ absorbed/ adsorbed state in aquatic environments based on fugacity modeling. Photodegradation will also plays a role in the dissipation of the compounds, but, generally will occur at a lower rate, i. e., half­ lives may be longer than biodegradation. Mobility of the anions is expected to be high based on adsorption estimates, however, migration to ground water should be substantially mediated through their rapid biodegradation, volatilization, or through their uptake and utilization within plant cells. Runoff to surface is expected to dominate the nondegradation pathways of dissipation. Partitioning to air is expected to be low from water sources (based on the Henry's Law constant) and high from dryer surfaces such as soils (based on volatility). Bioconcentration is not expected to occur. Shallow aquifer ground water concentrations of the anions of the citric acid cycle may reach low part per milligram (ppm) under conditions of exaggerated surface contamination (1­ 100 ppm) such as those observed beneath landfills and wood­ treatment facilities. However, they are generally found in the low parts per billion (ppb) elsewhere (< 100 ppb) some of which is attributable to natural sources (http:// toxnet. nlm. nih. gov). Surface water concentrations (fresh water and marine­ estuarine) have been reported to reach the low­ to mid­ ppb range (10­ 300 ppb). As with ground water occurrence, surface water concentrations can be attributed to natural sources as well. No data were available to determine the effects of drinking water treatment on concentrations of the anions at the consumer tap. Based on the strong oxidizing nature of the chlorination step of treatment utilities and the chemical structure of these compounds, it is unlikely that these compounds will be found in treated water at concentrations equivalent to those found in the environment. There are no ambient water quality criteria or drinking water maximum contaminant or health advisory levels for these compounds. Based on the Agency's toxicity categories, as a group, these compounds would be classified as slightly toxic to practically non­ toxic to aquatic organisms. Terrestrial organism toxicity, using mammal data as a surrogate for the absence of avian data, indicate that these compounds would be classified as slightly toxic to practically non­ toxic except via the inhalation route where toxicity is significantly greater, one or more orders of magnitude greater depending Page 3 of 8 on the compound. At anticipated environmental concentrations, substances associated with the citric acid cycle are not expected to exceed the available toxicity data for both aquatic and terrestrial organisms to include exposures and risks via the inhalation route. Introduction The compounds contained in this review are grouped together because of their close structural relationships, carboxylic acids and their salts, and the role each plays in cell metabolism, specifically in the tricarboxylic acid cycle (also known as the citric acid or Kreb's cycle). The compounds subject to this review are as follows: acetic acid, acetic acid ammonium salt, acetic acid calcium salt, acetic acid magnesium salt, acetic acid manganese salt, acetic acid potassium salt, acetic acid sodium salt, citric acid, citrate, citric acid sodium salt, citric acid sodium salts, fumaric acid and malic acid. These compounds are naturally occurring in foods and essential to normal metabolic processes. Critic, fumaric and malic acid play key roles in the metabolic energy system called the Citric Acid Cycle or Kreb's Cycle. The cycle consists of a series of enzymatic chemical reactions occurring within the cell that are responsible for the final breakdown of food molecules to form carbon dioxide, water, and energy. Citric, fumaric, and malic acid are the integral components in this reaction, each being used over and over again to produce energy. They are not found in appreciable amount as waste products from animals as they play a key role in the acid­ base balance within animal systems. This process is active in all animals and higher plants and is carried out in the mitochondria (American Chemical Council, 2001). Acetic Acid and its Salts The chemical structures, physical­ chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of these compounds are similar. Acetic acid and its salts undergo dissociation in aqueous media at pH's commonly found in the environment to the acetate anion and the respective cations. The toxicity of each compound is driven by acetate, with the cations playing a minor role. Table 1 provides key environmental physical­ chemical properties and fate data. Biodegradation appears to be the most significant removal mechanism following the dissociation of the compound into the acetate anion and respective salt. Data indicate that acetic acid and sodium acetate (acetic acid, sodium salt) photodegrade, although the rate is substantially slower than that of biodegradation. Fugacity modeling predicts 73% of any acetic acid released to the environment would partition to water based on solubility and partition coefficients, with the remainder partitioning into the air. Therefore, the data suggest that acetic acid and its salts are not persistent in the environment. Ecotoxicity data for aquatic and terrestrial animals are available for four of the seven compounds, Table 1. The ecotoxicity data indicate that these compounds are slightly to practically nontoxic on an acute basis. The three remaining salts are closely related to the other salts in structure, properties and behavior and would be expected to have similar toxicity. Terrestrial Page 4 of 8 animal toxicity based on available mouse and rat data would indicate acetic acid is practically nontoxic on an acute basis and no chronic effects were observed in available studies. Citric Acid and its Salts Citric acid and its salts are comprised of four compounds, which include citric acid, sodium citrate, tripotassium citrate, and trisodium citrate. The chemical structures and available data indicate that the physical­ chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of these four compounds are similar, Table 2. As in the case of the other acids and salts in this category, citric acid and its salts undergo dissociation in aqueous media into the citrate anion and the respective cations. The toxicity of each compound is driven by citrate, with the cations playing a minor role. These compounds are highly water soluble and of moderate to low volatility. Data on the environmental fate of citric acid and its trisodium salt indicate that citric acid and its salts dissociate into their respective cations and the citrate anion, which is subsequently readily biodegraded. Studies indicate that citric acid and its trisodium salt are readily biodegraded (90­ 98% degradation after 48 hours). Fugacity modeling predicts that 100% of any citric acid released to the environment would partition to water based on solubility and partitioning coefficients. Therefore, the existing data indicates that citric acid and its salts are not persistent in the environment. Aquatic toxicity data for fish, Daphnia and algae are available for citric acid and its trisodium salt and indicate that these compounds practically non­ toxic on an acute basis, with LC50 values ranging from 120 to >18, 000 mg/ L, Table 2. Terrestrial animal toxicity based on available mouse data would indicate citric acid is practically non­ toxic on an acute basis and no chronic effects were observed in available studies. Fumaric Acid Available data indicate that fumaric acid is highly soluble in water and has low volatility. Fugacity modeling predicts that virtually all (99.8%) of any fumaric acid released to the environment would partition to water based on solubility and partitioning coefficients. Fumaric acid dissociates into fumate and hydrogen ion followed by fumate undergoing degradation by both biotic and abiotic mechanisms. Nearly complete biodegradation was observed after 21 days under aerobic conditions, Table 3. These data indicate that fumaric acid is not persistent in the environment. Aquatic LC50 values for fish and Daphnia were greater than 200 mg/ L. The value for the more sensitive algae was 41 mg/ L. These data indicate that fumaric acid is slightly to practically non­ toxic to aquatic animals and plants on an acute basis. Terrestrial animal toxicity based on Page 5 of 8 available rat data would indicate fumaric acid is practically non­ toxic on an acute basis and no chronic effects were observed in available studies. Malic Acid Malic acid is highly soluble in water and has a low volatility. Malic acid dissociates into malate and hydrogen ion and pH's commonly found in the aquatic environment. Malate is considered readily biodegradable in soil and water and fugacity modeling predicts that 100% of any malic acid released to the environment would partition to water based on solubility and partitioning coefficients, Table 3. Based on these data, malic acid is not likely to be persistent in the environment. Data on the aquatic toxicity of malic acid to aquatic invertebrates are available. No data on toxicity to fish and algae were available. A 48­ hour LC50 for Daphnia magna was 240 mg/ L, which classifies malic acid as practically non­ toxic to aquatic invertebrates on an acute basis. Given this data and the aquatic toxicity data for the structurally related compounds in this category, malic acid is likely to be practically non­ toxic to other aquatic species on an acute basis. Terrestrial animal toxicity based on available rat data would indicate malic acid is practically nontoxic on an acute basis and no chronic effects were observed in available studies. References American Chemistry Council, 2001. U. S. High Production Volume (HPV) Chemical Challenge Program, Assessment Plan for Acetic Acid and Salts Category. Prepared by: American Chemistry Council, Acetic Acid and Salts Panel, June 28, 201. TOXNET 2002. Online Scientific Search Engine, National Library of Medicine, National Institutes of Health. Search results for Acetic Acid and salts, Citric Acid and salts, and Fumaric Acid. U. S. EPA, 1992. Reregistration Eligibility Decision (RED): Citric Acid Fact Sheet. Office of Prevention, Pesticides and Toxic Substances. EPA­ 738­ F­ 92­ 017. June 1992. Page 6 of 8 Table 1. Chemical Properties of Acetic Acid and Salts Chemical Property Acetic Acid Acetic Acid, Ammonium salt Acetic Acid, Calcium salt Acetic Acid, Magnesium salt Acetic Acid, Manganese salt Acetic Acid, Potassium salt Acetic Acid, Sodium salt Vapor Pressure (mmHg) 11.4 @ 20 o C 1. 4x10 ­4 @25 o C 14.7 @25 o C NA NA 7. 08x10 ­7 @25 o C 7. 08x10 ­7 @25 o C Log Kow ­0.17 ­2.79 ­0.97 NA NA ­3.72 ­3.72 Kd's (Koc) 0. 65 (228) Clastic mud 0.085 (6.5) muddy sand 0.046 (27) carbonate sand NA NA NA NA NA NA Water Solubility (g/ L) 50 @20 o C 1, 480 @4 o C 430 @25 o C very solu ble soluble 2530g/ L @25 o C 365g/ L @20 o C pKa 4. 76 @25 o C NANANANANA NA Photodegradation 50% after 21 days NA NA NA NA NA 6. 6% after 17h Biodegradation 99% after 7 days using AS days to weeks (SAR) Readily biodegrades NA NA NA 100% after 5 days using AS Fish Acute Toxicity 96h LC50 ) 75mg/ L (Lowest value ­ Bluegill sunfish) 238mg/ L (mosquito fish) NA NA NA >6100mg/ L (rainbow trout) 100mg/ L (zebra fish) Daphnia Acute Toxicity 65mg/ L 48h EC50 ) NA NA NA NA 7170mg/ L 24h LC50 ) >1000mg/ L 48h EC50 ) Page 7 of 8 Algae Toxicity 4000mg/ L (8­ day growth inhibition) NA NA NA NA NA 2460mg/ L after 60­ h growth inhibition) Mammal Acute Oral (LD50 ) 4960 mg/ kg­ bw (mouse) NA 4280mg/ kg­ bw (rat) 8610mg/ kg­ bw (rat) 3730mg/ kg bw (rat) 3250mg/ kg­ bw (rat) 3530mg/ kg­ bw (rat) AS: Activated Sludge. SAR: Structure Activity Relationship. NA: Not Available. Table 2. Chemical Properties of Citric Acid and Salts Chemical Property Citric Acid Citric Acid, Sodium salt Citric Acid, Tripotassium salt Citric Acid, Trisodium salt Vapor Pressure (mmHg@ 25 o C) 3.7x10 ­9 @25 o C NA NA 2. 09x10 ­12 @25 o C Log Kow ­1.72 NA NA ­0.28 Water Solubility (g/ L @25 o C) 1330g/ l @20 o C NA NA ~425g/ L @25 o C pKa pK1: 3. 13; pK2: 4.76; pK3: 6.4 NA NA NA Photodegradation NA NA NA NA Biodegradation 98% after 48­ h using domestic sewage NA NA 90% after 48­ h using AS Fish Acute Toxicity (96h­ LC50 ) 1516mg/ L (Bluegill sunfish) NA NA >18000­ 32000mg/ L (guppy) Daphnia Acute Toxicity 120mg/ L (72h­ EC50 ) NA NA 5600­ 10000mg/ L (48h­ EC50 ) Algae Toxicity 640mg/ L 8­ day growth inhibition) NA NA >18000­ 32000mg/ L 96h EC50 ) Mammal Acute Oral 5790mg/ kg­ bw (mouse) 7100mg/ kg­ bw (mouse) NA NA Page 8 of 8 Table 3. Chemical Properties of Fumaric and Malic Acid Chemical Property Fumaric Acid Malic Acid Vapor Pressure (mmHg@ 25 o C) 1.54x10 ­4 4.6x10 ­6 Log Kow 0.33 @23 o C ­1.26 Water Solubility (g/ L @25 o C) 7g/ L 592g/ L pKa pK1: 3. 02; pK2: 4.46 @18 o C pK1: 3. 4; pK2: 5. 05 Photodegradation 50% degradation after 7.3h 50% degradation after 2 days Biodegradation 98% after 21 days using domestic sewage readily biodegrades Fish Acute Toxicity 245mg/ L (48h­ LC50 ­zebrafish)) NA Daphnia Acute Toxicity 212 mg/ L (48h­ EC50 ) 240mg/ L (48h­ EC50 ) Algae Toxicity 41mg/ L (72h­ EC50 ­ green algae) NA Rat Acute Oral 9300mg/ kg­ bw (female rat) 1600­ 3200mg/ kg­ bw (mouse, rat)

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Page 1 of 8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 10, 2002 MEMORANDUM SUBJECT: Tolerance Review of Compounds of Group 13, Lignins, Cellulose and Pines as Inert Ingredients in Terrestrial and/ or Aquatic Agricultural and Non­ Agricultural Uses FROM: Sid Abel, Senior Environmental Scientist Environmental Fate and Effects Division (7507C) TO: Kathryn Boyle, Inerts Team Lead Registration Division (7505C) This memorandum transmits the Environmental Fate and Effects Division's (EFED) fate, exposure and ecotoxicity assessment of compounds of the Lignins, Cellulose and Pine compounds and Furfural. The assessment is based on readily available information from the Agency, peer reviewed public literature sources and Structure Activity Relationships (SAR). Information contained in these sources permits EFED to conduct a qualitative assessment of environmental fate, exposures and toxicity of these compounds. If you should have any questions concerning the information within, please contact me at 305­ 7346. Page 2 of 8 Conclusions A review of the readily available information and use of Structure Activity Relationships (SAR) on the compounds that make up the ligninsulfonates, cellulose compounds, pinenes and furfural is sufficient to conduct a qualitative assessment of the likely fate, exposures and toxicity associated with their use as pesticide inert ingredients. Environmental loadings will be attributable to anthropogenic (feedstock for chemical syntheses and as a solvent in many consumer and commercial products) and natural sources (plants). Available data and SARs indicate that the ligninsulfonates, cellulose compounds, pinenes, and furfural will undergo primary biologically mediated degradation in a matter of days to weeks and ultimate degradation (mineralization) in a matter of weeks to months. Transformation and/ or degradation via hydrolysis and direct soil and water photolysis is not expected to occur for any of these compounds. Atmospheric photo­ oxidation is expected to occur for the pinenes and furfural and represents a very important degradation pathways for these compounds. Reaction rates halflives range from hours to days. With the exception of furfural, this group of compounds are expected to be predominantly found in the sorbed state in water, while furfural will be mainly in dissolution. Where available, literature data is in good agreement with SAR estimates. Transport to surface water in the sorbed state is expected to dominate the nondegradation pathways of dissipation for all but furfural. Furfural will reach surface water in dissolution based on high water solubility and low sorption coefficients. Groundwater contamination is not likely to be significant for any of these compounds. In water, partitioning to the sediment is likely for all compounds except furfural. Partitioning to air from water surfaces is expected to be high for all compounds based Henry's Law constant and high from dryer surfaces such as soils based on volatility. Bioconcentration is expected to be significant for the pinenes only. Shallow aquifer ground water contamination of furfural may occur, however, biologically mediated degradation under aerobic conditions will limit loadings, thus, concentrations. Based on the high volatility of these compounds and aeration sequences used in many drinking water treatment utilities, it is unlikely that most of these compounds will be found in treated water at concentrations equivalent to those found in the environment. There are no ambient water quality criteria or drinking water maximum contaminant or health advisory levels for these compounds. Based on the Agency's toxicity categories the ligninsulfonates and cellulose compounds are classified as practically non­ toxic to aquatic organisms and the pinenes are classified as highly toxic to very highly toxic to aquatic organisms. Furfural is classified as slightly toxic. Terrestrial organisms toxicity, using mammal data as a surrogate in the absence of avian data, indicate that these compounds may be classified as practically non­ toxic. Page 3 of 8 LIGNINSULFONATES The available chemical structures, physical­ chemical properties, environmental fate, and aquatic and terrestrial toxicity of these compounds are somewhat similar, Table 1, with differences mainly attributable to differences in cation group (Ca, Na, NH4 , Mg, P, Zn). Major uses include dispersants, emulsion stabilizer, and chelating agents. One reference indicated sodium lignonsulfonate is used to enhance the biodegradation of PCBs. As a group, the ligninsulfonates are soluble to very highly water soluble depending on the cation. Once in water, dissociation of the cation is expected depending on pH. They are not expected to be mobile in terrestrial environments, moving equally with the water and sediment phase to surface water. Ground water migration is not likely. Once in water, the dissociated cation and anion are likely to remain in dissolution. Volatility from soil and water (Henry's Law Constant) is not expected. Primary microbial mediated degradation may limit transport of parent material to surface and ground water from applications or releases to land. Fugacity modeling predicts approximately 50% of releases will be associated with the water phase and 50% with soils. Predicted volatilization half­ lives in rivers and lakes is on the order of decades. Therefore, the data suggest that the ligninsulfonates may be persistent in aquatic environment of low microbial activity and much less persistent in environments with ample microbial activity. According to the MSDS (Wesco Technologies, Ltd., 2002), pH of the various compounds range from 4 to 10 for both liquid and powder forms, Table 1. Properties for zinc­ ligninsulfonate cannot be determined because a representative structure could not be found. MSDS reports the compound's pH as 4 to 5 for both the liquid and powder form. Estimated ecotoxicity data for aquatic animals are available Table 1. The ecotoxicity estimates indicate that these compounds are practically nontoxic on an acute basis. Estimated acute toxicity is much greater than 1000 mg/ L for freshwater fish, Daphnia magna, and green algae. Chronic toxicity levels are very similar. Terrestrial animal toxicity based on available rat data would indicate that through the oral route, the ligninsulfonates are practically non­ toxic on an acute basis. CELLULOSE COMPOUNDS The chemical structures, physical­ chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of these compounds is expected to be similar. No compound specific data were found in the readily available information. Structural analyses cannot be conducted without representative structures for one or more of the compounds. Cellulose is a glucose polymer of high molecular weight found in all plants. Glucose units are joined by
­ 1, 4linkages The cellulose compounds are the most abundant compounds found in nature. Whether simple or complex, they play a major role in carbohydrate metabolism of living organisms. As a result, they may be grouped with compounds such as those of the citric acid cycle in terms of importance, environmental behavior and toxicity. Cellulose compounds are polymer compounds with cellulose itself being unbranched. Chemical modification of cellulose produces polymeric materials that are familiar commercial products. Adding carbonyl groups and cations, such as Page 4 of 8 sodium, will tend to increase solubility and reactivity in nature. Carboxymethylcellulose is synthesized when cellulose is reacted with chloroacetate. These compounds are commonly used in detergents. A carboxylic acid, carboxymethylcellulose may be synthesized to the sodium or ether compound listed as inert ingredients. Cellulose compounds are expected to be biodegradable in the environment as primary sources of energy. Volatilization is expected to be minimal. Sorption will be dependent on type and abundance of functional groups, e. g., carbonyl (R­ C= O). Terrestrial animal toxicity based on available rat data would indicate cellulose compounds are practically non­ toxic on an acute basis. PINENES AND FURFURAL The physical­ chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of ­ pinene,
­ pinene and furfural are presented in Table 2. ­ Pinene (turpentine) is naturally occurring in a wide variety of plants and is used as a solvent, fragrance, flavoring and synthetic intermediate. ­ Pinene will readily volatilize from soil and moving water to the atmosphere within hours and within days from lakes. Once in the atmosphere, ­ pinene will degrade with photochemically­ produced hydroxyl radicals with a estimated half­ life of 4 hours. Reaction with ozone occurs with a half­ life of approximately 40 minutes. Night­ time reactions with nitrate radicals occurs with a half­ life of 6 minutes. Mobility is soil is expected to be low. Biologically mediated primary degradation is expected to occur rapidly in aerobic soils. Complete removal was observed in three different soil slurries from Georgia. Degradation is seawater samples occurred with a half­ life of approximately 6­ 8 hours. Bioconcentration in aquatic organisms may occur based on an estimated BFC of 2800. ­ Pinene has been detected in the Black Warrior River in AL and in sea water from Resurrection Bay, AK. Concentrations were reported in the low parts per billion (< 100 ppb). Based on the above information, ­ pinene is not expected to persist in the environment.
­ Pinene (turpentine) is naturally occurring, with ­ pinene, but in smaller amounts, in a wide variety of plants used as a solvent, fragrance, flavoring and synthetic intermediate.
­ Pinene will readily volatilize from soil and moving water to the atmosphere within hours and within days from lakes. Once in the atmosphere,
­ pinene will degrade with photochemically­ produced hydroxyl radicals with a estimated half­ life of 4. 9 hours. Reaction with ozone occurs with a halflife of approximately 22 hours. Night­ time reactions with nitrate radicals may occur, no relevant information could be located on estimated half­ lives. Mobility is soil is expected to be low. Biologically mediated primary degradation is expected to occur rapidly in aerobic soils. Bioconcentration in aquatic organisms may occur based on an estimated BFC of 444.
­ Pinene has been detected in the Black Warrior River in Alabama, concentrations were not reported. Based on the above information,
­ pinene is not expected to persist in the environment. Furfural is an aldehyde important as a solvent for certain petrochemical processes and as a raw material for preparation of polymers, plastics, and tetrahydrofuran. Furfural will volatilize Page 5 of 8 from soil and moving water to the atmosphere within days and within months from lakes. Once in the atmosphere, furfural will degrade with photochemically­ produced hydroxyl radicals with a estimated half­ life of 3 to 4 hours. Reaction with ozone is uncertain and may not occur. Nighttime reactions with nitrate radicals may be an important degradation pathway, however, data to estimate half­ lives could not be located. Mobility is soil is expected to be high, with ground and surface contamination likely. Biologically mediated primary degradation is expected to occur in aerobic soils within days and ultimate degradation within weeks. Bioconcentration in aquatic organisms is not expected to occur. Fugacity modeling suggest that approximately 55% of furfural will be found in water and 44 percent on soil. Based on the above information, furfural is not expected to persist in the environment. Estimated ecotoxicity data for aquatic animals are available Table 2. The ecotoxicity estimates indicate ­ pine is very highly toxic to aquatic organisms on an acute basis. ­ Pinene may present an acute concern for marine/ estuarine invertebrates based on documented environmental concentrations near the levels of predicted toxicity. Acute toxicity estimates are 0. 72 mg/ L for freshwater fish, 0. 51 mg/ L for marine/ estuarine fish, 0. 93 mg/ L for Daphnia magna, 0. 042 mg/ L for mysid shrimp, and 0. 66 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 0. 138 mg/ L. Terrestrial animal toxicity based on available rat data would indicate that ­ pinene is practically non­ toxic on an acute basis.
­ pine very highly toxic to aquatic organisms on an acute basis.
­ Pinene may present an acute concern for marine/ estuarine invertebrates based on probable environmental concentrations at or near the levels of predicted toxicity. Acute toxicity estimates are 0.62 mg/ L for freshwater fish, 0. 45 mg/ L for marine/ estuarine fish, 0. 79 mg/ L for Daphnia magna, 0. 034 mg/ L for mysid shrimp, and 0.56 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 0.117 mg/ L. Terrestrial animal toxicity based on available rat data would indicate that
­ pinene is practically non­ toxic on an acute basis. Furfural is slightly toxic to aquatic organisms on an acute basis. Acute toxicity estimates are 18.8 mg/ L for freshwater fish, 26.3 mg/ L for Daphnia magna, and 518 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 4 mg/ L. Terrestrial animal toxicity cannot be determine at this time. References Meylan, William and Philip Howard, 1998. ECOSAR Class Program, Version 0.99d. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D. C. Meylan, William and Philip Howard, 2000. Estimation Program Interface, Version 3. 10. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Page 6 of 8 Pollution prevention and Toxics, Washington, D. C. TOXNET 2002. Online Scientific Search Engine, National Library of Medicine, National Institutes of Health. Search results for Lignins, Cellulose Compounds, Pinenes, Furfural http:// toxnet. nlm. nih. gov/. Wesco Technologies, Ltd, 2002. Material Safety Data Sheets (MSDS) Wesco Technologies, Ltd., San Clemente, CA. Internet search for various ligninsulfonates at: http:// www. wtl. com/ msds/ zl. htm. Page 7 of 8 Table 1. Available Estimated (E) and Measured (M) Chemical Properties and Ecotoxicological Endpoints of Select Lignins Chemical Property Calcium Lignosulfonate Sodium Lignosulfonate Ammonium Lignosulfonate pH 4.5­ 10 (liquid); 4­ 10 (powder) 4. 5­ 10 (liquid and powder) ~4.5 (liquid; ~6. 5 (powder) Vapor Pressure (mmHg) 6.65x10 ­20 @25 o C (E) 5.92x10 ­27 @25 o C (E) 2.165.92x10 ­24 @25 o C (E) Log Kow 0. 33( E) ­3. 45 (E) ­0. 59 (E) Koc 4. 63x10 4 (E) 1. 85x10 5 (E) 4. 63x10 4 (E) Water Solubility (mg/ L) 236.2 (E) 5.22x10 5 @25 o C (E) 2050 @25 o C (E) Henry's Law Constant atm­ m 3 /mole 1.96x10 ­22 (E) 7. 64x10 ­33 (E) 4. 51x10 ­33 (E) Hydrolysis/ Photodegradation NA NA NA Biodegradation Ultimate: months; Primary: days to weeks (E) Ultimate: months; Primary: days to weeks (E) Ultimate: months; Primary: days to weeks (E) Fish Acute Toxicity (96h­ LC50 ) FW: >8000mg/ L (E) >7300 mg/ L (48­ h Rainbow trout ­M) FW: >1.7x10 6 mg/ L (E) FW: >29300 mg/ L (E) Daphnia Acute Toxicity >1300 mg/ L (48h­ EC50 ) (E) >46700 mg/ L (E) >3130 mg/ L (E) Algae Toxicity (96h­ EC50 ) >79000 mg/ L (E) 1. 7x10 8 mg/ L (E) 4. 95x10 5 mg/ L (E) Fish Chronic Toxicity (30­ day) >130 mg/ L (E) 2. 92x10 5 mg/ L (E) >4700 mg/ L (E) Daphnia Chronic Toxicity (21­ day) 890 mg/ L (E) 1. 8x10 5 mg/ L (E) >3100 mg/ L (E) E: (SAR) Structure Activity Relationship. NA: Not Available. pH: Wesco Technologies, LTD, San Clemente, CA, http:// www. wtl. com/ msds/ zl. htm Page 8 of 8 Table 2. Available Estimated (E) and Measured (M) Chemical Properties and Ecotoxicological Endpoints of Select Pinene Compounds Furfural Chemical Property
­Pinene  ­Pinene Furfural Vapor Pressure (mmHg) 4.75 @25 o C (M) 2.93 @25 o C (M) 2.21 @25 o C (M) Log Kow 4.83( M) 4.35 (E) 0. 41 (M) Koc 1204 (E) 1204 (E) 17.7 (E) Water Solubility (mg/ L) 1. 891 @25 o C (M) 4.886 @25 o C (E) 0.5.36x104 @25 o C (E) Henry's Law Constant (atm­ m 3 /mole) 2. 94x10 ­1 (M) 9. 2x10 ­2 (E) 3. 37x10 ­6 (M) Hydrolysis /Photodegradation Not Expected to Occur Not Expected to Occur NA Biodegradation Ultimate: weeks to months; Primary: days to weeks (E ­ SAR) Complete removal in 250 hours in 3 different soil slurries from Georgia Ultimate: weeks to months; Primary: days to weeks (E SAR Ultimate: weeks; Primary: days (E ­ SAR) Fish Acute Toxicity (96h­ LC50 ) FW: 0.72 mg/ L (E) M/ E: 0.51 mg/ L (E) FW: 0. 62 mg/ L (E) M/ E: 0.45 mg/ L (E) FW: 18.8mg/ L (E) Daphnia Acute Toxicity 0.93 mg/ L (48h­ EC50 ) (E) 0.79 mg/ L (48h­ EC50 ) (E) 26.3 mg/ L (48h­ EC50 )( E) Mysid Shrimp Toxicity (96h­ LC50 ) 0. 042 mg/ L (E) 0. 034 mg/ L (E) NA Algae Toxicity (96h­ EC50 ) 0. 66 mg/ L (E) 0.56 mg/ L (E) 517.7 mg/ L Fish Chronic Toxicity (30­ day) 0.138 mg/ L (E) 0. 117 mg/ L (E) 4. 0 mg/ L (E) (32­ day) AS: Activated Sludge. NA: Not Available. SAR: Structure Activity Relationship.

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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 Chemicals: Mineral Acids (see specific chemicals below) PC Codes: 999999 DP Barcode: D282321 May 7, 2002 SUBJECT: Environmental Fate and Effects Review of Mineral Acids as Inert Ingredients in Pesticide Products TO: Kathryn Boyle (7508C) Registration Division Bentley Gregg (7508C) Special Review and Reregistration Division FROM: Norman Birchfield, Ph. D., Biologist (7507C) REVIEWER: Sid Abel, Chief (7507C) Environmental Risk Branch 1 Environmental Fate and Effects Division THROUGH: Elizabeth Behl, Chief (7507C) Environmental Risk Branch 4 Environmental Fate and Effects Division Summary EFED has reviewed the available data on the expected environmental fate and effects of releasing selected mineral acids and salts (see Table 2 for specific chemicals addressed) into the environment. In general, the constituents of the mineral acids are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients. The mineral acids included in this assessment have a large number of industrial, food, and 2 pharmacological uses in addition to their uses in pesticide products. Non­ pesticide uses of mineral acids included in this assessment are frequently expected to be the dominant source of release into the environment. Acids and Bases The following chemicals are considered to be strong enough acids or bases to alter environmental pHs: ammonium hydroxide, calcium hydroxide, hydrochloric acid, phosphoric acid, potassium carbonate, potassium hydroxide, sodium hydroxide, sulfuric acid, sulfurous acid, tetrasodium pyrophosphate, tricalcium phosphate, and trisodium phosphate. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pH's range from 5 to 9. The Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater (USEPA 1999). At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. The acids and bases included in this assessment are not expected to be persistent in the environment. Instead they are expected to dissociate, react with organic or inorganic materials, and complex with ionic substrates. Salts Containing Metals Salts containing metals frequently dissociate in water resulting in a cationic (positively charged) metal in solution. Based on their solubility, the follow metal containing chemicals are expected to dissociate in solution: aluminum sulfate, ferric chloride, ferric sulfate, magnesium carbonate, magnesium chloride, magnesium sulfate, and zinc sulfate. Metal salts with low solubilities which are expected to remain largely intact include: aluminum hydroxide (alum), barium sulfate, and manganese carbonate. Dissociation is frequently dependent on pH, with lower pH's (more acidic conditions) resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals is also dependent on water hardness. Toxicity of metals varies with the species of metal and its concentration. EPA's Office of Water publishes recommended water criteria values based on toxicity of selected chemicals. The following table show available Office of Water's recommended criteria for the metals included in this assessment. 3 Table 1. Recommended criteria for selected metals in water. From USEPA 1999. Chemical Freshwater concentrations µ g/ L Saltwater concentrations µ g/ L Federal Register Cite/ Source CMC 1 CCC 2 CMC CCC Aluminum (pH 6. 5­ 9. 0) 750 87 NA NA 53FR33178 Iron NA 1000 NA NA EPA Gold Book Zinc 120 120 90 81 62FR42160 IRIS 10/ 010/ 92 1 Criteria Maximum Concentration (CMC) is the highest concentration of a pollutant to which aquatic life can be exposed for a short period of time (1 hour average) (acute); 2 Criteria Continuous Concentration (CCC) is the highest concentration of a pollutant to which aquatic life can be exposed for an extended period of time (4 days) without deleterious effects (chronic). USEPA Office of Water recommend a freshwater water quality criteria value of 1 ppm (USEPA 1999) implying relatively low toxicity. Zinc and aluminum have recommended criteria implying these metals are more toxic. Recommended values were not available for magnesium, barium or manganese, however, the chemicals containing barium and manganese possess low solubility, reducing the potential for aquatic exposure. Since metals are elements they do not degrade and thus are permanent in the environment. Free and soluble metals are liekly to dissipate by being sequestered in soil, sediment, and plants. Nitrogen and Phosphorus Containing Chemicals The nitrogen and phosphorus chemicals included in this assessment are: ammonium bicarbonate, ammonium chloride, ammonium hydroxide, ammonium nitrate, ammonium polyphosphate, ammonium sulfate, calcium phosphate, diammonium phosphate, disodium phosphate, monoammonium phosphate, phosphoric acid, potassium phosphate, sodium acid pyrophosphate, sodium dihydrogen phosphate, sodium hexametaphosphate, sodium nitrate, sodium nitrite, sodium tripolyphosphate, tetrapotassium pyrophosphate, tetrasodium pyrophosphate, tricalcium phosphate, and trisodium phosphate. Nitrogen and phosphorus containing chemicals are commonly used as fertilizers. They generally posses relatively low toxicity to terrestrial and aquatic organisms. As nutrients, they can cause increased plant growth which can be detrimental in aquatic ecosystems causing eutrophication. Eutrophication occurs when algae blooms die and are degraded by bacteria which drain oxygen from the water body. With the exception of tricalcium phosphate, all of the phosphorus and nitrogen containing chemicals in this assessment are expected to be highly soluble. Phosphates 4 despite being highly soluble tend to bind to soil reducing their tendency to overload aquatic systems. Ultimately, the nitrogen and phosphorus chemicals included in this assessment are expected to be taken up and metabolized by plants to form naturally occurring compounds. 5 Table 2. Chemical included in this assessment and their properties. The following information was collected from the National Library of Medicine's Hazardous Substance Database (HSDB) (http:// toxnet. nlm. nih. gov/ cgi­ bin/ sis/ htmlgen? HSDB). Chemicals Solubility pH Vapor pressure Uses Aluminum hydroxide Low solubility at pH 7 NA NA Adsorbent; emulsifier; ion­ exchanger, in chromatography; mordant in dyeing; filtering medium; manufacture glass, fireclay, paper, pottery, printinginks, lubricating compositions, detergents; waterproofing fabrics; in antiperspirants, dentifrices; used in pharmacy as the gel or dried gel. Aluminum sulfate SOL IN 1 PART WATER Aq soln (1 g/ 1 ml water) not less than 2.9 Essentially zero. Tanning leather, sizing paper, mordant in dyeing; purifying water; manuf lakes, aluminum resinate; fireproofing & waterproofing cloth; clarifying oils & fats; treating sewage; waterproofing concrete; deodorizing & decolorizing petroleum; antiperspirants; agricultural pesticides; manuf of aluminum salts. Food additive. Ammonium bicarbonate 17.4% at 20 deg C 7.8 (0.1 N) 7. 85 kPa (58.9 mm Hg) In baking powder formulations; in cooling baths; in fire extinguishers; manuf porous plastics, ceramics; manuf dyes, pigments; in compost heaps to accelerate decompn; as fertilizer; for defatting textiles; in cold wave solns; in chrome leather tanning; to remove gypsum from heat exchanges and other processing equipment. Ammonium chloride 28.3% at 25 deg C 5.5 (1% sol'n) 1 mm Hg Plant dessicant, cotton defoliant, as flux for coating sheet iron with zinc; tinning; in dry & leclanche batteries; dyeing; freezing mixtures; electroplating; to clean soldering irons; safety explosives; lustering cotton; tanning; in washing powders; manufacturing dyes; in cement for iron pipes; for snow treatment (slows melting on ski slopes); therapeutic: systemic acidifier; vet: expectorant; diaphoretic; acidifying diuretic Chemicals Solubility pH Vapor pressure Uses 6 Ammonium hydroxide NA 10.6 (0.01 N solution) 2160 mm Hg @25degC Textiles; mfr of rayon, rubber; condensation polymerization; pharmaceuticals; ceramics; photography (development of latent images); ammonia soaps; lubricants; fireproofing wood; ink mfr; ammonium cmpd; saponifying fats & oils; org synth; detergent; household cleanser; food additive; drinking water treatment. Ammonium nitrate 118.3 G/ 100 CC OF H2O @ 0 DEGC 0. 1 M soln in water: 5.43 NA Direct application nitrogen fertilizer; chem int for nitrous oxide; component of mixt with fuel oil for indust explosives & blasting agents. Herbicides & insecticides; absorbent for nitrogen oxides; oxidizer in solid rocket propellants; nutrient for antibiotics & yeast; catalyst. Used as a dessicant for cotton. Ammonium polyphosphate Solinwater NA NA The largestuse ofpolyphosphoric acid is as an intermediate in the production of high quality liquid fertilizers. May be used as a stabilizer in skimmed sweetened condensed milk and dry milk. Catalytic applications of phosphoric acid, particularly in the form of condensed thermal polyphosphoric acids, make use of its acidic, nonoxidizing, and dehydrating properties. Condensed acids of 82­ 84% P2O5 content are employed as catalysis in the petroleum and chemical industries for alkylation, dehydrogeneration, polymerization, and isomerization reactions, including ethylbenzene, gasoline, and plasticizer alcohols. Ammonium sulfate 76.7g / 100 g water@ 25 deg C 5.5 (0.1 M aq soln) NA Food additive. Mfr of ammonia alum; in the mfr of hydrogen sulfide to free it from nitrogen oxides; analytical uses; freezing mixtures; flameproofing fabrics and paper; mfr viscose silk; tanning, galvanizing iron; in fractionation of proteins. Chemicals Solubility pH Vapor pressure Uses 7 Barium sulfate 0. 000222 G/ 100 CC WATER @ 18 DEG C 5% SUSPENSIO N IN WATER IS NEUTRAL TO LITMUS PAPER NA Manufacture photographic papers, artificial ivory, cellophane; filler for rubber, linoleum, oil cloth, polymeric fibers & resins, paper, lithographic inks; as a water coloring pigment for colored paper, in wallpaper; as a size for modifying colors of other pigments, in heavy concrete for radioactive shield. Pigment extender for oil & water based paints; pigment (as component of lithopone) in paint & fabrics, plaster; filler in cosmetics (eg, lipstick); hardening agent for cement. Calcium chloride 74.5 G/ 100 CC WATER @ 20 DEG C NA NA Used for antifreeze & refrigerating soln, in fire extinguishers; to preserve wood, stone; mfr ice, glues, cements; fireproofing fabrics; automobile antifreeze mixtures; to melt ice & snow; as coagulant in rubber mfr, as size in admixture with starch paste; in concrete mixes to give quicker initial set & greater strength; freezeproofing of coal & ores; dust control on unpaved roads; sizing & finishing cotton fabrics; as brine for filling inflatable tires on tractors to incr traction. Calcium phosphate (Calcium Bis( dihydrogen phosphate)) 1.8 g/ 100 cc @ 30 deg C NA NA In fertilizers; acidulant in baking powder & wheat flours; in enameling; mineral supplement for foods & feeds Calcium hydroxide 1730 mg/ l @20degC 12.4 (AQ SOLN SAT @25DEG C) NA In lubricants, drilling fluid, pesticides, fireproofing coatings, water paint; as egg preservative; mfr of paper pulp; in SBR rubber vulcanization; dehairing hides; in water treatment; in mortar, plaster, cement and other binding and paving materials Calcium sulfate 0.209 G/ 100 CC WATER AT 30 DEG C NA NA Used in mfr of portland cement; in soil treatment; for mfr of plaster of paris; artificial marble; as white pigment; filler or glaze in paints, enamels, pharmaceuticals, paper, insecticide dusts, in yeast mfr, water treatment, polishing powders; in mfr of sulfuric acid, calcium carbide, ammonium sulfate, porous polymers; tofu Chemicals Solubility pH Vapor pressure Uses 8 Diammonium phosphate 1 g dissolves in 1.7 ml water About 8 NA Fireproofing textiles, paper, wood, and vegetable fibers; impregnating lamp wicks; preventing afterglow in matches; flux for soldering tin, copper, brass, and zinc; purifying sugar; in yeast cultures; in dentifrices; in corrosion inhibitors; in fertilizers. Disodium phosphate Soluble in 8 parts water 9.1 for 1% aq soln @ 25 deg C NA Emulsifier (processed cheese, quick cook cereals, pharmaceuticals); metal phosphatising/ electroplating reagent); pottery glazes/ porcelain/ enamels; scale inhibitor (boiling water treatment); textile/ leather auxiliary; detergents. Ferric chloride 74.4 G/ 100 CC @ 0 DEG C NA 1 MM HG @ 194.0 DEG C Treatment of sewage and industrial wastes; etching agent for engraving, photography, and printed circuitry; condensation catalyst in Friedel­ crafts reactions; mordant; oxidizing, chlorinating, and condensing agent; disinfectant; pigment; feed additive; water purification. Ferric sulfate Slowly sol in water NA NA In preparation of iron alums, other iron salts and pigments; as coagulant in water purification and sewage treatment; in etching aluminum; in pickling stainless steel and copper; as mordant in textile dyeing and calico printing; in soil conditioners; as polymerization catalyst. Hydrochloric acid 82.3 G/ 100 CC WATER @ 0 DEGC 2.02 (0.01 N) 3. 54X10+ 4 mm Hg @ 25 deg C In the production of chlorides; refining ore in the production of tin and tantalum; for the neutralization of basic systems; as laboratory reagent; hydrolyzing of starch and proteins in the preparation of various food products; pickling and cleaning of metal products; as catalyst and solvent in organic synthesis; for oil­ and gaswell treatment; in removing scale from boilers and heat­ exchange equipment; pharmaceutic aid (acidifier). Chemicals Solubility pH Vapor pressure Uses 9 Magnesium carbonate 0.0106 G/ 100 CC COLD WATER NA NA Used to prepare high purity magnesium compounds in the paint and printing inks industries as well as in the manufacture of fireproofing, fire extinguishing, flooring, and polishing compounds and as fillers and smoke suppressants in the plastics and rubber industries; USP grade is used as an additive to table salt to keep it free flowing, a bulking compound in powder formulations, and an antacid. Magnesium chloride 54.25 G/ 100 CC WATER @ 20 DEG C NA NA Source of magnesium metal, chem int for magnesium oxychloride for cement; catalyst; flocculating agent; agent in fire extinguishers; agent in textile & paper mfr; component for ceramics; fireproofing agent for wood; component of refrigerating brines Magnesium sulfate 26 G/ 100 CC OF WATER AT 0 DEG C NEUTRAL TO LITMUS NA As a cathartic & analgesic in medicine; finishing agent for textiles; as water correcting agent in brewing indust; component of fireproofing compositions, preservatives, tanning & coagulating agents; int for magnesium trisilicate; component of nickel baths for plating other metals; catalyst support for platinum in sulfuric acid production Manganese carbonate Sol in dil acid; insol in water NA NA As pigment (" Manganese White"); drier for varnishes; in feeds Monoammoniu m phosphate 1 g dissolves in about 2. 5 ml water pH of 0.2 Molar aq soln: 4. 2 NA As baking powder with sodium bicarbonate; in fermentations (yeast cultures, etc.); fireproofing of paper, wood, fiberboard, etc. Ammonium dihydrogen phosphate used to protect pesticides in spray mixtures prepared with alkaline waters Chemicals Solubility pH Vapor pressure Uses 10 Phosphoric acid 548 G SOL IN 100 CC COLD WATER 1.5 (0.1 N aq soln) 0.0285 torr @20DEGC Over 90% of the phosphoric acid produced in the United States and worldwide is used for agricultural applications as both fertilizers and animal feed supplements. In the manufacture of superphosphates for fertilizers, other phosphate salts, polyphosphates, detergents. Acid catalyst in making ethylene, purifying hydrogen peroxide. As acidulant and flavor, synergistic antioxidant and sequestrant in food. Pharmaceutic aid (solvent). In dental cements; process engraving; rustproofing of metals before painting; coagulating rubber latex; as analytical reagent. Potassium carbonate 110.5g in 100g water at 20 deg C pH= 11.6 (aq soln) NA Manufacture soap, glass, pottery, smalts and many potassium salts; in analytical chemistry. Television glass accounts for a substantial portion of the consumption of potassium carbonate because the potassium salt is more compatible with the lead, barium, and strontium oxides contained in these glasses than is sodium carbonate. Potassium chloride 1 G DISSOLVE S IN 2. 8 ML WATER OF SATURATE D AQ SOLN @15DEG C: ABOUT 7 NA Fertilizer component (primary plant nutrient), chem int in prodn of other potassium salts, medication, photography. Potassium dihydrogen phosphate SOL 33 G/ 100 CC WATER @ 25 DEG C 4. 4 ­ 4. 7 NA In buffers for determination of pH; pharmaceutical aid (buffering agent) Baking powder; nutrient solutions; yeast foods; buffer & sequestrant in foods A widespread use is as a mineral nutrient for fermentation broths. Special liquid fertilizers, buffering systems, paper processing. Potassium hydroxide Sol in 0. 9 part water 13.5 (0.1 Molar aq soln) 1 MMHG@ 714 DEG C Food additive; electroplating; photoengraving & lithography; printing inks; in analytical chemistry & in org synth; mfr liq soap; pharmaceutical aid (as alkalizing agent); mordant for woods; absorbing carbon dioxide; mercerizing cotton; paint & varnish removers. Chemicals Solubility pH Vapor pressure Uses 11 Potassium phosphate (monopatassiu m phosphate) SOL 33 G/ 100 CC WATER @ 25 DEG C pH= 4. 4­ 4. 7 NA A widespread use is as a mineral nutrient for fermentation broths. Special liquid fertilizers, buffering systems, paper processing. Its piezoelectric properties has led to its use in sonar systems and other electronic applications. Potassium sulfate 1 G DISSOLVE S IN: 8.3 ML WATER AQ SOLN IS NEUTRAL; PH ABOUT 7 NA Fertilizer for chloride­ sensitive crops (eg, tobacco); accelerator in wallboard (construction industry); agent in mfr of glass; cathartic in human medicine; water­ corrective agent for foods (eg, brewery water); setting­ expansion control agent for dental materials Sodium acid pyrophosphate (disodium pyrophosphate) Sol in water NA NA Chiefly in baking powders. FOOD ACIDULANT. Electroplating; metal cleaning & phosphatizing; drilling muds buffer; sesquestrent peptizing agent in cheese & meat products; frozen desserts Sodium bicarbonate Solubility in water = 8.7g/ 100g solution at 20 deg C 0. 1 MOLAR SOLUTION @25DEG C: 8.3 NA Leavening agent in baking powder & food ingredients; component of soaps, detergents & pharmaceuticals; agent in leather tanning, textile mfr, paper mfr, fire extinguishers & mfr of indust & household chems Sodium bisulfate Soluble NA NA Monosodium salt of sulfuric acid Sodium chloride 35.7 g/ 100 ml of water at 0 deg C 6.7­ 7.3 1 mm Hg at 865 deg C In the production of chemicals (sodium hydroxide, soda ash, hydrogen chloride, chlorine, metallic sodium), ceramic glazes, metallurgy, curing hides, food preservative, mineral waters, soap manufacture (salting out), home water softeners, highway deicing, regeneration of ion­ exchange resins, photography, food seasoning, herbicide, fire extinguishing, nuclear reactors, mouthwash, medicine (heat exhaustion), salting out dyestuffs, supercooled solutions. Chemicals Solubility pH Vapor pressure Uses 12 Sodium dihydrogen phosphate 4.87X10+ 5 mg/ l @ 25 deg C pH of 0.1 molar aq soln at 25 deg C: 4.5 NA In baking powders; in boiler water treatment; as dry acidulant and sequestrant for foods. Buffering agent (electroplating baths); acidulant (processed meats, egg products, powdered drinks); builder (industrial cleaning formulations); metal phosphatising reagent; mineral supplement; softening/ conditioning agent (boiler water treatment; textile dyeing/ printing auxiliary. Sodium hexa metaphosphate SOL IN WATER NA NA AKA Calgon. Softening water without precipitate formation, as in dyeing, laundering, textile processing, and washing operations; corrosion inhibitor in de­ icing salt preparations; frozen desserts; pretanning hides in the manufacture of leather; dispersing clays and pigments; threshold treatment for scale; and corrosion prevention. Sodium hydroxide 1 g dissolves in 0.9 ml water 0.05% WT/ WT SOLN ABOUT 12 1 mmHg @ 739 deg C NaOH solutions are used to neutralize acids and make sodium salts, e. g., in petroleum refining to remove sulfuric and organic acids; to treat cellulose in making viscose rayon and cellophane; in reclaiming rubber to dissolve out the fabric; in making plastics to dissolve casein. NaOH solns hydrolyze fats and form soaps; they precipitate alkaloids (bases) and most metals (as hydroxides) from water solns of their salts. Pharmaceutic aid (alkalizer). Sodium nitrate 92.1 G/ 100 CC WATER AT 25 DEG C AQ SOLN IS NEUTRAL NA More than half of the sodium nitrate produced worldwide is used as a fertilizer for crops such as cotton, tobacco, and vegetables... in the U. S. it is of minor importance compared to other fertilizers. The major industrial use is in the explosives industry. Oxidizer & fluxing agent in the mfr of glass & enamels; component of charcoal briquettes, heat­ transfer salt; curing agent & preservative in meats; chem for recovery of tin from scrap; oxidizing agent (eg, in metal coloring solns); chem int (eg, for potassium nitrate) Chemicals Solubility pH Vapor pressure Uses 13 Sodium nitrite SOL IN 1. 5 PARTS COLD WATER pH ABOUT 9 NA Diazotization (by reaction with hydrochloric acid to form nitrous acid), rubber accelerators, color fixative and preservative in cured meats, meat products, fish; pharmaceuticals, photographic and analytical reagent, dye manufacture. Sodium sulfate SOL IN ABOUT 3. 6 PARTS WATER NA NA Tanning; pharmaceuticals; freezing mixtures; laboratory reagent; food additive Sodium sulfite Sol in 3. 2 parts water Chiefly in photographic developers and instead of "hypo" for fixing prints; bleaching wool, straw, silk; generating SO2; as reducer in mfr dyes; silvering glass; removing traces of Cl in bleached textiles and paper; preserving meat, egg yolks, etc. Dietary supplement; antioxidant. Sodium tripolyphosphat e (pentasodium tripolyphosphat e) 20g/ 100 ml at 25 deg C 1% soln @ 25 deg C = 9.7­ 9.8 NA One of the most widely used and most effective builder in heavy­ duty fabric washing compositions. Because of its high sequestration power, it also finds extensive application in automatic dish washing detergents. It forms stable hydrates and thus aids in the manufacture of crisp spray­ dried laundry powders. Texturizer in food. Phosphorus source for cattle. Sulfuric acid SOL IN WATER 0.01 N sol= 2.1 5.93X10­ 5 mm Hg at 25 deg C Used in fertilizers, chemicals, dyes and pigments, etchant, alkylation catalyst, electroplating baths, iron and steel, rayon and film, industrial explosives, lab reagent, nonferrous metallurgy. Used as herbicide. SulfurousacidNANA NA NA Forms from sulfur dioxide Tetrapotassium pyrophosphate NA NA NA NA See tetrasodium pyrophosphate. Tetrasodium pyrophosphate 6.7 G/ 100 ML @ 25 DEG C 10.2 (1% SOLN) NA Indust & institutional detergent builder; in water treatment; in household laundry detergents; in processed cheeses; in other food applications; in textile & clay processing, elastomers, & paper processing Chemicals Solubility pH Vapor pressure Uses 14 Tricalcium phosphate 2.5 mg/ 100 g water at 25 deg C NA NA Manuf of fertilizers, H3PO4 and P compds; manuf milk­ glass, polishing and dental powders, porcelains, pottery; enameling; clarifying sugar syrups; in animal feeds; as noncaking agent; in the textile industry. Stabilizer for plastics; in meat tenderizers; in food as buffer Trisodium phosphate 8.8 G SOL IN 100 CC WATER pH of 0.1% soln: 11.5 NA Removing insecticide residues from fruit & inhibiting mold. In photographic developers; clarifying sugar; removing boiler scale, softening water; manufacture of paper; laundering; tanning leather; in detergent mixture. In dairy substitutes (milk­ based pudding, sour cream, cheese). Zinc sulfate 101 g/ 100 g water @ 70 deg C NA NA Zinc sulfate & hydrated lime, 8 lb of each to 100 gal of water, are used to prepare spray called zinc­ lime which is the zinc equivalent of bordeaux mixt. Zinc­ lime is used extensively for control of bacterial spot disease of peaches. Depressant in froth flotation, eg, for lead­ zinc ores; component of spinning bath in mfr of rayon; chem int for mfr of the pigment lithopone, of carbamate fungicides, eg, zineb, for mfr of zinc metal, for mfr of other zinc compounds, eg, zinc stearate; component of zinc plating baths; chemical for water treatment; component of cosmetics, eg, skin fresheners; reagent for paper bleaching, in mfr of glue; accelerating agent in dental impression material; agent in textile dyeing & printing; preservative for wood & hides; fireproofing agent 15 References National Library of Medicine. Hazardous Substance Database (HSDB) (http:// toxnet. nlm. nih. gov/ cgi­ bin/ sis/ htmlgen? HSDB). Federal Register. The Federal Register is available on the internet at: http:// www. access. gpo. gov/ su_ docs/ aces/ aces140.html USEPA Gold Book. Quality Criteria for Water, 1986 (EPA 440/ 5­ 86­ 001) USEPA. Integrated Risk Information System (IRIS). Available on the internet at: http:// www. epa. gov/ iris/ USEPA. National Recommended Water Quality Criteria ­ Corrrection, Office of Water, April 1999, publication number EPA 822­ 99­ 001. Available on the internet at: http:// www. epa. gov/ ost/ pc/ revcom. pdf

epa

2024-06-07T20:31:44.106702

regulations

EPA-HQ-OPP-2002-0280-0006

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 29, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert ingredients associated with cellulose and paper. 2 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Cellulose and Paper Petition No.: no Tolerance Reassessments?: yes Chemical Substance CAS Reg. No. 40 CFR 180.1001 citation alpha ­ cellulose (c)( e) croscarmellose sodium (a cross­ linked form of sodium carboxymethyl cellulose) 74811­ 65­ 7 (c) sodium carboxymethyl cellulose 9004­ 32­ 4 (c) Paper fiber, deinked or recycled, conforming to 21 CFR 109.30( a)( 9) and 21 CFR 176.260 (d) Paper fiber, produced by the kraft (sulfate) or sulfite pulping processes. (d) Other chemicals considered in this assessment are: methyl cellulose, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, and cellulose acetate. The tolerance exemptions for these chemicals have been previously reassessed and are included in this assessment only for their structural similarities to cellulose and to consider for List 4A classification. HPV Chemical? No Use Pattern (pesticidal): Cellulose can be used as a solid diluent, carrier, and suspending agent. Cellulose derivatives are used as suspending agents, surfactants, thickeners, and dispersing agents in food and cosmetics. Cellulose acetate is used as a pesticide rate release regulating agent. Paper is used as a carrier. 3 Use Pattern (non­ pesticidal): Cellulose and cellulose derivatives are used as a both direct and indirect food additives. As direct food additives they are used in baked goods and baking mixes, fats and oils, cheese, meat and poultry products, sweet sauces, toppings, syrups, gelatins, puddings and fillings, gravies, dairy product analogs, candy and chewing gum. As indirect food additives they are used as substances migrating to food from food packaging. The cellulose derivatives are used in cosmetics such as hair products, eye and facial makeup and skin care preparations. They can also be used in surface coatings, as polymerization additives, in adhesives, and in detergents and cleaners. Croscarmellose sodium is used as a disintegrating agent in pharmaceuticals (tablets). Cellulose fibers are used as a component of insulation. 1. Introduction: Cellulose, or alpha­ cellulose, is a naturally­ occurring polymeric material. It can also be referred to as a macromolecule or polysaccharide. Chemically, cellulose is a long chain of glucose molecules that are linked with beta (1­ 4) glycosidic bonds. The molecular weight of isolated cellulose as reported by FDA is approximately 50, 000 daltons. Cellulose is part of the plant cell wall of wood, cotton, and various plant crops consumed for nutrition. It is the most abundant carbohydrate in nature. Dietary cellulose (i. e., fiber) from edible plants is consumed by humans on a daily basis. Humans do not possess the enzyme necessary to break the beta (1­ 4) glycosidic bond; thus, cellulose passes unchanged through the intestinal tract. The Dietary Guidelines for Americans published by the USDA (United States Department of Agriculture) recommend eating foods with adequate fiber. The National Cancer Institute recommends that an individual consume 20 to 30 grams of fiber each day with an upper limit of 35 grams per day. The derivatives are not naturally occurring materials, but are manufactured from cellulose. These are polymeric substances with high molecular weights: the information available indicates ranges of 40,000 to 480,000 daltons depending on the degree of polymerization Paper is manufactured by applying a watery suspension of cellulose fibers, known as pulp, to a screen thus allowing the water to drain and leaving the fibrous particles behind in a sheet. Pulp is produced by digesting a cellulose containing material into its fibrous constituents via chemical and/ or mechanical means. In the case of wood, the most common pulping material, chemical pulping actions release cellulose fibers by selectively destroying the chemical bonds in the glue­ like substance (lignin) that binds the fibers together. The two major chemical pulping processes used in the US are kraft/ soda pulping and sulfite pulping. Kraft pulping produced 80 percent of all US pulp tonnage during 1993. After the pulping process, dependent on the type of paper desired, paper manufacturing includes various processes to separate and remove impurities, bleaching and coloring processes to achieve the desired color, adding various resins or texture materials depending on the desired end­ result, and drying by pressing and heating to bond the fibers. The following information was used in performing this assessment: The available information consisted of information retrieved from various websites, such as, 4 °EPA( www. epa. gov) ° TOXNET ( www. toxnet. nlm. nih. gov.) ° World Health Organization (WHO) (jecfa. ilsi. org/ section1. htm) and (www. inchem. org/ document/ jecfa/ jecmono/ v26je08.htm) and those websites containing descriptions of cellulose and paper. Additionally, the following documents were used: ° GRAS (Generally Recognized as Safe) Food Ingredients ­ Cellulose and Derivatives were evaluated in a 1972 assessment by FDA. ° Certain Cellulose Derivatives as Food Ingredients were evaluated by the Food and Drug Administration (FDA) in a 1974 assessment. ° Final Report on the Safety Assessment of Hydroxypropylcellulose, Hydroxypropylcellulose, Methylcellulose, Hydroxypropylmethylcellulose, and Cellulose Gum: Cosmetic Ingredient Review Journal of the American College of Toxicology Vol. 5 No. 3 (1986) 2. Chemical Specific Uses of Cellulose and Cellulose Derivatives: Microcrystalline cellulose is obtained by treating alpha cellulose with mineral acids. It is used to convert liquid foods to granular forms or smooth­ spreading gels, and as an anticaking or binding agent. Methyl cellulose is used as a thickener, stabilizer, emulsifier, bodying or bulking agent, and binder in foods. It was first used in foods in the US in 1960. Carboxymethyl cellulose and it sodium salt (sodium carboxymethyl cellulose or cellulose, carboxymethyl ether, sodium salt are used as thickening agents and stabilizers in foods. Little distinction is made between the two chemicals. Both were first used in foods in the US in 1945. Hydroxypropylmethyl cellulose is used as a thickening agent, stabilizer, and emulsifier. Ethyl cellulose is used as a coating for vitamin preparations, as a binder and filler, and as a component of paper and paperboard food packaging materials. It is in hard candy and chewing gum. 3. FDA's Conclusions There is a large toxicity database for cellulose and its derivatives. It includes acute, subchronic, chronic/ carcinogenic, and reproductive studies. The metabolism and absorption has been well­ documented. FDA's overall conclusion is as follows: 5 "Cellulose is a major constituent of many foods of plant origin. As such it is a significant portion of the diet, but is neither degraded nor absorbed. Cellulose derivatives considered in this report are virtually unabsorbed and little or no degradation of absorbable products occurs in the human digestive tract. In man, consumption of large amounts appears to have no effect other than providing dietary bulk, reducing the nutritive value of such foodstuffs and possibly exerting a laxative effect." FDA's chemical­ specific hazard conclusions are as follows: Cellulose and Microcrystalline Cellulose "There is no evidence in the available information on pure and regenerated cellulose, including microcrystalline cellulose, that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current, or that might reasonably be expected in future." Methyl Cellulose "In humans, virtually 100 percent of orally ingested methyl cellulose can be recovered in the feces within four days, indicating that absorption does not occur. However, in pregnant mice, very high doses of methyl cellulose, while not teratogenic, cause a significant increase in maternal mortality and retardation of fetal maturation." According to the summary of the study in the FDA Assessment pregnant rats, hamsters, and mice were administered doses of methyl cellulose in corn oil. In rats at doses up to 1320 mg/ kg/ day for 10 consecutive days, there was no clearly discernible effect on nidation or on maternal or fetal survival. In hamsters, doses of up to 1000 mg/ kg/ day for five days (gestation days 6 to 10) did not produce significant effects on nidation (fertilization) or on maternal or fetal survival. Daily doses of up to 345 mg/ kg/ day from day 6 through day 15 of gestation in mice had no clearly discernible effect on nidation or on maternal or fetal survival. However, doses of 1600 mg/ kg/ day caused a significant increase in mortality in treated dams and a decrease in the pregnancy rate of survivors. There was a marked increase in the number of resorption sites. The live fetuses were smaller and exhibited significant retardation in maturation. The findings resembled those produced by high molecular­ weight polysaccharides such as the vegetable gums. The dose of 1600 mg/ kg/ day is higher than that tested in either the rat or hamster. It is possible that the effects could be due to nutritional deficiencies due to deliberately high doses of indigestible material. Information in the FDA assessment indicated that the average daily intake for cellulose deliberately added to foods ranged from 48 to 360 mg/ kg/ day (1970s). Cellulose derivatives were at significantly lower levels and ranged from less than 1 to 36 mg/ kg/ day. It is unlikely that levels 6 of human consumption of methyl cellulose would reach levels comparable to those at which effects were seen. Carboxymethyl Cellulose and Sodium Carboxymethyl Cellulose "Because carboxymethyl cellulose becomes the sodium salt in the presence of sodium ion, no distinction between the two substances as used in food need be made." There is no evidence to suggest that either chemical substance would be a hazard to the public when used at levels that are now current or that might reasonably be expected in the future." Hydroxypropylmethyl Cellulose "There is no evidence in the available information on hydroxypropylmethyl cellulose that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at levels that are now current and in the manner now practiced" (thickening agent, stabilizer and emulsifier). Given the nature of the chemical substance, the use pattern specified above as a food additive is very likely to also be the use pattern for pesticide products." Hydroxyethyl Cellulose In the FDA assessment, there is less toxicity information available for hydroxyethyl cellulose than for other cellulose derivatives. However, given the chemical similarities of the derivatives, there is no reason to believe that this cellulose derivative should interact with the human body with any significant difference. All cellulose derivatives examined are of low toxicity; therefore, hydroxyethyl cellulose should also be of low toxicity. Cellulose Acetate In the FDA Assessment, cellulose acetate was only examined for use as a food packaging material. It was concluded that: "There is no evidence in the available information ..... that demonstrates or suggests reasonable grounds to suspect, a hazard to the public when ..... used in food packaging materials as now practiced or as they might be expected to be used for such purposes in future." TOXNET indicated that cellulose acetate is an amorphous white solid material in granular, flake, or powder form from which fibers can be formed by extrusion. It is a thermoplastic material and can be heat­ set or extruded. The OSHA (Occupational Safety and Health Administration) Chemical Sampling Information Form contains no exposure limits or health factor concerns. The establishment of the tolerance exemption for cellulose acetate in 1995 was based on its conformance with the polymer exemption guidance criteria. 7 4. World Health Organization (WHO) Cellulose derivatives have been examined at eight meetings of the FAO/ WHO Joint Expert Committee on Food Additives (JECFA). Various toxicological studies (acute, chronic/ carcinogenic, reproduction, mutagenicity, metabolism and absorption, and observations in man were discussed for: ethyl cellulose, ethyl hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, methylethyl cellulose, and sodium carboxymethyl cellulose. The human observations concerned the laxative effects of modified celluloses. The conclusion was reached that cellulose derivatives have "a low toxicity." The estimate of acceptable daily intake is "not specified", which is defined as: A term applicable to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual evaluations, the establishment of an acceptable daily intake expressed in numerical form is not deemed necessary. An additive meeting this criterion must be used within the bounds of good manufacturing practice, i. e., it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal inferior food quality or adulteration, and it should not create a nutritional imbalance The only concern specified was that the ability to produce laxation should be taken into account when using these substances as food additives. 5. SAR Assessment Several of the cellulose derivatives were evaluated by the SAR (structure activity relationship) process. Both sodium carboxymethyl cellulose and ethyl hydroxyethyl cellulose were rated as low concern for both human health and ecotoxicity concerns. Hydroxypropylmethyl cellulose and methyl cellulose were only rated for human health, for which they were rated as low concern. 6. Paper Assessment The tolerance exemption for paper was established on April 14, 1988 (53 FR 12418) (FRL­ 3365­ 8). The rationale for establishing the tolerance exemption included its similarities to other cellulosic materials already cleared under 40 CFR 180.1001( c), and the fact that pulp is cleared under 21 CFR 186.1673 as an indirect food substance affirmed as generally recognized as safe (GRAS). 8 The Agency no longer uses comparisons to similar materials as the basis for action unless the materials have already undergone the tolerance reassessment process and have been determined to be reassessed. In this case, the similar materials alpha­ cellulose, oat hulls, shells (almond, cocoa, coconut, and walnut), and wood flour have already been reassessed, or in the case of alpha­ cellulose is being reassessed in this document. As explained previously paper is mostly cellulose fibers. Paper is derived from pulp. Pulp is derived mostly from wood. The tolerance exemption for de­ inked and/ or recycled paper was established on August 1, 1989 (54 FR 31674) (FRL­ 3623­ 5). Paper that is to be recycled must first be de­ inked, that is, the ink as well as the various coatings and additives are separated from the fibers (such as cellulose) that form the structure of paper. It is the cellulose fibers that are recycled. These fibers are then combined with fibers that have not been previously made into paper. The rationale for establishing the de­ inked and/ or recycled tolerance exemption included the above tolerance exemption for paper, and the fact that pulp from reclaimed paper is cleared under 21 CFR 176.260 as a component of articles used in producing, processing, preparing, treating, packaging, transporting, or holding food subject to certain provisions. It is not expected that residues of paper when used as a carrier (the use that would be expected due to the nature of paper) would be present in raw agricultural commodities. When applied to crops, paper would not be expected to be absorbed by the plant. 7. Croscarmellose Sodium Croscarmellose sodium is a cross­ linked carboxymethylcellulose sodium that is sometimes referred to as sodium cellulose glycolate. The cross­ linking reduces its water solubility and permits the material to swell and take up many times its weight in water. These properties make croscarmellose sodium similar to those of sodium starch glycolate, a cross­ linked potato starch derivative. Sodium starch glycolate is produced by crossing­ linking and carboxymethylation of potato starch. Both chemicals are used as disintegrants (disintegrating agents) in the pharmaceutical industry. The only concern for either of these chemicals would be for inhalation of respirable particles (less than 10 microns). Since either of these materials can absorb many times their own weight in water and swell (in volume), inhalation of respirable particles may lead to lung effects. However, these concerns can be addressed by the acute end­ product toxicity testing performed at the time of product registration. 8. Hazard Characterization: Other than the inhalation concerns for croscarmellose sodium, there is no available information on any of the chemicals considered in this document indicative of a hazard or significant adverse effects ­ to the general public or any population subgroup. There have been 9 many reviews of these materials by organizations such as FDA and WHO. The available information indicate that these chemical substances pass through the intestinal tract unabsorbed. They are of low toxicity. 9. Type of risk assessment: qualitative 10. Sensitivity of Infants and Children: These chemicals have low toxic potential. In addition, humans of all ages are highly exposed to them from natural and anthropogenic sources. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 11. Fate Assessment: Cellulose derivatives would undergo biological degradation in a matter of days to weeks, and ultimate degradation to carbon dioxide and water in a matter of weeks to months. In water, partitioning to the sediment is likely; therefore, celluloses would be expected to be found in the sorbed state in water. Transport to surface in the sorbed state would dominate the nondegradation pathways of dissipation. Groundwater contamination is not likely to be significant, given the partitioning to the sediment. 12. Ecotoxicity Assessment Cellulose derivatives would be practically non­ toxic to aquatic organisms. Terrestrial animal toxicity based on the available data would indicate cellulose derivatives are practically nontoxic on an acute basis. 13. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." Cellulose and its derivatives are structurally related; however, all are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these chemicals have a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. 14. IIFG Recommendations: By consensus there were no objections to the following: 10 The following tolerance exemptions are reassessed: In 40 CFR 180.1001 (c) alpha cellulose, croscarmellose sodium, and sodium carboxymethylcellulose. In 40 CFR 180.1001 (d) Paper fiber, deinked or recycled, conforming to 21 CFR 109.30( a)( 9) and 21 CFR 176.260, and Paper fiber, produced by the kraft (sulfate) or sulfite pulping processes. In 40 CFR 180.1001 (e) alpha­ cellulose. Given the non­ toxic nature of cellulose and its derivatives, the following List reclassifications are made or confirmed: cellulose (CAS Reg. No. 9004­ 34­ 6, 65996­ 61­ 4): List 4A cellulose acetate (CAS Reg. No. 9004­ 35­ 7: List 4A carboxymethyl cellulose (CAS Reg. No. 9000­ 11­ 7): List 4A hydroxypropylmethyl cellulose (CAS Reg. No. 9004­ 65­ 3): List 4A methyl cellulose (CAS Reg. No. 9004­ 67­ 5): List 4A sodium carboxymethyl cellulose (CAS Reg. No. 9004­ 32­ 4, 51395­ 75­ 6): List 4A Given the derivation of paper from cellulose, the history and nature of paper, and the role that it plays in our daily lives, the List 4A reclassifications are reconfirmed for paper. Croscarmellose sodium is classified as List 4B, due to the inhalation concerns. Tolerance exemptions (with List 4A classification) may be established for: ethyl cellulose (CAS Reg. No. 9004­ 57­ 3) hydroxyethyl cellulose (CAS Reg. No. 9004­ 62­ 0) cellulose, regenerated (CAS Reg. No. 68442­ 85­ 3) hydroxypropyl cellulose (CAS Reg. No. 9004­ 64­ 2). ethyl hydroxyethyl cellulose (CAS Reg. No. 9004­ 58­ 4) Attachment: EFED review (Abel; April 10, 2002)

epa

2024-06-07T20:31:44.115476

regulations

EPA-HQ-OPP-2002-0280-0007

Supporting & Related Material

Page 1 of 16 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 28, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: February 26 Meeting of the IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert ingredients associated with acetic acid and the citric acid cycle grouping. Page 2 of 16 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Acetic Acid and Salts Citric Acid Cycle Chemicals and Salts Petition No.: no Tolerance Reassessments?: yes Common Chemical Names: acetic acid, sodium acetate, citric acid, sodium citrate, potassium citrate, calcium citrate, malic acid, and fumaric acid Chemical Category/ Group: organic acids and their salts CAS. Reg. No.: in tables HPV Chemical? yes Data Posted? yes Use Pattern (pesticidal): Citric acid and malic acid are FIFRA 25( b) active ingredients. As an active ingredient, citric acid is used as a disinfectant, sanitizer, fungicide and scale remover for use in toilets and food processing equipment. Both citric acid and fumaric acid are in 40 CFR 180.2. Acetic acid and citric acid are used in food­ contact surface sanitizing solutions. As an active ingredient acetic acid is used on rights of ways, golf courses, open spaces, driveways and industrial sites at concentrations similar to that in vinegar to dessicate (dry out) plants. Use Pattern (non­ pesticidal): These are naturally occurring chemicals, food acids that are found in a wide variety of unprocessed foods, especially fruits. FDA clearances exist for these chemicals allowing their use in candy, jelly, ice cream, cakes, cookies, pies, soft drinks, fruit drinks, cheese, and animal drugs and feeds. Malic acid is a flavoring agent. Fumaric acid is an antioxidant and can be a component of adhesives. Citric acid can be used in various cleaners and strippers. Page 3 of 16 1. Physical/ Chemical Properties: Table 1. Chemical Properties of Acetic Acid and Salts Chemical Property Acetic Acid Acetic Acid, Calcium salt Acetic Acid, Magnesium salt Acetic Acid, Potassium salt Acetic Acid, Sodium salt Vapor Pressure (mmHg) 11.4 @ 20 o C 14.7 @25 o C NA 7. 08x10 ­7 @25 o C 7.08x10 ­7 @25 o C Log Kow ­0.17 ­0.97 NA ­3.72 ­3.72 Kd's (Koc) 0. 65 (228) Clastic mud 0.085 (6.5) muddy sand 0.046 (27) carbonate sand NA NA NA NA Water Solubility (g/ L) 50 @20 o C 430 @25 o C very soluble 2530 @25 o C 365 @20 o C pKa 4. 76 @25 o C NA NA NA NA Photodegradation 50% after 21 days NA NA NA 6.6% after 17h Biodegradation 99% after 7 days using AS * Readily biodegrades NA NA 100% after 5 days using AS Fish Acute Toxicity 96h LC50) 75mg/ L (Lowest value ­ Bluegill sunfish) NA NA >6100mg/ L (rainbow trout) 100mg/ L (zebra fish) Daphnia Acute Toxicity 65mg/ L 48h EC50) NA NA 7170mg/ L 24h LC50) >1000mg/ L (48h­ EC50) Algae Toxicity 4000mg/ L (8­ day growth inhibition) NA NA NA 2460mg/ L after 60­ h growth inhibition) Mammal Acute Oral (LD50) 4960 mg/ kg­ bw (mouse) 4280mg/ kg bw (rat) 8610mg/ kg bw (rat) 3250mg/ kg­ bw (rat) 3530mg/ kg­ bw (rat) * AS: Activated Sludge. Page 4 of 16 Table 2. Chemical Properties of Citric Acid and Salts Chemical Property Citric Acid Citric Acid, Sodium salt Citric Acid, Tripotassium salt Citric Acid, Trisodium salt Vapor Pressure (mmHg@ 25 o C) 3.7x10 ­9 @25 o C NA NA 2.09x10 ­12 @25 o C Log Kow ­1.72 NA NA ­0.28 Water Solubility (g/ L @25 o C) 1330 @20 o C NA NA ~425 @25 o C pKa pK1: 3. 13; pK2: 4.76; pK3: 6.4 NA NA NA Photodegradation NA NA NA NA Biodegradation 98% after 48­ h using domestic sewage NA NA 90% after 48­ h using AS Fish Acute Toxicity (96h­ LC50) 1516mg/ L (Bluegill sunfish) NA NA >18000­ 32000mg/ L (guppy) Daphnia Acute Toxicity 120mg/ L 72h EC50) NA NA 5600­ 10000mg/ L (48h­ EC50) Algae Toxicity 640mg/ L 8­ day growth inhibition) NA NA >18000­ 32000mg/ L (96h­ EC50) Mammal Acute Oral 5790mg/ kg­ bw (mouse) 7100mg/ kg­ bw (mouse) NA NA Table 3. Chemical Properties of Fumaric and Malic Acid Chemical Property Fumaric Acid Malic Acid Vapor Pressure (mmHg@ 25 o C) 1.54x10 ­4 4.6x10 ­6 Log Kow 0.33 @23 o C ­1.26 Water Solubility (g/ L @25 o C) 7 592 pKa pK1: 3. 02; pK2: 4.46 @18 o C pK1: 3. 4; pK2: 5. 05 Photodegradation 50% degradation after 7.3h 50% degradation after 2 days Page 5 of 16 Biodegradation 98% after 21 days using domestic sewage readily biodegrades Fish Acute Toxicity 245mg/ L (48h­ LC50 ­zebra fish)) NA Daphnia Acute Toxicity 212 mg/ L (48h­ EC50) 240mg/ L (48h­ EC50) Algae Toxicity 41mg/ L (72h­ EC50 ­ green algae) NA Rat Acute Oral 9300mg/ kg­ bw (female rat) 1600­ 3200mg/ kg­ bw (mouse, rat) 2. Introduction: Acetic acid is produced in biological tissues by fermentation of carbohydrates and also by organic synthesis. Vinegar which is a 5 to 8 % solution of acetic acid, is also a commonly consumed food. Citric acid is widely distributed in plants and animals and occurs naturally in foods such as citrus fruits and tomatoes in substantial quantities. It is also one of the most widely used food additives. As a dietary supplement, calcium citrate is a source of calcium. Malic acid occurs naturally as the major acid in apples, apricots, cherries, carrots and other foods. It is also used as a flavor booster in candy, jelly fruit drinks and ice cream. Fumaric acid occurs in apples, beans, and carrots. It is commonly used to control pH and produce light textures in such foods as cake and cookies. The following information was used in performing this assessment: The available information consisted of information retrieved from various websites, such as, °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng0000.html) and (www. cdc. gov/ niosh/ npg/ npg. html) ° TOXNET ( www. toxnet. nlm. nih. gov.), °NTP( ntp­ server. niehs. nih. gov.), Additional information included the information submitted to EPA's High Production Volume Challenge Program "Assessment Plan and Robust Summaries for the Acetic Acid and Salts Category." (Submitted June 28, 2001) Citric acid was also previously evaluated by the Agency in 1992 in the Citric Acid RED. Information identified as MRID was submitted to the Agency in support of citric acid as an active ingredient. Acetic acid, calcium citrate, citric acid, sodium acetate, and sodium citrate have also been Page 6 of 16 evaluated by the Food and Drug Administration (FDA). They are FDA­ affirmed GRAS (Generally Regarded As Safe). Calcium acetate is also FDA­ affirmed GRAS (21 CFR 184.1185). Fumaric acid is approved for use as a direct and indirect food additive "at a level not in excess of the amount reasonably required to accomplish the intended effect." International Safety Cards gave the following information on acetic acid (aqueous form): It is a colorless liquid and a weak acid. The substance and the vapor are corrosive to the eyes, the skin and the respiratory tract. There may be effects on the gastrointestinal tract. The TLV (Threshold Limit Value) is 25 mg/ m3 or 10 ppm. Pure acetic acid is a solid below 62 o F. It's most concentrated from is known as glacial acetic acid. According to the International Safety Cards available for the other chemicals discussed in this document, they are all solids (granules, crystalline powder or flakes). No TLVs have been established. 3. The Citric Acid Cycle: Citric acid, malic acid and fumaric acid are produced during the Citric Acid Cycle, which is also known as the Krebs Cycle. This cycle is essential for the metabolism of glucose and other simple sugars. The cycle consists of a series of enzymatic chemical reactions. These processes occur within the cell and are responsible for the final breakdown of food molecules to form carbon dioxide, water, and energy. For risk assessment purposes an important feature of this cycle is that these acids are used over and over again, thus giving the body an effective means of processing any ingested citric, fumaric, or malic acid. 4. Role of the Cation Generally, in dealing with any acid salt, dissociation yields the anion from the acid and a cation. Generally, concerns for human and ecological health would stem from the acid moiety. Cations such as sodium, potassium, magnesium and calcium. are all minerals and required for proper functioning of biological systems. For risk assessment purposes an important feature of these minerals is that the body does have an effective means of processing them.. Sodium is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. Potassium is important in regulating blood pressure, regulating cellular water content, maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the electrical activity of the heart and muscles. Calcium is necessary for bone and teeth formation. It is also important to the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the Page 7 of 16 maintenance of cell membranes. Magnesium is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. Page 8 of 16 5. Toxicological Profile Table Table 4a: Acute Toxicological Profile: acetic acid and sodium acetate Chemical CAS No. Acute Oral LD 50 Acute Dermal LD 50 Acute Inhalation LD 50 Skin Irritation Eye irritation Acetic acid 64­ 19­ 7 LD 50 10% solution:: 3530 mg/ kg (MRID No. 99320) LD 50 Rat: 3000mg/ kg to 3800 mg/ kg (MRID No. 33062) LD 50 Mice: 4400 to 5600mg/ kg (MRID No. 33062) LDLo Rabbit: 600 mg/ kg LD 50 : Rat 1.05mL/ kg (MRID No. 99320) LDLo Rabbit: 1060 uL/ kg LCLo: Rat 16000ppm/ 4 hours LD 50 Mice: 5620 ppm/ 1 hour Human: 50 mg/ 24 hours: Mild Rabbit: 50 mg/ 24 hours: Mild Public literature indicates strong skin irritation Human skin sensitization has occurred to concentrated acetic acid Public literature indicates strong eye irritation Sodium acetate 127­ 09­ 3 LD 50 Rat: 3500 mg/ kg LD 50 Mouse: 4960 mg/ kg Not available Not available Not available Applied continuously for 3 hours to rabbit eyes at 0. 1 M: No disturbance of the cornea Page 9 of 16 Table 4b: Toxicological Profile: acetic acid and sodium acetate Chemical CAS No. Subchronic/ Chronic Toxicity Developmental/ Reproductive Toxicity Genetic Toxicity Other Relevant Information Acetic acid 64­ 19­ 7 0. 5% acetic acid in drinking water for 2­ 4 months reduced the food intake of rats (MRID no. 33062) Grastric lesions were noted in rats fed 4500 mg/ kg acetic acid for 30 days. (MRID No.. 33062) Apple cider vinegar (5% acetic acid) was administered to pregnant mice, rats, and rabbits up to 1600 mg/ kg from GD 6 15– mice and rats; GD 6 18– rabbits. No abnormalities were observed (MRID No.. 90747). Ames test (With and without activation; Strains TA100, TA1535, TA97, TA98, TA102; Zeiger et al, 1992): Negative NIOSH has estimated that 595,000 workers are potentially exposued to acetic acid in the US Detected in 2/ 12 human milk samples (Pellizzari et al, 1982) OSHA: 10 ppm per 8 hr duration. NIOSH: 10 ppm per 8 hr duration. 15 ppm per 15 min duration. 50 ppm considered `immediately dangerous to life or health' FDA: GRAS (maximum limits listed in 21CFR184.1005) Sodium acetate 127­ 09­ 3 Not available 1. In vitro studies suggest not teratogenic (ToxNet; MRID No. 33062) 2. Kavlock et al (1987). CD1 mice dosed via gavage at 1000 mg/ kg/ day from GD8­ 12. No adverse effects seen. Sister chromatid exchange: negative Negative: Ames test (With and without activiation Strains TA1535, TA1537, TA1538 and D4, MRID no. 33076) FDA­ affirmed GRAS: 21 CFR 184.1721 (not to exceed current good manufacturing practice) Page 10 of 16 Table 5a: Acute Toxicological Profile: citric acid and salts Chemical CAS No. Acute Oral LD 50 Acute Dermal LD 50 Acute Inhalation LD 50 Skin Irritation Eye irritation Citric acid 77­ 92­ 9 LD 50 (mouse) 5040 mg/ kg LDLo (rabbit) 7000 mg/ kg Not available Not available Rabbit: 500 mg/ 24 Hours: Miild Rabbit: 700 ug/ 24 Hours: Severe Calcium citrate 7693­ 13­ 2 Not available Not available Not available Not available Not available Potassium citrate 866­ 84­ 2 Sodium citrate 68­ 04­ 2 (anhydrous) 6132­ 04­ 3 (dihydrate) 6858­ 44­ 2 pentahydrate Not available Not available Not available Not available Not available Table 5b: Toxicological Profile: citric acid and salts Chemical CAS No. Subchronic/ Chronic Toxicity Developmental/ Reproductive Toxicity Genetic Toxicity Other Relevant Information Citric acid 77­ 92­ 9 Not available Not available Ames test (With and without activation; Strains TA100, TA97, TA98, TA104; Al­ Ani and Al­ Lami et al, 1988): Negative FDA­ affirmed GRAS: 21 CFR 184.1033 (no limitation) Chemical CAS No. Subchronic/ Chronic Toxicity Developmental/ Reproductive Toxicity Genetic Toxicity Other Relevant Information Page 11 of 16 Sodium citrate 68­ 04­ 2 (anhydrous) 6132­ 04­ 3 (dihydrate) 6858­ 44­ 2 (penta­ hydrate) Not available In vitro studies suggest not teratogenic Negative: Ames test (With and without activiation Strains TA97, TA102) FDA­ affirmed GRAS: 21 CFR 184.1751 (no limitation) Potassium citrate 866­ 84­ 2 Calcium citrate 7693­ 13­ 2 Not available Not available Ames test (With and without activation; Strains TA97, TA98TA102 TA104; Fujita et al, 1988): Negative FDA­ affirmed GRAS: 21 CFR 184.1195 (no limitation) (may be used in infant formula) Page 12 of 16 Table 6a: Acute Toxicological Profile: fumaric acid Chemical CAS No. Acute Oral LD 50 Acute Dermal LD 50 Acute Inhalation LD 50 Skin Irritation Eye irritation Fumaric acid 110­ 17­ 8 LD 50 Rat: 6800­ 10,700 mg/ kg LD 50 Mouse: 5000 mg/ kg LDLo Rabbit: 5000 mg/ kg Not available Not available Rabbit: 500 mg/ 24 Hours: Mild Rabbit: 100 mg/ 24 Hours: Moderate Table 6b: Toxicological Profile: fumaric acid Chemical CAS No. Subchronic/ Chronic Toxicity Developmental/ Reproductive Toxicity Genetic Toxicity Other Relevant Information Fumaric acid 110­ 17­ 8 1. Co­ administration with a naphthyridine derivative resulted in fewer stomach and lung tumors. 2. Co­ injection with aflatoxin B1 reduced nuclear degeneration of hepatocytes 3. Tumor inhibition study: 1% in mouse diet for 48WK following 88 WK of thioacetamide treatment. Reduced incidence In vitro studies suggest not teratogenic 1. Mouse lymphoma (with and without activation): Positive at 2856­ 8000 µg/ ml. 2. Ames test (With and without activiation; Strains TA97, TA98, TA100, TA102, TA1535) FDA: Direct and indirect food additive "At a level not in excess of the amount reasonably required to accomplish the intended effect." Page 13 of 16 6. FDA­ Sponsored Developmental Toxicity Studies These studies were performed by the Food and Drug Research Laboratories in the 1970's. They have not been reviewed by the Agency, but were reported in the HPV submission. Acetic Acid At the highest dose tested (1600 mg/ kg/ day) in the mouse, the rat, and the rabbit, there were no effects on nidation (fertilization), or on maternal or fetal survival. Malic Acid At the only dose tested (350 mg/ kg/ day) in the rat, there were no treatment­ related fetal or maternal toxic effects. No increases in fetal malformations were observed. At the only dose tested (266 mg/ kg/ day) in the mouse, there were no treatment­ related fetal or maternal toxic effects. No increases in fetal malformations were observed. Citric Acid At the only dose tested (241 mg/ kg/ day) in the rat, there was no indication of adverse effects on nidation, maternal, or fetal survival.. 7. Hazard Characterization: There is no available information on any of the chemicals considered in this document indicative of a hazard, significant adverse effects, to the general public or any population subgroup. These chemicals are naturally occurring and are part of human metabolic activity. 8. Type of risk assessment: qualitative 9. Sensitivity of Infants and Children: These chemicals have low toxic potential. In addition, humans of all ages are highly exposed to them from natural and anthropogenic sources. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 10. Fate and Ecotoxicity Assessment: Page 14 of 16 Acetic Acid and Salts Acetic acid and its salts undergo dissociation in aqueous media at pHs commonly found in the environment to the acetate anion and the respective cations. The toxicity of each compound is driven by the acetate anion with the cations paying a minor role. Data suggest that acetic acid and its salts are not persistent in the environment. The available ecotoxicity data indicate that these compounds are slightly to practically nontoxic on an acute basis. Citric Acid and Salts Similarly, citric acid and its salts also undergo dissociation in aqueous media in the environment to the citrate anion and the respective cations. The toxicity of each compound is driven by the citrate anion with the cations paying a minor role. The available information indicate that citric acid and its trisodium salt are readily biodegraded and modeling predicts that any citric acid released to the environment would partition to water. Therefore existing data indicates that citric acid and its salts would not be persistent in the environment. The available ecotoxicity data indicate that these compounds are practically nontoxic on an acute basis. Fumaric Acid Fumaric acid is highly soluble in water and has low volatility. Virtually all the fumaric acid released to the environment would partition to water. Complete biodegradation would take approximately 21 days. The available ecotoxicity data indicate that fumaric acid is slightly to practically non­ toxic on an acute basis. Malic Acid Malic acid is highly soluble in water and has a low volatility. It is considered to be readily biodegradable in soil and water. Modeling predicts that any citric acid released to the environment would partition to water. Existing data indicates that malic acid salts would not be persistent in the environment. Based on a limited amount of data and malic acid's structural similarities to the above chemicals, malic acid is likely to be practically non­ toxic on an acute basis. 11. Fate and Ecotoxicity Characterization Page 15 of 16 A review of the readily available information on the chemical substances discussed in this document is sufficient to conduct a qualitative assessment of the potential exposures and risks associated with their use as pesticide inert ingredients. Environmental loadings are attributable to natural (plants and animal materials) and anthropogenic (food additives, drugs, and related products) sources. Available data indicate that they rapidly dissociate in the aquatic environment at environmentally relevant pHs to the corresponding acid (anion) and its respective cation. Anions of the respective compounds undergo aerobically mediated mineralization in days to weeks; mineralization is complete degradation to CO2 and water. Mobility of the anions is expected to be high based on adsorption estimates, however, migration to ground water should be substantially mediated through their rapid biodegradation, volatilization, or through their uptake and utilization within plant cells. 12. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity." The citric acid cycle chemicals are structurally related; however, all are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these chemicals have a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. 13. IIFG Recommendations: By consensus there were no objections to the following: The following tolerance exemptions are reassessed: In 40 CFR 180.2 citric acid and fumaric acid. In 40 CFR 180.1001 (c) acetic acid, calcium citrate, citric acid, potassium citrate, and sodium acetate. In 40 CFR 180.1001 (d) sodium citrate. In 40 CFR 180.1001 (e) acetic acid, citric acid, and potassium citrate. The tolerance exemption for fumaric acid in 40 CFR 180.1001 (d) was inadvertently deleted and can be re­ established. Additionally, tolerance exemptions can be established for the potassium, calcium and magnesium salts of acetic acid and malic acid. The following List reclassifications are made: Acetic acid: Reclassified from List 4A to List 4B. Glacial acetic acid does not meet the criteria of Page 16 of 16 a List 4A. The original intent was to establish List 4A classification for Vinegar. Vinegar (maximum of 8% acetic acid in solution): List 4A Acetic acid: sodium, potassium, calcium, magnesium salts: List 4A Citric acid: List 4A, to harmonize with its use as FIFRA 25( b) active ingredient Citric acid: sodium, potassium, calcium, salts: List 4A Malic acid : List 4A, to harmonize with its use as FIFRA 25( b) active ingredient Fumaric acid: List 4A based on its similarities to malic and citric acid Attachment: EFED review (Abel; February 28, 2002)

epa

2024-06-07T20:31:44.160055

regulations

EPA-HQ-OPP-2002-0280-0008

Supporting & Related Material

Page 1 of 20 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Documents on Reassessing Exemptions from the Requirement of a Tolerance for the Mineral Acids (Hydrochloric, Carbonic, Phosphoric, and Sulfuric) and their Ammonium, Calcium, Ferrous, Ferric, Magnesium, Potassium, Sodium, and/ or Zinc Salts Collectively these Decision Documents cover four mineral acids and the salts of these acids. The individual Decision Documents are: (1) Hydrochloric Acid and Salts, (2) Salts of Carbonic Acid, (3) Phosphoric Acid and Salts, and (4) Sulfuric Acid and Salts. The Inert Ingredient Focus Group reassessment is based on various conclusions of the FAO/ WHO Joint Expert Committee on Food Additives, conclusions of various FDA GRAS (Generally Recognized As Safe) Assessments, information previously used by OPP as part of the reregistration process, and other information available on government websites. In total 46 exemptions from the requirement of a tolerance in 40 CFR 180 are reassessed. This total consists of 18 in the phosphoric acid document, nine in the hydrochloric acid document, six in the carbonic acid document, and 13 in the sulfuric acid document. Page 2 of 20 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Hydrochloric Acid and Salts Petition No.: no Tolerance Reassessments?: yes Chemical Category/ Group: mineral acid and salts The following describes the various ways that hydrochloric acid and its salts are used. Table 1: Use Pattern (pesticidal ­ inert ingredient) Chemical Name PC Code 40 CFR 180.1001 Inert Use Pattern (Pesticidal) Current Inert List hydrochloric acid 045901 845901 (c) solvent, neutralizer 3 ammonium chloride 900327 (c) intensifer, fire suppressant 4B calcium chloride 875605 (c), (e) stabilizer 4B ferric chloride 834901 (d) limitation of 2%, suspending, dispersing agent 4B magnesium chloride 013902 813902 (c) safener 4B potassium chloride 813904 (c) solid diluent, carrier 4B sodium chloride 800012 (c) solid diluent, carrier 4A There is also a tolerance exemption for sodium chloride in 40 CFR 180.2. Use Pattern: (pesticidal ­ active ingredient) At this time, only hydrochloric acid and magnesium chloride are used as active ingredients. Page 3 of 20 Hydrochloric acid is used as a disinfectant in 48 products. Many of these products are toilet bowl cleaners, with concentrations of hydrochloric acid ranging from 9.5 to 60%. However, potable human drinking water systems, meat and poultry processing plants, and hospitals are also use sites. Magnesium chloride is used as an herbicide at iceplants in only one product. There are no longer any EPA­ registered active ingredient uses for any of the other above­ listed chloride salts. Table 2: Use Pattern (FDA GRAS) Chemical GRAS Citation GRAS Uses hydrochloric acid 21 CFR 182.1057 neutralizing agent ammonium chloride 21 CFR 184.1138 dough strengthener, flavor enhancer, leavening agent, processing aid calcium chloride 21 CFR 184.1193 anticaking agent, antimicrobial agent, curing or pickling agent, firming agent, flavor enhancer, humectant, nutrient supplement, pH control agent, processing aid, stabilizer and thickener, surface­ active agent, synergist, texturizer ferric chloride 21 CFR 184.1297 flavoring agent magnesium chloride 21 CFR 184.1426 flavoring agent and adjuvant, nutrient supplement potassium chloride 21 CFR 184.1622 flavor enhancer, flavoring agent, nutrient supplement, pH control agent, stabilizer or thickener Ammonium chloride and calcium chloride also have uses in food contact surface sanitizing solutions under 21 CFR 178.1010. Page 4 of 20 Table 3: Use Pattern (non­ pesticidal): Chemical Uses hydrochloric acid in the production of chlorides; refining ore in the production of tin and tantalum; to neutralize basic systems; laboratory reagent; hydrolyzing of starch and proteins in the preparation of various food products; pickling and cleaning of metal products; as catalyst and solvent in organic synthesis; for oil­ and gas­ well treatment; in removing scale from boilers and heat­ exchange equipment; pharmaceutic aid (acidifier). ammonium chloride solutions for eye irrigation, fertilizer, dyeing, electroplating, safety explosives, lustering cotton, washing powders, electrolyte for dry cell batteries, soldering, metal and refinishing flux, galvanizing calcium chloride used for antifreeze and refrigerating solution, in fire extinguishers, to preserve wood and stone, ice manufacturing, glues, cements, fireproofing fabrics, automobile antifreeze mixtures, to melt ice and snow, as coagulant in rubber manufacturing, as size in admixture with starch paste, in concrete mixes to give quicker initial set and greater strength, freezeproofing of coal and ores, dust control on unpaved roads, sizing and finishing cotton fabrics, as brine for filling inflatable tires on tractors to increase traction. ferric chloride treatment of sewage and industrial wastes; etching agent for engraving, photography, and printed circuitry; condensation catalyst in Friedel­ crafts reactions; mordant; oxidizing, chlorinating, and condensing agent; disinfectant; pigment; feed additive; water purification. magnesium chloride source of magnesium metal, chemical intermediate for magnesium oxychloride for cement, catalyst, flocculating agent, agent in fire extinguishers, agent in textile and paper manufacturing, component for ceramics, fireproofing agent for wood, component of refrigerating brines potassium chloride fertilizer component (primary plant nutrient); chemical intermediate in production of other potassium salts; photography; medical uses both orally and intravenously for treating potassium depletion states; dietary supplement. sodium chloride In the production of chemicals (sodium hydroxide, soda ash, hydrogen chloride, chlorine, metallic sodium), ceramic glazes, metallurgy, curing hides, food preservative, food seasoning, mineral waters, soap manufacture (salting out), home water softeners, highway deicing, regeneration of ion­ exchange resins, photography, herbicide, fire extinguishing, nuclear reactors, mouthwash, medicine (heat exhaustion ­ intravenous solutions for fluid replacement), saline solutions for eye washes and contact lens solutions, salting out dyestuffs, supercooled solutions. It should be noted that ammonium chloride and potassium chloride have uses as fertilizers. Plants need various elements (metals and non­ metals) for proper growth. Especially for agricultural crops, plants are supplied these elements as part of chemical fertilizers. The most important elements for plant growth are nitrogen, phosphorus, and potassium. Other metals needed in the soil for plant up­ take are calcium, magnesium, iron, and trace elements such as zinc. Both potassium chloride and ammonium chloride are intentionally added to growing agricultural crops as needed to promote plant growth. Page 5 of 20 Page 6 of 20 Assessment of Hydrochloric Acid and its Salts Hydrochloric acid and its ammonium, sodium, potassium, calcium, magnesium, and iron salts are being assessed as a group due to their chemical similarities. Due to its acidic nature the toxicity of hydrochloric acid will be different from those of the more neutral chloride salts. However, the chloride salts all contain the chloride ion and thus share some common chemistries. A major focus of this assessment is the work previously performed by FDA in assessing the safety of these chemicals as food additives. 1. Physical/ Chemical Properties: The physical and chemical properties of hydrochloric acid and its various salts are described in the May 7, 2002 EFED Assessment. See attached. 2. Information Sources: The following information was used in performing this assessment. The available information consisted of information retrieved from various websites, such as: °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng1184.html), (www. cdc. gov/ niosh/ ipcsneng/ neng1051.html), (www. cdc. gov/ niosh/ ipcsneng/ neng0764.html), (www. cdc. gov/ niosh/ npg/ npgd0229.html), and (www. cdc. gov/ niosh/ npg/ npgd0346.html) ° TOXNET ( www. toxnet. nlm. nih. gov.), °WHO( www. inchem. org/ documents/ jecfa/ jecmono/ v05je83.htm) and (www. inchem. org/ documents/ jecfa/ jecmono/ 40abcj43.htm) Various FDA GRAS Assessments were used, as well as, the FAO/ WHO Assessments. 3. NIOSH (National Institute for Occupational Safety and Health) The NIOSH Pocket Guide for hydrogen chloride indicates that hydrogen chloride is a colorless to slightly yellow gas with a pungent, irritating odor. It is nonflammable. Additional information on the NIOSH web­ site included the Occupational Health Guideline for Hydrogen Chloride. Hydrogen chloride gas irritates the eyes, mucous membranes, and skin. The current OSHA standard for hydrogen chloride is a ceiling of 7 mg/ m 3 . Ingestion of hydrochloric acid can cause severe burns of the mucous membranes of the mouth, esophagus, and stomach. The NIOSH International Chemical Safety Cards for magnesium and calcium chloride indicate that TLVs (Threshold Limit Values) have not been established. Both chemicals can irritate the skin and the respiratory tract, and when dissolved in water liberate a considerable amount of heat. Page 7 of 20 According the International Chemical Safety Card for ammonium chloride, the substance irritates the eyes, the skin and the respiratory tract. The TLV is established only for the fume. The NIOSH International Chemical Safety Cards for iron salts (soluble, as Fe) which includes ferric chloride indicates an exposure limit of 1 mg/ m 3 (time weighted average). 4. Acid Characteristics An acid is a substance that when dissolved in water yields H + ions. The increase of the concentration of the H + ions lowers the pH. Mineral acids contain a non­ metal such as phosphorus, nitrogen, sulfur, or chlorine which may or may not be combined with oxygen. When combined with oxygen, these anions can be referred to as oxyanions. Strong acids are those acids that when dissolved completely transfer their H + ions to water. Hydrochloric acid is an example of a strong acid. 5. Cations: Sodium, Potassium, Calcium, Magnesium, and Iron Generally, a salt of a strong acid, such as hydrochloric acid, when dissolved in water dissociates to yield the chloride ion (an anion, which is negatively charged) and a positively charged cation. In the human body, these salts tend to dissociate and thus, for the most part, react in the body as the anion and the cation. Metals such as calcium, sodium, magnesium, potassium, and iron are also required for proper functioning of human biological systems. For risk assessment purposes an important feature of these metals is that overall the body does have an effective means of processing them. The primary means of exposure to these cations is ingestion. Four of the most common cations required for functioning of human biology are: sodium, potassium, calcium and magnesium. Chemically, sodium and potassium belong to the same chemical family: calcium and magnesium belong to a different chemical family. Sodium: The average human body burden of sodium is approximately 20 grams (g) for a 70 kilogram (kg) adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Dietary Allowance (RDA) for sodium. Potassium: The average human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, Page 8 of 20 maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day. Calcium: The average human body burden of calcium is approximately 1 kg for a 70 kg adult; or 1/ 70th of our weight is calcium. The calcium cation is necessary for bone and teeth formation. It is also important for the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the maintenance of cell membranes. The RDAs for calcium are 1000 mg/ day for adults aged 19 to 50 years and 1200 mg/ day for individuals older than 50 years. Magnesium: The average human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA for magnesium is 310 to 320 mg/ day for adult females and 400 to 420 mg/ day for adult males with the RDA increasing with increasing age. Iron: Another common metal cation that is needed for functioning of human biology, but in smaller amounts often referred to as trace, is iron. The human body burden of iron is approximately 4.1 g for a 70 kg adult. Iron functions as a carrier of oxygen. The hemoglobin molecule in blood transports oxygen from the lungs to the cells. The myoglobin molecule supplies oxygen to muscle cells. Iron deficiency is characterized by anemia, stunted growth, fatigue, and lowered resistance to infection. The RDAs for iron are 10 mg/ day [0.14 mg/ kg/ day for an adult (70 kg) male (25 to 50 years)] and 15 mg/ day [0. 25 for an adult (60 kg) female (19 to 50 years)]. Pregnant and nursing woman have increased requirements for iron. Dietary iron is poorly absorbed. The intestinal mucosa is a limiting factor in iron absorption. Normal absorption is about 1 mg/ day in an adult male, and about 1.4 mg/ day in an adult female. Absorption occurs in the divalent (ferrous) form, which must then be oxidized to the trivalent (ferric) form for use. Acute toxicity of iron ingested from normal dietary sources has not been reported. However, death especially in young children has resulted from ingestion of large overdoses of medicinal iron. (doses ranging from 40 to 1600 mg/ kg ­ average 900 mg/ kg). It is noted that the iron from ferric salts is less well absorbed than that from ferrous salts. 6. Ammonium Salt: Ammonium chloride dissociates to the chloride anion and the positively charged ammonium cation (NH4 + ). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen (NH4 + )hasto Page 9 of 20 enter the body from an outside source. These sources are the nitrogen­ containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered "essential" amino acids, i. e., they must be consumed in the diet. Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine. Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According to FDA in the "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), "the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day. Page 10 of 20 7. Toxicological Profile Table With the exception of the information in IRIS (Integrated Risk Information System), the Agency has not reviewed any of the toxicological studies in the following table for hydrochloric acid or any of its salts. The reviews of these studies were obtained from Toxnet, as well as other government websites. Table 4: Toxicological Profile Chemical Toxicity Other Information Hydrochloric Acid Severely corrosive by all routes as 1N solution; IRIS RfC = 2 x 2 ­2 mg/ m 3 based on hyperplasia of nasal mucosa, larynx and trachea in rat chronic inhalation study; LOAEL = 15 mg/ m 3 (10ppm); Chemical has no systemic toxicity associated with exposure except the acute effects of corrosion/ irritation depending upon the pH of the solution. CERCLA Reportable Quantity: greater than 10 lb (4. 54 kg); Hazardous Air Pollutant (HAP) chemical; 1995 production 7. 33 billion lbs; Ammonium Chloride Mild skin and respiratory system irritant; Dust irritating to eyes; Ingestion of 40 to 50 g over a short period would be expected to exhaust available body buffers of the average adult and produce potentially fatal acidosis. Mild acidosis occurs at a dose of 2 g; One sixth molar ammonium chloride was given to mice orally in the drinking water after day 7 during pregnancy and although the offspring were small sized no congenital defects were found; Absorbed almost 100% in the gastrointestinal tract CERCLA Reportable Quantity: greater than 5000 lb (2270 kg); Page 11 of 20 Magnesium Chloride Rat oral LD50 = 2800 mg/ kg; signs: convulsions, changes in respiration and cardiac function; Drug use as electrolyte replenisher in hemadialysis and peritoneal dialysis fluid; Cathartic; 90­ day study in rats with magnesium chloride hexahydrate doses 0, 0. 1, 0. 5, 2. 5% in diet ­NOAEL = 2. 5% (highest dose tested (HDT)); Developmental study in rats with magnesium chloride hexahydrate ­doses: 0, 200, 400, 800mg/ kg/ day NOAEL= 800mg/ kg/ day (HDT); Carcinogenicity study in mice with magnesium chloride hexahydrate ­doses 0, 0.5, 2% in diet for 96 wks– not carcinogenic Deliquescent US production 1972 8.6 x 10 11 grams Calcium Chloride Rat oral LD50 = 1000 mg/ kg; Mouse LD50 = 1940 mg/ kg; Anhydrous form irritating to skin, eyes and mucus membranes Hygroscopic; Liberates heat during water absorption and on dissolution; US production 1993 1.4 billion lbs Ferric Chloride Rat oral LD50 = 0. 5­ 5 g/ kg added to bottled water; Skin, eye and mucous membrane irritant; Carcinogenicity study in rats at doses of 0, 0. 25, 0. 5% in drinking water was negative; Excess ingestion of iron produces liver toxicity; Acute ingestion of 0. 5 g of iron produces severe toxicity Hygroscopic; CERCLA Reportable Quantity: greater than 100 lb (45. 4 kg); US production 1. 2 x 10 11 grams; iron drinking water guideline 300 ug/ L Page 12 of 20 Potassium Chloride Rat oral LD50 = 2600 ­ 3020 mg/ kg; Mild eye irritation for rabbits; Irritating to skin and mucous membranes; Commercial dietary salt substitute; US production 1980 = 3 x 10 12 grams; OSHA PEL = 15 mg/ m 3 , 5 mg/ m 3 for respirable particles Sodium Chloride Skin, eye and mucous membrane irritant; Affects blood pressure in humans; Average daily intake of US citizens 10­ 12 g/ day with 3 g occurringnaturally,3 g added incooking, 4­6 g inprocessed foods Common table salt, sea salt Page 13 of 20 8. OPP REDs (Reregistration Eligibility Decision Document) Mineral Acid RED The following information on the acute toxicity of hydrochloric acid was in the 1993 RED: The oral LD50 is 1000 mg/ kg, toxicity category III. The dermal LD50 is > 2000 mg/ kg, toxicity category III. Hydrochloric acid is toxicity category I for eye and dermal irritation. No other toxicological data were required based on the use patterns at the time of the RED and the corrosiveness shown in the acute studies for dermal and eye irritation. Inorganic Halide RED This 1993 RED included sodium chloride. The oral LD50 (rat) is 3000 mg/ kg, toxicity category III. Sodium chloride was classified as moderate, toxicity category III for eye irritation, and mild, toxicity category IV for skin irritation. Because of its abundance in the environment and low toxicity to humans, no additional toxicity data were required. 9. FDA GRAS (Generally Recognized As Safe) Assessments Hydrochloric Acid The FDA Assessment is titled "Evaluation of the Health Aspects of Hydrochloric Acid as a Food Ingredient" (1979). Hydrochloric acid has a variety of FDA approvals for food additive use. "Food stuffs to which hydrochloric acid has been added expose consumers predominantly to chloride ions and other chemical products resulting from its reaction to chloride ions and other chemical products resulting from its reaction with neutralizing agents or chemicals in the food. Free hydrochloric acid would be expected to be present in only minute amounts, if at all." The human stomach normally contains sufficient hydrochloric acid to maintain the pH of gastric juice at 1.5 to 2. 5. The introduction of any hydrochloric acid into the stomach proportionally depresses the secretion of the acid by the stomach. According to FDA: "Hydrochloric acid in concentrated form is a strongly corrosive agent and the consequences of exposure to it are well­ known. However, as it is used in food processing, or as a food additive to adjust the pH, hydrochloric acid is neutralized or buffered by the food to which it is added. Thus, human consumption is not of the acid, but of the chloride ion in the salts formed in the neutralization process..... There is no evidence in the available information on hydrochloric acid that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current or that might reasonably be expected Page 14 of 20 in the future." Ammonium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974). "Ammonia and ammonium ion are integral components of normal metabolic processes and play an essential role in the physiology of man. Although there have been no significant feeding studies specifically designed to ascertain the safety threshold of ammonium compounds as food ingredients, numerous metabolic studies have been reported in the scientific literature. Extrapolation of these findings to the concentrations of ammonium compounds normally present in foods does not suggest that there would be untoward effects at such levels." Calcium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Certain Calcium Salts as Food Ingredients" (1975). The estimated per capita daily intake of calcium chloride is 160 mg. Both the calcium and the chloride are common constituents of food and are metabolized by the normal metabolic processes in humans. Magnesium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Magnesium Salts as Food Ingredients" (1976). Magnesium is (1) a dietary essential, (2) involved in many metabolic reactions, (3) important in electrolyte balance, and (4) present in fruits, vegetables, grains, milk, meat and fish. No chronic toxicity data were available. The "status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient." The conclusion was reached that there was no available information on magnesium chloride to demonstrate, or suggest "reasonable grounds to suspect, a hazard to the public when ... used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future." Potassium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Sodium Chloride and Potassium Chloride as Food Ingredients" (1979). The concentration of potassium in blood serum is maintained normally between 3. 5 and 5 meq/ L. "The available evidence indicates that in normal individuals potassium chloride is well tolerated, and that metabolism quickly and efficiently adjusts potassium in the Page 15 of 20 body to narrow homeostatic levels. Certain health conditions are known to affect the normal homeostatic control of sodium and potassium in the body to narrow homeostatic levels. Certain health conditions are known to affect the normal homeostatic control of sodium and potassium metabolism, and patients with these conditions must adjust their diets to avoid proscribed electrolyte intakes. Water intake, efficiency of the kidney, and the ratio of sodium to potassium in the diet are interrelated factors that must be evaluated in considering the health aspects of changing the relative intakes of sodium chloride and potassium chloride." It was concluded: "There is no evidence in the available information on potassium chloride that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current or that might reasonably be expected in the future." Sodium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Sodium Chloride and Potassium Chloride as Food Ingredients" (1979). Sodium chloride, commonly known as table salt, occurs abundantly in nature, in sea water and mineral springs, and in large underground deposits. The mineral form is called halite. It is a food ingredient and has historically been considered an essential part of the diet. The body must have some sodium. The human body has a homoeostatic control to maintain the proper balance of sodium, potassium. and chlorine in the human body. The concentration of sodium in blood serum is maintained normally between 136 to 145 meq/ L. That of chlorine is 96 to 106 meq/ L. The American diet is considered to contain an abundance of salt which if consumed in excess, may have adverse health consequences. In fact, treatment of certain diseases such as hypertension can require restriction of salt intake. Acute and chronic toxic effects, including death, can occur when salt is ingested in excessive amounts. There is no daily requirement for salt, as it would be a level highly dependent all dietary sources, the level of potassium and the sodium to potassium ratio in the diet, and health conditions such as sweating. The Assessment considers that the consumption of sodium chloride in the aggregate should be lowered in the United States. The Assessment concluded: "The evidence on sodium chloride is insufficient to determine that the adverse effects reported are not deleterious to the health of a significant proportion of the public when it is used at levels that are now current and in the manner now practiced." 10. FAO/ WHO Expert Committee on Food Additives Page 16 of 20 WHO has performed two assessments: hydrochloric acid in 1966 and calcium acetate, chloride, gluconate, and sulfate in 1973. Both assessments discussed that from a toxicological point of view, there were no concerns for the chloride ion. It was considered to be naturally­ occurring and a normal participant of animal and human metabolism. 11. Human Health Hazard Characterization: Hydrochloric acid in its concentrated form is highly corrosive. Due to this property toxicity testing can only be performed on dilute concentrations or on neutralized forms of the acid such as a salt. The consequences of acute exposure to hydrochloric acid are well­ understood. Dermal exposure can lead to burns. Exposure to the gas can cause severe irritation of the upper respiratory tract. Exposure to hydrochloric acid in pesticide products as an inert ingredient would be in the role of a pH adjuster. This is indicative of the use of small amounts of hydrochloric acid that are incorporated in a pesticide product to lower the pH . After the pH adjustment is performed, the hydrochloric acid would be neutralized. As an active ingredient hydrochloric acid is subject to FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) registration requirements and various labeling language as specified in the RED. Hydrochloric acid, whether used as an inert or an active ingredient, must be used and applied according to good manufacturing or good agricultural practices. However, there are no significant adverse effects, to the general public or any population subgroup from consumption of residues of hydrochloric acid resulting from pesticide product uses. As a group salts of hydrochloric acid constitute a group of chemicals with many uses including direct use in the food supply. In particular sodium chloride, common table salt, can be purchased and used by the public in the amounts specifically chosen for their individual wants and desires. According to the information available to the Agency, sodium chloride used in food processing results in consumption of 4 to 6 grams of sodium chloride in the average diet per day. The average individual adds up to another 3 grams of sodium chloride during cooking and at the table. The available toxicity data indicates that the human body metabolizes chloride, ammonium, calcium, iron, magnesium, potassium, and sodium ions through well­ understood pathways. In fact, all are necessary human nutrients. Various salts of hydrochloric acid have been used in the food supply for a number of years. There are no available data to indicate any significant adverse effects to the general public or any population subgroup from consumption of residues of the ammonium, calcium, iron, magnesium, potassium, and sodium salts of hydrochloric acid resulting from pesticide product uses. Page 17 of 20 Given the long history of safe use, the available toxicity data, an understanding of the human body's ability to metabolize these chemicals, and the evaluations by FDA and WHO, the IIFG believes that ammonium, sodium, potassium, magnesium, calcium and iron chloride are of low oral toxicity. 12. Type of Risk Assessment/ Risk Characterization: The toxicity of these chemicals derives from the irritation and caustic effects; therefore, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate. Given the widespread occurrence of hydrochloric acid and its ammonium, calcium, iron, magnesium, potassium, and sodium salts in the existing food supply, the amounts that may be present in food as a result of the use of these chemicals in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. There is no available information on any of the salts of hydrochloric acid considered in this document indicative of a human health hazard resulting from the EPA­ regulated uses as well as the FDA GRAS uses to the general public or any population subgroup. No additional information are needed to assess the safety of hydrochloric acid and its salts. 13. Sensitivity of Infants and Children: Due to its acidic nature, its corrosive potential, there is high acute toxicity for hydrochloric acid. Hydrochloric acid must be used in pesticide products according to good manufacturing or good agricultural practices. The ammonium, calcium, iron, magnesium, potassium, and sodium salts of hydrochloric acid have low toxic potential. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 14. Environmental Fate and Ecotoxicity Assessment/ Characterization: In general, the constituents of the mineral acids, such as hydrochloric acid, are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients. Hydrochloric acid is a strong acid. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pHs range from Page 18 of 20 5 to 9. EPA's Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater. At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. Hydrochloric acid is not expected to be persistent in the environment. Instead it is expected to dissociate, react with organic or inorganic materials, and complex with ionic substrates. Hydrochloric acid salts dissociate in water resulting in a positively charged (cationic) metal in solution. Dissociation is frequently dependent on pH, with lower (more acidic) pHs resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals varies with the species of metal and its concentration. EPA's freshwater water quality criteria for iron is 1 ppm implying relatively low toxicity. Metals do not degrade and thus are permanent in the environment. They are likely to dissipate by being sequestered in soil, sediment, and plants. 15. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide chemical's residues and "other substances that have a common mechanism of toxicity." The chemicals considered in this document are structurally related; however, all of the salts are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these pesticide chemicals have a common mechanism of toxicity with other substances or how to include these pesticide chemicals in a cumulative risk assessment. 16. Determination of Safety: Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of hydrochloric acid and its ammonium, sodium, potassium, calcium, magnesium, and iron salts. Therefore, the following exemptions from the requirement of a tolerance are reassessed: In 40 CFR 180.2 sodium chloride. In 40 CFR 180.1001 (c) ammonium chloride, calcium chloride, hydrochloric acid, magnesium chloride, potassium chloride, and sodium chloride. In 40 CFR 180.1001 (d) ferric chloride. In 40 CFR 180.1001 (e) calcium chloride. 17. List Reclassifications: The following List reclassifications are made or confirmed: Hydrochloric acid: List 4B. With the restriction of use as a solvent, pH adjuster, neutralizing agent. Ammonium chloride: List 4B Page 19 of 20 Calcium chloride: List 4B Ferric chloride: List 4B, current limitation remains in place. Magnesium chloride: List 4B Potassium chloride: List 4A considering its use as a salt substitute Sodium chloride: List 4A considering its use as common table salt The following table lists the various chemical names, CAS Reg. No., and CAS Index Names that will be used for listing in 40 CFR. 180. Note that both the anhydrous and the hydrated forms are included. The Agency sees no reason to distinguish between these chemicals given that the only difference is the attachment of the water molecules. Chemical Name CAS Reg. No. Chemical Abstracts Index Name Hydrochloric acid 7647­ 01­ 0 Hydrochloric acid (6CI, 7CI, 8CI, 9CI) Ammonium chloride 12125­ 02­ 9 Ammonium chloride (( NH4) Cl) (9CI) Calcium chloride 10043­ 52­ 4 Calcium chloride (CaCl2) (9CI) Calcium chloride hydrate (CaCl2. 1/ 3H2O) 56073­ 24­ 6 Calcium chloride (CaCl2), hydrate (3: 1) (9CI) Calcium chloride, hydrate (8CI) 22691­ 02­ 7 Calcium chloride (CaCl2), hydrate (9CI) Calcium chloride dihydrate 10035­ 04­ 8 Calcium chloride (CaCl2), dihydrate (9CI) Calcium chloride hexahydrate 7774­ 34­ 7 Calcium chloride (CaCl2), hexahydrate (9CI) Calcium chloride monohydrate 13477­ 29­ 7 Calcium chloride (CaCl2), monohydrate (9CI) Ferric chloride 7705­ 08­ 0 Iron chloride (FeCl3) (8CI, 9CI) Ferric chloride monohydrate 60684­ 13­ 1 Iron chloride (FeCl3), monohydrate (9CI) Ferric chloride dihydrate 54862­ 84­ 9 Iron chloride (FeCl3), dihydrate (9CI) Iron III chloride hexahydrate 10025­ 77­ 1 Iron chloride (FeCl3), hexahydrate Ferric chloride dodecahydrate 58694­ 80­ 7 Iron chloride (FeCl3), dodecahydrate (9CI) Ferric chloride nonahydrate 58694­ 79­ 4 Iron chloride (FeCl3), nonahydrate (9CI) Ferric chloride sesquihydrate 115321­ 78­ 3 Iron chloride (FeCl3), hydrate (2: 3) (9CI) Ferric chloride trihydrate 58694­ 75­ 0 Iron chloride (FeCl3), trihydrate (9CI) Magnesium chloride 7786­ 30­ 3 Magnesium chloride (MgCl2) (9CI) Magnesium chloride hexahydrate 7791­ 18­ 6 Magnesium chloride (MgCl2), hexahydrate (9CI) Potassium chloride 7447­ 40­ 7 Potassium chloride (KCl) (9CI) Page 20 of 20 Sodium chloride 7647­ 14­ 5 Sodium chloride (NaCl) (9CI) Attachment: EFED Review of Mineral Acids (Birchfield; May 7, 2002)

epa

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EPA-HQ-OPP-2002-0280-0009

Supporting & Related Material

Page 1 of 19 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Documents on Reassessing Exemptions from the Requirement of a Tolerance for the Mineral Acids (Hydrochloric, Carbonic, Phosphoric, and Sulfuric) and their Ammonium, Calcium, Ferrous, Ferric, Magnesium, Potassium, Sodium, and/ or Zinc Salts Collectively these Decision Documents cover four mineral acids and the salts of these acids. The individual Decision Documents are: (1) Hydrochloric Acid and Salts, (2) Salts of Carbonic Acid, (3) Phosphoric Acid and Salts, and (4) Sulfuric Acid and Salts. The Inert Ingredient Focus Group reassessment is based on various conclusions of the FAO/ WHO Joint Expert Committee on Food Additives, conclusions of various FDA GRAS (Generally Recognized As Safe) Assessments, information previously used by OPP as part of the reregistration process, and other information available on government websites. In total 46 exemptions from the requirement of a tolerance in 40 CFR 180 are reassessed. This total consists of 18 in the phosphoric acid document, nine in the hydrochloric acid document, six in the carbonic acid document, and 13 in the sulfuric acid document. Page 2 of 19 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Sulfuric Acid and Salts Petition No.: no Tolerance Reassessments?: yes Chemical Category/ Group: mineral acid and salts The following describes the various ways that sulfuric acid and its salts are used. Table 1: Use Pattern (pesticidal ­ inert ingredient) Chemical Name Inert PC Code 40 CFR 180.1001 Inert Use Pattern (Pesticidal) Current Inert List sulfuric acid 878001 (c) 0. 1% of pesticide formulation; pH control agent 3 ammonium sulfate 805601 (c) solid diluent, carrier 4B ferric sulfate 900332 (c) solid diluent, carrier 4B magnesium sulfate 850503 (c) solid diluent, carrier safener 4B potassium sulfate 805603 (c) solid diluent, carrier 4B sodium sulfate 805604 (c), (e) solid diluent, carrier 4B sodium bisulfate 873201 (d) acidifying/ buffering agent 4B zinc sulfate (basic and monohydrate) 889001 911567 (c), (c), (e) coating agent solid diluent, carrier water repellent, dessicant 3 There is also a tolerance exemption for ferrous sulfate in 40 CFR 180.2. The tolerance exemption for calcium sulfate (40 CFR 180.1001( e)) was reassessed in the IIFG Decision Document "Weathered Materials", dated January 31, 2002. It is classified as List Page 3 of 19 4A. At this time, only sulfuric acid, ferrous sulfate monohydrate, ferric sulfate, sodium bisulfate, and zinc sulfate are used as active ingredients. There are no longer any EPA­ registered active ingredient uses for any of the other above­ listed sulfate salts. Table 2: Use Pattern (pesticidal ­ active ingredient) Chemical Name. Active PC Code 40 CFR Number of Products Active Use Pattern (Pesticidal) sulfuric acid 078001 180.1019 8 used to kill bacteria on potatoes, milking equipment and in food processing areas; as a dessicant ferrous sulfate monohydrate 180.2 15 used to kill moss and algae on ornamentals and turf ferric sulfate 034902 none 2 used to kill moss on ornamental lawns and turf sodium bisulfate 073201 none 3 used to kill bacteria on poultry , in toilet bowls, and in air treatment zinc sulfate monohydrate 527200 none 2 used to kill moss on wood and other surfaces Table 3: Use Pattern (FDA GRAS): Chemical GRAS Citation GRAS Uses sulfuric acid 21 CFR 184.1095 pH control agent, processing aid ammonium sulfate 21 CFR 184.1143 dough strengthener, firming agent, processing aid ferrous sulfate 21 CFR 184.1315 nutrient supplements, processing aid, use in infant formula ferric sulfate 21 CFR 184.1307 flavoring agent magnesium sulfate 21 CFR 184.1443 flavor enhancer, nutrient supplement, processing aid Page 4 of 19 potassium sulfate 21 CFR 184.1643 flavoring agent and adjuvant zinc sulfate 21 CFR 182.8997 (no limitations specified) Sulfuric acid also has uses in food contact surface sanitizing solutions under 21 CFR 178.1010. Table 4: Use Pattern (non­ pesticidal) Chemical Uses sulfuric acid used in fertilizers, chemicals, dyes and pigments, etchant, alkylation catalyst, electroplating baths, iron and steel, rayon and film, industrial explosives, lab reagent, nonferrous metallurgy ammonium sulfate manufacture of ammonia alum; in the manufacture of hydrogen sulfide to free it from nitrogen oxides; analytical uses; freezing mixtures; flameproofing fabrics and paper; manufacture of viscose silk; tanning, galvanizing iron; in fractionation of proteins. ferric sulfate preparation of iron alums, other iron salts and pigments; coagulant in water purification and sewage treatment; aluminum etching; pickling stainless steel and copper; as mordant in textile dyeing and calico printing; soil conditioners; polymerization catalyst. magnesium sulfate also known as epsom salts; as a cathartic and analgesic in medicine; finishing agent for textiles; as water­ correcting agent in brewing industry; component of fireproofing compositions, preservatives, tanning & coagulating agents; chemical intermediate for magnesium trisilicate; component of nickel baths for plating other metals; catalyst support for platinum in sulfuric acid production potassium sulfate fertilizer for chloride­ sensitive crops (tobacco); accelerator in wallboard (construction industry); agent in manufacture of glass; cathartic in human medicine; water­ corrective agent for foods (brewery water); setting­ expansion control agent for dental materials sodium sulfate tanning; pharmaceuticals; freezing mixtures; laboratory reagent zinc sulfate zinc sulfate & hydrated lime, 8 lb of each to 100 gal of water, are used to prepare spray called zinc­ lime which is the zinc equivalent of bordeaux mixt. Zinc­ lime is used extensively for control of bacterial spot disease of peaches. depressant in froth flotation, eg, for lead­ zinc ores; component of spinning bath in manufacturer of rayon; chemical intermediate for manufacture of lithopone (pigment), carbamate fungicides (zineb), zinc metal, other zinc compounds (zinc stearate); component of zinc plating baths; chemical for water treatment; component of cosmetics (skin fresheners); reagent for paper bleaching; in manufacter of glue; accelerating agent in dental impression material; agent in textile dyeing and printing; preservative for wood and hides; fireproofing agent It should be noted that potassium sulfate has use as a fertilizer and sulfuric acid is used in the preparation of fertilizers. Plants need various elements (metals and non­ metals) for proper growth. Especially for agricultural crops, plants are supplied these elements as part of chemical Page 5 of 19 fertilizers. The most important elements for plant growth are nitrogen, phosphorus, and potassium. Other metals needed in the soil for plant up­ take are calcium, magnesium, iron, and trace elements such as zinc. Potassium sulfate is intentionally added to growing agricultural crops as needed to promote plant growth. Assessment of Sulfuric Acid and its Salts Sulfuric acid and its ammonium, sodium, potassium, calcium, magnesium, iron, and zinc salts are being assessed as a group due to their chemical similarities. Due to its acidic nature the toxicity of sulfuric acid will be different from those of the more neutral sulfate salts. However, these sulfate salts all contain the sulfate ion (as either HSO4 ­1 or SO4 ­2 ), and thus share some common chemistries. A major focus of this assessment is the work previously performed by FDA in assessing the safety of these chemicals as food additives. 1. Physical/ Chemical Properties: The physical and chemical properties of sulfuric acid and its various salts are described in the May 7, 2002 EFED Assessment. See attached. 2. Information Sources: The following information was used in performing this assessment: The available information consisted of information retrieved from various websites, such as, °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng1197.html), (www. cdc. gov/ niosh/ ipcsneng/ neng0362.html), (www. cdc. gov/ niosh/ 74­ 128.html) (www. cdc. gov/ niosh/ idlh/ 7664939.html) ° TOXNET ( www. toxnet. nlm. nih. gov.) ° NTP (ntp­ server. niehs. nih. gov/ NewHomeRoc/ 9RoCFacts. html) °WHO( www. inchem. org/ documents/ jecfa/ jecmono/ v05je83.htm) and (www. inchem. org/ documents/ jecfa/ jecmono/ 40abcj43.htm) Various FDA GRAS Assessments were used, as well as, the FAO/ WHO Assessment for sodium sulfate. 3. NIOSH (National Institute for Occupational Safety and Health) The NIOSH IDHL (immediately dangerous to life or health) Documentation and the International Chemical Safety Card for sulfuric acid indicate that it is a colorless, oily, odorless liquid. The IDHL is 15 mg/ m 3 . The TLV (Threshold Limit Value) is 1 mg/ m 3 (TWA). Sulfuric Page 6 of 19 acid reacts violently with water. It is corrosive to the skin and the respiratory tract, and on ingestion. The NIOSH International Chemical Safety Card for magnesium sulfate indicates that a TLV has not been established. No effects were noted. 4. Acid Characteristics An acid is a substance that when dissolved in water yields H + ions. The increase of the concentration of the H + ions lowers the pH. Mineral acids contain a non­ metal such as phosphorus, nitrogen, sulfur, or chlorine which may or may not be combined with oxygen. When combined with oxygen, these anions can be referred to as oxyanions. Strong acids are those acids that when dissolved completely transfer their H + ions to water. Sulfuric acid is an example of a strong acid. 5. Cations: Sodium, Potassium, Calcium, Magnesium, Iron, and Zinc Generally, a salt of a strong acid, such as sulfuric acid, when dissolved in water, dissociates to yield the sulfate anion (an anion which is negatively charged) and a positively charged cation. In the human body, these salts tend to dissociate and thus, for the most part, react in the body as the anion and the cation. Metals such as calcium, sodium, magnesium, potassium, iron and zinc are required for proper functioning of human biological systems. For risk assessment purposes an important feature of these metals is that overall the body does have an effective means of processing them. The primary means of exposure to these cations is ingestion. Four of the most common cations required for functioning of human biology are: sodium, potassium, calcium and magnesium. Chemically, sodium and potassium belong to the same chemical family: calcium and magnesium belong to a different chemical family. Sodium: The average human body burden of sodium is approximately 20 grams (g) for a 70 kilogram (kg) adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Dietary Allowance (RDA) for sodium. Potassium: The average human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the Page 7 of 19 electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day. Calcium: The average human body burden of calcium is approximately 1 kg for a 70 kg adult; or 1/ 70th of our weight is calcium. The calcium cation is necessary for bone and teeth formation. It is also important to the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the maintenance of cell membranes. The RDAs for calcium are 1000 mg/ day for adults aged 19 to 50 years and 1200 mg/ day for individuals older than 50 years. Magnesium: The average human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA for magnesium is 310 to 320 mg/ day for adult females and 400 to 420 mg/ day for adult males with the RDA increasing with increasing age. Two common metal cations that are needed for functioning of human biology, but in smaller amounts often referred to as trace, are iron and zinc. Iron: The human body burden of iron is approximately 4.1 g for a 70 kg adult. Iron functions as a carrier of oxygen. The hemoglobin molecule in blood transports oxygen from the lungs to the cells. The myoglobin molecule supplies oxygen to muscle cells. Iron deficiency is characterized by anemia, stunted growth, fatigue, and lowered resistance to infection. The RDAs for iron are 10 mg/ day [0. 14 mg/ kg/ day for an adult (70 kg) male (25 to 50 years)] and 15 mg/ day [0. 25 for an adult (60 kg) female (19 to 50 years)]. Pregnant and nursing woman have increased requirements for iron. Dietary iron is poorly absorbed. The intestinal mucosa is a limiting factor in iron absorption. Normal absorption is about 1 mg/ day in an adult male, and about 1.4 mg/ day in an adult female. Absorption occurs in the divalent (ferrous) form, which must then be oxidized to the trivalent (ferric) form for use. Acute toxicity of iron ingested from normal dietary sources has not been reported. However, death especially in young children has resulted from ingestion of large overdoses of medicinal iron. (doses ranging from 40 to 1600 mg/ kg ­ average 900 mg/ kg). It is noted that the iron from ferric salts is less well absorbed than that from ferrous salts. Zinc: The average human body burden of zinc is approximately 100 milligram (mg) for a 70 kg adult. The zinc cation is a component of many enzymes and therefore has substantial involvement in many metabolic processes. It also assists in wound healing, blood formation, and general Page 8 of 19 growth and maintenance of the body's tissues. The RDAs for zinc are 15 mg/ day [0. 21 mg/ kg/ day for an adult (70 kg) male] and 12 mg/ day [0. 2 mg/ kg/ day for an adult (60 kg) female]. According to FDA, the average daily intake of zinc from food (including water) was 0. 23 mg/ kg/ day in the early 1980s. Consuming too much zinc (i. e. , 10 to 15 times the RDA) can cause health concerns such as anemia, pancreatic and kidney effects, and certain developmental effects. Consuming too little zinc can cause loss of appetite , decreased sense of taste and smell, decreased immune function, slow wound healing, skin sores, and developmental effects. 6. Ammonium Salt: Ammonium sulfate dissociates to the negative anion and the positively charged ammonium cation (NH4 + ). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen (NH4 + ) has to enter the body from an outside source. These sources are the nitrogen­ containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered "essential" amino acids, i. e., they must be consumed in the diet. Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine. Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According to FDA in the "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), "the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day. Page 9 of 19 7. Toxicological Profile Table The Agency has not reviewed any of the toxicological studies in the following table for sulfuric acid or any of its salts. The reviews of these studies were obtained from Toxnet, as well as other government websites. Table 5: Toxicological Profile Chemical Toxicity Other Information Sulfuric Acid Solutions of greater than 10% are severely corrosive by all routes of exposure; Solutions of less than >10% are strong irritants; IARC: There is sufficient evidence that occupational exposure to strong­ inorganic­ acid mists containing sulfuric acid is carcinogenic; ATSDR: No significant developmental or reproductive effects in mice or rabbits exposed to 20 mg/ m 3 sulfuric acid aerosols 7 hours per day on gestation days 6 to 15 CERCLA Reportable Quantity: greater than 1000 lb (454 kg); 1993 US production= 80.3 billion lbs; Ammonium Sulfate 13 week oral in rats; doses 0, 0.38, 0.75, 1.5, 3.0%; NOEL = 1.5% in males (886 mg/ kg/ day), 3% in females (1975 mg/ kg/ day), (HDT) Ferric Sulfate Irritant to skin, eyes and mucous membranes; Excessive iron intake may cause toxicity Primary use is in waste water treatment; Page 10 of 19 Magnesium Sulfate Cathartic; Massive doses may cause systemic toxicity primarily loss of fluid and electrolytes; Negative in Ames TA100, TA1535, TA98 with and without activation; Negative in E. coli with and without activiation; Lowest published oral toxic dose in humans: 428 mg/ kg (m) 351 mg/ kg( f); Changes in serum composition (f, m), muscle weakness (f, m), cardiac arrhythmias (f); Lowest published lethal dose in rats after oral exposure 5g/ kg US production 5. 7x10 11 g (1985) Potassium Sulfate Saline cathartic; Systemic toxicity unlikely unless massive doses consumed; Toxicity results from excessive loss of fluid and electrolytes. 1985 US production 2x10 11 g; EPA Drinking Water standard: 250,000 ug/ L sulfate ion Sodium Sulfate Mouse oral LD50 = 5989mg/ kg; Non­ toxic and non­ irritating to skin and mucous membranes; Saline cathartic; systemic toxicity unlikely unless massive doses consumed; Toxicity results from excessive loss of fluid and electrolytes; Negative in cell transformation (viral enhanced) in Syrian hamster embryo (SA7/ SHE) cells; Positive in Saccharomyces cerevisiae reverse gene mutation assay 1993 US production 1. 44billion lb; EPA Drinking Water standard: 250,000 ug/ L sulfate ion Zinc Sulfate Irritating to skin, eyes and mucous membranes; Use as an emetic may result in hemolytic and renal toxicity; Ames negative in TA97, TA102 with and without activation with S­ 9; Negative in Cell transformation with Syrian hamster embryo cells; Negative in Saccharomyces cerevisiae. Regulated by Clean Water Act; subject to effluent regulations: EPA DW 5000ug/ L ; US production 3. 5x10 10 g (1985) Page 11 of 19 8. OPP REDs (Reregistration Eligibility Decision Document) Mineral Acid RED The following information on the acute toxicity of sulfuric acid was extracted from the 1993 Mineral Acid RED: The oral LD50 is 350 mg/ kg, toxicity category II. The dermal LD50 is > 2000 mg/ kg, toxicity category III. Sulfuric acid is toxicity category I for eye and dermal irritation. No other toxicological data were required based on the use patterns at the time of the issuance of the RED and the corrosiveness shown in the acute studies for dermal and eye irritation. There was also information on the acute toxicity of sodium bisulfate in the 1993 RED: The oral LD50 is 3000 mg/ kg, toxicity category III. The dermal LD50 is > 10,000 mg/ kg, toxicity category III. Sodium bisulfate is toxicity category I for eye irritation, and toxicity category IV for dermal irritation. No other toxicological data were required based on the use patterns at the time of the issuance of the RED and the fact that it forms ubiquitous metabolic products, sodium and sulfate, that are of little toxicological concern. Iron Salts RED The Iron Salts RED (1993) contains toxicity information on ferric sulfate, ferrous sulfate monohydrate, and ferrous sulfate heptahydrate. The ferric sulfate oral LD50 is 1487 to 2101 mg/ kg, toxicity category III. The dermal LD50 is > 2000 mg/ kg, toxicity category III. The inhalation LC50 is > 1. 1 mg/ L, toxicity category III. Ferric sulfate is toxicity category I for eye irritation and toxicity category IV for dermal irritation. For ferrous sulfate heptahydrate the LD50 is 1520 mg/ kg. A sensitization study with ferric and ferrous sulfate found no indication of contact sensitization by this compound. According to the RED, a "mutagenicity study in E. coli reported positive results at 30 umol/ L. With due regard for the continuing exposure that human beings have had to the iron and sulfate components of these chemicals over many generation, it is considered unlikely that this reported result in microorganisms has any bearing on probable effects in humans or other mammals at the levels expected from use of these compounds as pesticides." Zinc Salts RED The following information on the acute toxicity of zinc sulfate was extracted from the 1992 Zinc Salts RED: The oral LD50 is > 2949 mg/ kg, toxicity category III. Zinc sulfate acid is classified as toxicity category I for eye irritation based on one study in which "severe irritation was found when 0.09 g of 99% zinc sulfate was applied to rabbit eyes. In another study, the application of 420 ug zinc sulfate to the rabbit eye found moderate irritation." Zinc sulfate is toxicity category IV for dermal irritation (very slight irritation). In a chronic study, "zinc sulfate caused hematological changes in rats and dogs fed about Page 12 of 19 100 ppm in the diet. ... In another report, mice given up to 5000 ppm of zinc as zinc sulfate in drinking water showed no evidence of carcinogenicity and no differences between treated and control groups." "When rats were given 333 mg/ kg zinc sulfate orally on days 1­ 18 of pregnancy, there was post­ implantation mortality. Teratologic studies with oral zinc sulfate in three species of animals were negative for effects on pregnancy, maternal or fetal survival, or abnormalities. In these studies mice were given up to 30 mg/ kg/ day for days 6­ 15 of gestation, rats were given up to 42.5 mg/ kg/ day for days 6­ 15 of gestation, and hamsters were given up to 88 mg/ kg/ day for days 6­ 10 of gestation. According to the RED, "[ p] ositive results have been seen with zinc sulfate in some studies, including a Drosophila melanogaster sex chromosome assay with an oral 5 mmol/ L dose and a mutation assay with Saccharomyces cerevisiae at 100 mmol/ L. DNA inhibition was seen in human HeLa cells at 1 umol/ L/ 4 hours and oncogenic transformation occurred at 200 umol/ L with hamster embryo." It was concluded that: "Although some positive mutagenicity studies have been reported, there is no indication of mutagenic effects in normal living organisms from everyday exposure. Living organisms have long been exposed to the components of zinc [sulfate] without such exposure being attributed to mutagenicity." 9. FDA GRAS (Generally Recognized As Safe) Assessments Ammonium Sulfate In the FDA Assessment titled "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), the following general conclusion on ammonium compounds was reached: "Ammonia and ammonium ion are integral components of normal metabolic processes and play an essential role in the physiology of man. Although there have been no significant feeding studies specifically designed to ascertain the safety threshold of ammonium compounds as food ingredients, numerous metabolic studies have been reported in the scientific literature. Extrapolation of these findings to the concentrations of ammonium compounds normally present in foods does not suggest that there would be untoward effects at such levels." Ammonium sulfate was evaluated in the "FDA Assessment titled Evaluation of the Health Aspects of Sulfuric Acid and Sulfates as Food Ingredients." (1975) Ammonium sulfate has been used in food in the US since 1957. For infants (0 to 23 months) the average daily intake of ammonium sulfate in 1975 ranged from 0.53 to 2.58 mg/ kg. For adults, it was 1.01 mg/ kg. Magnesium Sulfate Page 13 of 19 The FDA Assessment is titled "Evaluation of the Health Aspects of Magnesium Salts as Food Ingredients" (1976). Magnesium is (1) a dietary essential, (2) involved in many metabolic reactions, (3) important in electrolyte balance, and (4) present in fruits, vegetables, grains, milk, meat and fish. There are no chronic toxicity data. The "status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient." It was concluded that there was no available information on magnesium sulfate that "demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future." Potassium and Sodium Sulfate The FDA Assessment is titled "Evaluation of the Health Aspects of Sulfuric Acid and Sulfates as Food Ingredients." (1975). For infants (0 to 23 months) the average daily intake of potassium sulfate in 1975 ranged from 0.05 to 0.49 mg/ kg. For adults, it was 0.17 mg/ kg. No information was given for sodium sulfate. Sulfates are present in many foods. Several amino acids contain sulfur. "Sulfates are not rapidly absorbed from the gastrointestinal tract." In a metabolism studies in rats, mice and dogs, it was observed that most sulfate (in rats greater than 80% ) was excreted in 24 hours, most of it in the urine. "Sulfates are natural constituents of foods and normal products of sulfur metabolism in animals..... it is evident that the toxic manifestations following oral administration of the sulfates considered in this report appear only at levels that are many times greater than those to which man is exposed in his daily diet." It was concluded that: "There is no evidence in the available information on sulfuric acid, and on ammonium, calcium, potassium, and sodium sulfates that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future." Zinc Sulfate In the "GRAS (Generally Recognized As Safe) Food Ingredients ­ Zinc Salts" document (1972), the available information related to the safety of zinc sulfate as a food ingredient is summarized. However, the document offered no conclusions. 10. FAO/ WHO Expert Committee on Food Additives WHO performed an assessment on sodium sulfate in 2000. This assessment references an evaluation of the sulfate ion at the twenty­ ninth meeting (Annex 1, reference 70). At that time an ADI of "not specified" was established based on the fact that "sulfate is a natural constituent of food and is a product of sulfur metabolism in animals." Sodium sulfate was not included in that Page 14 of 19 ADI: at the time, there was no information to indicate the sodium sulfate was being used as a food­ grade material. Various studies were described including those on renal clearance and laxative trials in humans, and long­ term and developmental studies in mice. It was concluded: "... that the results of the published studies in experimental animals do not raise concern about the toxicity of sodium sulfate. The compound has a laxative action, which is the basis for its clinical use. The minor adverse effects reported after use of ingested purgative preparations containing sodium sulfate may not be due to the sodium sulfate itself. In the absence of any evidence of toxicity, the Committee allocated a temporary ADI `not specified'..... The ADI was made temporary because no information was available on the functional effect and actual uses of sodium sulfate in foods." 11. Human Health Hazard Characterization: Sulfuric acid in its concentrated form is highly corrosive. Due to this property toxicity testing can only be performed on dilute concentrations or on neutralized forms of the acid such as a salt. The consequences of acute exposure to sulfuric acid are well­ understood. "Concentrated sulfuric acid has an extremely irritant, corrosive, and destructive action on all living matter including human tissues, not by virtue of its acidity (in concentrated form it is only slightly ionized) but because of its affinity for water. The affinity is so strong that it will remove the elements of water from even anhydrous organic matter such as carbohydrates, resulting in charring or carbonization with the liberation of heat. In sulfuric acid splashing accidents, the heat liberated by dilution of the concentrated acid with water used to flush the affected areas, can add thermal burn to chemical injury of the body." Thus sulfuric acid "can burn and char the skin. It is even more rapidly injurious to the mucous membranes, and exceedingly dangerous to the eyes. Dilute sulfuric acid, while it does not possess this charring property, irritates the skin and mucous membranes by virtue of its acidity and can cause dermatitis." Exposure to a mist of sulfuric acid can cause irritant effects on the mucous membranes and chemical corrosive effects upon the teeth. Strong inorganic acid mists containing sulfuric acid are listed as known human carcinogens. Exposure to sulfuric acid in pesticide products as an inert ingredient would be in the role of a pH adjuster, that is, a liquid form, not a mist. This is indicative of the use of small amounts of sulfuric acid that are incorporated in a pesticide product to lower the pH . After the pH adjustment is performed, the sulfuric acid would be neutralized. As an active ingredient sulfuric acid is subject to FIFRA registration requirements and various labeling language as specified in the RED (Reregistration Eligibility Decision). Sulfuric acid must be used and applied according Page 15 of 19 to good manufacturing or good agricultural practices. However, there are no significant adverse effects, to the general public or any population subgroup from consumption of residues of sulfuric acid resulting from such uses. As a group these salts of sulfuric acid constitute a group of chemicals with many uses including direct use in the food supply. The available toxicity data indicates that the human body metabolizes sulfate, ammonium, calcium, iron, magnesium, potassium, sodium and zinc ions through well­ understood pathways. In fact, all are necessary human nutrients. Various salts of sulfuric acid have been used in the food supply for a number of years. There are no available data to indicate any significant adverse effects to the general public or any population subgroup from consumption of residues of the ammonium, calcium, iron, magnesium, potassium, sodium, and zinc salts of sulfuric acid resulting from pesticide product uses. Given the long history of safe use, the available toxicity data, an understanding of the human body's ability to metabolize these chemicals, and the evaluations by FDA and WHO, the IIFG believes that ammonium, sodium, potassium, magnesium, calcium, iron, and zinc sulfate salts are of low oral toxicity. 12. Type of Risk Assessment/ Risk Characterization: The toxicity of these chemicals derives from the irritation and caustic effects; therefore, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate. Given the widespread occurrence of sulfuric acid and its salts in the existing food supply, the amounts that can be applied to food as a result of a use in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. There is no available information on any of the salts of sulfuric acid considered in this document indicative of a human health hazard resulting from the EPA­ regulated uses as well as the FDA GRAS uses to the general public or any population subgroup. No additional information is needed to assess their safety. 13. Sensitivity of Infants and Children: Due to its acidic nature, its corrosive potential, there is high acute toxicity for sulfuric acid. Sulfuric acid must be used in pesticide products according to good manufacturing or good agricultural practices. The ammonium, sodium, potassium, magnesium, calcium, iron, and zinc salts of sulfuric acid have low toxic potential. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 14. Environmental Fate and Ecotoxicity Assessment/ Characterization: Page 16 of 19 In general, the constituents of the mineral acids, such as sulfuric acid, are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients. Sulfuric acid is a strong acid. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pHs range from 5 to 9. EPA's Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater. At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. Sulfuric acid is not expected to be persistent in the environment. Instead it is expected to dissociate, react with organic or inorganic materials, and complex with ionic substrates. The magnesium, sodium, potassium, iron, and zinc salts of sulfuric acid should dissociate in water resulting in a positively charged (cation) metal in solution. Dissociation is frequently dependent on pH, with lower (more acidic) pHs resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals varies with the species of metal and its concentration. EPA's freshwater water quality criteria for iron is 1 ppm implying relatively low toxicity. Zinc has recommended criteria implying these metals are more toxic. Metals do not degrade and thus are permanent in the environment. They are likely to dissipate by being sequestered in soil, sediment, and plants. 15. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide chemical's residues and "other substances that have a common mechanism of toxicity." The chemicals considered in this document are structurally related; however, all of the salts are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these pesticide chemicals have a common mechanism of toxicity with other substances or how to include these pesticide chemicals in a cumulative risk assessment. 16. Determination of Safety: Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of sulfuric acid and its ammonium, sodium, potassium, calcium, magnesium, iron, and zinc salts. Therefore, the following exemptions from the requirement of a tolerance are reassessed: In 40 CFR 180.2 ferrous sulfate. In 40 CFR 180.1001 (c) ammonium sulfate, ferric sulfate, magnesium sulfate, potassium sulfate, sodium Page 17 of 19 sulfate, sulfuric acid, zinc sulfate (basic and monohydrate), and zinc sulfate (basic and monohydrate). In 40 CFR 180.1001 (d) sodium bisulfate. In 40 CFR 180.1001 (e) sodium sulfate and zinc sulfate (basic and monohydrate). Also sulfuric acid in 40 CFR 180.1019. 17. List Reclassifications: The following List reclassifications are made or confirmed: Sulfuric acid: List 4B. With the restriction of use as a pH control agent; current limitation remains in place Ammonium sulfate: List 4B Ferrous sulfate: List 4B Ferric sulfate: List 4B Magnesium sulfate: List 4A, given its neutral pH in solution Potassium sulfate: List 4A, given its neutral pH in solution Sodium sulfate: List 4A, given its neutral pH in solution Sodium bisulfate: List 4B, given its acidic nature, similar to that of sulfuric acid Zinc sulfate: List 4B The following table lists the various chemical names, CAS Reg. No., and CAS Index Names that will be used for listing in 40 CFR. 180. Note that both the anhydrous and the hydrated forms are included. The Agency sees no reason to distinguish between these chemicals given that the only difference is the attachment of the water molecules. Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Sulfuric acid 7664­ 93­ 9 Sulfuric acid (8CI, 9CI) Ammonium sulfate 7783­ 20­ 2 Sulfuric acid diammonium salt (8CI, 9CI) Ammonium bisulfate 7803­ 63­ 6 Sulfuric acid, monoammonium salt (8CI, 9CI) Calcium sulfate 7778­ 18­ 9 Sulfuric acid, calcium salt (1: 1) (8CI, 9CI) Calcium sulfate ½ hydrate {CaSO4 . 1/ 2H20} 10034­ 76­ 1 Sulfuric acid, calcium salt, hydrate (2: 2: 1) (9CI) Calcium sulfate dihydrate {CaSO4 . 2H20} 10101­ 41­ 4 Sulfuric acid, calcium salt (1: 1), dihydrate (8CI, 9CI) Ferric sulfate 10028­ 22­ 5 Sulfuric acid, iron( 3+) salt (3: 2) (8CI, 9CI) Iron( II) sulfate 7720­ 78­ 7 Sulfuric acid, iron( 2+) salt (1: 1) (8CI, 9CI) Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Page 18 of 19 Iron( II) sulfate dihydrate 10028­ 21­ 4 Sulfuric acid, iron( 2+) salt (1: 1), dihydrate (9CI) Iron (II) sulfate heptahydrate {FeSO4 . 7H20} 7782­ 63­ 0 Sulfuric acid, iron( 2+) salt (1: 1), heptahydrate (8CI, 9CI) Iron (II) sulfate pentahydrate {FeSO4 . 5H20} 13450­ 80­ 1 Sulfuric acid, iron( 2+) salt (1: 1), pentahydrate (8CI, 9CI) Iron (II) sulfate tetrahydrate {FeSO4 . 4H20} 20908­ 72­ 9 Sulfuric acid, iron( 2+) salt (1: 1), tetrahydrate (8CI, 9CI) Iron (II) sulfate ennahydrate {FeSO4 . 9H20} 73248­ 92­ 7 Sulfuric acid, iron( 2+) salt (1: 1), nonahydrate (9CI) Magnesium sulfate 7487­ 88­ 9 Sulfuric acid magnesium salt (1: 1) (8CI, 9CI) Magnesium sulfate heptahydrate (epsom salt) {MgSO4 . 7H2O} 10034­ 99­ 8 Sulfuric acid magnesium salt (1: 1), heptahydrate (8CI, 9CI) Magnesium sulfate monohydrate {MgSO4 . H2O} 14168­ 73­ 1 Sulfuric acid magnesium salt (1: 1), monohydrate (8CI, 9CI) Potassium pyrosulfate {K2S2O7} 7790­ 62­ 7 Disulfuric acid, dipotassium salt (9CI) Potassium hydrogen sulfate {KHSO4} 7646­ 93­ 7 Sulfuric acid, monopotassium salt (8CI, 9CI) Potassium sulfate 7778­ 80­ 5 Sulfuric acid dipotassium salt (8CI, 9CI) Sodium sulfate 7757­ 82­ 6 Sulfuric acid disodium salt (8CI, 9CI) Sodium sulfate decahydrate {Na2SO4 .10H2O} 7727­ 73­ 3 Sulfuric acid disodium salt, decahydrate (8CI, 9CI) Sodium sulfate heptahydrate {Na2SO4 .7H2O} 13472­ 39­ 4 Sulfuric acid disodium salt, heptahydrate (8CI, 9CI) Sodium pyrosulfate {Na2S2O7} 13870­ 29­ 6 Disulfuric acid, disodium salt (9CI) Sodium sulfate hydrogen monohydrate {NaHSO4 .H2O} 10034­ 88­ 5 Sulfuric acid, monosodium salt, monohydrate (8CI, 9CI) Sodium bisulfate 7681­ 38­ 1 Sulfuric acid, monosodium salt (8CI, 9CI) Zinc sulfate (basic and monohydrate) 68813­ 94­ 5 Sulfuric acid, zinc salt, basic (9CI) Chemical Name CAS. Reg. No. Chemical Abstacts Index Name Page 19 of 19 7446­ 19­ 7 Sulfuric acid, zinc salt (1: 1), monohydrate (8CI, 9CI) Zinc sulfate 7733­ 02­ 0 Sulfuric acid, zinc salt (1: 1) (8CI, 9CI) Zinc sulfate heptahydrate {ZnSO4 . 7H2O} 7446­ 20­ 0 Sulfuric acid, zinc salt (1: 1), heptahydrate (8CI, 9CI) Zinc sulfate hexahydrate 13986­ 24­ 8 Sulfuric acid, zinc salt (1: 1), hexahydrate (8CI, 9CI) Attachment: EFED Review of Mineral Acids (Birchfield; May 7, 2002)

epa

2024-06-07T20:31:44.197121

regulations

EPA-HQ-OPP-2002-0280-0010

Supporting & Related Material

Page 1 of 17 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Documents on Reassessing Exemptions from the Requirement of a Tolerance for the Mineral Acids (Hydrochloric, Carbonic, Phosphoric, and Sulfuric) and their Ammonium, Calcium, Ferrous, Ferric, Magnesium, Potassium, Sodium, and/ or Zinc Salts Collectively these Decision Documents cover four mineral acids and the salts of these acids. The individual Decision Documents are: (1) Hydrochloric Acid and Salts, (2) Salts of Carbonic Acid, (3) Phosphoric Acid and Salts, and (4) Sulfuric Acid and Salts. The Inert Ingredient Focus Group reassessment is based on various conclusions of the FAO/ WHO Joint Expert Committee on Food Additives, conclusions of various FDA GRAS (Generally Recognized As Safe) Assessments, information previously used by OPP as part of the reregistration process, and other information available on government websites. In total 46 exemptions from the requirement of a tolerance in 40 CFR 180 are reassessed. This total consists of 18 in the phosphoric acid document, nine in the hydrochloric acid document, six in the carbonic acid document, and 13 in the sulfuric acid document. Page 2 of 17 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Salts of Carbonic Acid Petition No.: no Tolerance Reassessments?: yes Chemical Category/ Group: mineral acid and salts The following describes the various ways that salts of carbonic acid are used. Table 1: Use Pattern (pesticidal ­ inert ingredient) Chemical Name PC Code 40 CFR 180.1001 Inert Use Pattern (Pesticidal) Current Inert List ammonium bicarbonate 873401 (c) surfactant, suspending agent, dispersing agent 4B magnesium carbonate 873503 (c), (e) anticaking agent, conditioning agent 4B potassium carbonate 873504 (d) buffering agent 4B sodium bicarbonate 873505 (c) neutralizer 4A There is also a tolerance exemption for sodium carbonate 40 CFR 180.2. The tolerance exemptions for calcium carbonate were reassessed in the IIFG Decision Document "Weathered Materials", dated January 31, 2002. Calcium carbonate is a List 4A Potassium bicarbonate (40 CFR 180.1177) and sodium bicarbonate (40 CFR 180.1176) are used as active ingredients. (Note that both tolerance exemptions were established postFQPA Potassium bicarbonate is used in six products at 204 use sites, which includes many food crops, as well as ornamentals and turf. It is used against 45 pests including mildew and leaf spot. Sodium bicarbonate is in one product which is a product used only to formulate other pesticides. There are no longer any EPA­ registered active ingredient uses for any of the other above­ listed Page 3 of 17 carbonate salts. It is noted that there is information in this document on other carbonate salts for which tolerance exemptions do not currently exist. These data are being used as surrogate data. Table 2: Use Pattern (FDA GRAS) Chemical GRAS Citation GRAS Uses ammonium bicarbonate 21 CFR 184.1135 dough strengthener, leavening agent, pH control agent, texturizer ammonium carbonate 21 CFR 184.1137 leavening agent, pH control agent magnesium carbonate 21 CFR 184.1425 anticaking and free­ flow agent, flour treating agent, lubricant and release, nutrient supplement, pH control agent, processing aid, synergist potassium bicarbonate 21 CFR 184.1613 formulation aid, nutrient supplement, pH control agent, processing aid potassium carbonate 21 CFR 184.1619 flavoring agent and adjuvant, nutrient supplement, pH control agent, processing aid sodium bicarbonate 21 CFR 184.1736 (no limitations specified) sodium carbonate 21 CFR 184.1742 antioxidant, curing and pickling agent, flavoring agent and adjuvant, pH control agent, processing aid Sodium bicarbonate also is used in food contact surface sanitizing solutions under 21 CFR 178.1010. Page 4 of 17 Table 3: Use Pattern (non­ pesticidal) Chemical Uses ammonium bicarbonate in baking powder formulations; in cooling baths; fire extinguishers; manufacture of porous plastics, ceramics; manufacture of dyes and pigments; in compost heaps to accelerate decomposition; as fertilizer; for defatting textiles; in cold wave solutions; in chrome leather tanning; to remove gypsum from heat exchangers and other processing equipment. magnesium carbonate used to prepare high purity magnesium compounds in the paint and printing inks industries; manufacture of fireproofing, fire­ extinguishing, flooring, and polishing compounds; fillers and smoke suppressants in the plastics and rubber industries; USP grade is used as an additive to table salt to keep it free flowing; a bulking compound in powder formulations; an antacid. potassium carbonate manufacture of soap, glass, pottery, smalts and many potassium salts; in analytical chemistry; Television glass accounts for a substantial portion of the consumption of potassium carbonate because the potassium salt is more compatible with the lead, barium, and strontium oxides contained in these glasses than is sodium carbonate. sodium bicarbonate Leavening agent in baking powder and food ingredients; component of soaps, detergents and pharmaceuticals; agent in leather tanning; textile manufacturing; paper manufacturing; fire extinguishers; in industrial and household chemicals It should be noted that ammonium bicarbonate can be used as a fertilizer. Plants need various elements (metals and non­ metals) for proper growth. Especially for agricultural crops, plants are supplied these elements as part of chemical fertilizers. The most important elements for plant growth are nitrogen, phosphorus, and potassium. Other metals needed in the soil for plant up­ take are calcium, magnesium, iron, and trace elements such as zinc. Ammonium bicarbonate can be intentionally added to growing agricultural crops as needed to promote plant growth. Assessment of the Salts of Carbonic Acid The ammonium, sodium, potassium, and magnesium salts of carbonic acid are being assessed as a group due to their chemical similarities. However, these salts all contain either the bicarbonate ion (HCO3 ­1 ) or the carbonate ion (CO3 ­2 ), and thus share some common chemistries. A major focus of this assessment is the work previously performed by FDA in assessing the safety of these chemicals as food additives. 1. Physical/ Chemical Properties: The physical and chemical properties of the salts of carbonic acid are described in the May 7, 2002 EFED Assessment. See attached. 2. Information Sources: Page 5 of 17 The following information was used in performing this assessment: The available information consisted of information retrieved from various websites, such as, °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng1333.html), (www. cdc. gov/ niosh/ ipcsneng/ neng0969.html), ° TOXNET ( www. toxnet. nlm. nih. gov.), °WHO( www. inchem. org/ documents/ jecfa/ jecmono/ v17je02.htm) Various FDA GRAS Assessments were also used. 3. NIOSH (National Institute for Occupational Safety and Health) The NIOSH International Chemical Safety Card for ammonium hydrogen carbonate indicates that a TLV (Threshold Limit Value) has not been established. The chemical can irritate the skin and the respiratory tract. The NIOSH International Chemical Safety Card for magnesium carbonate indicates a TLV (Threshold Limit Value) of 10 mg/ m 3 . The chemical may have effects on the lungs if the magnesite (the naturally occurring form of magnesium carbonate) contains more than 1% crystalline silica. 4. Acid Characteristics An acid is a substance that when dissolved in water yields H + ions. The increase of the concentration of the H + ions lowers the pH. Mineral acids contain a non­ metal such as phosphorus, nitrogen, sulfur, or chlorine which may or may not be combined with oxygen. When combined with oxygen, these anions can be referred to as oxyanions. Strong acids are those acids that when dissolved completely transfer their H + ions to water. Others acids such as carbonic are referred to as weak acids: they exist in solution as a mixture of acid molecules and various ions formed by the dissociation of the acid molecule. The predominant anions for carbonic acid are bicarbonate (HCO3 ­1 ) at pHs below 8 and carbonate (CO3 ­2 ) at pHs above 10. 5. Cations: Sodium, Potassium, and Magnesium Generally, when any salt of an acid, such as carbonic acid, is dissolved in water, dissociation yields the anions, which are negatively charged, and a positively charged cation. In the human body, these salts tend to dissociate and thus, for the most part, react in the body as the anion and the cation. Metals such as sodium, magnesium, and potassium are required for proper functioning of human biological systems. For risk assessment purposes an important feature of these metals is that overall the body does have an effective means of processing them. The primary means of exposure to these cations is ingestion. Four of the most common cations required for functioning Page 6 of 17 of human biology are: sodium, potassium, calcium and magnesium. Chemically, sodium and potassium belong to the same chemical family: calcium and magnesium belong to a different chemical family. Sodium: The average human body burden of sodium is approximately 20 grams (g) for a 70 kilogram (kg) adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Dietary Allowance (RDA) for sodium. Potassium: The average human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day. Magnesium: The average human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA for magnesium is 310 to 320 mg/ day for adult females and 400 to 420 mg/ day for adult males with the RDA increasing with increasing age. 6. Ammonium Salt: Ammonium carbonate salts dissociate to form the positively charged ammonium cation (NH4 + ). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen (NH4 + ) has to enter the body from an outside source. These sources are the nitrogen­ containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered "essential" amino acids, i. e., they must be consumed in the diet. Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine. Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According Page 7 of 17 to FDA in the "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), "the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day. Page 8 of 17 7. Toxicological Profile Table The Agency has not reviewed any of the toxicological studies in the following table for any of the salts of carbonic acid. The reviews of these studies were obtained from Toxnet, as well as other government websites. Table 4: Toxicological Profile Chemical Toxicity Other Information Ammonium carbonate Contact with eyes or skin causes irritation, if inhaled will cause difficulty in breathing; Ammonium compounds used as fertilizers are a toxicological hazard when livestock have access to residues or pools of solution on a pasture CERCLA Reportable Quantity: greater than 5000 lb (2270 kg); Designated as a hazardous substance under section 311( b)( 2)( A) of the Federal Water Pollution Control Act and further regulated by the Clean Water Act Ammonium bicarbonate Inhalation may cause respiratory irritation; Contact with eyes or skin causes irritation; There appears to be a more rapid excretion of ammonia following ammonium bicarbonate infusions, which result in higher unionized ammonia levels in blood compared with those following ammonium chloride infusions; Mutagenicity: Ames assays strains TA 97 and TA102 with and without rat liver activation: Negative. CERCLA Reportable Quantity: greater than 5000 lb (2270 kg); Designated as a hazardous substance under section 311( b)( 2)( A) of the Federal Water Pollution Control Act and further regulated by the Clean Water Act Page 9 of 17 Magnesium Carbonate Repeated doses may cause diarrhea, which may cause fluid and electrolyte imbalance; Can cause hypermagnesemia in those with severely impaired renal function; Can alkalinize the urine; Magnesium salts are poorly absorbed from the intestine; Normal range of magnesium serum concentrations 1. 5 to 2. 5 mEq/ L 1974 Production in US: 5.4 x 10 6 kg (1227 tons), with another 2% of that amount imported that year . Potassium Carbonate Oral LD50 : Rat 1870 mg/ kg; Mouse 2570 mg/ kg; Inhalation LC50 : Rat > 500 mg/ m 3 ; Irritating to skin , mucous membrane of eyes and upper respiratory tract; Irritant and caustic action similar to that of potassium hydroxide, but less severe; Negative in the Ames assays with two strains of Salmonella typhimurium (TA 97 and TA102) with and without activation Common Name: Potash. Sodium Bicarbonate Developmental Toxicity: No effects found up to 580 mg/ kg in mice, 340 mg/ kg in rats, and 330 mg/ kg in rabbits; Negative in the Ames assays with two strains of Salmonella typhimurium (TA 97 and TA102) with and without activation; Daily doses up to 25 mEq/ kg were administered to patients for 3 weeks, changes in plasma electrolyte concentration were not remarkable, plasma total carbon dioxide increased by only 5 mEq/ L with largest dose, considerable weight gain was most prominent effect; No reports of toxicity caused by the ingestion of baking soda; Daily dose limited to 200 mEq in persons under 60 year age and 100 in those older; Adults with normal renal function can tolerate up to 1700 mEq daily with minimal symptoms; Contra indicated for alkalosis (metabolic or respiratory), chloride loss due to vomiting or continuous GI suction, or hypocalcemia; Eliminated principally in the urine, alkalizes it Common Name: Baking soda. 1984 Production in US: 3.2 x 10 8 kg (72727 tons), with another 5% of that amount imported same year. Page 10 of 17 Sodium Carbonate Oral LD50 : rat 2880 to 4090 mg/ kg; Inhalation LC50 : rat 2300 mg/ m 3 (2 hour); Inhalation LC50 : mouse 1200 mg/ m 3 (2 hour); Skin irritation: mild; Eye irritation : mild­ moderate; Aqueous solutions are strongly alkaline; Concentrated solutions tend to produce local necrosis of mucous membranes; Sensitivity reactions may occur from repeated topical use; Ingestion of large quantities may produce corrosion of GI tract, vomiting, diarrhea, circulatory collapse, death; Dusts of vapors of sodium carbonate may cause irritation of mucous membranes with subsequent coughing and shortness of breath; A primary irritant at concentrations below 15% and caustic at concentrations above approximately 15%, depending on contact time, areas of exposure, and other factors; Developmental toxicity test on gestation days 6 to 15 in rats, mice and rabbits at levels of 3. 4 to 340 mg/ kg: no effects on nidation or survival of the dams or fetuses. Common name: washing soda Page 11 of 17 8. Agency Review of Toxicity Data for Potassium Bicarbonate and Sodium Bicarbonate Sodium bicarbonate has an acute oral LD50 greater than 5000 mg/ kg in rats, an acute dermal LD50 greater than 2000 mg/ kg in rabbits, and an acute inhalation LC50 greater than 4.74 mg/ L in rats. It causes minimal eye irritation and slight dermal irritation in rabbits, and is a dermal non­ sensitizer in guinea pigs. Potassium bicarbonate has an acute oral LD50 greater than 2825 mg/ kg in rats, an acute dermal LD50 greater than 2000 mg/ kg in rabbits, and an acute inhalation LC50 greater than 4.96 mg/ L in rats. It causes slight eye irritation and slight dermal irritation in rabbits, and is a dermal non­ sensitizer in guinea pigs. 9. FDA GRAS (Generally Recognized As Safe) Assessments The FDA Assessment is titled "Evaluation of the Health Aspects of Carbonates and Bicarbonates as Food Ingredients" (1975). "Carbonates and bicarbonates are used in foods as neutralizers and leavening agents. These anions occur in body fluids and tissues as the result of normal metabolic processes and are important in the control of acid­ base balance. Except for calcium, most.... are fairly soluble in water." The possible average daily intake of added carbonates (i. e., those used as food additives) at that time were: Table 5: Daily Intake Chemical Name 0 to 5 Months (mg/ kg) 6 to11 Months (mg/ kg) 12 to 23 Months (mg/ kg) 2 to 65+ Years (mg/ kg) ammonium bicarbonate 3 12188 ammonium carbonate 8 343512 magnesium carbonate 2 8 12 6 potassium 11 2 <1 bicarbonate potassium carbonate 3 15 22 10 sodium bicarbonate 29 171 251 80 sodium carbonate 1 6 6 2 Potassium and Sodium Carbonate and Bicarbonate Page 12 of 17 In the FDA Assessment acute, short­ term, and developmental toxicity studies and mutagenicity studies were evaluated for potassium carbonate and bicarbonate. For sodium carbonate and bicarbonate acute, short­ term, and developmental toxicity studies, and mutagenicity and metabolism studies were evaluated. There was also some human data. No chronic studies were identified. "The results of acute toxicity and short­ term feeding experiments are not readily extrapolated in determining toxic levels for carbonate salts consumed by humans. Treatment of gastric or peptic ulcers in patients with large amounts of carbonate salts in various forms has been utilized for many years and only rarely have deleterious results of changes of acid­ base balance been reported. When the human respiratory and renal functions are normal, the mechanisms for disposing of bicarbonate intake in large amounts through excretion appear to be highly efficient." "There is no evidence in the available information on ... potassium carbonate, potassium bicarbonate, sodium carbonate, [or] sodium bicarbonate ... that demonstrates or suggests reasonable grounds to suspect a hazard to the public when used at levels that are now current or that might reasonably be expected in the future." Ammonium Carbonate and Bicarbonate The FDA Assessment is titled "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974). "Ammonia and ammonium ion are integral components of normal metabolic processes and play an essential role in the physiology of man. Although there have been no significant feeding studies specifically designed to ascertain the safety threshold of ammonium compounds as food ingredients, numerous metabolic studies have been reported in the scientific literature. Extrapolation of these finding to the concentrations of ammonium compounds normally present in foods does not suggest that there would be untoward effects at such levels." Magnesium Carbonate The FDA Assessment is titled "Evaluation of the Health Aspects of Magnesium Salts as Food Ingredients" (1976). Magnesium is (1) a dietary essential, (2) involved in many metabolic reactions, (3) important in electrolyte balance, and (4) present in fruits, vegetables, grains, milk, meat and fish. No chronic toxicity data were available. The "status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient." The conclusion was reached that there was no available information on magnesium chloride to demonstrate, or suggest Page 13 of 17 "reasonable grounds to suspect, a hazard to the public when ... used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future." 10. FAO/ WHO Expert Committee on Food Additives Ammonium carbonate and ammonium hydrogen carbonate (previously known as ammonium bicarbonate) were evaluated previously in 1966. The evaluation was performed using the available data on ammonium carbonate and ammonium bicarbonate as well as surrogate data on ammonium chloride and various carbonate salts. Acute, short­ term, and developmental toxicity studies, mutagenicity studies, and human studies were used. "These compounds (ammonium ion and bicarbonate ion ) are normal metabolites in man. Although specific toxicological data for ammonium carbonate and ammonium bicarbonate are limited, extrapolation of results from studies with ammonium compounds (primarily ammonium chloride) and with sodium or potassium carbonate provide a basis for evaluation. Clinical studies in man show that administration of high doses of ammonium chloride or of sodium bicarbonate results in changes in the acid­ base balance. This is the normal physiological response. The levels of ammonium carbonate and bicarbonate in the diet from food additive use are extremely small compared to the levels required to cause physiological changes and pose no toxicological hazard." The estimate of acceptable daily intake for man is "not specified." "The statement `ADI not specified' means that, on the basis of the available data (toxicological, biochemical, and other), the total daily intake of the substance, arising from its use or uses at the levels necessary to achieve the desired effect and from its acceptable background in food, does not, in the opinion of the Committee, represent a hazard to health. For this reason, and for the reasons stated in individual evaluations, the establishment of an acceptable daily intake (ADI) in mg/ kg bw is not deemed necessary." 11. Human Health Hazard Characterization: When dissolved in water, salts of carbonic acids form basic solutions. The toxicity (the irritation and caustic effects) of these chemicals tend to resemble those of the hydroxides, although to a lesser extent. In solution these chemicals could effectively perform as buffering agents, pH adjusters, or neutralizers in pesticide products. This is indicative of the use of small amounts of the chemical that are incorporated in a pesticide product to modify and/ or control the pH. After the pH adjustment is performed, the aqueous solution of carbonate salts would be neutralized. If used as an active ingredient the chemical is subject to FIFRA registration requirements and various labeling language. These chemicals must be used and applied according to good manufacturing or good agricultural practices. However, there are no significant adverse effects, to the general public or any population subgroup from consumption of residues of the ammonium, potassium, magnesium, and sodium salts of carbonic acid resulting from pesticide Page 14 of 17 product uses. As a group these salts of carbonic acid constitute a group of chemicals with many uses including direct use in the food supply. Various ammonium, magnesium, potassium, and sodium salts of carbonic acid have been reviewed by both FDA and WHO. These chemicals have been used in the food supply for a number of years. The available toxicity data indicates that the human body metabolizes carbonates, ammonium, magnesium, potassium, and sodium ions through well­ understood pathways. In fact, the metals are necessary human nutrients. Given the long history of safe use, the available toxicity data, and an understanding of the human body's ability to metabolize these chemicals, and the evaluations by FDA and WHO, the IIFG believes that ammonium, potassium, sodium and magnesium carbonate salts are of low oral toxicity. 12. Type of Risk Assessment/ Risk Characterization: The toxicity of these chemicals derives from the irritation and caustic effects; therefore, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate. Given the widespread occurrence of these chemicals in the existing food supply, the amounts that can be applied to food as a result of a use in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. There is no available information on any of the chemicals considered in this document indicative of a human health hazard resulting from the EPA­ regulated uses as well as the FDA GRAS uses to the general public or any population subgroup. No additional information is needed to assess their safety. 13. Sensitivity of Infants and Children: Overall, when considering the oral pathway (ingestion), these chemicals have low toxic potential. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 14. Environmental Fate and Ecotoxicity Assessment/ Characterization: In general, the constituents of the salts of carbonic acid are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a Page 15 of 17 number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pHs range from 5 to 9. EPA's Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater. At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. The magnesium, potassium and sodium salts of carbonic acid should dissociate in water resulting in a positively charged (cation) metal in solution. Dissociation is frequently dependent on pH, with lower (more acidic) pHs resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals varies with the species of metal and its concentration. Metals do not degrade and thus are permanent in the environment. They are likely to dissipate by being sequestered in soil, sediment, and plants. 15. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information" concerning the cumulative effects of a particular pesticide chemical's residues and "other substances that have a common mechanism of toxicity." The chemicals considered in this document are structurally related; however, these salts of carbonic acid are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these pesticide chemicals have a common mechanism of toxicity with other substances or how to include these pesticide chemicals in a cumulative risk assessment. 16. Determination of Safety: Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of ammonium, sodium, potassium, and magnesium salts. Therefore, the following exemptions from the requirement of a tolerance are reassessed: In 40 CFR 180.2 sodium carbonate. In 40 CFR 180.1001 (c) ammonium bicarbonate, magnesium carbonate, and sodium bicarbonate. In 40 CFR 180.1001 (d) potassium carbonate. In 40 CFR 180.1001 (e) magnesium carbonate. 17. List Reclassifications: The following List reclassifications are made or confirmed: Ammonium bicarbonate: List 4B Ammonium carbonate: List 4B Magnesium carbonate (less than 1% crystalline silica): List 4A given its similarities to calcium carbonate Potassium Bicarbonate: List 4A given its similarities to sodium bicarbonate Potassium Carbonate: List 4B given its similarities to potassium hydroxide Page 16 of 17 Sodium Bicarbonate: List 4A considering its use as baking soda Sodium Carbonate: List 4B given its similarities to potassium carbonate Given the chemical similarities, and that data/ information on the following chemicals was used as surrogate data for tolerance reassessment, exemptions from the requirement of a tolerance may be established for ammonium carbonate, potassium bicarbonate, and sodium carbonate. The following table lists the various chemical names, CAS Reg. No., and CAS Index Names that will be used for listing in 40 CFR. 180. Note that both the anhydrous and the hydrated forms are included. The Agency sees no reason to distinguish between these chemicals given that the only difference is the attachment of the water molecules. Chemical Name CAS. Reg. No. Chemical Abstacts Index Name ammonium bicarbonate 1066­ 33­ 7 Carbonic acid, monoammonium salt (8CI, 9CI) ammonium carbonate 10361­ 29­ 2 Carbonic acid, ammonium salt (8CI, 9CI) ammonium carbonate 506­ 87­ 6 Carbonic acid, diammonium salt (8CI, 9CI) magnesium carbonate 546­ 93­ 0 Carbonic acid, magnesium salt (1: 1) (8CI, 9CI) potassium carbonate 584­ 08­ 7 Carbonic acid, dipotassium salt (8CI, 9CI) potassium hydrogen carbonate {KHCO3} 298­ 14­ 6 Carbonic acid, monopotassium salt (8CI, 9CI) potassium carbonate trihydrate {2K2CO3 .3H2O} 18662­ 52­ 7 Carbonic acid, dipotassium salt, trihydrate (8CI) sodium bicarbonate {NaHC03} 144­ 55­ 8 Carbonic acid monosodium salt (8CI, 9CI) sodium carbonate {Na2CO3} 497­ 19­ 8 Carbonic acid disodium salt (8CI, 9CI) sodium carbonate decahydrate {Na2CO3 . 10H2O} 6132­ 02­ 1 Carbonic acid disodium salt, decahydrate (8CI, 9CI) sodium carbonate heptahydrate {Na2CO3 . 7H2O} 56399­ 31­ 6 Carbonic acid disodium salt, heptahydrate (9CI) sodium carbonate monohydrate {Na2CO3 . H2O} 5968­ 11­ 6 Carbonic acid disodium salt, monohydrate (8CI, 9CI) sodium sesquicarbonate {Na2CO3 . NaHCO3 . 2H2O} 533­ 96­ 0 Carbonic acid, sodium salt (2: 3) (8CI, 9CI) Attachment: Page 17 of 17 EFED Review of Mineral Acids (Birchfield; May 7, 2002)

epa

2024-06-07T20:31:44.205939

regulations

EPA-HQ-OPP-2002-0280-0011

Supporting & Related Material

Page 1 of 15 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 8, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: January 8, 2002 Meeting of the IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert ingredients associated with the "plant and animal byproducts" grouping. Page 2 of 15 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for the Plant and Animal By­ Product Grouping Chemical Name: Several, see below. Category: Plant and Animal Byproducts CAS Reg. No.: Several, see below. Introduction: The meeting of the Inert Ingredient Focus Group (IIFG) to discuss the "plant and animal byproducts" grouping was held on January 8, 2002. Focus Group members in attendance were: Kathryn Boyle (RD), Kerry Leifer (RD), Robert Forrest (RD), Jeanie McAndrews (RD), Steve Schaible (RD), HarryCraven (EFED), Diana Locke (HED), Michael Doherty( HED), Melba Morrow (AD), Tom Brennan (HED), Mark Perry (SRRD), and Larry Schnaubelt (SRRD). The presenters were: Mark Perry and Larry Schnaubelt (SRRD). The Executive Secretaries for the meeting were Jeanie McAndrews and Steve Schaible (RD). Also in attendance at the meeting were Marianne Lewis, Judy Loranger, and Ben Gregg, all of SRRD. At this meeting, the available information on twenty­ five different plant and animal byproduct substances was discussed to determine if sufficient information was available to make tolerance reassessment decisions on the various materials and to make the determination as to whether the various materials should be classified as List 4A or List 4B substances. The 25 substances discussed do not represent the universe of plant and animal byproduct inert ingredients, but instead are a subset which have existing tolerance exemptions listed in 40 CFR Part 180 and can therefore be counted towards tolerance reassessment. The available information consisted of information retrieved from various websites such as TOXNET, FirstGov, and NTP, as specified in the methodology for lower toxicity chemicals. General Internet searches on the substance names and their toxicity were also used. Information handed out at this meeting included: (1) a short summary dividing the substances into 25 groups for discussion purposes; (2) an animal toxicity data summary for linseed oil; and (3) a summary of developmental, reproductive, and chronic toxicity studies for gum arabic. Page 3 of 15 For purposes of evaluation in accordance with the newly developed inert ingredient methodology, manyinert substances undergoing tolerance or tolerance exemption reassessment have been placed into groups based on possible common characteristics or potential similarity based on the fact that they are derived from materials that may generally be considered similar to each other. The term" plant and animal byproducts" is used by the Agency to describe a group of chemical substances that are derived fromplant and animal sources. Some of the substances in this group, such as walnut shells or coconut shells, are only minimally processed from the direct plant material. This is usually a change only in the physical formof the substance, and is accomplished by activities such as grinding or chopping. Some, however, require more significant processing in order to generate the endproduct such as lecithin from oil, or glue from animal collagen. The plant and animal byproduct substances considered by the IIFG are used for a variety of purposes as inert ingredients. In pesticide products, these substances are used as surfactants, thickeners, carriers, emulsifiers, adhesive, dispersing agents, and many other uses. Ecological Effects: The substances in this group are derived fromnaturally occurring plant and animal materials and no adverse ecological effects were reported in the available literature. However, it was considered that three compounds (guar gum, sodiumalginate, and soap bark, which act as a foaming agent, foam stabilizer, and stabilizer/ thickener, respectively) could have ecological impacts. After consultation with OPPT and using Structural Activity Relationships (SARs), the IIFG believes that these compounds are of low concern for ecotoxicity. The IIFG believes that no significant adverse ecological effects are anticipated from exposure to any of these substances. Discussion Abrief summation of the available information was given for each of the chemical substances. If available, the CAS RegistryNumber is given in parenthesis. Comments made during the discussion or after the meeting that pertained only to a specific group are in italics below. Current List classification is also in italics. 1. Animal Glue: S manufactured from collagen derived from animal hides S glue may be slightly allergenic to individuals with sensit ivity to certain proteins; allergic reactions are reversible. Animal glue is a protein, and alien proteins may cause allergic reactions. However, these contact (dermally­ induced) reactions are reversible and are generally not life threatening. 2. Coconut Shells, Douglas Fir Bark (List 4A), Walnut Shells (List 4A): S coconut shells used to make activated charcoal (carbon) S Douglas fir bark commonly used as a landscaping mulch Page 4 of 15 These compounds are minimally processed from their natural forms, in most cases being only ground or shredded more finely. As these substances are in effect naturally occurring, it is not expected that pesticidal use of these substances will result in adverse exposure to humans or the environment. 3. Coffee Grounds: (CAS: 68916­ 18­ 7) (List 4A) As the extract from ground coffee beans is widely consumed, it is unlikely that use of coffee grounds as an inert ingredient in a pesticide formulation will result in unacceptable risk to humans. 3. Licorice Root: (CAS: 68916­ 18­ 7) (List 3­ "licorice extract") S contains glycyrrhizinic acid which exhibits actions similar to natural mineralocorticoids of the adrenal cortex S licorice root is one of the most commonly used herbs in the world; licorice extracts are used as a food additive flavoring agent in mouthwash, root beer, chewing gum, candy, ice cream, baked goods, and as a pharmaceutical additive S licorice and licorice derivatives are on FDA's list of direct food substances affirmed as generally recognized as safe (GRAS) (21 CFR 184.1408); maximumlevels permitted in food are specified S according to ToxNet, licorice extract is characterized as being "slightly toxic" by the oral route; toxicity endpoints are as follows: LD50 rat oral = 14,200 mg/ kg, LD50 rat inter­ peritoneal = 1420 mg/ kg, LD50 rat subcutaneous = 4200 mg/ kg, LD50 mouse inter­ peritoneal = 1500 mg/ kg. S cases of poisonings are mostly chronic in nature, not acute; chronic exposure longer than 4­ 6 weeks may cause hypokalemia (low potassium levels), hypernatremia (high sodium levels), hypertension, myopathy, and cardiac problems S "licorice extract" (CAS: 97676­ 23­ 8) is classified as List 3; this CAS Number actually refers to "oils, licorice" S no serious adverse reactions have been published about licorice root; single chemical extracts have caused serious adverse reactions on occasion when used in medicine or candy, but the whole root does not cause these serious reactions. Exposure to licorice root from use as an inert ingredient in pesticidal products will be well below those levels of licorice extract already considered safe by other federal agencies. 4. Sperm Oil: (CAS: 8002­ 24­ 2) S liquid wax derived from sperm whale blubber. S used as a lubricant for watches and other delicate instruments, in leather treatment products and soap making S sperm oil is a food additive permitted for direct application to food for human consumption (21 CFR 172.210) as well as an indirect food additive in adhesives, paper and paperboard components, and polymers (21 CFR Parts 175, 176, and 177) Page 5 of 15 Barring incidence data on adverse effects after exposure to spermoil, this chemical should be added to List 4A. According to Jerome Blondell (HED) and Norman Spurling, there are no records for sperm oil in the Incidence Data System database. 5. Wood Flour (Wood Dust):. S according to health and safety guidelines put out by the Occupational Safety and Health Administration (OSHA), acute exposure to red cedar dust may result in irritation of the eyes, skin and respiratory tract. Chronic occupational exposure may result in dermatitis reactions, asthma, pneumonitis, bronchitis and nasal cancer. S it is believed that toxicity is dependant on wood type, with nasal cancer and more severe respiratory effects being associated with exposure to dust from hardwoods such as beech, walnut, and oak S OSHA permissible exposure limit (PEL) for red cedar dust is 15 mg/ m 3 for total dust, and 5 mg/ m 3 for respirable fractions (nuisance dust) S National Institute of Occupational Safety and Health (NIOSH) recommended exposure limit (REL) is 1 mg/ m 3 (as a time­ weighted average (TWA) for up to 10 hour workday and a 40 hour work week), based on pulmonary dysfunction and other respiratory effects Exposure to wood dust or wood flour in a formulated pesticide product is likely to be well below the levels which result in chronic effects fromdaily occupational inhalation exposure to rawwood dust. 6. Camphor: (CAS: 76­ 22­ 2) (List 3) S derived from the camphor tree, Cinnamomum camphora S Japanese white camphor oil (CAS: 8008­ 51­ 3) and d­ camphor (CAS: 464­ 49­ 3) permitted as a food additive permitted for direct addition to food for human consumption (21 CFR 172.510 and 172.515, respectively) S reported uses include as an ingredient in non­ alcoholic beverages, baked goods, condiments, and in over­ the­ counter medications to relieve muscle aches, nasal congestion and cold sores; also used in the manufacture of plastics, lacquers/ varnishes, pyrotechnics and embalming fluid S currently present in approximately 950 non­ pesticidal products S ingredient in insecticides and moth and mildew preventatives S OSHA PEL: TWA 2 mg/ m 3 S NIOSH REL: TWA 2 mg/ m 3 S tolerance exemption specifies that camphor not compose more than 5% (w/ w) of pesticide formulation. Camphor is rapidly absorbed through the skin, respiratory and GI tracts. Camphor readily crosses the placenta and cases of fetal death after ingestion by mother have been reported. Ingestion of 0.7 to 1. 0 g has proven fatal in children. Human fatalities have also been reported as a result of dermal and respiratory exposure. A Poisindex review of camphor ingestions (estimated to exceed 2 mg/ kg) showed that 90% of patients remained asymptomatic, 4% developed minor symptoms and 6% developed major symptoms. Humans are considered more susceptible to the effects of camphor than other species. Camphor is irritating to skin, upper respiratory tract, and the gastrointestinal Page 6 of 15 tract. It is toxic and reacts rapidly; exposure may result in dizziness, tension, hallucinations and mental confusion. Chronic camphor poisoning is uncommon due to its high toxicity and rapid action. A developmental toxicity study in rabbits (with d­ camphor) showed no fetal or maternal toxicity at 400 mg/ kg/ day, yet an associated range finding study found 60% maternal mortalityat 500 mg/ kg/ day. Another developmental toxicity study in rats (d­ camphor) demonstrated that camphor does not affect fetal growth, viability or morphological development at doses which caused only minor maternal toxicity (800 mg/ kg/ day). Camphor will be further evaluated using a more formal (Tier 2) assessment process. 7. Mixed Phytosterols (plant sterols): S phytosterols (e. g., campesterol, sitosterol, and stigmasterol) are ubiquitous compounds in plant s similar to animal sterols but having an extra methyl or ethyl substituent in the side chain; plant sterols are found in plant cell walls and in plant oils; the content of sterols in plant oilsrange fromhundredsofmg per100 g tolessthan10 mg S the tolerance exemption expression in 40 CFR180.1001( d) is for use in pesticide products of "mixed phytosterols (consisting of campest erol, sitosterol, and stigmasterol, with minor amounts of associated plant sterols) derived from edible vegetable oils" as a surfactant S most information describes potential benefits derived from dietary consumption­ mixed phytosterols and phytosterol esters lower total blood cholesterol and LDL­ C; it is believed that phytosterols interfere with dietary and endogenous (biliary) cholesterol absorption 8. Soapbark (Quillaja Saponin): (CAS: 1393­ 03­ 9) (List 3) S derived from soapbark tree S contains saponins which are natural detergents/ surfactants that have been used to make soap and used as a foaming agent in certain beverages (like root beer) S permitted as a food additive permitted for direct addition to food for human consumption (21 CFR 172.510) S liquid solutions and dusts reported to cause reversible eye irritation and respiratory sensitization S no adverse effect on death rate or incidence of histopathological findings (including tumors) were observed in mice (both sexes) fed quillaja extract for 84 weeks; at high dose there was decreased body weight gain and differences in hematological examinations and in some absolute and relative organ weights of both sexes Soap bark may be associated with formulations of fire retardants which may have ecological impacts. After consultation with OPPT and using Structural Activity Relationships (SARs) the IIFG believes that these compounds are of low concern for ecotoxicity. Therefore, the IIFG believes that no significant adverse ecological effects are anticipated from exposure to soapbark. 9. Wool Fat (anhydrous lanolin): (CAS: 8006­ 54­ 0) (List 4A­ lanolin) S lanolin is a greasy, yellow substance extracted fromsheep wool; a mixture of cholesterol and Page 7 of 15 the esters of several fatty acids S anhydrous lanolin refers to lanolin which contains less than 0. 25% water S used as an ointment base in cosmetics and pharmaceuticals, as a lubricant, and in finishing and preserving leather; also a constituent of some varnishes and paint S lanolin is regulated by FDAas a food additive permitted for direct addition to food for human consumption (21 CFR 172.615), as well as an indirect food additive (21 CFR Parts 175­ 178) S dermal sensitivity to lanolin has been reported, with a high incidence of lanolin allergy amongst eczema patients; ToxNet reports that lanolin should not be used in ointments intended for use by sensitive individuals S lanolin is considered practically non­ toxic by the oral route, according to ToxNet. S pesticidal uses of lanolin as an active ingredient were canceled in 1998 as there were no active product registrations containing the substance S "lanolin" (CAS: 8020­ 84­ 6) is classified as List 4A The focus group believes that this substance is not an allergen, but that there was individual sensitivity to the substance. 10. Castor oil: (CAS: 8001­ 79­ 4) (List 4B) S a natural oil obtained from the seed of the castor bean; after the hulls are removed the seeds are cold pressed S medicinal castor oil is prepared from the yield of the first pressing; this is used as a purgative and laxative; oil from the second pressing is used as a lubricant for machinery, as a softening agent in making artificial leather, in the dressing of genuine leather, in brake fluids, and in paints and plastic materials S FDA direct food additive permitted in food for human consumption, as a releasing and antisticking agent, not to exceed 500 ppmin hard candy (21 CFR 172.876); as a natural flavoring substance or substance used in conjunction with flavors (172.510); and as an indirect food additive (numerous citations in 21 CFR Parts 175­ 178); also used in cosmetics and pharmaceuticals S EPA FIFRA 25b active ingredient S Irritating to rabbit skin; slightly toxic by oral route. Another source considers castor oil to be "moderately toxic" by ingestion. Contraindicated for pregnant women; overdose has caused stillbirth and kidney damage. As referenced on National Toxicology Program's (NTP) web site, animal feeding studies (up to 10% in diet for 13 wks.) in rats and mice resulted in no significant adverse effects. Genotoxicity studies were negative for mutation induction in Salmonella typhimurium, for induction of sister chromatid exchanges and for induction of micro nuclei in mice peripheral blood erythrocytes. Dietary exposure to residues of castor oil from pesticidal use as an inert ingredient will not approach levels regulated by FDA as a direct or indirect food additive or ingredient in cosmetics. 11. Hydrogenated Castor Oil: (CAS: 8001­ 78­ 3) (List 3) Page 8 of 15 S manufactured by hydrogenation of castor oil in the presence of nickel catalyst with pressure and temperature; a hard, brittle wax that is extremely insoluble and is well suited for products needing resistance to water, oils, petroleum, and petroleum derivatives S mainly used in manufacturing greases, but also used in paper coatings for food packaging The tolerance exemption in 40 CFR 180.1036 for hydrogenated castor oil reads as follows: "The adhesive hydrogenated castor oil is exempt from the requirement of a tolerance for residues in or on the raw agricultural commodity cottonseed when used as an inert adhesive for formulations of the attractant gossyplure to disrupt the mating of the pink bollworm." 12. Boiled Linseed Oil: (CAS: 8001­ 26­ 1) (List 4A­ linseed oil) S an amber­ colored, fatty oil extracted from the cotyledons and inner coats of the linseed, the seed of the flax plant (Linum usitatissimum); also known as flaxseed oil S raw oil is pale in color and practically odorless and t asteless; boiled oil is darker and has a bitter taste and unpleasant odor S used as a drying agent in paints, varnishes, adhesives, inks and resins S linseed oil (not boiled) is an EPA FIFRA 25b active ingredient S linseed oil (not boiled) is an FDA prior sanctioned food ingredient; "substances classified as drying oils, when migrating fromfood­ packaging material (as components of finished resins) shall include... linseed oil" (21 CFR 181.26) S according to ToxNet, boiled linseed oil should not be taken internally, due to the addition of lead and other toxic element; the boiled oil may cause skin, eye and respiratory tract irritation through the inhalation route. Consumption of boiled linseed oil is contraindicated since lead, manganese and/ or cobalt is often added S rats fed boiled linseed oil during lactation and gestation had most offspring die within 3 days of birth: 6­ month old Wistar rats were fed boiled linseed oil during gestation and lactation (compared to a control group fed fresh linseed oil or peanut oil); mortality in the young was higher than normal, it was assumed cyclic monomers det ect ed in the liver fatty acids were responsible for toxicity in the boiled oil S the fresh oil does not have the toxicity concerns that are associated with the boiled oil The tolerance exemption in 40 CFR 180.1056 for boiled linseed oil reads as follows: "Boiled linseed oil (containing no more than 0.33 percent manganese naphthenate and no more than 0.33 percent cobalt naphthenate) is exempt from the requirement of a tolerance when used as a coating agent for S ethyl hexahydro­ 1H­ azepine­ 1­ carbothioate. No more than 15 percent of the pesticide formulation may consist of `boiled linseed oil. ' This exemption is limited to use on rice before edible parts form." 13. Carrageenan: (CAS: 9000­ 07­ 1) (List 4A) S derived from red algae S used as a thickener/ stabilizer in foods such as chocolate, milk, ice cream, pudding, yogurt, Page 9 of 15 frostings and cream soups S FDA direct food additive (21 CFR 172.620) and a substance generally recognized as safe by FDA (21 CFR 182.7255) S natural carrageenan, which has a molecular weight between 100,000 and 1, 000,000 can be chemically altered to form degraded carrageenan; degraded carrageenan has a molecular weight between 20,000 and 30,000, and has demonstrated significantly higher toxicity in animal studies, including malignancies in the gastrointestinal tract; degradation may occur in the human body S considered to be a "water absorbing polymer" S algin gum (CAS: 9049­ 05­ 2), or calcium carrageenan, is included on List 3 Carrageenan will be further evaluated using a more formal (Tier 2) assessment process. 14. Dextrin: (CAS: 9004­ 53­ 9) (List 4A), Corn Dextrin S natural polymer used clinically as a peritoneal dialysis solution and as a controlled drug delivery formulation; also used in distilleries, breweries, and the manufacture of cotton goods, rayon, paper products, adhesives, explosives and steel S acute toxicity includes skin irritation, as well as inhalation and ingestion hazard (large amounts may cause gastro­ intestinal upset). Another source reported no adverse health effects expected from inhalation or skin contact­ however, dust may cause eye irritation (mechanical). Negative in a series of 10 mutagenicity studies (1992) which tested "indigestible dextrin". S direct food additive affirmed as GRAS (21 CFR 184.1277) 15. Furcelleran: (CAS: 9000­ 21­ 9) S extracted fromFurcellaria fastigiata (red seaweed) and used as an emulsifier, stabilizer, and thickener in foods S FDA direct food additive (21 CFR 172.655) S a potential "water absorbing polymer" Furcelleran will be further evaluated using a more formal (Tier 2) assessment process due to its relationship to carrageenan. 16. Guar Gum: (CAS: 9000­ 30­ 0) (List 4A) S used as a surfactant and related adjuvant of surfactant; also used as a stabilizer/ thickener in foods, as a binding and disintegrating agent in tablets, and in suspensions, emulsions, lotions, creams, and toothpaste S a direct food additive affirmed as GRAS by FDA, with maximum permitted usage levels in foods (21 CFR 184.1339) S acute toxicity: LD 50 (oral) rat ­ 6770 mg/ kg, mouse ­ 8100 mg/ kg, rabbit ­ 7000 mg/ kg, hamster ­ 6000 mg/ kg S guar dust may cause respiratory tract irritation and sensitization; and that some individuals may develop a respiratory allergic response, or persons with a history of respiratory allergies Page 10 of 15 may have those conditions aggravated, by exposure to guar dust. Negative in a series of 15 mutagenicity studies (1992), as well as four 1982 studies, and one pre­ 1980 study. Negative in rat (F344) and mouse (B6C3F1 ) in a National Cancer Institute (NCI) carcinogenesis bioassay S considered to be a "water absorbing polymer" S FDAhas reportedly banned the use of guar gumas an active ingredient in drugs. Because this complex carbohydrate swells when wet it had been used in weight­ loss products to produce a feeling of fullness. One brand resulted in hospitalization of 10 patients and one death from a blood clot after surgery to remove a throat blockage. Guar gum can cause diarrhea, vomiting, bloating, and intestinal blockages. 17. Gum Arabic (Acacia): (CAS: 9000­ 01­ 5) (List 4A) S A neutral, or slightly acidic, salt of a complex polysaccharide; derived from acacia tree sap S used in pharmaceuticals, adhesives, inks, textile printing, cosmetics, and as a thickening agent and colloidal in stabilizer in confectionary and food products; also used extensively in flavor emulsions S a direct food additive affirmed as GRAS by FDA (21 CFR 184.1330) S gum arabic is considered to have low oral toxicity with LD50 values reported as follows: oral ­ >16 g/ kg ­ rat; >16 g/ kg ­ mouse; 8 g/ kg ­ rabbit; and > 18 g/ kg ­ hamster. Estimates of the probable oral lethal dose for humans are > 15,000 mg/ kg S gum arabic has been shown to be a severe allergen in the workplace and has led to skin lesions and sever asthmatic attacks in humans upon exposure to the dust S a 1971 study of 37 German printing workers exposed to gum arabic mist reported allergic reactions [" Printer's Asthma"], as well as well­ defined radiological findings in the lungs, with occasional chronic bronchitis and pulmonary congestion; hypersensitivity reactions upon dermal exposure to the dust have also been observed S two MSDS's reported eye irritation, one as severe with redness and pain S a potential "water absorbing polymer" In a subchronic 13­ week oral mouse study no compound­ related effects were observed. In a 13­ week oral rat study no compound­ related effects were observed except for a reduction in feed consumption at the two highest dose in males and all doses in females, as compared with the control animals. The author reported NOAELs of 5, 200 mg/ kg/ day and 13,800 mg/ kg/ day, respectively, for male and female rats. The date of this study was reported as 1982. In an NTP cancer study, there were no statistically significant differences obtained from oral administration of gumarabic when control rates were compared to those observed in treated groups. The IIFG believes that while there are no concerns for exposure via the oral route, there could be a contact or a mist problem for occupational exposure, based on the presented information. 18. Lecithin: (CAS: 8002­ 43­ 5) (List 4A) S a naturally occurring mixture of the phosphatides of choline, ethanolamine, and inositol; Page 11 of 15 isolated as a gum following hydration of solvent extracted soy, safflower, or corn oils. S widely used in food and industrial applications; affirmed by FDA as GRAS, and used in foods with no limitations other than current good manufacturing practice (21 CFR 184.1400) S in many products, lecithin is derived from soybean S acute toxicity: may cause transient eye irritation. Also, a 2­ day study of mice exposed to aerosolized lecithin reported lungs showing focal endothelial cell swelling and interstitial edema Many products containing lecithin are derived from soy. While soybeans are considered to be allergens, the information available to the Agency indicates that the allergen invoking compound is not carried over in the extraction process that produces highly refined soybean oil. Therefore there are no allergen concerns associated with lecithin even though it is processed from soybeans. Studies support that most soy­ allergic individuals can safely eat products containing soy lecithin without experiencing any allergic reaction. Tolerance reassessment and list classification decisions will also apply to "lecithins, soya" (CAS: 8030­ 76­ 0). 19. Sodium Alginate: (CAS: 9005­ 38­ 3) S the sodiumsalt of alginic acid; produced from brown algae (Phaeophyceae) by processing to form alginic acid, then reacted with sodium hydroxide S a combustible, colorless or yellowish granular or powdery solid; insoluble in alcohol and ether; forms a viscous colloid in water S affirmed as GRAS by FDA, with maximum permitted usage levels in foods (21 CFR 184.1724) S used as a foamstabilizer in brewing, a thickener and suspending agent in soft drinks, a binding agent in pharmaceutical tablets, and as a stabilizer in numerous food items S other than minor irritation of eyes and skin in some individuals, no other health effects are known to exist S according to ToxNet, practically non­ toxic S considered to be a "water absorbing polymer" 20. Xanthan Gum: (CAS: 11138­ 66­ 2) (List 4A) S a water soluble, polysaccharide gum derived from Xanthomonas campestris; molecular weight between five and ten million S used in salad dressings and other products, and as a carrier for controlled release drugs S FDA direct food additive (21 CFR 172.695) S a probable "water absorbing polymer", based on similar properties to the other gums in this group 21. Locust Bean Gum: (CAS: 9000­ 40­ 2) (List 4B) S also known as carob gum; derived from the carob seed S affirmed GRAS by FDA (21 CFR 184.1343) Page 12 of 15 S used as a stabilizer, thickener, and binder in foods and cosmetics; a pharmaceutic agent; and in paints, textiles and paper manufacturing S acute oral LD50 values were reported as follows: 13 gm/ kg in rats and mice; 9100 mg/ kg in rabbits; and 10 gm/ kg in hamsters. When heated to decomposition this compound emits acrid smoke and fumes. Reported negative for both sexes of rats and mice in a NTP Carcinogenesis Bioassay. No further toxicity/ hazard information was reported. S considered to be a "water absorbing polymer" Discussion Tolerance reassessment decisions for camphor, carrageenan, and furcelleran have been deferred until these substances can be further evaluated. For the remaining substances, there are no concerns for ecotoxicity, or for most dietary or dermal human exposures. Tolerance exemptions can be reassessed for these 25 substances. While there is the potential for adverse effects to wood flour or wood dust fromthe inhalation route, individuals are not likely to be exposed at the levels described by OSHA from pesticidal application of products containing wood dust or wood flour as an inert ingredient. OSHA PELs reflect full time jobs, that may lead to daily exposures (often indoors) over the course of many years; it is likely that these worker activities will create the possibility of respirable sized particles as a result of routine operations. By contrast, mixing/ loading and applying granular or dust pesticide products that have these same wood dust will not have the same level or types of exposures. The first major difference is the time and duration of exposure. For most cases the applicators will not be exposed on a daily basis. In fact, it is much more likely that pesticide handlers, both professional and homeowners, will only have short­ term exposures (from 1day/ month to 1day/ year). Additionally, the exposure to the substance as an inert ingredient is likely to be significantly less than levels experienced through occupational exposure. Several of the plant products used as thickeners have been identified as being water absorbing polymers. This termrefers to substances which are able to absorb their weight in water, such as guar gum, sodiumalginate, and locust bean gum. Other related substances such as xanthan gum and gum arabic are also likely to have this property based on similar characteristics. These chemicals have been identified as posing moderate concern for human health through the inhalation route if the particle size is sufficiently small to be inhaled into deep lungs (< 10 microns), and if the substance is sufficiently present in the formulation. However, in their use as thickeners in pesticide formulations, they will have already absorbed water and "swelled" to a larger particle size, and will therefore not be of toxicological concern through an inhalation route. The CAS Registry Number on List 3 for "licorice extract" is 97676­ 23­ 8. The CAS Number for "licorice extract" referenced in both ToxNet and by FDA is 68916­ 18­ 7. Using the National Institutes of Health, National Library of Medicine's, ChemIDplus Locator webpage, the CAS Number 97676­ 23­ 8 refers to the term" licorice oils" and the proper CAS Number for licorice extract Page 13 of 15 is 68916­ 18­ 7. Confusion around these terms will be cleared up by expanding the List classification term to include licorice and its derivatives. Currently, boiled linseed oil is not included on any of the inert ingredient Lists, but has specific tolerance exemption language included in 180.1056; "linseed oil" (presumably unboiled) is included in List 4A. It appears that the CAS number is the same regardless of whether the substance is boiled or unboiled. IIFG Determinations By consensus there were no objections to the following: All existing tolerance exemptions for the plant and animal byproduct substances listed below can be reassessed. In 40 CFR180.1001( c): animal glue; coconut shells; coffee grounds; corn dextrin; dextrin; guar gum; gum arabic (acacia); lecithin; licorice root; sodium alginate; sperm oil; walnut shells; wood flour; and xanthan gum. In 40 CFR 180.1001( d): Douglas fir bark, ground; locust bean gum; mixed phytosterols (consisting of campesterol, sitosterol, and stigmasterol, with minor amounts of plant sterols) derived from edible vegetable oils; soapbark (quillaja); and wool fat (anhydrous lanolin). In 180.1001( e): castor oil, U. S. P.; dextrin; sodiumalginate; and xanthan gum. In 180.1036 and 180.1056, hydrogenated castor oil and boiled linseed oil, respectively. Terms to be expanded or consolidated as part of the tolerance reassessment decision are as follows: 1. "Wool fat (anhydrous lanolin)" in 180.1001( d) shall become "lanolin (including anhydrous lanolin)" 2. "Dextrin" and "corn dextrin" in 180.1001( c) (both terms) and 180.1001( e) (dextrin only) will be combined into the term "dextrin (including corn dextrin)" and listed in both paragraphs. 3. The tolerance reassessment decision for "lecithin" will also apply to "lecithins, soya" and a tolerance exemption for this substance can be established. By consensus the following List classifications have been determined: 1. Animal glue: Add to List 4A; contact allergenic reactions are likely to be reversible and the exposure levels and durations likely fromuse as an inert ingredient in pesticidal formulations do not justify classifying this substance as List 4B. 2. Coconut shells, walnut shells, and Douglas fir bark: List 4A based on the fact that these substances are naturally occurring and processing fromtheir natural formis minimal for their use as inert ingredients. Page 14 of 15 3. Coffee grounds: List 4A, no concern expected to humans or the environment. 4. Licorice root: Reclassify "licorice extract" from List 3 to List 4B, and change the List classification term to "Licorice and licorice derivatives" such that licorice root, licorice oils, and licorice extract are all reflected. CAS numbers for both licorice extract and licorice oils should be listed. Licorice is widely used in foods and pharmaceuticals; toxicity data for licorice extract suggests some chronic effects at high doses (doses not likelyto be experienced through inert ingredient use in pesticide formulations). 5. Spermoil: Classify as List 4A; derived from whale blubber, no incidence data exist in OPP's Incident Data System database for this substance. 6. Wood flour: Classify as List 4A; literature suggests potential chronic exposure concerns for wood dust frominhalation route in occupational setting. These exposure durations and levels will not be realized from use of wood dust in a pesticide formulated product. 7. Mixed phytosterols: Classify as List 4A based on the fact that no concerns were identified. 8. Soapbark (Quillaja Saponin): Reclassify from List 3 to List 4A; based on SAR, low concern for ecotoxicity, no concerns for human health. 9. Wool fat (anhydrous lanolin): Currently the term "lanolin" is included on List 4A­ it should remain on list 4A but the term should be expanded to "lanolin (including anhydrous lanolin)" and list both CAS numbers. There is no toxicologically significant difference between the two substances. 10. Castor oil: Reclassify from List 4B to List 4A. 11. Hydrogenated castor oil: Reclassify from List 3 to List 4B. 12. Boiled linseed oil: "Linseed oil, boiled" should be classified as List 4B. The existing "linseed oil" term in List 4A should remain on List 4A but be changed to specify "unboiled". 13. Dextrin and corn dextrin: Currently only dextrin in included in List 4A. Both should be reflected on List 4A under the term "dextrin (including corn dextrin)". 14. Guar gum: Keep on List 4A. 15. Gumarabic (Acacia): Reclassify fromList 4Ato List 4B, based on contact exposure concerns and occupational concerns with gum arabic mist. 16. Lecithin: Keep at List 4A; the pesticidal use of this substance is not expected to result in exposures near that from existing use of lecithin as a dietary supplement. "Lecithins, soya" Page 15 of 15 (CAS: 8030­ 76­ 0) should be added to List 4A. 17. Sodium Alginate: Add to List 4A; while this substance may be applied to water through use in fire retardant products, SARanalysis suggests that no significant adverse ecological effects are anticipated from exposure to this substance. 18. Xanthan gum: Keep on List 4A. 19. Locust Bean Gum: This substance is currently on List 4B, yet is added to all types of food. The group recommended that this compound be moved to List 4A.

epa

2024-06-07T20:31:44.213134

regulations

EPA-HQ-OPP-2002-0282-0001

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES October 8, 2002 Dear Colleagues and Citizens: I would like to take this opportunity to invite you to provide input to EPA's Strategic Plan, which will guide resource and program decisions over the next five years. EPA developed its first Strategic Plan in 1997 and revised it in 2000. EPA's next Strategic Plan will cover resource and program directions from FY2003 through FY2008. As we establish our strategic goals for the next 5 years and develop the strategies we will employ to achieve our objectives, we want to be sure that we have reached a broad range of interested and affected parties, benefitted from their input and advice, and prepared a sound, practical Plan that addresses national priorities for protecting the environment and human health and will achieve results. In particular, we are interested in your views on the following questions: 1. What are the most important human health and environmental challenges related to pesticides, industrial chemicals and pollution prevention that EPA should address in the next 10 years? 2. What specific strategies and activities should EPA strengthen or initiate to address those challenges? 3. What specific accomplishments should EPA commit to achieve by FY2008 or beyond related to pesticides and industrial chemicals? Please be as quantitative and outcome­ oriented as possible in your suggestions. 4. What do you think are the most important changes EPA could make to become more effective and efficient in the pesticide, industrial chemicals and pollution prevention program areas? 5. What other suggestions do you have regarding future challenges, accomplishments, strategies, activities, effectiveness and efficiency of other EPA programs (e. g., water, air, waste, research, enforcement, etc.)? 6. What organizational challenges are you currently facing that impact your organization's ability to carry out its mission? You can provide comments to us through EPA's E­ Docket at http:// www. epa. gov/ edocket. On this site, you will be able to access EPA's current Strategic Plan, including OPPTS' current priorities under Goal 3 (Safe Food), Goal 4 (Preventing Pollution and Reducing Risk in Communities, Homes, Workplaces and Ecosystems) and Goal 6 (Reduction of Global and Cross­ Border Environmental Risks). In order to ensure that we can consider your input for the first draft of the next strategic plan, we ask that you provide input by November 11, 2002. Over the years, we have achieved many environmental successes by working together. While we have many challenges ahead, I am confident that by continuing our work together, we can continue this record of achievement. Sincerely, Stephen L. Johnson Assistant Administrator Office of Prevention, Pesticides and Toxic Substances Goals, Objectives and Subobjectives in Current (FY2000) EPA Strategic Plan Goal 3: Safe Food The foods Americans eat will be free from unsafe pesticide residues. Particular attention will be given to protecting sub­ populations that may be more susceptible to adverse effects of pesticides or have higher dietary exposures to pesticide residues. These include children and people whose diets include large amounts of noncommercial foods. Objectives By 2006, reduce public health risk from pesticide residues in food from pre­ Food Quality Protection Act (FQPA) levels (pre­ 1996). By 2008, use on food of current pesticides that do not meet the new statutory standard of "reasonable certainty of no harm" will be eliminated. By 2006, at least 7 percent of agricultural pesticide acre treatments will use reduced­ risk pesticides. Subobjectives By 2006, residues of carcinogenic and cholinesterase inhibiting neurotoxic pesticides on the foods most frequently eaten by children will be reduced by 50 percent from baseline levels determined using data from 1994 through 1996. Through 2006, all registration activities (including registration of new conventional chemicals, new uses, "me­ toos," antimicrobials, etc.) will meet the applicable standards mandated by law. By 2008, active ingredient and product reregistration will be completed for all pesticides subject to reregistration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)­ 88. By 2006, 100 percent of the reassessments of pesticide residue tolerances mandated by FQPA will be completed. By 2006, Registration Review will be fully established and operational. Through 2008, provide research results to support the new FQPA regulatory standard of "reasonable certainty of no harm" for pesticides used on food. Goal 4 Risk in Communities, Homes, Workplaces, and Ecosystems Pollution prevention and risk management strategies aimed at eliminating, reducing, or minimizing emissions and contamination will result in cleaner and safer environments in which all Americans can reside, work, and enjoy life. EPA will safeguard ecosystems and promote the health of natural communities that are integral to the quality of life in this nation. Objectives By 2005, public and ecosystem risk from pesticides will be reduced through migration to lowerrisk pesticides and pesticide management practices, improving education of the public and at­ risk workers, and forming "pesticide environmental partnerships" with pesticide user groups. By 2007, significantly reduce the incidence of childhood lead poisoning and reduce risks associated with polychlorinated biphenyls (PCBs), mercury, dioxin, and other toxic chemicals of national concern. By 2007, prevent or restrict introduction into commerce of chemicals that pose risks to workers, consumers, or the environment and continue screening and evaluating chemicals already in commerce for potential risk. By 2005, facilitate the prevention, reduction, and recycling of toxic chemicals and municipal solid wastes, including PBTs. In particular, reduce by 20 percent the actual (from 1992 levels) and by 30 percent the production­ adjusted (from 1998 levels) quantity of Toxic Release Inventory (TRI) reported toxic pollutants which are released, disposed of, treated, or combusted for energy recovery, half through source reduction. Subobjectives By 2010, reduce by at least 10 percent (from the average 1993 to 1995 levels) the incidence of adverse health effects from pesticide exposures for which individuals required health care. By 2008, reduce potential exposure (as indicated by sales or use volume) to carcinogenic and cholinesterase inhibiting neurotoxic pesticides used in or around residential areas by 50 percent each from 1995 levels for both consumer­ and restricted­ use pesticides. By 2005, reduce by 50 percent from 1995 levels the number of incidents and amount of mortality to terrestrial and aquatic wildlife caused by the 15 pesticides currently responsible for the greatest mortality to such wildlife. Each year, none of the top 15 species on the Office of Pesticide Programs/ Fish and Wildlife Service/ U. S. Department of Agriculture priority list of threatened or endangered species will be jeopardized by exposure to pesticides. By 2005, implement stewardship strategies to reduce pesticide risk by the use of Integrated Pest Management (IPM) through agreements with 80 pesticide user groups. By 2010, detections of the 15 pesticides most frequently found in surface water in the U. S. Geological Survey (USGS) 1994 National Water Quality Assessment (NAWQA) data will be reduced by 50 percent. Any new pesticide registered since 1996 found in USGS 2010 NAWQA data for surface water will have a detection frequency no greater than 30 percent. By 2010, 50 percent of all pesticides with the potential to leach to groundwater will be managed through labeling or other methods to prevent groundwater contamination. By 2007, EPA will reduce the incidence of blood lead levels at or above 10
g/ dL in children between the ages of 1 and 5 years from approximately 900,000 children in 1991 through 1994 to fewer than 200,000. By 2007, EPA will achieve continued reductions in remaining uses of PCBs at concentrations above 500 ppm in transformers and capacitors, retiring from service and safely disposing of 120,000 transformer units and 210,000 capacitor units cumulatively from 2002 through 2007. EPA will also achieve significant reductions in exposures to toxic fibers, mercury, and dioxin. By 2007, EPA will allow no new chemicals for which it receives Pre­ Manufacture Notifications to be introduced into commerce that pose significant unmanaged risks to workers, consumers, or the environment. By 2007, inform the public about potential chemical hazards and risks associated with High Production Volume (HPV) chemicals in commerce by making screening level hazard, as well as limited exposure, data sets publicly available for 90 percent of the approximately 2, 800 HPV chemicals. In addition, EPA, in cooperation with the Organization for Economic Cooperation and Development (OECD), will make publicly available internationally recognized hazard classification determinations for at least one human health and one ecological endpoint for 500 HPV chemicals for which hazard data sets are available. EPA will also make publicly available basic screening level information on endocrine disruption potential for at least 50 HPV chemicals by 2007. By 2007, EPA will promote the use of pollution prevention (P2) for meeting environmental goals by (1) increasing the purchase of environmentally preferable products by the federal government; (2) increasing adoption of environmentally protective business practices such as environmental accounting practices and P2 opportunity assessments; (3) increasing integration of P2 into EPA's regulatory, enforcement, and compliance programs; and (4) reducing the generation of pollutants by facilities assisted by state and tribal P2 programs supported by EPA. By 2007, Design for the Environment (DfE) voluntary partnership risk­ reduction efforts since 1992 will cumulatively lower exposure for more than 4 million workers, and toxic chemical use and wastes in more than 400,000 businesses using more than 750 chemical substances. By 2007, accomplish the following cumulative results through commercialization of green chemistry approaches [as evidenced in nominations submitted for EPA's Green Chemistry Challenge Awards from 1996 (year awards program initiated) through 2007]: elimination of 250 million pounds of hazardous substances from new and existing chemical products and processes; elimination of 25 million gallons of hazardous solvents; savings of 2 billion gallons of water; and savings of 25 billion Btu of energy. By 2005, EPA will utilize multiple tools to reduce use and releases of priority PBTs by preventing the entry of new PBTs into commerce; achieve through voluntary efforts a net reduction of 50 percent (from 1991 levels) in the volume of priority PBTs in hazardous waste streams; and reduce by 50 percent from 1990 levels releases of mercury to air nationwide and to water within the Great Lakes Basin. Goal 6: Reduction of Global and Cross­ Border Environmental Risks The United States will lead other nations in successful, multilateral efforts to reduce significant risks to human health and ecosystems from climate change, stratospheric ozone depletion, and other hazards of international concern. Objectives By 2006, reduce the risks to ecosystems and human health, particularly in tribal and other subsistence­ based communities, from persistent, bioaccumulative toxicants (PBTs) and other selected toxins which circulate in the environment on global and regional scales. Subobjectives By 2006, substantially reduce the global release and long­ range, transboundary movement of PBTs and other selected toxics by characterizing baseline conditions and transport patterns, negotiating key international treaties and initiatives, and engaging in the information exchange and capacity building needed to facilitate the implementation of these treaties and initiatives, especially in key identified source countries. In so doing, reduce the worldwide use of lead in gasoline to below 1993 levels, reduce domestic mercury releases to the air and water from human activities in the United States by 50 percent from 1990 levels, and reduce domestic mercury use by 50 percent from 1995 levels. By 2006, EPA will develop and standardize chemical testing methods, hazard characterization, exposure characterization (including monitoring instrumentation and methods), risk assessment, and good laboratory practices; collect release data through use of pollution release and transfer registers; and share the technical and financial burden of testing and assessing specific chemicals.

epa

2024-06-07T20:31:44.220678

regulations

EPA-HQ-OPP-2002-0283-0001

Notice

Bronopol; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or Food

78459 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ edocket. Title: NSPS for Lime Manufacturing ( 40 CFR part 60, subpart HH) ( OMB Control No. 2060 0063, EPA ICR Number 1167.07). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: The New Source Performance Standards ( NSPS) for Lime Manufacturing Plants were proposed on May 3, 1977 and promulgated on April 26, 1984. These standards apply to each rotary lime kiln used in lime manufacturing, which commenced construction, modification or reconstruction after May 3, 1977. The standards do not apply to facilities used in the manufacture of lime at kraft pulp mills. The purpose of this NSPS is to control the emissions of particulate matter ( PM) from lime manufacturing plants, specifically from the operation of the rotary lime kilns. The standards limit particulate emissions to 0.30 kilogram per megagram ( 0.60 lb/ ton) of stone feed, and limit opacity to 15% when exiting from a dry emission control device. This information is being collected to assure compliance with 40 CFR part 60, subpart HH. There are three types of reporting requirements for owners or operators of facilities under this NSPS: ( 1) Notifications ( e. g., notice for new construction or reconstruction, anticipated and actual startup dates, initial performance test, and demonstration of the CMS); ( 2) a report on the results of the performance test; and ( 3) semiannual reports of instances of occurrence and duration of any startup, shutdown, or malfunctions. The purpose of the notifications are to inform the Agency or delegated authority when a source becomes subject to this standard. Performance tests are conducted to ensure that the new plants operate within the boundaries outlined in the standard. The semiannual reports are used for problem identification, as a check on source operation and maintenance, and for compliance determinations. Under this standard the data collected by the affected industry is retained at the facility for a minimum of two years and made available for inspection by the Administrator. The Administrator has judged that PM emissions from lime manufacturing plants cause or contribute to air pollution that may reasonably be anticipated to endanger public health or welfare. Owners/ operators of lime manufacturing plants must notify EPA of construction, modification, startups, shutdowns, malfunctions and performance test dates, as well as provide reports on the initial performance test and annual excess emissions. The industry costs associated with the information collection activity in the standards are capital costs and O& M costs associated with continuous emissions monitoring and labor costs associated with recordkeeping and reporting. In order to ensure compliance with the standards promulgated to protect public health, adequate reporting and recordkeeping is necessary. In the absence of such information, enforcement personnel would be unable to determine whether the standards are being met on a continuous basis, as required by the Clean Air Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 42 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Lime Manufacturing Plants. Estimated Number of Respondents: 53. Frequency of Response: On occasion, initial, and semiannual. Estimated Total Annual Hour Burden: 4,434 hours. Estimated Total Annual Cost: $ 91,500. Changes in the Estimates: There is an increase of 244 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This increase is due to an increase in the number of existing facilities subject to this standard resulting from the availability of more accurate data. Dated: December 10, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32399 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0283; FRL 7277 5] Bronopol; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0283, must be received on or before January 23, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8380; e­ mail address: gandhi. bipin@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, pesticide manufacturer, or antimicrobial pesticide manufacturer. Potentially affected entities may include, but are not limited to: Industry ( NAICS 111), e. g., Crop production. Industry ( NAICS 112), e. g., Animal production. Industry ( NAICS 311), e. g., Food manufacturing. VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78460 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices Industry ( NAICS 32532), e. g., Pesticide manufacturing. Industry ( NAICS 32561), e. g., Antimicrobial pesticide. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0283. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0283. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0283. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78461 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0283. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0283. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 10, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. PP 2E6475 EPA has received a pesticide petition ( PP 2E6475) from BASF Corporation: 3000 Continental Drive ­ North, Mount Olive, NJ 07828 1234; proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for 2­ bromo­ 2­ nitro­ 1,3­ propanediol ( Bronopol) ( CAS Reg. No. 52 51 7) in or on all raw agricultural commodities when used as an in­ can preservative in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. Residue chemistry data are not generally required by EPA regarding tolerance exemption petitions. Consequently no plant metabolism data have been generated. 2. Analytical method. Since this petition is for an exemption from the requirement of a tolerance, an enforcement analytical method for 2­ bromo­ 2­ nitro­ 1, 3­ propanediol is not needed. 3. Magnitude of residues. Based on the proposed amount of 2­ bromo­ 2­ nitro­ 1,3­ propanediol to be used in the final products ( 0.04% or less by weight of the total formulation) and the recommended frequency and rates of application to growing crops, raw agricultural commodities after harvest, and animals, the residues are expected to be essentially undetectable and not toxicologically significant. B. Toxicological Profile 1. Acute toxicity. Bronopol was given as single oral doses of 200, 280, 390, 550, or 770 mg/ kg, as a solution in distilled water, to groups of ten male and ten female rats. The rats were observed for a seven­ day period. Overt signs of toxicity were seen immediately after dosing with 280 mg/ kg or more, and within 1 hour in males given 200 mg/ kg. The signs included sedation, wheezing, gasping, nasal exudate, cyanosis, increased salivation and ataxia. Animals given 550 or 770 mg/ kg VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78462 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices also had slow or labored respiration, and two females became prostrate. Most deaths occurred within 19 hours after dosing, but some occurred up to 72 hours. There were no gross abnormalities at autopsy of the decedents or in animals killed at the end of the study. The LD50 in male rats was 307 mg/ kg and in female rats was 342 mg/ kg. In a further oral study groups of ten male rats were given single doses of Bronopol at 36, 54, 80, 120, 270, 400, or 600 mg/ kg, as a suspension in 0.4% aqueous Cellosize solution. The rats were observed for up to ten days after treatment. Overt signs of toxicity were seen within 30 minutes after dosing with 80 mg/ kg or more, and included wheezing, gasping or labored respiration and nasal exudate. Animals in the higher dose groups were inactive and adopted a low or hunched body position. Deaths occurred in these groups up to five days after treatment; macroscopic findings in the decedents included evidence of gastrointestinal irritation at 120 mg/ kg or more, enlarged and dark red adrenals in some animals given 400 or 600 mg/ kg, small spleens in a few rats given 80 or 120 mg/ kg, and pale areas on the livers at 600 mg/ kg. At terminal autopsy, one animal given 400 mg/ kg also had a small spleen. Statistical analysis of the mortality data indicated that the LD50 was 254 mg/ kg. In an acute inhalation study a group of six rats and two groups of eight rats were exposed for 6­ hour periods to Bronopol dust at nominal concentrations of 5, 0.5, or 0.05 mg per liter air respectively. The animals were then kept under observation for up to 14 days. Exposure of rats to 5 mg dust per liter air caused severe eye irritation, dyspnea and loss of bodyweight. Exposure to 0.5 mg dust per liter air caused only slight eye irritation and mild dyspnea, while no definite signs of irritation were observed in animals exposed to 0.05 mg dust per air. In a second inhalation study four groups of 10 rats ( 5 males and 5 females) were exposed to Bronopol at 0 ( filtered air negative control), 0.038, 0.089 or 0.588 mg/ by inhalation ( nose­ only) over a period of 4 hours. Exposure was followed by an observation period of 14 days. In the high dose group one animal died overnight after exposure, and 2 more animals were killed during the following day because of severe eye inflammation. Signs of marked irritancy were recorded in high dose animals but disappeared by the third observation day. Minor treatment­ related signs ( piloerection and hunched posture) were observed on the day of treatment in some intermediate dose rats. There was no effect in the low dose group. There were no treatment­ related effects on body weight or treatment­ related pathological findings except for local dermatitis and ulceration in 2 high dose animals possibly attributable to dermal exposure to the test article. Several studies as summarized below determined 2­ bromo­ 2­ nitro­ 1,3­ propanediol to be irritant to the eye. Bronopol in polyethylene glycol 300 0.1 ml volumes of 0.5 or 2% Bronopol in polyethylene glycol 300 were instilled into one eye of each of six rabbits, three rabbits per concentration. The other eye in each case was treated with solvent only. The 2% solution was instilled only once, whereas the 0.5% solution was instilled on four successive days. The 2% solution of Bronopol in polyethylene glycol 300, instilled once, caused moderate inflammation and slight conjunctival edema which subsided after 5 hours. The 0.5% solution, instilled on four successive days, had effects similar to those produced by the solvent alone. Bronopol in saline ­ Two drops of a solution containing 0.5% w/ v Bronopol in normal saline were applied to one eye of three New Zealand White rabbits once daily on four successive days. The other eye ( control) of each rabbit was treated with normal saline. The eyes were examined for irritation at 15 and 30 minutes, and at 1, 2, 3, 4, and 24 hours after treatment each day. One rabbit developed moderate inflammation and very slight edema of the conjunctiva between two and four hours after the first application, but this subsided within 24 hours. No other reactions were observed. Bronopol in polyethylene glycol 400 ­ One drop of Bronopol at 0 ( vehicle control), 0.5, 2, or 5% in polyethylene glycol 400 was added to one eye of 12 rabbits, 3 animals per test concentration. The other eye of each rabbit was left untreated. After 24 hours the eyes were irrigated with 300 ml of lukewarm water. Ocular reactions were assessed according to the FDA method at 1, 24, 48, and 72 hours, and then 7, 14, and 21 days after treatment. Immediately after treatment, with all the solutions, most rabbits exhibited head shaking and blinking and/ or rubbing the treated eye. After 1 hour all the animals developed conjunctival reactions which had largely subsided by 24 hours, except in the most severely affected cases. One rabbit treated with 5% Bronopol had conjunctival reactions that persisted for 72 hours. The lower concentrations produced less severe and less persistent conjunctival reactions, and none of the concentrations elicited reactions in the cornea or iris. It was concluded that Bronopol in polyethylene glycol 400 was irritant at 5% but not at 2 or 0.5%, when instilled once only into the eye of the New Zealand White rabbit. Bronopol is also irritant to the skin. In a cumulative irritancy study dilutions of Bronopol at 0 ( vehicle control), 0.1, 0.5, 1, 2.5, and 5% in petrolatum was applied daily for 21 days to the same site on the back of 8 men. The treatment sites were occluded. Readings were made daily on a scale of 0 to 4. The skin irritancy threshold concentration of Bronopol was approximately 0.5 to 1.0%. To determine if the subjects had been sensitized, they were further elicited after a 10­ day rest period. Two subjects reacted at 0.5 and 1% Bronopol. One reacted at 0.1%. These men received a product use test consisting of applications ( without patching) to the cubital fossa twice daily for 7 days. These were negative. In a single, 4 hour, semi­ occluded dermal application of undiluted Bronopol to the skin of six rabbits produced severe dermal reactions, including eschar formation, necrosis and severe edema. Other adverse dermal reactions noted were slight hemorrhage of the dermal capillaries, blanching or brown discoloration of the skin, desquamation and scar tissue. The absence of fur growth was also occasionally noted on day fourteen with further effects indicative of corrosion. A primary irritation index of 6.2 was produced and evidence of corrosive effects were noted fourteen days after treatment. Undiluted Bronopol was found to be a severe irritant/ corrosive to rabbit skin. An acute rabbit dermal toxicity study gave a dermal LD50 of > 2,000 mg/ kg body weight. The study was based on the EEC, OECD and EPA/ OPPTS guidelines. A single oral dose of 2,000 mg/ kg body weight of the test material preparation in 0.5% Tylose was applied in a group of ten rats ( five males and five females) to the clipped epidermis ( dorsal and dorsolateral parts of the trunk) and covered by a semi occlusive dressing for 24 hours. No mortality occurred. Signs of toxicity noted in the 2,000 mg/ kg groups comprised poor general state, dyspnea and apathy. Findings were observed until including study day 1. The following skin effects were observed at the application site: white discoloration, erythema, edema, eczematoid skin change, scaling, and crust formation. Findings were observed until termination of the study. The animals did not gain weight during the first post exposure observation week but restarted to gain weight thereafter. No abnormalities were noted in the animals necropsied at the end of the study, VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78463 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices except in the skin of the application site, where incrustation and full thickness necrosis ( 9/ 10 animals) was observed. Under the conditions of this study, the acute dermal median lethal dose ( LD50) of the test substance was found to be greater than 2000 mg/ kg body weight for male and female animals. 2­ bromo­ 2­ nitro­ 1,3­ propanediol is classed as a weak skin sensitizer as indicated in four Magnusson and Kligman guinea pig skin sensitization studies as summarized below. Study 1 ­ The test method was the Magnusson and Kligman guinea pig maximization test, but using 10 test animals, 4 treated controls and 4 untreated controls. Induction in the test animals was by intradermal injections of 0.03% w/ v Bronopol in saline and Complete Freunds Adjuvant in the shoulder region. The induction process was supplemented 7 days later by 1.5% w/ v Bronopol in distilled water applied under occlusion to the injection sites. Fourteen days later the animals were challenged on the shaved flank by occluded patch with 0.4% w/ v Bronopol in distilled water. Twentyfour hours after the challenge the patch was removed and the reaction site examined 24 and 48 hours after removal. A further 3 challenges were made at either 1 or 2 week intervals. The treated controls were 4 guinea pigs treated the same as the test animals except that the test substance was omitted from the intradermal injection and the covered patch induction procedures. At each challenge 4 previously untreated animals were challenged as per the test animals. This group formed the untreated control. In the Magnusson and Kligman Maximization test, sensitization is normally assessed after one challenge. At this stage in this test there was no sensitization. One animal was sensitized after 2 challenges and a further animal after 3 challenges. In this test 2/ 10 animals sensitized after one challenge is classified as a mild sensitizer ( Grade II), but since 3 challenges were necessary before 2/ 10 animals were sensitized, the sensitization potential must be regarded as less than mild, hence Bronopol was found to be a weak sensitizer by this method. Study 2 ­ Induction was carried out as in Study 1 except that 9 guinea pigs were used; induction was 0.02% Bronopol in saline and induction supplementation was 6 7 days later with 5% Bronopol in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 1% Bronopol in saline. One week later the animals were subjected to a crossreaction challenge with 2% formalin. Further challenges were made with Bronopol and formalin after 2 and 3 weeks. Any challenge reactions were recorded after 24 and 48 hours. 2/ 9 animals showed sensitization reactions to Bronopol at challenge 1. Animals were not challenged with Bronopol at challenge 2. No sensitization reactions were seen at challenge 3 and 1/ 9 animals showed an equivocal reaction at challenge 4. 1/ 9 animals showed an equivocal reaction to formalin at challenge 2, but there was no evidence of cross­ reaction at challenges 3 and 4. It was concluded that Bronopol was a weak sensitizer under the conditions of this test. There was no significant evidence of cross­ reaction to challenge with formalin. Study 3 ­ Induction was carried out as in Study 1 except that 9 guinea pigs were used; induction was 0.02% Bronopol in saline and induction supplementation was 6 7 days later with 2.5% Bronopol in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 0.25% Bronopol in saline; a second challenge was made after a further 7 days. Any challenge reactions were recorded after 24 and 48 hours. There was no evidence of sensitization in the 9 animals tested at either challenge, and it was concluded that Bronopol was not a sensitizer under the conditions of this test. Study 4 ­ Induction was carried out as in Study 1 except that induction was 0.02% Myacide BT ( a minimum of 98% Bronopol) in saline and induction supplementation was 6 7 days later with 2.5% Myacide BT in saline. Fourteen days later the animals were challenged ( 24 hour occluded patch) with 0.25% Myacide BT in saline; a second challenge was made after a further 7 days. Any challenge reactions were recorded after 24 and 48 hours. There was no evidence of sensitization in the 10 animals tested at either challenge, and it was concluded that Myacide BT was not a sensitizer under the conditions of this test. The overall conclusion was that Bronopol has a very low, and variable, sensitization potential in the stringent Magnusson and Kligman guinea pig maximization test and is at most a weak sensitizer in this species. There was no evidence that the animals had become sensitized to formalin. 2. Genotoxicty. Mutagenicity studies including in vitro/ in vivo in mouse erythrocytes ( micronucleus assay), chromosomal aberration test in human lymphocytes, Salmonella typhimurium plate ( Ames) tests with and without activation were negative. Bronopol did not induce mutations in the in vitro bacterial mutagenicity assay ( TX 86004) or the V79 cell mutation assay ( TX 86043), neither was there evidence of activity in assays for host­ mediated bacterial mutagenicity or dominant lethality conducted in mice TX 74034). Furthermore, there was no increase in the incidence of micronuclei in polychromatic erythrocytes of bone marrow from male and female mice, 24, 48, or 72 hours after administration of single oral doses up to a maximum tolerated level of 160 mg/ kg ( TX 86001). However, weak in vitro clastogenic activity was detected in cultured human lymphocytes exposed for 24 hours, in the absence of S 9, to Bronopol at 30 µ g/ ml ( TX 86049). Bronopol is normally self­ stabilizing at about pH 4 in aqueous media, but decomposes at elevated temperature and more alkaline pH to release formaldehyde as a breakdown product. Under the conditions of the human lymphocyte chromosome assay, only about 10% of an initial 30 µ g/ ml concentration of Bronopol in the culture medium ( pH 6.9) could be detected by analysis after 2 hours incubation at 370 C ( DT 86029), and a formaldehyde concentration of 4.2 µ g/ ml was found at this time ( DT 86030); the calculated value for formaldehyde released from complete breakdown of the 30 µ g/ ml concentration of Bronopol is 4.5 µ g/ ml. Formaldehyde shows clastogenic properties in vitro that include the induction of chromosome aberrations in human lymphocytes. Furthermore, in a lymphocyte assay conducted in­ house ( TX 86050), formaldehyde, in the absence of S 9 activation, elicited chromosome damage that was qualitatively and quantitatively similar to that seen in the assay of Bronopol. These findings, supported by the analytical data, indicate that the in vitro clastogenicity seen with Bronopol is due to its breakdown to formaldehyde. Although formaldehyde is a clastogen in vitro, its reactivity precludes distribution in vivo, so it is inactive in bone marrow and germ cells. The relative instability of Bronopol, like that of other non­ carcinogenic formaldehyde­ releasing agents, does not allow it to transport formaldehyde to these sites. In contrast, the carcinogen, hexamethylphosphoramide ( HMPA), is more stable and requires metabolic activation to release formaldehyde; as a result, HMPA is clastogenic in bone marrow and has adverse effects in germ cells. In conclusion, the testing of Bronopol over a wide range of genetic endpoints has revealed only a single adverse finding, namely weak in vitro clastogenicity, and this result is clearly VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78464 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices attributable to the release of formaldehyde from Bronopol under the conditions of the lymphocyte assay. The consensus of negative findings in shortterm in vitro tests, together with the negative finding in an in vivo test for chromosome damage and the absence of oncogenicity in the life span studies in rats and mice ( see below), indicates that Bronopol does not present a genotoxic hazard. In a 2­ year rat ( drinking water) chronic toxicity and tumorgenicity, Bronopol dissolved in tap water was dosed to 28 day old rats in 4 groups ( 45 male and 45 female in the main groups and 15 male and 15 female in the satellite groups) via the drinking water for 104 weeks at 0 ( untreated control), 10, 40, and 160 mg/ kg/ day. The main groups were reserved for evaluation of tumorigenic potential and were not used for blood and urine samples during the study; the satellite groups were used for blood and urine samples during the study and were not included in the tumorigenicity assessment. The results at the various dose levels may be summarized as follows: 160 mg/ kg/ day Reduced grooming activity during the final year of treatment. Significantly increased mortality. Reduced weight gain from week 3 onwards among males and from week 7 onwards among females. Lower food intake among males from week 13 onwards. Marked reduction in water intake throughout the dosing period and an associated reduction in urine volume noted at weeks 25, 52, and 103. Increase incidence of progressive glomerulonephrosis in males and females. At week 52, urine repeatedly positive for hemoglobin in 4/ 10 males and 1/ 10 females, at week 77 in 4/ 10 males and 3/ 10 females, and at week 103 in 10/ 10 males and 1/ 10 females. Stomach lesions in 20 males and 15 females and the gastric lymph nodes showed dilation of the sinusoids in 4 males and 5 females. Squamous metaplasia, inflammation or atrophic acini in the salivary glands of 12 males and 11 females. 40 mg/ kg/ day Reduced weight gain from weeks 27 to 78 among males. Lower food intake from weeks 53 to 78 among males. Moderate reduction in water intake throughout the dosing period. At week 77, urine repeatedly positive for hemoglobin in 6/ 10 males and at week 103 in 3/ 10 males. Stomach lesion in 1 male. Squamous metaplasia, inflammation or atrophic acini in the salivary glands of 12 males and 2 females. 10 mg/ kg/ day Small but definite reduction in water intake throughout the dosing period. At week 77, urine repeatedly positive for hemoglobin in 2/ 10 males and at week 103 in 2/ 9 males. Stomach lesions in 1 male and 1 female. Squamous metaplasia and/ or inflammation or atrophic acini in the salivary glands of 5 males and 1 female. Control At week 52, urine repeatedly positive for hemoglobin in 1/ 10 males and 0/ 10 females, at week 77 in 2/ 10 males and 0/ 10 females, and at week 103 in 3/ 10 males and 1/ 10 females. Stomach lesions in 1 male and 2 females. Squamous metaplasia and/ or inflammation or atrophic acini in the salivary glands of 3 males and 2 females. The evidence of toxic effects related to the administration of Bronopol was a reduction in food intake, impaired food utilization efficiency associated with reduced bodyweight gain, and increased mortality. Changes in the stomach and gastric lymph nodes were attributed to the irritant effect of Bronopol. Unpalatability reduced the water intake and was associated with a reduced output of urine, an increased incidence of hemoglobinuria and an exacerbation of the spontaneous incidence of progressive glomerulonephrosis. Treatment with Bronopol exacerbated a spontaneous change in the salivary glands. These effects were dose related and apart from a small effect on water intake that was related to palatability, there was no evidence of toxicity at 10 mg/ kg/ day. There was no evidence to suggest that the administration of Bronopol affected the tumor incidence. In summary, the study gave a systemic no observed adverse effect level ( NOAEL) of 10 mg/ kg/ day, a lowest effect level ( LEL) of 40 mg/ kg/ day and found 2­ bromo­ 2­ nitro­ 1,3­ propanediol ( Bronopol) to be not carcinogenic. 3. Reproductive and developmental toxicity. In a two­ generation reproduction study in rats Bronopol was administered to rats in the drinking water at concentrations of 25, 70, or 200 mg/ kg/ day. Thirteen males and 26 females were treated for a minimum of 80 days prior to mating. They were mated on two separate occasions to produce the F1a and F1b litters. Weanlings from the F1b litters were randomly selected ( 13 males and 26 females) to become parents of the next generation. The F1 parents were treated for a minimum of 87 days prior to mating, and were mated on two separate occasions to produce the F2a and F2b litters. In the F0 generation, one female from each of the control and low­ dose groups, and one male and five females from the high­ dose group died or were sacrificed in extremis during the study; in the F1 generation, one female from each of the low­, mid­ and high­ dose groups died before the end of the study. There were no treatment­ related aspects, so these deaths were considered to have been incidental to Bronopol. Food consumption for the high­ dose group was consistently lower than controls for the F0 males, for F0 females during the initial two weeks of treatment and the lactation periods for both mates, and for F1 females during the lactation period of the F2a mate. Water consumption was reduced in all treated groups, in a dose­ related manner, throughout most of the study; this contributed to the lower achieved dosages of Bronopol that animals received, namely 22.55, 55.2, or 147 mg/ kg. The female fertility index for the high­ dose group was slightly lower than control at the F1 mate only. Mean body weights of the offspring of the F0 and F1 high­ dose parents ( F1a and F1b, and F2a and F2b, respectively) were lower than the control throughout the lactation periods. Mean body weights of the F1b pups from the low­ and middose groups were slightly lower than control on day 21 of the lactation period. There were no other test articlerelated macroscopic or microscopic changes. There was a dose­ related increase in the kidney weights of treated F0 females, though the difference between the low dose group and controls was minimal. In the high­ dose group animals there was a decrease in the absolute weights of the livers, and possibly also the hearts, of F1 males, and in the absolute liver weights of F2b males and females; these females also had lower absolute kidney weights. In conclusion, ingestion of Bronopol elicited signs of toxicity at all dosages, though the only reproductive or litter parameter affected at the 25 and 70 mg/ kg/ day dosages was body weight of F1b pups at weaning, where a minimal decrease was seen. An early rat dermal developmental toxicity study gave a maternal NOAEL > 40 mg/ kg/ day ( HDT) considering 2­ bromo­ 2­ nitro­ 1,3­ propanediol as a severe dermal irritant in rats. Further development toxicity studies have been carried out for both the rat and the rabbit. In the rat study three groups of 24 timed­ mated female rats were dosed once daily, orally by gavage, with VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78465 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices solutions of Bronopol at dose levels of 10, 28, or 80 mg/ kg/ day from days 6 to 15 of pregnancy, inclusive. A similar group of females were dosed with the vehicle ( purified water acidified to pH 4) by the same route and over the same period, and served as controls. Maternal clinical signs, bodyweights and food consumption were recorded. On day 20 of pregnancy, the females were killed and a necropsy was performed. Numbers of corpora lutea and live and dead implantations were recorded. Live fetuses were weighed, sexed and examined for external and visceral abnormalities. Two thirds of the fetuses were also examined for skeletal abnormalities. There was evidence of maternal toxicity following oral gavage administration of Bronopol at 80 mg/ kg/ day, characterized by retarded bodyweight gain over days 6 to 7 of pregnancy. There was no evidence of maternal toxicity at either 10 or 28 mg/ kg/ day. There was no evidence of developmental toxicity at any of the dose levels investigated. There may be an association of treatment at 80 mg/ kg/ day with advanced ossification of sacral arches and at 28 and 80 mg/ kg/ day with advanced ossification of the forelimb phalanges. However, neither of these findings in these groups was unusually advanced when compared to historical background data. In a second study using rabbit groups of 18, 19, or 20 timed­ mated female animals were dosed daily between 7 and 19 days of pregnancy, inclusive, by the oral route with aqueous solutions of Bronopol at dose levels of 0 ( control), 5, 20, 40, and 80 mg/ kg/ day. Day 0 of pregnancy was the day of mating. 80 mg/ kg/ day was selected as a level which should elicit maternal effects. However, in the event that the effects may have been too severe, 40 mg/ kg/ day was selected as the next highest level known to be tolerated by the pregnant rabbit. The lower dose level of 5 mg/ kg/ day and the intermediate dose level of 20 mg/ kg/ day were expected to be ` no effect' levels. Maternal clinical condition, bodyweight, and food consumption were recorded. The females were killed on day 28 of pregnancy and a necropsy was performed. They were weighed, sexed and examined for external, visceral, and skeletal abnormalities. At 80 mg/ kg/ day, Bronopol elicited severe maternal toxicity at the onset of dosing. The animals recovered after dosing ceased, but the outcome of pregnancy was affected. There was embryotoxicity characterized by growth retardation and a slightly higher than expected incidence of fetal abnormalities. This embryotoxicity was considered likely to be related to the maternal toxicity. At 40 mg/ kg/ day, which was considered to be the highest level likely to be tolerated by the pregnant rabbit without eliciting severe maternal toxicity, there was no evidence of adverse effects of treatment on the pregnant rabbit or developing embryos. This dose level was therefore considered to be the ` no effect' level of Bronopol with regard to developmental toxicity. 4. Subchronic toxicity. A 13­ week rat gavage study showed a NOAEL of 20 mg/ kg/ day and a lowest observed adverse effect level ( LOAEL) of 80 mg/ kg/ day. Bronopol as a solution in distilled water was dosed to CD rats ( 4 groups of 20 males and 20 females) by oral gavage once per day, seven days per week for 13 weeks at 0 ( untreated control), 20, 80, and 160 mg/ kg/ day. Reaction to treatment was as follows: 160 mg/ kg/ day ­ Severe respiratory distress and abdominal distension; reduced bodyweight gain and food consumption; death of 22 males and 14 females ( includes 4 male and 3 female rats which replaced rats dying after one dose); all surviving rats were killed on day 9; autopsy showed gaseous and fluid distension of the gastro­ intestinal tract in the majority of decedents; ulceration, epithelial hyperplasia and hyperkeratosis or congested vessels in the stomachs of 2 males and 4 females. 80 mg/ kg/ day ­ Severe respiratory distress and abdominal distension, the latter sign confined to 6 males and 6 females which subsequently died. At week 6, only 4 males and 2 females showed slight respiratory difficulty. Seven males and 9 females died with autopsy showing gaseous and fluid distension of the gastro­ intestinal tract; reduced bodyweight gain and food consumption for the first week of treatment only; renal changes in 2 males. 20 mg/ kg/ day ­ In one male, respiratory distress, which subsequently regressed; renal changes in 2 males. A 13­ week dog gavage study showed a NOAEL of 8 mg/ kg/ day and LOAEL of 20 mg/ kg/ day. Bronopol dissolved in water was dosed to Beagle dogs ( 4 groups of 3 males and 3 females) by oral gavage once per day, seven days per week for 3 months ( 13 weeks) at 0 ( untreated control), 4, 8, and 20 mg/ kg/ day. One pair of dogs was dosed at levels of 20 40 mg/ kg/ day, over a period of 2 weeks in order to determine the vomiting threshold of Bronopol. This was found to be at a dosage of approximately 20 mg/ kg/ day. During the study vomiting occurred within 30 minutes of dosing and no other clinical signs were observed. Macroscopic post mortem examination revealed no abnormalities. In the main study there were no deaths. Vomiting, mainly at 20 mg/ kg/ day, within 0.5 hour of dosing was observed with occasional passage of liquid feces and red­ stained mucus in isolated animals, both dosed and control. There were no adverse effects on food or water consumption, or on bodyweight. There were no abnormalities of the eye; no macroscopic post mortem abnormalities; or morphological changes or variations from normal in histological tissue examination which could be related to dosage of the test compound. After dosing for 6 weeks, one animal receiving 8 mg/ kg/ day had a serum alkaline phosphatase value approximating to the upper limit of normality of 35 King Armstrong units; after 12 weeks, however, the value was well within normal limits. After dosing for 12 weeks the group mean total white cell count, although within normal limits, was significantly lower in dogs receiving 8 and 20 mg/ kg/ day than in the controls. One animal receiving 4 mg/ kg/ day had a serum glutamicpyruvic transaminase value after 12 weeks which exceeded the upper limit of normality of 50 mU/ ml. Apart from the liver of one dog receiving 20 mg/ kg/ day which was heavier than would normally be expected, all organ weights were within normal limits. However, when expressed as a percentage of bodyweight the mean liver and spleen weights for dogs receiving 20 mg/ kg/ day were significantly heavier than the control values. 5. Chronic toxicity. A 2­ year toxicity/ carcinogenicity Bronopol study ( administration via drinking water) in rats showed a NOAEL of 7 mg/ kg/ day and a LEL of < 32 mg/ kg/ day. For more detail see the carcinogenicity summary in Unit B. 2. In a study on potential local and tumorigenic effects from repeated dermal application to mice Bronopol dissolved in 90% acetone/ water was applied to the shaved dorsum of 3 groups of mice ( 52 male and 52 female per group) at 0 ( vehicle control), 0.2%, and 0.5%. Application was at the rate of 0.3 ml per mouse on three days ( Monday, Wednesday, and Friday) in each week for 80 weeks. The results are summarized as follows: Among some mice treated with 0.5% Bronopol, there was minimal hair loss at the periphery of the shaved area during the first three weeks of treatment. A marginally inferior survival rate was recorded among male mice, although the prime cause of death VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78466 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices among decedents showed no relation to treatment. Between weeks 26 and 52, an inferior bodyweight gain was recorded among male mice treated with 0.5% Bronopol, although bodyweight gain over the 80 week treatment period was comparable with that of the controls. Bodyweight gain among other treated mice was not disturbed by treatment. Food intake and efficiency of food utilization showed no disturbance by treatment. Macroscopic examination of decedents and mice killed after 80 weeks of treatment, revealed pathology which was common to some animals from control and treated groups. Microscopic examination of decedents and mice killed at termination revealed changes consistent with the age and strain of mouse employed. Treatment with Bronopol did not alter the spontaneous tumor profile of the mice. 6. Animal metabolism. Rat and dogs were used in a metabolic study with both oral and cutaneous dosing as follows: Oral Dosing in Rats was by stomach tube with aqueous solutions of [ 14C]­ Bronopol ( 1 mg/ kg). Oral Dosing Dogs ­ Beagle dogs were dosed with [ 14C]­ Bronopol ( 2 mg) mixed with unlabelled Bronopol ( 6 8 mg) as an aqueous solution in gelatin capsules. Cutaneous Dosing Rats and Rabbits ­ Initially solutions of [ 14C]­ Bronopol ( 4 mg/ kg) in water, acetone and acetone/ water ( 9: 1, v/ v) were applied to the clipped backs of rats to determine the influence of the vehicle on percutaneous absorption. Acetone was determined to be the preferred application vehicle. In the main tests an acetone solution of [ 14C]­ Bronopol ( 4.8 mg/ ml) was applied to shaved/ depilated areas of the backs of rats and rabbits at the rates of 0.05 ml per rat and 0.2 0.4 ml per rabbit, the treated areas being occluded with secured polythene. After an oral dose of [ 14C]­ Bronopol ( 1 mg/ kg) to rats or dogs, the radioactivity was completely absorbed, evenly distributed and rapidly excreted. Excretion was almost complete in 24 hours. During 5 days, rats excreted 83.3% in the urine, 5.8% in the feces ( via the bile) and 8.4% in the expired air; 1.6% was still retained probably by incorporation into pathways of intermediary metabolism of [ 14C]­ glycerol produced by biotransformation of [ 14C]­ Bronopol. During 5 days, dogs excreted 81.8% in the urine and 3.1% in the feces. After an oral dose of [ 14C]­ Bronopol ( 1 mg/ kg), peak blood levels of radioactivity were reached in rats and dogs within 2 hours, and declined with an initial halflife of 4 ± 1 hour. After an oral dose of [ 14C]­ Bronopol ( 1 mg/ kg) to the rat and the dog, Bronopol and its metabolites were evenly distributed. Only in tissues concerned with excretion did levels of radioactivity exceed those in the blood. When applied to the skin of rats, [ 14C]­ Bronopol was absorbed to a greater extent from an acetone solvent vehicle than from water: acetone ( 1: 9, v/ v) or water alone. In rats, at least 7 and 15% of an applied dose was percutaneously absorbed during 24 and 96 hours respectively. In rabbits, at least 9% of an applied dose was percutaneously absorbed during 24 hours. Pretreatment of rabbit skin with a depilatory enhanced absorption. Microhistoautoradiographs of rabbit skin showed that [ 14C]­ Bronopol was mainly localized on the epidermis around the hair follicles. The limited percutaneous absorption of Bronopol may occur through the hair follicles. Five metabolites, which were more polar than Bronopol, were detected in the urine of rats and dogs given an oral dose of [ 14C]­ Bronopol. One metabolite, shown by comparison of infra­ red and mass spectra with synthetic material to be 2­ nitropropane­ 1,3­ diol, accounted for more than 40% of the administered dose. Unchanged Bronopol, which is unstable in plasma, was not detected. A similar pattern of urinary metabolites of [ 14C]­ Bronopol was found after cutaneous application as after oral administration of the compound. Further metabolic studies were carried out in male and female rats following single oral doses of [ 14C]­ Bronopol at 10 and 50 mg/ kg and repeated dosing at 10 mg/ kg/ day with Bronopol for 14 days followed by a single oral dose, 10 mg/ kg of [ 14C]­ Bronopol. The compound was well absorbed and rapidly excreted mainly via urine. Radioactivity found in the carcass and tissues at 168 hours after dosing accounted for less than 3% of dose. There were no major consistent differences between male and female rats. Bronopol was highly metabolized and intact compound was not detected in the urine. The urinary metabolite chromatographic patterns contained numerous polar metabolites and similar patterns were found for each group. The major metabolite observed was equivalent to desbromo­ bronopol ( 2­ nitro­ propane­ 1,3­ diol). Extensive metabolism led to radiolabeled onecarbon units excreted as carbon dioxide in expired air. 7. Metabolite toxicology. As determined in the animal metabolism studies in Unit B. 6. numerous polar metabolites were identified in urine from rat and dog. Unchanged 2­ bromo­ 2­ nitro­ 1,3­ propanediol was not detected. The major peak in most samples corresponded to desbromobronopol ( debrominated bronopol), i. e. 2­ nitropropane­ 1, 3­ diol. This metabolite is not considered of toxicological concern. 8. Endocrine disruption. No specific tests have been conducted with 2­ bromo­ 2­ nitro­ 1,3­ propanediol to determine whether the chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. However, there were no significant findings in other relevant toxicity tests, i. e., teratology and multigeneration reproduction studies, which would suggest that 2­ bromo­ 2­ nitro­ 1,3­ propanediol produces effects characteristic of the disruption of endocrine functions. C. Aggregate Exposure 1. Dietary exposure i. Food. The proposed use of 2­ bromo­ 2­ nitro­ 1, 3­ propanediol as a preservative in end­ use pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals is not expected to result in any significant additional, dietary exposure, due to the low concentration of 2­ bromo­ 2­ nitro­ 1, 3­ propanediol employed in the formulation and the extremely low probability of significant contact by the general public following treatment. 2­ bromo­ 2­ nitro­ 1, 3­ propanediol has FDA approval for indirect food contact use as a preservative in adhesives that are components of food packaging or storage materials ( 21 CFR 175.105); as a slimicide for use in pulp and papermaking at a maximum level of 0.6 lb/ ton of dry weight fiber ( 21 CFR 176.300); and paper components in contact with aqueous and fatty foods at a level not to exceed 0.01% by weight of those components ( 21 CFR 176.170). These uses are not expected to result in quantifiable residues of 2­ bromo­ 2­ nitro­ 1, 3­ propanediol in the diet. Uses as a preservative in concentrates of agricultural pesticide products also is not expected to be a source of quantifiable residues in food. There are no acute or chronic toxicological concerns associated with the proposed use of 2­ bromo­ 2­ nitro­ 1,3­ propanediol as an inert ingredient in concentrates of agricultural pesticide products. An acute dietary risk assessment, therefore, is not required. Chronic exposure to 2­ bromo­ 2­ nitropropane­ 1, 3­ diol through food is essentially insignificant. ii. Drinking water. Contamination of drinking water would not be expected to VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78467 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices occur under the proposed use conditions of 2­ bromo­ 2­ nitro­ 1, 3­ propanediol as a preservative at very low concentrations in pesticide products intended for applications, principally to growing crops, raw agricultural commodities after harvest, and animals; as either a direct pour­ on application or as a spray. Neither method of application is expected to contaminate water supplies intended for human consumption. Bronopol is not applied to water and is not used for the disinfection of human or animal drinking water. 2. Non­ dietary exposure. 2­ bromo­ 2­ nitro­ 1, 3­ propanediol is used as an industrial biocide for the prevention of biofouling in areas such as recirculating water in cooling towers and evaporative condensers, air conditioners, air washers and humidifier systems, oil, gas and industrial process water, metal working fluids and paper mill pulp and process water; and for the preservation of surfactants, adhesives, starch, pigment and extender slurries, paints, latex and antifoam emulsions, absorbent clays, water based printing inks and print solutions, water based pesticides and chemical toilet solutions. The margins of exposure ( MOEs) calculated for direct applicators occupationally exposed by either the dermal or inhalation route, based on worst­ case estimates, revealed there is no level for concern. Estimated exposures to professional painters using paint preserved with 2­ bromo­ 2­ nitro­ 1, 3­ propanediol were used as the worst­ case for estimating secondary occupational exposure risk. MOEs were not exceeded and EPA has concluded that risk associated with secondary exposure are not of concern. 2­ bromo­ 2­ nitro­ 1, 3­ propanediol is also used in the preservation of consumer, household and institutional products. Based on the worst­ case estimate for professional painters chronically exposed to 2­ bromo­ 2­ nitro­ 1, 3­ propanediol, EPA has concluded that risk associated with these uses are not of concern. 2­ bromo­ 2­ nitro­ 1, 3­ propanediol also is used to preserve pharmaceuticals, cosmetics, and toiletries, which are regulated by FDA. The Cosmetic, Toiletries and Fragrance Association's ( CTFA's) Cosmetic Ingredient Review ( 1980) states that 2­ bromo­ 2­ nitro­ 1,3­ propanediol is safe as a cosmetic ingredient at concentrations up to 0.1% except where there is a risk of nitrosamine or nitrosamide formation. Similarly, 2­ bromo­ 2­ nitro­ 1,3­ propanediol is listed in Annex VI of the EC Cosmetics directive as an approved preservative for use up to 0.1% except where there is a risk of nitrosamine formation. Based on toxicity data, an aggregate risk or likelihood of the occurrence of an adverse health effect resulting from all routes of exposure to 2­ bromo­ 2­ nitro­ 1, 3­ propanediol is not expected. D. Cumulative Effects There is no reliable information that would indicate or suggest that 2­ bromo­ 2­ nitro­ 1, 3­ propanediol has any toxic effects on mammals that would be cumulative with those of any other chemical. E. Safety Determination 1. U. S. population. The reference dose ( RfD) for 2­ bromo­ 2­ nitro­ 1, 3­ propanediol based on the 2­ year chronic study ( drinking water) in rats with a NOAEL of 10 mg/ kg/ day and using an uncertainty factor of 100 is calculated to be 0.1 mg/ kg of body weight ( bwt)/ day. The estimated worst­ case theoretical maximum residue contribution ( TMRC) resulting from this action will be 0.000024 mg/ kg/ bwt/ day for the overall U. S. population and represents 0.024 percent of the RfD. Based upon this information and review of its use, EPA has found that, when used in accordance with good agricultural practice, this ingredient is useful and a tolerance is not necessary to protect the public health. 2. Infants and children. Nothing in the available literature would suggest that infants and children are more sensitive to the effects of 2­ bromo­ 2­ nitro­ 1, 3­ propanediol than adults. Exposure of infants to 2­ bromo­ 2­ nitro­ 1, 3­ propanediol resulting from its proposed use as an inert ingredient in certain pesticide formulations is expected to be negligible and will not put infants and children at increased risk. F. International Tolerances BASF Corporation is not aware of the existence of any international tolerances for 2­ bromo­ 2­ nitro­ 1, 3­ propanediol. [ FR Doc. 02 32400 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 S FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background. On June 15, 1984, the Office of Management and Budget ( OMB) delegated to the Board of Governors of the Federal Reserve System ( Board) its approval authority under the Paperwork Reduction Act, as per 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR 1320 Appendix A. 1. Board approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the OMB 83 I's and supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Request for Ccomment on Information Collection Proposal. The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following: a. whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility; b. the accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; c. ways to enhance the quality, utility, and clarity of the information to be collected; and d. ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology. DATES: Comments must be submitted on or before February 24, 2003. ADDRESSES: Comments may be mailed to Ms. Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, N. W., Washington, DC 20551. However, because paper mail in the Washington area and at the Board of Governors is subject to delay, please consider submitting your comments by e­ mail to regs. comments@ federalreserve. gov, or VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:44.226639

regulations

EPA-HQ-OPP-2002-0285-0001

Notice

Draft Guidance on How to Comply with Data Citation Regulations; Notice of Availability

68866 Federal Register / Vol. 67, No. 219 / Wednesday, November 13, 2002 / Notices 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the registration activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Registration Applications EPA received applications as follows to register pesticide products containing active ingredients not included in any previously registered products pursuant to the provision of section 3( c)( 4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications. Products Containing Active Ingredients not Included in any Previously Registered Products 1. File symbol: 71771 T. Applicant: Nichino America, Inc., 4550 New Linden Hill Road, Wilmington, DE 19808. Product name: ET­ 751 2.5% EC Herbicide. Product type: Herbicide. Active ingredient: Pyraflufen­ ethyl ( ethyl 2­ chloro­ 5­( 4­ chloro­ 5­ difluoromethoxy­ 1­ methylpyrazol­ 3­ yl)­ 4­ fluorophenoxyacetate) at 2.5%. Proposed classification/ Use: None. For use on terrestrial non­ cropland to control broadleaf weeds. 2. File symbol: 71711 A. Applicant: Nichino America, Inc. Product name: ET­ 751 Technical. Product type: Herbicide. Active ingredient: Pyraflufenethyl at 97.9%. Proposed classification/ Use: None. For manufacturing use of end­ use products to be used to control certain broadleaf weeds on terrestrial non­ cropland. 3. File symbol: 59639 RNO. Applicant: Valent U. S. A. Corporation, 1333 North Carolina Blvd., Suite 600, P. O. Box 8025, Walnut Creek, CA 94596 8025. Product name: S­ 3153 Flufenpyr­ ethyl Technical. Product type: Herbicide. Active ingredient: Flufenpyr­ ethyl, ethyl [ 2­ chloro­ 4­ fluoro­ 5­( 5­ methyl­ 6­ oxo­ 4­ trifluoromethyl­ 1,6­ dihydropyridazin­ 1­ yl) phenoxy] acetate at 98.0%. Proposed classification/ Use: None. For formulation into herbicide products to control postemergence broadleaf weed species in field corn, forage; field corn, grain; field corn, stover; soybean, seed; sugarcane. 4. File symbol: 59639 RRN. Applicant: Valent U. S. A. Corporation. Product name: S­ 3153 WDG Herbicide. Product type: Herbicide. Active ingredient: Flufenpyr­ ethyl at 57.6%. Proposed classification/ Use: None. For manufacturing use of end­ use products to be used to control postemergence broadleaf weed species in field corn, soybeans and sugarcane. 5. File symbol: 59639 RRR. Applicant: Valent U. S. A. Corporation. Product name: S­ 3153 Atrazine WDG. Product type: Herbicide. Active ingredient: Flufenpyr­ ethyl 75.0%. Proposed classification/ Use: None. For manufacturing use of end­ use products to be used to control postemergence broadleaf weed species in field corn and sugarcane. List of Subjects Environmental protection, Pesticides and pest. Dated: October 27, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 28504 Filed 11 12 02; 8: 45am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0285; FRL 7278 1] Draft Guidance on How to Comply with Data Citation Regulations; Notice of Availability AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the availability of draft guidance on how to comply with the Agency's data citation requirements for registration of new pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act. When applicants do not fully comply with the data citation regulations, the result can be significant delays in the processing of registration applications, the potential for an increase in adversarial petitions being submitted to the Agency by data submitters, and increased expenditures of resources for all involved, the Agency, applicants, and data submitters. EPA believes that the guidance provided through the notice will assist applicants comply with the data citation requirements and ultimately result in fewer delays in the registration process. DATES: Comments, identified by docket ID number OPP 2002 0285, must be received on or before December 13, 2002. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Peter Caulkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5447; fax number: ( 703) 305 6920; e­ mail address: caulkins. peter@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you submit applications for registration of pesticides pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), or if you submit data to the Agency in support of registration or reregistration under FIFRA. Potentially affected entities may include, but are not limited to: Pesticide Manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0285. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that VerDate 0ct< 31> 2002 15: 21 Nov 12, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13NON1. SGM 13NON1 68867 Federal Register / Vol. 67, No. 219 / Wednesday, November 13, 2002 / Notices is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket, but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or on paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0285. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0285. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0285. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0285. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. A. 1. D. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then VerDate 0ct< 31> 2002 15: 21 Nov 12, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13NON1. SGM 13NON1 68868 Federal Register / Vol. 67, No. 219 / Wednesday, November 13, 2002 / Notices identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition, one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at your estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternatives. 7. Make sure to submit your comments by the comment period deadline identified. 8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments. II. What Action is the Agency Taking? Applicants who choose to rely on data citation, rather than submitting their own data to meet EPA data requirements, must assure that the offerto pay letters they provide to data submitters satisfy EPA's regulatory requirements as provided in 40 CFR part 152, subpart E. When applicants do not follow these procedures, delays in the processing of registration applications result. In addition, improper offer­ topay letters can increase the potential for adversarial petition actions brought under 40 CFR 152.99. When applicants do not comply with data citation requirements, EPA, data submitters, and applicants expend, unnecessarily, significant resources during the application process. In an effort to avoid needless disputes and save the resources of all concerned, the Agency believes it would be helpful to clarify the obligations of data citers. By providing this guidance, the Agency hopes to streamline the registration process, provide assistance to applicants for pesticide registration, and to help data submitters preserve their data protection rights. The draft Pesticide Registration Notice does not address the issue of when offers­ to­ pay must be made or when documentation demonstrating that offers­ to­ pay have been made must be submitted to the Agency. EPA expects to issue guidance on this related matter through a separate means. In addition, the Agency will soon make available to the public several letters that have been issued recently regarding data compensation matters. These letters provide useful guidance to the regulated community and the general public, including persons who prepare applications for registration and those who submit data in support of registration actions. The Agency intends to announce the availability of these letters through a separate notice in the Federal Register. List of Subjects Environmental protection, Administrative practice and procedures, Pesticides and pests. Dated: November 1, 2002. Marcia E. Mulkey, Director, Office of Pesticide Programs. [ FR Doc. 02 28693 Filed 11 12 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ FRL 7407 8] Proposed Administrative Settlement Under the Comprehensive Environmental Response, Compensation and Liability Act; Nazcon Concrete Superfund Site AGENCY: Environmental Protection Agency. ACTION: Notice; request for public comment. SUMMARY: In accordance with section 122( i)( 1) of CERCLA, 42 U. S. C. 9622( i)( 1), notice is hereby given of a proposed administrative settlement concerning the Nazcon Concrete Superfund Site, Beltsville, Prince George's County, Maryland. The administrative settlement was signed by the Acting Regional Administrator of the United States Environmental Protection Agency ( EPA), Region III, on October 31, 2002, and is subject to review by the public pursuant to this document. The Environmental Protection Agency is proposing to enter into a settlement pursuant to section 122( h) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended ( CERCLA), 42 U. S. C. 9622( h). The proposed settlement resolves EPA's claim for past response costs under section 107 of CERCLA, 42 U. S. C. 9607 against NAZCON, Inc. for response costs incurred at the Nazcon Concrete Superfund Site, Beltsville, Prince George's County, Maryland. The proposed settlement requires NAZCON, Inc. to pay $ 15,000 to the EPA Hazardous Substance Fund. NAZCON, Inc., as the Settling Party, has executed binding certifications of its consent to participate in this settlement. NAZCON, Inc. has agreed to pay $ 15,000 subject to the contingency that EPA may elect not to complete the settlement based on matters brought to its attention during the public comment period established by this notice. For thirty ( 30) days following the date of publication of this notice, EPA will receive written comments relating to the proposed settlement. EPA will consider all comments received and may withdraw or withhold consent to the proposed settlement if such comments disclose facts or considerations which indicate that the proposed settlement is inappropriate, improper, or inadequate. DATES: Comments must be submitted on or before December 12, 2002. ADDRESSES: Comments should be addressed to the Docket Clerk, United States Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania, 19103, and should reference the Nazcon Concrete Superfund Site, Beltsville, Maryland, U. S. EPA Docket No. CERCLA 03 2002 0255 DC. The proposed settlement agreement is available for public inspection at the United States Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania, 19103. A copy of the proposed settlement agreement can be obtained from Suzanne Canning, Regional Docket Clerk ( 3RC00), United States Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania, 19103, telephone number ( 215) 814 2476. VerDate 0ct< 31> 2002 15: 21 Nov 12, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13NON1. SGM 13NON1

epa

2024-06-07T20:31:44.239869

regulations

EPA-HQ-OPP-2002-0285-0004

Notice

Draft Guidance on How to Comply with Data Citation Regulations; Extension of Comment Period

[ Federal Register: December 11, 2002 ( Volume 67, Number 238)] [ Notices] [ Page 76179] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr11de02­ 37] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0285; FRL­ 7285­ 4] Draft Guidance on How to Comply with Data Citation Regulations; Extension of Comment Period AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice; extension of comment period. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: EPA issued a notice in theFederal Register of November 13, 2002, titled `` Draft Guidance on How to Comply with Data Citation Regulations.'' This document is extending the comment period for 30 days, from December 13, 2002, to January 12, 2003. DATES: Comments, identified by docket ID number OPP­ 2002­ 0285 must be received on or before January 12, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION of the November 13, 2002 Federal Register document. FOR FURTHER INFORMATION CONTACT: Peter Caulkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460­ 0001; telephone number: ( 703) 305­ 5447; e­ mail address: caulkins. peter@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? The Agency included in the November 13, 2002 Federal Register notice a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP­ 2002­ 0285. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305­ 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. C. How and to Whom Do I Submit Comments? To submit comments, or access the official public docket, follow the detailed instructions as provided in Unit I. C. of theSUPPLEMENTARY INFORMATION of the November 13, 2002Federal Register document. If you have questions, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. What Action is EPA Taking? This document extends the public comment period established in theFederal Register of November 13, 2002 ( 67 FR 68866) ( FRL­ 7278­ 1). In that document, EPA announcedthe availability of draft guidance on how to comply with the Agency's data citation requirements for registration of new pesticide products under the Federal Insecticide, Fungicide, and Rodenticide Act. The draft quidance will assist applicants in complying with the data citation requirements that ultimately would result in fewer delays in the registration process. EPA is hereby extending the comment period, which was set to end on December 13, 2002, to January 12, 2003. List of Subjects Environmental protection, Administrative practice and procedures, Pesticides and pests. Dated: December 4, 2002. Peter Caulkins, Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02­ 31164 Filed 12­ 6­ 02; 10: 10 am] BILLING CODE 6560­ 50­ S

epa

2024-06-07T20:31:44.247279

regulations

EPA-HQ-OPP-2002-0291-0001

Rule

Bacillus Cereus Strain BP01; Exemption from the Requirement of a Tolerance

70012 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations If the EPA receives adverse written comment, we will publish a final rule informing the public that this rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. The EPA does not intend to institute a second comment period on this action. Any parties interested in commenting on these actions must do so at this time. VI. Administrative Requirements Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), this action is not a `` significant regulatory action'' and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, `` Actions Concerning Regulations That Significantly Effect Energy Supply, Distribution, or Use'' ( 66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act ( 5 U. S. C. 601 et seq.). Because this rule approves pre­ existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104 4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 ( 65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 ( 64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 `` Protection of Children from Environmental Health Risks and Safety Risks'' ( 62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards ( VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( 15 U. S. C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 ( 44 U. S. C. 3501 et seq.). The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a `` major rule'' as defined by 5 U. S. C. 804( 2). Under section 307( b)( 1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 21, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307( b)( 2).) List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements. Dated: October 15, 2002. David A. Ullrich, Acting Regional Administrator, Region 5. For the reasons stated in the preamble, part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52 [ AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U. S. C. 7401 et seq. Subpart P Indiana 2. Section 52.770 is amended by adding paragraph ( c)( 153) to read as follows: § 52.770 Identification of plan. * * * * * ( c) * * * ( 153) On April 30, 2002 and September 6, 2002, Indiana submitted revised particulate matter regulations for Union Tank Car's railcar manufacturing facility in Lake County, Indiana. The submittal amends 326 IAC 6 1 10.1. The revisions consist of relaxing the limits for the grit blaster. The new limits are 0.01 grains per dry standard cubic foot and 9.9 pounds per hour. ( i) Incorporation by reference. Amendments to Indiana Administrative Code Title 326: Air Pollution Control Board, Article 6: Particulate Rules, Rule 1: Nonattainment Area Limitations, Section 10.1: Lake County PM10 emission requirements. Filed with the Secretary of State on July 26, 2002 and effective on August 25, 2002. Published in 25 Indiana Register 4076 on September 1, 2002. [ FR Doc. 02 29473 Filed 11 19 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0291; FRL 7277 3] Bacillus Cereus Strain BPO1; Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus cereus strain BPO1 on raw and processed food when applied/ used as a VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1 70013 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations foliar applied biological plant growth regulator intended to promote root mass growth, earlier fruit initiation, increased fruit retention, and increased nutrient utilization. Micro Flow Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus cereus strain BPO1. DATES: This regulation is effective November 20, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0291, must be received on or before January 21, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit IX. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Robyn Rose, Biopesticides and Pollution Prevention Division ( 7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9581; e­ mail address: rose. robyn@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Industry ( NACIS 111, 112, 311, 32532), e. g., Crop Production, Animal Production, Food Manufacturing, Pesticide Manufacturing. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP 2002 0291. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings In the Federal Register of November 21, 2001 ( 66 FR 58481) ( FRL 6802 1), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a( e), as amended by FQPA ( Public Law 104 170), announcing the filing of a pesticide tolerance petition ( PP 1F6324) by Micro Flow Company, P. O. Box 5948 Lakeland, FL 33807 5948. This notice included a summary of the petition prepared by the petitioner Micro Flow Company. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.1181 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus cereus strain BPO1. III. Risk Assessment New section 408( c)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( c)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section of the FFDCA ( b)( 2)( C) requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Additionally, section 408( b)( 2)( D) of the FFDCA requires that the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. IV. Toxicological Profile Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Acute mammalian toxicity/ pathogenicity studies via oral, dermal, inhalation, eye, intratracheal, and VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1 70014 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations intravenous routes were conducted with Bacillus cereus strain BPO1. No pathogenicity was observed. BPO1 was also tested for entero toxin emetic­ toxin production; no toxins were detected. Bacillus cereus has been implicated in nosocomial infections in rare instances and in food poisoning incidents. In the ELISA Analysis of Enterotoxin data submitted, there was no evidence of diarrhoeal type enterotoxin production in the culture filtrates of Bacillus cereus strain BOP1 or the end use product. In a blood agar hemolysis assay conducted with BPO1, weak alpha hemolysis was observed. Based on the results of the studies in this unit, subchronic, reproductive, teratology, chronic, and mutagenicity studies were not deemed necessary. 1. Acute oral toxicity/ pathogenicity ( OPPTS 870.1100; 152A 10 and 152B 10; MRIDs 4417737 05 and 441773 06). In the acute oral toxicity test, five male and five female rats were treated with a split dose, ( 10 milliliters/ kilograms/ dose) ( mL/ kg) for a total of 5,000 milligrams ( mg)/ kg of Bacillus cereus strain BP01; the second dose administered 1 hour after the first dose. Rats were weighed and observed for mortality or abnormalities for 14 days. No abnormalities were noted in body weight or weight gain throughout the study or upon necropsy. The oral lethal dose ( LD) 50 Bacillus cereus strain BP01 was determined to be greater than 5,000 mg/ kg body weight. In the acute oral toxicity/ pathogenicity test, 15 males and 15 females received a dose of 1.23 x 108 colony forming units ( CFU) of the test substance by oral gavage; nine males and nine females were treated with 1.23 x 108 CFU killed test substance ( by steam sterilization). Rats were weighed on days 0, 3, 7, 14, and 18 and signs of toxicity were observed daily. Randomly sampled rats from each sex and each test group were sacrificed on days 0, 3, 7, 14, and 18 and examined for any macroscopic abnormalities. Samples of the kidneys, liver, spleen, and stomach as well as feces were homogenized and plated to determine the number of typical Bacillus cereus colonies after incubation at 30 0C for at least 18 hours. No clinical sign were noted throughout the study and no abnormalities were noted in any animal at necropsy. Two males displayed a loss in body weight from day 0 to 3 and five females lost weight from day 7 to 14. No other abnormalities were noted in body weights or weight gain. Bacillus cereus strain BP01 is not toxic, pathogenic or infective when 1 x 108 CFU was administered orally. A distinct clearance pattern was observed throughout the study. 2. Acute dermal toxicity ( OPPTS 870.1200; 152A 11; MRID 441773 07). Five male and five female rabbits were given a dose of 4.4 x 1010 CFU ( 2 grams ( g)) dermally for 24 hours and observed after dosing for signs of toxicity and dermal irritation for 14 days. No clinical signs, except dermal irritation, were noted during the study and no abnormalities were noted upon necropsy. Two males and five females displayed a loss in body weight from day 0 to day 7. All animals displayed a weight gain through the end of the study. All males and females showed slight to well defined redness through day 4; very slight erythema was present in up to three males and three females through day 11. Dermal irritation was no longer apparent by day 12. Slight signs of edema were apparent in two males on day 3. Edema was no longer present by day 4. The LD50 of Bacillus cereus strain BP01 is greater than 2 grams per animal. Mild to moderate dermal irritation was noted and was no longer present by day 13. 3. Acute intratracheal toxicity/ pathogenicity ( OPPTS 885.3150; 152A 12; MRID 441773 08). Fifty female and fifty male rats received a single dose of 7 x 107 ( males), or 9.33 x 107 CFU ( females) of the test substance in a volume of 0.5 mL by intratracheal administration; fifty females and fifty males were treated with the same concentration of killed test substance ( by steam sterilization); an additional fifty males and fifty females served as controls. Rats were weighed weekly and observed for signs of toxicity daily. Ten rats of each sex from each group were sacrificed on days 0, 7, 14, 21, and 36. Animals were examined for macroscopic abnormalities by necropsy. Lungs were evaluated by histopathological examination. Samples of the kidneys, liver, spleen, brain, mesenteric lymph nodes, blood, lungs, and caecum were homogenized, plated, and incubated for at least 18 hours then examined for typical Bacillus cereus colonies. Body weight losses were noted in females from the test substance group, one during the first, second and third weeks. No other abnormalities were noted in body weight or weight gain throughout the study. In the group treated with the test substance, three females displayed a rough hair coat, two females showed signs of labored respiration, and one female had hunched posture on day 0. Clinical signs were no longer apparent by day 2. Each treatment group had three males and females displaying mottled, dark red lungs on day 0. Red to tan lesions remained on the majority of animals through day 21. Bacillus cereus strain BP01 is not toxic, pathogenic or infective to rats at an intratracheal dose of either 7 x 108 or 9.33 x 108 CFU. A slow but typical clearance pattern was observed; slow clearance in the lung with distinct clearance pattern noted in the liver and spleen. The lesions present in the histopathology sections in both the killed and live test substance animals indicate an inflammatory response to the treatment due to the presence of particulate material. 4. Acute intravenous toxicity ( OPPTS 885.3200; 152A 13; MRID 441773 09). Five male and five female rates were intravenously injected with either 0.5 mL of Bacillus cereus, 0.5 mL of the killed test substance, or kept as a naive control. The rats were weighed before initial dosing and weekly thereafter. Animals were observed for clinical signs twice daily for 14 days. All rats were examined by necropsy for any macroscopic abnormalities at the end of the study. One female displayed a loss in body weight from day 0 to day 17. No other abnormalities were noted in body weight or weight gain throughout the study. No clinical signs were reported by the testing facilty and no abnormalities were noted upon necropsy. Although Bacillus cereus strain BP01 is not toxic to rats at an intravenous dose of 2.0 x 107 CFU, the registrant failed to submit the clearance portion of the study. However, this study does not need to be repeated because the oral and intratracheal studies demonstrated distinct clearance patterns. 5. Primary eye irritation ( OPPTS; 870.2400; 152A 14; MRID 441773 10). Three male and three female, young adult, New Zealnad White rabbits were given a single dose of 0.1g ( equivalent to 2.2 x 109 CFU) of the microbial pest control agent ( MPCA) in the everted lower right eyelid of each animal. The eye was gently held together for 2 seconds to prevent a loss of material. The left eye served as the control for each animal. The Draize Method was used to score ocular irritation and lesions at 1 hour, and 1, 2, 3, 4, and 7 days post dosing. A 2% fluorescein solution and ultraviolet light was used after 24 hours to evaluate corneal epithelial damage. Slight to moderate redness, chemosis, and occasional discharge was observed in all 6 animals within 1 hour post dosing. Clinical signs were no longer apparent by day 3. No abnormalities were observed in any control eye during the study. The primary irritation scores at 24 hours post dosing was 4.8 when a 0.1g ( 2 x 109 CFU) ocular dose was administered. VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1 70015 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations Ocular irritation was no longer present by day 3. 6. Immunotoxicity ( OPPTS 880.3800). Immune response, teratogenicity, virulence enhancement, and mammalian mutagenicity ( 40 CFR 158.740( c)( 2)( vi) through ( xv), were not required since survival, replication, infectivity, toxicity, or persistence of the microbial agent was not observed in the test animals treated in the Tier I infectivity tests. 7. Hypersensitivity ( OPPTS 870.2600; 152 15). Incidents of hypersensitivity must be reported to the Agency in a timely manner. There have been no reports of incidents of hypersensitivity to Bacillus cereus since it was registered. V. Aggregate Exposures In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses). A. Dietary Exposure 1. Food. While the suggested use pattern may result in dietary exposure with possible residues on food and feed, negligible risk is expected for both the general population, infants and children. Submitted acute toxicology tests confirm that based upon the use sites, use patterns, application method, use rates, low exposure, and lack of significant toxicology concerns, the potential risks, if any, to humans are considered negligible, therefore an exemption from the requirement of a tolerance is warranted. Acute exposure could occur from the proposed outdoor use sites but would be very low because of the low application rates of less than 48 fluid ounces of BP01/ acre/ year in cotton and less than 32 fluid ounces of BP01/ acre/ year in soybean. Considering the low application rates, lack of toxicity/ pathogenicity, ubiquitous nature and natural occurrence of Bacillius cereus, no residue data were required. 2. Drinking water exposure. The microorganism Bacillus cereus is ubiquitous in many soils throughout the world. Bacillus cereus is not known as an aquatic bacterium and therefore is not expected to proliferate in aquatic habitats. The potential exists for Bacillus cereus strain BPO1 to enter ground water or other drinking water sources, after application. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to Bacillus cereus through drinking water. Moreover, Bacillus cereus strain BPO1 is not considered to be a risk to drinking water. The Agency has no drinking water exposure concerns, because exposure is minimal to non­ existent and the demonstrated lack of toxicity or pathogenicity for the Bacillus cereus Strain BP01 microbe. B. Other Non­ Occupational Exposure The potential of non­ dietary exposures to Bacillus cereus strain BPO1 pesticide residues for the general population, including infants and children, is unlikely since this is only an agricultural use pesticide. The Agency believes that the potential aggregate exposure, derived from dermal and inhalation exposure via mixing, loading, and applying Bacillus cereus strain BPO1, should fall well below the currently tested microbial safety levels. 1. Dermal exposure. Dermal exposure via the skin would be the primary route of exposure for mixer/ loader applications. Unbroken skin is a natural barrier to microbial invasion of the human body. Dermal absorption could occur only if the skin were cut, if the microbe were a pathogen equipped with mechanisms for entry through or infection of the skin, or if metabolites were produced that could be dermally absorbed. Submitted acute dermal toxicity data confirmed a lack of dermal toxicity and mild to moderate dermal irritation was only observed until day 13 of the study. 2. Inhalation exposure. Inhalation would be the primary route of exposure for mixer/ loader applications. Because the pulmonary study showed no adverse effects, the risks anticipated for the route of exposure are considered minimal. VI. Cumulative Effects The Agency has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity to this, the Agency is confident that there will not be cumulative effects from the registration of this product VII. Determination of Safety for U. S. Population, Infants and Children 1. U. S. population. There is a reasonable certainty that no harm will result from aggregate exposure to the U. S. population from exposure to Bacillus cereus. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the very low levels of mammalian toxicity ( no toxicity at the maximum doses tested, Toxicity Categories III and IV for irritation) associated with Bacillus cereus strain BP01 and the history of safe use of Bacillus cereus. 2. Infants and children. FFDCA section 408( b)( 2)( C) provides that EPA shall apply an additional tenfold margin of exposure ( safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of exposure ( safety) will be safe for infants and children. Margins of exposure ( safety) are often referred to as uncertainty ( safety) factors. A battery of acute toxicity/ pathogenicity studies is considered sufficient by the Agency to perform a risk assessment for microbial pesticides. Other strains of Bacillus cereus have been implicated in nosocomial infections in rare instances and in food poisoning incidents. In the ELISA Analysis of Enterotoxin test data submitted there was no evidence of diarrhoeal type enterotoxin production in the culture filtration of Bacillus cereus strain BPO1 or the end use product. Data relating to the post application die off of Bacillus cereus species vs. background soil population counts demonstrated that this organism is very stable in the soil and rhizosphere. Also, for food use of microbial pesticides, the acute toxicity/ pathogenicity studies have allowed for the conclusion that an exemption from the requirement of a tolerance is appropriate and adequate to protect human health, including that of infants and children. VIII. Other Considerations A. Endocrine Disruptors EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) `` may have an effect in humans that is similar to an effect produced by a naturally­ occurring estrogen, or other such endocrine effects as the Administrator may designate.'' Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there is no VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1 70016 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, Bacillus cereus may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. Based on available data, no endocrine system­ related effects have been identified with consumption of Bacillus cereus strain BP01. It is a naturally occurring bacteria. To date, there is no evidence to suggest that Bacillus cereus affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor. B. Analytical Method( s) The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation based upon the lack of mammalian toxicity of Bacillus cereus and the lack of exposure with the plant growth regulator use pattern. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purpose for Bacillus cereus. C. Codex Maximum Residue Level There are no Codex harmonization consideration since there is currently no codex tolerance for Bacillus cereus residues. IX. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0291 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before January 21, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by telephone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP 2002 0291, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1 70017 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Rules and Regulations the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). X. Regulatory Assessment Requirements This final rule establishes an exemption from the tolerance requirement under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications '' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. XI. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: October 31, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. 2. Section 180.1181 is revised to read as follows: § 180.1181 Bacillus cereus strain BPO1; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance for residues of the Bacillus cereus strain BPO1 in or on all raw agricultural commodities when applied/ used in accordance with label directions. [ FR Doc. 02 29331 Filed 11 19 02; 8: 45 am] BILLING CODE 6560 50 S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [ DA 02 2231, MB Docket No. 02 223, RM 10520] Digital Television Broadcast Service; Avalon, CA AGENCY: Federal Communications Commission. ACTION: Final rule. SUMMARY: The Commission, at the request of Pappas Southern California License, LLC., and pursuant to Section 531 of the Public Health, Security and Bioterrorism Preparedness and Reponse Act of 2002, allots DTV channel 47c at Avalon, California. DTV channel 47c can be allotted to Avalon at the VerDate 0ct< 31> 2002 14: 01 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 20NOR1. SGM 20NOR1

epa

2024-06-07T20:31:44.251684

regulations

EPA-HQ-OPP-2002-0292-0001

Notice

Agricultural Worker Risk Assessment Process; Notice of Public Meeting

64368 Federal Register / Vol. 67, No. 202 / Friday, October 18, 2002 / Notices 2003, Contact: Terry Humphrey (505) 751– 4718. This document is available on the Internet at: http:// www. elcaminoreal. org. EIS No. 020423, Final EIS, NPS, CA, Santa Cruz Island Primary Restoration Plan, Implementation, Channel Island National Park, Santa Cruz Island, Santa Barbara County, CA, Wait Period Ends: November 18, 2002, Contact: Alan Schmierer (415) 427– 1441. EIS No. 020424, Final Supplement, FRC, WA, Rocky Creek Hydroelectric Project, (FERC No. 10311– 002) Construction and Operation of a 8.3 megawatt (Mw) Project, Application for License, Rocky Creek, Skagit County, WA, Wait Period Ends: November 18, 2002, Contact: Dianne Rodman (202) 502– 6077. EIS No. 020425, Final EIS, FHW, NY, County Road (Mill Hill Road and Glen Road) Improvements, From Howard Drive to State Route 9N including a New Bridge over the East Branch of the Ausable River, Funding and COE Section 404. Permit, Essex County, NY, Wait Period Ends: November 18, 2002, Contact: Robert Arnold (518) 431– 4127. EIS No. 020426, Draft EIS, AFS, MT, Garver Project, Regeneration Harvest and Old Growth, Implementation, Kootenai National Forest, Three Rivers Ranger District, Lincoln County, MT, Comment Period Ends: December 18, 2002, Contact: Kathy Mohar (406) 295– 4693. EIS No. 020427, Final EIS, NPS, WV, National Coal Heritage Area, Strategic Management Action Plan, Implementation, Boone, Cabell, Fayette, Logan, McDowell, Mercer, Mingo, Raliegh, Summers, Wayne and Wyoming Counties, WV, Wait Period Ends: November 18, 2002, Contact: Peter Samuel (215) 597– 1848. Dated: October 15, 2002. Joseph C. Montgomery, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. 02– 26594 Filed 10– 17– 02; 8: 45 am] BILLING CODE 6560– 50– P ENVIRONMENTAL PROTECTION AGENCY [OPP– 2002– 0292; FRL– 7278– 5] Agricultural Worker Risk Assessment Process; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA's Office of Pesticide Programs will hold a public seminar on the agricultural worker risk assessment decision process on October 29– 30, 2002. The agenda is being developed and will be posted by October 15, 2002, on EPA's website at www. epa. gov/ pesticides/. The following topics are being planned for presentation and discussion: Overview of the worker risk assessment process; agricultural handler risk assessment for selected crop/ handler scenarios; post application risk assessment for selected crop/ post application worker scenarios; and presentations relating to post exposure evaluation. DATES: The meeting will be held on Tuesday, October 29, 2002, from 8: 30 a. m. to 5 p. m., and on Wednesday, October 30, 2002, from 8: 30 a. m. to 4: 30 p. m. ADDRESSES: The meeting will be held at the Georgetown University Conference Center, 3800 Reservoir Road, Washington, DC, in the Leavey Center (Entrance #1 to the Georgetown University Medical Center), Salon C. The telephone number is 202– 687– 3200. FOR FURTHER INFORMATION CONTACT: Margie Fehrenbach, Office of Pesticide Programs, 7501C, Environmental ProtectionAgency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703– 308– 4775; fax number: 703– 308– 4776; e­ mail address: Fehrenbach. Margie@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general; however, persons may be interested who work in agricultural settings or persons who are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act (FQPA); (Public Law 104– 170) of 1996. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Potentially affected entities may include, but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer and farmworker groups; pesticide users and growers; pest consultants; State, local and tribal governments; academia; public health organizations; food processors; and the public. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP– 2002– 0292. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is 703– 305– 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search, '' then key in the appropriate docket ID number. II. Background Stakeholders from two of EPA's Federal advisory committees, the Pesticide Program Dialogue Committee (PPDC) and the Committee to Advise on Reassessment and Transition (CARAT), have expressed interest in better understanding the process followed by the Office of Pesticide Programs when developing agricultural worker risk assessments. EPA is planning two seminars to address these issues. The first seminar will focus on the inputs, decisions, calculations and end results of the worker risk assessment process for agricultural handlers and post applicators. Presentations will include VerDate 0ct< 09> 2002 20: 13 Oct 17, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18OCN1. SGM 18OCN1 64369 Federal Register / Vol. 67, No. 202 / Friday, October 18, 2002 / Notices information about occupational incident data bases and post exposure evaluations. There will also be presentations by the Task Forces for Agricultural Handlers Exposure and Agricultural Reentry. The public is invited to these seminars. Participation from the two advisory committees is also invited and represent the following sectors: Pesticide user, grower and commodity groups; industry and trade associations; environmental/ public interest and farmworker groups; Federal, State and tribal governments; public health organizations; animal welfare; and academia. III. How Can I Request to Participate in this Meeting? This meeting will be open to the public. Opportunity will be provided for questions and comments by the public. Any person who wishes to file a written statement may do so before or after the meeting. These statements will become part of the permanent record and will be available for public inspection at the address listed under Unit I. B. 1. List of Subjects Environmental protection, Agriculture, Agricultural workers, Chemicals, Foods, Pesticides, Pests, Risk assessment. Dated: October 15, 2002. Kathleen D. Knox, Acting Director, Office of Pesticide Programs. [FR Doc. 02– 26712 Filed 10– 16– 02; 3: 21 pm] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [FRL– 7395– 1] Clean Water Act Section 303( d): Availability of 37 Total Maximum Daily Loads (TMDLs) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces the availability for comment of the administrative record file for 37 TMDLs and the calculations for these TMDLs prepared by EPA Region 6 for waters listed in the state of Arkansas, under section 303( d) of the Clean Water Act (CWA). These TMDLs were completed in response to the lawsuit styled Sierra Club, et al. v. Browner et al., No. LR– C– 99– 114. DATES: Comments must be submitted in writing to EPA on or before November 18, 2002. ADDRESSES: Comments on the 37 TMDLs should be sent to Ellen Caldwell, Environmental Protection Specialist, Water Quality Protection Division, U. S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, TX 75202– 2733. For further information, contact Ellen Caldwell at (214) 665– 7513. The administrative record file for these TMDLs are available for public inspection at this address as well. Documents from the administrative record file may be viewed at www. epa. gov/ region6/ water/ artmdl. htm, or obtained by calling or writing Ms. Caldwell at the above address. Please contact Ms. Caldwell to schedule an inspection. FOR FURTHER INFORMATION CONTACT: Ellen Caldwell at (214) 665– 7513. SUPPLEMENTARY INFORMATION: In 1999, five Arkansas environmental groups, the Sierra Club, Federation of Fly Fishers, Crooked Creek Coalition, Arkansas Fly Fishers, and Save our Streams (plaintiffs), filed a lawsuit in Federal Court against the United States Environmental Protection Agency (EPA), styled Sierra Club, et al. v. Browner et al., No. LR– C– 99– 114. Among other claims, plaintiffs alleged that EPA failed to establish Arkansas TMDLs in a timely manner. EPA proposes these TMDLs pursuant to a consent decree entered in this lawsuit. EPA Seeks Comments on 37 TMDLs By this notice EPA is seeking comment on the following 37 TMDLs for waters located within the state of Arkansas: Segment­ reach Waterbody name Pollutant 11140203– 20– 11.9 ...................................................................... Dorcheat Bayou .......................................................................... Mercury. 11140203– 22– 8.4 ........................................................................ Dorcheat Bayou .......................................................................... Mercury. 11140203– 24– 7 ........................................................................... Dorcheat Bayou .......................................................................... Mercury. 11140203– 26– 23.3 ...................................................................... Dorcheat Bayou .......................................................................... Mercury. 11110206– 02– 8.7 ........................................................................ Fourche LaFave River ................................................................ Mercury. 11010014– 36 ............................................................................... South Fork Little Red River ........................................................ Mercury. 11140203 ..................................................................................... Columbia Lake ............................................................................ Mercury. 11110206 ..................................................................................... Cove Creek Lake ........................................................................ Mercury. 11110206 ..................................................................................... Dry Fork Lake ............................................................................. Mercury. 11110206 ..................................................................................... Nimrod Lake ................................................................................ Mercury. 11010014 ..................................................................................... Johnson Hole .............................................................................. Mercury. 11110201 ..................................................................................... Shepherd Springs Lake .............................................................. Mercury. 11110207 ..................................................................................... Lake Sylvia .................................................................................. Mercury. 11110207 ..................................................................................... Spring Lake ................................................................................. Mercury. 08040201– 02– 22.5 ...................................................................... Ouachita River ............................................................................ Mercury. 08040201– 04– 2.5 ........................................................................ Ouachita River ............................................................................ Mercury. 08040202 ..................................................................................... Oxbow River— Oxbows below Camden ..................................... Mercury. 08040202 ..................................................................................... Felsenthal Wildlife Refuge .......................................................... Mercury. 08040202– 02– 4 ........................................................................... Ouachita River ............................................................................ Mercury. 08040202– 03– 8.4 ........................................................................ Ouachita River ............................................................................ Mercury. 08040202– 04– 28.9 ...................................................................... Ouachita River ............................................................................ Mercury. 08040203 ..................................................................................... Lake Winona ............................................................................... Mercury. 08040203– 01– 0.2 ........................................................................ Saline River ................................................................................. Mercury. 08040204– 01– 2.8 ........................................................................ Saline River ................................................................................. Mercury. 08040204– 02– 53 ......................................................................... Saline River ................................................................................. Mercury. 08040204– 04– 16.4 ...................................................................... Saline River ................................................................................. Mercury. 08040204– 06– 17.5 ...................................................................... Saline River ................................................................................. Mercury. 08040201– 01– 12 ......................................................................... Moro Creek ................................................................................. Mercury. 08040201– 03– 20 ......................................................................... Champagnolle Creek .................................................................. Mercury. 08040202– 03– 8.4 ........................................................................ Little Champagnolle .................................................................... Mercury. 08040205– 02– 17.9 ...................................................................... Bayou Bartholomew .................................................................... Mercury. VerDate 0ct< 09> 2002 20: 13 Oct 17, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18OCN1. SGM 18OCN1

epa

2024-06-07T20:31:44.262035

regulations

EPA-HQ-OPP-2002-0293-0001

Notice

Pesticide Product; Registration Approval

72172 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0293; FRL 7278 9] Pesticide Product; Registration Approval AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces Agency approval of applications to register the pesticide products containing active ingredients not included in any previously registered products pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. FOR FURTHER INFORMATION CONTACT: Rosemary Biancardi, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8145; e­ mail address: biancardi. rosemary@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0293. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. In accordance with section 3( c)( 2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office ( A 101), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. The request should: Identify the product name and registration number and specify the data or information desired. A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service ( NTIS), 5285 Port Royal Rd., Springfield, VA 22161. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/.'' An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Did EPA Approve the Application? The Agency approved the applications after considering all required data on risks associated with the proposed use of `` dipotassium phosphate,'' `` dipotassium phosphonate,'' `` sucrose octanoate esters [( a­ D­ glucopyranosyl, b­ Dfructofuranosyl octanoate), mono­, di­ and triesters of sucrose octanoate],'' `` sodium carbonate peroxyhydrate,'' and `` rust Puccinia thlaspeos strain woad,'' and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of `` dipotassium phosphate,'' `` dipotassium phosphonate,'' `` sucrose octanoate esters [( a­ D­ glucopyranosyl, b­ Dfructofuranosyl octanoate), mono­, di­ and triesters of sucrose octanoate],'' `` sodium carbonate peroxyhydrate,'' and `` rust Puccinia thlaspeos strain woad'' when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment. III. Approved Applications 1. EPA issued a notice, published in the Federal Register of May 10, 2000, ( 65 FR 30112) ( FRL 6556 6), which announced that Foliar Nutrient, Inc., 320 First Ave., Cairo, GA 31728 had submitted an application to register the pesticide product, Lexx­ A­ Phos Fungicide, ( EPA File Symbol 72499 R), containing 22.67% dipotassium phosphate and ( the registered active ingredient) 20.40% dipotassium phosphonate. This product was not previously registered. The application was approved on September 16, 2002, as Lexx­ A­ Phos Fungicide ( EPA Registration Number 72499 1. The technical grade of the active will be used for incorporation into the end­ use product Lexx­ A­ Phos Fungicide, which is intended to control certain fungal diseases in woody ornamentals, turfgrasses and nonbearing fruits and nut tree crops. This use is classified as a terrestrial non­ food application. ( D. Benmhend) 2. EPA issued a notice, published in the Federal Register of August 11, 1999 ( 64 FR 43701) ( FRL 6095 2), which announced that AVA Chemical Ventures, L. L. C., 80 Rochester Avenue, Suite 214, Portsmouth, NH 03801, had submitted applications to register the pesticide products, Avachem Sucrose Octanoate Manufacturing Use Product [ 63%], a manufacturing­ use product for formulation into biological insecticide VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72173 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices end­ use products ( EPA File Symbol 70950 R), and Sucrose Octanoate [ 32.1%], a biological insecticide end­ use product ( EPA File Symbol 70950 E), containing sucrose octanoate ( C8 fatty acid mono­, di­ and triesters of sucrose octanoate and sucrose dioctanoate) ( a­ Dglucopyranoside b­ D­ fructofuranosyl, monooctanoate and dioctanoate), which has since been designated by the Agency as sucrose octanoate esters [( a­ D­ glucopyranosyl, b­ D­ fructofuranosyloctanoate mono­, di­ and triesters of sucrose octanoate]. These products were not previously registered. The applications were approved on September 16, 2002, as Avachem Sucrose Octanoate Manufacturing Use Product ( EPA Registration Number 70950 1) for formulating into biochemical insecticide/ miticide enduse products and Avachem Sucrose Octanoate [ 40.0%] ( EPA Registration Number 70950 2) for use as a biochemical insecticide/ miticide enduse product. ( D. Greenway) 3. EPA also issued a notice, published in the Federal Register of August 11, 1999 ( 64 FR 43701) ( FRL 6095 2), which announced that BioSafe Systems, 80 Commerce St., Glastonbury, CT 06033, had submitted an application to register the pesticide product, TerraCare Granular, Algaecide, Fungicide ( EPA File Symbol 70299 G), containing the active ingredient sodium percarbonate at 40% redesignated as sodium carbonate peroxyhydrate. This product was not previously registered. The application was approved on September 20, 2002, as TerraCyteTM ( EPA Registration Number 70299 3) for use as an algaecide and fungicide on ornamental plants and turf. ( A. Ball) 4. EPA issued a notice, published in the Federal Register of March 8, 2002 ( 67 FR 10717) ( FRL 6824 3), which announced that Greenville Farms, 6189 N. 1200 E., Logan, Utah 84341, had submitted an application to register the pesticide product, Woad Warrior, a herbicide ( EPA File Symbol 73417 R), containing Puccinia thlaspeos `` strain woad'' on rust­ infected pieces of dyer's woad at 100% and at least 7.6 x 109 teliospores/ pound of woad warrior. This product was not previously registered. The application was approved on June 26, 2002, as Woad Warrior containing the rust Puccinia thlaspeos `` strain woad'' as the active ingredient. ( EPA Registration Number 73417 1) for controlling dyer's woad, an invasive weed rapidly spreading in several Western states. ( B. Mandula) List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: November 20, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [ FR Doc. 02 30602 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ FRL 7417 2] Generic Assessment Endpoints for Ecological Risk Assessments ( External Review Draft); Notice of Availability AGENCY: Environmental Protection Agency. ACTION: Notice of availability and opportunity for public comment. SUMMARY: The U. S. Environmental Protection Agency ( EPA) is announcing a 60­ day public comment period for the draft document titled Generic Assessment Endpoints for Ecological Risk Assessments prepared by the Agency's Risk Assessment Forum ( RAF). The document is intended to assist EPA during the process of ecological risk assessment in selecting assessment endpoints, which are valued ecological entities and attributes to be protected. EPA will consider the public comment submissions in revising the document. DATES: The 60­ day public comment period begins December 4, 2002, and ends February 3, 2003. Comments must be provided by February 3, 2003. ADDRESSES: The draft is available via the Internet on the EPA Risk Assessment Forum's home page at http:// www. epa. gov/ ncea/ raf under the What's New and External Review Drafts menus. Comments may be submitted electronically, by mail, or in person, as described in the instructions under SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, please contact Scott Schwenk, U. S. EPA, Office of Research and Development, National Center for Environmental Assessment ( 8601D), 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: 202 564 6667; fax: 202 565 0062; e­ mail: schwenk. scott@ epa. gov. SUPPLEMENTARY INFORMATION: I. Submission of Comments Electronic comments are preferred and may be sent by e­ mail to: risk. forum@ epa. gov. Alternatively, comments may be mailed to the Technical Information Staff ( 8623D), NCEA W, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, or delivered to the Technical Information Staff at 808 17th Street, NW., 5th Floor, Washington, DC 20006; telephone: 202 564 3261; facsimile: 202 565 0050. In the case of paper comments, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. Please note that all comments received in response to this notice will be placed in a public record. For that reason, commentors should not submit personal information ( such as medical data or home address), Confidential Business Information, or information protected by copyright. Due to limited resources, acknowledgments will not be sent. II. Background Ecological risk assessment is a process for evaluating the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors. A critical early step in conducting an ecological risk assessment is to select assessment endpoints. Assessment endpoints represent valued ecological entities, and their attributes, upon which riskmanagement actions are focused. Selecting assessment endpoints is often challenging because of the diversity of species, ecological communities, and ecological functions from which those involved in risk assessment can choose and because of statutory ambiguity regarding what is to be protected. The purpose of the RAF document is to assist EPA risk assessors by providing a set of generic ecological assessment endpoints that can be considered and adapted for use in specific ecological risk assessments, building on existing EPA guidance and experience. The document is not prescriptive, but rather is intended to be a useful starting point that is flexible enough to be applied to many different types of ecological risk assessments. The document is undergoing peer review concurrent with the public comment period described in this notice. Dated: November 12, 2002. George W. Alapas, Director, National Center for Environmental Assessment. [ FR Doc. 02 30763 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1

epa

2024-06-07T20:31:44.267387

regulations

EPA-HQ-OPP-2002-0294-0001

Notice

Alpha-Cyclodextrin, Beta-Cyclodextrin, and Gamma-Cyclodextrin; Notice of FIling a Pesticide Petition to Establish an Exemption from the Requirement of a Toleranc

69003 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices test systems and other scientifically relevant information, to determine whether certain substances may have hormonal effects in humans. In 1996, EPA chartered a scientific advisory committee, the Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), under the authority of the Federal Advisory Committee Act ( FACA ) to advise it on establishing a program to carry out Congress' directive. EDSTAC recommended a multi­ step approach including a series of screens ( Tier I Screens) and tests ( Tier II Tests) for determining whether a chemical substance may have an effect similar to that produced by naturally occurring hormones. EPA adopted many of EDSTAC's recommendations in the program that it developed, the EDSP, to carry out Congress' directive. EDSTAC also recognized that there currently are no validated testing systems for determining whether a chemical may have an effect in humans that is similar to an effect produced by naturally occurring hormones. Consequently, EPA is in the process of developing and validating the screens and tests that EDSTAC recommended for inclusion in the EDSP. In carrying out this validation exercise, EPA is working closely with, and adhering to the principles of the Interagency Coordinating Committee for the Validation of Alternate Methods ( ICCVAM). EPA also is working closely with the Organization for Economic Cooperation and Development's ( OECD) Endocine Testing and Assessment Task Force to validate and harmonize endocrine screening tests of international interest. Finally, to ensure that EPA has the best and most up­ to­ date advice available regarding the validation of the screens and tests in the EDSP, EPA recently chartered EDMVS of the NACEPT. EDMVS provides independent advice and counsel to the Agency through NACEPT, on scientific and technical issues related to validation of the EDSP Tier I screens and Tier II tests, including advice on methods for reducing animal use, refining procedures involving animals to make them less stressful, and replacing animals where scientifically appropriate. EDMVS has met five times since its establishment in September 2001. The objectives of the October 2001 meeting ( docket control number OPPTS 42212D) were for EPA to provide: 1. An overview of EPA's EDSP. 2. Background information on test protocol validation and approaches. 3. For the EDMVS to develop a clear understanding of their scope, purpose and operating procedures. 4. For the EDMVS and the EDSP to determine the next steps. The objectives of the December 2001 meeting ( docket control number OPPTS 42212E) were for the EDMVS to provide input and advice on: 1. EDMVS's mission statement and work plan. 2. The in utero through lactation assay detailed review paper. 3. The pubertal assay study design for the multi­ dose and chemical array protocols. 4. The mammalian 1­ generation study design. The objectives of the March 2002 meeting ( docket control number OPPTS 42212F) were for the EDMS to provide input and advice on: 1. EDSP's implementation process and practical aspects of validation. 2. The in utero through lactation assay protocol. 3. The fish reproduction assay detailed review paper. 4. Special studies on fathead minnow assays, vitellogenin assay, and avian dosing protocol. 5. The steroidogenesis detailed review paper. 6. The aromatase detailed review paper. 7. A proposed standard suite of chemicals for testing in the Tier I screening assay. 8. The current efforts related to evaluating the relevance of animal data to human health. 9. EPA's approach to addressing lowdose issues. The objective of the June 2002 teleconference meeting ( docket ID number OPPT 2002 0020) was for the EDMVS to provide input and advice on the steroidogenesis detailed review paper. The objectives of the July 2002 meeting ( docket ID number OPPT 2002 0029) were: 1. To review criteria, recommended by EDSTAC and adopted by EDSP for screens. 2. To receive an update on the NICEATM estrogen and androgen receptor binding efforts. 3. To discuss and provide advice on general dose setting issues, and to provide comments and advice on: A pubertals special study restricted feeding. A mammalian 2­ generation draft PTU special study. An amphibian metamorphosis detailed review paper. An invertebrate detailed review paper. III. Meeting Objectives for the December 2002 Teleconference Meeting The objective of the December 2002 teleconference meeting ( docket ID number OPPT 2002 0059) is for the EDMVS to provide input and advice on the Tier II fish lifecycle assay detailed review paper. A list of the EDMVS members and meeting materials are available on our Web site ( http:// www. epa. gov/ scipoly/ oscpendo/ edmvs. htm), and in the EPA Docket. List of Subjects Environmental protection, Endocrine disruptors. Dated: November 4, 2002. Joseph Merenda, Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances. [ FR Doc. 02 28910 Filed 11 13 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0294; FRL 7279 3] Alpha­ cyclodextrin, Beta­ cyclodextrin, and Gamma­ cyclodextrin; Notice of Filing a Pesticide Petition to Establish an Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of alphacyclodextrin beta­ cyclodextrin, and gamma­ cyclodextrin in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0294, must be received on or before December 16, 2002. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Treva Alston, Minor Use, Inerts, and Emergency Reponse Branch, Registration Division ( 7505W), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8373; e­ mail address: alston. treva@ epa. gov. VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69004 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP 2002 0294. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0294. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69005 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID number OPP 2002 0294. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID number OPP 2002 0294. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP 2002 0294. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI, and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 4, 2002. Debra Edwards, Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the Wacker Biochem Corporation and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. PP 2E6514 Summary of Petitions EPA has received a pesticide petition ( 2E6514) from Wacker Biochem Corporation, 3301 Sutton Road, Adrian, MI 49221 9397 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.950 to establish an exemption from the requirement of a tolerance for alphacyclodextrin ( CAS No. 10016 20 3), beta­ cyclodextrin ( CAS No. 7585 39 9), and gamma­ cyclodextrin ( CAS No. 17465 86 0) in or on raw agricultural commodities resulting from the use of alpha­, beta­, and gamma­ cyclodextrin as ingredients in pesticide formulations used in accordance with good agricultural practices. Alphacyclodextrin beta­ cyclodextrin, and gamma­ cyclodextrin are naturally occurring compounds derived from the degradation of starch by the glucosyltransferase enzyme ( CGTase). Dglucose molecules that are formed by the digestion of starch are joined `` headto tail'' to form alpha­, beta­, and gamma­ cyclodextrin which are ringshaped molecules. Alpha­, beta­, and gamma­ cyclodextrin are comprised of six, seven and eight D­ glucose units, respectively. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. While no studies have been conducted to evaluate the metabolism of alpha­, beta­, and gammacyclodextrin in plants, the metabolic products in plants are anticipated to be VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69006 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices ubiquitous, naturally occurring simple sugars and CO2. The anticipated plant metabolites are not of toxicological concern. 2. Analytical method. An analytical method is not required for enforcement purposes since Wacker Biochem is requesting the establishiment of an exemption from the requirement of a tolerance without any numerical limitation. B. Toxicological Profile Alpha­ cyclodextrin: The Food & Agriculture Organization/ World Health Organization ( FAO/ WHO) Joint Expert Committee on Food Additives ( JECFA) has evaluated alpha­ cyclodextrin and in 2001 allocated an acceptable daily intake ( ADI) of `` not specified.'' This is the most desirable ADI allocation issued by JECFA. Beta­ cyclodextrin: A GRAS ( generally recognized as safe) petition was submitted by Roquette America Inc/ American Maize­ Products Co. for use as a formulation aid in the production of dry flavoring mixes ( February 3, 1992) and for use as a flavor protectant ( September 20, 1996). A self­ affirmation of beta­ cyclodextrin as a flavor carrier in foods was completed by Cerestar USA on February 4, 1998. Wacker Biochem Corporation has submitted to the FDA an independent GRAS determination for beta­ cyclodextrin for use as a flavor carrier or protectant in baked goods prepared from dry mixes, breakfast cereal, chewing gum, compressed, candies, gelatins and puddings, flavored coffee and tea, processed cheese products, dry mix for beverages, flavored savory snacks and crackers, dry mixes for soups ( GRAS Notice No. 74). FDA has not yet completed its review of the self­ affirmation. Gamma­ cyclodextrin: Wacker Biochem Corporation has determined that gamma­ cyclodextrin is generally recognized as safe ( GRAS) when used as a stabilizer, emulsifier, carrier and formulation aid in foods. The toxicology and metabolism data relevant to the proposed tolerance exemption are summarized in Table 1. TABLE 1. TOXICITY AND METABOLISM Study Cyclo­ dextrin Result Acute oral toxicity Alpha­ LD50 > 10,000 mg/ kg ( rat) Beta­ LD50 > 12,000 mg/ kg ( rabbit) Gamma­ LD50 > 8,000 mg/ kg ( rat) Acute dermal toxicity No data are available Acute inhalation toxicity No data are available Primary eye irritation Alpha­ Crystalline form: Eye irritant, but not corrosive 50% suspension: Non­ irritant Beta­ Slight irritant Gamma­ Non­ irritant Primary dermal irritation Alpha­ Non­ irritant Beta­ Non­ irritant Dermal sensitization Alpha­ Non­ sensitizer Beta­ Non­ sensitizer Gamma­ Non­ sensitizer 28 Day feeding study: rodent Alpha­ NOEL = 5% in the diet Beta­ NOEL = 5% in the diet 90 Day feeding study: rat Alpha­ NOAEL = 20% in diet highest dose tested ( HDT) Beta­ NOAEL = 400 mg/ kg/ day by gavage Gamma­ NOAEL = 20% in diet HDT 90 Day feeding study: dog Alpha­ NOAEL = 20% in diet HDT Beta­ NOEL = 2.5% in diet LOEL = 5% in diet. Hematology and clinical chemistryeffects observed indicated slight toxicity Gamma­ NOAEL = 20% in diet HDT VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69007 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices TABLE 1. TOXICITY AND METABOLISM Continued Study Cyclo­ dextrin Result Subchronic dermal toxicity No data are available Chronic feeding and oncogenicity Beta­ 1 year dog NOAEL = 1% in diet = 350 mg/ kg/ day LOAEL = 2.5% in diet = 925 mg/ kg/ day Increased levels of protein were observed in urine 2­ year rat: NOEL for oncogenicity = 6% in diet Small percentage is absorbed by the intestinal walls and causes kidney damage Beta­ cyclodextrin is not degraded in the small intestine. In the large intestine it undergoes bacterial degradation, leading to gas generation and diarrhea Teratology study: rodent Alpha­ Not teratogenic, embryotoxic or fetotoxic at doses up to 20% of diets in both rats and rabbits HDT Beta­ Not teratogenic, embryotoxic or fetotoxic at 5,000 mg/ kg/ day in rats HDT and at 1,000 mg/ kg/ day in rabbits HDT Gamma­ Not teratogenic, embryotoxic or fetotoxic at doses up to 20% of diets in both rats and rabbits HDT 2­ Generation reproduction Beta­ NOAEL in rats = 1% in diet = 700 mg/ kg/ day LOAEL in dams and offspring = 2.5% in the diet Gene mutation test Alpha­ Negative Ames test Gamma­ Negative Ames test Structural chromosomal aberration test Beta­ Negative in rats at dose of 2% in diet Other genotoxic effects Alpha­ Negative micronucleus test Gamma­ Negative micronucleus test Metabolism ( oral dosing Alpha Absorption: 2% dose absorbed Distribution: Liver (> 0.05% dose) and kidney (> 0.01% dose) Metabolism: Extensively and predominantly metabolized to C02 by intestinal flora Excretion: 60% dose expelled as CO2 26 33% dose incorporated 7 14% dose excreted in urine and feces Beta­ Absorption: No significant absorption as intact molecule. Absorption as sugars is similar to that of glucose; occurs via passive transport Distribution: Max. 0.9% in GI tract 60 hours after dosing Metabolism: Hydrolysis to open chain dextrins and glucose occurs in the large intestine by intestinal flora Excretion: 66.8% dose as CO2 in expired air within 23 hours of dosing. 0.6% to 4% in feces within 60 hours of dosing Gamma­ Absorption: > 0.1% as intact molecule Metabolism: Rapid and total degradation to glucose in the upper intestinal tract by intestinal flora Excretion: 60% dose expelled as CO2 37% dose incorporated 3% dose excreted in urine and feces 1. Metabolite toxicology. Alpha­, beta­, and gamma­ cyclodextrin are metabolized to simple sugars and CO2. These metabolites are also metabolites of the digestion of carbohydrates in the diet and have no significant toxicity. 2. Endocrine disruption. Based upon the available data, alpha­, beta­, and gamma­ cyclodextrin are not anticipated to disrupt the endocrine system. C. Aggregate Exposure 1. Food. Alpha­ cyclodextrin, betacyclodextrin and beta­ cyclodextrin are naturally occurring compounds and are used as food additives. Alpha­ cyclodextrin food additive uses include: Carrier; encapsulating agent for food additives, flavorings and vitamins; stabilizer; and absorbent. The ADI is `` not specified.'' VerDate 0ct< 31> 2002 17: 13 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69008 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices Beta­ cyclodextrin is used as a flavor carrier or protectant. See Table 2 for a detailed list of uses and the maximum concentrations. TABLE 2. MAXIMUM CONCENTRATION OF BETA­ CYCLODEXTRIN IN FOODS Beta­ Cyclodextrin Use Maximum Concentration Baked goods prepared from dry mixes breakfast cereal chewing gum compressed candies 2% Gelatins and puddings flavored coffee and tea processed cheese products dry mix for beverages 1% Flavored savory snacks and crackers 0.5% Dry mixes for soups 0.2% Gamma­ cyclodextrin is used in foods such as bread spreads, frozen dairy desserts, ready to eat dairy desserts, desserts prepared from dry mixes, fruit fillings, cheese and cream fillings, chewing gum, dietary supplements. See Table 3 for a complete list of uses and the maximum concentrations. TABLE 3. MAXIMUM CONCENTRATION OF GAMMA­ CYCLODEXTRIN IN FOODS Gamma­ Cyclodextrin Use Maximum Use Concentration Carrier for flavors, sweeteners and colors < 1% Dry mixes for beverages < 1% Dry mixes for soups < 1% Dry mixes for dressings, gravies, and sauces < 1% Dry mixes for puddings, gelatins, and fillings < 1% Instant coffee and instant tea < 1% Coffee whiteners < 1% Compressed candies < 1% Chewing gum < 1% Breakfast cereals ( ready­ to­ eat) < 1% Savory snacks and crackers < 1% Spices and seasonings < 1% Carrier for vitamins < 1% For use in dry food mixes and dietary supplements < 90% 1 Carrier for polyunsaturated fatty acids For use in dry food mixes and dietary supplements < 80% 1 Flavor modifier Soya milk < 2% Stabilizer Bread spreads ( fat­ reduced) < 20% Frozen dairy desserts < 3% Baked goods ( excl. bread, but incl. dough and baking mixes) < 2% Bread < 1% Fruit­ based fillings < 3% Fat­ based fillings < 5% VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1 69009 Federal Register / Vol. 67, No. 220 / Thursday, November 14, 2002 / Notices TABLE 3. MAXIMUM CONCENTRATION OF GAMMA­ CYCLODEXTRIN IN FOODS Continued Gamma­ Cyclodextrin Use Maximum Use Concentration Processed cheese < 3% Dairy deserts ( ready­ to­ eat and prepared from dry mixes) < 3% 1Percent by weight of gamma­ cyclodextrin relative to the nutrient for which gamma­ cyclodextrin is used as a carrier. The proposed use of alpha­, beta­, and gamma­ cyclodextrin as ingredients in pesticide formulations is anticipated to result in no significant additional dietary exposure to alpha­, beta­, and gamma­ cyclodextrin. 2. Drinking water. Any alpha­, beta­, and gamma­ cyclodextrin in drinking water sources is anticipated to degrade to simple sugars and CO2 that will be used by plants as building blocks for the plant's growth. No significant exposure of alpha­, beta­, and gammacyclodextrin via drinking water is anticipated. 3. Non­ dietary exposure. Cyclodextrins are used extensively in the cosmetic industry. Alpha­, beta­, and gamma­ cyclodextrin are too large to be absorbed through the skin, so no significant systemic exposure is anticipated to result from the cosmetic use or other residential uses of alpha­, beta­, and gamma­ cyclodextrin. D. Cumulative Effects Alpha­, beta­, and gammacyclodextrin have no significant toxic effects for consideration of cumulative effects. E. Safety Determination 1. U. S. population. Alpha­, beta­, and gamma­ cyclodextrin are low toxicity, naturally occurring compounds that are use as food additives. The D­ glucose building blocks of alpha­, beta­, and gamma­ cyclodextrin are also the result of digestion of starchy foods such as bread, rice, potatoes and pasta. Alpha­ , beta­, and gamma­ cyclodextrin are part of the current U. S. diet, and the proposed new uses of alpha­, beta­, and gamma­ cyclodextrin as ingredients in pesticide formulations is not anticipated to contribute significantly to the amount of alpha­, beta­, and gammacyclodextrin in the U. S. diet. The proposed new use of alpha­, beta­, and gamma­ cyclodextrin for use as an inert ingredient in pesticide formulations has a reasonable certainty of no harm to the U. S. population. 2. Infants and children. Alpha­, beta­ , and gamma­ cyclodextrin have no significant toxic effects that are specific to infants or children. The proposed new uses of alpha­, beta­, and gammacyclodextrin as ingredients in pesticide formulations has a reasonable certainty of no harm to infants or children. F. International Tolerances Alpha­ cyclodextrin: The FAO/ WHO JECFA has evaluated alpha­ cyclodextrin and in 2001 allocated an ADI of `` not specified.'' This is the most desirable ADI and is limited to low toxicity compounds. Beta­ cyclodextrin: A request was submitted to the CODEX Alimentarius Commission for additive clearance in the General Standard on Food Additives ( INS No. 459) at a maximum level of 50,000 milligrams/ kilogram ( mg/ kg) in food category 5.3, for chewing gum. A new monograph for beta­ cyclodextrin has been published in the First Supplement to the Fourth Edition of the Food Chemicals Codex. Betacyclodextrin is published in Annex V of the Official Journal of the European Communities­ Food Additives as a carrier only for food additives up to 1 gram/ kilogram food. An ADI of 5 mg/ kg body weight was established at the February 1995 joint FAO/ WHO meeting of the expert committee on food additives and is published in WHO Food Additive Series 35. Gamma­ cyclodextrin: The FAO/ WHO JECFA has evaluated alpha­ cyclodextrin and in 2,000 ( 53rd meeting) allocated an ADI of `` not specified.'' This is the most desirable ADI and is limited to low toxicity compounds. [ FR Doc. 02 28909 Filed 11 13 02; 8: 45 am] BILLING CODE 6560 50 S FEDERAL COMMUNICATIONS COMMISION Notice of Public Information Collection( s) Being Reviewed by the Federal Communications Commission November 7, 2002. SUMMARY: The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection( s), as required by the Paperwork Reduction Act of 1995, Pub. L. 104 13. An agency may not conduct or sponsor a collection of information unless it displays a current valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act ( PRA) that does not display a valid control number. Comments are requested concerning ( a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; ( b) the accuracy of the Commission's burden estimate; ( c) ways to enhance the quality, utility, and clarity of the information collected; and ( d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. DATES: Written comments should be submitted on or before January 13, 2003. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible. ADDRESSES: Direct all comments to Les Smith, Federal Communications Commission, Room 1 A804, 445 12th Street, SW., Washington, DC 20554, or via the Internet to lesmith@ fcc. gov. FOR FURTHER INFORMATION CONTACT: For additional information or copies of the information collection( s) contact Les Smith at 202 418 0217 or via the Internet at lesmith@ fcc. gov. SUPPLEMENTARY INFORMATION: OMB Control Number: 3060 0960. Title: Application of Network Non­ Duplication, Syndicated Exclusivity, and Sports Blackout Rules to Satellite Retransmissions of Broadcast Signals. Form Number: N/ A. Type of Review: Revision of a currently approved collection. Respondents: Businesses or other forprofit entities. Number of Respondents: 1,407. Estimated Time per Response: 0.5 to 1.0 hours. Frequency of Response: On occasion reporting requirements; Third party disclosure. Total Annual Burden: 63,992 hours. VerDate 0ct< 31> 2002 15: 40 Nov 13, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 14NON1. SGM 14NON1

epa

2024-06-07T20:31:44.277014

regulations

EPA-HQ-OPP-2002-0295-0001

Notice

Tetrachlorvinphos; Availability of Interim Risk Management Decision Document

77491 Federal Register / Vol. 67, No. 243 / Wednesday, December 18, 2002 / Notices Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOlineSuport@ ferc. gov. or toll­ free at ( 866) 208 3676, or for TTY, contact ( 202) 502 8659. n. Anyone may submit a protest or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In determining the appropriate action to take, the Commission will consider all protests filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any protests or motions to intervene must be received on or before the specified deadline date for the particular application. All filings must ( 1) bear in all capital letters the title `` PROTEST'' or `` MOTION TO INTERVENE;'' ( 2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; ( 3) furnish the name, address, and telephone number of the person protesting or intervening; and ( 4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. Linwood A. Watson, Jr., Deputy Secretary. [ FR Doc. 02 31897 Filed 12 17 02; 8: 45 am] BILLING CODE 6717 01 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0295; FRL 7279 2] Tetrachlorvinphos; Availability of Interim Risk Management Decision Document AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the availability of the interim risk management decision document for tetrachlorvinphos. This decision document has been developed as part of the public participation process that EPA and the U. S. Department of Agriculture ( USDA) are now using for involving the public in the reassessment of pesticide tolerances under the Food Quality Protection Act ( FQPA), and the reregistration of individual organophosphate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). FOR FURTHER INFORMATION CONTACT: For general information contact: Demson Fuller, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8062; e­ mail address: fuller. demson@ epamail. epa. gov. SUPPLEMENTARY INFORMATION I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, nevertheless, a wide range of stakeholders will be interested in obtaining the interim risk management decision document for tetrachlorvinphos, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides on food and pets. Since other entities also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0295. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. What Action is the Agency Taking? EPA has assessed the risks of tetrachlorvinphos and reached an Interim Tolerance Reassessment Eligibility Decision ( TRED) or a Report on FQPA Tolerance Reassessment Progress and Interim Risk Management Decision for this pesticide. With risk mitigation measures adopted, tetrachlorvinphos fits into its own risk cup­ its individual, aggregate risks are within acceptable levels. The RED for tetrachlorvinphos was completed in 1995. At that time, the Agency assessed the risk for dietary, occupational, ecological, and residential concerns. With the passage of FQPA, the tolerances for tetrachlorvinphos needed to be reassessed according to the FQPA safety standard. In this current assessment, the Agency looked at dietary, residential and occupational concerns. Tetrachlorvinphos is currently applied dermally to livestock to control flies and mites; used as a feed­ through ( oral) larvicide in cattle, hogs, goats, and horses; in cattle ear tags to control flies; and in poultry production to control beetles, flies, and mites. Tetrachlorvinphos also is used as a dust/ powder, aerosol, and pump spray on pets and in pet sleeping areas, and in collars and shampoos for direct treatment of pets. It is used as a spray to control nuisance and public health pests ( flies) in and around refuse sites, recreational areas, and for general outdoor treatment. Dietary risks from eating food items containing residues of tetrachlorvinphos are below the level of concern for the entire U. S. population, including infants and children. Drinking water is not a significant source of exposure. Residential handler and post application risks were also not of concern for all exposure scenarios. However, the Agency has concern over VerDate 0ct< 31> 2002 17: 41 Dec 17, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18DEN1. SGM 18DEN1 77492 Federal Register / Vol. 67, No. 243 / Wednesday, December 18, 2002 / Notices the potential for over­ application of powder products. Labels need to be modified to specify how much product to apply to treat pets of different sizes. Additionally, based on discussions with stakeholders, EPA believes that directions for outdoor uses as premise sprays around kennels, yards, campgrounds, and parks, and along foot paths and roadways leading to such areas, must clearly limit use to spot treatments only. Worker risks for most scenarios are not of concern if measures to reduce exposure, such as personal protective equipment, are used. However, use of the EC formulation as a paint­ on poses high risks to workers despite the maximum protection feasible. Therefore this use will be removed from product labels. For other scenarios, such as applying dusts with power dusting equipment, additional data are needed to confirm that risks to workers will not be excessive. In addition, EPA has determined that labels for tetrachlorvinphos feedthrough products for horses must state that the product is a chlolinesterase inhibitor, describe signs of cholinesterase inhibition in horses, caution against the use with other cholinesterase inhibiting compounds, and direct horse owners to consult a veterinarian before using products containing tetrachlorvinphos on debilitated, aged, breeding, pregnant or nursing animals. The interim risk management decision document for tetrachlorvinphos was made through the organophosphate pesticide pilot public participation process, which increases transparency and maximizes stakeholder involvement in EPA's development of risk assessments and risk management decisions. The pilot public participation process was developed as part of the EPA­ USDA Tolerance Reassessment Advisory Committee ( TRAC), which was established in April 1998, as a subcommittee under the auspices of EPA's National Advisory Council for Environmental Policy and Technology. A goal of the pilot public participation process is to find a more effective way for the public to participate at critical junctures in the Agency's development of organophosphate pesticide risk assessments and risk management decisions. EPA and USDA began implementing this pilot process in August 1998, to increase transparency and opportunities for stakeholder consultation. EPA worked extensively with affected parties to reach the decisions presented in the interim risk management decision documents, which conclude the pilot public participation process for tetrachlorvinphos. As part of the pilot public participation process, numerous opportunities for public comment were offered as these interim risk management decision documents were being developed. The tetrachlorvinphos interim risk management decision document therefore is issued in final, without a formal public comment period. The docket remains open, however, and any comments submitted in the future will be placed in the public docket. The risk assessments for tetrachlorvinphos were released to the public through a notice published in the Federal Register of January 15, 1999 ( 64 FR 2644) ( FRL 6056 9) and March 27, 2000 ( 65 FR 16197) ( FRL 6551 4). Addenda to these assessments are also available in the public docket. EPA's next step under FQPA is to complete a cumulative risk assessment and risk management decision for the organophosphate pesticides, which share a common mechanism of toxicity. The interim risk management decision document on tetrachlorvinphos cannot be considered final until this cumulative assessment is complete. When the cumulative risk assessment for the organophosphate pesticides has been completed, EPA will issue its final tolerance reassessment decision for tetrachlorvinphos and further risk mitigation measures may be needed. List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: December 3, 2002. Lois A. Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02 31361 Filed 12 17 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ FRL 7423 8] Clean Water Act Section 303( d): Final Agency Action on 37 Total Maximum Daily Loads ( TMDLs) AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of availability. SUMMARY: This notice announces final agency action on 37 TMDLs prepared by EPA Region 6 for waters listed in the state of Arkansas, under section 303( d) of the Clean Water Act ( CWA). These TMDLs were completed in response to the lawsuit styled Sierra Club, et al. v. Clifford, et al., No. LR C 99 114. Documents from the administrative record files for the final 37 TMDLs, including TMDL calculations and responses to comments, may be viewed at http:// www. epa. gov/ earth1r6/ 6wq/ artmdl. htm. ADDRESSES: The administrative record files for these 37 TMDLs may be obtained by writing or calling Ms. Ellen Caldwell, Environmental Protection Specialist, Water Quality Protection Division, U. S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, TX 75202 2733. Please contact Ms. Caldwell to schedule an inspection. FOR FURTHER INFORMATION CONTACT: Ellen Caldwell at ( 214) 665 7513. SUPPLEMENTARY INFORMATION: In 1999, five Arkansas environmental groups, the Sierra Club, Federation of Fly Fishers, Crooked Creek Coalition, Arkansas Fly Fishers, and Save our Streams ( plaintiffs), filed a lawsuit in Federal Court against the United States Environmental Protection Agency ( EPA), styled Sierra Club, et al. v. Browner et al., No. LR C 99 114. Among other claims, plaintiffs alleged that EPA failed to establish Arkansas TMDLs in a timely manner. EPA Takes Final Agency Action on 37 TMDLs By this notice EPA is taking final agency action on the following 37 TMDLs for waters located within the state of Arkansas: Segment­ reach Waterbody name Pollutant 11140203 20 11.9 ....................................................................... Dorcheat Bayou ........................................................................... Mercury 11140203 22 8.4 ......................................................................... Dorcheat Bayou ........................................................................... Mercury 11140203 24 7 ............................................................................ Dorcheat Bayou ........................................................................... Mercury 11140203 26 23.3 ....................................................................... Dorcheat Bayou ........................................................................... Mercury 11110206 02 8.7 ......................................................................... Fourche LaFave River ................................................................. Mercury 11010014 36 ................................................................................ South Fork Little Red River ......................................................... Mercury 11140203 ...................................................................................... Columbia Lake ............................................................................. Mercury VerDate 0ct< 31> 2002 18: 59 Dec 17, 2002 Jkt 200001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 18DEN1. SGM 18DEN1

epa

2024-06-07T20:31:44.285274

regulations

EPA-HQ-OPP-2002-0298-0001

Rule

Thiamethoxam; Pesticide Tolerance

66561 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations * * * * * [ FR Doc. 02 27833 Filed 10 31 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0298; FRL 7279 6] Thiamethoxam; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of thiamethoxam and its metabolite in or on corn forage, corn stover and popcorn, corn grain and sweet corn ( kernal and cob with husk removed). Syngenta Crop Protection, Inc. requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA) , as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective November 1, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0298, must be received on or before December 31, 2002. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Dani Daniel, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: 703 305 5409; e­ mail address: daniel. dani@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does This Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS Examples of Potentially Affected Entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0298. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml__ 00/ Title__ 40/ 40cfr180__ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings In the Federal Register of June 27, 2002 ( 67 FR 43310 43314) ( FRL 7183 2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104 170), announcing the filing of a pesticide petition ( PP 0F6142) by Syngenta Crop Protection, Inc., P. O. Box 18300 Greensboro, NC 27419 8300. That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.565 be amended by establishing tolerances for combined residues of the insecticide thiamethoxam, 3­[( 2­ chloro­ 5­ thiazolyl) methyl] tetrahydro­ 5­ methyl­ N­ nitro­ 4H­ 1,3,5­ oxadiazin­ 4­ imine and its metabolite ( N­( 2­ chloro­ thiazol­ 5­ ylmethyl)­ N ­ methyl­ N ­ nitro­ guanidine) in or on the raw agricultural commodities: field corn forage at 0.10 parts per million ( ppm), sweet corn forage at 0.10 ppm, popcorn forage at 0.10 ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, field corn grain at 0.07 ppm, popcorn grain at 0.02 ppm, and sweet corn ( kernal and cob with husk removed) at 0.02 ppm. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of VerDate 0ct< 09> 2002 15: 13 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66562 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL 5754 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a tolerance for combined residues of thiamethoxam and its metabolite on field corn forage at 0.10 parts per million ( ppm), sweet corn forage at 0.10 ppm, popcorn forage at 0.10 ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, field corn grain at 0.07 ppm popcorn grain at 0.02 ppm, and sweet corn ( kernal and cob with husk removed) at 0.02 parts per million ( ppm). EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by thiamethoxam are discussed in Table 1 of this unit as well as the no­ observed­ adverse­ effectlevel ( NOAEL) and the lowest­ observedadverse effect­ level ( LOAEL) from the toxicity studies reviewed. TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90 day oral toxicity ­ rat NOAEL = 1.74 ( males), 92.5 ( females) mg/ kg/ day LOAEL = 17.64 ( males), 182.1 ( females) mg/ kg/ day based on increased incidence of hyaline change of renal tubular epithelium ( males), fatty change in adrenal gland of females, liver changes in females, all at the LOAEL. 870.3100 90 Day oral toxicity­ mouse NOAEL = 1.41 ( males), 19.2 ( females) mg/ kg/ day LOAEL = 14.3 ( males), 231 ( females) mg/ kg/ day based on increased incidence of hepatocellular hypertrophy. At higher dose levels: decrease in bodyweight and bodyweight gain, necrosis of individual hepatocytes, pigmentation of Kupffer cells, and lymphocytic infiltration of the liver in both sexes; slight hematologic effects and decreased absolute and relative kidney weights in males; and ovarian atrophy, decreased ovary and spleen weights and increased liver weights in females. 870.3150 90 oral toxicity ­ dog NOAEL = 8.23 ( males), 9.27 ( females) mg/ kg/ day LOAEL = 32.0 ( males), 33.9 ( females) mg/ kg/ day based on slightly prolonged prothrombin times and decreased plasma albumin and A/ G ratio ( both sexes); decreased calcium levels and ovary weights and delayed maturation in the ovaries ( females); decreased cholesterol and phospholipid levels, testis weights, spermatogenesis, and spermatic giant cells in testes ( males). 870.3200 28 dermal toxicity ­ rat NOAEL = 250 ( males), 60 ( females) mg/ kg/ day LOAEL = 1,000 ( males), 250 ( females) mg/ kg/ day based on increased plasma glucose, triglyceride levels, and alkaline phosphatase activity and inflammatory cell infiltration in the liver and necrosis of single hepatocytes in females and hyaline change in renal tubules and a very slight reduction in body weight in males. At higher dose levels in females, chronic tubular lesions in the kidneys and inflammatory cell infiltration in the adrenal cortex were observed. 870.3700 Prenatal developmental ­ rat Maternal NOAEL = 30 mg/ kg/ day LOAEL = 200 mg/ kg/ day based on decreased body weight, body weight gain, and food consumption. Developmental NOAEL = 200 mg/ kg/ day LOAEL = 750 mg/ kg/ day based on decreased fetal body weight and an increased incidence of skeletal anomalies. 870.3700 Prenatal developmental ­ rabbit Maternal NOAEL = 50 mg/ kg/ day LOAEL = 150 mg/ kg/ day based on maternal deaths, hemorrhagic uterine contents and hemorrhagic discharge, decreased body weight and food intake during the dosing period. Developmental NOAEL = 50 mg/ kg/ day LOAEL = 150 mg/ kg/ day based on decreased fetal body weights, increased incidence of post­ implantation loss and a slight increase in the incidence of a few skeletal anomalies/ variations. VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66563 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Continued Guideline No. Study Type Results 870.3800 Reproduction and fertility effects ­ rat Parental/ Systemic NOAEL = 1.84 ( males), 202.06 ( females) mg/ kg/ day LOAEL = 61.25 ( males), not determined ( females) mg/ kg/ day based on increased incidence of hyaline change in renal tubules in F0 and F1 males. Reproductive NOAEL = 0.61 ( males), 202.06 ( females) mg/ kg/ day LOAEL = 1.84 ( males), not determined ( females) mg/ kg/ day based on increased incidence and severity of tubular atrophy observed in testes of the F1 generation males. Offspring NOAEL = 61.25 ( males), 79.20 ( females) mg/ kg/ day LOAEL = 158.32 ( males), 202.06 ( females) mg/ kg/ day based on reduced body weight gain during the lactation period in all litters . 870.4100 Chronic toxicity ­ dog NOAEL = 4.05 ( males), 4.49 ( females) mg/ kg/ day LOAEL = 21.0 ( males), 24.6 ( females) mg/ kg/ day based on increase in creatinine in both sexes, transient decrease in food consumption in females, and occasional increase in urea levels, decrease in ALT, and atrophy of seminiferous tubules in males. 870.4200 Carcinogenicity ­ mouse NOAEL = 2.63 ( males), 3.68 ( females) mg/ kg/ day LOAEL = 63.8 ( males), 87.6 ( females) mg/ kg/ day based on hepatocyte hypertrophy, single cell necrosis, inflammatory cell infiltration pigment deposition, foci of cellular alteration, hyperplasia of Kupffer cells and increased mitotic activity; also, an increase in the incidence of hepatocellular adenoma ( both sexes). At higher doses, there was an increase in the incidence of hepatocellular adenocarcinoma ( both sexes) and the number of animals with multiple tumors evidence of carcinogenicity 870.4300 Combined chronic carcinogenicity ­ rat NOAEL = 21.0 ( males), 50.3 ( females) mg/ kg/ day LOAEL = 63.0 ( males), 155 ( females) mg/ kg/ day based on increased incidence of lymphocytic infiltration of the renal pelvis and chronic nephropathy in males and decreased body weight gain, slight increase in the severity of hemosiderosis of the spleen, foci of cellular alteration in liver and chronic tubular lesions in kidney in females no evidence of carcinogenicity 870.5100 870.5265 Gene mutation in S. typhimurium and E. coli No evidence of gene mutation when tested up to 5,000 µ g/ plate. There was no evidence of cytotoxicity. 870.5265 Gene mutation in S. typhimurium No evidence of gene mutation when tested up to 5,000 µ g/ plate. The S9 fraction was from non­ induced mouse liver, Aroclor 1254 induced mouse liver, or thiamethoxam induced mouse liver, following dietary administration of thiamethoxam for 14 days at concentrations up to 2,500 ppm. 870.5300 Gene mutation in chinese hamster V79 cells at HGPRT locus No evidence of gene mutation when tested up to solubility limit. 870.5375 CHO cell cytogenetics No evidence of chromosomal aberrations when tested up to cytotoxic or solubility limit concentrations. 870.5395 In vivo mouse bone marrow micronucleus Negative when tested up to levels of toxicity in whole animals; however no evidence of target cell cytotoxicity. 870. 5550 UDS assay Negative when tested up to precipitating concentrations 870.6200 Acute neurotoxicity screening battery ­ rat NOAEL = 100 mg/ kg/ day LOAEL = 500 mg/ kg/ day based on drooped palpebral closure, decrease in rectal temperature and locomotor activity and increase in forelimb grip strength ( males only). At higher dose levels, mortality, abnormal body tone, ptosis, impaired respiration, tremors, longer latency to first step in the open field, crouched­ over posture, gait impairment, hypo­ arousal, decreased number of rears, uncoordinated landing during the righting reflex test, slight lacrimation ( females only) and higher mean average input stimulus value in the auditory startle response test ( males only). VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66564 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Continued Guideline No. Study Type Results 870.6200 Subchronic neurotoxicity screening battery ­ rat NOAEL = 95.4 ( males), 216.4 ( females) mg/ kg/ day, both highest dose tested. LOAEL = not determined. No treatment­ related observations at any dose level. LOAEL was not achieved. May not have been tested at sufficiently high dose levels; however, new study not required because the weight of the evidence from the other toxicity studies indicates no evidence of concern. 870.7485 Metabolism and pharmacokinetics ­ rat Absorbed rapidly and extensively, widely distributed, followed by very rapid elimination, mostly in urine. Highest tissue concentrations in skeletal muscle: 10 15% of administered dose. Half life times from tissues ranged from 2 6 hours. Tissue residues after 7 days extremely low. Approximately 84 95% of administered dose excreted in urine and 2.5 6% excreted in feces within 24 hours. Greater than 0.2% detected in expired air. Most excreted as unchanged parent: 70 80% of dose. The major biotransformation reaction is cleavage of oxadiazine ring to corresponding nitroguanidine compound Minor pathways: ( 1) cleavage of nitroguanidine group yielding guanidine derivative, ( 2) hydrolysis of guanidine group to corresponding urea, ( 3) demethylation of guanidine group, and ( 4) substitution of the chlorine of the thiazole ring by glutathione. Cleavage between thiazole­ and oxadiazine ring occurs to a small extent. Glutathione derivatives prone to further degradation of the glutathione moiety resulting in various sulfur­ containing metabolites ( e. g. mercapturates, sulfides, and sulfoxides). Both the thiazole and oxadiazine moiety susceptible to oxidative attack. Small but measurable amounts exhaled, most probably as CO2. Metabolites eliminated very rapidly. Enterohepatic circulation negligible. 870.7485 Metabolism and pharmacokinetics ­ mouse Approximately 72% of administered dose excreted in the urine; 19% excreted in feces. Small but measurable amount detected in expired air ( approximately 0.2% of dose). Predominant metabolites: unchanged parent ( 33 41% of administered dose; 2 other metabolites: 8 12% and 9 18% of administered dose. These are the same structures that were most commonly observed in rat excreta, however the proportions are quite different in mouse excreta. One additional significant metabolite ( mouse R6) was isolated from feces samples. Between 30 60% of the administered dose was excreted as metabolites. 870.7600 Dermal penetration ­ rat Estimates of dermal absorption were based on the sum of radioactivity in skin test site, urine, feces, blood, and carcass. Percentage dermal absorption is 27.0, highest mean dermal absorption value across all groups. This value is considered to represent the potential cumulative dermal absorption of test material that might occur after a 10 hour dermal exposure. As the study design did not permit analysis of the fate of skin bound residues, residues at skin site were included in determination of dermal absorption. Hepatic cell proliferation study ­ mouse NOAEL = 16 ( males), 20 ( females) mg/ kg/ day LOAEL = 72 ( males), 87 ( females) mg/ kg/ day based on proliferative activity of hepatocytes. At higher dose levels, increases in absolute and relative liver wts, speckled liver, hepatocellular glycogenesis/ fatty change, hepatocellular necrosis, apoptosis and pigmentation were observed. Replicative DNA synthesis in 28 day feeding study ­ male rat NOAEL = 711 mg/ kg/ day ( highest dose tested) LOAEL = not established. Immunohistochemical staining of liver sections from control and high­ dose animals for proliferating cell nuclear antigen gave no indication for a treatment­ related increase in the fraction of DNA synthesizing hepatocytes in S­ phase. CGA 293343 did not stimulate hepatocyte cell proliferation in male rats. Special study to assess liver biochemistry in mouse NOAEL = 17 ( males), 20 ( females) mg/ kg/ day LOAEL = 74 ( males), 92 ( females) mg/ kg/ day based on marginal to slight increases in absolute and relative liver weights, a slight increase in the microsomal protein content of the livers, moderate increases in the cytochrome P450 content, slight to moderate increases in the activity of several microsomal enzymes, slight to moderate induction of cytosolic glutathione S­ transferase activity. Treatment did not affect peroxisomal fatty acid boxidation. VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66565 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non­ dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10­ 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non­ linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for thiamethoxam used for human risk assessment is shown in Table 2 of this unit: TABLE 2. SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR THIAMETHOXAM FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietarygeneral population including infants and children NOAEL = 100 mg/ kg/ day UF = 100 Acute RfD = 1 mg/ kg/ day FQPA SF = 10 aPAD = acute RfD/ FQPA SF = 0.1 mg/ kg/ day Acute mammalian neurotoxicity study in the rat LOAEL = 500 mg/ kg/ day based on treatment­ related neurobehavioral effects observed in the FOB and LMA testing ( drooped palpebral closure, decreased rectal temperature and locomotor activity, increased forelimb grip strength) Chronic Dietary all populations NOAEL= 0.6 mg/ kg/ day UF = 100 Chronic RfD = 0.006 mg/ kg/ day FQPA SF = 10 cPAD = chronic RfD/ FQPA SF = 0.0006 mg/ kg/ day 2­ Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. Oral Nondietary ( all durations NOAEL= 0.6 mg/ kg/ day LOC for MOE = 1,000 ( Residential) 2­ Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. Dermal ( all durations Residential) Oral study NOAEL= 0.6 mg/ kg/ day( dermal absorption rate = 27%) LOC for MOE = 1,000 ( Residential) LOC for MOE = 100 ( Occupational) 2­ Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. Inhalation ( all durations Residential) Oral study NOAEL= 0.6 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 1,000 ( Residential) LOC for MOE = 100 ( Occupational) 2­ Generation reproduction study LOAEL = 1.8 mg/ kg/ day based on increased incidence and severity of tubular atrophy in testes of F1 generation males. Cancer ( oral, dermal, inhalation Likely carcinogen for humans based on increased incidence of hepatocellular adenomas and carcinomas in male and female mice. Quantification of risk based on most potent unit risk: male mouse liver adenoma and/ or carcinoma combined tumor rate. The upper bound estimate of unit risk, Q1* ( mg/ kg/ day)­ 1 is 3.77 x 10­ 2 in human equivalents. * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.565) for the combined residues of thiamethoxam and its metabolite, in or on a variety of raw agricultural commodities. The following raw agricultural commodities have established tolerances: barley, canola, cotton, sorghum, wheat, tuberous and corm vegetables crop subgroup, fruiting vegetables, crop group, tomato paste, cucurbit vegetables crop group, pome fruits crop group, VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66566 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations milk and the meat and meat by products of cattle, goats, horses, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from thiamethoxam in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model ( DEEM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994 1996 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: tolerence level residues and 100% crop treated. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994 1996 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: percent crop treated ( based on projected market shares) and anticipated residues ( tier 3). iii. Cancer. The dietary exposure for determining cancer risk is based on the chronic exposure explained in the previous paragraph using the same assumptions. Section 408( b)( 2)( E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408( b)( 2)( E) of the FFDCA, EPA will issue a data call­ in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408( b)( 2)( F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408( b)( 2)( F) of the FFDCA, EPA may require registrants to submit data on PCT. The Agency used percent crop treated ( PCT) information as follows in Table 3. TABLE 3. THIAMETHOXAM USES AND ESTIMATES OF PERCENT CROP TREATED Crop Percent Crop Treated Tuberous and Corm Vegetables ­ Crop Subgroup 1 C 9 Fruiting Vegetables ( Except Cucurbits ­ Crop Group 8 15 Cucumbers 5 Melons 13 Casabas 44 Crenshaws 44 Squash 44 Pumpkin 44 Apples 5 Crabapples 53 Pears 9 Quinces 53 Loquats 53 Field, corn 6 Pop, sweet corn 100 Since the May 23, 2001 Final Rule establishing tolerances for thiamethoxam, the Agency has updated the percent crop­ treated value for apples. The registrant is voluntarily restricting use of thiamethoxam on apples to only three states, Michigan, New York and Pennsylvania. These three states account for 28% of the U. S. apple production ( 122,000 out of 430,200 bearing acres). After consultation with experts in the field, EPA believes that no more than 10% of the apple acreage in these states will be treated with thiamethoxam. Thus, using a percent crop­ treated value of 5% for the U. S. apple acreage is expected to be an over­ estimate of the acres which will actually be treated with thiamethoxam. The Agency used 6% CT for field corn since this is the percent crop­ treated value for the market leader. Sweet corn exposure estimates, which currently make up the bulk of the exposure for the cereal grains, assume 100% crop treated. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer­ based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and regional populations. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for thiamethoxam in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of thiamethoxam. The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCIGROW which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model) for a screening­ level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66567 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead, drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to thiamethoxam they are further discussed in the aggregate risk sections below. Based on the PRZM/ EXAMS and SCIGROW models the estimated environmental concentrations ( EECs) of thiamethoxam for acute exposures are estimated to be 11.4 parts per billion ( ppb) for surface water and 1.94 ppb for ground water. The EECs for chronic exposures are estimated to be 0.77 ppb for surface water, and 1.94 ppb for ground water. 3. From non­ dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non­ dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Although such uses have been requested, they are not being assessed at this time. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether thiamethoxam has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, thiamethoxam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that thiamethoxam has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997). D. Safety Factor for Infants and Children 1. Safety factor for infants and children i. In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure ( MOE) analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. ii. Prenatal and postnatal sensitivity. The developmental toxicity studies indicated no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetus to in utero exposure based on the fact that the developmental NOAELs are either higher than or equal to the maternal NOAELs. However, the reproductive studies indicate effects in male rats in the form of increased incidence and severity of testicular tubular atrophy. These data are considered to be evidence of increased quantitative susceptibility for male pups when compared to the parents. iii. Conclusion. Based on: a. Effects on endocrine organs observed across species. b. The significant decrease in alanine amino transferase levels in the companion animal studies and in the dog studies. c. The mode of action of this chemical in insects ( interferes with the nicotinic acetyl choline receptors of the insect's nervous system) thus a developmental neurotoxicity study is required. d. The transient clinical signs of neurotoxicity in several studies across species. e. The suggestive evidence of increased quantitative susceptibility in the rat reproduction study, the Agency is retaining the FQPA factor which is l0X. E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water [ e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD ­ ( average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA are used to calculate DWLOCs: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening­ level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short­ term, intermediate­ term, chronic, and cancer. When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66568 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations exposure from food to thiamethoxam will occupy 3% of the aPAD for the U. S. population, 2% of the aPAD for females 13 49 years old, 7% of the aPAD for all infants less than 1 year old and 9% of the aPAD for children 1 2 years old. In addition, there is potential for acute dietary exposure to thiamethoxam in drinking water. The surface water EEC is 11.4 µ g/ L and the ground water EEC is 1.94 µ g/ L. Since the surface water value is greater than the ground water value, the surface water value will be used for comparison purposes and will protect for any concerns for ground water concentrations. After calculating DWLOCs and comparing them to the EECs for surface water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD. TABLE 4. AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO THIAMETHOXAM Population Subgroup aPAD, mg/ kg/ day % aPAD ( Food) Ground Water EEC, µ g/ L Surface Water EEC, µ g/ L DWLOC, µ g/ L U. S. Population 0.1 3 1.94 11.4 3,400 All Infants ( 0 1 yr) 0.1 7 1.94 11.4 930 Children ( 1 2 yr) 0.1 9 1.94 11.4 910 Children ( 3 5 yr) 0.1 7 1.94 11.4 940 Children ( 6 12 yr) 0.1 4 1.94 11.4 960 Youth ( 13 19 yr) 0.1 2 1.94 11.4 980 Adult ( 20 49 yr) 0.1 2 1.94 11.4 3,400 Adult ( 50+ yr) 0.1 2 1.94 11.4 3,400 Females ( 13 49 yr) 0.1 2 1.94 11.4 2,900 a Population subgroups shown include the U. S. general population and the maximally exposed subpopulation of adults, infants and children, and women of child­ bearing age for each exposure scenario. b DWLOC = Maximum Water Exposure ( mg/ kg/ day) H 1,000 µ g/ mg body weight ( 70 kg general population/ males 13+, 60 kg females 13+, 10 kg infants and children) Water Consumption ( 2 L/ day adults, 1 L/ day infants and children). Maximum water exposure = aPAD ­ dietary exposure ( mg/ kg/ day) 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to thiamethoxam from food will utilize 5% of the cPAD for the U. S. population, 13% of the cPAD for all infants < 1 year old and 19% of the cPAD for children 1 2 years old. Proposed residential uses are not being addressed in this risk assessment. In addition to chronic dietary exposure, there is potential for chronic dietary exposure to thiamethoxam in drinking water. The surface water EEC is 0.6 µ g/ L and the groundwater EEC is 1.94 µ g/ L. Since the groundwater value is greater than the surface water value, the groundwater value will be used for comparison purposes and will protect for any concerns for surface water concentrations. After calculating the DWLOCs and comparing them to the EECs for groundwater, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. TABLE 5. AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON­ CANCER) EXPOSURE TO THIAMETHOXAM Population Subgroup cPAD, mg/ kg/ day % cPAD ( Food) Surface Water EEC, µ g/ L Ground Water EEC, µ g/ L DWLOC µ g/ L U. S. Population 0.0006 5 0.77 1.9 20 All Infants ( 0 1 yr) 0.0006 13 0.77 1.9 5.3 Children ( 1 2 yr) 0.0006 19 0.77 1.9 4.9 Children ( 3 5 yr) 0.0006 14 0.77 1.9 5.2 Children ( 6 12 yr) 0.0006 7 0.77 1.9 5.6 Youth ( 13 19 yr) 0.0006 4 0.77 1.9 5.8 Adult ( 20 49 yr) 0.0006 4 0.77 1.9 20 Adult ( 50+ yr) 0.0006 4 0.77 1.9 20 Females ( 13 49 yr) 0.0006 4 0.77 1.9 17 3. Short­ term risk. Short­ term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Thiamethoxam is not registered for use VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66569 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 4. Intermediate­ term risk. Intermediate­ term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Thiamethoxam is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which does not exceed the Agency's level of concern. 5. Aggregate cancer risk for U. S. population. The cancer aggregate dietary risk estimate was calculated, using the Agency's 6% estimated market share for treatment of field corn. The dietary cancer risk from residues in food is 0.9 x 10­ 6. For risk management purposes, EPA considers a cancer risk to be greater than negligible when it exceeds the range of 1 in 1 million. EPA has generally treated cancer risks up to 3 in 1 million as within the range of 1 in 1 million. The DWLOC for cancer aggregate risk ( no residential uses) is calculated using the following equations: DWLOCcancer( µ g/ L) = [ chronic water exposure( mg/ kg/ day) x ( body weight ( kg))] ÷ [ consumption ( L) x 10­ 3 mg/ µ g] chronic water exposure ( mg/ kg/ day)= negligible risk ÷ Q* ­ [( chronic food exposure)( mg/ kg/ day)] Assuming that the negligible risk value could be as high as 3 x 10­ 6 , the chronic water exposure value is estimated to be: 3 x 10­ 6 ÷ 3.77 x 10­ 2 ­ 0.0000245 = 0.0000551 mg/ kg/ day The DWLOCcancer = 0.0000551 mg/ kg/ day x 70 kg ÷ 2L x 10­ 3 mg/ µ g = 1.9 µ g/ L The surface water EEC is 0.6 µ g/ L and the ground water EEC is 1.9 µ g/ L. Since the ground water value is greater than, the surface water value it will be used for comparison purposes and will protect for any concerns for surface water concentrations. The estimated chronic ground water value for thiamethoxam ( 1.9 µ g/ L) is essentially at the DWLOCcancer level for the general population using the 6% market share for treated field, corn seed. The Agency used a screening level model designed to estimate pesticide concentrations in shallow ground water. A number of factors lead EPA to believe that the actual lifetime exposure through drinking water will be less than the DWLOCcancer. These reasons are as follows: a. Thiamethoxam is systemic. EPA's Tier 1 ground water model assumes that all of the product that is applied to the crop is available for runoff. The registrant has submitted data to show that a percentage ( 15 25%) of the product is absorbed by the plant, resulting in that much less product available to leach into ground water. Although the registrant has submitted data on only 2 crops, beans and cucumbers, it is likely that the total amount of thiamethoxam that is available to leach into ground water is less than the amount EPA uses as an input into its model. Due to limited data on the amount absorbed, EPA is unable to quantify this. b. Although the Agency model is based on aerobic soil half lives, EPA's risk assessment for cancer estimate is for lifetime exposure. Data indicate the anaerobic aquatic half life for thiamethoxam is shorter than the aerobic soil half life and longer than the aerobic aquatic half life. Although EPA is unable to predict with a high degree of certainty about what happens to thiamethoxam over time in ground water, this does provide some support for an expectation that concentrations in ground water will decline between annual applications. c. Shallow ground water modeling is not the perfect model for representing all drinking water from ground water sources. It is likely to be an overestimate of most drinking water, which tends to originate from deeper sources. EPA's experience is that the model is reasonably accurate for shallow drinking water, but the Agency believes that it is less accurate for drinking water from deeper sources. d. The Agency has established conditions of registration for the previous uses which include two prospective ground water studies and a retrospective monitoring study, so that the reasonable certainty of no harm finding will be sustained. Preliminary results have indicated no detections of thiamethoxam in ground water. e. The cancer risk from the food uses alone is 0.9 x 10­ 6. The dietary risk is based on residue data derived from the average of field trials, which were performed at a higher applied­ on rate than were accepted by the EPA. It is not unusual in the Agency's experience for field trial data to be an order of magnitude above actual monitoring. Since thiamethoxam has only recently been registered, actual monitoring data is not yet available. It is likely that the actual risk contribution from food will be much lower than current data indicate, which would result in a larger DWLOCcancer. EPA expects that this refined DWLOCcancer would be larger than the EECs for the proposed uses. It should be noted that there are no detectable residues in the subject corn commodities. Thus, EPA does not expect that the general population would be exposed to levels exceeding the DWLOCcancer over a lifetime. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to thiamethoxam residues. A. Analytical Enforcement Methodology Adequate enforcement methodology High Performance Liquid Chromatography using ultra violet or mass spectrometry ( HPLC/ UV or MS) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: ( 703) 305 5229; e­ mail address: furlow. calvin@ epa. gov. B. International Residue Limits There are no international residue limits for thiamethoxam. V. Conclusion Therefore, the tolerances are established for combined residues of thiamethoxam, 3­[( 2­ chloro­ 5­ thiazolyl) methyl] tetrahydro­ 5­ methyl­ Nnitro 4H­ 1,3,5­ oxadiazin­ 4­ imine and its metabolite N­( 2­ chloro­ thiazol­ 5­ ylmethyl)­ N ­ methyl­ nitro­ guanidine, in or on field corn forage at 0.10 ppm, sweet corn forage at 0.10 ppm, popcorn forage at 0.10 ppm, field corn stover at 0.05 ppm, sweet corn stover at 0.05 ppm, field corn grain at 0.07 ppm, popcorn grain at 0.02 ppm, and sweet corn ( kernal and cob with husk removed) at 0.02 ppm. VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66570 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0298 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before December 31, 2002. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP 2002 0298, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). VII. Regulatory Assessment Requirements This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1 66571 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticide and pests, Reporting and recordkeeping requirements. Dated: October 24, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.565 is amended by alphabetically adding commodities to the table in paragraph ( a) to read as follows: § 180.565 Thiamethoxam; tolerances for residues. ( a) * * * Commodity Parts per million * * * * * Corn, field, forage ..................... 0.10 Corn, pop, forage ..................... 0.10 Corn, sweet, forage .................. 0.10 Corn, field, grain ....................... 0.020 Corn, pop, grain ........................ 0.02 Corn, field, stover ..................... 0.05 Corn pop, stover ....................... 0.05 Corn, sweet, stover .................. 0.05 Corn, sweet, kernal plus cob with husks removed .............. 0.02 * * * * * * * * * * [ FR Doc. 02 27830 Filed 10 31 02; 8: 45 am] BILLING CODE 6560 50 S DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 172, 174, 175, 176, and 177 [ Docket No. RSPA 01 10568 ( HM 207B)] RIN 2137 AC64 Hazardous Materials: Retention of Shipping Papers AGENCY: Research and Special Programs Administration ( RSPA), DOT. ACTION: Final rule; response to appeals. SUMMARY: In this final rule, RSPA is making changes to a final rule published on July 12, 2002, in which RSPA amended the Hazardous Materials Regulations ( HMR) to require shippers and carriers to retain a copy of each hazardous material shipping paper, or an electronic image thereof, for a period of 375 days after the date the hazardous material is accepted by a carrier. This final rule responds to five appeals of the July 12, 2002 final rule. EFFECTIVE DATES: This final rule is effective on November 1, 2002. Voluntary compliance is authorized as of August 12, 2002. FOR FURTHER INFORMATION CONTACT: Deborah Boothe of the Office of Hazardous Materials Standards, ( 202) 366 8553, Research and Special Programs Administration, U. S. Department of Transportation, 400 Seventh Street, SW., Washington, DC 20590. SUPPLEMENTARY INFORMATION: I. Background On July 12, 2002, The Research and Special Programs Administration ( RSPA, we) published a final rule under Docket HM 207B ( 67 FR 46123) amending the Hazardous Materials Regulations ( HMR; 49 CFR parts 171 180) to require shippers and carriers to retain a copy of each hazardous material shipping paper, or an electronic image thereof, for a period of 375 days after the date the hazardous material is accepted by a carrier. The July 12, 2002 final rule incorporates into the HMR the requirements in the Federal hazardous material transportation law ( Federal hazmat law) to require that, after a hazardous material `` is no longer in transportation,'' each offeror and carrier of a hazardous material must retain the shipping paper `` or electronic image thereof for a period of 1 year to be accessible through their respective principal places of business.'' 49 U. S. C. 5110( e), added by Public Law 103 311, Title I, section 115, 108 Stat. 1678 ( Aug. 26, 1994). That section also provides that the offeror and carrier `` shall, upon request, make the shipping paper available to a Federal, State, or local government agency at reasonable times and locations.'' The July 12, 2002 final rule requires each person who offers or transports a hazardous material in commerce to retain a copy of the shipping paper for 375 days after the date the shipment is accepted by the initial carrier. To facilitate enforcement of this requirement, the final rule requires each VerDate 0ct< 09> 2002 13: 19 Oct 31, 2002 Jkt 200001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 01NOR1. SGM 01NOR1

epa

2024-06-07T20:31:44.291808

regulations

EPA-HQ-OPP-2002-0301-0001

Notice

Experimental Use Permit; Receipt of Application

67832 Federal Register / Vol. 67, No. 216 / Thursday, November 7, 2002 / Notices Responsible Official: Gregg A. Cooke, Regional Administrator. Oscar Ramirez, Jr., Acting Director, Water Quality Protection Division ( 6WQ). [ FR Doc. 02 28352 Filed 11 6 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ FRL 7405 9] Notification of the National Advisory Council for Environmental Policy and Technology ( NACEPT) Standing Committee on Compliance Assistance Meeting; Open Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notification of public NACEPT standing committee on compliance assistance meeting on December 3, 2002. SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92 463, notice is hereby given that the U. S. Environmental Protection Agency ( EPA) will hold an open meeting of the NACEPT Standing Committee on Compliance Assistance ( Committee) on Tuesday, December 3, 2002 from 8 a. m. to 4 p. m. The meeting will be held at the Adams Mark Hotel at 111 Pecan Street East, San Antonio, Texas 78205. Seating at the meeting will be on a first­ come basis and limited time will be provided for public comment. The meeting will focus on the areas of the Compliance Assistance program on which the Committee has been asked to advise the EPA. These are: ( 1) Strengthening the national compliance assistance network by helping identify opportunities to enhance communication among compliance assistance providers and by promoting collaboration in compliance assistance planning and tool development; ( 2) developing and testing performance measurement systems to demonstrate the effectiveness and environmental outcomes of compliance assistance; and ( 3) acting as a sounding board to provide feedback on compliance assistance policies, strategies or other related matters. A formal agenda will be available at the meeting. SUPPLEMENTARY INFORMATION: NACEPT is a federal advisory committee under the Federal Advisory Committee Act, Public Law 92 463. NACEPT provides advice and recommendations to the EPA Administrator and other EPA officials on a broad range of domestic and international environmental policy issues. NACEPT consists of a representative cross­ section of EPA's partners and principal constituents who provide advice and recommendations on policy issues and serve as a sounding board for new strategies. Over the last two years, EPA has undertaken a number of actions to improve our compliance assistance activities. To ensure that the Agency's efforts to improve compliance assistance are implemented in a way that continues to reflect stakeholder needs, NACEPT created a new Standing Committee on Compliance Assistance. This will provide a continuing Federal Advisory Committee forum from which the EPA can continue to receive valuable stakeholder advice and recommendations on compliance assistance activities. For further information concerning the NACEPT Standing Committee on Compliance Assistance, including the upcoming meeting, contact Joanne Berman, Designated Federal Officer ( DFO), on ( 202) 564 7064, or e­ mail: berman. joanne@ epa. gov. Inspection of Subcommittee Documents: Documents relating to the above topics will be publicly available at the meeting. Dated: October 31, 2002. Frederick F. Stiehl, Acting Director, Office of Compliance. [ FR Doc. 02 28354 Filed 11 6 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0301; FRL 7279 4] Experimental Use Permit; Receipt of Application AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces receipt of an application 67979 EUP E from Syngenta Seeds requesting an experimental use permit ( EUP) for the plant­ incorporated protectant Bacillus thuringiensis VIP3A. The Agency has determined that the application may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11( a), the Agency is soliciting comments on this application. DATES: Comments, identified by docket ID number OPP 2002 0301, must be received on or before December 9, 2002. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5412; e­ mail address: cole. leonard@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are interested in agricultural biotechnology or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0301. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA VerDate 0ct< 31> 2002 16: 18 Nov 06, 2002 Jkt 200001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07NON1. SGM 07NON1 67833 Federal Register / Vol. 67, No. 216 / Thursday, November 7, 2002 / Notices Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0301. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0301. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC, 20460 0001, Attention: Docket ID Number OPP 2002 0301. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0301. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. VerDate 0ct< 31> 2002 16: 18 Nov 06, 2002 Jkt 200001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07NON1. SGM 07NON1 67834 Federal Register / Vol. 67, No. 216 / Thursday, November 7, 2002 / Notices 1 Imputed costs, such as taxes that would have been paid and return on equity that would have been provided had the services been furnished by a private business firm, are referred to as the private­ sector adjustment factor ( PSAF). The tenyear recovery rate is based upon the pro forma income statements for Federal Reserve priced services published in the Board's Annual Report. Beginning in 2000, the PSAF included additional financing costs associated with pension assets attributable to priced services. This ten­ year cost recovery rate has been computed as if these costs were not included in the PSAF calculations prior to 2000. If these costs were included in the calculations, and assuming that the Reserve Banks would not have made any contemporaneous cost or revenue adjustments, the 10­ year recovery rate would be 98.7 percent. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background Syngenta Seeds, 3054 Cornwallis Road, Research Triangle Park, North Carolina 27709 2257, has applied for an EUP for field testing of the plantincorporated protectant Bacillus thuringiensis VIP3A insect control protein as expressed in cotton plants. The proposed states are Alabama, Arizona, Arkansas, California, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, and Texas. The total acreage for this plant­ incorporated protectant EUP will be 904.5. III. What Action is the Agency Taking? Following the review of the Syngenta Seeds application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the Federal Register. IV. What is the Agency's Authority for Taking this Action? The Agency's authority for taking this action is under 40 CFR part 172. List of Subjects Environmental protection, Experimental use permits. Dated: October 29, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [ FR Doc. 02 28356 Filed 11 6 02; 8: 45 am] BILLING CODE 6560 50 S FEDERAL RESERVE SYSTEM [ Docket No. R 1133] Federal Reserve Bank Services AGENCY: Board of Governors of the Federal Reserve System. ACTION: Notice. SUMMARY: The Board has approved the fee schedules for Federal Reserve priced services and electronic connections and a private­ sector adjustment factor ( PSAF) for 2003 of $ 171.7 million. These actions were taken in accordance with the requirements of the Monetary Control Act of 1980, which requires that, over the long run, fees for Federal Reserve priced services be established on the basis of all direct and indirect costs, including the PSAF. DATES: The new fee schedules become effective January 2, 2003. FOR FURTHER INFORMATION CONTACT: For questions regarding the fee schedules: Joseph Baressi, Financial Services Analyst, ( 202/ 452 3959); William Driscoll, Financial Services Analyst, check payments, ( 202/ 452 3117); Edwin Lucio, Financial Services Analyst, ACH payments, ( 202/ 736 5636); Gregory Cannella, Financial Services Analyst, Fedwire funds transfer, Fedwire securities, and noncash collection services, ( 202/ 530 6214); Marybeth Butkus, Senior Financial Services Analyst, special cash services, ( 202/ 452 3917); or Amy Pierce, Senior IT Analyst, electronic connections, ( 202/ 736 5675), Division of Reserve Bank Operations and Payment Systems. For questions regarding the PSAF: Brenda Richards, Senior Financial Analyst, ( 202/ 452 2753) or Gregory Evans, Manager, Financial Accounting, ( 202/ 452 3945), Division of Reserve Bank Operations and Payment Systems. For users of Telecommunications Device for the Deaf ( TDD) only, please call 202/ 263 4869. Copies of the 2003 fee schedules for the check service are available from the Board, the Federal Reserve Banks, or the Reserve Banks' financial services Web site at http:// www. frbservices. org. SUPPLEMENTARY INFORMATION: I. Priced Services A. Discussion Over the period 1992 through 2001, the Reserve Banks recovered 99.8 percent of their total costs for providing priced services, including special project costs, imputed expenses, and targeted after­ tax profits or return on equity ( ROE). 1 Table 1 summarizes the priced services' actual, estimated, and budgeted cost recovery rates for 2001, 2002, and 2003 respectively. Cost recovery is estimated to be 92.2 percent in 2002 and budgeted to be 94.4 percent in 2003. The aggregate cost­ recovery rates are heavily influenced by the performance of the check service, which accounts for approximately 85 percent of the total cost of priced services. The electronic services ( FedACH, Fedwire funds transfer, Fedwire securities, and national settlement) account for approximately 15 percent of costs, while noncash and special cash services represent a de minimis amount. VerDate 0ct< 31> 2002 16: 18 Nov 06, 2002 Jkt 200001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 07NON1. SGM 07NON1

epa

2024-06-07T20:31:44.309007

regulations

EPA-HQ-OPP-2002-0305-0004

Supporting & Related Material

1 DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 [ Docket Number: TMD­ 00­ 02­ FR] RIN: 0581­ AA40 National Organic Program AGENCY: Agricultural Marketing Service, USDA. ACTION: Final Rule with request for comments. SUMMARY: This final rule establishes the National Organic Program ( NOP or program) under the direction of the Agricultural Marketing Service ( AMS), an arm of the United States Department of Agriculture ( USDA). This national program will facilitate domestic and international marketing of fresh and processed food that is organically produced and assure consumers that such products meet consistent, uniform standards. This program establishes national standards for the production and handling of organically produced products, including a National List of substances approved for and prohibited from use in organic production and handling. This final rule establishes a national­ level accreditation program to be administered by AMS for State officials and private persons who want to be accredited as certifying agents. Under the program, certifying agents will certify production and handling operations in compliance with the requirements of this regulation and initiate compliance actions to enforce program requirements. The final rule includes requirements for labeling products as organic and containing organic ingredients. This final rule also provides for importation of organic agricultural products from foreign programs determined to have equivalent organic program 2 requirements. This program is authorized under the Organic Foods Production Act of 1990, as amended. EFFECTIVE DATE: This rule becomes effective [ 60 days after publication in the Federal Register]. Comments: Comments on specified aspects of the final regulations must be submitted on or before [ 90 days after publication in the Federal Register]. ADDRESSES: Interested persons are invited to submit written comments on specified aspects of the final regulation to: Keith Jones, Program Manager, National Organic Program, USDA­ AMSTMP NOP, Room 2945­ So., Ag Stop 0275, P. O. Box 96456, Washington, DC 20090­ 6456. Comments may also be filed via the Internet through the National Organic Program's homepage at: www. ams. usda. gov/ nop. Written comments on specified aspects of the final regulations should be identified with the docket number TMD­ 00­ 02­ FR. To facilitate the timely scanning and posting of comments to the NOP homepage, multiple­ page comments submitted by regular mail should not be stapled or clipped. It is our intention to have all comments to this final rule, whether mailed or submitted via the Internet, available for viewing on the NOP homepage in a timely manner. Comments submitted in response to this final rule will be available for viewing at USDA­ AMS, Transportation and Marketing Programs, Room 2945­ South Building, 14th and Independence Avenue, SW, Washington, DC, from 9: 00 a. m. to 12: 00 noon and from 1: 00 p. m. to 4: 00 p. m., Monday through Friday ( except for official Federal holidays). Persons wanting to visit the USDA South Building to view comments received in response to this final rule are requested to make an appointment in advance by calling ( 202) 720­ 3252. 3 FOR FURTHER INFORMATION CONTACT: Richard Mathews, Senior Agricultural Marketing Specialist, USDA­ AMS­ TMP­ NOP, Room 2510­ So., P. O. Box 96456, Washington, DC 20090­ 6456; Telephone: ( 202) 205­ 7806; Fax: ( 202) 205­ 7808. SUPPLEMENTARY INFORMATION: Prior Documents in this Proceeding This final rule is issued pursuant to the Organic Food Production Act of 1990 ( Act or OFPA), as amended ( 7 U. S. C. 6501 et seq.). This final rule replaces the proposed rule published in the Federal Register March 13, 2000. The public submitted 40,774 comments on the proposed rule. Comments to the proposed rule were considered in the preparation of this final rule. The following notices related to the National Organic Standards Board ( NOSB) and the development of this proposed regulation have been published in the Federal Register. Six notices of nominations for membership on the NOSB were published between April 1991 and June 2000 ( 56 FR 15323, 59 FR 43807, 60 FR 40153, 61 FR 33897, 64 FR 33240, 65 FR 35317). Two notices of extension of time for submitting nominations were published on September 22, 1995, and September 23, 1996 ( 60 FR 49246, 61 FR 49725). Twenty notices of meetings of the NOSB were published between March 1992 and November 2000 ( 57 FR 7094, 57 FR 27017, 57 FR 36974, 58 FR 85, 58 FR 105, 58 FR 171, 59 FR 58, 59 FR 26186, 59 FR 49385, 60 FR 51980, 60 FR 15532, 61 FR 43520, 63 FR 7389, 63 FR 64451, 64 FR 3675, 64 FR 28154, 64 FR 54858, 65 FR 11758, 65 FR 33802, 65 FR 64657). One notice of public hearings on organic livestock and livestock products was published on December 30, 1993 ( 58 FR 69315). Two notices specifying a procedure for submitting names of substances for inclusion on or removal from the National List of Approved and Prohibited Substances were published on March 27, 1995 ( 60 FR 4 15744), and July 13, 2000 ( 65 FR 43259. A rule proposing the NOP was published on December 16, 1997 ( 62 FR 65850). An extension of the time period for submitting comments to the proposed rule was published on February 9, 1998 ( 63 FR 6498). One request for comments on Issue Papers was published on October 28, 1998 ( 63 FR 57624). A notice of a program to assess organic certifying agencies was published on June 9, 1999 ( 64 FR 30861). A rule proposing the NOP was published on March 13, 2000 ( 65 FR 13512). A notice of public meeting and request for comments on organic production and handling of aquatic animals to be labeled as organic was published on March 23, 2000 ( 65 FR 15579). One advance notice of proposed rulemaking and request for comments on reasonable security for private certifying agents was published on August 9, 2000 ( 65 FR 48642). This preamble includes a discussion of the final rule and supplementary information, including the Regulatory Impact Assessment, Unfunded Mandates Reform Act Statement, Regulatory Flexibility Act Analysis, Federalism Impact Statement, and Civil Justice Impact Statement. The Civil Rights Impact Analysis is not included as an attachment but may be obtained by writing to the address provided above or via the Internet through the National Organic Program's homepage at: http:// www. ams. usda. gov/ nop. Approval of Paperwork Reduction Act Requirements for this Final Rule The reporting requirements and recordkeeping burden imposed by this rule were published in the March 13, 2000, Federal Register for public comment. The Agency addressed these comments in the final rule to ensure that the least amount of the burden is placed on the public. The information collection and recordkeeping requirements have been reviewed and approved by the Office of Management and Budget under OMB Number 0581­ 0191, National Organic 5 Program. National Organic Program Overview Subpart A ­ Definitions Description of Regulations This subpart defines various terms used in this part. These definitions are intended to enhance conformance with the regulatory requirements through a clear understanding of the meaning of key terms. We have amended terms and definitions carried over from the proposed rule where necessary to make their wording consistent with the language used in this final rule. We have revised the definitions of the following words for greater clarity: person, practice standard, inert ingredient, processing, tolerance. We have removed the definitions for the following terms because the terms are not used in this final rule or have been determined to be unnecessary: accredited laboratory, estimated national mean, system of organic production and handling. We received comments on some of these definitions that have been deleted. We have not addressed those comments here because the relevant definitions have been deleted. Definitions ­ Changes Based on Comments This subpart differs from the proposed rule in several respects as follows: ( 1) Many commenters requested changes to the definition of " excluded methods." Comments included requests to use the more common term, " genetically modified organisms( GMO)"; to include the products of excluded methods/ GMO's in the definition; to more closely follow the NOSB definition by adding gene deletion, doubling, introduction of a foreign gene, and changing gene position; to include that excluded methods are prohibited by the 6 Act and by the regulations in this part; to change the wording of the reference to " recombinant DNA"; and to add that the definition of excluded methods only covers " intentional use." We have accepted some of the comments and have modified the definition accordingly. Specifically, we have included reference to the " methods" gene deletion, gene doubling, changing positions of genes, and introducing foreign genes that were included in the original NOSB definition. This will make the definition even more closely parallel the NOSB recommendation. We also refer to recombinant DNA technology, which is technically more accurate than the proposed rules reference to recombinant DNA as a " method." We have not accepted the comments that requested adding the products of excluded methods to the definition. The emphasis and basis of these standards is on process, not product. We have specifically structured the provisions relating to excluded methods to refer to the use of methods. Including the products of excluded methods in the definition would not be consistent with this approach to organic standards as a process­ based system. For the same reason, we have retained the term, " excluded methods," to reinforce that process­ based approach. We have also rejected comments requesting that we include the prohibition on excluded methods in the definition and, likewise, those requesting that we refer to " intentional use" of excluded methods. The final rule maintains and clarifies the prohibition on the use of excluded methods in organic production systems. The prohibition is most properly addressed in the appropriate provisions of the regulations, particularly in Section 205.105, and not in the definition. Similarly, although we recognize that a distinction between intentional and unintentional use of excluded methods may be meaningful, particularly as it pertains to issues of drift, this is an issue that is best handled in the sections of the regulation governing use of 7 excluded methods, not in the definition. The definition for " excluded methods" now reads: A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology ( including gene deletion, gene doubling, introducing a foreign gene, and changing the position of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture." ( 2) Many commenters objected to the definition of " compost" in the proposed rule because it required that compost must be produced in a facility that was in compliance with the Natural Resource Conservation Service's ( NRCS) practice standard for a composting facility. We agree with these commenters and removed the requirement to comply with the NRCS practice standard. However, the final rule incorporates new requirements for the production of compost that are included in the definition. The final rule requires that compost must be produced through a process that combines plant and animal materials with an initial C: N ratio of between 25: 1 and 40: 1. Furthermore, producers using an in­ vessel or static aerated pile system must maintain the composting materials at a temperature of between 131 E F and 170 E F for 3 days. Producers using a windrow system must maintain the composting materials at a temperature between 131 E F and 170 E F for 15 days, during which time, the materials must be turned a minimum of five times. We developed the requirements in the final rule for producing an allowed composted material by integrating standards used by the Environmental Protection Agency ( EPA) and USDA's Natural Resources Conservation Service ( NRCS). The requirements for the carbon­ 8 to­ nitrogen ( C: N) ratio for composting materials is the same as that found in the NRCS practice standard for a composting facility. The time and temperature requirements for in­ vessel, static aerated pile, and window composting systems are consistent with those which EPA regulates under 40 CFR 503 for the production of Class A sewage sludge. Additionally, AMS reviewed these compost production requirements with USDA's Agricultural Research Service ( ARS). This subject is discussed further under subpart C, Crop Production, Changes Based on Comment. ( 3) Some commenters stated that allowing nonagricultural or synthetic substances as feed supplements contradicted the definition for " feed supplement" in the proposed rule. These commenters stated that the definition stipulated that a feed supplement must, itself, be a feed material and that the proposed definition for " feed" did not include nonagricultural or synthetic substances. These commenters stated that the definition of " feed supplement" needed to be amended to accommodate nonagricultural or synthetic substances, or such substances should not be allowed. We agree with these commenters and amended the definition for " feed supplement" to read " a combination of feed nutrients added to livestock feed to improve the nutritional balance or performance of the total ration." One commenter recommended modifying the definition of " feed additive" to " a substance added to feed in micro quantities to fulfill a specific nutritional need; i. e., essential nutrients in the form of amino acids, vitamins, and minerals." We agree that this modification provides a more precise description of " feed additive" and have included the change. The changes to the definitions for " feed supplement" and " feed additive" are further discussed under item ( 4) of Livestock Production ­ Changes Based on Comments. ( 4) One commenter stated that the definition for " forage" inaccurately described it as " vegetable matter," and suggested that " vegetative matter" was a more suitable description. We 9 agree with the suggestion and have incorporated the change. ( 5) Some commenters stated that the definition for " mulch" implied that all mulch materials must either be organic or included on the National List. These commenters maintained that, if this was the intent of the proposed rule, the provision was too restrictive. They recommended revising the definition to clarify that natural but nonorganic plant and animal materials, if managed to prevent contamination from prohibited substances, could be used as mulch without being added to the National List. This was the intent in the proposed rule, and we have modified the definition to make this provision clearer. ( 6) Many commenters stated that the final rule should include a definition of " organic production" that required that certified operations must preserve or protect biodiversity. These commenters stated that the preservation of biodiversity is a requirement in many existing organic certification standards, including the Codex guidelines. They also stated that the NOSB had included the requirement to preserve biodiversity in its definition of organic. We agree with the intent of these comments but prefer the term, " conserve," to " preserve" because it reflects a more dynamic, interactive relationship between the operation and biodiversity over time. We included a definition for organic production as " a production system that is managed in accordance with the Act and regulations in this part to respond to site­ specific conditions by integrating cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity." We deleted the definition for " organic system of production and handling" in the final rule. ( 7) Several commenters, including the NOSB, were concerned that the definition for " planting stock" as " any plant or plant tissue, including rhizomes, shoots, leaf or stem cuttings, 10 roots, or tubers, used in plant production or propagation" was sufficiently broad to be applied to annual seedlings. We agree that it is important to establish that annual seedlings are not covered by the definition of " planting stock" and amended the definition to exclude them. The definition for planting stock in the final rule states " any plant or plant tissue other than annual seedlings but including rhizomes, shoots, leaf or stem cuttings, roots, or tubers, used in plant production or propagation." The final rule retains the definition for " annual seedling " from the proposed rule. ( 8) Several commenters recommended that the definition of " processing" should be amended to include " distilling" as an allowed practice. We agree with this comment and added distilling as an allowed processing practice. ( 9) Several commenters recommended that the final rule include a definition for " processing aid" that is consistent with the definition proposed by the NOSB and used by the Food and Drug Administration ( FDA). We agree with these commenters and have included a definition for processing aid that is the same as the definition used by FDA and found in 21 CFR Part 101.100( a)( 3)( ii). ( 10) Many commenters questioned whether the term, " State organic certification program," in the proposed rule included organic programs from States that did not offer certification services. These commenters stated that the final rule should include provisions for all State organic programs regardless of whether they functioned as certifying agents. We agree with these commenters and have amended the final rule by incorporating the term, " State organic program," as " a State program that meets the requirements of section 6506 of the Act, is approved by the Secretary, and is designed to ensure that a product that is sold or labeled as organically produced under the Act is produced and handled using organic methods." The term, 11 " State organic program," encompasses such programs whether they offer certification services or not. ( 11) One commenter stated that the definition for " wild crop" only referred to a plant or part of a plant that was harvested from " an area of land." This commenter was concerned that the definition would preclude the certification of operations that produce wild aquatic crops, such as seaweed, and stated that the OFPA does allow for certifying such operations. We agree with this commenter and changed the definition to refer to a plant or part of a plant harvested from a " site." ( 12) Many commenters stated that the soil fertility and crop nutrient management practice standard lacked a definition for " manure." These commenters maintained that the different provisions contained in the practice standard for " manure" and " compost" would be difficult to enforce without clear definitions to differentiate between the two materials. We agree with these comments and added a definition for manure as " feces, urine, other excrement, and bedding produced by livestock that has not been composted." ( 13) Some commenters stated that the National List in the final rule should include an annotation for narrow range oils to limit their use to a specific subset of such materials recommended by the NOSB. We agree with this comment but, rather than add an annotation, we have included the specifications recommended by the NOSB in a new definition for narrow range oils. Narrow range oils are defined as " petroleum derivatives, predominately of paraffinic and napthenic fractions with a 50­ percent boiling point ( 10 mm Hg) between 415 E F and 440 E F. ( 14) Many commenters maintained that the final rule needed a definition of the term, " pasture," to describe the relationship between ruminants and the land they graze. These commenters stated that a meaningful definition of " pasture" must incorporate the nutritional 12 component that it provides livestock, as well as the necessity to manage the land in a manner that protects the natural resources of the operation. We agree with these commenters and have added a definition of " pasture" as " land used for livestock grazing that is managed to provide feed value and maintain or improve soil, water, and vegetative sources." ( 15) Many commenters stated that a definition for " split operation" was necessary to prevent commingling between organic and nonorganic commodities on operations that produced or handled both forms of a commodity. We agree with these comments and have included a definition for " split operation" as " an operation that produces or handles both organic and nonorganic agricultural products." Definitions ­ Changes Requested But Not Made This subpart retains from the proposed rule terms and their definitions on which we received comments as follows: ( 1) Many commenters objected to the definition of " sewage sludge" because it excluded ash generated in a sewage sludge incinerator and grit and screenings generated during preliminary treatment of domestic sewage in treatment works. We have not changed the definition for " sewage sludge" because it provides the most comprehensive and enforceable description of the types of materials that commenters wanted to prohibit. The definition for " sewage sludge" in the proposed rule arose in response to significant public comment on the first proposed rule for national organic standards ( 62 Federal Register, No. 241) that recommended prohibiting biosolids in organic production. When incorporating those comments into the proposed rule, we did not use the term, " biosolids," because it does not have a standardized definition under Federal regulations. The term, " biosolids," is commonly used to refer to " sewage sludge," which is the 13 regulatory term established in 40 CFR Part 503. We incorporated the precise definition from 40 CFR Part 503, even though it does not include ash, grit, or screenings, because it provided the clearest description of the types of materials identified in public comment. While commenters are correct that ash, grit, or screenings from the production of sewage sludge are not prohibited by this definition, these materials are prohibited elsewhere in the regulation. The soil fertility and crop nutrient management practice standard in section 205.203 establishes the universe of allowed materials and practices. These allowed materials and practices are crop rotations, cover crops, plant and animal materials ( including their ash), nonagricultural, natural materials, and, under appropriate conditions, mined substances of low and high solubility and synthetic materials included on the National List. Ash, grit, or screenings from the production of sewage sludge cannot be included in any of these categories and, therefore, cannot be used in organic production. We retained the definition of " sewage sludge" because it most clearly conveys the wide array of commercially available soil amendments that might be considered for organic production but that the final rule expressly prohibits. We have not added specific exclusions for sewage sludge, ash, grit, or screenings because these materials are prohibited through other provisions in the practice standard. ( 2) The proposed rule prohibited the handler of an organic handling operation from using ionizing radiation for any purpose. The vast majority of commenters agreed with this prohibition and further recommended that the term, " ionizing radiation," should be defined to identify the specific applications that are prohibited. Most commenters supported a definition based on the FDA requirements in 21 CFR part 179.26 for the treatment or processing of food using ionizing radiation. While agreeing with the prohibition on ionizing radiation, these commenters favored 14 allowing certain forms of irradiation such as the use of X­ rays to inspect for debris such as stones that were inadvertently commingled with organically handled food. Other commenters recommended a prohibition on all forms of irradiation, which would include X­ rays for inspection purposes, ultraviolet light, and microwaves in addition to ionizing radiation. Finally, a number of commenters stated that ionizing radiation is a safe and effective process for handling food and, therefore, should not be prohibited in organic handling. We have not added a definition for " ionizing radiation" to the final rule because we have incorporated specific references to the applications that are prohibited in the regulatory text. The final rule prohibits the handler of an organic handling operation from using ionizing radiation as specified under 21 CFR part 179.26. These are the FDA­ approved uses of ionizing radiation that commenters most frequently recommended that we prohibit in organic handling operations. They include the use of cobalt­ 60, cesium­ 137, and other sources of radiation for the purpose of controlling microbial contaminants, pathogens, and pests in food or to inhibit the growth and maturation of fresh foods. At its June 2000 meeting, the NOSB recommended prohibiting ionizing radiation for the purpose of controlling microbial contaminants, pathogens, parasites, and pests in food, preserving a food, or inhibiting physiological processes such as sprouting or ripening. The final rule does not prohibit the handler of an organic handling operation from using the FDA­ approved applications of X­ rays for inspecting food. The prohibition on ionizing radiation in the final rule is based solely on consumer preference as reflected in the overwhelming public comment stating that organically handled foods should not be treated in that manner. ( 3) Some commenters recommend that the final rule incorporate definitions for the terms, " food additives," " extraction methods," " incidental additive," and " substantially transform." 15 However, these terms are not used in the final rule and do not require a definition. Definitions ­ Clarifications Following our review of the definitions provisions in the proposed rule, we decided to further clarify the following provision in the final rule: We were concerned that " State entity," the meaning of which encompasses both domestic and foreign political subdivisions, may be confused with " State," the meaning of which is limited to the States of the United States, its territories, the District of Columbia, and Puerto Rico. To avoid any possible confusion as to which provisions in this final rule apply to States and which apply to the broader political subdivisions, we have replaced the term, " State entity," with the term, " governmental entity," while retaining the same definition language in the proposed rule. Subpart B ­ Applicability This subpart provides an overview of what has to be certified under the National Organic Program ( NOP); describes exemptions and exclusions from certification; addresses use of the term, " organic"; addresses recordkeeping by certified production and handling operations; and addresses allowed and prohibited substances, methods, and ingredients in organic production and handling. Description of Regulations Except for exempt and excluded operations, each production or handling operation or specified portion of a production or handling operation that produces or handles crops, livestock, livestock products, or other agricultural products that are intended to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must be certified. Certified operations must meet all applicable requirements of 16 these regulations. This final rule becomes effective 60 days after its publication in the Federal Register and will be fully implemented 18 months after its effective date. Eighteen months after the effective date, all agricultural products that are sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." must be produced and handled in compliance with these regulations. Products entering the stream of commerce prior to the effective date will not have to be relabeled. The U. S. Department of Agriculture ( USDA) seal may not be affixed to any " 100 percent organic" or " organic" product until 18 months after the final rule's effective date. We anticipate that certifying agents and production and handling operations will move as quickly as possible after the effective date of the final rule to begin operating under the national organic standards. Certifying agents must begin certifying organic production and handling operations to the national standards upon receipt of their accreditation from the Administrator. Any production or handling operation or specified portion of a production or handling operation that has been already certified by a certifying agent on the date that the certifying agent receives its accreditation under this part shall be deemed to be certified under the Act until the operation's next anniversary date of certification. We have taken this approach because we believe that such certifying agents will, upon the effective date of the final rule, demonstrate their eligibility for accreditation by applying the national standards to the certification and renewal of certification of their clients. We also believe this approach will provide relief to certified operations which might otherwise have to be certified twice within a 12­ month period ( prior to their certifying agent's accreditation and again following their certifying agent's accreditation). This relief will only be available to those certified operations certified by a certifying agent that receives its accreditation 17 within 18 months from the effective date of the final rule. Certifying agents can apply for accreditation anytime after the effective date of the rule. Applications will be processed on a first­ come, first­ served basis. Those certifying agents who apply for accreditation within the first 6 months after the effective date of the final rule and are determined by the Administrator to meet the requirements for accreditation will be notified of their status approximately 12 months after the final rule's effective date. This approach is being taken because of the market advantage that could be realized by accredited certifying agents if USDA did not announce the accreditations simultaneously. Exempt and Excluded Operations This regulation establishes several categories of exempt or excluded operations. An exempt or excluded operation does not need to be certified. However, operations that qualify as exempt or excluded operations can voluntarily choose to be certified. A production or handling operation that is exempt or excluded from obtaining certification still must meet other regulatory requirements contained in this rule as explained below. Exempt Operations ( 1) A production or handling operation that has $ 5,000 or less in gross annual income from organic sales is exempt from certification. This exemption is primarily designed for those producers who market their product directly to consumers. It will also permit such producers to market their products direct to retail food establishments for resale to consumers. The exemption is not restricted to U. S. producers. However, as a practical matter, we do not envision any significant use of the exemption by foreign producers because: ( 1) the products from such operations cannot be used as ingredients identified as organic in processed products produced by 18 another handling operation, and ( 2) it is unlikely that such operations will be selling their products directly to consumers in the United States. An exempt producer or handler must comply with the labeling requirements of section 205.310 and the organic production and handling requirements applicable to its type of operation. For example, a producer of organic vegetables that performs no handling functions would have to comply with the labeling requirements of section 205.310 and the applicable production requirements in sections 205.202 through 205.207. The labeling and production and handling requirements protect the integrity of organically produced products. ( 2) A retail food establishment or portion of a retail food establishment that handles organically produced agricultural products but does not process them is exempt from all of the requirements in these regulations. ( 3) A handling operation or portion of a handling operation that handles only agricultural products containing less than 70 percent organic ingredients by total weight of the finished product ( excluding water and salt) is exempt from the requirements in these regulations, except the recordkeeping provisions of section 205.101( c); the provisions for prevention of contact of organic products with prohibited substances in section 205.272; and the labeling regulations in sections 205.305 and 205.310. The recordkeeping provisions maintain an audit trail for organic products. The prevention of contact with prohibited substances and the labeling requirements protect the integrity of organically produced products. ( 4) A handling operation or portion of a handling operation that uses the word, " organic," only on the information panel is exempt from the requirements in these regulations, except the recordkeeping provisions of section 205.101( c); the provisions for prevention of contact of 19 organic products with prohibited substances as provided in section 205.272; and the labeling regulations in sections 205.305 and 205.310. The recordkeeping provisions maintain an audit trail for organic products. The prevention of contact with prohibited substances and labeling requirements protect the integrity of organically produced products. As noted above, exempt handling operations producing multiingredient products must maintain records as required by section 205.101( c). This would include records sufficient to: ( 1) prove that ingredients identified as organic were organically produced and handled and ( 2) verify quantities produced from such ingredients. Such records must be maintained for no less than 3 years, and the operation must allow representatives of the Secretary and the applicable State program's governing State official access to the records during normal business hours for inspection and copying to determine compliance with the applicable regulations. Excluded Operations ( 1) A handling operation or portion of a handling operation that sells organic agricultural products labeled as " 100 percent organic," " organic," or " made with..." that are packaged or otherwise enclosed in a container prior to being received or acquired by the operation, remain in the same package or container, and are not otherwise processed while in the control of the handling operation is excluded from the requirements in these regulations, except for the provisions for prevention of commingling and contact of organic products with prohibited substances in section 205.272. The requirements for the prevention of commingling and contact with prohibited substances protect the integrity of organically produced products. This exclusion will avoid creating an unnecessary barrier for handlers who distribute nonorganic products and who want to offer a selection of organic products. 20 ( 2) A retail food establishment or portion of a retail food establishment that processes on the premises of the retail food establishment raw and ready­ to­ eat food from certified agricultural products labeled as " 100 percent organic," " organic," or " made with..." is excluded from the requirements in these regulations, except for the provisions for prevention of contact of organic products with prohibited substances as provided in section 205.272 and the labeling regulations in section 205.310. The prevention of commingling and contact with prohibited substances and labeling requirements protect the integrity of organically produced products. Excluded retail food establishments include restaurants; delicatessens; bakeries; grocery stores; or any retail outlet with an in­ store restaurant, delicatessen, bakery, salad bar, or other eatin or carry­ out service of processed or prepared raw and ready­ to­ eat food. There is clearly a great deal of public concern regarding the handling of organic products by retail food establishments. We have not required certification of retail food establishments at this time because of a lack of consensus as to whether retail food establishments should be certified, a lack of consensus on retailer certification standards, and a concern about the capacity of existing certifying agents to certify the sheer volume of such businesses. Retail food establishments, not exempt under the Act, could at some future date be subject to regulation under the NOP. Any such regulation would be preceded by rulemaking with an opportunity for public comment. No retailer, regardless of this exclusion and the exceptions found in the definitions for " handler" or " handling operation," may sell, label, or provide market information on a product unless such product has been produced and handled in accordance with the Act and these regulations. Any retailer who knowingly sells or labels a product as organic, except in accordance 21 with the Act and these regulations, will be subject to a civil penalty of not more than $ 10,000 per violation under this program. Recordkeeping Requirements for Certified Operations A certified operation must maintain records concerning the production and handling of agricultural products that are sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." sufficient to demonstrate compliance with the Act and regulations. Such records must be adapted to the particular business that the certified operation is conducting, fully disclose all activities and transactions of the certified operation in sufficient detail to be readily understood and audited, be maintained for not less than 5 years beyond their creation, and be sufficient to demonstrate compliance with the Act and regulations. Certified operations must make the records required by this regulation available for inspection by authorized representatives of the Secretary, the applicable State organic program's ( SOP) governing State official, and the certifying agent. Access to such records must be provided during normal business hours. Examples of Records Each exempt, excluded, and certified operation should maintain the records which demonstrate compliance with the Act and the regulations applicable to it and which it believes establish an audit trail sufficient to prove to the Secretary, the applicable SOP's governing State official, and the certifying agent that the exempt, excluded, or certified operation is and has been in compliance with the Act and regulations. Examples of records include: application and supporting documents for certification; organic system plan and supporting documents; purchased inputs, including seeds, transplants, livestock, and substances ( fertilizers, pesticides, and veterinary biologics consistent with the 22 livestock provisions of subpart C), cash purchase receipts, receiving manifests ( bills of lading), receiving tickets, and purchase invoices; field records ( planting, inputs, cultivation, and harvest); storage records ( bin register, cooler log); livestock records, including feed ( cash purchase receipts, receiving manifests ( bills of lading), receiving tickets, purchase invoices, copies of grower certificates), breeding records ( calendar, chart, notebook, veterinary documents), purchased animals documentation ( cash purchase receipts, receiving manifests ( bills of lading), receiving tickets, purchase invoices, copies of grower certificates), herd health records ( calendar, notebook, card file, veterinary records), and input records ( cash purchase receipts, written records, labels); producer invoice; producer contract; receiving manifests ( bills of lading); transaction certificate; producer certificate; handler certificate; weigh tickets, receipts, and tags; receiving tickets; cash purchase receipts; raw product inventory reports and records; finished product inventory reports and records; daily inventories by lot; records as to reconditioning, shrinkage, and dumping; production reports and records; shipping reports; shipping manifests ( bills of lading); paid freight and other bills; car manifests; broker's contracts; broker's statements; warehouse receipts; inspection certificates; residue testing reports; soil and water testing reports; cash receipt journals; general ledgers and supporting documents; sales journals; accounts payable journals; accounts receivable journals; cash disbursement journals; purchase invoices; purchase journals; receiving tickets; producer and handler contracts; cash sales receipts; cash purchase journals; sales invoices, statements, journals, tickets, and receipts; account sales invoices; ledgers; financial statements; bank statements; records of deposit; canceled checks; check stubs; cash receipts; tax returns; accountant's or other work papers; agreements; contracts; purchase orders; confirmations and memorandums of sales; computer data; computer printouts; and compilations 23 of data from the foregoing. Allowed and Prohibited Substances A certified operation must only use allowed substances, methods, and ingredients for the production and handling of agricultural products that are sold, labeled, or represented as " 100 percent organic," " organic," or made with..." for these products to be in compliance with the Act and the NOP regulations. Use of ionizing radiation, sewage sludge, and excluded methods are prohibited in the production and handling of organic agricultural products. Applicability ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: ( 1) Violations of the Act or Regulations. We have amended section 205.100 by adding a new paragraph ( c), which addresses violations of the Act and these regulations. A number of commenters advocated for provisions within the final rule describing what legal proceedings USDA would conduct against operations or persons that violate the NOP. We agree that this rule should include provisions addressing violations of the Act and these regulations. Accordingly, we have added at section 205.100 the misuse of label provisions and false statement provisions of section 2120 ( 7 U. S. C. 6519) of the Act. Specifically, section 205.100( c) provides that persons not in compliance with the labeling requirements of the Act or these regulations are subject to a civil penalty of not more than $ 10,000 per violation and that persons making false statements under the Act to the Secretary, a governing State official, or an accredited certifying agent shall be subject to the provisions of section 1001 of Title 18, United States Code. The provisions of the Act and these regulations apply to all operations or persons that sell, label, or represent their agricultural product as organic. 24 ( 2) Prohibition on Use of Excluded Methods. We have moved section 205.600 from subpart G, Administrative, to subpart B, Applicability, and replaced paragraph ( d), which referred the reader to section 205.301, with new paragraphs ( d) through ( g). As amended, this section, redesignated as section 205.105, includes all of the provisions covered under old section 205.600. The vast majority of commenters strongly supported the prohibition on the use of excluded methods in organic production and handling but raised concerns that they could not point to one provision that prohibited use of excluded methods in all aspects of organic production and handling. To close what they perceived to be " loopholes" in the prohibition, commenters made several suggestions for inclusion of new provisions prohibiting use of excluded methods in particular aspects of organic production and handling that they believed were not covered in the proposed rule. Other commenters pointed to inconsistencies in the way the prohibition on use of excluded methods was described in different sections, raising concerns that these apparent inconsistencies may create confusion for organic operations, certifiers, and consumers. Although we intended that use of excluded methods would be prohibited in all aspects of organic production and handling, the structure of the proposed rule may not have made that clear. We also share the concerns that, in attempting to identify all aspects of organic production and handling where excluded methods might be used, we may inadvertently have left out some provisions, creating confusion for organic operations, certifying agents, and consumers and creating doubt as to the scope of the prohibition on use of excluded methods. Similarly, to the extent that the prohibition on excluded methods may have been described differently in various sections of the proposed rule, we also share the concern that these inconsistencies could create 25 confusion. As a result of these concerns, we have created a new provision in section 205.105 that prohibits the use of excluded methods ( and ionizing radiation and sewage sludge) generally. This provision should alleviate perceptions that some areas of organic production may not have been covered by the prohibitions in the proposed rule. It also allows us to eliminate from the regulation most of the individual references to the prohibition on use of these methods, thereby eliminating any potential confusion where these provisions may have appeared inconsistent. These changes do not lift the prohibition on use of these methods in those sections. In fact, the purpose of this new provision is to make clear that use of these methods is prohibited in the production and handling of organic products. ( 3) Animal Vaccines. The proposed rule specifically asked for public comment on the potential impact of the prohibition on use of excluded methods as it relates to animal vaccines. A number of commenters raised concerns that there may be some critical vaccines that are only available in forms produced using excluded methods. Several commenters requested that we prohibit use of animal vaccines produced using excluded methods but that we provide for a temporary exemption until such time as vaccines produced without using excluded methods are approved for use on the National List. Other commenters requested that we prohibit use of vaccines produced using excluded methods without exception. We have concluded that the potential impact of prohibiting vaccines produced using excluded methods on animal production systems is still unknown. We do not know of any critical animal vaccine that is only available in a form produced using excluded methods, but it is unclear whether producers and certifying agents are tracking the possible use of such vaccines. There 26 also appears to be no international consensus on the use in organic production systems of animal vaccines produced using excluded methods, although there is precedent for such an exemption. European Union regulations, for example, allow for use of animal vaccines produced using excluded methods. Based on comments received and because the potential impact of the prohibition on use of excluded methods is still uncertain, we have created the possibility at section 205.105( e) for the NOSB to exercise one very narrow exception to allow use of animal vaccines produced using excluded methods but only if they are explicitly approved on the National List. We believe the issue of animal vaccines requires further deliberation and that it is most appropriate to consider it through the National List process, which mandates review by the NOSB and Technical Advisory Panels. Consideration of animal vaccines produced using excluded methods is appropriate for the National List review process because animal vaccines, we believe, are most appropriately considered synthetic materials. That is why the provision is structured so that vaccines produced using excluded methods could only be used in organic production if they are affirmatively included on the National List. We do not believe that a broad­ based exemption of the type suggested in some comments, even if only temporary, is appropriate. The Act allows use of animal vaccines in organic livestock production. Given the general prohibition on the use of excluded methods, however, we believe that animal vaccines produced using excluded methods should not be allowed without an explicit consideration of such materials by the NOSB and without an affirmative determination from the NOSB that they meet the criteria for inclusion on the National List. It is for that reason that we have not granted this request of commenters but, rather, provided an opportunity for review of this narrow range of materials 27 produced using excluded methods through the National List process. It is important to make clear, however, that this provision does not open all potential applications of excluded methods to a case­ by­ case review in the context of the National List, nor are we proposing that any particular vaccines be reviewed for inclusion on the National List at this time. The prohibition on use of excluded methods applies across the board to all phases of organic production and handling. We are simply responding to comments suggesting that a narrow exception for animal vaccines may be appropriate and providing for the possibility that such an exception could be invoked upon thorough review and recommendation by the NOSB Applicability ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Exemption of Handling Operations Producing Multiingredient Products. Some commenters asserted that only certified handling operations should be allowed to identify ingredients in multiingredient products as organic. These commenters believe that consumers will be misled if noncertified handling operations are allowed to identify ingredients as organic even if the organic claim is limited to the information panel. We do not agree with these assertions and have retained the proposed rule provisions that do not require handler certification when a product only identifies ingredients as organic within the information panel. Although handling operations only making organic claims on the information panel are exempt from certification, these operations are required to use organic product from certified operations. They are also required to prevent contact of organic products with prohibited substances as set forth in section 205.272, adhere to the labeling provisions of sections 205.305 and 205.310, and maintain records 28 in accordance with section 205.101( c). We believe consumers will understand the distinction between products that have the organic nature of the product stated on the principal display panel and those that merely identify an ingredient as organic on the information panel. ( 2) Retailer Exclusion from Certification. Many commenters objected to the provisions of section 205.101( b)( 2) which exclude retail food establishments from certification. These commenters assert that only final retailers that do not process agricultural products should be excluded from certification. There is clearly a great deal of public concern regarding the handling of organic products by retail food establishments. We have not required certification of retail food establishments at this time because of a lack of consensus as to whether retail food establishments should be certified, a lack of condenses on retailer certification standards, and a concern about the capacity of existing certifying agents to certify the sheer volume of such businesses. In addition, most existing certification programs do not include retail food establishments, and we do not believe there is sufficient consensus to institute such a significant expansion in the scope of certification at this time. However, since a few States have established procedures for certifying retail food establishments, we will assess their experience and continue to seek consensus on this issue of establishing retailer provisions under the NOP. Any such change would be preceded by rulemaking with an opportunity for public comment. The exclusion of nonexempt retail food establishments from this final rule does not prevent a State from developing an organic retail food establishment program as a component of its SOP. However, as with any component of an SOP, the Secretary will review such components on a case­ by­ case basis. ( 3) Producer Exemption Level. Several commenters advocated for an increase in the 29 producer exemption level above the $ 5,000 limit. Comments supporting the exemption suggested increasing the statutory limit for qualifying for the exemption to as high as $ 75,000. Other commenters stated that all producers should be certified and opposed the exemption even though it is required by the Act. These commenters were concerned about maintaining the integrity of the organic product and about the lack of verification of the exempt operations. We have not increased or removed the $ 5,000 producer exemption because the exemption is mandated by section 2106( d) ( 7 U. S. C. 6505( d)) of the Act. Our purpose is to limit the financial burdens of certification on such operations but not to exempt them from the standards for organic production and handling. Accordingly, exempt production and handling operations must comply with the applicable organic production and handling requirements of subpart C and the labeling requirements of section 205.310. Some of the commenters wanting a change in the producer exemption level suggested that the NOP add provisions for restricting these producers to marketing at farmers markets or roadside stands. We disagree with these comments. While we believe that most producers qualifying for the exemption are indeed likely to be small producers who market their products directly to consumers, we do not believe it is in the best interest of these producers to restrict their market opportunity to a specific sales method. A few comments suggested that we establish a sliding­ scale certification fee based upon either the size of the operation or sales of agricultural product instead of the exemption. The NOP does not establish fees for certification. Certifying agents may establish a sliding­ scale system as long as their fees are reasonable and applied in a consistent and nondiscriminatory manner. 30 Finally, some commenters expressed concern that exempt operations were forbidden from certification. This interpretation is not correct. Any production or handling operation, including an exempt operation, which makes application for certification as an organic operation and meets the requirements for organic certification may be certified. ( 4) Handler exemption. Many commenters disagreed with the proposed rule provision providing for an exemption of $ 5,000 to handlers. These commenters asked the NOP to remove the phrase, " or handlers," from the exemption provision. The commenters argue that the handler exemption is not authorized by the Act. We disagree with the commenters, and we have retained the handler exemption in the final rule. The Act states that the exemption is available to " persons" selling not more than $ 5,000 annually in value of agricultural products. The Act's definition of " persons" includes handlers. Thus, handlers grossing $ 5,000 or less qualify for the exemption. ( 5) Categories of Income to Qualify for an Exemption. Some commenters want the $ 5,000 producer/ handler exemption to include all sales of agricultural products, not just sales of organic agricultural products. These commenters perceive this provision to be a loophole for large, split operations. We disagree with these commenters, and we have retained the $ 5,000 producer/ handler exemption based upon total sales of organic agricultural products. We do not believe there is a significant number of split operations which only gross $ 5,000 in annual sales of organic products and, therefore, qualify for this exemption. In setting the exemption levels, the Department sought to maximize the benefits to small producers afforded by the Act while setting a threshold level that minimizes the potential of product mislabeling. ( 6) Limiting Handler Exclusions. Many commenters argued that brokers, distributors, warehousers, and transporters should not be excluded from certification. We do not agree with 31 these commenters. Brokers, distributors, warehousers and transporters do not alter the product and, in many cases, do not take title to the product. Certifying these handlers would be an unnecessary burden on the industry. Traditionally, distributors and trucking companies have been excluded from State and private certification requirements. ( 7) Recordkeeping Requirements for Excluded Operations. Several commenters argued that excluded operations should be required to comply with the same recordkeeping requirements as exempt operations. Some commenters expressed concern over the inability to verify compliance for either exempt or excluded operations and asked that exempt or excluded operations be subject to additional recordkeeping requirements. We disagree with these commenters and have retained the provisions from the proposed rule on recordkeeping for excluded operations. Given the nature of these excluded operations, for example, operations that only sell prepackaged organic products, we believe that extensive recordkeeping requirements would be an unwarranted regulatory burden. ( 8) Recordkeeping Burden on Small Certified Operations. Some commenters questioned whether small certified operations have the ability to implement a recordkeeping system which complies with the provisions of section 205.103. These commenters argue that recordkeeping requirements must be tailored to the scale of the operation. We do not believe that the recordkeeping requirements as described in section 205.103 conflict with the suggestions of the commenters. The recordkeeping requirements provide that the records must be adapted to the particular business that the certified operation is conducting and be sufficient to demonstrate compliance with the Act and regulations. It is USDA's intent that each production and handling operation decide for itself what recordkeeping scheme is appropriate, given the complexity and 32 scope of the individual business. These provisions provide considerable latitude for each production and handling operation to decide what records are necessary to demonstrate its compliance with the Act and the NOP regulations. ( 9) Public Access to Records. Several commenters asked that the public have full access to any certifying agent record on organic production and/ or handling operations. Other commenters expressed concerns about certifying agents divulging confidential business information and asked that records containing confidential business information not be taken from the business' physical location. We have not changed this provision. The recordkeeping requirements are designed to seek a balance between the pubic's right to know and a business's right to retain confidential business information. Certifying agents must have access to certain records during their review of the operation to determine the operation's compliance with the NOP. However, certifying agents are required to protect an operation's confidential business information. Requiring full public access could compromise a business' competitive position and place an unfair burden on the organic industry. ( 10) Fair Labor Practices on Organic Farms. Many commenters asked the NOP to develop fair labor practice standards as a part of the final rule. We have not adopted these comments. Other statutes cover labor and worker safety standards. The Act does not provide the authority to include them in these regulations. However, these regulations do not prohibit certifying agents from developing a voluntary certification program, separate from organic certification, that address fair labor and worker safety standards. ( 11) " Transitional Organic" Label. Several commenters requested that the NOP adopt 33 regulations on the conversion of operations to organic production and create a " transitional organic" label. We have not included provisions within the final rule that provide for " transitional organic" labeling. Although many commenters requested that we provide for transition labeling, there does not appear to be sufficient consensus to establish such a standard at this time. Given this lack of consensus, it is unclear what marketplace value such a label might have, and we are concerned that allowing such a label at this point might lead to greater consumer confusion rather than providing clarity. Applicability ­ Clarifications Clarification is given on the following issues raised by commenters as follows: ( 1) " Genetic" drift. Many commenters raised issues regarding drift of the products of excluded methods onto organic farms. These commenters were concerned that pollen drifting from near­ by farms would contaminate crops on organic operations and that, as a result, organic farmers could lose the premium for their organic products through no fault of their own. Many commenters argued that we should use this rule to somehow shift the burden to the technology providers who market the products of excluded methods or the nonorganic farming operations that use their products. Some, for example, suggested that this regulation should require that the nonorganic operations using genetically engineered varieties plant buffer strips or take other steps to avoid drift onto organic farms. Others suggested that the regulation could provide for citizens' right to sue in cases of drift. While we understand the concerns that commenters have raised, the kind of remedies they suggested are outside the scope of the Act and this regulation. The Act only provides for the regulation of organic operations. We cannot use this regulation to impose restrictions, such as 34 requiring buffer strips or other measures, on operations that are not covered by the Act. Similarly, while citizens may have the ability to bring suit under other laws, the Act itself does not provide for the right to bring suit as a Federal cause of action, and we could not grant it through this regulation. Drift has been a difficult issue for organic producers from the beginning. Organic operations have always had to worry about the potential for drift from neighboring operations, particularly drift of synthetic chemical pesticides. As the number of organic farms increases, so does the potential for conflict between organic and nonorganic operations. It has always been the responsibility of organic operations to manage potential contact of organic products with other substances not approved for use in organic production systems, whether from the nonorganic portion of a split operation or from neighboring farms. The organic system plan must outline steps that an organic operation will take to avoid this kind of unintentional contact. When we are considering drift issues, it is particularly important to remember that organic standards are process based. Certifying agents attest to the ability of organic operations to follow a set of production standards and practices that meet the requirements of the Act and the regulations. This regulation prohibits the use of excluded methods in organic operations. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of this regulation. As long as an organic operation has not used excluded methods and takes reasonable steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan, the unintentional presence of the products of excluded methods should not affect the status of an organic product or operation. 35 Issues of pollen drift are also not confined to the world of organic agriculture. For example, plant breeders and seed companies must ensure genetic identity of plant varieties by minimizing any cross­ pollination that might result from pollen drift. Under research conditions, small­ scale field tests of genetically engineered plants incorporate various degrees of biological containment to limit the possibility of gene flow to other sexually compatible plants. Federal regulatory agencies might impose specific planting requirements to limit pollen drift in certain situations. Farmers planting nonbiotechnology­ derived varieties may face similar kinds of questions if cross­ pollination by biotechnology­ derived varieties alters the marketability of their crop. These discussions within the broader agricultural community may lead to new approaches to addressing these issues. They are, however, outside the scope of this regulation by definition. ( 2) Additional NOP Standards for Specific Production Categories. Many commenters asked that the NOP include in the final rule certification standards for apiculture, greenhouses, mushrooms, aquatic species, culinary herbs, pet food, and minor animal species ( e. g., rabbits) food. The NOP intends to provide standards for categories where the Act provides the authority to promulgate standards. During the 18­ month implementation period, the NOP intends to publish for comment certification standards for apiculture, mushrooms, greenhouses and aquatic animals. These standards will build upon the existing final rule and will address only the unique requirements necessary to certify these specialized operations. Some of the other questions raised by commenters are already addressed in the final rule. For example, feed for minor species is covered by livestock feed provisions within subpart C and the livestock feed labeling provisions within subpart D. The production and utilization of culinary herbs, including herbal teas, is covered by the provisions of the final rule. We do not envision 36 needing to do additional rulemaking on these two categories. Other requests by commenters have not been addressed. We have not addressed the labeling of pet food within this final rule because of the extensive consultation that will be required between USDA, the NOSB, and the pet food industry before any standards on this category could be considered. ( 3) Standards for Cosmetics, Body Care Products, and Dietary Supplements. A few commenters asked that the NOP include in the final rule certification standards for cosmetics, body care products, and dietary supplements. Producers and handlers of agricultural products used as ingredients in cosmetics, body care products, and dietary supplements could be certified under these regulations. Producers and handlers of these ingredients might find an increased market value for their products because of the additional assurance afforded by certification. The ultimate labeling of cosmetics, body care products, and dietary supplements, however, is outside the scope of these regulations. ( 4) Private Label Products. Many commenters asked about the certification status of so­ called " private label products." Private label products are items for which a retailer contracts with a processor to produce the product to the retailer's specifications and to be sold under the retailer's name. Commenters believe the proposed rule was unclear on the certification requirements for these products. Any product labeled as " 100 organic," " organic," or " made with..." must be certified regardless of the business arrangements under which the product was produced. When a retail operation contracts for the production, packaging, or labeling of organic product, it is the certified production or handling operation that is responsible for complying with the applicable organic production or handling regulations. 37 ( 5) State Oversight of Exempt and Excluded Operations. Many commenters asked for clarification on the State's enforcement responsibility for exempt and excluded operations. The NOP is ultimately responsible for the oversight and enforcement of the program, including oversight of exempt and excluded operations and cases of fraudulent or misleading labeling. We expect, however, that States would want to monitor for false claims or misleading labeling under these regulations and would forward any complaints to the NOP. States that have an approved SOP which includes regulation of operations excluded under the NOP would be required to enforce those provisions. ( 6) Nonedible Fibers Products in the NOP. Some commenters asked the NOP to clarify the certification status of fibers such as cotton and flax. The final rule allows for certification of organically produced fibers such as cotton and flax. However, the processing of these fibers is not covered by the final rule. Therefore, goods that utilize organic fibers in their manufacture may only be labeled as a " made with..." product; e. g., a cotton shirt labeled " made with organic cotton." ( 7) Recordkeeping for Operations That Produce Organic and Nonorganic Product. Several commenters recommended that " split operations," which are operations producing organic and nonorganic agricultural products, be required to maintain separate records. These commenters believe that the proposed rule did not provide adequate provision for the maintenance of separate recordkeeping. The provisions within section 205.103( b)( 1) and ( b)( 2) do indicate that operations which produce both organic and nonorganic agricultural products must maintain a recordkeeping system that differentiates the organic portion of the operations from the records related to other portions of operations. 38 ( 8) NOP Program Manual. A few commenters, particularly States, noted that the proposed rule made several references to program manuals as a mechanism for further clarifying certain portions of the rule. These commenters asked whether certifying agents should consider information contained in these manuals as enforceable regulations. NOP program manuals cannot be and are not intended to be the equivalent of regulations. Rather, the NOP envisions development of a program manual to serve as guidance for certifying agents regarding implementation­ and certification­ related issues. Material contained within the program manual will be designed to address the organic agriculture principles of each final rule section, as appropriate, and to offer information that certifying agents should consider in making certification decisions that will be reliably uniform throughout the country. The use of program manuals as guidance to assist in developing uniform certification decisions is a standard industry practice, and the NOP has compiled examples of program manuals from both large and small certifiers. Because the NOP intends to use the examples it has acquired as the basis for any NOP guidance manual, we believe that most certifying agents will find such NOP manual, when developed, familiar and useful. Additionally, we will use the NOSB public meeting process to seek guidance from industry and the public on what information would be useful in a program manual and to provide input on the program manual as it is developed. Of course, if in developing program guidance, it appears that modifications or changes in the NOP final rule are required, such modifications would be made through notice and comment rulemaking. ( 9) Use of Products from Exempt Operations as Organic Ingredients. A few commenters responded to the question in the proposed rule in which we asked whether handlers should be allowed to identify organically produced products produced by exempt production operations as 39 organic ingredients. The proposed rule provided that all ingredients identified as organic in a multiingredient product must have been produced by a production or handling operation certified by an accredited certifying agent. The commenters supported this position. These commenters believe that the potential for mislabeling outweighed any financial benefit that might accrue to exempt producers through expanded market opportunities. We concur, and, therefore, have retained the prohibition on using products produced by an exempt production or handling operation as organic ingredients ( 10) Exemption of Handling Operations Producing Multiingredient Products. We have amended section 205.101( a)( 3) by changing " 50 percent" to " 70 percent" to make it consistent with the amendments to the labeling provisions. We have also edited section 205.101( a)( 4) for clarification purposes. Additionally, we amended sections 205.101( a)( 3) and 205.101( a)( 4) by citing the labeling requirements of section 205.305. These amendments have been made to clarify that handling operations exempted under these sections are subject to the labeling requirements of section 205.305. ( 11) Production and Handling in Compliance with Federal Statutes. We have amended section 205.102 by removing paragraph ( c). This paragraph provided that any agricultural product that is sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients)" must be produced and handled in compliance with applicable Federal statutes and their implementing regulations. We have taken this action because the provision is an identical restatement of section 2120( f) ( 7 U. S. C. 6519( f)) of the Act. The Act makes clear that all production and handling operations are to comply with all applicable Federal statutes and their implementing regulations. Therefore, it is unnecessary to repeat the requirement 40 in these regulations. ( 12) Foreign Applicants. We have removed section 205.104, which provided that the regulations in this part, as applicable, apply equally to domestic and foreign applicants for accreditation, accredited certifying agents, domestic and foreign applicants for certification as organic production or handling operations, and certified organic production and handling operations unless otherwise specified. These regulations, as written, apply equally to all applicants for accreditation, accredited certifying agents, applicants for organic certification, and certified organic operations. Accordingly, we have determined that section 205.104 is not necessary. Subpart C ­ Organic Crop, Wild Crop, Livestock, and Handling Requirements Description of Regulations General Requirements This subpart sets forth the requirements with which production and handling operations must comply in order to sell, label, or represent agricultural products as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))." The producer or handler of an organic production or handling operation must comply with all applicable provisions of subpart C. Any production practice implemented in accordance with this subpart must maintain or improve the natural resources, including soil and water quality, of the operation. Production and handling operations which sell, label, or represent agricultural products as organic in any manner and which are exempt or excluded from certification must comply with the requirements of this subpart, except for the development of an organic system plan. Production and Handling ( General) 41 The Organic Food Production Act of 1990 ( OFPA or Act) requires that all crop, wild crop, livestock, and handling operations requiring certification submit an organic system plan to their certifying agent and, where applicable, the State organic program ( SOP). The organic system plan is a detailed description of how an operation will achieve, document, and sustain compliance with all applicable provisions in the OFPA and these regulations. The certifying agent must concur that the proposed organic system plan fulfills the requirements of subpart C, and any subsequent modification of the organic plan by the producer or handler must receive the approval of the certifying agent. The organic system plan is the forum through which the producer or handler and certifying agent collaborate to define, on a site­ specific basis, how to achieve and document compliance with the requirements of certification. The organic system plan commits the producer or handler to a sequence of practices and procedures resulting in an operation that complies with every applicable provision in the regulations. Accreditation qualifies the certifying agent to attest to whether an organic system plan comports with the organic standard. The organic system plan must be negotiated, enacted, and amended through an informed dialogue between certifying agent and producer or handler, and it must be responsive to the unique characteristics of each operation. An organic system plan contains six components. First, the organic system plan must describe the practices and procedures used, including the frequency with which they will be used, in the certified operation. Second, it must list and characterize each substance used as a production or handling input, including the documentation of commercial availability, as applicable. Third, it must identify the monitoring techniques which will be used to verify that the organic plan is being implemented in a manner which complies with all applicable requirements. 42 Fourth, it must explain the recordkeeping system used to preserve the identity of organic products from the point of certification through delivery to the customer who assumes legal title to the goods. Fifth, the organic system plan must describe the management practices and physical barriers established to prevent commingling of organic and nonorganic products on a split operation and to prevent contact of organic production and handling operations and products with prohibited substances. Finally, the organic system plan must contain the additional information deemed necessary by the certifying agent to evaluate site­ specific conditions relevant to compliance with these or applicable State program regulations. Producers or handlers may submit a plan developed to comply with other Federal, State, or local regulatory programs if it fulfills the requirements of an organic system plan. The first element of the organic system plan requires a narrative or other descriptive format that identifies the practices and procedures to be performed and maintained, including the frequency with which they will be performed. Practices are tangible production and handling techniques, such as the method for applying manure, the mechanical and biological methods used to prepare and combine ingredients and package finished products, and the measures taken to exclude pests from a facility. Procedures are the protocols established for selecting appropriate practices and materials for use in the organic system plan, such as a procedure for locating commercially available, organically produced seed. Procedures reflect the decision­ making process used to implement the organic system plan. By requiring information on the frequency with which production and handling practices and procedures will be performed, the final rule requires an organic system plan, to include an implementation schedule, including information on the timing and sequence of all relevant 43 production and handling activities. The plan will include, for example, information about planned crop rotation sequences, the timing of any applications of organic materials, and the timing and location of soil tests. Livestock management practices might describe development of a rotational grazing plan or addition of mineral supplements to the feed supply. A handling operation might identify steps involved in locating and contracting with farmers who could produce organic ingredients that were in short supply. The second element that must be included in an organic system plan is information on the application of substances to land, facilities, or agricultural products. This requirement encompasses both natural and synthetic materials allowed for use in production and handling operations. For natural materials which may be used in organic operations under specific restrictions, the organic plan must detail how the application of the materials will comply with those restrictions. For example, farmers who apply manure to their fields must document in their organic system plans how they will prevent that application from contributing to water contamination. A producer and handler who bases the selection of seed and planting stock material under section 205.204 or an agricultural ingredient under section 205.301 on the commercial availability of that substance must provide documentation in the organic system plan. The third element of the organic system plan is a description of the methods used to evaluate its effectiveness. Producers and handlers are responsible for identifying measurable indicators that can be used to evaluate how well they are achieving the objectives of the operation. For example, production objectives could be measured through regular tallies of bushels or pounds of product sold from the farm or in numbers of cases sold from a handling operation. Indicators that can identify changes in quality or effectiveness of management 44 practices could be relatively simple, such as the information contained in a standard soil test. The specific indicators used to evaluate a given organic system plan will be determined by the producer or handler in consultation with the certifying agent. Thus, if the organic system plan calls for improvements in soil organic matter content in a particular field, it would include provisions for analyzing soil organic matter levels at periodic intervals. If herd health improvement is an objective, factors such as somatic cell count or observations about changes in reproductive patterns might be used as indicators. The fourth element of the organic system plan is a description of the recordkeeping system used to verify and document an audit trail, as appropriate to the operation. For each crop or wildcrop harvested, the audit trail must trace the product from the field, farm parcel, or area where it is harvested through the transfer of legal title. A livestock operation must trace each animal from its entrance into through removal from the organic operation. A handling operation must trace each product that is handled and sold, labeled, or represented as organic from the receipt of its constituent ingredients to the sale of the processed product. The fifth element which must be included in an organic system plan pertains to split production or handling operations. This provision requires an operation that produces both organic and nonorganic products to describe the management practices and physical barriers established to prevent commingling of organic and nonorganic products. This requirement addresses contact of organic products, including livestock, organic field units, storage areas, and packaging to be used for organic products, with prohibited substances. The specific requirements to be included in an organic system plan are not listed here. The accreditation process provides an assurance that certifying agents are competent to determine the 45 specific documentation they require to review and evaluate an operation's organic system plan. Section 205.200( a)( 6) allows a certifying agent to request additional information needed to determine that an organic system plan meets the requirements of this subpart. The site­ specific nature of organic production and handling necessitates that certifying agents have the authority to determine whether specific information is needed to carry out their function. Crop Production Any field or farm parcel used to produce an organic crop must have been managed in accordance with the requirements in sections 205.203 through 205.206 and have had no prohibited substances applied to it for at least 3 years prior to harvest of the crop. Such fields and farm parcels must also have distinct, defined boundaries and buffer zones to prevent contact with the land or crop by prohibited substances applied to adjoining land. A producer of an organic crop must manage soil fertility, including tillage and cultivation practices, in a manner that maintains or improves the physical, chemical, and biological condition of the soil and minimizes soil erosion. The producer must manage crop nutrients and soil fertility through rotations, cover crops, and the application of plant and animal materials. The producer must manage plant and animal materials to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. Plant and animal materials include raw animal manure, composted plant and animal materials, and uncomposted plant materials. Raw animal manure must either be composted, applied to land used for a crop not intended for human consumption, or incorporated into the soil at least 90 days before harvesting an edible product that does not come into contact with the soil or soil particles and at 46 least 120 days before harvesting an edible product that does come into contact with the soil or soil particles. Composted plant or animal materials must be produced through a process that establishes an initial carbon­ to­ nitrogen ( C: N) ratio of between 25: 1 and 40: 1 and achieves a temperature between 131 E F and 170 E F. Composting operations that utilize an in­ vessel or static aerated pile system must maintain a temperature within that range for a minimum of 3 days. Composting operations that utilize a windrow composting system must maintain a temperature within that range for a minimum of 15 days, during which time the materials must be turned five times. In addition to these practices and materials, a producer may apply a crop nutrient or soil amendment included on the National List of synthetic substances allowed in crop production. The producer may apply a mined substance of low solubility. A mined substance of high solubility may only be applied if the substance is used in compliance with the annotation on the National List of nonsynthetic materials prohibited in crop production. Ashes of untreated plant or animal materials which have not been combined with a prohibited substance and which are not included on the National List of nonsynthetic substances prohibited for use in organic crop production may be used to produce an organic crop. A plant or animal material that has been chemically altered by a manufacturing process may be used only if it is included on the National List of synthetic substances allowed for use in organic production. The producer may not use any fertilizer or composted plant and animal material that contains a synthetic substance not allowed for crop production on the National List or use sewage sludge. Burning crop residues as a means of disposal is prohibited, except that burning may be used to suppress the spread of disease or to stimulate seed germination. 47 The producer must use organically grown seeds, annual seedlings, and planting stock. The producer may use untreated nonorganic seeds and planting stock when equivalent organic varieties are not commercially available, except that organic seed must be used for the production of edible sprouts. Seed and planting stock treated with substances that appear on the National List may be used when an organically produced or untreated variety is not commercially available. Nonorganically produced annual seedlings may be used when a temporary variance has been established due to damage caused by unavoidable business interruption, such as fire, flood, or frost. Planting stock used to produce a perennial crop may be sold as organically produced planting stock after it has been maintained under a system of organic management for at least 1 year. Seeds, annual seedlings, and planting stock treated with prohibited substances may be used to produce an organic crop when the application of the substance is a requirement of Federal or State phytosanitary regulations. The producer is required to implement a crop rotation, including but not limited to sod, cover crops, green manure crops, and catch crops. The crop rotation must maintain or improve soil organic matter content, provide for effective pest management in perennial crops, manage deficient or excess plant nutrients, and control erosion to the extent that these functions are applicable to the operation. The producer must use preventive practices to manage crop pests, weeds, and diseases, including but not limited to crop rotation, soil and crop nutrient management, sanitation measures, and cultural practices that enhance crop health. Such cultural practices include the selection of plant species and varieties with regard to suitability to site­ specific conditions and resistance to prevalent pests, weeds, and diseases. Mechanical and biological methods that do not entail 48 application of synthetic substances may be used as needed to control pest, weed, and disease problems that may occur. Pest control practices include augmentation or introduction of pest predators or parasites; development of habitat for natural enemies; and nonsynthetic controls such as lures, traps, and repellents. Weed management practices include mulching with fully biodegradable materials; mowing; livestock grazing; hand weeding and mechanical cultivation; flame, heat, or electrical techniques; and plastic or other synthetic mulches, provided that they are removed from the field at the end of the growing or harvest season. Disease problems may be controlled through management practices which suppress the spread of disease organisms and the application of nonsynthetic biological, botanical, or mineral inputs. When these practices are insufficient to prevent or control crop pests, weeds, and diseases, a biological or botanical substance or a synthetic substance that is allowed on the National List may be used provided that the conditions for using the substance are documented in the organic system plan. The producer must not use lumber treated with arsenate or other prohibited materials for new installations or replacement purposes that comes into contact with soil or livestock. A wild crop that is to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must be harvested from a designated area that has had no prohibited substances applied to it for a period of 3 years immediately preceding the harvest of the wild crop. The wild crop must also be harvested in a manner that ensures such harvesting or gathering will not be destructive to the environment and will sustain the growth and production of the wild crop. Livestock Production Any livestock product to be sold, labeled, or represented as organic must be maintained 49 under continuous organic management from the last third of gestation or hatching with three exceptions. Poultry or edible poultry products must be from animals that have been under continuous organic management beginning no later than the second day of life. Milk or milk products must be from animals that have been under continuous organic management beginning no later than 1 year prior to the production of such products, except for the conversion of an entire, distinct herd to organic production. For the first 9 months of the year of conversion, the producer may provide the herd with a minimum of 80­ percent feed that is either organic or produced from land included in the organic system plan and managed in compliance with organic crop requirements. During the final 3 months of the year of conversion, the producer must provide the herd feed in compliance with section 205.237. Once the herd has been converted to organic production, all dairy animals shall be under organic management from the last third of gestation. Livestock used as breeder stock may be brought from a nonorganic operation into an organic operation at any time, provided that, if such livestock are gestating and the offspring are to be organically raised from birth, the breeder stock must be brought into the organic operation prior to the last third of gestation. Should an animal be brought into an organic operation pursuant to this section and subsequently moved to a nonorganic operation, neither the animal nor any products derived from it may be sold, labeled, or represented as organic. Breeder or dairy stock that has not been under continuous organic management from the last third of gestation may not be sold, labeled, or represented as organic slaughter stock. The producer of an organic livestock operation must maintain records sufficient to preserve the identity of all organically managed livestock and all edible and nonedible organic livestock products produced on his or her operation. 50 Except for nonsynthetic substances and synthetic substances included on the National List that may be used as feed supplements and additives, the total feed ration for livestock managed in an organic operation must be composed of agricultural products, including pasture and forage, that are organically produced. Any portion of the feed ration that is handled must comply with organic handling requirements. The producer must not use animal drugs, including hormones, to promote growth in an animal or provide feed supplements or additives in amounts above those needed for adequate growth and health maintenance for the species at its specific stage of life. The producer must not feed animals under organic management plastic pellets for roughage or formulas containing urea or manure. The feeding of mammalian and poultry slaughter byproducts to mammals or poultry is prohibited. The producer must not supply animal feed, feed additives, or feed supplements in violation of the Federal Food, Drug, and Cosmetic Act. The producer of an organic livestock operation must establish and maintain preventive animal health care practices. The producer must select species and types of livestock with regard to suitability for site­ specific conditions and resistance to prevalent diseases and parasites. The producer must provide a feed ration including vitamins, minerals, protein, and/ or amino acids, fatty acids, energy sources, and, for ruminants, fiber. The producer must establish appropriate housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of diseases and parasites. Animals in an organic livestock operation must be maintained under conditions which provide for exercise, freedom of movement, and reduction of stress appropriate to the species. Additionally, all physical alterations performed on animals in an organic livestock operation must be conducted to promote the animals' welfare and in a manner that minimizes stress and pain. 51 The producer of an organic livestock operation must administer vaccines and other veterinary biologics as needed to protect the well­ being of animals in his or her care. When preventive practices and veterinary biologics are inadequate to prevent sickness, the producer may administer medications included on the National List of synthetic substances allowed for use in livestock operations. The producer may not administer synthetic parasiticides to breeder stock during the last third of gestation or during lactation if the progeny is to be sold, labeled, or represented as organically produced. After administering synthetic parasiticides to dairy stock, the producer must observe a 90­ day withdrawal period before selling the milk or milk products produced from the treated animal as organically produced. Every use of a synthetic medication or parasiticide must be incorporated into the livestock operation's organic system plan subject to approval by the certifying agent. The producer of an organic livestock operation must not treat an animal in that operation with antibiotics, any synthetic substance not included on the National List of synthetic substances allowed for use in livestock production, or any substance that contains a nonsynthetic substance included on the National List of nonsynthetic substances prohibited for use in organic livestock production. The producer must not administer any animal drug, other than vaccinations, in the absence of illness. The use of hormones for growth promotion is prohibited in organic livestock production, as is the use of synthetic parasiticides on a routine basis. The producer must not administer synthetic parasiticides to slaughter stock or administer any animal drug in violation of the Federal Food, Drug, and Cosmetic Act. The producer must not withhold medical treatment from a sick animal to maintain its organic status. All appropriate medications and treatments must be used to restore an animal to health when methods acceptable to organic production standards 52 fail. Livestock that are treated with prohibited materials must be clearly identified and shall not be sold, labeled, or represented as organic. A livestock producer must document in his or her organic system plan the preventative measures he or she has in place to deter illness, the allowed practices he or she will employ if illness occurs, and his or her protocol for determining when a sick animal must receive a prohibited animal drug. These standards will not allow an organic system plan that envisions an acceptable level of chronic illness or proposes to deal with disease by sending infected animals to slaughter. The organic system plan must reflect a proactive approach to health management, drawing upon allowable practices and materials. Animals with conditions that do not respond to this approach must be treated appropriately and diverted to nonorganic markets. The producer of an organic livestock operation must establish and maintain livestock living conditions for the animals under his or her care which accommodate the health and natural behavior of the livestock. The producer must provide access to the outdoors, shade, shelter, exercise areas, fresh air, and direct sunlight suitable to the species, its stage of production, the climate, and the environment. This requirement includes access to pasture for ruminant animals. The producer must also provide appropriate clean, dry bedding, and, if the bedding is typically consumed by the species, it must comply with applicable organic feed requirements. The producer must provide shelter designed to allow for the natural maintenance, comfort level, and opportunity to exercise appropriate to the species. The shelter must also provide the temperature level, ventilation, and air circulation suitable to the species and reduce the potential for livestock injury. The producer may provide temporary confinement of an animal because of inclement weather; the animal's stage of production; conditions under which the health, safety, or well­ being 53 of the animal could be jeopardized; or risk to soil or water quality. The producer of an organic livestock operation is required to manage manure in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, heavy metals, or pathogenic organisms and optimizes nutrient recycling. Handling Mechanical or biological methods can be used to process an agricultural product intended to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ingredients" for the purpose of retarding spoilage or otherwise preparing the agricultural product for market. Processed multiingredient products labeled " 100 percent organic," may only use wholly organic ingredients, pursuant to paragraph ( a) of section 205.301. Nonagricultural substances that are allowed for use on the National List and nonorganically produced agricultural products may be used in or on " organic" and " made with..." products pursuant to paragraphs ( b) and ( c) of section 205.301, respectively. Documentation of commercial availability of each substance to be used as a nonorganic ingredient in products labeled " organic" must be listed in the organic handling system plan in accordance with section 205.201. Handlers are prohibited from using: ( 1) ionizing radiation for the treatment or processing of foods; ( 2) ingredients produced using excluded methods; or ( 3) volatile synthetic solvents in or on a processed product or any ingredient which is sold, labeled, or represented as organic. The prohibition on ionizing radiation for the treatment or processing of foods is discussed under Applicability, section 205.105. This rule does not prohibit an organic handling operation from using Food and Drug Administration ( FDA)­ approved X­ rays for inspecting packaged foods for foreign objects that may be inadvertently commingled in the packaged product. 54 The two paragraphs on excluded methods and ionizing radiation in section 205.270( c) of the proposed rule are replaced with new paragraph ( c)( 1) which cross­ references those practices under paragraphs ( e) and ( f) of section 205.105. New section 205.105 clearly specifies that ionizing radiation and excluded methods are two practices that handlers must not use in producing organic agricultural products and ingredients. The prohibition on the use of volatile synthetic solvents, also included under paragraph ( c) of section 205.270 does not apply to nonorganic ingredients in " made with..." products. The practice standard for facility pest management under section 205.271 requires the producer or handler operating a facility to use management practices to control and prevent pest infestations. Prevention practices in paragraph ( a) include removing pest habitats, food sources, and breeding areas; preventing access to handling facilities; and controlling environmental factors, such as temperature, light, humidity, atmosphere, and air circulation, to prevent pest reproduction. Permitted pest control methods in paragraph ( b) include mechanical or physical controls, such as traps, light, or sound. Lures and repellents using nonsynthetic substances may be used as pest controls. Lures and repellents with synthetic substances that are allowed on the National List also may be used. Prevention and control practices in paragraphs ( a) and ( b) may be used concurrently. If the practices in paragraphs ( a) and ( b) are not effective, amended paragraph ( c) provides that handlers may then use a nonsynthetic or synthetic substance consistent with National List. If the measures and substances provided under paragraphs ( a), ( b), and ( c) are not effective, synthetic substances not on the National List may be used to control pest infestations. Under new paragraph ( d), the handler and the operation's certifying agent, prior to using such a substance, 55 must agree on the substance to be used to control the pest, measures to be taken to prevent contact with organically produced product, and ingredients that may be in the handling facility. This rule recognizes that certain local, State, and Federal laws or regulations may require intervention with prohibited substances before or at the same time substances allowed in paragraphs ( b) and ( c) are used. To the extent that this occurs, this rule permits the handler to follow such laws and regulations to market a product as organically handled, provided that the product does not come into contact with the pest control substance used. The extent of pest infestation cannot be foreseen when an organic plan is submitted by the certified operation and approved by the certifying agent. A handler who uses any nonsynthetic or synthetic substance to control facility pests must update its organic handling system plan to address all measures taken or intended to be taken to prevent contact between the substance and any organically produced ingredient or finished product. Section 205.272 provides additional practice standards that must be followed by an organic handling operation to prevent the commingling of organic and nonorganic products and to protect organic products from contact with prohibited substances. An organic handling operation must not use packaging materials and storage containers or bins that contain a synthetic fungicide, preservative, or fumigant in handling an organic product. The operation also must not use or reuse any storage bin or container that was previously in contact with any prohibited substance unless the reusable bin or container has been thoroughly cleaned and poses no risk of prohibited materials contacting the organic product. Temporary Variances This subpart establishes conditions under which certified organic operations may receive 56 temporary variances from the production and handling provisions of this subpart. The Administrator may establish temporary variances due to: ( 1) Natural disasters declared by the Secretary; ( 2) unavoidable business interruption caused by natural catastrophes such as drought, wind, fire, flood, excessive moisture, hail, tornado, or earthquake; or ( 3) to conduct research on organic production and handling techniques or inputs. An SOP's governing State official or a certifying agent may recommend that the Administrator establish a temporary variance for various reasons including an unavoidable business interruption. The Administrator will determine how long a temporary variance will be in effect at the time it is established, subject to such extension as the Administrator deems necessary. Temporary variances may not be issued to allow use of any practice, material, or procedure which is prohibited under section 205.105. The proposed rule inadvertently omitted the SOP's governing State official as having authority to recommend a temporary variance to the Administrator. We have added that authority in paragraph ( b) of section 205.290. Upon notification by the Administrator that a temporary variance has been established, the certifying agent must inform each production and handling operation it certifies that may be affected by the temporary variance. For example, if a drought causes a severe shortage of organically produced hay, a dairy operation may be permitted to substitute some nonorganic hay for a portion of the herd's diet to prevent liquidation of the herd. The producer must keep records showing the source and amount of the nonorganic hay used and the timeframe needed to restore the total feed ration to organic sources. The certifying agent may require that the next organic plan include contingency measures to avoid the need to resort to nonorganic feed in case of a future shortage. 57 General ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: ( 1) Maintain or Improve Provision for Production Operations Only. A number of commenters questioned whether the requirement in the proposed rule that an operation must " maintain or improve the natural resources of the operation, including soil and water quality" applied to handling as well as production operations. They stated that handling operations are not integrated into natural systems the way that production systems are. As a result, these commenters were uncertain how handlers could fulfill the " maintain or improve" requirement. The " maintain or improve" requirement addresses the impact of a production operation on the natural resource base that sustains it and, as such, does not apply to handling operations. We have modified the final rule in section 205.200 by limiting the " maintain or improve" requirement to production practices. ( 2) Management Practices and Physical Barriers to Prevent Commingling. Many commenters, including numerous certifying agents, stated that the proposed provisions for an organic system plan were not adequate for the task of certifying an operation that produces both organic and nonorganic products. The commenters requested that the final rule incorporate the provisions established in the OFPA for certifying these split operations. These provisions include separate recordkeeping for the organic and nonorganic operations and the implementation of protective practices to prevent the commingling of product and the unintentional contact of organic product with prohibited substances. We have amended the provisions for an organic system plan in section 205.201( a)( 5) to require greater accountability regarding the segregation of organic and nonorganic products in a split operation. The changes we made incorporate language 58 from the OFPA (" physical facilities, management practices") to provide clear criteria for producers, handlers and certifying agents to agree upon an organic system plan that protects the integrity of organic product. ( 3) Commercial Availability. The proposed rule required that a raw or processed agricultural product sold, labeled, or represented as organic must contain not less than 95 percent organically produced raw or processed agricultural product. Additionally, section 205.606 of the proposed rule allowed any nonorganically produced agricultural product to be used in the 5 percent nonorganic component of an agricultural product sold, labeled, or represented as organic. Many commenters objected to these provisions and recommended that nonorganically produced agricultural products should only be allowed in an organic product when the organically produced form was not commercially available. Commenters stated that allowing nonorganically produced agricultural products within the 5 percent would significantly weaken demand for many organically produced commodities, especially herbs and spices. These commenters stated that herbs and spices often constitute less than 5 percent of the ingredients in a raw or processed agricultural product and that handlers producing an organic product would instinctively seek out the less expensive nonorganic variety. They also indicated that the 5 percent component is an important market for many products produced from organically produced livestock, such as milk derivatives and meat by­ products, that are not typically marketed directly to consumers. Commenters stated that the preponderance of current certification programs use the commercial availability criterion when determining whether a nonorganically produced agricultural product may be used within the 5 percent component. Commenters cited the National Organic Standards Board's ( NOSB) recommendation that organic agricultural products be used in this 5 percent 59 component unless they are commercially unavailable and requested that the final rule incorporate the criteria for determining commercial availability that accompanied that NOSB recommendation. We agree with commenters that a preference for organically produced agricultural commodities, when commercially available, can benefit organic producers, handlers, and consumers in a variety of ways. We believe that the commercial availability requirement may allow consumers to have confidence that processed products labeled as " organic" contain the highest feasible percentage of organic ingredients. Some producers may benefit from any market incentive to supply organically produced minor ingredients that handlers need for their processed products. We recognize that the provision does impose an additional requirement on handlers who must ascertain whether the agricultural ingredients they use are commercially available in organic form. The NOSB recommended that the final rule contain a commercial availability provision based upon the guidelines developed by the American Organic Standards project of the Organic Trade Association. For these reasons, we have amended the final rule to require that an agricultural commodity used as an ingredient in a raw or processed product labeled as organic must be organic when the ingredient is commercially available in an organic form. While recognizing the potential benefits of applying the commercial availability standard to all agricultural ingredients in a processed product, we are concerned that enforcing this provision could impose an excessive burden on handlers. Although many commenters stated that some existing certifying agents apply a commercial availability standard, we do not have complete information on the criteria used by these certifying agents, and we are unsure whether a consensus exists on criteria for commercial availability within the organic community. Additionally, we are 60 concerned that, unless the standard is clearly articulated and consistently interpreted and enforced, it will not be effective. Disagreement among certifying agents regarding when and under what circumstances an ingredient is commercially available would undermine our intent to create an equitable and enforceable standard. AMS is soliciting additional comment and information on a number of issues concerning the development of standards for the commercial availability of organically produced agricultural commodities used in processed products labeled as " organic." On the basis of these comments and information and additional recommendations that the NOSB may develop, AMS will develop a commercial availability standard for use in implementing the final rule. AMS intends to develop the commercial availability standard and incorporate it within the final rule prior to the commencement of certification activities by accredited certifying agents. This approach will provide organic handlers and certifying agents the standard necessary to incorporate the consideration of commercial availability of ingredients in an organic system plan at the time that the USDA organic standard comes into use. Specifically, AMS requests comments and information addressing the following questions: What factors, such as quantity, quality, consistency of supply, and expense of different sources of an ingredient, should be factored into the consideration of commercial availability? What relative importance should each of these factors possess, and are there circumstances under which the relative importance can change? What activities and documentation are sufficient to demonstrate that a handler has taken appropriate and adequate measures to ascertain whether an ingredient is commercially available? How can AMS ensure the greatest possible degree of consistency in the application of the 61 commercial availability standard among multiple certifying agents? Could potentially adverse effects of a commercial availability standard, such as uncertainty over the cost and availability of essential ingredients, impact or impede the development of markets for organically processed products? What economic and administrative burdens are imposed by the commercial availability standards found in existing organic certification programs? How would producers benefit from market incentives to increase use of organic ingredients that result from a commercial availability standard? Would lack of a commercial availability standard provide a disincentive for handlers of products labeled " organic" to seek out additional organic minor ingredients? What impacts could this have on producers of minor ingredients? AMS welcomes any new or unpublished research results or information that exists concerning a commercial availability standard. AMS specifically invites comment from establishments which currently operate using commercial availability or a comparable provision in the conduct of their business. AMS will receive comment on this issue until 90 days after publication of the final rule. ( 4) Conservation of Biodiversity. Many commenters recommended amending the definition of organic production to include the requirement that an organic production system must promote or enhance biological diversity ( biodiversity). Commenters stated that the definitions for organic production developed by the NOSB and the Codex Commission include this requirement. We agree with these commenters and have amended the definition of organic production to require that a producer must conserve biodiversity on his or her operation. The use 62 of " conserve" establishes that the producer must initiate practices to support biodiversity and avoid, to the extent practicable, any activities that would diminish it. Compliance with the requirement to conserve biodiversity requires that a producer incorporate practices in his or her organic system plan that are beneficial to biodiversity on his or her operation. General ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: Organic Plan Excessively Restrictive. One organic inspector was concerned that the requirements of the organic system plan were too prescriptive and would create an excessive paper work burden for producers and handlers. The commenter stated that the excessive specificity of certain requirements ( composition and source of every substance used), combined with the ambiguity of others ( soil and tissue testing required but with no mention of the frequency), would confuse the working relationship between a producer or handler and his or her certifying agent. The commenter was concerned that strict adherence to the specifications in the organic system plan would compromise the ability of producers and handlers to run their businesses. While agreeing that flexibility in the development of the organic system plan was valuable, the commenter stated that producers and handlers, not the certifying agent, must retain the primary managerial role for their operation. Other commenters maintained that the organic system plan requirements were too ambiguous and would inhibit certifying agents' efforts to review necessary information. For example, a trade association commented that the absence of specific recordkeeping requirements for livestock feed materials, medications, and health care activities would impair compliance monitoring. 63 The provisions for an organic system plan were one of the most significantly revised components of the proposed rule, and, with minor changes related to split operations, we have retained them in the final rule. These provisions provide ample discretion for producers, handlers, and certifying agents to perform their duties while recognizing that mutual consent is a prerequisite for them to meet their responsibilities. The organic system plan enables producers and handlers to propose and certifying agents to approve site and operation­ specific practices that fulfill all applicable program requirements. Producers and handlers retain the authority to manage their operations as they deem necessary, but any actions they undertake that modify their organic system plan must be approved by the certifying agent. With regard to recordkeeping, certifying agents are authorized to require the additional information, such as the livestock records mentioned in the comment, that they deem necessary to evaluate compliance with the regulations. One certifying agent stated that the requirement to maintain or improve the natural resources of the operation was worthy in principle but unreasonable to achieve. This commenter stated that the long­ term consequences of an organic system plan could not be foreseen and recommended requiring that producers " must endeavor" to maintain or improve the operation's natural resources. We have not changed this requirement because the vast majority of commenters supported an organic system plan that mandated the " maintain or improve" principle. A good working relationship between the producer and his or her certifying agent, including the annual inspection and accompanying revisions to the organic system plan, can rectify the unforeseen and unfavorable conditions that arise. Crop Production ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: 64 ( 1) Crop nutrient management. The fundamental requirement of the soil fertility and crop nutrient management practice standard, that tillage, cultivation, and nutrient management practices maintain or improve the physical, chemical, and biological condition of the soil and minimize erosion, remains unaltered. The proposed rule required that a producer budget crop nutrients by properly utilizing manure or other animal and plant materials, mined substances of low or high solubility, and allowed synthetic amendments. Many commenters disagreed with using the term, " budget," which they considered too limiting to characterize nutrient management in organic systems. These commenters recommended that the practice standard instead emphasize the diverse practices used in organic systems to cycle nutrients over extended periods of time. We agree with these commenters and have amended the final rule to require that producers manage crop nutrients and soil fertility through the use of crop rotations and cover crops in addition to plant and animal materials. Additionally, we clarified that producers may manage crop nutrients and soil fertility by applying mined substances if they are used in compliance with the conditions established in the National List. Finally, we removed the word, " waste," from our description of animal and plant materials in the proposed rule to emphasize the importance of these resources in organic soil fertility management. ( 2) Compost Practice Standard. The proposed rule required that a composted material used on an organic operation must be produced at a facility in compliance with the Natural Resource Conservation Service ( NRCS) practice standard. While many commenters agreed with the need for greater oversight of the feedstocks and procedures used to produce compost, most stated that the NRCS practice standard would not be suitable for this purpose. Commenters 65 stated that the requirements in the NRCS practice standard were not designed for organic operations and would prohibit many established, effective composting systems currently used by organic producers. For example, adoption of the NRCS practice standard would prevent producers from using nonfarm wastes as compost feedstocks. Materials such as food processing by­ products and leaves from curbside collection programs have long been used with beneficial results. Commenters also stated that the minimum acceptable requirements for the design, construction, and operation of a composting facility contained in the practice standard were appropriate for a voluntary cost share program but were excessive as a compliance requirement for organic certification. Commenters questioned whether producers could justify the investment of time and resources needed to comply with the multiple design and operation criteria specified in the NRCS practice standard. We agree with commenters who stated that, given the diversity of composting systems covered by a national organic standard, requiring full compliance with the NRCS practice standard would be overly prescriptive. We maintain, however, that implementation of the OFPA requires a rigorous, quantitative standard for the production of compost. The OFPA contains significant restrictions on applying raw manure that are reflected in the soil fertility and crop nutrient management practice standard. These restrictions pertain to raw manure and do not apply once fresh animal materials are transformed into a composted material. An organic producer using a composted material containing manure must comply with the nutrient cycling and soil and water conservation provisions in his or her organic system plan but is not constrained by the restrictions that apply to raw manure. Therefore, producers intending to apply soil 66 amendments will require clear and verifiable criteria to differentiate raw manure from composted material. We developed the requirements in the final rule for producing an allowed composted material by integrating standards used by the Environmental Protection Agency ( EPA) and USDA's Natural Resources Conservation Service ( NRCS). The requirements for the carbon­ tonitrogen ( C: N) ratio for composting materials are the same as that found in the NRCS practice standard for a composting facility. The time and temperature requirements for in­ vessel, static aerated pile, and windrow composting systems are consistent with that EPA regulates under 40 CFR Part 503 for the production of Class A sewage sludge. Additionally, AMS reviewed these compost production requirements with USDA's Agricultural Research Service ( ARS). The conditions in the final rule for producing an allowed composted material begin with the selection of appropriate feedstocks. The producer's first responsibility is to identify the source of the feedstocks used in the composting system. This requirement ensures that only allowed plant and animal materials are included in the composting process, that they are not contaminated with prohibited materials, and that they are incorporated in quantities suitable to the design of the composting system. Certifying agents will exercise considerable discretion for evaluating the appropriateness of potential feedstock materials and may require testing for prohibited substances before allowing their use. For example, a certifying agent could require a producer to monitor off­ farm inputs such as leaves collected through a municipal curbside program or organic wastes from a food processing facility. Monitoring may be necessary to protect against contamination from residues of prohibited substances, such as motor oil or heavy metals, or gross inert materials such as glass shards that can enter the organic waste stream. The final rule further requires that the producer adhere to quantitative criteria when 67 combining and managing the plant and animal materials that are being composted. When combining feedstocks to initiate the process, producers must establish a C: N ratio of between 25: 1 and 40: 1. This range allows for very diverse combinations of feedstock materials while ensuring that, when properly managed, the composting process will yield high quality material. While some commenters maintained that specifying any C: N ratio in the final rule would be too restrictive, it would be far more problematic not to establish a range. The 25: 1 to 40: 1 range ensures that producers will establish appropriate conditions under which the additional requirements in this practice standard, most notably the time and temperature criteria, can be achieved with minimal producer oversight. Composting operations using a C: N ratio lower than 25: 1 require increasingly intensive management as the ratio drops due to the risk of putrefaction. Operations in excess of the 40: 1 range may achieve the minimum temperature but are likely to drop off quickly and result in a finished material that is inadequately mature and deficient in nitrogen. The producer is not required to perform a physical analysis of each feedstock component if he or she can demonstrate that an estimated value is reliable. For example, estimates of the carbon and nitrogen content in specific manures and plant materials are generally recognized. Other feedstocks of consistent quality may be tested once and assumed to approximate that value. The producer must develop in his or her organic system plan the management strategies and monitoring techniques to be used in his or her composting system. To produce an allowed composted material, the producer must use an in­ vessel, static aerated pile, or windrow composting system. Producers using an in­ vessel or static aerated pile system must document that the composting process achieved a temperature between 131 E F and 170 E F and maintained 68 that level for a minimum of 3 days. Producers using a windrow composting system must document that the composting process achieved a temperature between 131 E F and 170 E F and maintained that level for a minimum of 15 days. Compost produced using a windrow system must be turned five times during the process. These time and temperature requirements are designed to minimize the risk from human pathogens contained in the feedstocks, degrade plant pathogens and weed seeds, and ensure that the plant nutrients are sufficiently stabilized for land application. The final rule does not contain provisions for the use of materials commonly referred to as " compost teas." A compost tea is produced by combining composted plant and animal materials with water and a concentrated nutrient source such as molasses. The moisture and nutrient source contribute to a bloom in the microbial population in the compost, which is then applied in liquid form as a crop pest or disease control agent. The microbial composition of compost teas are difficult to ascertain and control and we are concerned that applying compost teas could impose a risk to human health. Regulation of compost teas was not addressed in the proposed rule. The National Organic Program ( NOP) will request additional input from the NOSB and the agricultural research community before deciding whether these materials should be prohibited in organic production or whether restrictions on their use are appropriate. In addition to managing crop nutrients with raw manure and composted plant and animal materials, a producer may use uncomposted plant materials. These are materials derived exclusively from plant sources that a producer manages in a manner that makes them suitable for application in a cropping system. For example, plant materials that are degraded and stabilized through a vermicomposting process may be used as a soil fertility and crop nutrient amendment. ( 3) Mined Substances of High Solubility. The proposed rule treated mined substances of 69 high solubility as a single category of soil amendment and allowed their use where warranted by soil and crop tissue testing. Many commenters objected to the general allowance for this category of substances and were particularly disappointed that the NOSB annotations on two such materials, sodium ( Chilean) nitrate and potassium chloride, were not included. Commenters cited the potential detrimental effects of these highly soluble and saline substances on soil quality and stated that several international organic certification programs severely prescribe or prohibit their use. One certifying agent recommended that natural substances of high solubility and salinity be handled comparably to similar synthetic materials such as liquid fish products and humic acids that appear on the National List, complete with their original NOSB annotations. At its June 2000 meeting, the NOSB recommended that the NOP delete general references to mined substances of high solubility from the final rule, and incorporate the NOSB's specific annotations for materials of this nature. We have adopted this recommendation by retaining a place for mined substances of high solubility in the soil fertility and crop nutrient management practice standard but restricting their use to the conditions established for the material as specified on the National List of prohibited natural substances. Under this approach, mined substances of high solubility are prohibited unless used in accordance with the annotation recommended by the NOSB and added by the Secretary to the National List. We deleted the provision from the proposed rule that use of the substance be " justified by soil or crop tissue analysis." The final rule contains two materials­­ sodium nitrate and potassium chloride­­ that may be used in organic crop production with the annotations developed the NOSB. While " mined substances of high solubility" is not a discrete, recognized category such as crop nutrients, the proposed rule mentioned sodium nitrate, potassium chloride, potassium nitrate 70 ( niter), langbeinite ( sulfate of potash magnesia), and potassium sulfate in this context. Based on the recommendation of the NOSB, the final rule would prohibit use of these materials, unless the NOSB developed recommendations on conditions for their use and the Secretary added them to the National List. The NOP would welcome further guidance from the NOSB on these materials. ( 4) Burning crop residues. The proposed rule prohibited burning as a means of crop disposal, except for burning prunings from perennial crops to suppress the spread of disease. Many commenters supported the principle behind the prohibition but maintained that the proposed language was too restrictive and would preclude certain beneficial agronomic practices. Several producers stated that the proposed rule would prevent them from collecting and burning residues from diseased annual crops, which they felt was an effective and beneficial practice. Other producers cited their use of prescriptive burning as a management practice for certain native or wild crops. As evidenced by the allowance for burning to suppress disease with perennial crops, the proposed rule was not designed to preclude the selective use of fire in organic production. We agree with the commenters that a more flexible allowance for the practice is warranted, and we have amended the provision to allow burning of annual and perennial crop residues for the suppression of disease and to stimulate seed germination. Producers must establish their need and procedures for burning in their organic system plan, and the practice cannot be used solely to remove crop debris from fields. ( 5) Requirement for Organic Seed in Sprout Production. The proposed rule allowed nonorganically produced seeds for all purposes, including sprout production, when the certifying agent concurred with the producer that organically produced seeds were not commercially available. While commenters predominately supported this approach with seed used for planting, 71 they were virtually unanimous in stating that it is never appropriate to allow nonorganically produced and handled seeds in organic sprout production. Commenters cited the NOSB's June 1994 recommendation that seed used for the production of edible sprouts shall be organically produced and stated that existing certification standards do not provide an exemption based on commercial availability. We agree with these commenters and have modified the final rule to require that organic seed must be used for the production of edible sprouts. ( 6) Mitigating the Effects of a Biological, Botanical, or Synthetic Substance. The proposed rule required that producers who used a biological or botanical substance or an allowed synthetic substance to control crop pests, weeds, or disease evaluate and mitigate the effects of repetitive use of the same or similar substances. While agreeing that pest resistance and shifts in pest populations were important considerations, commenters stated that managing these issues was beyond the ability of individual operations. Commenters recommended that the NOP develop principles and practices for managing pest resistance and shifts in pest types that would apply to all production operations. We agree with these comments and have deleted the requirement to evaluate and mitigate the effects of using the same or similar crop pest, weed, or disease control substances. The final rule requires that producers document the use of such substances in their organic systems plans, subject to the approval of their certifying agent. ( 7) Prohibition on Use of Treated Lumber. The proposed rule did not specifically address the use of lumber that had been treated with a prohibited substance, such as arsenic, in organic production. Citing the explicit prohibition on these substances in existing organic standards, many commenters felt that treated lumber should be excluded in the final rule. Commenters also cited the NOSB's recommendation to prohibit the use of lumber treated with a prohibited substance for 72 new construction and replacement purposes effective upon publication of the final rule. We have included a modified version of the NOSB's recommendation within the crop pest, weed, and disease management practice standard. This provision prohibits the use of lumber treated with arsenate or other prohibited materials for new installations or replacement purposes in contact with an organic production site. We included this modification to clarify that the prohibition applies to lumber used in direct contact with organically produced and handled crops and livestock and does not include uses, such as lumber for fence posts or building materials, that are isolated from production. The prohibition applies to lumber used in crop production, such as the frames of a planting bed, and for raising livestock, such as the boards used to build a farrowing house. ( 8) Greater Rigor in the Wild Harvest Production Organic System Plan. A number of commenters stated that the wild­ crop harvesting practice standard was insufficiently descriptive and that the proposed rule failed to apply the same oversight to wild harvest operations as it did to those producing crops and livestock. Some commenters maintained that the proposed rule did not require a wild harvest producer to operate under an approved organic system plan. These commenters proposed specific items, including maps of the production area that should be required in a wild harvest operation's organic system plan. One commenter recommended that the definition for " wild crop" be modified to allow the harvest of plants from aquatic environments. We amended the practice standard for wild­ crop harvesting to express the compliance requirements more clearly. Wild­ crop producers must comply with the same organic system plan requirements and conditions, as applicable to their operation, as their counterparts who produce crops and livestock. Wild harvest operations are production systems, and they must satisfy the 73 general requirement that all practices included in their organic system plan must maintain or improve the natural resources of the operation, including soil and water quality. We modified the practice standard to emphasize that wild harvest production is linked to a designated site and expect that a certifying agent would incorporate mapping and boundary conditions into the organic system plan requirements. Finally, we changed the definition of " wild crop" to specify that harvest takes place from a " site" instead of " from land," thereby allowing for aquatic plant certification. Crop Production ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Application of Raw Manure. The soil fertility and crop nutrient management practice standard in the proposed rule permitted the application of raw manure to crops not intended for human consumption and established restrictions for applying it to crops used for human food. For human food crops, the proposed rule required a 120­ day interval between application and harvest of crops whose edible portion had direct contact with the soil or soil particles, and a 90­ day interval for crops that did not. These provisions reflected the recommendations developed by the NOSB at its June 1999 meeting. The practice standard also required that raw manure must be applied in a manner that did not contribute to the contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. The majority of commenters supported the provisions for applying raw manure. Some commenters stated that the provisions effectively balanced the benefits of applying raw manure to the soil with the environmental and human health risks associated with its use. These commenters 74 stated that the lengthy intervals between application and harvest would not impose an unreasonable or unfeasible burden on organic producers. The NOSB strongly supported the provisions in the proposed rule, emphasizing that raw manure contributed significant benefits to soil nutrient, structure, and biological activity that other soil fertility practices and materials do not provide. Other commenters stated that the provisions were consistent with the requirements in existing organic standards and added that the restrictions were justifiable because they reflected responsible management practices. For differing reasons, a number of commenters disagreed with the proposed provisions. Some commenters cited the human health risks associated with pathogenic organisms found in raw manure and stated that the proposed intervals between application and harvest were not adequately protective. These commenters recommended that the NOP conduct more extensive risk assessment procedures before determining what, if any, intervals between application and harvest would adequately protect human health. Some of these commenters identified the risk assessment methodology and pathogen treatment procedures governing the production and use of sewage sludge as the most suitable precedent for guiding the additional work required in this area. Conversely, a number of commenters stated that the provisions in the proposed rule were excessive because they exceeded the minimum 60­ day interval between application and harvest established in the OFPA. Many of these commenters recommended eliminating the distinction between crops that come into contact with soil or soil particles and those that don't and applying a uniform 60­ day interval between harvest and application for any crop to which raw manure had been applied. Some commenters stated that the 120­ day interval severely limited the flexibility of producers who operated in regions such as the Northeast where the growing season lasted only 75 slightly longer. Other commenters maintained that the practice standard did not address specific practices, such as applying raw manure to frozen fields, that they maintained should be expressly prohibited. The responsibility to use raw manure in a manner that is protective of human health applies to all producers, whether organic or not, who apply such materials. We acknowledge the commenters who noted that the OFPA cites food safety concerns relative to manure use and, therefore, that food safety considerations should be reflected in the practice standard for applying raw manure in the final rule. Some of the commenters favored more extensive risk assessment procedures or lengthening the interval between application and harvest. We have not, however, changed the provisions for applying raw manure. Although public health officials and others have identified the use of raw manure as a potential food safety concern, at the present time, there is no science­ based, agreed­ upon standard for regulating the use of raw manure in crop production. The standard in this rule is not a public health standard. The determination of food safety demands a complex risk assessment methodology, involving extensive research, peer review, and field testing for validation of results. The only comparable undertaking in Federal rulemaking has been EPA's development of treatment and application standards for sewage sludge, an undertaking that required years of dedicated effort. The NOP does not have a comparable capacity with which to undertake a comprehensive risk assessment of the safety of applying raw manure to human food crops. To delegate the authority to determine what constitutes safe application of raw manure to certifying agents would be even more problematic. A certifying agent cannot be responsible for establishing a Federal food safety standard. Therefore, the standard in this rule is a reflection of AMS' view 76 and of the public comments that this standard is reasonable and consistent with current organic industry practices and NOSB recommendations for organic food crop production. Should additional research or Federal regulation regarding food safety requirements for applying raw manure emerge, AMS will ensure that organic production practice standards are revised to reflect the most up­ to­ date food safety standard. Neither the identification of food safety as a consideration in the OFPA nor the inclusion of this practice standard in the final rule should be construed to suggest that organically produced agricultural products are any safer than nonorganically produced ones. USDA has consistently stated that certification is a process claim, not a product claim, and, as such, cannot be used to differentiate organic from nonorganic commodities with regard to food safety. National organic standards for manure use cannot be used to establish a food safety standard for certified commodities in the absence of as uniform Federal regulation to ensure the safety of all human food crops to which raw manure has been applied. The OFPA was designed to certify a process for informational marketing purposes. Neither have we changed the practice standard in response to comments that the requirement in the final rule should not exceed the 60­ day interval contained in the OFPA. The OFPA clearly establishes that the interval must be no less than 60 days and does not preclude a longer standard. The NOSB has strongly supported the proposed 90­ and 120­ day intervals, and the vast majority of commenters indicated that these provisions would be feasible for virtually all organic cropping systems. The requirement in the practice standard that raw manure must be applied in a manner that does not contribute to the contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances provides 77 certifying agents the discretion to prohibit specific practices that would not be in compliance. With this discretion, a certifying agent could prohibit practices, such as applying manure to frozen ground or too close to water resources, that many commenters stated were not appropriate for organic production. ( 2) No Prohibition on Manure from Nonorganic Operations. The proposed rule identified animal and plant waste materials as important components in soil fertility and crop nutrient management without providing criteria for distinguishing allowed and prohibited sources. A large number of commenters objected to this provision and stated that manure from nonorganic sources may contain residues from prohibited substances, including animal medications. These commenters maintained that some of these residues, such as antibiotics, may remain active for extended intervals, and others, such as heavy metals, could accumulate on the organic operation. Commenters stated that if either or both conditions prevailed, the integrity of the organic operation would be jeopardized. Many producers and certifying agents emphasized that the proposed rule conflicted with the Codex guidelines that prohibit the use of manure from factory farms. These commenters were concerned that failure to restrict the use of manure from nonorganic operations would put their products at a competitive disadvantage, particularly in European markets. When raising this issue, most commenters requested that the final rule either prohibit the use of manure from factory farms or state that certifying agents could regulate the practice by requiring residue testing and restrictions on application. We have not changed the provisions for using manure from nonorganic operations in the final rule. In many discussions on the subject throughout the years, the NOSB has never recommended that manure from nonorganic farms be prohibited. Existing organic certification 78 standards routinely permit the use of manure from nonorganic operations with appropriate oversight, and the final rule incorporates a similar approach. Under the final rule, a certifying agent can require residue testing when there is reasonable concern that manure, either raw or as a component of compost, contains sufficient quantities of prohibited materials to violate the organic integrity of the operation. Providing certifying agents the discretion to require screening for prohibited materials will minimize the risk of introducing contaminants while maintaining the ecologically important practice of recycling organic material from nonorganic operations. Additionally, the final rule requires that producers apply manure and compost in a manner that maintains or improves the soil and water quality of their operation. This provision provides an additional safeguard that certifying agents may use to ensure that the application of any form of manure protects the natural resources of the operation. ( 3) Rotating a Field in and out of Organic Production. Some commenters stated that a producer should not be allowed to rotate fields on their operation in and out of organic production. These commenters were concerned that producers could apply prohibited substances that persisted for many years, such as soil fumigants, and begin harvesting organically produced crops after 3 years. They stated that, without a prohibition on the rotation of fields in this manner, organic producers could effectively use a prohibited substance on their operation. We have not amended the final rule to prohibit the rotation of a field on an operation in and out of organic production. The statutory prohibition on the application of a prohibited substance is 3 years, and this requirement is contained in section 205.202( b). This prohibition restricts the application of a prohibited substance, not its residual activity. If AMS receives evidence that the rotation of fields in this manner threatens to compromise organic production, the 79 NOP and NOSB will collaborate on developing standards to remedy it. ( 4) Use of Seed Treatments on the National List. The seed and planting stock practice standard in the proposed rule generated a very diverse array of responses that, while largely favorable, highlighted a potentially disruptive impact on organic producers. The practice standard favored organic seed and planting stock over nonorganically produced but untreated varieties and nonorganically produced, untreated seed and planting stock over nonorganically produced seeds and planting stock treated with an allowed synthetic substance. Producers could use the less preferable seed or planting stock variety if they demonstrated to their certifying agent that an equivalent variety in the preferred form was not commercially available. Most commenters endorsed the principle of requiring organic seed and planting stock and agreed that the proposed provisions were a workable approach to enforcement. They stated that the provisions created an incentive for seed and planting stock providers to develop supplies for organic markets, yet enabled producers who made a good faith effort but failed to locate seed or planting stock in the preferred form the ability to continue producing organically. Most commenters indicated that this approach would support the existing market for organic seed and planting stock while fostering its continued development. A number of commenters, however, stated that the seed and planting stock practice standard was unreasonable and unworkable and would adversely affect organic producers. These effects would include significantly reduced planting options due to the nonavailability of seed in any allowed form and higher seed costs, which represent a significant percentage of the total production cost for some commodities. These commenters maintained that the three categories of seed and planting stock allowed in the order of preference could not reliably provide producers 80 with many commercial varieties currently being planted. They pointed out that there were no synthetic seed treatments on the National List in the proposed rule, thereby eliminating the use of treated seed in organic production. Commenters stated that producers often rely upon seed and planting stock varieties that are uniquely well adapted for their growing conditions or marketing requirements and that these particular varieties would very often not be available in untreated form. These commenters concluded that the proposed practice standard would compel many producers to abandon many tried and true varieties of seed and planting stock and perhaps phase out organic production entirely. One commenter maintained that the proposed rule's stated intention of using the practice standard to stimulate production of organic seed and planting stock was not within the purpose of the OFPA. We have not changed the seed and planting stock practice standard in response to these commenters because the prohibition on using synthetic materials not on the National List is a requirement of the OFPA. The final rule cannot allow producers to use synthetic seed treatments that have not been reviewed, favorably recommended by the NOSB, and added to the National List by the Secretary. The practice standard creates incentives for producers to seek out seed and planting stock inputs that are the most compatible with organic production, yet includes allowances when preferred forms are not commercially available. While no seed treatments are included on the National List in the final rule, individuals may petition the NOSB for review of such substances. Additionally, the practice standard creates an incentive for seed and planting stock producers and suppliers to develop natural treatments suitable for organic systems that would not need to appear on the National List. The objectives of spurring production of organically grown seed and promoting research in natural seed treatments are compatible with the 81 OFPA's purpose of facilitating commerce in organically produced and processed food. We designed the practice standard to pursue these objectives while preventing the disruption that an ironclad requirement for organically produced seed and planting stock may have caused. ( 5) Practice Standard for Maple Syrup. Many commenters stated that the proposed rule lacked production and handling standards for operations that produce maple syrup. Commenters stated that maple syrup production is a significant enterprise for many organic producers and that the absence of a practice standard in the final rule would adversely affect existing markets for organic products. Many commenters recommended that the final rule incorporate the maple syrup practice standard from an existing certification program or the American Organic Standards. We have not included a practice standard for the production and handling of maple syrup because the final rule contains sufficient provisions for the certification of these types of operations. After reviewing existing practice standards for maple syrup, we determined that the standards in the final rule for crop production, handling operations, and allowed and prohibited materials on the National List provided comparable guidance. Crop Production ­ Clarifications Clarification is given on the following issues raised by commenters: ( 1) Applicability of Crop Rotation Requirement to all Operations. One State program commented that the crop rotation practice standard in the proposed rule was unreasonable for producers who operated in regions where limited rainfall and irrigation resources or unique soil conditions made cover cropping impractical. This commenter stated that certain dryland cropping systems, such as aloe vera production, function as " semi­ perennial" systems that do not include 82 rotations, yet fulfill the objectives of the crop rotation practice standard. A certifying agent expressed a similar concern by suggesting that the crop rotation practice standard be changed by adding " may include, but is not limited to" prior to the list of allowed management practices. This commenter felt that the " may include" clause afforded individual growers greater discretion by acknowledging that not every allowed management practice would be applicable to all operations. We have retained the language from the proposed rule because it already provides the flexibility to develop site­ specific crop rotation practices requested by these commenters. The regulation as originally written includes the " but not limited to" clause that allows producers to include alternative management practices in their organic system plan. Additionally, the regulation states that the producer must implement a crop rotation that provides the required functions " that are applicable to the operation." This further establishes that the crop rotation component of an organic system plan must be considered within the context of site­ specific environmental conditions including climate, hydrology, soil conditions, and the crops being produced. The final rule requires implementation of a crop rotation, but the producer and certifying agent will determine the specific crops and the frequency and sequencing of their use in that rotation. Crop rotations must fulfill the requirements of this practice standard­­ to maintain or improve soil organic matter content, provide for pest management, manage deficient or excess plant nutrients, and control erosion­­ and are not obligated to use any specific management practice. We structured this and other practice standards, as well as the requirements of the organic system plan, to enable producers and certifying agents to develop organic system plans adapted to natural variation in environmental conditions and production systems. ( 2) Excluding Annual Seedlings from Planting Stock. The proposed rule allowed a 83 producer to use nonorganically produced seeds and planting stock if organically produced equivalent varieties were not commercially available. Several commenters, including the NOSB, were concerned that the definition of planting stock as " any plant or plant tissue, including rhizomes, shoots, leaf or stem cuttings, roots, or tubers, used in plant production or propagation" was sufficiently broad to be applied to annual seedlings. While many commenters, including the NOSB, supported the commercial availability exemption in the case of seeds and planting stock, they objected to extending it to annual seedlings. The proposed rule did not intend to include annual seedling within the definition of planting stock and included a separate definition of " annual seedling" as " a plant grown from seed that will complete its life cycle or produce a harvestable crop yield within the same crop your or season in which it is planted." The proposed rule addressed annual seedlings as a distinct category within the seed and planting stock practice standard. There was no allowance for using nonorganically produced annual seedlings based on commercial availability, and such seedlings can only be used when a temporary variance has been issued due to a catastrophic business interruption. The growth of markets for organically produced annual seedlings, unlike those for seeds and planting stock, obviates the need for the commercial availability provision. We have retained this approach in the final rule. Livestock Production ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: ( 1) Whole Herd Conversion. The proposed rule required that livestock receive 1 year of continuous organic management prior to the milk or milk products they produce being labeled as organic. Based on the feed provisions in that proposal, producers would be required to provide a 100­ percent organic feed ration ( exclusive of National List substances allowed as feed 84 supplements and additives) for that entire year. Many producers, consumers, State certification programs, and certifying agents commented that the full year organic feed requirement created an insurmountable barrier for small and medium­ size dairy operations wishing to convert to organic production. They maintained that the added expense of a full year, 100­ percent organic feed requirement was economically prohibitive. These commenters stated that " new entry" or " whole herd" conversion provisions in existing certification standards have been instrumental in enabling established nonorganic dairies to make the transition to organic production. Commenters stated that these provisions typically allow producers to provide livestock 80­ percent organic or selfraised feed for the first 9 months of a herd's transition, before requiring 100­ percent organic feed for the final 3 months. Some commenters stated that many current organic dairies had capitalized on this whole herd conversion provision and that the consistent growth in demand for organic milk and milk products reflected consumer acceptance of the principle. At its June 2000 meeting, the NOSB reiterated its prior endorsement of the conversion principle for operations that jointly convert dairy herds and the land on which they are raised. The NOSB recommended allowing a producer managing an entire, distinct herd to provide 80­ percent organic or self­ raised feed during the first 9 months of the final year of conversion, and 100­ percent organic feed for the final 3 months. The recommendation further required that dairy animals brought onto an organic dairy must be organically raised form the last third of gestation, except that feed produced on land managed under an organic system plan could be fed to young stock up to 12 months prior to milk production. While the preponderance of comments supported the whole herd conversion provision, a significant number of individuals, certifying agents, and State certification programs opposed it. 85 Some commenters felt that requiring less than 1 full year of 100­ percent organic feed would not satisfy consumer expectations for an organically managed dairy. Other commenters stated that the whole herd conversion merely favored one segment of organic producers over another. They maintained that the full year, 100­ percent organic feed requirement would stimulate markets for organically produced hay and grain, thereby rewarding good row crop rotation. One certifying agent was concerned that the conversion provision would create a permanent exemption and that split operation dairies could use it repeatedly to bring nonorganic animals into the organic operation. The final rule contains a provision for whole herd conversion that closely resembles those found in the NOSB recommendation and the existing certification standards. The final rule requires that an entire, distinct dairy herd must be under organic management for 1 year prior to the production of organic milk. During the first 9 months of that year, the producer must provide a feed ration containing a minimum of 80­ percent organic feed or feed that is raised from land included in the organic system plan and managed in compliance with organic crop requirements. The balance of the feed ration may be nonorganically produced, but it must not include prohibited substances including antibiotics or hormones. The producer must provide the herd 100­ percent organic feed for the final 3 months before the production of organic milk. The producer must comply with the provisions in the livestock health and living conditions practice standard during the entire year of conversion. After the dairy operation has been certified, animals brought on to the operation must be organically raised from the last third of gestation. We did not incorporate the NOSB's recommendation to provide young stock with nonorganic feed up to 12 months prior to the production of certified milk. By creating an ongoing allowance for using nonorganic feed 86 on a certified operation, this provision would have undermined the principle that a whole herd conversion is a distinct, one­ time event. We anticipate that the provisions added to the final rule will address the concerns of commenters who objected to the conversion principle. Consumers have embraced milk and milk products from dairies certified under private whole herd conversion provisions essentially identical to that in the final rule. While the conversion provision may temporarily reduce demand for organic feed materials, it encourages producers to develop their own supplies of organic feed. The conversion provision also rewards producers for raising their own replacement animals while still allowing for the introduction of animals from off the farm that were organically raised from the last third of gestation. This should protect existing markets for organically raised heifers while not discriminating against closed herd operations. Finally, the conversion provision cannot be used routinely to bring nonorganically raised animals into an organic operation. It is a one­ time opportunity for producers working with a certifying agent to implement a conversion strategy for an established, discrete dairy herd in conjunction with the land resources that sustain it. ( 2) Organic Management for Livestock from the Last Third of Gestation. The proposed rule required that organically managed breeder and dairy stock sold, labeled, or represented as organic slaughter stock must be under continuous organic management from birth. Many commenters stated that this requirement was an inappropriate relaxation of most existing organic standards, which require organic management for all slaughter stock from the last third of gestation. These commenters cited the NOSB's 1994 recommendation that all slaughter stock must be the progeny of breeder stock under organic management from the last third of gestation or longer. Commenters also recommended extending the organic management provision to cover 87 the last third of gestation to make it consistent with the requirements in section 205.236( a)( 4) for the organically raised offspring of breeder stock. We agree with the argument presented by commenters and have changed the final rule to require that breeder or dairy stock be organically raised from the last third of gestation to be sold as organic slaughter stock. ( 3) Conversion Period for Nonedible Livestock Products. The proposed rule required that livestock must be under continuous organic management for a period not less than 1 year before the nonedible products produced from them could be sold as organic. Several commenters questioned the basis for creating different origin of livestock requirements based on whether the operation intended to produce edible or nonedible products. These commenters stated that the OFPA does not sanction such a distinction, nor is it contained in existing certification standards. They questioned why the proposed rule created such a provision in the absence of a favorable NOSB recommendation. We agree that the creation of a separate origin of livestock requirement for animals intended to provide nonedible products could be confusing. We have changed this provision in the final rule to require that nonedible products be produced from livestock that have been organically managed from the last third of gestation. ( 4) Provisions for Feed Supplements and Feed Additives. The proposed rule provided that nonagricultural products and synthetic substances included on the National List could be used as feed additives and supplements. Many commenters stated that allowing nonagricultural products and synthetic substances as feed supplements contradicted the definition for " feed supplement" found in the proposed rule. That definition stipulated that a feed supplement must, itself, be a feed material, and the definition for " feed" in the proposed rule precluded using nonagricultural products and synthetic substances. These commenters requested that either the 88 definition of " feed supplement" be changed to make it consistent with the allowance for nonagricultural products and synthetic substances or else that the term be dropped from the final rule. The Food and Drug Administration ( FDA) recommended modifying the definitions for " feed additive" and " feed supplement" and further specifying the components required in a feed ration under the livestock health care practice standard. We amended the definition in the final rule to state that a feed supplement is " a combination of feed nutrients added to livestock feed to improve the nutritional balance or performance of the total ration." We retained the second component of the proposed definition, which described how a feed supplement could be offered to livestock. We amended the definition of " feed additive" to " a substance added to feed in micro quantities to fulfill a specific nutritional need; i. e., essential nutrients in the form of amino acids, vitamins, and minerals." The definitions for " feed supplement" and " feed additive" in the proposed rule were originally recommended by the NOSB. While our intent in the proposed rule was to codify as fully as possible the recommendations of the NOSB, we agree with commenters that the proposed definitions were was incompatible with the overall provisions for livestock feed. The definitions in the final rule are consistent with the NOSB's objective to create clear distinctions between feed, feed supplements, and feed additives while clarifying the role for each within an organic livestock ration. We also incorporated FDA's recommendation to include protein and/ or amino acids, fatty acids, energy sources, and fiber for ruminants as required elements of a feed ration in the livestock health care practice standard. These additions make the livestock health care practice standard more consistent with the National Research Council's Committee on Animal Nutrition's Nutrient Requirement series, which we cited in the proposed rule as the basis for feed requirements. 89 Many commenters addressed provisions in the proposed rule to allow or prohibit specific materials and categories of materials used in livestock feed. Among these, some commenters questioned whether enzymes were defined as a feed additive and, therefore, allowed. One certifying agent requested guidance on the status of supplementing livestock feed with amino acids. At its October 1999 meeting, the NOSB discussed the Technical Advisory Panel ( TAP) reviews on the use of enzymes and amino acids in livestock feed. The NOSB determined that natural sources of enzymes exist and that their use should be allowed in organic production. Their discussion of natural sources of enzymes concluded that enzymes derived from edible, nontoxic plants and nonpathogenic bacteria or fungi that had not been genetically engineered should be allowed as a nonorganic feed additive. The NOSB did not take a position on amino acids during this meeting but indicated that it would revisit the subject in the near future. Based on these recommendations, the final rule allows the use of natural enzymes but not amino acids as nonorganic feed additives. The NOSB's recommendation that natural sources of enzymes existed and were compatible with organic livestock production supports allowing them without adding them to the National List. Some commenters discussed the animal welfare and environmental benefits associated with providing amino acids in livestock feed and supported allowing them. However, without a recommendation from the NOSB that amino acids are natural or should be added to the National List as a synthetic, the final rule does not allow their use. Commenters questioned whether nonsynthetic but nonagricultural substances, such as ground oyster shells and diatomaceous earth, would be allowed in agricultural feed. In 1994, the NOSB recommended that natural feed additives can be from any source, provided that the additive is not classified as a prohibited natural on the National List. We agree with this 90 recommendation and have amended the final rule to allow such materials as feed additives and supplements. The only additional constraint on these materials is that every feed, feed additive, and feed supplement be used in compliance with the Federal Food, Drug, and Cosmetic Act, as stated in section 205.237( b)( 6). The NOSB recommended that ruminants maintained under temporary confinement must have access to dry, unchopped hay. Although this position was an NOSB recommendation and not part of the proposed rule, several commenters responded to it. Most of these commenters stated that the language was too restrictive and could preclude the use of many suitable forage products. One dairy producer stated that the requirement would not be practical for operations that mix hay with other feed components. We agree that the NOSB's proposed language is too prescriptive and have not included it in the final rule. ( 5) Provisions for Confinement. The proposed rule established the health, nutritional, and behavioral needs of the particular species and breed of animal as the primary considerations for determining livestock living conditions. The proposed rule also identified essential components of the practice standard, including access to shade, shelter, exercise areas, fresh air, and direct sunlight, while stating that species­ specific guidelines would be developed in conjunction with future NOSB recommendations and public comment. Finally, the proposed rule outlined the conditions pertaining to animal welfare and environmental protection under which producers could temporarily confine livestock. While supportive of the underlying principles of this practice standard, the vast majority of commenters stated that the actual provisions suffered from a lack of clarity and specificity. Many commenters were concerned that the proposed rule did not adequately ensure access to the 91 outdoors for all animals. While supportive of the access to pasture requirement for ruminant production, commenters stated that the final rule needed a clear definition of pasture to make the provision meaningful. Conversely, some commenters supported the less prescriptive approach adopted in the proposed rule. The NOSB added considerably to its earlier recommendations on livestock living conditions during its June 2000 meeting. Many commenters stated that the criteria identified as required elements in the provisions for livestock living conditions did not specifically include access to the outdoors. One commenter stated that the requirement that animals receive direct sunlight could be interpreted to simply require windows in livestock confinement facilities. Commenters were virtually unanimous that, except for the limited exceptions for temporary confinement, all animals of all species must be afforded access to the outdoors. Commenters also maintained that the outdoor area must accommodate natural livestock behavior, such as dust wallows for poultry and, in the case of ruminants, provide substantial nutrition. Many commenters specifically opposed dry lots as an allowable outdoor environment. The NOSB recommended that the final rule state that all livestock shall have access to the outdoors. As a result of these comments, we have revised the final rule to establish that access to the outdoors is a required element for all organically raised livestock. We further amended the final rule to include a definition of " pasture." The definition of " pasture" we included emphasizes that livestock producers must manage their land to provide nutritional benefit to grazing animals while maintaining or improving the soil, water, and vegetative resources of the operation. The producer must establish and maintain forage speciesappropriate for the nutritional requirements of the species using the pasture. 92 Numerous commenters requested clarification on species­ specific living conditions, such as the use of cages for poultry and confinement systems for veal production. The use of continuous confinement systems including cages for poultry and veal production is incompatible with the requirement that organically raised livestock receive access to the outdoors and the ability to engage in physical activity appropriate to their needs. There will be times when producers must temporarily confine livestock under their care, but these instances must be supported by the exemptions to the outdoor access requirement included in the final rule. Other commenters requested additional guidance on whether confinement for the purpose of finishing slaughter stock would be allowed, and, if so, how long that confinement could last. Commenters who supported an allowance for finishing most often recommended that, in the case of cattle, confinement should not exceed 90 days. The final rule does not include a specific length of time that cattle or other species may be confined prior to slaughter. We will seek additional input from the NOSB and public comment before developing such standards. Several commenters questioned whether a Federal, State, or local regulation that required confinement would supersede the requirement for outdoor access. These commenters were aware of county ordinances that prohibited free ranging livestock production to protect water quality. Organic operations must comply with all Federal, State, and local regulations. At the same time, to sell, label, or represent an agricultural commodity as " 100 percent organic," " organic," or " made with...," the producer or handler must comply with the all applicable requirements set forth in this regulation. Federal, State, or local regulations that prohibit a required practice or require a prohibited one will essentially preclude organic certification of the affected commodity within that jurisdiction. 93 ( 6) Prohibition on Parasiticides During Lactation. The proposed rule provided that breeder stock could receive synthetic parasiticides included on the National List, provided that the treatment occurred prior to the last third of gestation for progeny that were to be organically managed. Many commenters supported this principle but were concerned that the wording would allow producers to administer parasiticides to lactating breeder stock while the offspring were still nursing. These commenters felt that such an allowance violated the intent of the provision because offspring could be exposed to systemic parasiticides or their residues through their mother's milk. The NOSB recommended a prohibition on using allowed synthetic parasiticides during lactation for progeny that are organically managed. We agree with these commenters and have modified the final rule to prohibit the treatment of organically managed breeder stock with allowed synthetic parasiticides during the last third of gestation or lactation. Livestock Production ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Prohibition on Factory Farms. Many commenters requested that the final rule prohibit the certification of " factory farms." These commenters stated that factory farms are dependent upon practices and materials that are inconsistent with or expressly prohibited in the OFPA. The final rule does not contain such a prohibition because commenters did not provide a clear, enforceable definition of " factory farm" for use in the final rule. All organic operations, regardless of their size or other characteristics, must develop and adhere to an approved organic system plan that complies with these regulations in order to be certified. ( 2) Nonorganic Feed Protocol. The proposed rule required that, except for 94 nonagricultural products and synthetic substances included on the National List, a producer must provide livestock with a total feed ration composed of agricultural feed products, including pasture and forage, that is organically produced and, if applicable, handled. It also included provisions for temporary variances that, under very limited circumstances and with the approval of the certifying agent and the Administrator, would provide an exemption from specific production and handling standards. The preamble of the proposed rule described an emergency resulting in the unavailability of organic agricultural feed products as an example of a situation in which a temporary variance could be issued. Many commenters recommended that the final rule require a producer who received a temporary variance for a feed emergency to follow the order of preference for noncertified organic feed developed by the NOSB. This order of preference requires a producer to procure agricultural feed products from sources that are as close to complying with the standards for organic certification as possible. Commenters stated that adherence to the order of preference would most closely conform with the expectation of consumers that organically raised livestock received organic feed and would create an incentive for livestock feed producers to pursue certification. We have not included the NOSB's feed emergency order of preference in the final rule because it would be too prescriptive and difficult to enforce during an emergency. Receiving a temporary variance categorically exempts a producer from the provision for which it was issued, although that producer may not substitute any practice, material, or procedure that is otherwise prohibited, although that producer may not substitute any practice, material, or procedure that is otherwise prohibited under section 205.105 . Additionally, certified organic feed is far more available in terms of quantity and affordability than when the NOSB developed its order of 95 preference in 1994. We anticipate that producers whose original supply of organic agricultural feed products is interrupted will be able to fill the shortfall through the marketplace. ( 3) Prohibition on Physical Alterations. The proposed rule required that producers perform physical alterations as needed to promote animal welfare and in a manner that minimizes pain and stress. This provision was one component of the health care practice standard that required producers to establish and maintain preventive livestock health care practices. We stated in the preamble that there was insufficient consensus from previous public comment to designate specific physical alterations as allowed or prohibited and envisioned working with producers, certifying agents, and consumers to achieve that goal. We requested comment on techniques to measure animal stress that could be used to evaluate whether specific physical alterations were consistent with the conditions established in the proposed rule. We received significant numbers of comments both opposing and supporting the provision in the proposed rule for performing physical alterations. Many commenters opposed any allowance for physical alterations and argued that such practices are cruel and debilitating to animals. These commenters maintained that modifications in breed selection, stocking densities, and the configuration of living conditions could achieve results similar to physical alterations without harming the animal. They stated that by adapting their production systems to promote the physical and psychological welfare of animals, producers could obviate the need for physical alterations. In particular, commenters cited physical alterations to the beaks and feet of poultry as unnecessary due to the availability of alternative production systems. Many commenters expressed concern that the allowance for physical alterations would facilitate the certification of large confinement operations. Commenters also stated that performing physical alterations was 96 inconsistent with Codex guidelines and objected to the allowance before full public deliberation on the subject through the NOSB process. A large number of commenters stated that, if reasonable guidelines could be established, the allowance for physical alterations would be a beneficial, and even necessary, condition for organic livestock production. These commenters maintained that producers engage in physical alterations for the overall welfare of the flock or herd and that the pain and stress of performing them must be weighed against the pain and stress of not doing so. For example, these commenters cited the traumatic effect of cannibalism on poultry flocks that had not undergone beak trimming or the injuries caused by animals whose horns had not been removed. Many of these commenters stated that producers could reduce but not eliminate the need for physical alterations through alternative production practices such as breed selection and stocking densities. The NOSB supported the provision as written in the proposed rule, stating that it met the animal welfare requirements while allowing practices necessary for good animal husbandry. We have retained the proposed provision for physical alterations without taking any further position on whether specific practices are allowed or prohibited. We did not receive substantial new guidance on techniques to measure stress in animals due to physical alterations and have made no revisions in that regard. The final rule establishes that, when appropriately performed and within the context of an overall management system, specific physical alterations are allowed. It also mandates that, as an element of a preventative health care program, physical alterations must benefit the ultimate physical and psychological welfare of the affected animal. ( 4) Withdrawal for Synthetic Parasiticides in Lactating Livestock. The proposed rule required a 90­ day withdrawal period before milk and milk products produced from livestock 97 treated with an allowed synthetic parasiticide could be labeled as organic. Referencing the statement in the preamble to the proposed rule that the 90­ day withdrawal period was attributable to " consumer expectations of organically raised animals," a dairy producer commented that the provision ignored animal welfare and farm economic sustainability considerations. The commenter considered the 90­ day withdrawal period capricious and problematic since, for bovine dairy operations, it would compel producers to either shorten an animal's natural drying off period, or lose 30 days of organic milk production. The commenter stated that the optimal extended withdrawal period for this situation would be 60 days since this is the approximate duration of a dairy cow's natural dry period. Under this approach, livestock requiring treatment could receive an allowed synthetic parasiticide at the time of drying off, thus allowing the withdrawal period to coincide with the natural 60­ day period when the livestock were not lactating. Livestock could complete the withdrawal period prior to the birth of their offspring in approximately 60 days, at which time the mother's milk could again be sold as organic. The commenter maintained that the 60­ day period would satisfy consumer expectation for an extended withdrawal period after treatment with an allowed synthetic parasiticide without imposing an unnecessary constraint on the producer. We have retained the 90­ day withdrawal period in the final rule. The provisions in the final rule for treating livestock with an allowed synthetic parasiticide reflect the 90­ day withdrawal period recommended by the NOSB at its October 1999 meeting. The NOSB has the authority to reconsider this issue and propose an alternative annotation for the Secretary's consideration. ( 5) Delineation of Space Requirements for Animal Confinement. The proposed rule did not establish space requirements for livestock living conditions but stated that a producer must 98 accommodate the health and natural behavior of animals under his or her care. Some commenters stated their preference for space requirements because they are more uniform and enforceable. These commenters stated that some existing certification standards include space requirements in standards for livestock living conditions and that Codex guidelines support this approach. While not disagreeing that space requirements could be an effective certification tool for organic livestock production systems, we have not incorporated any such provisions in the final rule. We anticipate that additional NOSB recommendations and public comment will be necessary for the development of space requirements. At its June 2000 meeting, the NOSB agreed that it would be premature to include space requirements in the final rule. ( 6) Access to pasture versus pasture­ based. Commenters stated that the proposed rule's requirement that ruminants receive " access to pasture" did not sufficiently characterize the relationship that should exist between ruminants and the land they graze. Many of these commenters recommended that the final rule require that ruminant production be " pasture­ based." Many commenters stated that the final rule needed a more explicit description of the relationship between livestock and grazing land. The NOSB shared this perspective and recommended that the final rule require that ruminant production systems be " pasture­ based." In contrast, an organic dairy producer maintained that a uniform, prescriptive definition of pasture would not be appropriate in a final rule. This commenter stated that the diversity of growing seasons, environmental variables, and forage and grass species could not be captured in a single definition and that certifying agents should define pasture on a case­ by­ case basis. This commenter also disagreed with the " pasture­ based" requirement, stating that pasture should be only one of several components of balanced livestock nutrition. Singling out pasture as the foundation for ruminant 99 management would distort this balance and deprive other producers of the revenue and rotation benefits they generate by growing livestock feed. We retained the " access to pasture" requirement because the term, " pasture­ based," has not been sufficiently defined to use for implementing the final rule. The final rule does include a definition for pasture, and retention of the " access to pasture" provision provides producers and certifying agents with a verifiable and enforceable standard. The NOP will work with the NOSB to develop additional guidance for managing ruminant production operations. ( 7) Stage of Production. The proposed rule contained provisions for temporary confinement, during which time livestock would not receive access to the outdoors. Many commenters were concerned that the stage­ of­ production justification for temporary confinement could be used to deny animals access to the outdoors during naturally occurring life stages, including lactation. Commenters overwhelmingly opposed such an allowance and stated that the stage of production exemption should be narrowly applied. One commenter stated that a dairy operation, for example, might have seven or eight distinct age groups of animals, with each group requiring distinct living conditions. Under these circumstances, the commenter maintained that a producer should be allowed to temporarily house one of these age groups indoors to maximize use of the whole farm and the available pasture. At its June 2000 meeting, the NOSB stated that the allowance for temporary confinement should be restricted to short­ term events such as birthing of newborn or finish feeding for slaughter stock and should specifically exclude lactating dairy animals. We have not changed the provision in the final rule for the stage­ of­ production allowance in response to these comments. The NOSB has supported the principle of a stage­ of­ production 100 allowance but has not provided sufficient guidance for determining, on a species­ specific basis, what conditions would warrant such an allowance. Without a clearer foundation for evaluating practices, we have not identified any specific examples of practices that would or would not warrant a stage­ of­ production allowance. We will continue to explore with the NOSB specific conditions under which certain species could be temporarily confined to enhance their well­ being. In the final rule, temporary confinement refers to the period during which livestock are denied access to the outdoors. The length of temporary confinement will vary according to the conditions on which it is based, such as the duration of inclement weather. The conditions for implementing temporary confinement for livestock do not minimize the producer's ability to restrain livestock in the performance of necessary production practices. For example, it is allowable for a producer to restrain livestock during the actual milking process or under similar circumstances, such as the administration of medication, when the safety and welfare of the livestock and producer are involved. Handling ­ Changes Based on Comments The following changes are made based on comments received. ( 1) Commercial Availability. A large number of commenters, including organic handlers and certifying agents, stated that " commercial availability" must be included as a requirement for the 5 percent of nonorganic ingredients that are used in products labeled " organic." We agree and have added a commercial availability requirement as part of a handler's organic system plan under section 205.201 of this subpart. Up to 5 percent ( less water and salt) of a product labeled " organic," may be nonorganic agricultural ingredients. However, handlers must document that organic forms of the nonorganic ingredients are not commercially available 101 before using the nonorganic ingredients. ( 2) Prohibited Practices. Commenters were unclear about the extent of the prohibition on use of excluded methods and ionizing radiation. To make that prohibition clear, we have moved the handling prohibitions in proposed rule sections 205.270 ( c) to 205.105, Applicability, subpart B. Paragraphs ( c)( 1) and ( c)( 2) which listed excluded methods and ionizing radiation in the proposed rule are combined into paragraph ( c)( 1) that cross­ references new section 205.105. ( 3) Use of Predator Pests and Parasites. Paragraph ( b)( 1) of section 205.271 proposed that predator pests and parasites may be used to control pests in handling facilities. Under FDA's Good Manufacturing Practice, 21 CFR part section 110.35( c), it states that " No pests shall be allowed in any area of a food plant." Some commenters believed use of predator pests in handling facilities is prohibited by the FDA regulation. Other commenters stated that predator pests could be used in certain handling facilities under the FDA regulation. One commenter claimed that the FDA regulation in 21 CFR part 110.19 allows exemptions for certain establishments that only harvest, store, or distribute raw agricultural product. Another commenter suggested that use of predator pests should be allowed when FDA does not prohibit their use. We do not intend to be inconsistent with the FDA requirement and, thus, have removed proposed paragraph ( b)( 1) of section 205.271. Use of predator pests in various organic handling and storage areas is subject to FDA's Good Manufacturing Practice. Paragraphs ( b)( 2) and ( b)( 3) are redesignated. ( 4) Use of Synthetic Pheromone Lures. Proposed paragraph ( b)( 3) provided for use of nonsynthetic lures and repellant. A few handlers and certifying agents commented that nearly all pheromone lures use synthetic substances. Because pheromone lures do not come into contact 102 with products in a handling facility, commenters argued that such lures should be allowed, provided that the synthetic substance used is on the National List. We agree and have added " synthetic substances" to redesignated paragraph ( b)( 2) for use in lures and repellents. The synthetic substances used must be consistent with the National List. ( 5) Restrict Initial Use of Synthetics to National List Substances. Paragraph ( c) in the proposed rule provided for use of any synthetic substance to prevent or control pests. Several handlers and certifying agents stated that use of nonsynthetic and synthetic substances should initially be limited first to substances which are allowed on the National List. This would mean that substances not allowed for use on the National List could not be used initially to control or prevent pest infestations. We agree with these comments. Use of allowed substance before use of other substances is a fundamental principle of organic agriculture. Therefore, if preferred practices under paragraphs ( a) and ( b) are not successful in preventing or controlling pest infestations, handlers may then use, under amended paragraph ( c), only nonsynthetic or synthetic substances which are allowed for use on the National List. We have removed the proviso that applications of a pest control substance must be consistent with the product's label instructions. This requirement is readily understood and does not need to be explicitly stated in the regulations. Because paragraph ( c) now provides for use only of allowed National List substances, a new paragraph ( d) is added to allow for use of other synthetic substances, including synthetic substances not on the National List, to prevent or control pest infestations. These substances may be used only if the practices in paragraphs ( a), ( b), and ( c) are ineffective. Before the substance is 103 used, the handler and the operation's certifying agent must agree on the synthetic substance to be used and the measures to be taken to prevent contact of the substance with organic products and ingredients in the facility. We expect that this communication can be accomplished with telephone calls or by electronic means. This regulation does not preempt Federal, State, or local health and sanitation requirements. We recognize that inspectors who monitor compliance with those regulations may require immediate intervention and use of synthetic substances, not on the National List, before or at the same time as the methods specified in paragraphs ( b) and ( c). Therefore, to make this clear, we have added a new paragraph ( f). To ensure that the use of the substances does not destroy a product's organic integrity, we are requiring that the handler take appropriate measures to prevent contact of the product with the pest control substance used. ( 6) Preventing Contact with Prohibited Substances. Commenters recommended that, if prohibited substances are applied by fogging or fumigation, the organic product and packaging material must be required to be completely removed from the facility and reentry of the product or packaging be delayed for a period three times longer than that specified on the pesticide label. Commenters believed removal and reentry should be mandatory, regardless of the organic product or container. We understand the commenters' concerns. However, their recommendations are not appropriate for all pest infestations. We believe that measures needed to be taken to prevent contact with a synthetic substance must be determined on a case­ by­ case basis by the handler and certifying agent. As stated earlier, new paragraph ( d) of section 205.271 requires a handler and certifying agent to agree on control and prevention measures prior to application of a synthetic 104 substance. We believe that such an agreement will help safeguard a product's organic integrity. Use of a synthetic substance in fogging or fumigation should be based on, among other things, location of the pest relative to the organic products in the facility; the extent of the pest infestation; the substance and application method to be used; the state of the organically produced product or ingredient ( raw, unpackaged bulk, canned, or otherwise sealed); and health and sanitation requirements of local, State, and Federal authorities. Paragraph ( e) is changed to clarify that an operation's organic handling plan must be updated to document all measures taken to prevent contact between synthetic pest control substances and organically produced products and ingredients. ( 7) Repetitive Use of Pest Control Measures. One commenter suggested a change in the paragraph ( e) requirement that handlers' organic plans must include " an evaluation of the effects of repetitive use" of pest prevention and control materials. The commenter believed that the requirement was excessive and beyond what should be expected of handlers. The commenter indicated that handlers' organic plans should address the " techniques that will be used to minimize" the negative effects of repetitive use of pest control materials. We agree that " an evaluation of the effects of repetitive use" is more than what is reasonable to expect of handlers in their organic plans. We do not agree, however, that an organic plan should be required to address the " techniques" used to minimize the effects of repetitive use of pest control materials. However, we believe that handlers should update their organic handling plans to account for the use of pest control or prevention substances, particularly if the substances are prohibited substances. The update should include a description of the application methods used and the measures taken to prevent contact between the substance used 105 and the organic product. We have added these requirements in redesignated paragraph ( e). Proposed paragraph ( e) of section 205.271 is removed. Handling ­ Changes Requested But Not Made ( 1) Exceptions to Handling Processes. A commenter stated that many herbal products are extracted from organically produced herbs but that the extraction of those products " can employ significantly different methods than those used in the manufacture of more traditional foods." To be labeled as " organic" ingredients, substances such as herbs, spices, flavorings, colorings, and other similar substances, must be derived from a certified organic source and be extracted without the use of prohibited substances. ( 2) Allowed Synthetics Used in Packaging Materials and Storage Containers. A State department of agriculture commented that section 205.272( b)( 1) prohibits use of synthetic fungicides, preservatives, or fumigants in packaging materials and storage containers or bins. The comment stated that it is inconsistent to permit use of allowed substances as ingredients in processed products but prohibit their use as a preservative or fumigant in the packaging materials and storage containers and bins. The commenter suggested that paragraph ( b)( 1) be amended to permit use of National List­ allowed substances in section 205.605, particularly carbon dioxide and ozone, in packaging materials and storage containers or bins. We understand the commenter's concern. However, section 6510( a)( 5) of the Act specifically prohibits use of any packaging materials, storage containers, or bins that contain synthetic fungicides, preservatives, or fumigants. ( 3) Additional Measures to Prevent Product Contamination. A few commenters suggested changing paragraph ( e) of section 205.271 to require that handlers' organic handling 106 plans specify measures that would be taken to prevent contact between a pest control substance and " packaging materials." This would be in addition to measures preventing contamination of " any ingredient or finished product" in the handling facility. We understand the commenters' objective. However, for the reasons stated earlier in regard to commenters' request that mandatory removal of product during pest control treatment be required, we believe that such a requirement should not be mandatory for all packaging materials. Measures to prevent contamination of packaging material should be left to the handler and certifying agent to specify in the handling plan. Handling ­ Clarifications Clarification is given on the following issues raised by commenters. ( 1) Use of Nonorganic Ingredients in Processed Products. We have corrected paragraph ( c) of section 205.270 to clarify what must not be used in or on organically produced ingredients and nonorganically produced ingredients used in processed organic products. The prohibition on use of ionizing radiation, excluded methods, and volatile synthetic solvents applies to all organically produced ingredients. The 5 percent of nonorganic ingredients in products labeled " organic," also are subject to the three prohibited practices. The nonorganic ingredients in products labeled " made with organic ingredients" must not be produced using ionizing radiation or excluded methods but may be produced using volatile synthetic solvents. The nonorganic ingredients in products containing less than 70 percent organically produced ingredients may be produced and processed using ionizing radiation, excluded methods, and synthetic solvents. ( 2) Water Quality Used in Processing. A handler questioned whether public drinking water containing approved levels of chlorine, pursuant to the Safe Drinking Water Act, is 107 acceptable for use in processing products labeled " 100 percent organic." Water meeting the Safe Drinking Water Act may be used in processing any organically produced products. Temporary Variances ­ Changes Based on Comments Additional Causes for Issuing Temporary Variance. A few State department of agriculture commenters suggested that " drought" should be added to the regulatory text as a natural disaster warranting a temporary variance from regulations. We agree and have added drought to the regulatory text in paragraph ( a)( 2) of section 205.290. We have also added " hail" as a natural disaster warranting a temporary variance. Both drought and hail were mentioned in the preamble of the proposed rule but were unintentionally left out of the regulatory text. Temporary Variances ­ Changes Requested But Not Made Allowance of Temporary Variances. A few commenters suggested that SOP's governing State officials should be able to authorize temporary variances due to local natural disasters which may occur in a State. We do not agree that with these comments. For consistency of application, we believe that only the Administrator should have the authority to grant a temporary variance. Citing local conditions, an SOP's governing State official and certifying agents may recommend a temporary variance to the Administrator. We are committed to providing quick responses to such recommendations. Subpart D ­ Labels, Labeling, and Market Information The Act provides that a person may sell or label an agricultural product as organically produced only if the product has been produced and handled in accordance with provisions of the Act and these regulations. This subpart sets forth labeling requirements for organic agricultural 108 products and products with organic ingredients based on their percentage of organic composition. For each labeling category, this subpart establishes what organic terms and references can and cannot be displayed on a product package's principal display panel ( pdp), information panel, ingredient statement, and on other package panels. Labeling requirements also are established for organically produced livestock feed, for containers used in shipping and storing organic product, and for denoting organic bulk products in market information which is displayed or disseminated at the point of retail sale. Restrictions on labeling organic product produced by exempt operations are established. Finally, this subpart provides for a USDA seal and regulations for display of the USDA seal and the seals, logos, or other identifying marks of certifying agents. The intent of these sections is to ensure that organically produced agricultural products and ingredients are consistently labeled to aid consumers in selection of organic products and to prevent labeling abuses. These provisions cover the labeling of a product as organic and are not intended to supersede other labeling requirements specified in other Federal labeling regulations. The Food and Drug Administration ( FDA) regulates the placement of information on food product packages in 21 CFR parts 1 and 101. USDA's Food Safety and Inspection Service's ( FSIS) Federal Meat Inspection Act, Poultry Products Inspection Act, and Egg Products Inspection Act have implementing regulations in 9 CFR part 317 which must be followed in the labeling of meat, poultry, and egg products. The Federal Trade Commission ( FTC) regulations under the Fair Packaging and Labeling Act ( FLPA) in 16 CFR part 500 and the Alcohol Tobacco and Firearms ( ATF) regulations under the Federal Alcohol Administration Act ( FAA) in 27 CFR parts 4, 5, and 7, also must be followed, as applicable to the nature of the product. The labeling requirements specified in this subpart must be implemented in a manner so that they do not 109 conflict with the labeling requirements of these and other Federal labeling requirements. While this regulation does not require labeling of an organic product as organic, we assume that producers and handlers choose to label their organic products and display the USDA seal to the extent allowed in these regulations. They do this to improve the marketability of their organic product. Under the National Organic Program ( NOP), the assembly, packaging, and labeling of multiingredient organic products are considered handling activities. The certification of handling operations is covered in subpart C of this regulation. No claims, statements, or marks using the term, " organic," or display of certification seals, other than as provided in this regulation, may be used. Based on comments received, several important labeling changes from the proposed rule are made in this final rule. ( 1) The term, " organic," cannot be used in an agricultural product name if it modifies an ingredient that is not organically produced ( e. g., " organic chocolate ice cream" when the chocolate flavoring is not organically produced). ( 2) The 5 percent or less of nonorganic ingredients in products labeled " organic" must be determined not " commercially available" in organic form. ( 3) Display of a product's organic percentage is changed from required to optional for " organic" and " made with ..." products. ( 4) The minimum organic content for " made with..." products is increased from 50 percent to 70 percent. ( 5) In addition to listing individual ingredients, the " made with..." label may identify a food group on the label (" made with organic fruit"). ( 6) A new section is added to provide labeling of livestock feed that is organically produced. ( 7) Finally, a revised design for the USDA seal is established. In addition to these changes, we have made a few changes in the regulatory text for clarity and consistency purposes. These do not change the intent of the regulation. 110 Once a handler makes a decision to market a product as organic or containing organic ingredients, the handler is required to follow the provisions in this subpart regarding use, display, and location of organic claims and certification seals. Handlers who produce and label organic ingredients and/ or assemble multiingredient products composed of 70 percent or more organic ingredients must be certified as an organic handling operation. Handlers of products of less than 70 percent organic ingredients do not have to be certified unless the handler actually produces one or more of the organic ingredients used in the product. Repackers who purchase certified organic product from other entities for repackaging and labeling must be certified as an organic operation. Entities which simply relabel an organic product package are subject to recordkeeping requirements which show proof that the product purchased prior to relabeling was, indeed, organically produced and handled. Distributors which receive and transport labeled product to market are not subject to certification or any labeling requirements of this regulation. Many commenters appealed for " transition" or " conversion" labeling. This issue is discussed under Applicability in subpart B. Transition labeling is not provided for in the Act or the proposed rule and is not provided for in this regulation. Description of Regulations General Requirements The general labeling principle employed in this regulation is that labeling or identification of the organic nature of a product increases as the organic content of the product increases. In other words, the higher the organic content of a product, the more prominently its organic nature can be displayed. This is consistent with provisions of the Act which establish the three percentage categories for organic content and basic labeling requirements in those categories. 111 Section 205.300 specifies the general use of the term, " organic," on product labels and market information. Paragraph ( a) establishes that the term, " organic," may be used only on labels and in market information as a modifier of agricultural products and ingredients that have been certified as produced and handled in accordance with these regulations. The term, " organic," cannot be used on a product label or in market information for any purpose other than to modify or identify the product or ingredient in the product that is organically produced and handled. Food products and ingredients that are not organically produced and handled cannot be modified, described, or identified with the term, " organic," on any package panel or in market information in any way that implies the product is organically produced. Section 6519( b) of the Act provides the Secretary with the authority to review use of the term, " organic," in agricultural product names and the names of companies that produce agricultural products. While we believe that the term, " organic," in a brand name context does not inherently imply an organic production or handling claim and, thus, does not inherently constitute a false or misleading statement, we intend to monitor the use of the term in the context of the entire label. We will consult with the FTC and FDA regarding product and company names that may misrepresent the nature of the product and take action on a case­ by­ case basis. Categories of Organic Content Section 205.301 establishes the organic content requirements for different labeling provisions specified under this program. The type of labeling and market information that can be used and its placement on different panels of consumer packages and in market information is based on the percentage of organic ingredients in the product. The percentage must reflect the actual weight or fluid volume ( excluding water and salt) of the organic ingredients in the product. 112 Four categories of organic content are established: 100 percent organic; 95 percent or more organic; 70 to 95 percent organic; and less than 70 percent organic. 100 Percent Organic For labeling and market information purposes, this regulation allows a " 100 percent organic" label on: ( 1) agricultural products that are composed of a single ingredient such as raw, organically produced fruits and vegetables and ( 2) products composed of two or more organically produced ingredients, provided that the individual ingredients are, themselves, wholly organic and produced without any nonorganic ingredients or additives. Only processing aids which are, themselves, organically produced, may be used in the production of products labeled " 100 percent organic." With the exception of the description phrase " 100 percent" on the pdp, the labeling requirements for " 100 percent organic" products are the same as requirements for 95 percent organic products specified in section 205.303. Organic Products labeled or represented as " organic" must contain, by weight ( excluding water and salt), at least 95 percent organically produced raw or processed agricultural product. The organic ingredients must be produced using production and handling practices pursuant to subpart C. Up to 5 percent of the ingredients may be nonagricultural substances ( consistent with the National List) and, if not commercially available in organic form pursuant to section 205.201, nonorganic agricultural products and ingredients in minor amounts ( hereinafter referred to as minor ingredients) ( spices, flavors, colorings, oils, vitamins, minerals, accessory nutrients, incidental food additives). The nonorganic ingredients must not be produced using excluded methods, sewage sludge, or ionizing radiation. 113 Made with Organic Ingredients For labeling and market information purposes, the third category of agricultural products are multiingredient products containing by weight or fluid volume ( excluding water and salt) between 70 and 95 percent organic agricultural ingredients. The organic ingredients must be produced in accordance with subpart C and subpart G. Such products may be labeled or represented as " made with organic ( specified ingredients or food group( s))." By " specified," we mean the name of the agricultural product( s) or food group( s) forming the organic ingredient( s). Up to three organically produced ingredients or food groups may be named in the phrase. If one or more food groups are specified in the phrase, all ingredients in the product which belong to the food group( s) identified on the label must be organically produced. For the purposes of this labeling, the following food groups may be identified as organically produced on a food package label: beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, and vegetables. In addition, processed milk products ( butter, cheese, yogurt, milk, sour creams, etc.) also may be identified as a " milk products" food group. For instance, a vegetable soup made with 85 percent organically produced and handled potatoes, tomatoes, peppers, celery, and onions may be labeled " soup made with organic potatoes, tomatoes, and peppers" or, alternatively, " soup made with organic vegetables." In the latter example, the soup may not contain nonorganic vegetables. For the purposes of this labeling provision, tomatoes are classified, according to food use, as a vegetable. To qualify for this organic labeling, the nonorganic agricultural ingredients must be produced and handled without use of the first three prohibited practices specified in paragraph ( f) of section 205.301, but may be produced or handled using practices prohibited in paragraphs 114 ( f)( 4) through ( f)( 7). Because of the length of the labeling phrase " made with organic ( specified ingredients or food group( s))," such products are referred to in this preamble as " made with..." products. The labeling requirements for " made with..." products are specified in section 205.304. Product With Less Than 70 Percent Organic Ingredients The final labeling category covers multiingredient products with less than 70 percent organic ingredients ( by weight or fluid volume, excluding water and salt). The organic ingredients must be produced in accordance with subparts C and G. The remaining nonorganic ingredients may be produced, handled, and assembled without regard to these regulations ( using prohibited substances and prohibited production and handling practices). Organic labeling of these products is limited to the information panel only as provided in section 205.305. Products that fail to meet the requirements for one labeling category may be eligible for a lower labeling category. For example, if a product contains wholly organic ingredients but the product formulation requires a processing aid or less than 5 percent of a minor ingredient that does not exist in organic form, the product cannot be labeled " 100 percent organic" and must be labeled as " organic." If a multiingredient product is 95 percent or more organic but contains a prohibited substance in the remaining 5 percent, the product cannot be labeled as " organic," because of the presence of the prohibited substance, but may be labeled as a " made with..." product. Further, a handler who produces a " 100 percent organic" or " organic" product but chooses not to be certified under this program may only display the organic percentage on the information panel and label the ingredients as " organic" on the ingredient statement. The handler must comply with recordkeeping requirements in subpart E. 115 Livestock feed All agricultural ingredients used in raw and processed livestock feed that is labeled as " 100 percent organic" and " organic" must be organically produced and handled in accordance with the requirements of these regulations. The difference between the two labels is that feed labeled as " 100 percent organic" must be composed only of organically produced agricultural ingredients and may not contain nonorganic feed additives or supplements. The agricultural portion of livestock feed labeled as " organic" must contain only organically produced raw and processed agricultural ingredients and may contain feed additives and supplements in conformance with the requirements of section 205.237. Additionally, labeling of livestock feed containers must follow State livestock feed labeling laws. Prohibited Practices The labeling of whole products or ingredients as organic is prohibited if those products or ingredients are produced using any of the following production or handling practices: ( 1) ingredients or processing aids produced using excluded methods; ( 2) ingredients that have been produced using applications of sewage sludge; ( 3) ingredients that have been processed with ionizing radiation; ( 4) synthetic substances not on the National List; ( 5) sulfites, nitrates, or nitrites added to or used in processing of an organic product in addition to those substances occurring naturally in a commodity ( except the use of sulfites in the production of wine); ( 6) use of the phrase, " organic when available," or similar statement on labels or in market information when referring to products composed of nonorganic ingredients used in place of specified organic ingredients; and ( 7) labeling as " organic" any product containing both organic and nonorganic forms of an ingredient specified as " organic" on the label. 116 These seven prohibitions apply to the four labeling categories of products and are not individually repeated as prohibited practices in the following sections. Table 1, Prohibited Production and Handling Practices for Organic Labeling, shows how use of the seven prohibited practices affects the labeling of organically produced products and ingredients used in those products. 117 TABLE 1: PROHIBITED PRODUCTION AND HANDLING PRACTICES FOR LABELING CATEGORIES Organic and use label Use excluded methods Use sewage sludge Use ionizing radiation Use substances not on National List Contain added sulfites, nitrates, nitrites Use nonorganic ingredients and label " when available" Use both organic and nonorganic forms of same ingredient " 100 percent organic" Single/ multiingredients completely organic NO NO NO NO NO NO NO " Organic" Organic ingredients ( 95% or more) Nonorganic ingredients ( 5% or less) NO NO NO NO NO NO NO NO NO NO NO NO NO NO " Made with organic ingredients" Organic ingredients ( 70­ 95%) Nonorganic ingredients ( 30% or less) NO NO NO NO NO NO NO OK NO­ except wine OK NO NA* NO NA* Less­ than 70% organic ingredients Organic Ingredients ( 30% or less) Nonorganic Ingredients ( 70% or more) NO OK NO OK NO OK NO OK NO­ except wine OK NO NA* NO NA* * Not applicable, provided that the nonorganic ingredient is not labeled as " organic" on the ingredient statement and is not counted in the calculation of the product's organic percentage. 118 Calculating the Percentage of Organic Ingredients Section 205.302 specifies procedures for calculating the percentage, by weight or fluid volume, of organically produced ingredients in an agricultural product labeled or represented as " organic." The calculation is made by the handler at the time the finished product is assembled. The organic percentage of liquid products and liquid ingredients is determined based on the fluid volume of the product and ingredients ( excluding water and salt). When a product is identified on the pdp or the information panel as being reconstituted with water from a concentrate, the organic content is calculated on the basis of a single­ strength concentration. For products that contain organically produced dry and liquid ingredients, the percentage of total organic ingredients is based on the combined weight of the dry organic ingredient( s) and the weight of the liquid organic ingredient( s) ( excluding water and salt). For example, a product may be made using organically produced vegetable oils or grain oils or contain organic liquid flavoring extracts in addition to other organic and nonorganic ingredients. In such cases, the weight of the liquid organic oils or flavoring extracts, less any added water and salt, would be added to other solid organic ingredients in the product, and their combined weight would be the basis for calculating the percentage of organic ingredients. At the discretion of the handler, the total percentage of all organic ingredients in a food product may be displayed on any package panel of the product with the phrase, " contains X percent organic ingredients," or a similar phrase. If the total percentage is a fraction, it must be rounded down to the nearest whole number. The percentage of each organic ingredient is not required to be displayed in the ingredient statement. A certified operation that produces organic product may contract with another operation 119 to repackage and/ or relabel the product in consumer packages. In such cases, the repacker or relabeler may use information provided by the certified operation to determine the percentage of organic ingredients and properly label the organic product package consistent with the requirements of this subpart. Labeling " 100 Percent Organic" and " Organic" Products Section 205.303 includes optional, required, and prohibited practices for labeling agricultural products that are " 100 percent organic" or " organic." Products that are composed of wholly organic ingredients may be identified with the label statement, " 100 percent organic," on any package panel. Products composed of between 95 and 100 percent organic ingredients may be identified with the label statement " organic" on any package panel, and the handler must identify each organic ingredient in the ingredient statement. The handler may display the following information on the pdp, the information panel, and any other part of the package and in market information representing the product: ( 1) the term, " 100 percent organic" or " organic," as applicable to the content of the product; and ( 2) for products labeled " organic," the percentage of organic ingredients in the product. The size of the percentage statement must not exceed one­ half the size of the largest type size on the panel on which the statement is displayed. It also must appear in its entirety in the same type size, style, and color without highlighting; ( 3) the USDA seal; and ( 4) the seal, logo, or other identifying mark of the certifying agent ( hereafter referred to as " seal or logo") which certified the handler of the finished product. The seals or logos of other certifying agents which certified organic raw materials or organic ingredients used in the product also may be displayed, at the discretion of the finished product handler. If multiple organic ingredients are identified on the ingredient 120 statement, the handler of the finished product that combined the various organic ingredients must maintain documentation, pursuant to subpart B of this regulation. While certifying agent identifications can appear on the package with the USDA seal, they may not appear larger than the USDA seal on the package. There is no restriction on the size of the USDA seal as it may appear on any panel of a packaged product, provided that display of the Seal conforms with the labeling requirements of FDA and FSIS. If a product is labeled as " 100 percent organic" the ingredients may be identified with the term, " organic," but will not have to be so labeled because it is assumed from the 100 percent label that all ingredients are organic. For 95 percent­ plus products, each organically produced ingredient listed in the ingredient statement must be identified with the term, " organic," or an asterisk or other mark to indicate that the ingredient is organically produced. Water and salt cannot be identified as " organic" in the ingredient statement. The handler of these products also must display on the information panel the name of the certifying agent which certified the handling operation that produced the finished product. The handler may include the business address, Internet address, or telephone number of the certifying agent. This information must be placed below or otherwise near the manufacturer or distributor's name. Labeling Products " Made with Organic ( specified ingredients or food group( s))" With regard to agricultural products " made with..."­­ those products containing between 70 and 95 percent organic ingredients­­ this rule establishes, in section 205.304, the following optional, required, and prohibited labeling practices. Under optional practices, the " made with..." statement is used to identify the organically 121 produced ingredients in the product. The statement may be placed on the pdp and other panels of the package. The same statement can also be used in market information representing the product. However, the following restrictions are placed on the statement: ( 1) the statement may list up to three ingredients or food group commodities that are in the product; ( 2) the individually specified ingredients and all ingredients in a labeled food group must be organically produced and must be identified as " organic" in the ingredient statement on the package's information panel; ( 3) the statement cannot appear in print that is larger than one half ( 50 percent) of the size of the largest print or type appearing on the pdp; and ( 4) The statement and optional display of the product's organic percentage must appear in their entirety in the same type size, style, and color without highlighting. The following food groups can be specified in the " made with" labeling statement: fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, and vegetables. In addition, organically produced and processed butter, cheeses, yogurt, milk, sour cream, etc., may be identified as a " milk products" food group. For the purposes of this labeling, tomatoes are considered as vegetables, based on their use in a product. As noted immediately above, all of a product's ingredients that are in the specified food group( s) must be organically produced. Display of the " made with.." statement on other panels must be similarly consistent with the size of print used on those panels. These restrictions are in accordance with FDA labeling requirements and similar to the recommendations of the National Organic Standards Board ( NOSB). This provision helps assure that the " made with..." statement is not displayed in such a manner as to misrepresent the actual organic composition of the product. The USDA seal may not be displayed on the pdp of products labeled " made with organic 122 ingredients." However, at the handler's option and consistent with any contract agreement between the organic producer or handler and the certifying agent, the certifying agent's seal or logo may be displayed on the pdp and other package panels. Packages of " made with..." products may display on the pdp, information panel, or any package panel, the total percentage of organic ingredients in the product. Any organically produced ingredient, including any ingredient that is a member of a food group listed on the " made with..." statement, must be identified in the ingredient statement with the term, " organic." Alternatively, an asterisk or other mark may be placed beside each organically produced ingredient in the ingredients statement with an explanation that the mark indicates the ingredient is organically produced. The name of the certifying agent which certified the handler of the finished product must be displayed below or otherwise near the manufacturer or distributor's name. The statement may include the phrase, " Certified organic by..." or " Ingredients certified as organically produced by...." to help distinguish the certifying agent from the manufacturer or distributor. The handler may include the business address, Internet address, or telephone number of the certifying agent which certified the handler of the finished product. If the percentage of organic ingredients in the product is displayed, the handler who affixes the label to the product package is responsible for determining the percentage. The handler may use information provided by the certified operation in determining the percentage. As part of the certifying agent's annual certification of the handler, the certifier must verify the calculation and labeling of packages. Labeling Products with Less Than 70 Percent Organic Ingredients 123 Section 205.305 covers the final labeling category of packaged multiingredient agricultural products containing less than 70 percent organic ingredients. Handlers of " less than 70 percent" multiingredient products, who choose to declare the organic nature of their product, may do so only in the ingredient statement by identifying the organically produced ingredients with the term, " organic," or with an asterisk or other mark. If the handler identifies the ingredients that are organically produced, the handler also may declare the percentage of organic content in the product. The percentage may only be placed on the information panel so that it can be viewed in relation to the ingredient statement. Processed products composed of less than 70 percent organic content cannot display the USDA seal or any certifying agent's organic certification seal or logo anywhere on the product package or in market information. Handlers of such products are subject to this regulation in the following ways. Those handlers who only purchase organic and nonorganic ingredients and assemble a finished product of less than 70 percent organic content do not have to be certified as organic handlers. However, they are responsible for appropriate handling and storage of the organic ingredients ( section 205.101( a)( 3)) and for maintaining records verifying the organic certification of the ingredients used in the product ( section 205.101( c)). To the extent that the packaging process includes affixing the label to finished product package, those handlers are responsible for meeting the labeling requirements of this subpart. The nonorganic ingredients may be produced, handled, and assembled without regard to the requirements of this part. Table 2, Labeling Consumer Product Packages, provides a summary of the required and prohibited labeling practices for the four labeling categories. 124 TABLE 2: LABELING CONSUMER PRODUCT PACKAGES Labeling category Principle display panel Information panel Ingredient statement Other package panels " 100 percent Organic" ( Entirely organic; whole, raw or processed product) " 100 percent organic" ( optional) USDA seal and certifying agent seal( s) ( optional) " 100% organic" ( optional) Certifying agent name ( required); business/ Internet address, tele. # ( optional) If multiingredient product, identify each ingredient as " organic" ( optional) " 100 percent organic" ( optional) USDA seal and certifying agent seal( s) ( optional) " Organic" ( 95% or more organic ingredients) " Organic" ( plus product name) ( optional) " X% organic" ( optional) USDA seal and certifying agent seal( s) ( optional) " X % organic" ( optional) Certifying agent name ( required); business/ Internet address, tele. # ( optional) Identify organic ingredients as " organic" ( required if other organic labeling is shown) X% organic" ( optional) USDA seal and certifying agent seal( s) ( optional) " Made with Organic Ingredients" ( 70 to 95% organic ingredients) " made with organic ( ingredients or food group( s))" ( optional) " X % organic" ( optional) Certifying agent seal of final product handler ( optional) Prohibited: USDA seal " X % organic ingredients" ( optional) Certifying agent name ( required); business/ Internet address, tele. # ( optional) Prohibited: USDA seal Identify organic ingredients as " organic" ( required if other organic labeling is shown) " made with organic ( ingredients or food group( s))" ( optional) " X % organic" ( optional) Certifying agent seal of final product handler ( optional) Prohibited: USDA seal Less­ than 70% organic ingredients Prohibited: Any reference to organic content of product Prohibited: USDA seal & certifying agent seal " X % organic" ( optional) Prohibited: USDA seal & certifying agent seal Identify organic ingredients as " organic" ( optional) ( required if % organic is displayed) Prohibited: USDA seal & certifying agent seal Misrepresentation in Labeling of Organic Products. The labeling requirements of this final rule are intended to assure that the term, " organic," and other similar terms or phrases are not 125 used on a product package or in marketing information in a way that misleads consumers as to the contents of the package. Thus, we intend to monitor the use of the term, " organic," and other similar terms and phrases. If terms or phrases are used on product packages to represent " organic" when the products are not produced to the requirements of this regulation, we will proceed to restrict their use. Handlers may not qualify or modify the term, " organic," using adjectives such as, " pure" or " healthy," e. g., " pure organic beef" or " healthy organic celery." The term, " organic," is used in labeling to indicate a certified system of agricultural production and handling. Terms such as " pure," " healthy," and other similar adjectives attribute hygienic, compositional, or nutritional characteristics to products. Use of such adjectives may misrepresent products produced under the organic system of agriculture as having special qualities as a result of being produced under the organic system. Furthermore, use of such adjectives would incorrectly imply that products labeled in this manner are different from other organic products that are not so labeled. Moreover, " pure," " healthy," and other similar terms are regulated by FDA and FSIS. These terms may be used only in accordance with the labeling requirements of FDA and FSIS. The prohibition on use of these terms to modify " organic" does not otherwise preclude their use in other labeling statements as long as such statements are in accordance with other applicable regulations. Representations made in market information for organic products are also subject to the requirements and restrictions of other Federal statutes and applicable regulations, including the Federal Trade Commission Act, 15 U. S. C. 45 et seq. Labeling Organically Produced Livestock Feed Products New section 205.306 is added to provide for labeling of the two categories of livestock 126 feed that are organically produced under this regulation. Feed labeled " 100 percent organic" may contain only organically produced agricultural product. Such feed must not contain feed additives, supplements, or synthetic substances. Feed labeled " organic" must contain only organically produced agricultural products and may contain feed additives and supplements in accordance with section 205.237, Livestock Feed, and section 205.603 of the National List. This rule does not limit the percentage of such additives and supplements in organic feed products, which may be required under various State laws. Livestock feed labeled " 100 percent organic" and " organic" may, at the handler's option, display the USDA seal and the seal or logo of the certifying agent. The organic ingredients listed on the ingredient statement may be identified with the word, " organic," or other reference mark. The name of the certifying agent must be displayed on the information panel. The business address, Internet address, and other contact information for the certifying agent may be displayed. These are the only labeling options to indicate that livestock feed that is organically produced. Labeling of Products Shipped in International Markets Domestically produced organic products intended for export may be labeled to meet the requirements of the country of destination or any labeling requirements specified by a particular foreign buyer. For instance, a product label may require a statement that the product has been certified to, or meets, certain European Union ( EU) organic standards. Such factual statements regarding the organic nature of the product are permitted. However, those packages must be exported and cannot be sold in the United States with such a statement on the label because the statement indicates certification to standards other than are required under this program. As a safeguard for this requirement, we require that shipping containers and bills of lading for such 127 exported products display the statement, " for export only," in bold letters. Handlers also are expected to maintain records, such as bills of lading and U. S. Customs Service documentation, showing export of the products. Only products which have been certified and labeled in accordance with the requirements of the NOP may be shipped to international markets without marking the shipping containers " for export only." Organically produced products imported into the United States must be labeled in accordance with the requirements of this subpart. Labeling and market representation of the product cannot imply that the product is also certified to other organic standards or requirements that differ from this national program. Labeling Nonretail Containers Section 205.307 provides for labeling nonretail containers used to ship or store raw or processed organic agricultural products that are labeled " 100 percent organic," " organic," and " made with organic..." Labeling nonretail containers as containing organically produced product should provide for easy identification of the product to help prevent commingling with nonorganic product or handling of the product which would destroy the organic nature of the product ( fumigation, etc.). These labeling provisions are not intended for shipping or storage containers that also are used in displays at the point of retail sale. Retail containers must meet labeling provisions specified in section 205.307. Containers used only for shipping and storage of any organic product labeled as containing 70 percent or more organic content may, at the handler's discretion, display the following information: ( 1) the name and contact information of the certifying agent which certified the handler of the finished product; ( 2) the term, " organic," modifying the product name; ( 3) any 128 special handling instructions that must be followed to maintain the organic integrity of the product; and ( 4) the USDA seal and the appropriate certifying agent seal. This information is available to handlers if they believe display of the information helps ensure special handling or storage practices which are consistent with organic practices. Containers used for shipping and storage of organic product must display a production lot number if such a number is used in the processing and handling of the product. Much of this information may overlap information that the handler normally affixes to shipping and storage containers or information that is required under other Federal labeling regulations. There are no restrictions on size or display of the term, " organic," or the certifying agent seal unless required by other Federal or State statutes. Labeling Products at the Point of Retail Sale Section 205.308 applies to organically produced " 100 percent organic" and " organic" products that are not packaged prior to sale and are presented in a manner which allows the consumer to select the quantity of the product purchased. The terms, " 100 percent organic" and " organic," as applicable, may be used to modify the name of the product in retail displays, labeling, and market information. The ingredient statement of a product labeled " organic" displayed at retail sale must identify the organic ingredients. If the product is prepared in a certified facility, the retail materials may also display the USDA seal and the seal or logo of the certifying agent. If shown, the certifying agent seal must not be larger than the USDA seal. Section 205.309 addresses " made with..." products that are not packaged prior to sale and are presented in a manner which allows the consumer to select the quantity of the product 129 purchased. These products include, but are not limited to, multiingredient products containing between 70 and 95 percent organic ingredients. The " made with..." label may be used to modify the name of the product in retail displays, labeling, and market information. Up to three organic ingredients or food groups may be identified in the statement. If such statement is declared in market information at the point of retail sale, the ingredient statement and market information must identify the organic ingredients. Retail display and market information of bulk products cannot display the USDA seal but may, if the product is prepared in a certified facility, display the seal or logo of the certifying agent which certified the finished product. The certifying agent's seal or logo may be displayed at the option of the retail food establishment. Products containing less than 70 percent organic ingredients may not be identified as organic or containing organic ingredients at retail sale. The USDA seal and any certifying agent seal or logo may not be displayed for such products. Labeling Products Produced in Exempt or Excluded Operations Section 205.310 provides limited organic labeling provisions for organic product produced or handled on exempt and excluded operations. Such operations would include retail food establishments, certain manufacturing facilities, and production and handling operations with annual organic sales of less the $ 5,000. These operations are discussed more thoroughly in subpart B, Applicability. Any such operation that is exempt or excluded from certification or which chooses not to be certified may not label its organically produced products in a way which indicates that the operation has been certified as organic. Exempt producers may market whole, raw organic product directly to consumers, for example, at a farmers market or roadside stand as " organic 130 apples" or " organic tomatoes." Exempt producers may market their products to retail food establishments for resale to consumers. However, no terms may be used which indicate that such products are " certified" as organic. Finally, exempt organic producers cannot sell their product to a handler for use as an ingredient or for processing into an ingredient that is labeled as organic on the information panel. These provisions are truth in labeling provisions because display of a certification seal indicates that the product has been certified. We believe this requirement helps differentiate between certified and uncertified products and helps maintain the integrity of certified products while providing organic labeling opportunities for exempt and excluded operations. USDA Organic Seal This final rule establishes a USDA seal that can be placed on consumer packages, displayed at retail food establishments, and used in market information to show that certified organic products have been produced and handled in accordance with these regulations. The USDA seal can only be used to identify raw and processed products that are certified as organically produced. It cannot be used for products labeled as " made with organic ingredients" ( 70 to 95 percent organic ingredients) or on products with less than 70 percent organic ingredients. The USDA seal is composed of an outer circle around two interior half circles with an overlay of the words " USDA Organic." When used, the USDA seal must be the same form and design as shown in figure 1 of section 205.311 of this regulation. The USDA seal must be printed legibly and conspicuously. On consumer packages, retail displays, and labeling and market information, the USDA seal should be printed on a white background in earth tones with a 131 brown outer circle and separate interior half circles of white ( upper) and green ( lower). The term, " USDA," must appear in green on the white half circle. The term, " organic," must appear in white on the green half circle. The handler may print the USDA seal in black and white, using black in the place of green and brown. Size permitting, the green ( or black) lower half circle may have four light lines running from left to right and disappearing at the right horizon, to resemble a cultivated field. The choice between these two color schemes is left to the discretion of the producer, handler, or retail food establishment. Labeling ­ Changes Based on Comments The following changes are made based on comments received. ( 1) Use of " Organic" in Product Names. The NOSB, State organic program ( SOP) managers, certifying agents, and a large number of individual commenters strongly recommended that USDA prohibit use of the term, " organic," to modify an ingredient in a product name if the ingredient, itself, is not produced organically. The examples offered were " organic chocolate ice cream" and " organic cherry sweets" in which the ice cream and candy are at least 95 percent organic but the chocolate and cherry flavoring is not organically produced. We agree with commenters that such product names can be misleading and would be a violation of section 205.300( a). In the examples, the word, " organic," precedes the words, " chocolate" and " cherry," and clearly implies that those ingredients are organically produced. The chocolate and cherry flavorings must be organically produced to be used in this way. If the product is at least 95 percent organically produced but the flavoring is nonorganic, the word sequence must be reversed or the word, " flavored," must be added to the name; e. g., " chocolate organic ice cream" or " chocolate flavored organic ice cream." A sentence has been added to 132 section 205.300( a) to specify that the term, " organic," may not be used in a product name to identify an ingredient that is not organically produced. A similar comment was received asking how a single product with two separately wrapped components can be labeled if one of the components is organically produced and the other is not. The commenter's example was a carrot and dip snack pack in which the carrots are organically produced and the dip is a conventional product. Another example is ready­ to­ eat tossed green salad in which the salad greens are organically produced but the separately pouched salad dressing is a nonorganic component of the product. Such products also must be labeled in accordance with section 205.300( a). It would be misleading to label the snack pack " organic carrots and dip" or " organic green salad and ranch dressing," if the dip and ranch dressing are not produced with organic ingredients. The salad may be labeled " organic green salad with ranch dressing." Section 6519( b) of the Act provides the Secretary with the authority to take action against misuse of the term, " organic." USDA will monitor use of the term, " organic," in product names and will restrict use of the term in names that are determined to be deliberately misleading to consumers. Such determinations must be made on a case­ by­ cases basis. ( 2) Labeling Livestock Feed. In the definition of " agricultural product," the Act includes product marketed for " livestock consumption." This means that NOP regulations have applicability to livestock feed production. The Association of American Feed Control Officials ( AAFCO) and a few States departments of agriculture commented that the proposed provisions conflict with widely followed standards for livestock feed labeling. AAFCO's " Model Bill and Regulation" standards are incorporated in many State feed laws. The commenters claimed that 133 the requirement to identify organic ingredients in the ingredient statement conflicts with feed regulations which prohibit reference to an ingredient's " quality or grade." They also claimed that the percentage of organic content requirement is a quantitative claim that must be verified by independent sources ( e. g., sources other than the certifying agent). The commenters suggested that a provision be added to address labeling of commercial livestock feed. We have added new paragraph ( e) of section 205.301 which provides for two kinds of feed that can be labeled as " organic." The first is feed that contains only organically produced agricultural ingredients and contains no added nutrients or supplements. The second organic feed category also must contain only organically produced agricultural ingredients but may contain feed additives and supplements that are needed to meet the nutritional and health needs of the livestock for which the feed is intended. Feed labeled as " organic" must conform with the requirements of section 205.237, Livestock feed. That section provides that feed additives and supplements produced in conformity with section 205.603 of the National List may be used. The NOP requires that livestock under organic management must only be fed organically produced agricultural ingredients. We also have added new section 205.306 to address commenters' labeling concerns. The new section provides for optional display of a feed's organic percentage and optional identification of the feed ingredients that are organically produced. The labeling requirements are not intended to supersede the general feed labeling requirements established in the FFDCA and those found under various State laws. Handling processes, feed formulations and recordkeeping must be sufficient to meet the requirements of applicable State regulations. We believe the provisions in new paragraph ( e) of section 205.301 on feed content and 134 new section 205.306 on labeling will allow livestock feed producers to produce and label organic livestock feed that is in accordance with these regulations and State requirements. ( 3) Organic Processing Aids. Several industry leaders and SOP managers questioned whether the proposed rule intended to exclude the use of certified organic processing aids in the creation of " 100 percent organic" products. Commenters pointed out that a handler should be able to use organically produced processing aids to create products that are labeled as " 100 percent organic." The processing aid can be a by­ product of an organic agricultural product; e. g., a filter made of rice hulls from organically produced rice. AMS concurs. Accordingly, a change is made in paragraph ( f)( 4) of section 205.301 to provide for use of organically produced processing aids in products labeled " 100 percent organic." To help clarify this and correct an incomplete reference in the proposed rule preamble, we have changed the column heading of the fourth prohibited practice in the preamble table 1. ( 4) Content of " 100 Percent Organic Products." Certifying agents and several industry commenters called attention to the regulatory text of section 205.301( a) describing 100 percent organic products. They argued that the proposed rule would allow products with one or more 95 percent­ plus " organic" ingredients to be combined as components and have the resulting product be labeled as " 100 percent organic." We did not intend to allow any ingredient that is less than 100 percent organic to be used in a product labeled " 100 percent organic." To leave no doubt as to the nature of any product labeled " 100 percent organic," we have changed the wording of paragraph ( a) of section 205.301 to clarify that a multiingredient " 100 percent organic" product must be comprised entirely of 100 percent organic ingredients. 135 ( 5) Labeling of Organic Percentage. We received many comments requesting clearer display of a product's percentage of organic content. Most suggested that any product containing less than 100 percent organic ingredients should be required to display the organic percentage on the pdp. They argued that display of the organic percentage on the front of the package would enable consumers to more easily determine organic content, compare competing products, and make better purchase decisions. The NOSB did not recommend display of organic percentage on the pdp for all products containing organic ingredients. We also received several comments from handlers concerned that the required display of a product's organic percentage can be a burden on handlers. They stated that, to save packaging and printing costs, handlers order bulk quantities of printed packages, labels, and other printed marketing materials. When printed in advance of a growing season and harvest, the handler may not be able to assemble a product that is exactly consistent with the preprinted labeling information, particularly the percentage of organic content. One commenter representing a commodity association opposed the required percentage labeling because the association believes consumers will not understand any organic claim if a percentage of less than 100 percent is displayed. We believe that display of the percentage of organic content is important product information that can be very helpful to consumers in their purchase decisions. We also believe that the opportunity to display the percentage content of organically produced ingredients can be a positive factor in encouraging handlers to use more organic ingredients in their multiingredient products. At the same time, we understand the financial commitment involved in preprinting bulk quantities of packages and labels well in advance of harvests, which determine availability of 136 needed ingredients. This final rule implements changes in sections 205.303 and 205.304 for products labeled " organic" and " made with organic ingredients." The requirement to display the percentage of organic content on the information panel is removed. That requirement is replaced with optional labeling of the product's organic percentage on the pdp or any other package panels. This will allow those handlers to display the percentage of their product's organically produced contents on the pdp where it will be most immediately visible to consumers. Handlers who cannot, with certainty, display their product's organic percentage or who choose not to display the percentage, are not required to do so. This revised labeling provision also removes the requirement in section 205.305 that products with less than 70 percent organic content display the product's organic percentage on the information panel. Under this final rule, that percentage labeling is optional but is still restricted to the information panel. The percentage of a less than 70 percent organic product may not be displayed on the pdp and may not be displayed if the organic ingredients are not identified in the ingredient statement. ( 6) Designation of Organically Produced Ingredients. A certifying agent suggested that identification of organic ingredients in ingredient statements should be allowed to be made with an asterisk or similar mark, with the asterisk defined on the information panel. The commenter stated that the repetitive use of the word, " organic," may cause space problems on some small packages and that use of a mark is a common industry practice. We agree with the comment and have changed sections 205.303( b)( 1), 205.304( b)( 1), and 205.305( a)( i) of the regulatory text accordingly. Thus, organic ingredients may be identified in the ingredient statement with either 137 the term, " organic," or an asterisk or other mark, provided that the asterisk or other mark is defined on the information panel adjacent to the ingredient statement. ( 7) Minimum Organic Percentage for Labeling. In the proposed rule's preamble, we asked for public comment on whether the 50 percent minimum organic content for pdp labeling should be increased. The 50 percent minimum content was established in section 6505( c) of the Act. However, the Act also provides the Secretary with the authority to require such other terms and conditions as are necessary to implement the program. Thus, the minimum organic content level for pdp labeling could be changed if the change would further the purposes of the Act. Comments to the first ( 1997) proposal and to the revised proposed rule suggested that the minimum organic content for labeling purposes should be increased. All comments received, including comments from certifying agents, a leading organic association, the EU and other international commenters recommended that the minimum organic content to qualify for pdp labeling should be raised to 70 percent, which is the EU's minimum. All comments stated that the increase is necessary to make the NOP standards consistent with international organic standards. Commenters also pointed to advances in organic production and processing technologies and to increases in the availability of organically produced products and processed ingredients. These factors should make it easier for handlers to assemble food products with higher organic content. We concur with the comments. We view this as a tightening of labeling requirements in that pdp labeling now requires a higher percentage of organic ingredients and makes the U. S. standard consistent with international norms. In the proposed rule's preamble, we also asked for specific public comment on whether a minimum percentage of total product content should be required for any single organic ingredient 138 that is included in the pdp statement " made with organic ( specified ingredients)." No commenters responded to this question. Therefore, no required minimum percentage for a single organic ingredient in " made with..." products is established. ( 8) " Made With Organic ( Specified Food Groups)." Several industry organizations suggested that, as an alternative to listing up to three organic ingredients in the " made with..." label, the rule should also allow for identification of food " groups" or " classes" of food in the " made with" label. Commenters suggested, for instance, that a soup ( with 70 percent or more organic ingredients, less water and salt) containing organically produced potatoes, carrots, and onions may be labeled as " soup made with organic potatoes, carrots, and onions" or, alternatively, " soup made with organic vegetables." We agree that this label option offers handlers of such multiingredient products with more flexibility in their labeling. All ingredients in the identified food group must be organically produced and must be identified in the ingredient statement as " organic." In the above example, if soup also contains conventionally produced cauliflower, only " soup made with organic potatoes, carrots, and onions" can be displayed. We also believe that some parameters must be established as to what are considered as food groups or classes of food. For the purposes of this regulation, products from the following food groups may be labeled as " organic" in a " made with..." label: beans, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, and vegetables. In addition, organically produced and processed butter, cheeses, yogurt, milk, sour cream, etc. may be combined in a product and identified as " organic milk products." Organically produced and processed sugar cane, sugar beets, corn syrup, maple syrup, etc. may be used in a product and identified as " organic 139 sweeteners." Finally, to be consistent with the " made with..." labeling for individual ingredients, up to three food groups can be identified in the " made with..." statement. Section 205.304 is changed accordingly. ( 9) Labeling Products from Exempt and Excluded Operations. A change is made in redesignated section 205.310 which provides for labeling of organic products produced by exempt and excluded operations. SOP managers and an organic handler pointed out that the preamble suggested restrictions on labeling that would prevent exempt and excluded operations from identifying their products as " organic." After review of the proposed rule, we have revised redesignated section 205.310 to more clearly specify labeling opportunities for exempt operations. The regulatory text more clearly states that such operations may not label or represent their organic products as being " certified" as organic and that such exempt and excluded operations must comply with applicable production and handling provisions of subpart C. Labeling must be consistent with the four labeling categories based on the product's organic content. A State organic advisory board recommended that proposed section 205.309 be revised to apply to exempt and excluded operations which choose to be certified under this program. We do not believe it is necessary to provide separate regulatory text for exempt and excluded operations that are certified. An exempt operation is not precluded from organic certification, if qualified. ( 10) Redesigned USDA Seal. Leading industry members, certifying agents, SOP managers, and many individual commenters opposed the proposed wording and design of the USDA seal. Comments generally stated the following points: ( 1) the proposed Seal wording indicates that USDA is the certifying agent rather than accredited certifiers; ( 2) international 140 Organization for Standardization ( ISO) Guide 61 prohibits government bodies from acting or appearing as certifying agents; and ( 3) The shield or badge design indicates a certification of product " quality" and assurance of safety which is inconsistent with the NOP's claim to be a certification of " process" only. Commenters suggested several alternative seal statements, including: " Certified Organic ­ USDA Accredited," " Certified Organic ­ USDA Approved," " USDA Certified Organic Production," " Meets USDA Organic Production Requirements." Based on comments received, we are implementing a revised USDA seal which is shown in the regulatory text under section 301.311. It is a circular design with the words, " USDA Organic." The color scheme is a white background, brown outer circle, white and green inner semicircles, and green and white words. A black and white color scheme also may be used if preferred by the handler. Some commenters suggested changing the shape of the USDA seal to a circle or triangle which, they state, is more in keeping with recognized recycling and sustainability logos. We did not choose a triangle design because processors have commented that triangle designs may cause tears in shrink wrap coverings at the points of the triangle. Labeling ­ Changes Requested But Not Made ( 1) " Organic" in Company Names. Many commenters stated that the term, " organic," must not be used as part of a company name if the company does not market organically produced foods. They are concerned that the term in a company name would incorrectly imply that the product, itself, is organically produced. While we understand commenter concerns, we do not know the extent of the problem. We do not believe those concerns require such a prohibition in the regulations at this time. These 141 regulations may not be the best mechanism to address the issue. Section 6519( b) of the Act provides the Secretary with the authority to take action against misuse of the term, " organic." USDA will monitor use of the term, " organic," in company names and will work with the FTC to take action against such misuse of the term. These determinations must be made on a case­ bycase basis. The proposed rule did not specifically address this issue. We have added a sentence to paragraph ( a) of section 205.300 to this effect. ( 2) The " 100 Percent Organic" Label. A large number of commenters opposed the " 100 percent organic" label for different reasons. A few claimed that the label is not authorized under the Act. Several commenters suggested that consumers will not understand the difference between multiingredient products labeled " 100 percent organic" and " organic." Others raised the concern that the " 100 percent organic" phrase to modify raw, fresh fruits and vegetables in produce sections and farmers markets may be confusing to consumers. Regarding the first comment, the term is not specifically provided for in the Act. However, the Secretary has the authority under section 6506( a)( 11) to require other terms and conditions as may be necessary to develop a national organic program. When a product is wholly organic, pursuant to the production and handling requirements of the NOP, we believe the handler should have the option to differentiate it from products which, by necessity, are less than 100 percent organic. We believe the label meets the purposes of the Act. Regarding consumer confusion, we believe consumers will understand the difference between the two kinds of organic products and will make their organic purchases accordingly. Regarding the labeling of raw, fresh product as " 100 percent organic," organically produced products can be labeled to a lower labeling category. Raw, fresh fruits and vegetables 142 which qualify for a " 100 percent organic" label may be labeled simply as " organic," if the producer or retail operator believes that label is best for marketing purposes. ( 3) Explain Why Product Is Not 100 Percent Organic. A large number of commenters also suggested any " product that is less than 100 percent organic should carry that information on the main display panel..." By " that information," we assume the commenters are referring to the reasons why a product cannot be certified as " 100 percent organic." AMS believes such a labeling requirement is impractical. Products may fail to qualify for a " 100 percent organic" label for very technical, or little understood, reasons. Contemporary food processing often uses ingredients, processing technologies, and product formulations that are complicated, technical, and probably not of interest to the general organic consumer. Such information is not required on nonorganically produced products for the simple reason that it is not considered useful to consumers. Explanations of the different processing technologies used in food products would be cumbersome and would interfere with other product labeling. We believe the optional display of the organic percentage and required identification of organic ingredients on the information panel provides sufficient information for consumers to make purchase decisions. Other descriptive information regarding processing substances and procedures may, of course, be provided at the handler's option and placed in accordance with other Federal labeling requirements. ( 4) Check the Appropriate Organic Category. One commenter suggested that packages of organically produced product display a small box listing the four organic label categories and a check mark beside the category which fits the product. We understand the simplicity and comparative nature of such a standardized organic label 143 that allows easy comparison of similar products. However, we believe that the optional display of the product's organic percentage and required identification of organic ingredients will be more helpful to consumers and makes the grid box redundant. ( 5) Nonorganic Ingredients in Organic Products. A large number of comments were received on the composition and use of nonorganic ingredients in products labeled " made with..." and on conventional products with less than 50 ( now 70) percent organic ingredients. Several industry commenters suggested that nonorganic ingredients in " made with..." products must be " natural" ( nonsynthetic agricultural substances) and not be artificially produced. Commenters argued that all ingredients in " made with..." and less than 70 percent products should be produced in accordance with the prohibited practices under sections 205.105 and 205.301( f). A significant number of commenters opposed identification of organic ingredients in what they called " natural food" products. First, we do not agree that the nonorganic ingredients in " made with..." products must be restricted to only " natural" products. Such restrictions on the composition of nonorganic ingredients would significantly reduce handlers' options in producing those products and, thus, reduce consumers' options in purchasing products with organic ingredients. Regarding prohibited practices, this rule implements the strong industry and consumer demand that the prohibited practices found under section 205.105 ( excluded methods, irradiation, and sewage sludge) not be used in nonorganic ingredients in " made with..." products. However, we do not believe that restrictions on use of the other prohibited practices, found in section 205.301( f), would further the purposes of the Act. Application of all prohibited practices on the nonorganic ingredients in the " made with..." and less­ than 70 percent organic products would 144 essentially require that those products be organically produced. The Act allows for products that are not wholly organic. We believe the " made with..." label and the labeling restrictions on the less­ than 70 percent organic products clearly states to consumers that only some of the ingredients in those products are organically produced. If accepted, these comments would unnecessarily restrict a handler's ability to truthfully represent and market a conventionally produced agricultural product with some organic ingredients. A handler should not be prohibited from making a truthful claim about some ingredients in a less than 70 percent organic product. ( 6) Alternative " Made With..." Labels. A few SOP managers commented that the phrase, " made with...," is confusing. They stated that many processed foods contain at least 50 percent organic ingredients but do not make an organic claim on the pdp. They believe the label would be less confusing if it stated a minimum organic percentage rather than identifying the organic ingredients. They suggest the labeling category be changed to " contains at least 50 percent organic ingredients ( or, as revised in this rule, " contains at least 70 percent organic ingredients"). We disagree. Identification of up to three organically produced ingredients or food groups on the pdp gives consumers useful, specific information about the product's organic ingredients. This label, combined with the optional display of the percentage content on the pdp and required identification of organic ingredients, should provide enough information for consumers to make good decisions. A few commenters contended that the statement " made with organic ( specified ingredients)" is unclear and " open ended" and that consumers may assume the entire product is organically produced. The " made with..." labeling claim refers only to the organic ingredients and 145 not to the whole product. We do not believe that consumers will be confused by the label. ( 7) Use of Other Terms as Synonymous for " Organic". A few commenters representing international organic standards suggested that use of the terms, " biologic" and " ecologic," which are synonymous with " organic" in other countries, should be allowed under the NOP. Commenters claimed these terms are approved by Codex and their inclusion in this regulation would facilitate international trade and equivalency agreements. These terms were addressed in the proposed rule and are not accepted. Under the NOP, these terms may be used as eco­ labels on a product package but may not be used in place of the term, " organic." Although such terms may be considered synonymous with " organic" in other countries, they are not widely used or understood in this country. We believe their use as synonymous for " organic" would only lend to consumer confusion. Regarding the Codex labeling standard, we point out that Codex also provides that terms commonly used in a country may be used in place of " biologic" and " ecologic." Thus, the use of " organic" in the United States is consistent with Codex standards. With regard to the commenters' claim that the alternate labels would facilitate international trade, this regulation allows alternative labeling of products which are being shipped to international markets. Thus, a certified organic operation in the United States may produce a product to meet contracted organic requirements of a foreign buyer, label the product as " biologic" or " ecologic" on the pdp consistent with the market preferences of the receiving country, and ship the product to the foreign buyer. Other terms were suggested by commenters as alternatives to the term, " organic," including " grown by age­ old, natural methods," " grown without chemical input," and " residue 146 Free." These phrases may be consumer friendly but clearly do not convey the extensive and complex nature of contemporary organic agriculture. These phrases may be used as additional, eco­ labels, provided they are truthful labeling statements. They are not permitted as replacements for the term, " organic." ( 8) Reconstituted Organic Concentrates. A certifying agent objected to paragraph ( a)( 2) of section 205.302, which allows labeling of an organically produced concentrate ingredient which is reconstituted with water during assembly of the processed product. The commenter claimed that this provision gives consumers the message that reconstituted juice is equivalent to fresh juice when, the commenter claims, it is not the same. AMS disagrees. This labeling is consistent with current industry practices. The Act does not prohibit such labeling of concentrates. We believe it is in the interest of the program to allow labeling of organically produced concentrates, provided that the process to produce the concentrate and the reconstitution process is consistent with organic principles and the National List. ( 9) Calculating Reconstituted Versus Dehydrated Weight. Several comments were received regarding specific problems encountered in the calculation of the percentage of organic content as provided under section 295.302. A handler claimed the reconstituted weight of an organically produced spice should be counted in the percentage calculation rather than the dehydrated weight of the spice used in the formulation. A similar comment was received from a food cooperative suggesting that, if an organically produced concentrate ( in powdered form) is added to the same organically produced ingredient in its organic liquid form ( not from concentrate), then the product's organic percentage should be calculated based on the 147 concentrate's single­ strength reconstituted weight plus the weight of the natural organic liquid. AMS disagrees with these comments. This regulation provides for an ingredient's weight to be calculated, excluding added water and salt. If an organically produced spice is added to a product in its natural form, the weight of the spice is calculated. If the spice ingredient is in dehydrated, powdered form when added in the product formulation, the dehydrated weight of the spice must be the basis for its percentage of content calculation. If an organically produced dehydrated spice is reconstituted with water prior to product assembly, the spice must still be calculated at its dehydrated weight because percentage calculations are based on the ingredient weight, excluding water and salt. It would be misleading to calculate the weight of the concentrate ingredient in its reconstituted form. Likewise, if a powdered ingredient is added to the same organically produced ingredient in its natural, liquid form, the weight of the powdered ingredient must be used. Using the reconstituted weight of the powdered ingredient would increase the percentage of the ingredient above the actual weight of the ingredient in the product. We believe that if the comment were accepted, the handler would be able to use less natural organic liquid than the organic percentage and ingredient statement indicates. ( 10) Calculate Organic Percentage in Tenths of a Percent. A trade organization suggested that the organic percentage be rounded to tenths of one percent to accommodate products that may contain a minor ingredient or additive that comprises less than 1 percent of the product. The example provided was Vitamin D in milk. The comment suggested that it is misleading to consumers to suggest that 1 percent of a milk product is nonorganic when the Vitamin D additive may be comprise only a few tenths of one percent of the product. 148 AMS disagrees. Rounding down the percentage to a whole number is sufficient for consumer information and does not misrepresent the product's organic content. A handler may add a qualifying statement regarding the minor ingredient's weight in relation to the whole product weight. ( 11) Verifying Calculations. A State department of agriculture comment suggested that the paragraph ( c) of section 205.302 be revised slightly to provide that percentage calculations must be verified " to the satisfaction" of the certifying agent. The commenter believes that the suggested language allows the handler the flexibility to determine the number calculations that need to be checked in order to verify that the organic percentage calculation is correct. We do not believe the suggested change is necessary. We assume that any use of a certifying agent's seal on a product means that the certifying agent has checked and approves of the method of calculating the product's organic percentage. If the calculations are not to the certifying agent's satisfaction, the agent would not certify the handling process. While we appreciate the point made by the commenter, we do not believe the suggested change means what the commenter intends. Paragraph ( c) of section 205.302 does not specify the number and methods of calculations that need to be carried out by a certifying agent because that will depend on the handling process being certified and the ingredients in the product. We leave that to the discretion of the certifying agent. Also, the basis for a product's organic percentage calculation should be clarified in the organic plan. It is assumed that the certifying agent will either be satisfied that the methodology for calculating organic percentage is correct or the methodology will be changed. ( 12) Labeling Nonretail Shipping Containers. A few State departments of agriculture 149 commented that shipping and storage containers with organic products should be required to be labeled as containing organic product. Other commenters recommended that shipping containers be required to display the name of the grower and the certifying agent. They cite these requirements as current industry practice. This regulation does not require organic labeling on shipping and storage containers because those containers are not used in the marketplace. The only information required by the NOP is the production lot number of the product, if a lot number exists for the particular product. Product content and shipper information may be displayed, as required by other Federal or State regulations or at the discretion of the handler. Proper identification of the organic nature of a product with special instructions for shipment or storage could prevent exposure to prohibited substances that would lead to subsequent loss of the shipment as an organic product. ( 13) Disclaimers on Organic Products. Several commenters complained that consumers are misled by the organic labeling and the NOP. They claimed that when science­ based technologies ( genetic engineering, irradiation, chlorination, etc.) are not used on products, the food is less safe than conventionally produced foods. Some of the commenters suggested that a disclaimer regarding food safety and nutritional value be required on packages with organic labeling. AMS disagrees. The USDA seal indicates only that the product has been certified to a certain production and/ or handling " process" or " system." The seal does not convey a message of food safety or more nutritional value. The NOP prohibitions on use of excluded methods, ionizing radiation, sewage sludge, and some substances and materials are not intended to imply that conventionally produced products made by those methods or containing those prohibited 150 substances are less safe or nutritious than organically produced products. We do not believe that organic food packages or labeling should carry disclaimers of what the USDA seal or a certifying agent's seal does not represent. Other Federal and State seals and marketing claims are placed on consumer products, including food products, without disclaimers regarding those seals and claims. A disclaimer displayed in relation to USDA seal or a certifying agent's seal would confuse consumers. Finally, disclaimer statements also would present space problems on small product packages. Labeling ­ Clarifications Clarification is given on the following issues raised by commenters: ( 1) Certification Is to an Organic Process, Not Organic Product. Several commenters suggested that the final rule more clearly state that the NOP provides for certification of an organic process or system of agriculture and not certification of products, themselves, as " organic." They stated that the phrase "... contain or be created using..." in paragraphs ( a), ( b), and ( c) of section 205.301 implies certification of the product's content and not to the processedbased organic system of agriculture. We agree and have revised the wording in those paragraphs to clarify that such products must be organically produced in accordance with organic production and handling requirement of this regulation. ( 2) Phasing Out Use of Old Labels and Packages. Citing FDA regulations, the NOSB, certifying agents, and some State agencies suggested a minimum 18­ month period for handlers to use up their current supplies of packages and labels before complying with the new labeling requirements. 151 This rule provides for an interim period of 18 months between publication of the final rule and the implementation date of the program. Publication of this final rule serves notice to certified producers and handlers that they should begin planning for phasing out use of labels that are not in accordance with these requirements. The implementation process is discussed in Applicability, subpart B. An organic operation will automatically be certified under this program when its certifying agent is accredited by AMS. At that time, the operation may begin following these labeling requirements but may not display the new USDA seal until the implementation date. AMS assumes that certifying agents and their client certified operations will maintain frequent contact as to the status of the agent's application for accreditation so that the certified operation may schedule the phasing out of old labels and purchase of new labels and packages. AMS expects to accredit all currently operating certifying agents by the implementation date of this regulation. Stick­ on labels to comply with the new requirements are acceptable. Newly established organic operations certified for the first time must immediately begin using labels in accordance with this program. ( 3) Labeling of Products With Minor Ingredients. Several commenters questioned how the minor ingredients ( spices, flavors, colorings, preservatives, oils, vitamins, minerals, accessory nutrients, processing aids, and incidental food additives) needed for formulation or processing of many multiingredient products will be treated under the " 100 percent organic" and " organic" labeling categories. Because minor ingredients may not exist or are difficult to obtain in organic form, their use in a product can affect the labeling of the product, even though the percentage of the ingredient is extremely small compared to the rest of the product's ingredients. 152 Minor ingredients and processing aids must be treated as any other ingredient or substance which is used as an ingredient in or in the processing of an organically produced product. To be added as an ingredient or used in the processing of a product labeled " 100 percent organic," a minor ingredient must be extracted from a certified organic source without the use of chemicals or solvents. To be added as an ingredient or used in the processing of a product labeled " organic," a minor ingredient must be from an organic agricultural source, if commercially available. If not commercially available, the ingredient must be an agricultural product or a substance consistent with the National List. ( 4) Reusing Containers. A commenter complained that small producers should not be subjected to costly packaging and labeling requirements when their products are sold directly to the public at farmers markets and roadside stands. The commenter requested that small producers be able to reuse retail boxes and labels. The commenter did not specify which labeling provisions presented burdensome costs on small entities. We agree that costs for exempt operations, indeed all organic operations, should be kept to a minimum. NOP does not prohibit reuse of containers provided their labeling does not misrepresent product and does not allow organic product to come into contact with prohibited substances from the container's previous contents. ( 5) Clarifying Prohibited Labeling Practices. Commenters identified a few inconsistencies between the preamble and regulatory text regarding the seven prohibited production and processing practices now specified in section 205.301( f). We have made the following changes to clarify the intent of the regulation. A commenter correctly pointed out that the regulatory text of paragraph ( f) incorrectly 153 refers only to ingredients that cannot be produced using the seven prohibited production and handling practices listed in the paragraph. That text is not consistent with the preamble, which correctly states that whole products, as well as ingredients, labeled as " organic" cannot be produced or processed using the seven prohibited practices. The term, " whole products," is added to the introductory sentence of new section 205.301( f). A few commenters pointed out that all seven practices are prohibited in the production of nonorganic ingredients used in products labeled as " organic." The second sentence of proposed paragraph ( b) of section 205.301 ( products labeled " organic") incorrectly listed only the first three prohibited practices. A phrase is added to the introductory sentence of new paragraph ( f) to specify that the 5 percent or less of nonorganic ingredients in products labeled as " organic" may not be produced or handled using any of the seven prohibited practices. Finally, with the addition of the commercial availability requirement in section 205.201, a conforming change is needed in section 205.301( f)( 6) regarding use of nonorganic ingredients when organically produced ingredients are available. ( 6) Consistency with State Labeling Requirements. One State organic association commented that the State's law requires identification of the certifying agent if the term, " certified organic," appears on the label. The comment was not clear about where on the package the certifier must be identified; e. g., with the " certified organic" term on the pdp or anywhere on the package. The commenter did not specifically suggest changing the labeling provisions to include the certifying agent on the pdp. This regulation allows a handler the option of displaying the certifying agent's seal or logo on the pdp for products with 70 percent or more organically produced ingredients. This 154 regulation also requires identification of the certifying agent on the information panel of all products containing 70 percent or more organically produced ingredients. The identification must include an address or contact information and be placed adjacent to identification of the manufacturer, required by FDA. We believe these provisions are sufficient to meet the State's labeling requirements. The NOP will be available to consult with States regarding alternative labeling required to be used in the State. ( 7) Clarifying Labeling of Products in Other Than Packaged Form. We have modified sections 205.308 and 205.309 to clarify that products in other than packaged form at the point of retail sale that are prepared by an exempt or excluded operation may be labeled as " 100 percent organic," " organic," or " made with..." as appropriate. Consistent with the general restrictions on the labeling of products from such operations, which are found in section 205.310, such products may not display the USDA seal or any certifying agent's seal or other identifying mark or otherwise be represented as a certified organic product. Subpart E ­ Certification This subpart sets forth the requirements for a national program to certify production and handling operations as certified organic production or handling operations. This certification process will be carried out by accredited certifying agents. Description of Regulations General Requirements Production and handling operations seeking to receive or maintain organic certification must comply with the Act and applicable organic production and handling regulations. Such operations must establish, implement, and annually update an organic production or handling 155 system plan that is submitted to an accredited certifying agent. They must permit on­ site inspections by the certifying agent with complete access to the production or handling operation, including noncertified production and handling areas, structures, and offices. As discussed in subpart B, certified operations must maintain records concerning the production and handling of agricultural products that are sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" sufficient to demonstrate compliance with the Act and regulations. Records applicable to the organic operation must be maintained for not less than 5 years beyond their creation. Authorized representatives of the Secretary, the applicable State organic program's ( SOP) governing State official, and the certifying agent must be allowed access to the operation's records during normal business hours. Access to the operation's records will be for the purpose of reviewing and copying the records to determine compliance with the Act and regulations. Certified operations are required to immediately notify the certifying agent concerning any application, including drift, of a prohibited substance to any field, production unit, site, facility, livestock, or product that is part of the organic operation. They must also immediately notify the certifying agent concerning any change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and regulations. Certification Process To obtain certification, a producer or handler must submit an application for certification to an accredited certifying agent. The application must contain descriptive information about the applicant's business, an organic production and handling system plan, information concerning any previous business applications for certification, and any other information necessary to determine 156 compliance with the Act. Applicants for certification and certified operations must submit the applicable fees charged by the certifying agent. An applicant may withdraw its application at anytime. An applicant who withdraws its application will be liable for the costs of services provided up to the time of withdrawal of the application. The certifying agent will decide whether to accept the applicant's application for certification. A certifying agent must accept all production and handling applications that fall within its area( s) of accreditation and certify all qualified applicants to the extent of its administrative capacity to do so. In other words, a certifying agent may decline to accept an application for certification when the certifying agent is not accredited for the area to be certified or when the certifying agent lacks the resources to perform the certification. However, the certifying agent may not decline to accept an application on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status. Upon acceptance of an application for certification, a certifying agent will review the application to ensure completeness and to determine whether the applicant appears to comply or may be able to comply with the applicable production or handling regulations. As part of its review, the certifying agent will verify that an applicant has submitted documentation to support the correction of any noncompliances identified in a previously received notification of noncompliance or denial of certification. We anticipate that at a future date the certifying agent will also review any available U. S. Department of Agriculture ( USDA) data on production and handling operations for information concerning the applicant. 157 We anticipate using data collected from certifying agents to establish and maintain a password­ protected Internet database only available to accredited certifying agents and USDA. This database would include data on production and handling operations issued a notification of noncompliance, noncompliance correction, denial of certification, certification, proposed suspension or revocation of certification, and suspension or revocation of certification. Certifying agents would use this Internet database during their review of an application for certification. This data will not be available to the general public because much of the data would involve ongoing compliance issues inappropriate for release prior to a final determination. After a complete review of the application, which shall be conducted within a reasonable time, the certifying agent will communicate its findings to the applicant. If the review of the application reveals that the applicant may be in compliance with the applicable production or handling regulations, the certifying agent will schedule an on­ site inspection of the applicant's operation to determine whether the applicant qualifies for certification. The initial on­ site inspection must be conducted within a reasonable time following a determination that the applicant appears to comply or may be able to comply with the requirements for certification. The initial inspection may be delayed for up to 6 months to comply with the requirement that the inspection be conducted when the land, facilities, and activities that demonstrate compliance or capacity to comply can be observed. The certifying agent will conduct an initial on­ site inspection of each production unit, facility, and site that produces or handles organic products and that is included in the applicant's operation. As a benchmark, certifying agents should follow auditing guidelines prescribed by the International Organization for Standardization Guide 10011­ 1, " Guidelines for auditing quality 1 ISO Guide 10011­ 1 is available for viewing at USDA­ AMS, Transportation and Marketing Programs, Room 2945­ South Building, 14th and Independence Ave., SW, Washington, DC, from 9: 00 a. m. to 4: 00 p. m., Monday through Friday ( except official Federal holidays). A copy may be obtained from the American National Standards Institute, 11 West 42d Street, New York, NY 10036; Website: www. ansi. org; E­ mail: ansionline@ ansi. org; Telephone: 212­ 642­ 4900; Facsimile: 212­ 398­ 0023. 158 systems ­ Part 1: Auditing" ( ISO Guide 10011­ 1). 1 The certifying agent will use the on­ site inspection in determining whether to approve the request for certification and to verify the operation's compliance or capability to comply with the Act and regulations. Certifying agents will conduct on­ site inspections when an authorized representative of the operation who is knowledgeable about the operation is present. An on­ site inspection must also be conducted when land, facilities, and activities that demonstrate the operation's compliance with or capability to comply with the applicable production or handling regulations can be observed. The on­ site inspection must verify that the information provided to the certifying agent accurately reflects the practices used or to be used by the applicant or certified operation and that prohibited substances have not been and are not being applied to the operation. Certifying agents may use the collection and testing of soil; water; waste; plant tissue; and plant, animal, and processed products samples as tools in accomplishing this verification. The inspector will conduct an exit interview with an authorized representative of the operation who is knowledgeable about the inspected operation to confirm the accuracy and completeness of inspection observations and information gathered during the on­ site inspection. The main purpose of this exit interview is to present the inspection observations to those in charge of the firm in such a manner so as to ensure they clearly understand the results of the inspection. The firm is not required to volunteer any information during the exit interview but would be 159 required to respond to questions or requests for additional information. The inspector will raise and discuss during the exit interview any known issues of concern, taking into account their perceived significance. As a general rule, the inspector will not make recommendations for improvements to the operation during the exit interview. However, the certifying agent will have the discretion to decide the extent to which an inspector may discuss any compliance issue. At the time of the inspection, the inspector shall provide the operation's authorized representative with a receipt for any samples taken by the inspector. There shall be no charge to the inspector for the samples taken. The certifying agent shall, within a reasonable time, provide the inspected operation with a copy of the on­ site inspection report, as approved by the certifying agent, for any on­ site inspection performed and provide the operation with a copy of the test results for any samples taken by an inspector. Notification of Approval A certifying agent will review the on­ site inspection report, the results of any analyses for substances, and any additional information provided by the applicant within a reasonable time after completion of the initial on­ site inspection. The certifying agent will grant certification upon making two determinations: ( 1) that the applicant's operation, including its organic system plan and all procedures and activities, is in compliance with the Act and regulations and ( 2) that the applicant is able to conduct operations in accordance with its organic systems plan. Upon determining the applicant's compliance and ability to comply, the agent will grant certification and issue a " certificate of organic operation." The certification may include requirements for the correction of minor noncompliances within a specified time period as a 160 condition of continued certification. A certificate of organic operation will specify the name and address of the certified operation; the effective date of certification; the categories of organic operation, including crops, wild crops, livestock, or processed products produced by the certified operation; and the name, address, and telephone number of the certifying agent. Once certified, a production or handling operation's organic certification continues in effect until surrendered by the organic operation or suspended or revoked by the certifying agent, the SOP's governing State official, or the Administrator. Denial of Certification Should the certifying agent determine that the applicant is not able to comply or is not in compliance with the Act, the certifying agent will issue a written notification of noncompliance to the applicant. The notification of noncompliance will describe each noncompliance, the facts on which the notification is based, and the date by which rebuttal or correction of each noncompliance must be made. Applicants who receive a notification of noncompliance may correct the noncompliances and submit, by the date specified, a description of correction and supporting documentation to the certifying agent. As an alternative, the applicant may submit a new application to another certifying agent, along with the notification of noncompliance and a description of correction of the noncompliances and supporting documentation. Applicants may also submit, by the date specified, written information to the issuing certifying agent to rebut the noncompliance described in the notification of noncompliance. When a noncompliance cannot be corrected, a notification of noncompliance and a " notification of denial of certification" may be combined in one notification. The certifying agent will evaluate the applicant's corrective actions taken and supporting 161 documentation submitted or the written rebuttal. If necessary, the certifying agent will conduct a followup on­ site inspection of the applicant's operation. When the corrective action or rebuttal is sufficient for the applicant to qualify for certification, the certifying agent will approve certification. When the corrective action or rebuttal is not sufficient for the applicant to qualify for certification, the certifying agent will issue the applicant a written notice of denial of certification. The certifying agent will also issue a written notice of denial of certification when an applicant fails to respond to the notification of noncompliance. The notice of denial of certification will state the reasons for denial and the applicant's right to reapply for certification, request mediation, or file an appeal. An applicant who has received a notification of noncompliance or notice of denial of certification may apply for certification again at any time with any certifying agent. When the applicant submits a new application to a different certifying agent, the application must include, when available, a copy of the notification of noncompliance or notice of denial of certification. The application must also include a description of the actions taken, with supporting documentation, to correct the noncompliances noted in the notification of noncompliance. When a certifying agent receives such an application, the certifying agent will treat the application as a new application and begin a new application process. A certifying agent has limited authority to deny certification without first issuing a notification of noncompliance. This authority may be exercised when the certifying agent has reason to believe that an applicant for certification has willfully made a false statement or otherwise purposefully misrepresented its operation or its compliance with the requirements for certification. 162 Continuation of Certification Each year, the certified operation must update its organic production or handling system plan and submit the updated information to the certifying agent and pay the certification fees to continue certification. The updated organic system plan must include a summary statement, supported by documentation, detailing deviations from, changes to, modifications to, or other amendments to the previous year's organic system plan. The updated organic system plan must also include additions to or deletions from the previous year's organic system plan, intended to be undertaken in the coming year. The certified operation must update the descriptive information about its business and other information as deemed necessary by the certifying agent to determine compliance with the Act and regulations. The certified operation must also provide an update on the correction of minor noncompliances previously identified by the certifying agent as requiring correction for continued certification. Following receipt of the certified operation's updated information, the certifying agent will, within a reasonable time, arrange and conduct an on­ site inspection of the certified operation. When it is impossible for the certifying agent to conduct the annual on­ site inspection following receipt of the certified operation's annual update of information, the certifying agent may allow continuation of certification and issue an updated certificate of organic operation on the basis of the information submitted and the most recent on­ site inspection conducted during the previous 12 months. However, the annual on­ site inspection must be conducted within the first 6 months following the certified operation's scheduled date of annual update. As a benchmark, certifying agents should follow auditing guidelines prescribed by ISO Guide 10011­ 1. Upon completion of the inspection and a review of updated information, the certifying agent will determine whether 163 the operation continues to comply with the Act and regulations. If the certifying agent determines that the operation is in compliance, certification will continue. If any of the information specified on the certificate of organic operation has changed, the certifying agent will issue an updated certificate of organic operation. If the certifying agent finds that the operation is not complying with the Act and regulations, a written notification of noncompliance will be issued as described in section 205.662. In addition to annual inspections, a certifying agent may conduct additional on­ site inspections of certified operations that produce or handle organic products to determine compliance with the Act and regulations. The Administrator or SOP's governing State official may also require that additional inspections be performed by the certifying agent to determine compliance with the Act and regulations. Additional inspections may be announced or unannounced and would be conducted, as necessary, to obtain information needed to determine compliance with identified requirements. Such on­ site inspections would likely be precipitated by reasons to believe that the certified operation was operating in violation of one or more requirements of the Act or these regulations. The policies and procedures regarding additional inspections, including how the costs of such inspections are handled, would be the responsibility of each certifying agent. Misuse of such authority would be subject to review by USDA during its evaluation of a certifying agent for reaccreditation and at other times in response to complaints. Certified production and handling operations can file complaints with USDA at any time should they believe a certifying agent abuses its authority to perform additional inspections. Certification After Suspension or Revocation of Certifying Agent's Accreditation 164 When the Administrator revokes or suspends a certifying agent's accreditation, affected certified operations will need to make application for certification with another accredited certifying agent. The certification of the production or handling operation remains in effect during this transfer of the certification. The certified production or handling operation may seek certification by any qualified certifying agent accredited by the Administrator. To minimize the burden of obtaining the new certification, the Administrator will oversee transfer of the original certifying agent's file on the certified operation to the operation's new certifying agent. Upon initiation of suspension or revocation of a certifying agent's accreditation or upon suspension or revocation of a certifying agent's accreditation, the Administrator may initiate proceedings to suspend or revoke the certification of operations certified by the certifying agent. The Administrator's decision to suspend or revoke a producer's or handler's certification in light of the loss of its certifying agent's accreditation would be made on a case­ by­ case basis. Actions such as fraud, bribery, or collusion by the certifying agent, which cause the Administrator to believe that the certifying agent's clients do not meet the standards of the Act or these regulations, might require the immediate initiation of procedures to suspend or revoke certification from some or all of its client base. Removal of accreditation, regardless of the reason, in no way affects the appeals rights of the certifying agent's clients. Further, a certified operation's certification will remain in effect pending the final resolution of any proceeding to suspend or revoke its certification. A private­ entity certifying agent must furnish reasonable security for the purpose of protecting the rights of operations certified by such certifying agent. This security is to ensure the performance of the certifying agent's contractual obligations. As noted elsewhere in this rule, the 165 specific amount and type of security that must be furnished by a private certifying agent will be the subject of future rulemaking by USDA. We anticipate that the amount of the security will be tied to the number of clients served by the certifying agent and the anticipated costs of certification that may be incurred by its clients in the event that the certifying agent's accreditation is suspended or revoked. We anticipate that the security may be in the form of cash, surety bonds, or other financial instrument ( such as a letter of credit) administered in a manner comparable to cash or surety bonds held under the Perishable Agricultural Commodities Act. Certification ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: ( 1) Access to Production and Handling Operation. We have amended section 205.400( c) by changing " noncertified areas and structures" to " noncertified production and handling areas, structures, and offices." A commenter requested that section 205.400( c) be amended to allow for access to farm­ related structures only. The commenter believes that the requirements of section 205.400( c) could be interpreted as giving inspectors access to residential property. We agree with the commenter that residential privacy should be maintained. However, if a certified operation conducts business from or stores records at a residential property, the certified operation will be considered to be maintaining an office at the residential property. The records in such office shall be made accessible for review and copying. Accordingly, we have amended section 205.400( c) to further clarify which areas and structures are to be made accessible during an on­ site inspection. ( 2) Application for Certification. We have amended the first paragraph of section 205.401 by replacing the word, " request," each time it occurred with the word, " application." A 166 commenter recommended that we amend the first paragraph of section 205.401 by replacing the word, " request," with " application." We have accepted the commenter's recommendation because the amendment makes the language in the first paragraph consistent with the title and the requirements of the section. ( 3) Verification of Correction of Noncompliances. To make section 205.402( a)( 3) consistent with section 205.401( c) we have amended the language in section 205.402( a)( 3) to require that the certifying agent verify that an applicant who previously applied to another certifying agent and received a notification of denial of certification has submitted documentation to support the correction of any noncompliances identified in the notification of denial of certification. A commenter recommended that section 205.402( a)( 3) be amended by inserting " or denial of certification" after the phrase, " notification of noncompliance." We have accepted the commenter's recommended amendment because it is consistent with the requirements of section 205.401( c). Section 205.401( c) requires an applicant for certification to include the name( s) of any organic certifying agent( s) to which application has previously been made, the year( s) of application, and the outcome of the application( s) submission. The applicant is also required to include, when available, a copy of any notification of noncompliance or denial of certification issued to the applicant for certification. The words, " when available," have been added to this requirement in this final rule to satisfy concerns regarding the status of applicants who cannot find or no longer have a copy of any notification of noncompliance or denial of certification previously received. We see no down side to relaxing this requirement since the applicant must still comply with each of the other provisions in section 205.401( c), including the requirement that the applicant include a description of the actions taken to correct the noncompliances noted in any 167 notification of noncompliance or denial of certification, including evidence of such correction. Further, the certifying agent will be using USDA's database of certification actions during its review of an application for certification. ( 4) Timely Communication to the Applicant. We have amended section 205.402( b), by requiring at paragraph ( b)( 1) that the certifying agent, within a reasonable time, review the application materials received and communicate its findings to the applicant. A commenter requested that we amend section 205.402( b) which required a certifying agent to communicate to the applicant its findings on the review of application materials submitted by the applicant. Specifically, the commenter requested that section 205.402( b) be amended by adding to the end thereof, " in a timely manner so as to prevent the avoidable tillage of native habitat that had been identified in the application as lands for organic production." We concur that certification decisions should be timely. There are many reasons ( e. g., financial and contractual) for why certification must be timely. It would be impractical, however, to attempt to address all of the reasons for timely certification in these regulations. We have, therefore, amended section 205.402( b) as noted above. This amendment is consistent with the requirement in section 205.402( a) that the certifying agent, upon acceptance of an application for certification, review the application for completeness, determine by a review of the application materials whether the applicant appears to comply or may be able to comply with the requirements for certification, and schedule an on­ site inspection. The " upon acceptance" requirement necessitates that the certifying agent review the application for certification and provide feedback to the applicant in a timely manner. ( 5) On­ site Inspections. We have amended section 205.403( a)( 1) by specifying that the 168 initial and annual on­ site inspections of each production unit, facility, and site in an operation applies to those units, facilities, and sites that produce or handle organic products. A commenter recommended that section 205.403( a)( 1) be amended to specify that on­ site inspections of each production unit, facility, and site will include just those that produce or handle organic products. The commenter stated that this change was necessary because some retail corporations choose to certify all store locations regardless of whether the location sells organic products. The commenter went on to say that, if a location does not stock any organic products, the certifying agent should have the discretion to modify the inspection requirement. We have excluded all retail food establishments from certification. The exclusion is found in section 205.101( b)( 2). Accordingly, the commenter's recommendation is not applicable to retail food establishments. We have, however, made the recommended amendment to section 205.403( a)( 1) because of its potential applicability to other operations which may apply for certification. ( 6) Scheduling Initial On­ site Inspection. We have amended section 205.403( b) to provide that the initial inspection may be delayed for up to 6 months to comply with the requirement that the inspection be conducted when the land, facilities, and activities that demonstrate compliance or capacity to comply with the organic production and handling requirements can be observed. We received a comment stating that if an application is received in January for a crop that will be planted in May, it would be necessary to delay the inspection until late May or June to observe the crop in the field. The commenter went on to say that the alternative would be to conduct the initial inspection before the crop is planted, in order to meet the " within a reasonable time" requirement, and then conduct a reinspection during the growing 169 season. The commenter recommended amending section 205.403( b) to allow the certifying agent to delay the initial on­ site inspection until the land, facilities, and activities that demonstrate compliance or capacity to comply can be observed. We have accepted the recommendation because there may be situations where a later onsite inspection will prove mutually beneficial to the certifying agent and the operation to be inspected. However, certifying agents are reminded that the operation may be certified following a demonstration that the operation is able to comply with the organic production and handling requirements found in subpart C of these regulations. Accordingly, certifying agents should not unnecessarily delay the certification of an organic production or handling operation by insisting that the inspection only be performed when the operation can demonstrate its actual compliance with the organic production and handling requirements. Applicants who believe that the certifying agent is abusing its authority to delay the on­ site inspection may file a complaint with the Administrator. We have also amended the second sentence in section 205.403( b) by inserting the word, " all," and removing both references to " applicant" to clarify that the provision applies to all onsite inspections. ( 7) Exit Interview. We have amended section 205.403( d) by requiring that the inspector conduct an exit interview with " an authorized representative of the operation who is knowledgeable about the inspected operation" rather than " an authorized representative of the inspected operation" as required in the proposed rule. This amendment is consistent with the requirement in section 205.403( b) that an on­ site inspection be conducted when an authorized representative of the operation who is knowledgeable about the operation is present. 170 A commenter requested that we define " authorized representative." Another commenter recommended changing the term, " authorized representative," to " responsible executive." Our amendment of section 205.403( d) responds to both of these comments by clarifying the qualifications of an authorized representative. A third commenter stated that an exit interview is not a practical requirement and that an initial interview is often preferred. The commenter stressed that verification that the inspector has correctly understood what is presented is ongoing. This commenter also expressed the belief that there may be times when it may not be appropriate for the inspector to address issues of concern and that such issues may be best left to the certifying agent. The commenter recommended that the requirement for an exit interview be deleted or presented as an option. Another commenter suggested that issues of concern are often identified and discussed with the operation's representative during the course of the inspection. This commenter believes that it is unnecessarily confrontational to require an exit interview during which these issues of concern are repeated. This commenter recommended replacing the required exit interview with a communications provision that would require the inspector to discuss the need for any additional information as well as any issues of concern. The recommended provision would also authorize the certifying agent to provide the applicant with a summary of the inspector's areas of concern. While we agree that the language in section 205.403( d) needed clarification, we do not agree that the exit interview is impractical or unnecessarily confrontational. The exit interview is intended to give the inspector an opportunity to confirm the accuracy and completeness of inspection observations and information gathered during the on­ site inspection, to request any additional information necessary to establish eligibility for certification, and to raise and discuss 171 any known issues of concern. Issues of concern that may involve compliance issues will be handled as authorized by the certifying agent. The exit interview is also intended to give the inspected operation's authorized representative general information concerning the inspector's observations. Such exit interviews are required under ISO Guide 10011­ 1. Accordingly, requiring exit interviews is consistent with ISO standards and our expectation, as stated earlier in this preamble, that certifying agents benchmark their on­ site inspection procedures to ISO Guide 10011­ 1. ( 8) On­ site Inspection Documentation. We have amended section 205.402( b) by adding the requirements that the certifying agent: ( 1) provide the applicant with a copy of the on­ site inspection report, as approved by the certifying agent, for any on­ site inspection performed and ( 2) provide the applicant with a copy of the test results for any samples taken by an inspector. We have also amended section 205.403 by adding a new paragraph ( e) that requires the inspector, at the time of the inspection, to provide the operation's authorized representative with a receipt for any samples taken by the inspector. This new paragraph also addresses the requirement that the certifying agent provide the operation inspected with a copy of the inspection report and any test results. Having the certifying agent issue the on­ site inspection report to the operation inspected is consistent with ISO Guide 65, section 11( b). Several commenters recommended that section 205.403 be amended to require that the inspector issue a copy of the on­ site inspection report to the operation at the exit interview. They also recommended that the inspector be required to provide the operation with a receipt for samples collected for testing. The commenters, further, recommended that the certifying agent be required to provide the operation with a written report on the results of the testing performed on 172 the samples taken. A commenter also recommended that the operation be paid for any samples taken. One of the commenters recommended that section 205.403 be amended by adding protocol for an exit interview. We concur that the applicant for certification and certified operations should be provided with a copy of the on­ site inspection report, a receipt for samples taken, and a copy of the test results for samples taken. Accordingly, we have amended sections 205.402( b) and 205.403 as noted above. The protocol for an exit interview will be set forth in the certifying agent's procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates. The NOP is available to respond to questions and to assist certifying agents in the development of these procedures which are required under section 205.504( b)( 1). Accordingly, AMS is not amending the section to include a protocol for exit interviews. AMS is also not including a requirement that the certifying agent pay the applicant for samples taken, since such charges would just be charged back to the applicant as a cost for processing the applicant's application for certification. ( 9) Granting Certification. We have amended the last sentence of section 205.404( a) by removing the word, " restrictions," and replacing it with " requirements for the correction of minor noncompliances within a specified time period." A commenter suggested that the last sentence of section 205.404( a) be amended to read: " The approval may include restrictions or requirements as a condition of continued certification, which includes a time line for fulfilling the requirement." Another commenter requested that we define " restrictions." This commenter also recommended amending section 205.404( a) to clarify the meaning of " restrictions" and to require corrective 173 action by the operator within a specific time period. We agree with the commenters that the last sentence of section 205.404( a) was in need of further clarification. We also agree that it is appropriate for the regulations to require that the requirements for correction include a specified time period within which the corrections must be made. Accordingly, we amended section 205.404( a) as noted above. The certifying agent will make the determination of whether a violation of the Act and regulations is minor. Minor noncompliances are those infractions that, by themselves, do not preclude the certification or continued certification of an otherwise qualified organic producer or handler. The certifying agent would be free to modify the time period for correction should it believe it to be appropriate. We have also made editorial changes to section 205.404( a) consistent with suggestions we received on section 205.506. In the title to section 205.404 we have replaced " Approval of" with " Granting." In section 205.404( a) we have replaced " approve" with " grant" and " approval" with " certification." This change makes the language in section 205.404 consistent with ISO Guide 65, section 4.6, which addresses the granting of certification. ( 10) Payment of Fees. We have amended the introductory statement within section 205.406( a) by adding the requirement that, to continue certification, a certified operation annually pay the certifying agent's certification fees. A commenter recommended amending section 205.404( c) by adding a sentence providing that a certified operation's failure to pay the certifying agent's certification fees may be a cause for suspension or revocation of certification. We agree that the issue of payment of fees should be addressed but not in section 205.404( c), which deals with the duration of a certified operation's certification. We believe the issue of payment of certification fees is more appropriately addressed in section 205.406, which deals with 174 continuation of certification. Accordingly, we have amended section 205.406( a) to require payment of the certifying agent's fees as a condition of continued certification. This addition would allow a certifying agent to initiate suspension or revocation proceedings against any operation that fails to pay the required fees. The certifying agent is not required to initiate suspension or revocation proceedings for failure to pay the fees. In fact, the certifying agent is encouraged to use one or more of the legal debt collection alternatives available to it. ( 11) Denial of Certification. We have amended section 205.405 to include noncompliance and resolution provisions originally included by cross­ reference to section 205.662( a). We have made this amendment in response to a comment that these regulations do not provide an opportunity for a hearing upon denial of certification. We disagree with the commenter's assessment but have amended section 205.405( a) to eliminate confusion that may result from the cross­ reference to section 205.662( a). We have determined that section 205.662( a) may cause confusion for certification applicants because the section does not specifically address applicants. As amended, section 205.405( a) required a written notification of noncompliance that describes each noncompliance, the facts on which the noncompliance is based, and the date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. Section 205.405( b) lists the options available to the applicant, including the options of correcting the noncompliance or submitting written information to rebut the noncompliance. Successful correction or rebuttal will result in an approval of certification. When the corrective action or rebuttal is not sufficient for the applicant to qualify for certification, the certifying agent will issue a written notice of denial of 175 certification. This notice will state the reason( s) for denial and the applicant's right to request mediation in accordance with section 205.663 or to file an appeal in accordance with section 205.681. ( 12) Rebuttal of a Noncompliance. We have amended section 205.405( b)( 3) to clarify that rebuttal of a noncompliance shall be submitted to the certifying agent that issued the notification of noncompliance. We made this amendment in response to a commenter's question about who has authority to evaluate a written rebuttal. ( 13) Correction of Minor Noncompliances. We have amended section 205.406( a) by adding a new paragraph ( 3) which requires the certified operation to include with its annual reporting an update on the correction of minor noncompliances previously identified by the certifying agent as requiring correction for continued certification. A commenter recommended adding at 205.406( a) a requirement that the certified operation address any restrictions that have been applied to its certification under 205.404( a). We agree with the commenter that the annual reporting by the certified operation should include an update addressing the certified operation's compliance with the certifying agent's requirements for the correction of minor noncompliances. Accordingly, we amended section 205.406( a) as noted above and redesignated paragraph ( 3) as paragraph ( 4). The certifying agent will make the determination of whether a violation of the Act and regulations is minor. Minor noncompliances are those infractions that, by themselves, do not preclude the certification or continued certification of an otherwise qualified organic producer or handler. ( 14) Scheduling Annual On­ site Inspections. We have amended section 205.406( b) to provide that, when it is impossible for the certifying agent to conduct the annual on­ site inspection 176 following receipt of the certified operation's annual update of information, the certifying agent may allow continuation of certification and issue an updated certificate of organic operation on the basis of the information submitted and the most recent on­ site inspection conducted during the previous 12 months. The annual on­ site inspection, required by section 205.403, must, however, be conducted within the first 6 months following the certified operation's scheduled date of annual update. A commenter expressed the belief that the requirement for an on­ site inspection after receipt of the certified operation's annual update of information would have required that all annual on­ site inspections be performed at the same time of the year. The commenter went on to express the belief that, to avoid inspecting certified operations twice a year, certifying agents would have to schedule the annual update to occur during the growing season in order to comply with the requirement for timing inspections when normal production activities can be observed. The commenter stated that certifying agents should be given more flexibility for scheduling inspections and conducting their certification programs according to management procedures best suited to their agency. The commenter recommended amending section 205.406( b) by adding to the end thereof: " or base the decision regarding eligibility for renewal on an on­ site inspection conducted during the previous 12 months." We agree with the commenter that certifying agents should be given more flexibility for scheduling on­ site inspections so as to best meet the management needs of the certifying agent. Accordingly, we have amended section 205.406( b) to allow continuation of certification and issuance of an updated certificate of organic operation on the basis of the information submitted and the most recent on­ site inspection conducted during the previous 12 months. This option will 177 be available to the certifying agent when renewal is scheduled for a time when it is impossible to conduct the annual on­ site inspection following receipt of the annual update and at a time when land, facilities, and activities that demonstrate the operation's compliance or capability to comply can be observed. This change does not affect the requirement in section 205.403( a)( 1) that the certifying agent conduct an annual on­ site inspection of each certified operation. Further, the annual on­ site inspection must be conducted within the first 6 months following the certified operation's scheduled date of annual update. Certification ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Number of On­ site Inspections. A commenter recommended that section 205.403( a)( 1) be amended by adding a requirement that production operations be under active organic management for the last year of the 3­ year land conversion period and that two on­ site inspections be performed prior to organic certification. Section 205.403( a)( 1) provides that the certifying agent must conduct an initial on­ site inspection of each production unit, facility, and site that produces or handles organic products and that is included in an operation for which certification is requested. The requirement does not preclude a certifying agent from conducting additional on­ site inspections, if necessary, to establish the applicant's eligibility for certification. The Act requires a 3­ year period immediately preceding harvest, during which the production operation must be free from the application of prohibited substances. The Act does not, however, require that land be under active organic management during this period, and we do not believe such a requirement in these regulations is 178 necessary. Such a requirement, for example, would necessitate some process for verifying that an operation is under active organic management, which would, in effect, require a certification­ type decision a year before certification is granted and the operation can begin to label products as certified organic. Accordingly, we disagree with the commenter's recommendation that an operation be under active organic management for the last year of the 3­ year land conversion and that two on­ site inspections be required. ( 2) Unannounced Inspections. A commenter recommended that section 205.403( a)( 2)( iii) be amended to require additional unannounced inspections either by defining the circumstances under which the inspections should be undertaken or by setting a minimum percentage of unannounced inspections. The commenter claimed that 5 percent is a common percentage adopted by certifying agents around the world. Section 205.403 requires an initial on­ site inspection, annual on­ site inspection, and additional on­ site inspections to determine compliance with the Act and regulations, to verify that information provided reflects actual practices, and to verify, through testing if necessary, that prohibited substances are not used by the operation. Because of the widely disparate nature of certified operations, we believe the certifying agent is in the best position to determine the need for additional on­ site inspections. Accordingly, we have rejected the commenter's request that the regulations require additional unannounced visits either by defining the circumstances under which these should be undertaken or by setting a minimum percentage. ( 3) Timeliness of Certifying Agent Review Information. A commenter requested that section 205.404( a) be amended to specify a timeframe of 60 days rather than " Within a reasonable time" as the time by which the certifying agent must review the on­ site inspection report, the 179 results of any analyses for substances, and any additional information requested from or supplied by the applicant. Section 205.404( a) requires the certifying agent, within a reasonable time after completion of the initial on­ site inspection, to review the on­ site inspection report, the results of any analyses for substances conducted, and any additional information requested from or supplied by the applicant. Section 205.504( b)( 1) requires the certifying agent to submit a copy of the procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates. Such procedures and the certifying agent's performance in making timely certification decisions will be subject to review during accreditation and reaccreditation of the certifying agent. Certifying agents are expected to make timely decisions regarding whether to certify an applicant and whether a certified operation is in compliance with the Act and regulations. Applicants with complaints regarding timeliness of service could forward their complaints to the Administrator. Accordingly, timely service will be in the best interest of certifying agents since such complaints could have an impact on their reaccreditation or continued accreditation. Further, our original position is consistent with those commenters requesting flexibility in determining what constitutes reasonable time. Accordingly, we have not amended section 205.404( a) as requested. ( 4) Categories of Organic Operation. We received a variety of comments regarding the requirement that the certifying agent issue a certificate of organic operation which specifies the categories of organic operation, including crops, wild crops, livestock, or processed products produced by the certified operation. One commenter recommended that section 205.404( b)( 3) be amended, with regard to processing, to only require a processing category to be specified on the 180 certificate, such as food processing or feed processing. The commenter stated that it should not be necessary to list every product on the certificate. Specifically, the commenter recommended amending section 205.404( b)( 3) by inserting the words, " general categories of," immediately in front of the word, " processed." Another commenter recommended amending section 205.404( b)( 3) to require the identity of specific crops and the specific processing operations certified. Still another commenter requested that section 205.404( b) be amended by adding a new paragraph requiring that the certificate include the number of livestock of each species produced on the certified operation. This same commenter also recommended the addition of a new paragraph requiring that the certificate identify the specific location of each certified organic field and handling operation. We also received support for section 205.404( b)( 3) as written. This commenter does not support the addition of information regarding the number of livestock or the location of fields. We disagree with the suggestion that the certificate list every crop, wild crop, livestock, or processed product produced by the certified operation. We believe that listing categories of organic operation is sufficient. This does not, however, prevent the certifying agent, in cooperation with the certified operation, from listing specific crops, livestock, or processed products on the certificate. Such information could always be listed on the certificate when requested by the certified operation. We also disagree with the commenter who requested that certifying agents display the number of livestock of each species produced by the certified operation and the specific location of each certified organic field and handling operation. We do not believe it is necessary to list the quantity of product to be produced or handled at a certified operation, nor do we believe it is necessary to list the location of a certified operation's fields or 181 facilities. Such information may, however, be listed on the certificate upon the written request of the certified operation. By requiring the name, address, and telephone number of the certifying agent, the certificate would provide interested persons with a contact for obtaining releasable information concerning the certified operation. Further, the certifying agent is the first line of compliance under this program and, as such, is the person to whom all questions and concerns should be addressed about certified operations. ( 5) Annual Renewal of Certification. Numerous commenters requested that section 205.404( b)( 2) be amended to provide for the placement of an expiration date on the certificate of organic operation. The commenters want yearly expiration of certification and yearly expiration of the certificate of organic operation. Commenters also requested that section 205.404( c) be amended to provide that once certified, a production or handling operation's organic certification continues in effect until the expiration date on the certificate, until surrendered by the organic operation, or until suspended or revoked by the certifying agent, the SOP's governing State official, or the Administrator. Some commenters recommended the addition of a new paragraph 205.406( e) that would provide for automatic suspension of a certification if the certified operation did not provide the information required in paragraph 205.406( a) by the expiration date to be placed on the certificate of organic operation. We disagree with the commenters who have requested annual renewal of certification and that the certified operation's certification and its certificate of organic operation expire annually. We prefer continuous certification due to the very real possibility that the renewal process might not always be completed before expiration of the certification period. Expiration of the certification period would result in termination of the operation's certification. Even a short 182 period of interruption in an operation's organic status could have severe economic ramifications. Further, we believe that a regular schedule of expiration of certification is unnecessary inasmuch as all certified operations are required to annually update their organic system plan and submit any changes to their certifying agent. More importantly, unlike accreditation, where the Act provides for expiration and renewal, the Act does not provide for an expiration or renewal of certification. Therefore, it is also our position that once granted certification the production or handling operation retains that certification until voluntarily surrendered or removed, following due process, for violation of the Act or these regulations. ( 6) Denial of Certification. A commenter recommended that section 205.405( e) be amended to place a time restriction on reapplication for certification after denial of certification. The commenter suggested a 3­ year period. We disagree with this recommendation because the reasons for denial include a wide range of noncompliances. The ability to correct noncompliances will vary as will the time needed to correct the noncompliances. ( 7) Production and Handling Operation Certification Following Suspension or Revocation of Certifying Agent Accreditation. A few commenters requested amendment of section 205.406 through the addition of a new paragraph ( f). Specifically, the commenters requested provisions that would provide for USDA notification of certified operations regarding the suspension or revocation of their certifying agent's accreditation. Some of these commenters requested that the provisions also allow the affected certified operation to use current market labels for a maximum period of 12 months, provided the certified operation made application for certification with another USDA­ accredited certifying agent within 3 months of being notified of their certifying agent's suspension or revocation of accreditation. Another commenter requested that the new 183 paragraph provide that the affected certified operation will continue to operate as if certified by the USDA and will be allowed to use current market labels for a maximum period of 12 months. The commenter stated that this amendment would provide the certified operation with the time needed to obtain recertification by an accredited certifying agent and to prepare new labels. We disagree with the recommendations. USDA does not perform organic certification activities under any circumstance, including upon surrender, suspension, or revocation of an accredited certifying agent's accreditation. Operations certified by a certifying agent that surrenders or loses its USDA accreditation will be notified by USDA and given an opportunity to immediately begin seeking certification by the USDA­ accredited certifying agent of their choice. Certified operations shall not affix the seal or other representation of a certifying agent to any product that they produce after the certifying agent has surrendered or had its accreditation revoked. The certified operation may use the USDA organic seal. In the case of suspension of the certifying agent, the reasons for the suspension and the terms of the suspension will determine whether the certifying agent's certified operations will have to seek recertification or stop affixing the certifying agent's seal or other representation to their products. USDA will announce the suspension or revocation of a certifying agent's accreditation, and the announcement will address the status of operations certified by the certifying agent. Certification ­ Clarifications Clarification is given on the following issues raised by commenters as follows: ( 1) Recordkeeping. A commenter stated that most computerized recordkeeping systems used at retail and wholesale are set up to save the data for a maximum of 2 years; adding 3 additional years to that requirement would be extremely costly as systems modifications and 184 additional hardware and support would be required to meet the mandate. The commenter suggested that since food product is generally sold and consumed within a matter of months ( if not weeks), shortening this requirement to 2 years should meet the goal for tracking of any product through the distribution system. This commenter was referring to the requirement in section 205.400( d) that records be maintained for not less than 5 years beyond their creation. Section 205.103 requires that a certified operation maintain records; that the records be adapted to the particular business that the certified operation is conducting, fully disclose all activities and transactions of the certified operation in sufficient detail as to be readily understood and audited, be maintained for not less than 5 years beyond their creation, and be sufficient to demonstrate compliance with the Act and the regulations in this part; and that the certified operation must make such records available for inspection and copying during normal business hours by authorized representatives of the Secretary, the applicable SOP's governing State official, and the certifying agent. The requirements do not state in what form ( i. e., paper, electronic, film) that the records must be maintained. Therefore, in answer to the commenter's concern, database records more than 2 years old could be stored in any form, including on an electronic storage device, which would permit retrieval upon request. ( 2) Application Fees. A commenter recommended that section 205.401 be amended by adding a new paragraph ( e) which would require an applicant for certification to include, along with the other required application information, the application fees required by the certifying agent. The requested language is unnecessary because section 205.400( e) requires submission of the applicable fees charged by the certifying agent as a general requirement for certification. 185 ( 3) Applicant Identification. In reference to section 205.401( c) a commenter stated that an applicant that is a corporation could easily change the name of the corporation in order to avoid having to report applications submitted and denied under the previous name. The commenter went on to state that there must be a database available to certifying agents that includes names and location addresses of operations that have received a notification of noncompliance, denial of certification, or a suspension or revocation of certification. Section 205.401( b) requires the applicant to include in its application the name of the person completing the application; the applicant's business name, address, and telephone number; and, when the applicant is a corporation, the name, address, and telephone number of the person authorized to act on the applicant's behalf. As we stated in the preamble to the proposed rule, we anticipate using the data collected under section 205.501( a)( 15) to establish and maintain two Internet databases. The first Internet database would be accessible to the general public and would include the names and other appropriate data on certified organic production and handling operations. The second Internet database would be password protected and only available to accredited certifying agents and USDA. This second database would include data on production and handling operations issued a notification of noncompliance, noncompliance correction, denial of certification, certification, proposed suspension or revocation of certification, and suspension or revocation of certification. Certifying agents would use the second Internet database during their review of an application for certification. ( 4) Withdrawal of Application. Several commenters expressed the belief that allowing an applicant to voluntarily withdraw its application will be used as a tool to avoid denial of 186 certification. They expressed concern that voluntary withdrawal before denial of certification will allow the applicant to make application with a different certifying agent with a clean record. These commenters were responding to the provision in section 205.402( e) which allows an applicant for certification to withdraw its application at any time. We continue to believe that operations should not be unnecessarily stigmatized because they applied for certification before the operation was ready to meet all requirements for certification. While some operations may use voluntary withdrawal as a means to avoid the issuance of a notification of noncompliance or a notice of denial of certification, this should not adversely affect the National Organic Program ( NOP) because all certifying agents are responsible for using qualified personnel in the certification process and for ensuring an applicant's eligibility for certification. Further, all applicants for certification are required under section 205.401( c) to include in their application the name( s) of any organic certifying agent( s) to which application has previously been made, the year( s) of application, and the outcome of the application( s) submission. ( 5) On­ site Inspections. Section 205.403( a)( 2)( ii) provides that the Administrator or SOP's governing State official may require that additional inspections be performed by the certifying agent for the purpose of determining compliance with the Act and the regulations in this part. In commenting on this provision, a commenter asked, " Who is running this program: State or Federal officials?" This is a national organic program administered by the Agricultural Marketing Service of the United States Department of Agriculture. States may administer their own organic program. However, all SOP's are subject to USDA approval. The National Organic Standards and a 187 State's organic standards under a USDA­ approved SOP are the National Organic Standards for that State. The State, under USDA's approval of the SOP, has enforcement responsibilities for the Federal and State components of the organic program within the State. ( 6) Verification of Information. A commenter stated that section 205.403( c) is insufficiently comprehensive. The commenter stated that organic inspection is assessment of a process evaluated against comprehensive standards and, as such, it requires specific rules to provide confidence in the quality of the inspection. The commenter recommended amending section 205.403( c) by including requirements on minimum verification methods. Section 205.403( c) identifies what must be verified during the on­ site inspection. The details on how the verification will be accomplished will be set forth in the certifying agent's procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates and the certifying agent's procedures for reviewing and investigating certified operation compliance with the Act and regulations. The NOP is available to respond to questions and to assist certifying agents in complying with the on­ site inspection requirements, including those for the verification of information. ( 7) Notifying Customers of Change in Certification Status. A commenter stated that the regulations do not indicate when a certified organic producer must stop using the organic seal or whether they must notify customers of their denial of certification. The commenter recommended amending section 205.405 to include a provision for notifying customers of a certified operation's change in certification status. Any producer or handler who plans to sell, label, or represent its product as " 100 percent organic," " organic," or " made with..." must be certified unless exempted under the small 188 operation exemption under section 205.101( a)( 1) or not regulated under the NOP ( i. e., a producer of dog food). Only certified operations may represent themselves as certified. Operations denied certification may not represent their products as " 100 percent organic," " organic," or " made with..." Operations that have had their certification suspended or revoked will be subject to the terms and conditions of their suspension or revocation relative to the labeling of product produced prior to the suspension or revocation. No product produced by an operation after suspension or revocation of certification may be sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." Buyers of organic product can request to see the producer's or handler's certificate of organic operation. Operations that have lost their organic status will be unable to obtain an updated certificate. Buyers with questions regarding an operation's organic status may also contact the certifying agent identified on a certificate of organic operation. Further, as previously noted, we anticipate using the data collected under section 205.501( a)( 15) to establish and maintain an Internet database accessible to the general public that will include the names and other appropriate data on certified organic production and handling operations. ( 8) Continuation of Certification. A few commenters recommended amending section 205.406 to include a safety net for producers who are certified by a certifying agent that does not become accredited by USDA. They stated that the rule must clearly state that a certified organic producer will have the full 18­ month implementation period starting from the effective date of the final rule to get recertified if their certifying agent is not accredited. One of the commenters stated that because the NOP anticipates that the accreditation process will require 12 months, producers will, in effect, have 6 months to be certified by a new certifying agent should the 189 producer's certifying agent not be accredited. Certification under the NOP will become mandatory 18 months after the effective date of the final rule. Applications for accreditation will be processed on a first­ come, first­ served basis. Accreditations will be announced approximately 12 months after the effective date of the final rule for those qualified certifying agents who apply within the first 6 months following the effective date and for any other applicants that AMS determines eligible. Certifying agents will begin the process of certifying organic production and handling operations to the national standards upon receipt of their USDA accreditation. All production and handling operations certified by an accredited certifying agent will be considered certified to the national standards until the certified operation's anniversary date of certification. This phase­ in period will only be available to those certified operations certified by a certifying agent that receives its accreditation within 18 months from the effective date of the final rule. We anticipate that certifying agents and production and handling operations will move as quickly as possible to begin operating under the national organic standards. Operations certified by a certifying agent, which fails to apply for or fails to meet the requirements for USDA accreditation under the NOP, must seek and receive certification by a USDA­ accredited certifying agent before they can sell, label, or represent their products as organic, effective 18 months after the effective date of the final rule. Subpart F ­ Accreditation of Certifying Agents This subpart sets forth the requirements for a national program to accredit State and private entities as certifying agents to certify domestic or foreign organic production or handling operations. This subpart also provides that USDA will accept a foreign certifying agent's accreditation to certify organic production or handling operations if: ( 1) USDA determines, upon 2 ISO/ IEC Guide 65 is available for viewing at USDA­ AMS, Transportation and Marketing Programs, Room 2945­ South Building, 14th and Independence Ave., SW, Washington, DC, from 9: 00 a. m. to 4: 00 p. m., Monday through Friday ( except official Federal holidays). A copy may be obtained from the American National Standards Institute, 11 West 42d Street, New York, NY 10036; Website: www. ansi. org; E­ mail: ansionline@ ansi. org; Telephone: 212­ 642­ 4900; Facsimile: 212­ 398­ 0023. 190 the request of a foreign government, that the standards under which the foreign government authority accredited the foreign certifying agent meet the requirements of this part; or ( 2) the foreign governmental authority that accredited the certifying agent acted under an equivalency agreement negotiated between the United States Government and the foreign government. This National Organic Program ( NOP) accreditation process will facilitate national and international acceptance of U. S. organically produced agricultural commodities. The accreditation requirements in these regulations will, upon announcement of the first group of accredited certifying agents, replace the voluntary fee­ for­ service organic assessment program, established by AMS under the Agricultural Marketing Act of 1946. That assessment program verifies that State and private organic certifying agents comply with the requirements prescribed under the International Organization for Standardization/ International Electrotechnical Commission Guide 65, " General Requirements for Bodies Operating Product Certification Systems" ( ISO Guide 65). 2 ISO Guide 65 provides the general requirements that a certifying agent would need to meet to be recognized as competent and reliable. That assessment program was originally established to enable organic certifying agents in the absence of a U. S. national organic program to comply with European Union ( EU) requirements beginning on June 30, 1999. That assessment program verifies that State and private organic certifying agents are operating third­ party certification systems in a consistent and reliable manner, thereby facilitating 191 uninterrupted exports of U. S. organic agricultural commodities to the EU. ISO Guide 65 was used as a benchmark in developing the accreditation program described in this final rule. Certifying agents accredited under the NOP that maintain compliance with the Act and these regulations will meet or exceed the requirements of ISO Guide 65; therefore, the organic assessment program is no longer needed. Participation in the NOP does not preclude the accredited certifying agent from conducting other business operations, including the certification of agricultural products, practices, and procedures to standards that do not make an organic claim. An accredited certifying agent may not, however, engage in any business operations or activities which would involve the agent in a violation of or in a conflict of interest under the NOP. Description of Regulations The Administrator will accredit qualified domestic and foreign applicants in the areas of crops, livestock, wild crops, or handling or any combination thereof to certify domestic or foreign production or handling operations as certified organic operations. Qualified applicants will be accredited for 5 years. Application Process Certifying agents will apply to the Administrator for accreditation to certify production or handling operations operating under the NOP. The certifying agent's application must include basic business information, must identify each area of operation for which accreditation is requested and the estimated number of each type of operation to be certified annually, and must include a list of each State or foreign country where it currently certifies production or handling operations and where it intends to certify such operations. Certifying agents must also submit 192 personnel, administrative, conflict of interest, current certification, and other documents and information to demonstrate their expertise in organic production or handling techniques, their ability to comply with and implement the organic certification program, and their ability to comply with the requirements for accreditation. Certifying agents planning to certify production or handling operations within a State with an approved State organic program ( SOP) must demonstrate their ability to comply with the requirements of the SOP. The administrative information submitted by the applicant must include copies of its procedures for certifying operations, for ensuring compliance of its certified operations with the Act and regulations, for complying with recordkeeping requirements, and for making information available to the public about certified operations. The procedures for certifying operations encompass the processes used by the certifying agent to evaluate applicants, make certification decisions, issue certification certificates, and maintain the confidentiality of any business information submitted by the certified operation. The procedures for ensuring compliance of the certified operations will include the methods used to review and investigate certified operations, for sampling and residue testing, and to report violations. The personnel information submitted with the application must demonstrate that the applicant uses a sufficient number of adequately trained personnel to comply with and implement the organic certification program. The certifying agent will also have to provide evidence that its responsibly connected persons, employees, and contractors with inspection, analysis, and decision­ making responsibilities have sufficient expertise in organic production or handling techniques to successfully perform the duties assigned. They must also show that all persons who review applications for certification perform on­ site inspections, review certification documents, 193 evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and that all parties responsibly connected to the certifying agent have revealed existing or potential conflicts of interest. Applicants who currently certify production or handling operations must also submit a list of the production and handling operations currently certified by them. For each area in which the applicant requests accreditation, the applicant should furnish copies of inspection reports and certification evaluation documents for at least three operations. If the applicant underwent any other accrediting process in the year previous to the application, the applicant should also submit the results of the process. Certifying agents are prohibited from giving advice or providing consultancy services to certification applicants or certified operations for overcoming identified barriers to certification. This requirement does not apply to voluntary education programs available to the general public and sponsored by the certifying agent. The Administrator will provide oversight of the fees to ensure that the schedule of fees filed with the Administrator is applied uniformly and in a nondiscriminatory manner. The Administrator may inform a certifying agent that its fees appear to be unreasonable and require that the certifying agent justify the fees. The Administrator will investigate the level of fees charged by an accredited certifying agent upon receipt of a valid complaint or under compelling circumstances warranting such an investigation. Statement of Agreement. Upon receipt of the certifying agent's application for accreditation, the Administrator will send a statement of agreement to the person responsible for the certifying agent's day­ to­ day 194 operations for signature. The statement of agreement affirms that, if granted accreditation as a certifying agent under this subpart, the applicant will carry out the provisions of the Act and the regulations in this part. Accreditation will not be approved until this statement is signed and returned to the Administrator. The statement of agreement will include the applicant's agreement to accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to section 205.500 and the applicant's agreement to refrain from making false or misleading claims about its accreditation status, the USDA accreditation program, or the nature or qualities of products labeled as organically produced. Further, the statement will include the applicant's agreement to pay and submit the fees charged by AMS and to comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary. Applicants are also required to affirm through this statement of agreement that they will: ( 1) conduct an annual performance evaluation of all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services; and ( 2) have an annual program review conducted of their certification activities by their staff, an outside auditor, or a consultant who has expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part that are identified in the evaluation. A private entity certifying agent must additionally agree to hold the Secretary harmless for any failure on the agent's part to carry out the provisions of the Act and regulations. A private entity certifying agent's statement will also include an agreement to furnish reasonable security for 195 the purpose of protecting the rights of operations certified by such certifying agent. Such security will be in an amount and according to such terms as the Administrator may by regulation prescribe. A private entity certifying agent must agree to transfer all records or copies of records concerning its certification activities to the Administrator if it dissolves or loses its accreditation. This requirement for the transfer of records does not apply to a merger, sale, or other transfer of ownership of a certifying agent. A private entity certifying agent must also agree to make such records available to any applicable SOP's governing State official. Granting Accreditation. Upon receiving all the required information, including the statement of agreement, and the required fee, the Administrator will determine if the applicant meets the requirements for accreditation. The Administrator's determination will be based on a review of the information submitted and, if necessary, a review of the information obtained from a site evaluation. The Administrator will notify the applicant of the granting of accreditation in writing. The notice of accreditation will state the area( s) for which accreditation is given, the effective date of the accreditation, any terms or conditions for the correction of minor noncompliances, and, for a private­ entity certifying agent, the amount and type of security that must be established. Certifying agents who apply for accreditation and do not meet the requirements for accreditation will be provided with a notification of noncompliance which will describe each noncompliance, the facts on which the notification is based, and the date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. If the applicant is successful in its rebuttal or provides acceptable evidence demonstrating correction of the noncompliances, the NOP Program Manager 196 will send the applicant a written notification of noncompliance resolution and proceed with further processing of the application. If the applicant fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, fails to file a rebuttal by the date specified in the notification of noncompliance, or is unsuccessful in its rebuttal, the Program Manager will issue a written notification of accreditation denial to the applicant. An applicant who has received written notification of accreditation denial may apply for accreditation again at any time or file an appeal of the denial of accreditation with the Administrator by the date specified in the notification of accreditation denial. Once accredited, a certifying agent may establish a seal, logo, or other identifying mark to be used by certified production and handling operations. However, the certifying agent may not require use of its seal, logo, or other identifying mark on any product sold, labeled, or represented as organically produced as a condition of certification. The certifying agent also may not require compliance with any production or handling practices other than those provided for in the Act and regulations as a condition for use of its identifying mark. However, certifying agents certifying production or handling operations within a State with more restrictive requirements, approved by the Administrator, shall require compliance with such requirements as a condition of use of their identifying mark by such operations. Site Evaluations. One or more representatives of the Administrator will perform site evaluations for each certifying agent in order to examine the certifying agent's operations and to evaluate compliance with the Act and regulations. Site evaluations will include an on­ site review of the certifying agent's certification procedures, decisions, facilities, administrative and management systems, and 197 production or handling operations certified by the certifying agent. A site evaluation of an accreditation applicant will be conducted before or within a reasonable time after issuance of the applicant's notification of accreditation. Certifying agents will be billed for each site evaluation conducted in association with an initial accreditation, amendments to an accreditation, and renewals of accreditation. Certifying agents will not be billed by USDA for USDA­ initiated site evaluations conducted to determine compliance with the Act and regulations. As noted above, a certifying agent may be accredited prior to a site evaluation. If the Program Manager finds, following the site evaluation, that an accredited certifying agent is not in compliance with the Act or regulations, the Program Manager will issue the certifying agent a written notification of noncompliance. If the certifying agent fails to correct the noncompliances, report the corrections by the date specified in the notification of noncompliance, or file a rebuttal by the date specified in the notification of noncompliance, the Administrator will begin proceedings to suspend or revoke the accreditation. A certifying agent that has had its accreditation suspended may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and regulations. A certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination. Peer Review Panels. The Administrator shall establish a peer review panel pursuant to the Federal Advisory Committee Act ( FACA) ( 5 U. S. C. App. 2 et seq.). The peer review panel shall be composed of 3 ISO/ IEC Guide 61 is available for viewing at USDA­ AMS, Transportation and Marketing Programs, Room 2945­ South Building, 14th and Independence Ave., SW, Washington, DC, from 9: 00 a. m. to 4: 00 p. m., Monday through Friday ( except official Federal holidays). A copy may be obtained from the American National Standards Institute, 11 West 42d Street, New York, NY 10036; Website: www. ansi. org; E­ mail: ansionline@ ansi. org; Telephone: 212­ 642­ 4900; Facsimile: 212­ 398­ 0023. 198 not fewer than three members who shall annually evaluate the NOP's adherence to the accreditation procedures in subpart F of these regulations and ISO/ IEC Guide 613, General requirements for assessment and accreditation of certification/ registration bodies, and the NOP's accreditation decisions. This will be accomplished through the review of: ( 1) accreditation procedures, ( 2) document review and site evaluation reports, and ( 3) accreditation decision documents or documentation. The peer review panel shall report its finding, in writing, to the NOP Program Manager. Continuing Accreditation. An accredited certifying agent must submit annually to the Administrator, on or before the anniversary date of the issuance of the notification of accreditation, the following reports and fees: ( 1) a complete and accurate update of its business information, including its fees, and information evidencing its expertise in organic production or handling and its ability to comply with these regulations; ( 2) information supporting any changes requested in the areas of accreditation; ( 3) a description of measures implemented in the previous year and any measures to be implemented in the coming year to satisfy any terms and conditions specified in the most recent notification of accreditation or notice of renewal of accreditation; ( 4) the results of the most recent performance evaluations and annual program review and a description of adjustments to the certifying agent's operation and procedures implemented or to be implemented in response to the performance 199 evaluations and program review; and ( 5) the required AMS fees. Certifying agents will keep the Administrator informed of their certification activities by providing the Administrator with a copy of: ( 1) any notice of denial of certification, notification of noncompliance, notification of noncompliance correction, notification of proposed suspension or revocation, and notification of suspension or revocation issued simultaneously with its issuance and ( 2) a list, on January 2 of each year, including the name, address, and telephone number of each operation granted certification during the preceding year. One or more site evaluations will occur during the 5­ year period of accreditation to determine whether an accredited certifying agent is complying with the Act and regulations. USDA will establish an accredited certifying agent compliance monitoring program, which will involve no less than one randomly selected site evaluation of each certifying agent during its 5­ year period of accreditation. Larger and more diverse operations, operations with clients marketing their products internationally, and operations with a history of problems should expect more frequent site evaluations by USDA. Operations with clients marketing their products internationally will be annually site evaluated to meet the ISO­ Guide 61 requirement for periodic surveillance of accredited certifying agents. USDA may also conduct site evaluations during investigations of alleged or suspected violations of the Act or regulations and in followup to such investigations. Such investigations will generally be the result of complaints filed with the Administrator alleging violations by the certifying agent. Compliance site evaluations may be announced or unannounced at the discretion of the Administrator. Certifying agents will not be billed by USDA for USDA­ initiated site evaluations conducted to determine compliance with the Act and regulations. 200 An accredited certifying agent must provide sufficient information to persons seeking certification to enable them to comply with the applicable requirements of the Act and these regulations. The certifying agent must maintain strict confidentiality with respect to its clients and not disclose to third parties ( with the exception of the Secretary or the applicable SOP's governing State official or their authorized representatives) any business­ related information concerning any client obtained while implementing these regulations except as authorized by regulation. A certifying agent must make the following information available to the public: ( 1) certification certificates issued during the current and 3 preceding calender years; ( 2) a list of producers and handlers whose operations it has certified, including for each the name of the operation, type( s) of operation, products produced, and the effective date of the certification, during the current and 3 preceding calender years; and ( 3) the results of laboratory analyses for residues of pesticides and other prohibited substances conducted during the current and 3 preceding calender years. A certifying agent may make other business information available to the public if permitted in writing by the producer or handler. This information will be made available to the public at the public's expense. An accredited certifying agent must maintain records according to the following schedule: ( 1) records obtained from applicants for certification and certified operations must be maintained for not less than 5 years beyond their receipt; ( 2) records created by the certifying agent regarding applicants for certification and certified operations must be maintained for not less than 10 years beyond their creation; and ( 3) records created or received by the certifying agent pursuant to the accreditation requirements, excluding any records covered by the 10­ year requirement, must be maintained for not less than 5 years beyond their creation or receipt. Examples of records 201 obtained from applicants for certification and certified operations include organic production system plans, organic handling system plans, application documents, and any documents submitted to the certifying agent by the applicant/ certified operation. Examples of records created by the certifying agent regarding applicants for certification and certified operations include certification certificates, notices of denial of certification, notification of noncompliance, notification of noncompliance correction, notification of proposed suspension or revocation, notification of suspension or revocation, correspondence with applicants and certified operations, on­ site inspection reports, documents concerning residue testing, and internal working papers and memorandums concerning applicants and certified operations. Examples of records created or received by the certifying agent pursuant to the accreditation requirements include operations manuals; policies and procedures documents ( personnel, administrative); training records; annual performance evaluations and supporting documents; conflict of interest disclosure reports and supporting documents; annual program review working papers, memorandums, letters, and reports; fee schedules; annual reports of operations granted certification; application materials submitted to the NOP; correspondence received from and sent to USDA; and annual reports to the Administrator. The certifying agent must make all records available for inspection and copying during normal business hours by authorized representatives of the Secretary and the applicable SOP's governing State official. In the event that the certifying agent dissolves or loses its accreditation, it must transfer to the Administrator and make available to any applicable SOP's governing State official all records or copies of records concerning its certification activities. This requirement for the transfer of records does not apply to a merger, sale, or other transfer of ownership of a 202 certifying agent. Certifying agents are also required to prevent conflicts of interest and to require the completion of an annual conflict of interest disclosure report by all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent. Coverage of the conflict of interest provisions extends to immediate family members of persons required to complete an annual conflict of interest disclosure report. A certifying agent may not certify a production or handling operation if the certifying agent or a responsibly connected party of such certifying agent has or has held a commercial interest in the production or handling operation, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification. A certifying agent may certify a production or handling operation if any employee, inspector, contractor, or other personnel of the certifying agent has or has held a commercial interest, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification. However, such persons must be excluded from work, discussions, and decisions in all stages of the certification process and the monitoring of the entity in which they have or have held a commercial interest. The acceptance of payment, gifts, or favors of any kind, other than prescribed fees, from any business inspected is prohibited. However, a certifying agent that is a not­ for­ profit organization with an Internal Revenue Code tax exemption or, in the case of a foreign certifying agent, a comparable recognition of not­ for­ profit status from its government, may accept voluntary labor from certified operations. Certifying agents are also prohibited from 203 giving advice or providing consultancy services to certification applicants or certified operations for overcoming identified barriers to certification. To further ensure against conflict of interest, the certifying agent must ensure that the decision to certify an operation is made by a person different from the person who conducted the on­ site inspection. The certifying agent must reconsider a certified operation's application for certification when the certifying agent determines, within 12 months of certifying the operation, that a person participating in the certification process and covered under section 205.501( c)( 11)( ii) has or had a conflict of interest involving the applicant. If necessary, the certifying agent must perform a new on­ site inspection. All costs associated with a reconsideration of an application, including onsite inspection costs, shall be borne by the certifying agent. When it is determined that, at the time of certification, a conflict of interest existed between the applicant and a person covered under section 205.501( c)( 11)( i), the certifying agent must refer the certified operation to a different accredited certifying agent for recertification. The certifying agent must also reimburse the operation for the cost of the recertification. No accredited certifying agent may exclude from participation in or deny the benefits of the NOP to any person due to discrimination because of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status. Accredited certifying agents must accept all production and handling applications that fall within their areas of accreditation and certify all qualified applicants, to the extent of their administrative capacity to do so, without regard to size or membership in any association or group. Renewal of Accreditation. To avoid a lapse in accreditation, certifying agents must apply for renewal of accreditation 204 at least 6 months prior to the fifth anniversary of issuance of the notification of accreditation and each subsequent renewal of accreditation. The Administrator will send the certifying agent a notice of pending expiration of accreditation approximately 1 year prior to the scheduled date of expiration. The accreditation of certifying agents who make timely application for renewal of accreditation will not expire during the renewal process. The accreditation of certifying agents who fail to make timely application for renewal of accreditation will expire as scheduled unless renewed prior to the scheduled expiration date. Certifying agents with an expired accreditation must not perform certification activities under the Act and these regulations. Following receipt of the certifying agent's annual report and fees and the results of a site evaluation, the Administrator will determine whether the certifying agent remains in compliance with the Act and regulations and should have its accreditation renewed. Upon a determination that the certifying agent is in compliance with the Act and regulations, the Administrator will issue a notice of renewal of accreditation. The notice of renewal will specify any terms and conditions that must be addressed by the certifying agent and the time within which those terms and conditions must be satisfied. Renewal of accreditation will be for 5 years. Upon a determination that the certifying agent is not in compliance with the Act and regulations, the Administrator will initiate proceedings to suspend or revoke the certifying agent's accreditation. Any certifying agent subject to a proceeding to suspend or revoke its accreditation may continue to perform certification activities pending resolution of the proceedings to suspend or revoke the accreditation. Amending accreditation. An accredited certifying agent may request amendment to its accreditation at any time. 205 The application for amendment must be sent to the Administrator and must contain information applicable to the requested change in accreditation, a complete and accurate update of the certifying agent's application information and evidence of expertise and ability, and the applicable fees. Accreditation ­ Changes Based on Comments This subpart differs from the proposal in several respects as follows: ( 1) Advice and Consultancy Services. We have amended section 205.501( a)( 11)( iv) to clarify that certifying agents are to prevent conflicts of interest by not giving advice or providing consultancy services to applicants for certification and certified operations for overcoming identified barriers to certification. This amendment has been made in response to a commenter who stated that the provisions of section 205.501( a)( 11)( iv), as proposed, seemed to preclude the providing of advice and educational workshops and training programs. It was not our intent to prevent certifying agents from sponsoring in­ house publications, conferences, workshops, informational meetings, and field days for which participation is voluntary and open to the general public. The provisions as originally proposed and as amended are intended to prohibit certifying agents from telling applicants and certified operations how to overcome barriers to certification identified by the certifying agent. It would be a conflict of interest for a certifying agent to tell an operation how to comply inasmuch as the certifying agents impartiality and objectivity will be lost should the advice or consultancy prove ineffective in resolving the noncompliance. The provisions of section 205.501( a)( 11)( iv) are consistent with ISO Guide 61. To further clarify this issue, we have also amended section 205.501( a)( 16) by adding " for certification activities" after the word, " charges." 206 ( 2) Conflicts of Interest ­ Persons Covered. We have amended section 205.501( a)( 11)( v) to limit the completion of annual conflict of interest disclosure reports to all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent. A commenter recommended amending section 205.501( a)( 11)( v) to have it apply to all persons with direct oversight of or participation in the certification program rather than all persons identified in section 205.504( a)( 2). Section 205.504( a)( 2) includes all personnel to be used in the certification operation, including administrative staff, certification inspectors, members of any certification review and evaluation committees, contractors, and all parties responsibly connected to the certifying agent. We have decided that completion of annual conflict of interest disclosure reports by persons not involved in the certification process or responsibly connected to the certifying agent is unnecessary. As amended, section 205.501( a)( 11)( v) includes all persons with the opportunity to influence the outcome of a decision on whether to certify a specific production or handling operation. Completed conflict of interest disclosure reports will be used by certifying agents to identify persons with interests in applicants for certification and certified operations that may affect the impartiality of such persons. ( 3) Reporting Certifications Granted. We have amended section 205.501( a)( 15)( ii) ( formerly section 205.501( a)( 14)( ii)) by replacing " a quarterly calendar basis" with " January 2 of each year." A commenter stated that the requirement that certifying agents report certifications that they have granted on a quarterly basis to the Administrator is burdensome. The commenter requested that section 205.501( a)( 14)( ii) be amended to require a midyear or end­ year reporting. 207 Section 205.501( a)( 15)( ii) now requires the certifying agent to submit a list, on January 2 of each year, including the name, address, and telephone number of each operation granted certification during the preceding year. Certifying agents can fulfill this requirement by providing an up­ todate copy of the list of producers and handlers required to be made available to the public by section 205.504( b)( 5)( ii). ( 4) Notification of Inspector. We have added a new section 205.501( a)( 18) requiring the certifying agent to provide the inspector, prior to each on­ site inspection, with previous on­ site inspection reports and to notify the inspector of the certifying agent's decision relative to granting or denying certification to the applicant site inspected by the inspector. Such notification must identify any requirements for the correction of minor noncompliances. We have made this addition because we agree with the commenter that such information should be provided to the inspector and because the requirements are consistent with ISO Guide 61. ( 5) Acceptance of Applications. We have added a new section 205.501( a)( 19) requiring the certifying agent to accept all production or handling applications for certification that fall within the certifying agent's areas of accreditation and to certify all qualified applicants, to the extent of their administrative capacity to do so, without regard to size or membership in any association or group. We have made this addition because we agree with the many commenters who requested that certifying agents be required to certify all qualified applicants. We recognize, however, that there may be times when the certifying agent's workload or the size of its client base might make it necessary for the certifying agent to decline acceptance of an application for certification within its area of accreditation. This is why we have included the proviso, " to the extent of their administrative capacity to do so." We have included " without regard to size or 208 membership in any association or group" to address commenter concerns about discrimination in the providing of certification services. This addition is consistent with ISO Guide 61. ( 6) Ability to Comply with SOP. We have added a new section 205.501( a)( 20) requiring the certifying agent to demonstrate its ability to comply with an SOP, to certify organic production or handling operations within the State. This change, as pointed out by a State commenter, is necessary to clarify that a certifying agent must be able to comply with an SOP to certify production or handling operations within that State. ( 7) Performance Evaluation. We have amended section 205.501( a)( 6) by replacing " appraisal" with " evaluation" and expanding the coverage from inspectors to persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions. Corresponding amendments have also been made to section 205.510( a)( 4). Further, we have amended section 205.501( a)( 6) to clarify that the deficiencies to be corrected are deficiencies in certification services. We changed " appraisal" to " evaluation" at the request of a State commenter who pointed out that State inspectors generally perform other duties in addition to the inspection of organic production or handling operations. We concur that this change will help differentiate between the State's employee performance appraisal for all duties as a State employee and the evaluation of certification services provided under the NOP. Expanding the coverage from inspectors to all persons involved in the certification process makes the regulation consistent with ISO Guide 61. Sections 205.505( a)( 3) and 205.510( a)( 4) have been amended to make their language consistent with the changes to section 205.501( a)( 6). ( 8) Annual Program Evaluation. We have amended section 205.501( a)( 7) by replacing 209 " evaluation" with " review" and by replacing " evaluations" with " reviews." A commenter suggested amending section 205.501( a)( 7) by replacing the requirement of an annual program evaluation with an annual review of program activities. We agree that " review" is a more appropriate term than " evaluate" since to review is to examine, report, and correct while evaluate is more in the nature of assessing value. We have not, however, accepted that portion of the commenter's suggestion which would have removed the reference to the review being conducted by the certifying agent's staff, an outside auditor, or a consultant who has the expertise to conduct such reviews. We have not accepted this suggestion because the comment would have limited the review to being conducted by the certifying agent with no requirement that the certifying agent be qualified to conduct the review. Another commenter wanted to change the requirement to an annual assessment of the quality of the inspection system. We have not accepted this suggestion because it can be interpreted as narrowing the scope of the review from the full certification program to just the inspection component of the certification program. This commenter would also have limited the review to being conducted by the certifying agent with no requirement that the certifying agent be qualified to conduct the review. We believe that narrowing the scope of the review would be inconsistent with ISO Guide 65. It is also inconsistent with our intent that the entire certification program be reviewed annually. We also received a comment stating that it is a violation of ISO Guide 65 to have staff perform an internal review. We disagree with this commenter. ISO Guide 65 provides that the certification body shall conduct periodic internal audits covering all procedures in a planned and systematic manner. Sections 205.505( a)( 4) and 205.510( a)( 4) have been amended to make their language consistent with the changes to section 205.501( a)( 7). 210 ( 9) Certification Decision. We have added a new section 205.501( a)( 11)( vi) that requires the certifying agent to ensure that the decision to certify an operation is made by a person different from the person who carried out the on­ site inspection. Commenters requested that this provision be added to the requirement that certifying agents prevent conflicts of interest. We concur with the request because it clearly separates the act of inspecting an organic operation from the act of granting certification. This addition is also consistent with ISO Guide 65, section 4.2( f), which requires that the certification body ensure that each decision on certification is taken by a person different from those who carried out the evaluation. ( 10) Determination of Conflict of Interest. We have added a new section 205.501( a)( 12) addressing situations where a conflict of interest present at the time of certification is identified after certification. Several commenters requested the addition of a provision that, if a conflict of interest is identified within 12 months of certification, the certifying agent must reconsider the application and may reinspect the operation if necessary. We agree with the commenters that the issue of conflicts of interest present at the time of certification but identified after certification need to be addressed in the regulations. Accordingly, we have provided that an entity accredited as a certifying agent must reconsider a certified operation's application for certification and, if necessary, perform a new on­ site inspection when it is determined, within 12 months of certifying the operation, that any person participating in the certification process and covered under section 205.501( a)( 11)( ii) has or had a conflict of interest involving the applicant. Because the certifying agent is responsible for preventing conflicts of interest, all costs associated with a reconsideration of application, including onsite inspection costs, must be borne by the certifying agent. Further, a certifying agent must refer a certified operation to a different accredited certifying agent for 211 recertification when it is determined that any person covered under section 205.501( a)( 11)( i) at the time of certification of the applicant had a conflict of interest involving the applicant. Because the certifying agent is responsible for preventing conflicts of interest, the certifying agent must reimburse the operation for the cost of the recertification. Sections 205.501( a)( 12) through 205.501( a)( 17) have been redesignated as sections 205.501( a)( 13) through 205.501( a)( 18), respectively. ( 11) Financial Security. We published an advanced notice of proposed rulemaking and request for comments regarding financial security in the August 9, 2000, issue of the Federal Register. We issued a news release announcing the Federal Register publication on August 9, 2000. Numerous commenters expressed concern about reasonable security relative to its amount and impact on small certifying agents. A few commenters requested a definition for reasonable security. Others stated that the formula for determining the amount of security should be published in the Federal Register. The March 13, 2000, NOP proposed rule stated that the amount and terms of reasonable financial security would be the subject of additional rulemaking. The August 9, 2000, advanced notice of proposed rulemaking solicited comments on all aspects of reasonable security and protection of the rights of program participants. We requested comments from any interested parties, including producers and handlers of organic agricultural products, certifying agents, importers and exporters, the international community, and any other person or group. Six questions were provided to facilitate public comment on the advanced notice of proposed rulemaking. Comments addressing other relevant issues were also invited. The questions posed in the advanced notice of proposed rulemaking were: ( 1) From what risks or events might a customer of a private certifying agent require 212 reasonable security? ( 2) What are the financial instrument( s) that could provide the reasonable security to protect customers from these events? ( 3) What dollar amounts of security would give reasonable protection to a customer of a private certifying agent? ( 4) What are the financial costs to private certifiers, especially small certifiers, of providing reasonable security? ( 5) Do the risks or events provided in response to question # 1 necessarily require financial compensation? ( 6) Are there situations in which reasonable security is not needed? Following analysis of the comments received, we will publish a proposed rule on reasonable security in the Federal Register. The public will again be invited to submit comments. The proposed rule will include the proposed regulation, an explanation of the decision­ making process, an analysis of the costs and benefits, the effects on small businesses, and an estimate of the paperwork burden imposed by the regulation. ( 12) Use of Identifying Mark. We have amended section 205.501( b)( 2) to clarify that all certifying agents ( private and State) certifying production or handling operations within a State with more restrictive requirements, approved by the Secretary, shall require compliance with such requirements as a condition of use of their identifying mark by such operations. Numerous commenters stated that they wanted USDA to permit higher production standards by private certifying agents. See also item 17 under Accreditation ­ Changes Requested But Not Made. This amendment is intended to further clarify our position that no certifying agent ( State or 213 private) may establish or require compliance with its own organic standards. It is an SOP, not a State certifying agent, that receives approval from the Secretary for more restrictive requirements. See also item 7 under Accreditation ­ Clarifications. ( 13) Transfer of Records. To address the issues of a merger, sale, or other transfer of ownership, we have added the following to the end of section 205.501( c)( 3); " Provided, That, such transfer shall not apply to a merger, sale, or other transfer of ownership of a certifying agent." Commenters suggested amending section 205.501( c)( 3) to provide for the transfer of records accumulated from the time of accreditation to the Administrator or his or her designee, another accredited certifying agent, or an SOP's governing State official in a State where such official exists. It was also stated that this section needs to take into account a certifying agent's decision to merge or transfer accounts to another certifying agent in the case of loss of accreditation. Under the NOP, should a certifying agent dissolve or lose its accreditation, its certified operations will be free to seek certification with the accredited certifying agent of their choice. Accordingly, it would be inappropriate to automatically transfer an operation's records to another certifying agent as requested by the commenters. However, in analyzing the comments, we realized that a provision was needed for a merger, sale, or other transfer of ownership of a certifying agent; thus, the amendment to section 205.501( c)( 3). Section 205.505( b)( 3) has been amended to make its language consistent with the changes to section 205.501( c)( 3). ( 14) Fees for Information. We have amended section 205.504( b)( 5) by inserting " including any fees to be assessed" after the word, " used." This change is made in response to the question of whether fees may be charged for making information available to the public. It is our intent that certifying agents may charge reasonable fees for document search time, duplication, 214 and, when applicable, review costs. We anticipate that review costs will most likely be incurred when the information requested is located within documents which may contain confidential business information. ( 15) Information Available to the Public. We have amended section 205.504( b)( 5)( ii) by adding products produced to the information to be released to the public. This addition responds in an alternate way to commenters who wanted the information included on certificates of organic operation. That request was denied; see item 4, Changes Requested But Not Made, under subpart E, Certification. This addition is consistent with ISO Guide 61. ( 16) Equivalency of Certification Decisions and Statement of Agreement. We have amended sections 205.501( a)( 12) ( redesignated as 205.501( a)( 13)) and 205.505( a)( 1) by deleting the words, " USDA accredited" and " as equivalent to its own," and adding to the end thereof: " accredited or accepted by USDA pursuant to section 205.500." We have made this amendment to clarify that the provision applies to certification decisions by domestic certifying agents as well as foreign certifying agents accredited or accepted by USDA pursuant to section 205.500. There were many comments in support of section 205.501( a)( 12) as written. However some did not agree that certifying agents should have to recognize another agent's decision as equivalent to their own. These commenters want to maintain the right and ability not to use their seal on a product that does not meet their standards. The most strongly voiced comment stated: " delete section 205.501( a)( 12) and section 205.505( a)( 1). The requirements constitute a " taking" in violation of the Fifth Amendment and are unnecessary to accomplish the goal of establishing a consistent standard and facilitating trade." We do not concur with the commenters who want to change sections 205.501( a)( 12) and 215 205.505( a)( 1). We also do not agree with the comment that sections 205.501( a)( 12) and 205.505( a)( 1) constitute a taking in violation of the Fifth Amendment and are unnecessary to accomplish the goal of establishing a consistent standard and facilitating trade. We believe that, to accomplish the goal of establishing a consistent standard and to facilitate trade, it is vital that an accredited certifying agent accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to section 205.500. All domestic organic production and handling operations, unless exempted or excluded under section 205.101, must be certified to these national standards and, when applicable, any State standards approved by the Secretary. All domestic certified operations must be certified by a certifying agent accredited by the Administrator. No USDA­ accredited certifying agent, domestic or foreign, may establish or require compliance with its own organic standards. Certifying agents are not required to have an identifying mark for use under the NOP. However, if a certifying agent is going to use an identifying mark under the NOP, the use of such mark must be voluntary and available to all of the certifying agent's clients certified under the NOP. Accordingly, we have not changed the requirement that a certifying agent accept the certification decisions made by another USDAaccredited certifying agent. We have, however, as noted above, amended both sections to require that USDA­ accredited certifying agents accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to section 205.500. ( 17) Granting Accreditation. We have made editorial changes to section 205.506 consistent with the suggestion that we replace " approval of accreditation" with " granting of accreditation." In the title to section 205.506, we have replaced " Approval of" with " Granting." In section 205.506( a), we have replaced " approved" with " granted," and in section 205.506( b), 216 we have replaced " approval" with " the granting." We have made these change because, under the NOP, we grant accreditation rather than approve accreditation. ( 18) Correction of Minor Noncompliances. We have added a new section 205.506( b)( 3) providing that the notification granting accreditation will state any terms and conditions for the correction of minor noncompliances. Commenters requested the addition of language to section 205.506( b) which would clarify that the Administrator may accredit with required corrective actions for minor noncompliances. In the proposed rule, we addressed accreditation subject to the correction of minor noncompliances at section 205.510( a)( 3). We agree with commenters that, for the purposes of clarity, this issue should also be addressed in section 205.506 on the granting of accreditation. Accordingly, we have added new section 205.506( b)( 3) as noted above. We have also retained the provisions of section 205.510( a)( 3), which requires certifying agents to annually report on actions taken to satisfy any terms and conditions addressed in the most recent notification of accreditation or notice of renewal of accreditation. Section 205.506( b)( 3) has been redesignated as section 205.506( b)( 4). ( 19) Denial of Accreditation. We have amended section 205.507 to include noncompliance and resolution provisions originally included by cross­ reference to section 205.665( a). This cross­ reference created confusion for commenters, regarding section 205.665' s applicability to applicants for accreditation because the section does not specifically address applicants. Rather than specifically identifying applicants within section 205.665, we believe the issue is best clarified by addressing noncompliance and resolution within section 205.507. As amended, section 205.507 now states in paragraph ( a) that the written notification of noncompliance must describe each noncompliance, the facts on which the notification is based, 217 and the date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. This rewrite of paragraph ( a) also enabled us to eliminate paragraph ( b) since its provisions are addressed in amended paragraph ( a). The section also provides, at new paragraph ( b), that when each noncompliance has been resolved, the Program Manager will send the applicant a written notification of noncompliance resolution and proceed with further processing of the application. We have also clarified the applicant's appeal rights by adding " or appeal the denial of accreditation in accordance with section 205.681 by the date specified in the notification of accreditation denial" to the end of paragraph ( c). ( 20) Reinstatement of Accreditation. We have amended section 205.507( d) by removing the requirement that a certifying agent that has had its accreditation suspended reapply for accreditation in accordance with section 205.502. In its place, we provide that the certifying agent may request reinstatement of its accreditation. Such request may be submitted at any time unless otherwise stated in the notification of suspension. Amended section 205.507( d) also provides that the certifying agent's request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. We have made this change because unlike revocation, suspension does not terminate a certifying agent's accreditation. Accordingly, requiring a new application for accreditation is unnecessary and burdensome on the certifying agent. This change is consistent with changes to sections 205.662( f) and 205.665( g)( 1), which were made based on comments received on section 205.662( f). ( 21) Ineligible for accreditation. We have amended section 205.507( d) by deleting 218 " private entity" from the third sentence. The amended sentence provides that " A certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination." Several commenters recommended deletion of " private entity" so that private certifying agents would be regulated on an equivalent basis with State certifying agents. It is our intent to regulate private and State certifying agents on an equivalent basis. Accordingly, we made the recommended change. ( 22) Peer Review. We have amended section 205.509. As amended, the section requires that the Administrator establish a peer review panel pursuant to FACA ( 5 U. S. C. App. 2 et seq.). The peer review panel will be composed of not less than 3 members who will annually evaluate the NOP's adherence to the accreditation procedures in subpart F of these regulations and ISO/ IEC Guide 61, General requirements for assessment and accreditation of certification/ registration bodies, and the NOP's accreditation decisions. This will be accomplished through the review of accreditation procedures, document review and site evaluation reports, and accreditation decision documents and documentation. The peer review panel will report its finding, in writing, to the NOP's Program Manager. We developed this approach to peer review as a means of addressing the suggestions of the commenters and the need for administration of an effective and timely accreditation program. Many commenters wanted the opening language in the first sentence of section 205.509 changed from " The Administrator may" to the " The Administrator shall" establish a peer review panel to assist in evaluating applicants for accreditation, amendment to an accreditation, and renewal of accreditation as certifying agents. One of the most frequent comments, including a comment by the NOSB, was that peer reviewers should be compensated for their time and 219 expenses. Many commenters believe also that the peer review process should be collaborative. Some commenters who wanted this change recognized that a collaborative process where confidential information was shared could run into problems because FACA ( P. L. 92­ 463, 5 U. S. C. App.) meetings are open to the public. They advised creating a FACA panel but restricting public access during discussion of confidential business information based on 5 U. S. C. Section 522b( c)( 4) of the Government in the Sunshine Act. As requested, amended section 205.509 requires the formation of a peer review panel. Also as requested, peer reviewers, who will serve as a FACA committee, will be reimbursed for their travel and per diem expenses. The reviewers will also work collaboratively. We have not, however, provided for collaborative review of each applicant for accreditation by the peer review panel because of the administrative burden that an outside collaborative review process would place on the NOP. Currently, there are 36 private and 13 State certifying agencies. It is, therefore, likely that USDA will receive approximately 50 applications for accreditation the first year of the program. Given the need to make accreditation decisions in a timely, organized fashion, it would be infeasible to convene a panel of peers for each applicant for accreditation prior to rendering a decision on accreditation. However, as noted above, we have provided that a peer review panel will annually evaluate the NOP's adherence to the accreditation procedures in subpart F of these regulations and ISO/ IEC Guide 61, General requirements for assessment and accreditation of certification/ registration bodies, and validate the NOP's accreditation decisions. We have also amended current section 205.510( c)( 3) by removing the reference to reports submitted by a peer review panel to make that section consistent with the rewrite of section 205.509. 220 ( 23) Expiration of accreditation. We have added a new section 205.510( c)( 1) which provides that the Administrator shall send the accredited certifying agent a notice of pending expiration of accreditation approximately 1 year prior to the scheduled date of expiration. A commenter suggested USDA notification of certifying agents at least 1 year prior to the scheduled expiration of accreditation. We have made the suggested change because we believe notification about 1 year prior to expiration will facilitate the timely receipt of applications for renewal. We have redesignated sections 205.510( c)( 1) and 205.510( c)( 2) as 205.510( c)( 2) and 205.510( c)( 3), respectively. ( 24) Amendments to Accreditation. We have added a new section 205.510( f) to provide that an amendment to an accreditation may be requested at any time. The application for amendment must be sent to the Administrator and must contain information applicable to the requested change in accreditation. The application for amendment must also contain a complete and accurate update of the information submitted in accordance with section 205.503, Applicant information; and section 205.504, Evidence of expertise and ability. The applicant must also submit the applicable fees required in section 205.640. We have added this new section because we agree with the commenter who expressed concern that the regulations were not clear regarding amendments to accreditation. This addition is consistent with section 205.510( a)( 2) which allows certifying agents to request amendment of their accreditation as part of their annual report to the Administrator. Accreditation ­ Changes Requested But Not Made This subpart retains from the proposed rule, regulations on which we received comments as follows: 221 ( 1) Accreditation by USDA. A commenter stated that ISO/ IEC Guide 61 specifies, but the proposed rule did not specify, the requirements for USDA to assess and accredit certifying agents. The commenter questioned USDA's acceptance internationally as a competent accreditation body. A few commenters requested that USDA provide certifying agents with assurance of international trade acceptance of the USDA's accreditation program prior to implementation of the final rule. We do not believe that it is necessary to include in these regulations detailed procedures by which USDA will operate its accreditation program. USDA has developed its accreditation and certification programs with the intent that they meet or exceed international guidelines. Every country will make its own decision regarding acceptance of this accreditation program. Accordingly, while we do not anticipate problems with acceptance of our accreditation program, we cannot provide assurance against problems as requested by the commenters. ( 2) Equivalency at the European Community ( EC) Level. A commenter requested confirmation that an equivalency agreement would be negotiated at the EC level since the EC legislation provides for the basic rules while accreditation of certifying agents is a task for each member state. Another commenter pointed out that because Switzerland has the same regulations as the EC, equivalency would have to be done in close coordination with the EC. The commenter went on to say that according to Swiss and European practice, not only the organic product, but also the bodies involved will be mutually accepted. This commenter also stated that, due to Swiss import provisions, brokers must be subject to a certain control. Equivalency will be negotiated between the United States and the foreign government authority seeking the equivalency agreement. 222 ( 3) Period of Accreditation. It was suggested that accreditation should be for a 4­ year period with full reevaluation occurring once every 4 years and annual surveillance visits in the intervening years. We do not concur with changing the period of accreditation from 5 years to 4 years as suggested. The 5­ year period that we have provided that accreditation is consistent with the Act, which provides that accreditation shall be for a period of not to exceed 5 years. The commenter claims that the international norm is for full reevaluations to take place once every 4 years with annual surveillance visits in the intervening years. ISO Guide 61, section 3.5.1, provides that the accreditation body shall have an established documented program, consistent with the accreditation granted, for carrying out periodic surveillance and reassessment at sufficiently close intervals to verify that its accredited body continues to comply with the accreditation requirements. We believe that accreditation for 5 years is a reasonable period of time. Further, we believe that a 5­ year period of accreditation is consistent with ISO Guide 61 inasmuch as we require an annual evaluation of the certification program; annual review of persons associated with the certification process, including inspectors; annual reporting with a complete and accurate update of information required for accreditation; and one or more site evaluations during the period of accreditation in addition to the initial site evaluation for the period of accreditation. Accordingly, we have not made the recommended change. ( 4) Accreditation by Private­ Sector Accreditation Bodies. Numerous commenters wanted language added to section 205.500( c) that would allow private sector accreditation bodies to accredit foreign certifying agents. For example, several commenters suggested adding a provision reading as follows: " The foreign certifying agent is accredited by a private accreditation body recognized by the USDA as defined by an equivalency agreement negotiated between the 223 USDA and the accreditation body." Commenters also wanted us to amend section 205.502( a) to recognize accreditation by private accreditation programs. USDA is the accrediting body for all accreditations under the NOP. USDA will not recognize nongovernmental accrediting bodies. USDA will recognize foreign certifying agents accredited by a foreign government authority when USDA determines that the foreign government's standards meet the requirements of the NOP or when an equivalency agreement has been negotiated between the United States and a foreign government. ( 5) Requirements for Accreditation. Some commenters requested more specificity in the requirements for accreditation. For example, one recommended that section 205.501( a)( 1) should include the requirement that inspectors demonstrate completion of a specified training program or internship or ongoing education and/ or licensing. Another commenter wanted baseline criteria for denying an application due to expertise. Still others wanted a definition for ( 1) " experience and training pertaining to organic/ sustainable agricultural methods and their implementation on farm or in processing facilities," ( 2) " trained certifying agent personnel," and ( 3) " reasonable time." Finally, one wanted recordkeeping and evaluative parameters. AMS does not believe that it is necessary to present the requirements for accreditation to the extent of detail requested by the commenters. The intent is to provide flexibility to the certifying agents such that they can tailor their policies and procedures to the nature and scope of their operation. The NOP is available to respond to questions and to assist certifying agents in complying with the requirements for accreditation. ( 6) Volunteer Board Members. Some commenters suggested amending section 205.501( a)( 5) to include a reference to committees and to expand " sufficient expertise" to 224 " sufficient balance of interests and expertise." The commenters proposed the amendment to create a firewall between those persons involved in decision making and the volunteer board members. However, the purpose of section 205.501( a)( 5) is to ensure that the persons used by the certifying agent to assume inspection, analysis, and decision­ making responsibilities have sufficient expertise in organic production or handling techniques to successfully perform the duties assigned. Therefore, we have not made the suggested changes. Conflict of interest guidelines are found at section 205.501( a)( 11). ( 7) Confidentiality. A commenter stated that Texas law prevents the Texas Department of Agriculture from guaranteeing confidentiality to its clients. Accordingly, the commenter requested that section 205.501( a)( 10) be amended by adding to the end thereof: " or as required by State statutes." We have not made the suggested change because the Act requires that the certifying agent maintain strict confidentiality with respect to its clients under the NOP and not disclose any business­ related information concerning such client obtained while implementing the Act. To be accredited under the NOP, certifying agents must fully comply with the requirements of the Act and these regulations. Further, no SOP will be approved which does not comply with the NOP. ( 8) Certifying Agent Fees. Several commenters requested that the regulations prohibit royalty formulas ( i. e., fees from every certified sale) for certifying agent fees. It is not our intent to regulate how a certifying agent sets its fees beyond their being reasonable and nondiscriminatory. ( 9) Conflicts of Interest. We received numerous comments stating that section 205.501( a)( 11)( i) was too restrictive and unnecessary due to the provisions of section 225 205.501( a)( 11)( ii) to prevent conflicts of interest. Some argued that these conflict of interest provisions are beyond ISO requirements and place an undue burden on membership based certifying agents and the entities they serve. They requested a conflict of interest policy enabling membership­ based certification organizations to continue operating. A commenter suggested that section 205.501( a)( 11) be amended to require that a certifying agent's board members sign an affidavit listing potential conflicts of interest, identify issues where an organization decision might help them personally, and exclude themselves from decision­ making that would assist them personally. This commenter proposed the amendment for the purpose of creating a firewall between those persons involved in certification decision­ making and the volunteer board members. We do not believe that the conflict of interest provisions are too restrictive. These provisions are very similar to conflict of interest provisions under other USDA programs involving public­ private partnerships ( e. g., grain inspection). The certifying agent and its responsibly connected parties, including volunteer board members, hold positions of influence over the certifying agent's employees and persons with whom the certifying agent contracts for such services as inspection, sampling, and residue testing. Therefore, we continue to believe that avoiding such conflicts of interest is necessary to maintain the integrity of the organic certification process. ( 10) Conflicts of Interest and Prohibition on Certification. A commenter requested that we include an " or" between sections 205.501( a)( 11)( i) and 205.501( a)( 11)( ii). We have not made the recommended change because both sections must be complied with; they are not mutually exclusive. Section 205.501( a)( 11)( i) prohibits the certification of an applicant when the certifying 226 agent or a responsibly connected party of such certifying agent has or has held a commercial interest in the applicant for certification, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification. When the certifying agent and its responsibly connected persons are free of any conflict of interest involving the applicant for certification, the applicant may be certified if qualified. However, section 205.501( a)( 11)( ii) requires the certifying agent to exclude any person ( employees and contractors who do not meet the definition of responsibly connected), including contractors, with conflicts of interest from work, discussions, and decisions in all stages of the certification process and the monitoring of certified production or handling operations for all entities in which such person has or has held a commercial interest, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification. ( 11) Gifts and Contributions. Commenters recommended that section 205.501( a)( 11)( iii) be amended to allow not­ for­ profit organizations to accept gifts and contributions from certified operations for those programs not directly related to the certifying agent's organic certification activities. They also wanted it clarified that not­ for­ profit organizations can accept voluntary labor from certified operations for those programs not directly related to the certifying agent's organic certification activities. We have not made the requested changes. First, the acceptance of gifts and contributions would constitute a conflict of interest and would be contrary to ISO Guide 61. Certifying agents must have the financial stability and resources to perform their certification duties without relying on gifts and contributions from those they serve. Second, we have not added the requested provision on voluntary labor because section 205.501( a)( 11)( iii) already 227 addresses the acceptance of voluntary labor by not­ for­ profit organizations from certified operations. ( 12) Conflicts of Interest ­ Determination Period. Commenters wanted to increase the conflict determination period from 12 months to 24 months. Some also wanted the period to extend for 2 years after, with the exception of those who have left the employ of the certifying agent or are no longer under contract with the certifying agent. We disagree with the recommendations calling for a longer precertification conflict of interest prohibition period. We continue to believe that 12 months is a sufficient period to ensure that any previous commercial interest would not create a conflict of interest situation for two reasons. First, this time period is consistent with similar provisions governing conflicts of interest for government employees. Second, section 205.501( a)( 11)( v) requires the completion of an annual conflict of interest disclosure report by all personnel designated to be used in the certification operation, including administrative staff, certification inspectors, members of any certification review and program evaluation committees, contractors, and all parties responsibly connected to the certification operation. This requirement will assist certifying agents in complying with the requirements to prevent conflicts of interest. We also continue to believe that a longer prohibition period would have the effect of severely curtailing most certifying agents' ability to comply with the Act's requirement that they employ persons with sufficient expertise to implement the applicable certification program. Accordingly, we have not made the recommended change. The change recommended by the commenters who requested that the conflict of interest determination period extend for 2 years after certification is unnecessary. Certifying agents and 228 their responsibly connected parties, employees, inspectors, contractors, and other personnel are prohibited from engaging in activities or associations at any time during their affiliation with the certifying agent which would result in a conflict of interest. While associated with the certifying agent, all employees, inspectors, contractors, and other personnel are expected to disclose to the certifying agent any offer of employment they have received and not immediately refused. They are also expected to disclose any employment they are seeking and any arrangement they have concerning future employment with an applicant for certification or a certified operation. The certifying agent would then have to exclude that person from work, discussions, and decisions in all stages of the certification or monitoring of the operation making the employment offer. If a certifying agent or a responsibly connected party of the certifying agent has received and not immediately refused an offer of employment, is seeking employment, or has an arrangement concerning future employment with an applicant for certification, the certifying agent may not accept or process the application. Further, certifying agents and responsibly connected parties may not seek employment or have an arrangement concerning future employment with an operation certified by the certifying agent while associated with that certifying agent. Certifying agents and responsibly connected parties must sever their association with the certifying agent when such person does not immediately refuse an offer of employment from a certified operation. Accordingly, we have decided not to include a postcertification prohibition period in this final rule. ( 13) False and Misleading Claims. A commenter asked who will determine what is a misleading claim about the nature or qualities of products labeled as organically produced. This same commenter recommended amending section 205.501( a)( 13) by removing the prohibition 229 against making false or misleading claims about the nature or qualities of products labeled as organically produced. We disagree with this recommendation. Claims regarding accreditation status, the USDA accreditation program for certifying agents, and the nature and quality of products labeled as organically produced all fall under the authority of the Act. Accordingly, USDA will determine what is a misleading claim. We believe that the requirements are needed to prevent the dissemination of inaccurate or misleading information to consumers about organically produced products. We further believe that the change suggested by the commenter would undermine the goal of a uniform NOP by allowing certifying agents to make claims that would state or imply that organic products produced by operations that they certify are superior to those of operations certified by other certifying agents. These requirements would not prohibit certifying agents from sharing factual information with consumers, farmers, processors, and other interested parties regarding verifiable attributes of organic food and organic production systems. Accordingly, we have not made the recommended change to what is now section 205.501( a)( 14). ( 14) Certifying Agent Compliance With Terms and Conditions Deemed Necessary. A commenter recommended that we remove section 205.501( a)( 17). This section requires that certifying agents comply with and implement other terms and conditions deemed necessary by the Secretary. This requirement is consistent with section 6515( d)( 2) of the Act, which requires a certifying agent to enter into an agreement with the Secretary under which such agent shall agree to such other terms and conditions as the Secretary determines appropriate. Accordingly, we have not accepted the commenter's recommendation. This requirement is located at current section 205.501( a)( 21). 230 ( 15) Limitations on the Use of Certifying Agent's Marks. Numerous commenters stated that they wanted USDA to permit higher production standards by private certifying agents. A common argument for allowing higher standards was that practitioners must be allowed to " raise the bar" through superior ecological on­ farm practices or pursuit of other social and ecological goals. Some commenters recommended that the language in section 205.501( b)( 2) be replaced with provisions that would allow certifying agents to issue licensing agreements with contract specifications that clearly establish conditions for use of the certifying agent's identifying mark. We believe the positions advocated by the commenters are inconsistent with section 6501( 2) of the Act, which provides that a stated purpose of the Act is to assure consumers that organically produced products meet a consistent national standard. We believe that, to accomplish the goal of establishing a consistent standard and to facilitate trade, it is vital that an accredited certifying agent accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to section 205.500. All organic production and handling operations, unless exempted or excluded under section 205.101 or not regulated under the NOP ( i. e., a producer of dog food), must be certified to these national standards and, when applicable, any State standards approved by the Secretary. All certified operations must be certified by a certifying agent accredited by the Administrator. No accredited certifying agent may establish or require compliance with its own organic standards. Accredited certifying agents may establish other standards outside of the NOP. They may not, however, refer to them as organic standards nor require that applicants for certification under the NOP or operations certified under the NOP comply with such standards as a requirement for certification under the NOP. Use of the certifying agent's identifying mark must be voluntary and available to all of its 231 clients certified under the NOP. However, a certifying agent may withdraw a certified operation's authority to use its identifying mark during a compliance process. The certifying agent, however, accepts full liability for any such action. The national standards implemented by this final rule can be amended as needed to establish more restrictive national standards. Anyone may request that a provision of these regulations be amended by submitting a request to the NOP Program Manager or the Chairperson of the NOSB. Requests for amendments submitted to the NOP Program Manager will be forwarded to the NOSB for its consideration. The NOSB will consider the requested amendments and make its recommendations to the Administrator. When appropriate, the NOP will conduct rulemaking on the recommended amendment. Such rulemaking will include an opportunity for public comment. ( 16) Evidence of Expertise and Ability. A commenter stated that section 205.504, which addresses the documentation necessary to establish evidence of expertise and abilities, requires too much paperwork. We believe the amount of paperwork is appropriate for the task at hand, verifying a certifying agent's expertise in and eligibility for accreditation to certify organic production and handling operations to the NOP. We further believe that the level of paperwork is necessary to meet international guidelines for determining whether an applicant is qualified for accreditation as a certifying agent. ( 17) Procedures for Making Information Available to the Public. Comments on section 205.504( b)( 5) were mixed. Some commenters felt that the proposal fell short of the OFPA requirement to " Provide for public access to certification documents and lab analysis." Others thought that too much confidential information would be released. 232 The Act requires public access, at section 2107( a)( 9), to certification documents and laboratory analyses pertaining to certification. Accordingly, we disagree with those commenters who requested that such documents not be released to the public. We also disagree with the commenters who contend that the requirement for public disclosure falls short of what is required by the Act. Section 205.504( b)( 5) meets the requirements of the Act by requiring the release of those documents cited in section 2107( a)( 9) of the Act. The section also authorizes the release of other business information as authorized in writing by the producer or handler. ( 18) Accreditation Prior to Site Evaluation. Numerous commenters recommended that we require site visits prior to accreditation. Some commenters cited ISO Guide 61, section 2.3.1, in their arguments for site visits prior to accreditation. ISO Guide 61, section 2.3.1., provides that the decision on whether to accredit a body shall be made on the basis of the information gathered during the accreditation process and any other relevant information. Section 3.3.2 of ISO Guide 61 provides that the accreditation body shall witness fully the on­ site activities of one or more assessments or audits conducted by an applicant body before an initial accreditation is granted. We do not concur with the commenters. These regulations provide for assessment of the applicant's qualifications and capabilities through a rigorous review of the application and supporting documentation. Following this review, an initial site evaluation shall be conducted before or within a reasonable period of time after issuance of the applicant's " notification of accreditation." In cases where the document review raises concerns regarding the applicant's qualifications and capabilities and the Administrator deems it necessary, a preapproval site evaluation will be conducted. We have further provided that a site evaluation shall be conducted 233 after application for renewal of accreditation but prior to renewal of accreditation. Our purpose in allowing for initial accreditation prior to a site evaluation is to facilitate implementation of the NOP and to provide a means for newly established certifying agents to obtain a client base to demonstrate that they can meet the requirements of the NOP regulations. We believe this is consistent with the intent of ISO Guide 61, section 2.3.1. and fits within its " and any other relevant information" provision. Accordingly, we restate our position that accreditation approval without a site evaluation is appropriate, necessary in the case of established certifying agents that may need to make adjustments in their operations to comply with the NOP regulations, and necessary in the case of newly established certifying agents who will have to obtain a client base to demonstrate beyond the paperwork that they can meet the requirements of the NOP regulations. ( 19) Ineligibility After Revocation of Accreditation. Section 205.507( d) provides that a certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination. A commenter stated that the 3­ year period of ineligibility is overly long and effectively puts the certifying agent out of business. The commenter suggested that a 6­ to 12­ month period might be reasonable. We have not accepted the suggested 6­ to 12­ month ineligibility period because the Act requires a period of ineligibility of not less than 3 years following revocation of accreditation. ( 20) Qualifications of the Site Evaluator. A commenter recommended amending section 205.508( a) to indicate the required qualifications of the site evaluator. We have not accepted the recommendation. We do not believe that it is necessary to specify the required qualifications of site evaluators in these regulations. All USDA employees who will perform site evaluations under 234 the NOP are quality systems auditors trained in accordance with internationally recognized protocols. ( 21) Complaint Process. A commenter recommended that section 205.510 include a complaint process for complaints by certified operations regarding the performance of a certifying agent or inspector. The commenter also recommended that section 205.510 include a complaint process for the public should they feel that a certifying agent is not in compliance. We do not believe that it is necessary to include a complaint process in the regulations. All interested parties are free to file a complaint with an accredited certifying agent, SOP's governing State official, or the Administrator at any time. We will provide guidance to accredited certifying agents and SOP's governing State officials regarding the type of information to gather when receiving a complaint. SOP's governing State officials will include in their request for approval of their SOP information on their collection of complaint information. Certifying agents will include details regarding the collection of complaint information and the investigation of complaints involving certified operations in their procedures for reviewing and investigating certified operation compliance ( section 205.504( b)( 2)). This will include maintaining records of complaints and remedial actions relative to certification as well as documentation of followup actions. Further, certifying agents will include details regarding the collection of complaint information and the investigation of complaints involving inspectors and other personnel employed by or contracted by the certifying agents in their policies and procedures for training, evaluating, and supervising personnel ( section 205.504( a)( 1)). ( 22) Recordkeeping by Certifying Agents. A commenter stated that the 10­ year recordkeeping requirement of section 205.510( b)( 2) for records created by the certifying agent 235 regarding applicants for certification and certified operations is excessive. The commenter recommended a 5­ year retention period. We have not accepted the recommended 5­ year records retention period for records created by the certifying agent regarding applicants for certification and certified operations because the Act requires the retention of such records for 10 years. ( 23) Reaccreditation. A commenter recommended that section 205.510( c)( 1) be amended to require reaccreditation every 3 years. We have provided that accreditation will be for a period of 5 years. This is consistent with the Act which provides that accreditation shall be for a period of not to exceed 5 years. The commenter believes that a 5­ year period is not consistent with ISO Guide 61, section 3.5.1, which provides that the accreditation body shall have an established documented program, consistent with the accreditation granted, for carrying out periodic surveillance and reassessment at sufficiently close intervals to verify that its accredited body continues to comply with the accreditation requirements. We believe that accreditation for 5 years is a reasonable period of time. Further, we believe that a 5­ year period of accreditation is consistent with ISO Guide 61 inasmuch as we require an annual evaluation of the certification program; annual review of persons associated with the certification process, including inspectors; annual reporting with a complete and accurate update of information required for accreditation; and one or more site evaluations during the period of accreditation in addition to the initial site evaluation for the period of accreditation. Accordingly, we have not made the recommended change. This requirement is located at current section 205.510( c)( 2). ( 24) Notice of Renewal of Accreditation. A commenter recommended that section 205.510( d) be amended to include a timeframe within which the Administrator must notify an applicant of its renewal of accreditation. We believe that a mandated timeframe for notifying the 236 applicant of renewal of accreditation is inappropriate. We plan to process all applications for renewal of accreditation in the order in which they are received, to confirm the receipt of each application, and to establish a dialog with the applicant upon confirmation of receipt of an application for renewal of accreditation. The length of the renewal process will depend in large part on the nature of the operation seeking renewal of accreditation. To minimize the chances that an accreditation will expire during the renewal process, we have: ( 1) provided that the Administrator shall send the accredited certifying agent a notice of pending expiration of accreditation approximately 1 year before the date of expiration of the certifying agent's accreditation, ( 2) required that an application for renewal of accreditation must be received at least 6 months prior to expiration of the certifying agent's accreditation, and ( 3) provided that the accreditation of a certifying agent who makes timely application for renewal of accreditation will not expire during the renewal process. Accordingly, we have not made the recommended amendment. Accreditation ­ Clarifications Clarification is given on the following issues raised by commenters as follows: ( 1) Accreditation of Foreign Certifying Agents. A commenter suggested that section 205.500 be amended to provide that if there is a government system operating in a foreign country then the government is the appropriate pathway for that country to apply for accreditation. USDA will accept an application for accreditation to perform certification activities under the NOP from any private entity or governmental entity certifying agent and accredit such applicant upon proof of qualification for accreditation. USDA will provide for USDA 237 accreditation of certifying agents and acceptance of a foreign government's accreditation of certifying agent within the same country. This maximizes opportunity for certifying agents without the potential for confusion and overlap in documentation. Further, we believe these requirements facilitate world trade. ( 2) State Approval of Product From Foreign Countries. A commenter stated that any product making claims of organic agricultural ingredients to be sold in California shall fall under the jurisdiction of the California Organic Program for enforcement, inspection, and certification direction. The commenter further stated that, should any foreign certifying agents be accepted, they too shall be subject to the sovereign rights of the State of California to protect and enforce the laws of the State of California and to protect agricultural claims in this State. Any organic program administered by a State will have to be approved by the Secretary. Approval of an SOP will be contingent upon the State's agreeing to accept the certification decisions made by certifying agents accredited or accepted by USDA pursuant to section 205.500. ( 3) Equivalency. A commenter stated that USDA should declare in section 205.500 that there are no alternative methods of production that meet the Congressional purpose " to assure consumers that organically produced products meet a consistent standard." The commenter went on to state that, if USDA proceeds with equivalency then the regulations should be amended to provide for: ( 1) no importing until final determination, ( 2) no final determination until Federal Register publication and public comment, ( 3) audit of foreign agency and production sites, and ( 4) revocation of accreditation for violations. The commenter also recommended that foreign certifying agents be reviewed with the same frequency as State certifying agents. We disagree that there are no alternative methods of production that assure consumers 238 that organically produced products meet a consistent standard. Accordingly, we will negotiate equivalency agreements with foreign governments. A final equivalency agreement will be required before affected product may be imported into the United States and sold, labeled, or represented as organic. Equivalency agreements will be announced to the public through a notice in the Federal Register and a news release. Site evaluations are a possibility. Foreign certifying agents that receive USDA accreditation, rather than recognition through their government, will have to fully comply with the NOP and will be treated the same as domestic accredited certifying agents. ( 4) Evaluation of Equivalency. Commenters asked how equivalency would be evaluated and recommended basing equivalency, not on a check of formalities, but on the finding of substantive equivalence and equivalent effectiveness of certifying systems. The negotiation of an equivalency agreement will involve meetings between representatives of the foreign government seeking equivalency and representatives of USDA's Agricultural Marketing Service and Foreign Agricultural Service. Support will be provided by the Office of the U. S. Trade Representative. The process will also include the review of documents and possibly one or more site evaluations. Equivalency agreements will be announced to the public through a notice in the Federal Register and a news release. ( 5) Treatment of Certifying Agents Operating in More Than One Country. A few commenters requested that we amend section 205.500( c) by adding a provision to clarify the issue of how the international activities of foreign or domestic certifying agents will be treated when they operate in more than one country. We believe that the requested provision is unnecessary. Certifying agents, domestic and 239 foreign, accredited under the NOP will be expected to comply fully with the requirements of the NOP regardless of where they operate. The only exception would be when they operate in a country in which the Secretary has negotiated an equivalency agreement. ( 6) Accreditation of Foreign Certifying Agents. A commenter requested that we amend section 205.500( c) to exempt foreign applicants from having to be accredited certifying agents in USDA's program if the exporting country's national organic program meets international standards; e. g, Codex guidelines. We have provided for USDA accreditation of qualified foreign certifying agents upon application. We have also provided that USDA will accept a foreign certifying agent's accreditation to certify organic production or handling operations if it determines, upon the request of a foreign government, that the standards under which the foreign government authority accredited the foreign certifying agent meet the requirements of this part. We have further provided that USDA will accept a foreign certifying agent's accreditation to certify organic production or handling operations if the foreign government authority that accredited the foreign certifying agent acted under an equivalency agreement negotiated between the United States and the foreign government. These recognitions of foreign government programs, however, do not extend to international standards such as Codex guidelines. In either case, we are recognizing the ability of a foreign government's program to meet U. S. standards, not some other international standard. ( 7) States with an Organic Statute. A commenter stated that a State with an organic statute or regulations that does not certify organic producers or organic handlers should not have to be accredited. 240 The NOP requires the Secretary's approval of SOP's whether or not the State has a State certifying agent. A State may have an SOP but not have a State certifying agent. In this case the SOP must be approved by the Secretary. A State may have a State certifying agent but no SOP. In this case, the State certifying agent must apply for and receive accreditation to certify organic production or handling operations. Finally, a State may have an SOP and a State certifying agent. In this case, the SOP must be approved by the Secretary, and the State certifying agent must apply for and receive accreditation to certify organic production or handling operations. ( 8) Nondiscriminatory Services. A commenter wanted the addition of a provision in section 205.501( a) requiring certifying agents to provide nondiscriminatory services. We have not included the suggested addition in this final rule because the provision already exists in section 205.501( d). ( 9) Release of Information. A few commenters requested that we amend section 205.501( a)( 10) to include a general exclusion allowing the release of any information with the client's permission. We have not included the suggested addition in this final rule because section 205.504( b)( 5)( iv) already addresses the allowed release of other business information as permitted in writing by the producer or handler. ( 10) Use of the Term, " Certified Organic." In commenting on section 205.501( b)( 1), a commenter stated that if the term, " certified organic," is included on a label, it must state by whom, according to Maine State law. We do not believe that the requirements of section 205.501( b)( 1) would preclude a certified operation from complying with a State law requiring identification of the certifying agent on a product sold, labeled, or represented as " certified organic." Further, these regulations do not require a certified operation to use the word, 241 " certified," on its label. ( 11) Holding the Secretary Harmless. In commenting on the requirements of section 205.501( c)( 1), a commenter stated that certifying agents are responsible for representing USDA but seem to have no recourse. Another commenter asked, what happens if a certifying agent is found in violation of the Act but the violation was due to information or direction that came from USDA? Under the NOP, accredited certifying agents are required to comply with and carry out the requirements of the Act and these regulations. If they fail to do so, they are responsible for their actions or failures to act. This would not be true if the action or failure to act was at the direction of the Secretary. ( 12) Self­ evaluation of Ability to Comply. A commenter requested that section 205.504 be amended to provide clarity on the baseline requirements that would allow a certifying agent to conduct a self­ evaluation to determine its ability to comply. The commenter stated that there should be some type of baseline acceptance of expertise and ability. The commenter wants details regarding the " training" or " experience" requirements necessary to qualify for accreditation. This commenter also stated that criteria for inspector and reviewer training should be added and enlarged. We do not believe that it is necessary to present the requirements for accreditation to the extent of detail requested by the commenter. The intent is to provide flexibility to the certifying agents such that they can tailor their policies and procedures to the nature and scope of their operation. The NOP is available to respond to questions and to assist certifying agents in complying with the requirements for accreditation. 242 ( 13) Evidence of Expertise and Ability. Commenters stated that important elements of ISO Guide 65 are missing from section 205.504. They cite the maintenance of a complaints register and a register of precedents and provisions for subcontracting and a documents control policy or a document register. Certifying agents grant certification, deny certification, and take enforcement action against a certified operation's certification. Certifying agents are required to maintain records applicable to all such actions and to report such actions to the Administrator. Certifying agents may contract with qualified individuals for the performance of services such as inspection, sampling, and residue testing. Certifying agents are required to submit personnel information ( employed and contracted) and administrative policies and procedures to the Administrator. All such documents must be updated annually. The regulations also require the maintenance of records according to specified retention periods. All of these factors will be considered in granting or denying accreditation. We believe these requirements meet or exceed the ISO Guide 65 guidelines. ( 14) Personnel Evidence of Expertise. A commenter inquired about the frequency at which the personnel information, required by section 205.504( a) and used to establish evidence of expertise and ability, is to be updated. Section 205.510 requires that the certifying agent annually submit a complete and accurate update of the information required in section 205.504. ( 15) Responsibly Connected. A commenter stated that the term, " responsibly connected," as used in section 205.504( a)( 2) is a broad sweep. The commenter believes the term would include everyone they do business with. Section 205.504( a)( 2) requires the certifying agent to provide the name and position 243 description of all personnel to be used in the certification operation. The section assists the certifying agent in meeting the requirement by identifying categories of persons covered by the requirement including persons responsibly connected to the certifying agent. Responsibly connected does not include everyone that the certifying agent does business with. Responsibly connected is defined in the Definitions subpart of this final rule as " any person who is a partner, officer, director, holder, manager, or owner of 10 percent or more of the voting stock of an applicant or a recipient of certification or accreditation." This definition has not changed. ( 16) Independent Third­ Party Inspectors. A commenter recommended amending section 205.504( a)( 3)( I) to provide for the use of independent third­ party inspectors. We believe that this recommended amendment is unnecessary since nothing in these regulations precludes a certifying agent from contracting with independent third parties for inspection services. ( 17) Response to Accreditation Applicant. A commenter requested that section 205.506( a)( 3) be amended to provide a timeframe within which the Administrator has to respond to the accreditation application. While section 205.506( a)( 3) identifies the information to be reviewed by the Administrator prior to the granting of accreditation, we assume the commenter is seeking a specific time limit by which the Administrator will acknowledge receipt of an application for accreditation. In the alternative, the commenter may have been seeking a specific time limit by which the Administrator must grant or deny accreditation. We believe that a regulation­ mandated timeframe for notifying the applicant of receipt of an application or for granting or denying accreditation is unnecessary. We plan to process all applications in the order in which they are received, to confirm the receipt of each application upon receipt, and to establish a dialog with the applicant upon confirmation of receipt of an application for accreditation. We will work with 244 each applicant to complete the accreditation process as expeditiously as possible. A firm timeframe, however, cannot be set for granting or denying accreditation due to the anticipated uniqueness of each applicant and its application for accreditation. ( 18) Duration of Accreditation and Certification. A commenter asked, " How can certification be essentially in perpetuity and accreditation have a time restraint?" The commenter's question does not indicate a preference for certification or accreditation longevity. The commenter correctly points out that certification and accreditation, both of which must be updated annually, are granted for different time periods. The Act limits the period of accreditation to 5 years but does not establish a limit to the period of certification. We believe the requirement that the certified operation submit an annual update of its organic plan negates the need for a certification expiration date. ( 19) Denial of Accreditation. In commenting on section 205.507, a commenter stated that the regulations need to address what happens to a certifying agent's clients when the certifying agent fails to qualify for accreditation on its first attempt. Section 205.507( c) provides that an applicant who has received written notification of accreditation denial may apply for accreditation again at any time in accordance with section 205.502. Upon implementation of the certification requirements of the NOP, production and handling operations planning to sell, label, or represent their products as organic must be certified by a USDA­ accredited certifying agent before selling, labeling, or representing their products as organic. If a producer's or handler's choice of certifying agents does not receive USDA accreditation, the producer or handler must seek and receive certification under the NOP from a USDA­ accredited certifying agent before selling, labeling, or representing their products as 245 organic. Producers and handlers not so certified may not sell, label, or represent their products as organic. Any producer or handler who violates this requirement will be subject to prosecution under section 2120 of the Act. ( 20) Loss of Accreditation After Initial Site Visit. Commenting on section 205.508( b), a commenter stated the belief that accreditation before a site visit may cause problems if the certifying agent does not meet the requirements and, subsequently, loses its accreditation. We believe the problems will be no greater than will occur at any other time when it becomes necessary to revoke a certifying agent's accreditation, including when it becomes necessary to initiate proceedings to suspend or revoke the certification of one or more of the certifying agent's certified operations. However, just because revocation of a certifying agent's accreditation may be justified, it may not be necessary to suspend or revoke the certification of one or more of its clients. An operation certified by a certifying agent that has lost its accreditation must make application with a new certifying agent if it is going to continue to sell, label, or represent its products as organic. ( 21) Prohibition on Certification After Expiration of Accreditation. A commenter stated that, " USDA should allow certifying agents to apply the same provisions to expiration of certification of a certified operation." The provision referenced by the commenter is the section 205.510( c)( 1) ( current section 205.510( c)( 2)) requirement that certifying agents with an expired accreditation must not perform certification activities under the Act and these regulations. We have not accepted the commenter's request that the same prohibition be applied to production and handling operations with an expired certification because certification does not expire. ( 22) Expiration of Accreditation. Many commenters requested that we amend section 246 205.510( c)( 1) to require annual reports and " minivisits." The commenters cited ISO Guide 61, section 3.5.1. We do not believe that annual " minivisits" are necessary to meet the requirements of ISO Guide 61 or to assure compliance with the NOP. One or more site evaluations will be conducted during the period of accreditation. The certifying agent's annual report will be used as a determining factor in whether to conduct a site evaluation. A request for amendment to a certifying agent's area of accreditation will also result in a site evaluation. This requirement is located at current section 205.510( c)( 2). ( 23) Update and Review of Inspector Lists. In commenting on section 205.510( c)( 1) ( current section 205.510( c)( 2)) several commenters stated that updating and review of inspector lists must occur more frequently than every 5 years. They cited ISO Guide 61, section 3.5.1. Section 205.510( a)( 1) requires that the certifying agent annually update the information required in section 205.504. This includes the inspector information required by paragraphs 205.504( a)( 2) and 205.504( a)( 3)( i). Subpart G Administrative The National List of Allowed and Prohibited Substances Description of Regulations General Requirements This subpart contains criteria for determining which substances and ingredients are allowed or prohibited in products to be sold, labeled, or represented as " organic" or " made with organic ( specified ingredients or food group( s))." It establishes the National List of Allowed and Prohibited Substances ( National List) and identifies specific substances which may or may not be used in organic production and handling operations. Sections 6504, 6510, 6517, and 6518 of the 247 Organic Foods Production Act ( OFPA) of 1990 provide the Secretary with the authority to develop the National List. The contents of the National List are based upon a Proposed National List, with annotations, as recommended to the Secretary by the National Organic Standards Board ( NOSB). The NOSB is established by the OFPA to advise the Secretary on all aspects of the National Organic Program ( NOP). The OFPA prohibits synthetic substances in the production and handling of organically produced agricultural products unless such synthetic substances are placed on the National List. Substances appearing on the National List are designated using the following classifications: 1. Synthetic substances allowed for use in organic crop production 2. Nonsynthetic substances prohibited for use in organic crop production 3. Synthetic substances allowed for use in organic livestock production 4. Nonsynthetic substances prohibited for use in organic livestock production 5. Nonagricultural ( nonorganic) substances allowed as ingredients in or on processed products labeled as " organic" or " made with organic ( specified ingredients or food group( s)) 6. Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as organic" or " made with organic ( specified ingredients or food group( s)) This subpart also outlines procedures through which an individual may petition the Secretary to evaluate substances for developing proposed National List amendments and deletions. The NOSB is responsible for making the recommendation of whether a substance is 248 suitable for use in organic production and handling. The OFPA allows the NOSB to develop substance recommendations and annotations and forward to the Secretary a Proposed National List and any subsequent proposed amendments. We have made every effort to ensure the National List in this final rule corresponds to the recommendations on allowed and prohibited substances made by the NOSB. In developing their recommendations, the NOSB evaluates synthetic substances for the National List utilizing the criteria stipulated by the Act. Additionally, criteria for evaluating synthetic processing ingredients have been implemented by the NOSB. These criteria are an interpretation and application of the general evaluation criteria for synthetic substances contained in the OFPA that the NOSB will apply to processing aids and adjuvants. The NOSB adopted these criteria as internal guidelines for evaluating processing aids and adjuvants. The adopted criteria do not supersede the criteria contained in the OFPA or replace the Food and Drug Administration's ( FDA) regulations related to food additives and generally recognized as safe ( GRAS) substances. The NOSB has also provided recommendations for the use of synthetic inert ingredients in formulated pesticide products used as production inputs in organic crop or livestock operations. The Environmental Protection Agency ( EPA) regulates and maintains the EPA Lists of Inert ingredients used for pesticide. In this final rule, EPA Inerts List 1 and 2 are prohibited, EPA List 3 is also prohibited unless specifically recommended as allowed by the NOSB, and EPA List 4 Inerts are allowed unless specifically prohibited. In this final rule, only EPA List 4 Inerts are allowed as ingredients in formulated pesticide products used in organic crop and livestock production. The allowance for EPA List 4 Inerts only applies to pesticide formulations. Synthetic ingredients in any formulated products used as organic production inputs, including pesticides, fertilizers, animal drugs, and feeds, must be 249 included on the National List. As sanctioned by OFPA, synthetic substances can be used in organic production and handling as long as they appear on the National List. The organic industry should clearly understand that NOSB evaluation of the wide variety of inert ingredients and other nonactive substances will require considerable coordination between the NOP, the NOSB, and industry. Materials review can be anticipated as one of the NOSB's primary activities during NOP implementation. Considering the critical nature of this task, the organic industry should make a collaborative effort to prioritize for NOSB review those substances that are essential to organic production and handling. The development and maintenance of the National List has been and will be designed to allow the use of a minimal number of synthetic substances that are acceptable to the organic industry and meet the OFPA criteria. We expect the maintenance of the National List to be a dynamic process. We anticipate that decisions on substance petitions for the inclusion on or deletion from the National List will be made on an annual basis. Any person seeking a change in the National List should request a copy of the petition procedures that were published in the Federal Register ( 65 Fed Reg 43259 ­ 43261) on July 13, 2000, from the NOP. The National List petition process contact information is: Program Manager, National Organic Program, USDA/ AMS/ TMP/ NOP, Room 2945­ S, Ag Stop 0268, P. O. Box 96456, Washington, DC 20090­ 6456 or visit the NOP website: www. ams. usda. gov/ nop. Substances petitioned for inclusion on the National List will be reviewed by the NOSB, which will forward a recommendation to the Secretary. Any amendments to the National List will require rulemaking and must be published for comment in the Federal Register. Nothing in this subpart alters the authority of other Federal agencies to regulate 250 substances appearing on the National List. FDA issues regulations for the safe use of substances in food production and processing. USDA's Food Safety and Inspection Service ( FSIS) has the authority to determine efficacy and suitability regarding the production and processing of meat, poultry, and egg products. FDA and FSIS restrictions on use or combinations of food additives or GRAS substances take precedence over the approved and prohibited uses specified in this final rule. In other words, any combinations of substances in food processing not already addressed in FDA and FSIS regulations must be approved by FDA and FSIS prior to use. FDA and FSIS regulations can be amended from time to time under their rulemaking procedures, and conditions of safe use of food additives and GRAS substances can be revised by the amendment. It is important that certified organic producers and handlers of both crop and livestock products consult with FDA regulations in 21 CFR parts 170 through 199 and FSIS regulations in this regard. All feeds, feed ingredients, and additives for feeds used in the production of livestock in an organic operation must comply with the Federal Food, Drug, and Cosmetic Act ( FFDCA). Animal feed labeling requirements are published in 21 CFR Part 501, and new animal drug requirements and a listing of approved animal drugs are published in 21 CFR Parts 510­ 558. Food ( feed) additive requirements, a list of approved food ( feed) additives generally recognized as safe substances, substances affirmed as GRAS, and substances prohibited from use in animal food or feed are published in 21 CFR 570­ 571, 21 CFR 573, 21 CFR 582, 21 CFR 584, and 21 CFR 589, respectively. Furthermore, the Food and Drug Administration has worked closely with the Association of American Feed Control Officials ( AAFCO) and recognizes the list of additives and feedstuffs published in the AAFCO Official Publication, which is updated annually. Under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), EPA regulates 251 the use of all pesticide products, including those that may be approved for use in the NOP. In registering a pesticide under FIFRA, EPA approves the uses of each pesticide product. It is a violation of FIFRA to use a registered product in a manner inconsistent with its labeling. The fact that a substance is on the National List does not authorize use or a pesticide product for that use if the pesticide product label does not include that use. If the National List and the pesticide labeling conflict, the pesticide labeling takes precedence and may prohibit a practice allowed on the National List. National List ­ Changes Based On Comments This subpart differs from the proposal in several respects as follows: ( 1) Comprehensive Prohibition on Excluded Methods. Many commenters supported a comprehensive prohibition on the use of excluded methods in organic production and handling. These commenters stated that the proposed language on excluded methods could have allowed some uses since the general prohibition described in section 205.301 of the proposed rule could be interpreted as applying only to multiingredient products. In order to provide a comprehensive prohibition on the use of excluded methods, we incorporated a new provision within section 205.105. A more comprehensive discussion of this issue is found in subpart B, Applicability. ( 2) Substance Evaluation Criteria for the National List. Commenters stated that the final rule should include in the regulation text the evaluation criteria utilized by the NOSB for the development of substance recommendations. We agree, and we have inserted the substance evaluation criteria developed by the NOSB for processing ingredients and cited the criteria within the Act ( 7 U. S. C. 6518( m)) for crops and livestock production as new provisions for section 205.600, which is now entitled " Evaluation criteria for allowed and prohibited substances, 252 methods, and ingredients." ( 3) Substances Approved for Inclusion on the National List. Commenters stated that the National List did not contain all of the substances recommended by the NOSB for inclusion on the National List of Allowed and Prohibited Substances. We agree and have added the following substances consistent with the most recent NOSB recommendations: Crop Production: Lime sulfur as a plant disease control substance Elemental sulfur as a plant or soil amendment Copper as a plant or soil micronutrient Streptomycin sulfate as plant disease control substances with the annotation " for fire blight control in apples and pears only" Terramycin ( oxytetracycline calcium complex) as a plant disease control substance with the annotation " for fire blight control only" Magnesium sulfate as a plant or soil amendment with the annotation " allowed with a documented soil deficiency" Ethylene as a plant growth regulator, with the annotation " for regulation of pineapple flowering" We have added sodium nitrate and potassium chloride to the National List as nonsynthetic substances prohibited for use in crop production unless used in accordance with the substance annotations. Sodium nitrate is prohibited unless use is restricted to no more than 20 percent of the crop's total nitrogen requirement. Potassium chloride is prohibited unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil. These 253 additions are discussed further in item 3 under Changes Based on Comments, subpart C. Livestock Production: Oxytocin with the annotation " for use in postparturition therapeutic applications" EPA List 4 inert ingredients as synthetic inert ingredients for use with nonsynthetic substances or synthetic substances allowed in organic livestock production. Several commenters recommended that the final rule should specify which nonsynthetic substances are prohibited for use in livestock production. These commenters stated that the proposed rule prohibited six such substances for use in crop production and maintained that an analogous list for livestock operations would be beneficial. Of the six nonsynthetic substances in the proposed rule prohibited for use in crop production, four were based on NOSB recommendations ( strychnine, tobacco dust, sodium fluoaluminate ( mined), and ash from burning manure) and two were based on statutory provisions in the OFPA ( arsenic and lead salts). After reviewing these substances and the NOSB recommendations, we determined that the prohibition for one, strychnine, also applies to livestock production. Individuals may petition the NOSB to have additional nonsynthetic substances prohibited for use in organic crop and livestock production. Organic Handling ( Processing): Tribasic calcium phosphate Nonsynthetic colors Flavors, with the annotation " nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservatives" Nonsynthetic waxes, carnauba wax, wood resin 254 Cornstarch ( native), gums, kelp, lecithin and pectin were moved from section 205.605 to section 205.606 ( 4) Substance Removed from the National List. Commenters stated that certain substances on the National List in the proposed rule had not been recommended by the NOSB. We agree with the comment that the NOSB did not recommend that magnesium should be allowed as a plant or soil micronutrient and have removed it from the National List. ( 5) Changes in Substance Annotations on the National List. Commenters stated that certain annotations in the proposed rule did not capture the precise recommendations of the NOSB. We agree and have amended the annotations within the National List as follows: The annotation for hydrated lime as a plant disease control substance now states, " must be used in a manner that minimizes accumulation of copper in the soil." The annotation for horticultural oils as an insecticide substance and as a plant disease control substance now states, " Narrow range oils as dormant, suffocating, and summer oils." The annotation for hydrated lime in livestock production now states, " not permitted for soil application or to cauterize physical alterations or deodorize animal wastes." The annotation for the allowed synthetic parasiticide Ivermectin has been modified to state that the substance may not be used during the lactation period of breeding stock. The annotation for trace minerals and vitamins allowed as feed additives has been modified and now states, " used for enrichment or fortification when FDA approved." The annotation for magnesium sulfate in organic handling now states, " nonsynthetic sources only." The annotation for EPA List 4 Inerts allowed in crop and livestock production has been 255 modified to state, "... for use with nonsynthetic substances or synthetic substances listed in this section..." ( 6) Sulfur Dioxide for Organic Wines. Many commenters recommended that this final rule should allow for the use of sulfur dioxide in wine labeled " made with organic grapes." They argued that sulfur dioxide is necessary in organic wine production and that prohibiting its use would have a negative impact on organic grape production and wineries that produce wine labeled " made with organic grapes." The prohibition on the use of sulfur dioxide in the proposed rule was based upon the requirement in the Act that prohibited the addition of sulfites to organically produced foods. However, a change in the Act now allows the use of sulfites in wine labeled as " made with organic grapes." Therefore, we have added sulfur dioxide to the National List with the annotation, " for use only in wine labeled ` made with organic grapes,' Provided, That, total sulfite concentration does not exceed 100 ppm." The label for the wine must indicate the presence of sulfites. This addition to the National List is also in agreement with the NOSB recommendation for allowing the use of sulfur dioxide in producing wine to be labeled as " made with organic grapes." National List ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Restructuring the National List. Commenters requested a restructuring of the National List to improve its clarity and ease of use. Some of the commenters asked for minor changes involving the wording of section titles. Other commenters were opposed to the categories used in the National List because the categories are not in compliance with the Act. In 256 its June 2000 meeting, the NOSB asked the NOP to review a proposal from a research institute proposing that processing materials for the National List be categorized according to industry standards. This proposal recommended including new sections for substances used in " made with..." and substances used in the 5­ percent nonorganic portion of " organic" multiingredient products. We agree that the present structure of the National List may not have optimum clarity and ease of use. However, extensive restructuring of the National List without additional NOSB consideration and public discussion would be a significant variation from the policy that established the National List for this final rule. The NOP will work with the NOSB and the public to refine the National list consistent with industry norms and public expectations. ( 2) Use of EPA List 4 Inerts. The proposed rule allowed EPA List 4 Inerts to be used as synthetic inert ingredients with allowed synthetic active ingredients in crop production. Some commenters stated that certain substances among the EPA List 4 inerts should not be allowed in organic production. Some commenters went further and recommended that the allowance for synthetic inert ingredients should be limited to the subset of materials that the EPA designates as List 4A. We do not agree with these commenters and have retained the allowance for all inerts included on EPA List 4. List 4 inerts are classified by EPA as those of " minimal concern" and, after continuing consultation with EPA, we believe there is no justification for a further restriction to List 4A. If commenters believe that a particular List 4 inert should not be allowed in formulated products used in organic production, they can petition the NOSB to have that substance prohibited. ( 3) Removing Vaccines from the National List. Some commenters asserted that vaccines should not be included on the National List because the NOSB had never favorably recommended 257 their use in livestock production. However, the OFPA authorizes the use of vaccines, and in 1995, the NOSB recommended allowing their use. The NOSB stated that use of vaccines may be necessary to ensure the health of the animal and to remain in compliance with Federal, State, or regional regulations. We agree with the NOSB's recommendation and have retained vaccines as an allowed substance in livestock medication. ( 4) Adding Amino Acids to the National List. Some commenters recommended that amino acids should be added to the National List as allowed synthetic substances for livestock production. We have not added amino acids to the National List because the NOSB has not recommended that they should be allowed. This subject is discussed further in item 4, Livestock ­ Changes Based on Comments, subpart C. ( 5) Creating a Category for Prohibited Nonsynthetic Seed Treatments. A commenter stated that the National List of nonsynthetic substances prohibited for use in crop production should include provisions for seed treated with a nonsynthetic substance. This commenter stated that the final rule should acknowledge that a nonsynthetic seed treatment could be prohibited on the National List. We do not believe it is necessary to include a separate category for seed treatments under the prohibited nonsynthetic section of the National List. An individual may petition the NOSB to have a particular nonsynthetic seed treatments placed on the prohibited list without creating a new category for seed treatments. ( 6) Creating a Category for Treated Seed and Toxins Derived from Bacteria. Commenters stated that the National List of synthetic substances allowed in crop production should include categories for treated seed and toxins derived from bacteria. These commenters stated that these categories are sanctioned by the OFPA, and failure to consider them would place 258 a significant burden on organic producers. We believe it is unnecessary to include these categories on the National List. Specific substances from these categories could be incorporated in existing categories that reflect their function, such as plant disease control or insecticide. An individual may submit petitions to the NOSB to have specific substances from these categories considered for inclusion on the National List. ( 7) Remove Categories for Feed Supplements. A commenter stated that it was inappropriate for the National List of synthetic substances allowed in livestock production to contain categories for feed supplements and feed additives because they are not authorized in the OFPA. We disagree with this commenter because the identification of categories on the National List does not mean that all substances within that category are allowed. The categories help to clarify which types of materials may be included on the National List. The substances included under the categories of feed supplements and feed additives were recommended by the NOSB and added to the National List with the Secretary's approval. ( 8) Neurotoxic Substances on the National List. Many commenters requested that the NOP remove particular substances from section 205.605 of the National List. They stated these substances were sources of neurotoxic compounds that negatively effect human health. The substances cited were yeast ( autolysate and brewers), carrageenan, and enzymes. Moreover, these commenters argued against including on the National List some amino acids or their derivatives which the commenters claim have neurotoxic side effects. These commenters requested that amino acids should be prohibited from the National List due to the possibility that neurotoxic substances could be utilized for either organic agricultural production or handling. We do not agree with the requests of the commenters and we have not made the requested 259 changes. There are no amino acids currently on the National List; therefore, synthetic sources of amino acids are prohibited. Unless recommended for use by the NOSB, synthetic amino acids will not be included on the National List. The NOP has established a petition process for substances to be evaluated for inclusion on or removal from the National List of Allowed and Prohibited Substances in organic production and handling. Anyone seeking to have a particular substance removed from the National List may file a substance petition to amend the National List. ( 9) EPA List 4 Inerts for Organic Processing. A few commenters recommended that substances in EPA List 4 inerts that are allowed for use in crop production also be allowed for use as processing materials. We do not agree, and we have not included EPA List 4 Inerts on the National List for organic handling. Inerts listed on EPA List 4 have been evaluated and approved for use in pesticide formulations, not for use as processing materials. Inerts that are included on EPA List 4 would have to be further evaluated to determine whether such materials meet the criteria for inclusion on the National List. ( 10) Modifying Annotations of Organic Processing Substances. One commenter requested that the Department modify the annotation for phosphoric acid to include its use as a processing aid. We have not made the suggested change. Any change in the annotation of a substance can only occur through an NOSB recommendation. Individuals or groups can use the petition process to submit substance petitions to the NOSB for the evaluation to be included on or removed from the National List. ( 11) Nutritional Supplementation of Organic Foods. Some commenters asserted that 21 CFR 104.20 is not an adequate stand­ alone reference for nutritional supplementation of organic foods. As a result, these commenters recommended that the final rule include as additional cites 260 21 CFR 101.9( c)( 8) for FDA­ regulated foods and 9 CFR 317.30( c), 318.409( c)( 8) for foods regulated by FSIS to support 21 CFR 104.20. We did not implement the suggested changes of the commenters. Section 205.605( b)( 20) in the proposed rule allowed the use of synthetic nutrient vitamins and minerals to be used in accordance with 21 CFR 104.20, Nutritional Quality Guidelines For Foods, as ingredients in processed products to be sold as " organic" or " made with..." The commenters recommended cites, 21 CFR 101.9( c)( 8) for FDA­ regulated foods and 9 CFR 317.30( c); section 318.409( c)( 8) did not provide provisions for nutritional supplementation of foods. Instead, these suggested cites were particularly aimed toward: ( 1) the declaration of nutrition information on the label and in labeling of a food; ( 2) labeling, marking devices, and containers; ( 3) entry into official establishments; and ( 4) reinspection and preparation of products. The NOP, in consultation with FDA, considers 21 CFR 104.20 to be the most appropriate reference regarding nutritional supplementation for organic foods. ( 12) National List Petition Process as Part of the Final Rule. Commenters have requested that the National List Petition Process, approved by the NOSB at its June 2000 meeting ( and published in the Federal Register on July 13, 2000), be included in the final rule. We do not agree with the commenters, and we have retained the National List Petition Process regulation language from the proposed rule. We have separated the specific petition process from the regulation to provide for maximum flexibility to change and clarify the petition process to accommodate new considerations developed during the NOP implementation. If this process were part of this final rule, updates to the petition process would require notice and comment rulemaking. Any changes in the National List that may be a result of the petition process, however, would require notice and comment rulemaking. 261 ( 13) Nonapproved Substance Amendments to the National List. Commenters also requested to have many substances that are not on the National List and that have not be recommended by the NOSB for use in organic production and handling be added to the National List. We do not agree. Amendments to the National List must be petitioned for NOSB consideration, must have an NOSB recommendation, and must be published for public comment in the Federal Register. National List ­ Clarifications Clarification is given on the following issues raised by commenters as follows: ( 1) Inerts Use in Botanical or Microbial Pesticides. Commenters expressed concern that the prohibition on the use of EPA List 3 inerts would prevent organic producers from using certain botanical or microbial formulated products that are currently allowed under some certification programs. These commenters requested that the NOP and the NOSB expedite the evaluation of List 3 inerts used in nonsynthetic formulated products to prevent the loss of certain formulated products. The prohibition of List 3 inerts was based on the recommendation of the NOSB to add only those substances from List 4 to the National List. The NOSB also recommended that individual inert substances included on List 3 could be petitioned for addition to the National List. The NOP has requested that the NOSB identify for expedited review those List 3 inerts that are most important in formulated products used in organic production. Individuals may petition to have these inerts considered for inclusion on the National List. Additionally, the NOP will work with the EPA and the registrants of formulated products to expedite review of List 3 inerts currently included in formulated products used in organic production. Unless List 3 inerts are moved to List 4 or individually added to the National List, 262 they are prohibited for use in organic production. ( 2) Prohibiting Ash, Grit, and Screenings Derived from Sewage Sludge. Many commenters recommended that the ash, grit, and screenings derived from the production of sewage sludge should be added to the National List as nonsynthetic materials prohibited for use in crop production. While the use of sewage sludge, including ash, grit, and screenings, is prohibited in organic production, we did not add them to the National List as prohibited nonsynthetic substances. This subject is discussed further under subpart A, Definitions ­ Changes Requested But Not Made. ( 3) Allowed Uses for Pheromones. Some commenters were concerned that the annotation for using pheromones as " insect attractants" was too limiting and would not include uses such as mating disruption, trapping, and monitoring. The annotation for pheromones does not preclude any use for a pheromone that is otherwise allowed by Federal, State, or local regulation. ( 4) Nonagricultural Products as Livestock Feed Ingredients. Some commenters questioned whether nonsynthetic, nonagricultural substances such as fishmeal and crushed oyster shell needed to be added to the National List to be used in livestock feed. Nonsynthetic substances do not have to appear on the National List and may be used in organic livestock feed, provided that they are used in compliance with the FFDCA. This subject is discussed further under item 4, Livestock ­ Changes Based on Comments, subpart C. ( 5) Chlorine Disinfectant Limit Annotation for Organic Production and Handling. Some commenters requested clarification on the annotation for using chlorine materials as an allowed synthetic substance in crop and handling operations. The annotation in the proposed rule, which 263 has been retained in the final rule, stated that " residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Water Drinking Act." With this annotation, the residual chlorine levels at the point where the waste water stream leaves the production or handling operation must meet limits under the Safe Drinking Water Act. ( 6) Tobacco Use in Organic Production. One commenter questioned whether forms of tobacco other than tobacco dust, such as water extracts or smoke, were prohibited nonsynthetic substances. The technical advisory panel ( TAP) review on which the NOSB based its recommendation to prohibit tobacco dust identified nicotine sulfate as the active ingredient. Therefore, any substance containing nicotine sulfate as an active ingredient is prohibited in crop production. ( 7) Nonsynthetic Agricultural Processing Aids on the National List. A commenter requested clarification from the NOP on whether processing aids ( e. g., defoaming agents), which are nonsynthetic and nonorganic agricultural substances ( e. g., soybean oil), must appear on the National List when used in processing. In the this regulation, a nonsynthetic and nonorganic agricultural product, such as soybean oil, used as a processing aid does not have to appear on the National List. Such products are included in the provision in section 205.606 that nonorganically produced agricultural products may be used in accordance with any applicable restrictions when the substance is not commercially available in organic form. ( 8) Transparency of the National List Petition Process. Some commenters stated the petition process for amending the National List appears to have limited public access and should be more transparent. These commenters advocate that any amendments to the National List should be subject to notice and comment. They also requested clarity on how petitions are 264 prioritized and reviewed and the timeframes for review. Additionally, these commenters asked the NOP to expedite the review of materials for the National List. On July 13, 2000, AMS published in the Federal Register ( Vol. 65, 43259­ 43261) guidelines for submitting petitions for the evaluations of substances for the addition to or removal from the National List. In this notice, the NOP stated that most petition information is available for public inspection with the exception of information considered to be " confidential business information." The notice also specified that any changes to the National List must be published in the Federal Register for public comment. The published petition notice has also provided an indication to the industry about the urgency of the need for substance review and that the industry should provide pertinent information to the NOSB to expedite the review of materials not on the National List. State Organic Programs The Act provides that each State may implement an organic program for agricultural products that have been produced and handled within the State, using organic methods that meet the requirements of the Act and these regulations. The Act further provides that a State organic program ( SOP) may contain more restrictive requirements for organic products produced and handled within the State than are contained in the National Organic Program ( NOP). All SOP's and subsequent amendments thereto must be approved by the Secretary. A State may have an SOP but not have a State certifying agent. A State may have a State certifying agent but no SOP. Finally, a State may have an SOP and a State certifying agent. In all cases, the SOP's must be approved by the Secretary. In all cases, the State certifying agent must apply for and receive accreditation to certify organic production or handling operations pursuant to subpart F. 265 In States with an approved SOP, the SOP's governing State official is responsible for administering a compliance program for enforcement of the NOP and any more restrictive requirements contained in the SOP. The SOP governing State officials may review and investigate complaints of noncompliance involving organic production or handling operations operating within their State and, when appropriate, initiate suspension or revocation of certification. The SOP governing State officials may also review and investigate complaints of noncompliance involving accredited certifying agents operating within their State. They must report the findings of any review and investigation of a certifying agent to the NOP Program Manager along with any recommendations for appropriate action. States that do not have an SOP will not be responsible for compliance under the NOP, except that an accredited State certifying agent operating within such State will have compliance responsibilities under the NOP as a condition of its accreditation. The sections covering SOP's, beginning with section 205.620, establish: ( 1) the requirements for an SOP and amending such a program and ( 2) the process for approval of an SOP and amendments to the SOP's. Review and approval of an SOP will occur not less than once during each 5­ year period. Review related to compliance matters may occur at any time. Description of Regulations State Organic Program Requirements A State may establish an SOP for production and handling operations within the State that produces and handles organic agricultural products. The SOP and supporting documentation must demonstrate that the SOP meets the requirements for organic programs specified in the Act. An SOP may contain more restrictive requirements governing the production and handling 266 of organic products within the State. Such requirements must be based on environmental conditions or specific production or handling practices particular to the State or region of the United States, which necessitates the more restrictive requirement. More restrictive requirements must be justified and shown to be consistent with and to further the purposes of the Act and the regulations in this part. Requirements necessitated by an environmental condition that is limited to a specific geographic area of the State should only be required of organic production and handling operations operating within the applicable geographic area. If approved by the Secretary, the more restrictive requirements will become the NOP regulations for organic producers and handlers in the State or applicable geographical area of the State. All USDAaccredited certifying agents planning to operate within a State with an SOP will be required to demonstrate their ability to comply with the SOP's more restrictive requirements. No provision of an SOP shall discriminate against organic agricultural products produced by production or handling operations certified by certifying agents accredited or accepted by USDA pursuant to section 205.500. Specifically, an SOP may not discriminate against agricultural commodities organically produced in other States in accordance with the Act and the regulations in this part. Further, an SOP may not discriminate against agricultural commodities organically produced by production or handling operations certified by foreign certifying agents operating under: ( 1) standards determined by USDA to meet the requirements of this part or ( 2) an equivalency agreement negotiated between the United States and a foreign government. To receive approval of its SOP, a State must assume enforcement obligations in the State for the requirements of this part and any more restrictive requirements included in the SOP and approved by the Secretary. Specifically, the State must ensure compliance with the Act, the 267 regulations in this part, and the provisions of the SOP by certified production and handling operations operating within the State. The SOP must include compliance and appeals procedures equivalent to those provided for under the NOP. An SOP and any amendments thereto must be approved by the Secretary prior to implementation by the State. State Organic Program Approval Process An SOP and subsequent amendments thereto must be submitted to the Secretary by the SOP's governing State official for approval prior to implementation. A request for approval of an SOP must contain supporting materials that include statutory authorities, program descriptions, documentation of environmental or ecological conditions or specific production and handling practices particular to the State which necessitate more restrictive requirements than the requirements of this part, and other information as may be required by the Secretary. A request for amendment of an approved SOP must contain supporting materials that include an explanation and documentation of the environmental or ecological conditions or specific production practices particular to the State or region, which necessitate the proposed amendment. Supporting material also must explain how the proposed amendment furthers and is consistent with the purposes of the Act and the regulations in this part. Each request for approval of an SOP or amendment to an SOP and its supporting materials and documentation will be reviewed for compliance with the Act and these regulations. Within 6 months of receiving the request for approval, the Secretary will notify the SOP's governing State official of approval or disapproval. A disapproval will include the reasons for disapproval. A State receiving a notice of disapproval of its SOP or amendment to its SOP may 268 submit a revised SOP or amendment to its SOP at any time. Review of State Organic Programs SOP's will be reviewed at least once every 5 years by the Secretary as required by section 6507( c)( 1) of the Act. The Secretary will notify the SOP's governing State official of approval or disapproval of the program within 6 months after initiation of the review. State Organic Programs ­ Changes Based on Comments This portion of subpart G differs from the proposal in several respects as follows: ( 1) Publication of SOP's and Consideration of Public Comments. Some commenters assert that the USDA should not publish SOP provisions for public comment in the Federal Register. These commenters argued that it is not appropriate for the NOP to have nonresidents commenting on a particular State program as nearly all States have a mechanism to ensure full public participation in their regulation promulgation. They believe the comment process set forth in the proposed rule is a redundant and unacceptable intrusion on State sovereignty. We will not publish for public comment the provisions of SOP's under review by the Secretary in the Federal Register. We have removed the provision from this final rule, described in section 205.621( b), requiring the Secretary to publish in the Federal Register for public comment a summary of the SOP and a summary of any amendment to such a program. Alternatively, we will announce which SOP's are being reviewed through the NOP website. The NOP will issue public information notices that will announce each approved SOP and any approved amendments to an existing State program. The notices will identify the characteristics of the approved State program that warranted the more restrictive organic production or handling requirements. We also will include a summary of the new program on the NOP website. 269 ( 2) NOP Oversight of SOP's. Several commenters stated that, in the proposed rule, the provisions did not provide a comprehensive description of organic programs operated by States that would be under NOP authority. Some commenters implied that the proposed rule would only include States with organic certification programs, while other commenters inquired whether the sections 205.620 to 205.622 included other SOP activities beyond certification. To address the commenters' concerns, we have modified the section heading by adding the term, " organic," and removing the term, " certification," from the description and definition of SOP's. We have taken this action to clarify that, while certification is one component of the requirements, it does not define the extent of evaluation of State programs that will be conducted by the NOP. SOP's can choose not to conduct certification activities under their existing organic program. State programs whose provisions fall within the scope of the eleven general provisions described in the Act ( 7 U. S. C. 6506) will require Departmental review. States may conduct other kinds of organic programs that will not need review and approval by the NOP. Examples of these other programs may include: organic promotion and research projects, marketing; transition assistance or cost share programs, registration of State organic production and handling operations, registration of certifying agents operating within the State, or a consumer referral program. The NOP will not regulate such State activities. Such programs may not advertise, promote, or otherwise infer that the State's organic products are more organic or better than organic product produced in other States. Such programs and projects would be beyond the scope of this national program and will not be subject to the Secretary's review. State Organic Programs ­ Changes Requested But Not Made 270 ( 1) Limitations on SOP More Restrictive Requirements. Commenters expressed concern that limiting a State's ability to craft a regulation designated as a more restrictive requirement to environmental conditions or specific production and handling practices would hinder the ongoing development of SOP's. They were concerned that any State legislation modifying the SOP would need to be preapproved by the Secretary. We have retained the provision limiting the scope of more restrictive requirements States can include in their organic program as described in section 205.620( c). We believe the language contained in the provision is broad enough to facilitate the development of SOP's without hindering development or State program implementation and enforcement. Section 6507( b)( 1) of the Act provides that States may establish more restrictive organic certification requirements; paragraph ( b)( 2) establishes parameters for those requirements. More restrictive SOP requirements must: further the purposes of the Act, be consistent with the Act, not discriminate against other State's agricultural commodities, and be approved by the Secretary before becoming effective. We expect that a State's more restrictive requirements are likely to cover specific organic production or handling practices to address a State's specific environmental conditions. The Secretary will approve State's requests for more restrictive State requirements that are consistent with the purposes of the Act. However, we believe requests from States for more restrictive requirements will be rare. Although SOP's can impose additional requirements, we believe States will be reluctant to put their program participants at a competitive disadvantage when compared to producers and handlers in other States absent compelling environmental conditions or a compelling need for special production and handling practices. While preapproval of State legislation modifying an existing SOP is not required, the NOP envisions a close 271 consultation with States with existing programs to ensure consistency with the final rule. ( 2) SOP Enforcement Obligations. Some commenters expressed concern about States having adequate resources available to implement enforcement activities that they are obligated to conduct under the NOP. A few of these commenters argue that the enforcement obligation will result in their State programs being discontinued. A few commenters cited a lack of federal funding to support State enforcement obligations and suggested the NOP provide funding for enforcement activities. The proposed rule indicated that States with organic programs must assume enforcement obligations for this regulation within their State. We have retained this enforcement obligation in section 205.620( d). Many States currently have organic programs with the kind of comprehensive enforcement and compliance mechanisms necessary for implementing any State regulatory program. Assuming those enforcement activities are consistent with the NOP, this final rule adds no additional regulatory burden to the SOP's. The costs associated with the enforcement activities of an approved SOP should be similar to the enforcement costs associated with the existing State program. Additional clarification of SOP enforcement obligations is in the Accreditation, Appeals, and Compliance preamble discussions. ( 3) SOP Evaluation Notification Period. A few commenters indicated that the SOP review and decision notification period described in section 205.621( b) of the proposed rule could hinder a State's ability to develop or implement an SOP. These commenters cited potential cases in which particular States have requirements for regulatory promulgation that must occur within 6 months under a State legislative session that is held once every 2 years. These commenters suggested the NOP should reduce the notification time to 1 to 3 months. 272 We disagree with the commenters. In the proposed rule in section 205.621( b), the Secretary is required to notify the SOP's governing State official within 6 months of receipt of submission of documents and information regarding the approval of the SOP. We have retained this time period. We will review SOP applications as quickly as possible and will endeavor to make decisions in less than 6 months whenever possible. However, some SOP's may be very complex and require more review time. The NOP envisions working closely with the States and State officials to ensure a smooth transition to the requirements of this final rule. State Organic Programs ­ Clarifications ( 1) Discrimination Against Organic Products. Several commenters requested the addition of a provision prohibiting an SOP from discriminating against agricultural commodities organically produced in other States. Discrimination by a State against organically produced agricultural products produced in another State is prevented in two ways. First, any organic program administered by a State must meet the requirements for organic programs specified in the Act and be approved by the Secretary. Finally, a USDA­ accredited certifying agent must accept the certification decisions made by another USDA­ accredited certifying agent as its own. ( 2) Potential Duplication Between the Accreditation and SOP Review Process. Some commenters asked about possible duplication between the process for reviewing SOP's and the process of accreditation review. These commenters have asked the NOP to eliminate any duplication that may exist between the two review processes. The NOP will be conducting a review process for SOP's and a separate review process for accrediting State and private certifying agents. The two reviews are different. The SOP review is the evaluation of SOP compliance with the Act and the NOP regulations. If approved, the SOP becomes the NOP 273 standards for the particular State with which all certifying agents operating in that State must comply. Approved SOP's must be in compliance with the Act and the NOP regulations. They cannot have weaker standards than the NOP. States can have more restrictive requirements than the NOP if approved by the Secretary. The accreditation review is an evaluation of the ability of certifying agents to carry out their responsibilities under the NOP. This review is a measure of the competency of certifying agents to evaluate compliance to national organic standards. Certifying agents will not be unilaterally establishing regulations or standards related to the certification of organic products. They will only provide an assessment of compliance. Thus, SOP reviews and accreditation reviews are separate evaluations of different procedures. We acknowledge some of the information for the two evaluations may be similar; e. g., compliance procedures. The reviews do not duplicate the same requirements. However, the NOP envisions working with States to ensure documentation is not duplicated. ( 3) Scope of Enforcement by States. A number of State commenters have requested clarification on the proposed rule provision specifying that approved SOP's must assume enforcement obligations in their State for the requirements of the NOP and any additional requirements approved by the Secretary. These commenters have indicated that they remain uncertain as to what is expected by the term, " enforcement obligation." Approved SOP's will have to administer and provide enforcement of the requirements of the Act and the regulations of the NOP. The administrative procedures used by the State in administering the approved SOP should have the same force and effect as the procedures use by AMS in administering this program. This final rule specifies that the requirements for 274 environmental conditions or for special production and handling practices are necessary for establishing more restrictive requirements. These factors establish our position that a State must agree to incurring increased enforcement responsibilities and obligations to be approved as an SOP under the NOP. For instance, a State with an approved organic program will oversee compliance and appeals procedures for certified organic operations in the State. Those procedures must provide due process opportunities such as rebuttal, mediation, and correction procedures. Once approved by the Secretary, the State governing official of the SOP must administer the SOP in a manner that is consistent and equitable for the certified parties involved in compliance actions. ( 4) SOP's That Do not Certify and NOP Oversight. A few commenters requested that the NOP develop new provisions to include State programs that have organic regulations but do not conduct certification activities. These commenters argue that any SOP that has a regulatory impact on organic producers, regardless of whether or not the program includes certification, be approved by the Secretary. This regulation, in section 205.620( b), provides for NOP oversight of SOP's that do not conduct certification activities. ( 5) State's Use of Private Certifying Agents. Some commenters have requested that the NOP provide clarification of the proposed rule sections 205.620 through 205.622 on how these sections will affect States that delegate certification activities to private certifying agents. These commenters asked how the NOP intends to oversee this type of State activity. The NOP intends to give considerable latitude to States in choosing the most appropriate system or procedures to structure their programs. This may include a State establishing its own 275 certifying agent or relying on private certifying agents. However, States will not be accrediting certifying agents operating in their State. Accreditation of all certifying agents operating in the United States is the responsibility of USDA. Establishment of a single national accreditation program is an essential part of the NOP. As stated elsewhere in this final rule, any accreditation responsibilities of a State's current organic program will cease with implementation of this program. Pursuant to the Compliance provisions of this subpart, the governing State official charged with compliance oversight under the SOP may investigate and notify the NOP of possible compliance violations on the part of certifying agents operating in the State. However, the State may not pursue compliance actions or remove accreditation of any certifying agent accredited by the Secretary. That authority is the sole responsibility of the Secretary. If more restrictive State requirements are approved by the Secretary, we will review certifying agent qualifications in the State, as provided by section 205.501( a)( 20), and determine whether they are able to certify to the approved, more restrictive requirements. Our accreditation responsibilities include oversight of both State and private certifying agents, including any foreign certifying agents that may operate in a State. Subpart G ­ Fees This portion of subpart G sets forth the regulations on fees and other charges to be assessed for accreditation and certification services under the National Organic Program ( NOP). These regulations address the kinds of fees and charges to be assessed by the U. S. Department of Agriculture ( USDA) for the accreditation of certifying agents, the level of such fees and charges, and the payment of such fees and charges. These regulations also address general requirements to be met by certifying agents in assessing fees and other charges for the certification of producers 276 and handlers as certified organic operations. Finally, these regulations address the Secretary's oversight of a certifying agent's fees and charges for certification services. Description of Regulation Fees and Other Charges for Accreditation Fees and other charges will be assessed and collected from applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation. Such fees will be equal as nearly as may be to the cost of the accreditation services rendered under these regulations. Fees­ for­ service will be based on the time required to render the service provided calculated to the nearest 15­ minute period. Activities to be billed on the basis of time used include the review of applications and accompanying documents and information, evaluator travel, the conduct of on­ site evaluations, review of annual reports and updated documents and information, and the preparation of reports and any other documents in connection with the performance of service. The hourly rate will be the same as that charged by the Agricultural Marketing Service ( AMS), through its Quality System Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization " General Requirements for Bodies Operating Product Certification Systems" ( ISO Guide 65). Applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation during the first 18 months following the effective date of subpart F will receive service without incurring an hourly charge for such service. Applicants for initial accreditation and renewal of accreditation must pay at the time of application, effective 18 months following the effective date of subpart F, a nonrefundable fee of 277 $ 500.00. This fee will be applied to the applicant's fees­ for­ service account. When service is requested at a place so distant from the evaluator's headquarters that a total of one­ half hour or more is required for the evaluator( s) to travel to such a place and back to the headquarters or from a place of prior assignment on circuitous routing requiring a total of one­ half hour or more to travel to the next place of assignment on the circuitous routing, the charge for such service will include all applicable travel charges. Travel charges may include a mileage charge administratively determined by USDA, travel tolls, or, when the travel is made by public transportation ( including hired vehicles), a fee equal to the actual cost thereof. If the service is provided on a circuitous routing, the travel charges will be prorated among all the applicants and certifying agents furnished the service involved. Travel charges will become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F. The applicant or certifying agent will not be charged a new mileage rate without notification before the service is rendered. When service is requested at a place away from the evaluator's headquarters, the fee for such service shall include a per diem charge if the employee( s) performing the service is paid per diem in accordance with existing travel regulations. Per diem charges to applicants and certifying agents will cover the same period of time for which the evaluator( s) receives per diem reimbursement. The per diem rate will be administratively determined by USDA. Per diem charges shall become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F. The applicant or certifying agent will not be charged a new per diem rate without notification before the service is rendered. When costs, other than fees­ for­ service, travel charges, and per diem charges, are 278 associated with providing the services, the applicant or certifying agent will be charged for these costs. Such costs include but are not limited to equipment rental, photocopying, delivery, facsimile, telephone, or translation charges incurred in association with accreditation services. The amount of the costs charged will be determined administratively by USDA. Such costs will become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F. Payment of Fees and Other Charges Applicants for initial accreditation and renewal of accreditation must remit the nonrefundable fee along with their application. Remittance must be made payable to the Agricultural Marketing Service, USDA, and mailed to: Program Manager, USDA­ AMS­ TMP­ NOP, Room 2945­ South Building, P. O. Box 96456, Washington, DC 20090­ 6456 or such other address as required by the Program Manager. All other payments for fees and other charges must be received by the due date shown on the bill for collection, made payable to the Agricultural Marketing Service, USDA, and mailed to the address provided on the bill for collection. The Administrator will assess interest, penalties, and administrative costs on debts not paid by the due date shown on a bill for collection and collect delinquent debts or refer such debts to the Department of Justice for litigation. Fees and Other Charges for Certification Fees charged by a certifying agent must be reasonable, and a certifying agent may charge applicants for certification and certified production and handling operations only those fees and charges that it has filed with the Administrator. The certifying agent must provide each applicant with an estimate of the total cost of certification and an estimate of the annual cost of updating 279 the certification. The certifying agent may require applicants for certification to pay at the time of application a nonrefundable fee that must be applied to the applicant's fees­ for­ service account. A certifying agent may set the nonrefundable portion of certification fees; however, the nonrefundable portion of certification fees must be explained in the fee schedule submitted to the Administrator. The fee schedule must explain what fee amounts are nonrefundable and at what stage during the certification process the respective fees become nonrefundable. The certifying agent must provide all persons inquiring about the application process with a copy of its fee schedule. Fees ­ Changes Based on Comments This subpart differs from the proposal in the following respects: Nonrefundable Portion of Certification Fees. Commenters were not satisfied with the provision in section 205.642 that stated, " The certifying agent may require applicants for certification to pay at the time of application a nonrefundable fee of no more than $ 250.00, which shall be applied to the applicant's fee for service account." Some commenters believed we were requiring the certifying agents to bill fees for inspection services separately. One State agency expressed a concern that we were placing a limit on the initial fee the certifying agent could collect. As a result, the State agency commented that by not being allowed to collect the full certification fee at the time of application, the certifying agent, in effect, would be extending credit to the applicant. Commenters reported that some State agencies are prevented by statute from extending credit and are required to collect all fees at the time of application. Several commenters stated that the amount of $ 250.00 was too low and would not cover the costs the certifying agents could incur during the certification process. One organization noted that we should 280 consider prorating the amount of the of the fee to be refunded when an applicant for certification withdraws before the completion of the certification process. The organization recommended that the amount of the prorated fee should be based on how far along in the certification process the applicant had progressed before withdrawal. Another commenter believed it was inappropriate for USDA to set any fees for private certification programs and that the fees should be market driven. It was not our intent to limit the initial amount that certifying agents could collect from the applicant for certification. Our intent was to limit the portion of the fee that would be nonrefundable in order to reduce the potential liability for the small producer/ handler who may need to withdraw prematurely from the certification process. However, we acknowledge that this provision could be misinterpreted. We also realize that certifying agents may incur initial costs during the preliminary stage of the certification process that may be more or less than the $ 250.00 application rate proposed. As a result, we have removed the provision that stated certifying agents could collect a nonrefundable fee of not more than $ 250.00 at the time of application from applicants for certification. Certifying agents may set the nonrefundable portion of their certification fees. However, the nonrefundable portion of their certification fees must be explained in the fee schedule submitted to the Administrator. The fee schedule must explain what fee amounts are nonrefundable and at what stage during the certification process the respective fees become nonrefundable. Certifying agents will also provide all persons inquiring about the application process with a copy of its fee schedule. Fees ­ Changes Requested But Not Made 281 This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Farm Subsidy/ Transition Program. Many commenters asked that USDA subsidize or develop a cost­ share program for small farmers/ producers who are certified or who are in transition to organic farming. Some commenters wanted these costs to be fully subsidized; a few commenters suggested that USDA pay for any extra site visit costs; and many others wanted USDA to pay premium prices to farmers for their products during the period of transition to organic production. In addition, many commenters argued that USDA should fully fund certification costs. Finally, many commenters suggested that the USDA should provide additional financial support to the organic industry because the industry is relatively young and composed of a large number of small, low­ resource businesses. We have considered the commenters requests but have not made the suggested changes. The NOP under AMS is primarily a user­ fee­ based Federal program. Section 2107( a)( 10) of the Organic Food Production Act of 1990 ( OFPA) requires that the NOP provide for the collection of reasonable fees from producers, certifying agents, and handlers who participate in activities to certify, produce, or handle agricultural products as organically produced. Therefore, under the statutory authority of OFPA, it is outside of the scope of the NOP to provide for the subsidization of producers, handlers, and certifying agents as desired by some commenters. We have, however, established provisions in this part that we believe will minimize the economic impact of the NOP on producers, handlers, and certifying agents. ( 2) Small Farmer Exemption Versus Lower Certification Fees. Many commenters suggested that certification fees be lowered or based on a sliding scale rather than instituting an 282 exemption from certification for small farmers and handlers. We have not accepted the commenters' suggestion. We cannot remove the small farmer exemption because section 2106( d) of the Act requires that small farmers be provided an exemption from organic certification if they sell no more than $ 5,000 annually in value of agricultural products. Also, certification fees cannot be lowered by USDA because NOP under AMS is primarily a user­ fee­ based Federal agency. It is not our goal or objective to make a profit on our accreditation activities. However, our fees associated with the accreditation process are targeted toward recovering costs incurred during the accreditation process. Commenters expressed a concern that the accreditation fees charged by USDA would have an impact on the certification fees prescribed by certifying agents to operations seeking organic certification. We understand the commenters' concern that accreditation fees charged to certifying agents will most likely be calculated into the fees that certifiers charge their clients. However, we believe that our provision to waive the hourly service charges for accreditation during the first 18 months of implementation of the NOP should help reduce accreditation costs of the certifying agent and should, therefore, result lower certification fee charged by certifying agents. As provided by the Act and the regulations in this part, fees charged by certifying agents must be reasonable. Also, certifying agents must submit their fee schedule to the Administrator and may only charge those fees and charges filed with the Administrator. In addition, certifiers are required to provide their approved fee schedules to applicants for certification. Therefore, applicants for certification will be able to base their selection of a certifying agent on price if they choose. Moreover, there are no provisions in the regulations that preclude certifying agents from pricing their services on a sliding scale, as long as their fees are consistent and nondiscriminatory and are approved during 283 the accreditation process. ( 3) Accreditation Fees. Many industry commenters suggested that we reevaluate our accreditation fee structure. They believe the hourly accreditation rate proposed is unacceptable. Commenters were concerned that high accreditation costs would lead to high certification costs, which would have a greater impact on small operations. Some industry commenters also noted that we should be required to provide a fee schedule such as the certifiers are required to do. They stated that unless USDA provided a fee schedule that included travel costs, they would not be able to accurately budget for these costs. A few commenters wanted USDA to forgo charging travel costs or not charge travel time at the full rate. Several commenters also stated that the hourly rate stated in the proposal is much higher than what the people who actually perform the accreditations will earn. However, a large majority of the commenters favored the 18­ month period in which AMS will not charge the hourly accreditation rate to applicants. As stated in the proposal, the hourly rate will be the same as that of AMS' Quality Systems Certification Program. Due to the fact that AMS' Quality Systems Certification Program publishes one rate that is readily available to the public, it is our belief that it is unnecessary for the NOP to set up a separate fee schedule. The NOP will notify accredited certifying agents and applicants for accreditation of any proposed rate changes and final actions on such rates by AMS. We will also periodically report the status of fees to the National Organic Standards Board. Those applicants and certifying agents who need accreditation cost estimates, including travel, for budgetary or other reasons may notify the NOP. The NOP staff will provide the applicant with a cost estimate, based on information provided by the applicant. As stated in an earlier response (( 2) ­ Changes Requested But Not Made), the objective of the fee that is charged 284 to accredit certifying agents is not to gain a profit for accreditation activities but to recover costs incurred during the accreditation process. As such, these costs include but are not limited to salaries, benefits, clerical help, equipment, supplies, etc. Compliance This portion of subpart G sets forth the enforcement procedures for the National Organic Program ( NOP). These procedures describe the compliance responsibilities of the NOP Program Manager, State organic programs' ( SOP) governing State officials, and State and private certifying agents. These provisions also address the rights of certified production and handling operations and accredited certifying agents operating under the NOP. The granting and denial of certification and accreditation are addressed under subparts E and F. Description of Regulations The Secretary is required under the Act to review the operations of SOP's, accredited certifying agents, and certified production or handling operations for compliance with the Act and these regulations. The Program Manager of the NOP may carry out compliance proceedings and provide oversight of compliance proceedings on behalf of the Secretary and the Administrator. The Program Manager will initiate proceedings to suspend or revoke a certified operation's certification if a certifying agent or SOP's governing State official fails to take appropriate enforcement action. The Program Manager may also initiate proceedings to suspend or revoke a certified operation's certification if the operation is found to have been erroneously certified by a certifying agent whose accreditation has been suspended or revoked. We anticipate, however, that most investigations, reviews, and analyses of certification noncompliance and initiation of suspension or revocation will be conducted by the certified operation's certifying agent. With 285 regard to certifying agents, the Program Manager will, when appropriate, initiate proceedings to suspend or revoke the accreditation of a certifying agent for noncompliance with the Act and these regulations. In States with an approved SOP, the SOP's governing State official is responsible for administering a compliance program for enforcement of the NOP/ SOP. SOP's governing State officials may review and investigate complaints of noncompliance involving organic production or handling operations operating within their State and, when appropriate, initiate suspension or revocation of certification. SOP's governing State officials may also review and investigate complaints of noncompliance involving accredited certifying agents operating within their State. They must report the findings of any review and investigation of a certifying agent to the Program Manager along with any recommendations for appropriate action. The compliance provisions of the NOP are consistent with the requirements of the Administrative Procedure Act ( APA) ( 5 U. S. C. 553­ 559) in that this program provides for due process including an opportunity for hearing, appeal procedures, written notifications of noncompliance, and opportunities to demonstrate or achieve compliance before any suspension or revocation of organic certification or accreditation is invoked. A compliance action regarding certification carried out under an approved SOP's compliance procedures will have the same force and effect as a certification compliance action carried out under these NOP compliance procedures. The notification process for denying certification and accreditation is laid out in subparts E and F, respectively. Each notification of noncompliance, rejection of mediation, noncompliance resolution, proposed suspension or revocation, and suspension or revocation issued under these regulations 286 must be sent to the recipient's place of business via a delivery service which provides return receipts. Certified operations and certifying agents must respond to all compliance notifications via a delivery service which provides return receipts. Noncompliance Procedure for Certified Operations The Act provides for the enforcement of certification requirements. Statutory oversight of production and handling operations by certifying agents includes review of organic plans, on­ site inspections, residue and tissue testing, authority to conduct investigations and initiate suspension or revocation actions, and responsibility to report violations. Notification of Noncompliance A written notification of noncompliance will be sent to the certified operation when an inspection, review, or investigation reveals any noncompliance with the Act or these regulations. A noncompliance notification may encompass the entire operation or a portion of the operation. For instance, a violation at one farm may not warrant loss of certification at other farms of the certified operation not affected by the violation. The notification of noncompliance will provide: ( 1) a description of each condition, action, or item of noncompliance; ( 2) the facts upon which the notification is based; and ( 3) the date by which the certified operation must rebut the notification or correct the noncompliance and submit supporting documentation of the correction. A certified operation may continue to sell its product as organic upon receiving a notification of noncompliance and throughout the compliance proceeding and any appeal procedure which might follow the compliance proceeding unless otherwise notified by a State or Federal government agency. If a certified operation believes the notification of noncompliance is incorrect or not well­ 287 founded, the certified operation may submit a rebuttal to the certifying agent or SOP's governing State official, as applicable, providing supporting data to refute the facts stated in the notification. The opportunity for rebuttal is provided to allow certifying agents and certified operations to informally resolve noncompliance issues. The rebuttal process should be helpful in resolving differences which may be the result of misinterpretation of requirements, misunderstandings, or incomplete information. Alternatively, the certified operation may correct the identified noncompliances and submit proof of such corrections. When the certified operation demonstrates that each noncompliance has been corrected or otherwise resolved, the certifying agent or SOP's governing State official, as applicable, will send the certified operation a written notification of noncompliance resolution. Proposed Suspension or Revocation of Certification If the noncompliance is not resolved or is not in the process of being resolved by the date specified in the notification of noncompliance, the certifying agent or SOP's governing State official will send the certified operation a written notification of proposed suspension or revocation of certification for the entire operation or a portion of the operation affected by the noncompliance. The notification will state: ( 1) the reasons for the proposed suspension or revocation; ( 2) the proposed effective date of the suspension or revocation; ( 3) the impact of the suspension or revocation on the certified operation's future eligibility for certification; and ( 4) that the certified operation has a right to request mediation or to file an appeal. The impact of a proposed suspension or revocation may include the suspension or revocation period or whether the suspension or revocation applies to the entire operation or to a portion or portions of the operation. 288 If a certifying agent or SOP's governing State official determines that correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation of certification may be combined in one notification of proposed suspension or revocation. The certified operation will have an opportunity to appeal the proposed suspension or revocation. If a certifying agent or SOP's governing State official has reason to believe that a certified operation has willfully violated the Act or regulations, a notification of proposed suspension or revocation will be sent to the certified operation. The proposed suspension or revocation will be for the entire operation or a portion of the operation. This notification, because it involves a willful violation, will be sent without first issuing a notification of noncompliance. Mediation A production or handling operation may request mediation of any dispute regarding denial of certification or proposed suspension or revocation of certification. Mediation is not required prior to filing an appeal but is offered as an option which may resolve the dispute more quickly than the next step, which is filing an appeal. When mediation is requested, it must be requested in writing to the applicable certifying agent. The certifying agent will have the option of accepting or rejecting the request for mediation. If the certifying agent rejects the request for mediation, the certifying agent must provide written notification to the applicant for certification or certified operation. The written notification must advise the applicant for certification or certified operation of the right to request an appeal in accordance with section 205.681. Any such appeal must be requested within 30 days of the date of the written notification of rejection of the request for mediation. If mediation is accepted by the certifying agent, such mediation must be conducted 289 by a qualified mediator mutually agreed upon by the parties to the mediation. If an SOP is in effect, the mediation procedures established in the SOP, as approved by the Secretary, must be followed. The parties to the mediation will have no more than 30 days to reach an agreement following a mediation session. If mediation is unsuccessful, the production or handling operation will have 30 days from termination of mediation to appeal the denial of certification or proposed suspension or revocation in accordance with the appeal procedures in section 205.681. Any agreement reached during or as a result of the mediation process must be in compliance with the Act and these regulations. The Secretary reserves the right to review any mediated agreement for conformity to the Act and these regulations and to reject any agreement or provision not in conformance with the Act or these regulations Suspension or Revocation The certifying agent or SOP's governing State official will suspend or revoke the certified operation's certification when the operation fails to resolve the issue through rebuttal or mediation, fails to complete needed corrections, or does not file an appeal. The operation will be notified of the suspension or revocation by written notification. The certifying agent or SOP's governing State official must not send a notification of suspension or revocation to a certified operation that has requested mediation or filed an appeal while final resolution of either is pending. The decision to suspend or revoke certification will be based on the seriousness of the noncompliance. Such decisions must be made on a case­ by­ case basis. Section 6519 of the Act establishes that willful violations include making a false statement, knowingly affixing a false label, or otherwise violating the purposes of the Act. 290 In addition to suspension or revocation, a certified operation that knowingly sells or labels a product as organic, except in accordance with the Act, will be subject to a civil penalty of not more than $ 10,000 per violation. Further, a certified operation that makes a false statement under the Act to the Secretary, an SOP's governing State official, or a certifying agent will be subject to the provisions of section 1001 of title 18, United States Code. A certified operation whose certification has been suspended under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its certification. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the NOP. A certified operation or a person responsibly connected with an operation that has had its certification revoked will be ineligible to receive certification for an operation in which such operation or person has an interest for 5 years following the date of revocation. Accordingly, an operation will be ineligible for organic certification if one of its responsibly connected parties, was a responsibly connected party of an operation that had its certification revoked. The Secretary may, when in the best interest of the certification program, reduce or eliminate the period of ineligibility. Noncompliance Procedure for Certifying Agents The Program Manager, on behalf of the Secretary, may initiate a compliance action against an accredited certifying agent who violates the Act or these regulations. Compliance proceedings may be initiated as a result of annual reviews for continuation of accreditation, site evaluations, or investigations initiated in response to complaints of noncompliant activities. 291 Compliance proceedings also may be initiated on recommendation of an SOP's governing State official. A written notification of noncompliance will be sent by the Program Manager to an accredited certifying agent when an inspection, review, or investigation of such person reveals any noncompliance with the Act or these regulations. A notification of noncompliance will provide a description of each noncompliance found and the facts upon which the notification is based. Additionally, the notification will provide the date by which the certifying agent must rebut or correct each noncompliance described and submit supporting documentation of each correction. When documentation received by the Program Manager demonstrates that each noncompliance has been resolved, the Program Manager will send the certifying agent a written notification of noncompliance resolution. If a noncompliance is not resolved by rebuttal or correction, the Program Manager will issue a notification of proposed suspension or revocation of accreditation. The notification will state whether the suspension or revocation will be for the certifying agent's entire accreditation, that portion of the accreditation applicable to a particular field office, or a specific area of accreditation. For instance, if a certifying agent with field offices in different geographic areas is cited for a compliance violation at one field office, the Program Manager could determine that only that portion of the accreditation applicable to the noncompliant field office should be suspended or revoked. If the Program Manager determines that the noncompliance cannot be immediately or easily corrected, the Program Manager may combine the notification of noncompliance and the proposed suspension or revocation in one notification. 292 The notification of proposed suspension or revocation of accreditation will state the reasons and effective date for the proposed suspension or revocation. Such notification will also state the impact of a suspension or revocation on future eligibility for accreditation and the certifying agent's right to file an appeal. If the Program Manager has reason to believe that a certifying agent has willfully violated the Act or regulations, the Program Manager will issue a notification of proposed suspension or revocation of accreditation. The proposed suspension or revocation may be for the certifying agent's entire accreditation, that portion of the accreditation applicable to a particular field office, or a specified area of accreditation. This notification, because it involves a willful violation, will be sent without first issuing a notification of noncompliance. The certifying agent may file an appeal of the Program Manager's determination pursuant to section 205.681. If the certifying agent fails to file an appeal of the proposed suspension or revocation, the Program Manager will suspend or revoke the certifying agent's accreditation. The certifying agent will be notified of the suspension or revocation by written notification. A certifying agent whose accreditation is suspended or revoked must cease all certification activities in each area of accreditation and in each State for which its accreditation is suspended or revoked. Any certifying agent whose accreditation has been suspended or revoked must transfer to the Secretary all records concerning its certification activities that were suspended or revoked. The certifying agent must also make such records available to any applicable SOP's governing State official. The records will be used to determine whether operations certified by the certifying agent may retain their organic certification. A certifying agent whose accreditation is suspended by the Secretary may at any time, 293 unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. Such request must be accompanied by evidence demonstrating correction of each noncompliance and actions taken to comply with and remain in compliance with the Act and regulations. A certifying agent whose accreditation is revoked by the Secretary will be ineligible to be accredited as a certifying agent under the Act and regulations for a period of not less than 3 years following the date of revocation. State Organic Programs' Compliance Procedures An SOP's governing State official may initiate noncompliance proceedings against certified organic operations operating in the State. Such proceedings may be initiated for failure of a certified operation to meet the production or handling requirements of this part or the State's more restrictive requirements, as approved by the Secretary. The SOP's governing State official must promptly notify the Program Manager of commencement of noncompliance proceedings initiated against certified operations and forward to the Program Manager a copy of each notice issued. A noncompliance proceeding, brought by an SOP's governing State official against a certified operation may be appealed in accordance with the appeal procedures of the SOP. There will be no subsequent rights of appeal to the Secretary. Final decisions of a State may be appealed to the United States District Court for the district in which such certified operation is located. An SOP's governing State official may review and investigate complaints of noncompliance with the Act or regulations concerning accreditation of certifying agents operating in the State. When such review or investigation reveals any noncompliance, the SOP's governing State official must send a written report of noncompliance to the Program Manager. The SOP's 294 governing State official's report must provide a description of each noncompliance and the facts upon which the noncompliance is based. Compliance ­ Changes Based On Comments This portion of subpart G differs from the proposal in several respects as follows: ( 1) Written Notifications. We have added a new paragraph ( d) to section 205.660. The preamble to the proposed rule stated that all written notifications sent by certifying agents and SOP's governing State officials, as well as rebuttals, requests for mediation, and notices of correction of noncompliances sent by certified operations, will be sent to the addressee's place of business by a delivery service which provides dated return receipts. The assurance of completed communications and timely compliance procedures was given as the reason for delivery by a service which provides dated return receipts. The addition of paragraph ( d) at section 205.660 is one of the actions that we have taken in response to requests from commenters that we further clarify the compliance process. Paragraph ( d) requires that each notification of noncompliance, rejection of mediation, noncompliance resolution, proposed suspension or revocation, and suspension or revocation issued in accordance with sections 205.662, 205.663, and 205.665 and each response to such notification must be sent to the recipient's place of business via a delivery service which provides return receipts. This action will facilitate the effective administration of the compliance process by assuring a verifiable time line on the issuance and receipt of compliance documents and the response given to each such document. ( 2) Determination of Willful. The preamble statement that " only the Program Manager or governing State official may make the final determination that a violation is willful" was incorrect and inconsistent with the regulatory language in section 205.662( d). Section 205.662( d) provides 295 that, " if a certifying agent or State organic program's governing State official has reason to believe that a certified operation has willfully violated the Act or regulations in this part, the certifying agent or State organic program's governing State official shall send the certified operation a notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance." Accordingly, as recommended by a commenter, the incorrect statement has been deleted from the preamble to this final rule. ( 3) Proposed Suspension or Revocation. We have amended sections 205.662( c) and 205.665( c) by removing the redundant phrase " or is not adequate to demonstrate that each noncompliance has been corrected" from the first sentence of each section. ( 4) Suspension or Revocation. We have amended section 205.662( e)( 2) by adding " while final resolution of either is pending" to the end thereof. The language of section 205.662( e)( 2) now reads: " A certifying agent or State organic program's governing State official must not send a notification of suspension or revocation to a certified operation that has requested mediation pursuant to section 205.663 or filed an appeal pursuant to section 205.681 while final resolution of either is pending." We have made this change because we agree with those commenters who expressed the belief that section 205.662( e)( 2) needed to be amended to clarify the duration of the stay on the issuance of a notification of suspension or revocation when mediation is requested or an appeal is filed. Several commenters stated that section 205.662( e)( 2) needed to be amended to clarify that requesting mediation or filing an appeal does not indefinitely stop the suspension or revocation process. ( 5) Eligibility After Suspension or Revocation of Certification. We have amended section 296 205.662( f) such that it now parallels section 205.665( g) which addresses suspension and revocation of certifying agents. We have also changed the title of section 205.662( f) from " Ineligibility" to " Eligibility" to parallel section 205.665( g). A few commenters referred to the provisions in section 205.665( g), which addresses eligibility after suspension or revocation of accreditation, and requested clarification of the difference between suspension and revocation of certification. Upon reviewing section 205.662( f), we decided that amendment was needed to clarify the difference between suspension and revocation of certification relative to eligibility for certification. Accordingly, we added a new paragraph ( 1) which provides that a certified operation whose certification has been suspended under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its certification. The paragraph also provides that the request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. We also amended what is now paragraph ( 2) of section 205.662( f) to clarify that the period of ineligibility following revocation of certification is 5 years unless reduced or eliminated by the Secretary. Further, we have amended section 205.665( g)( 1) to clarify that a certifying agent that has had its accreditation suspended may request reinstatement of its accreditation rather than submit a new request for accreditation. The amendment also clarifies that the reinstatement may be requested at any time unless otherwise stated in the notification of suspension. This amendment makes section 205.665( g)( 1) similar to new paragraph ( 1) of section 205.662( f). This amendment is also consistent with commenter desires that the noncompliance procedures for certified 297 operations and accredited certifying agents be similar. ( 6) Penalties for Violations of the Act. We have amended section 205.662 by adding a new paragraph ( g) which incorporates therein the provisions of paragraphs ( a) and ( b) of section 2120, 7 U. S. C. 6519, Violations of Title, of the Act. Specifically, paragraph ( g) provides that, in addition to suspension or revocation, any certified operation that knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than $ 10,000 per violation. This paragraph also provides that any certified operation that makes a false statement under the Act to the Secretary, an SOP's governing State official, or a certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code. Commenters requested regulatory language citing section 2120, 7 USC 6519, Violations of Title, of the Act. Commenters also requested a clearer description of enforcement. Specifically, they want provisions describing how USDA will deal with operations that make false claims or do not meet the NOP requirements. Further, numerous commenters expressed concern that there are no penalties in the regulations other than suspension and revocation. The European Community stated that it did not find, in the proposal, requirements for penalties to be applied by certifying agents when irregularities or infringements are found. The European Community went on to say that the European Union requires such penalties. The Act provides for suspension and revocation of certification and the civil and criminal penalties addressed in 7 U. S. C. 6519. Certified operations are also required through the compliance program set forth in these regulations, to correct all noncompliances with the Act or regulations as a condition of retaining their certification. Furthermore, to get a suspended certification reinstated, an operation must submit a request to the Secretary. The request must be 298 accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. An operation or a person responsibly connected with an operation whose certification has been revoked will be ineligible to receive certification for a period of not more than 5 years. We believe adding paragraph ( g) will help clarify that there are penalties which may be imposed on certified operations that violate the Act and these regulations in addition to suspension or revocation. The provisions of the Act and these regulations apply to all persons who sell, label, or represent their agricultural product as organic. Accordingly, persons who falsely sell, label, or represent their product as organic, are subject to the provisions of paragraphs ( a) and ( b) of section 2120, 7 USC 6519, of the Act. To clarify this, we have added a new paragraph ( c) to section 205.100 of the Applicability subpart. Certifying agents, SOP's governing State officials, and USDA will receive complaints alleging violations of the Act or these regulations. Certifying agents will review all complaints that they receive to determine if the complaint involves one of their clients. If the complaint involves a client of the certifying agent, the agent will handle the complaint in accordance with its procedures for reviewing and investigating certified operation compliance. If the complaint involves a person who is not a client of the certifying agent, the certifying agent will refer the complaint to the SOP's governing State official, when applicable, or, in the absence of an applicable SOP's governing State official, the Administrator. SOP's governing State officials will review all complaints that they receive in accordance with their procedures for reviewing and investigating alleged violations of the NOP and SOP. The SOP's governing State official's 299 review of the complaint could result in referral of the complaint to a certifying agent when the complaint involves a client of the certifying agent, dismissal, or investigation by the SOP's governing State official. SOP's governing State officials will, as appropriate, investigate allegations of violations of the Act by noncertified operations operating within their State. USDA will review all complaints that it receives in accordance with its procedures for reviewing and investigating alleged violations of the NOP. USDA will refer complaints alleging violations of the NOP/ SOP to the applicable SOP's governing State official, who may, in turn, refer the complaint to the applicable certifying agent. In States without an approved SOP, USDA will refer complaints to the applicable certifying agent. USDA will, as appropriate, investigate allegations of violations of the Act by noncertified operations operating in States where there is no approved SOP. ( 7) Mediation. We have amended section 205.663 by providing that a dispute with respect to proposed suspension or revocation of certification may, rather than shall, be mediated. We have also provided that mediation must be requested in writing to the applicable certifying agent. The certifying agent will have the option of accepting or rejecting the request for mediation. If the certifying agent rejects the request for mediation, the certifying agent must provide written notification to the applicant for certification or certified operation. The written notification must advise the applicant for certification or certified operation of the right to request an appeal within 30 days of the date of the written notification of rejection of the request for mediation. If mediation is accepted by the certifying agent, such mediation must be conducted by a qualified mediator mutually agreed upon by the parties to the mediation. Several commenters wanted section 205.663 amended to provide that disputes " may," 300 rather than " shall," be mediated. The commenters advocated allowing the certifying agent to determine when mediation is a productive option. Several State commenters wanted to amend the second sentence to read as follows: " If a State organic program is in effect, the mediation procedures established in the State orgnic program, as approved by the Secretary, will be followed for cases involving the State organic program and its applicants or certified parties." Another commenter wanted to retain the requirement that disputes " shall" be mediated but wanted disputes mediated in accordance with 7 CFR Part 11 and section 205.681 of these regulations. We concur that certifying agents should be authorized to reject a request for mediation, especially when they believe that the noncompliance issue is not conducive to mediation. Accordingly, we amended section 205.663 as noted above. We disagree, however, with the State commenters who want to amend the second sentence. We believe that the recommended change would exclude the clients of private­ sector certifying agents operating within the State. USDA approval of an SOP will require that all certified operations operating within the State have the same opportunities for mediation, regardless of whether they are certified by a private or State certifying agent. If an approved SOP provides for mediation, such mediation must be available to all certified operations operating within the State. We also disagree with the commenter who requested that disputes be mediated in accordance with 7 CFR Part 11 and section 205.681 of these regulations. First, we believe that States with an approved SOP must be allowed to establish their own mediation program and procedures. Second, the Act and its implementing regulations are subject to the APA for adjudication. The provisions of the APA generally applicable to agency adjudication are not applicable to proceedings under 7 CFR Part 11, National 301 Appeals Division Rules of Procedure. Even if 7 CFR Part 11 were applicable, it does not address mediation procedures. Mediation is merely addressed in 7 CFR Part 11 as an available dispute resolution method along with its impact on the filing of an appeal. ( 8) Noncompliance Procedure for Certifying Agents. We have amended section 205.665( a)( 3) to clarify that, like certified operations, certifying agents must submit supporting documentation of each correction of a noncompliance identified in a notification of noncompliance. This amendment to section 205.665( a)( 3) was made in response to commenter concerns that the noncompliance procedures for certified operations and certifying agents be similar. It had been our intent that certifying agents would have to document their correction of noncompliances and that the noncompliance procedures for certified operations and certifying agents would be similar. Compliance ­ Changes Requested But Not Made This subpart retains from the proposed rule, regulations on which we received comments as follows: ( 1) Funding for Enforcement. Several commenters stated that USDA should provide funding to the States for the cost of performing enforcement activities. Others asked who should fund investigations and enforcement actions if certifying agents ( State and private) are enforcing compliance with a Federal law. Numerous commenters requested information on how enforcement will be funded. The National Organic Standards Board ( NOSB) recommended that the NOP examine existing models for capturing enforcement fees such as the State of California's registration program for all growers, handlers, and processors who use the word, " organic," in marketing their products. 302 We disagree with the commenters who stated that USDA should fund enforcement activities ( State and private). Costs for compliance under the NOP will be borne by USDA, States with approved SOP's, and accredited certifying agents. Each of the entities will bear the cost of their own enforcement activities under the NOP. AMS anticipates that States will consider the cost of enforcing their SOP's prior to seeking USDA approval of such programs. We also anticipate that certifying agents will factor the cost of compliance into their certification fee schedules. We agree that there may be alternatives, such as the State of California's registration program, available to raise funds for enforcing the NOP. We will help identify existing models and potential options that may be available in the future at the Federal, State, or certifying agent level. In the interim, we believe that SOP's should explore funding options at their level and that certifying agents should factor the cost of enforcement into their certification fees structure. ( 2) Stop Sale. A number of commenters requested that the regulations include the ability to stop sales or recall misbranded or fraudulently produced products. The Act does not authorize the NOP to stop sales or recall misbranded or fraudulently produced product. Accordingly, USDA cannot authorize stop sales or the recall of product. We also believe that the certified operation's right to due process precludes a stop sale or recall prior to full adjudication of the alleged noncompliance. However, the Food and Drug Administration ( FDA) and the USDA's Food Safety Inspection Service ( FSIS) have stop sale authority that may be used in certain organic noncompliance cases. Further, States may, at their discretion, be able to provide for stop sale or recall of misbranded or fraudulently produced products produced within their State. While the Act does not provide for stop sale or recall, it does provide at 7 U. S. C. 6519 that any person 303 who: ( 1) knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than $ 10,000 and ( 2) makes a false statement under the Act to the Secretary, an SOP's governing State official, or a certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code. ( 3) Notification of Proposed Suspension or Revocation. A commenter recommended replacing " notification of proposed suspension or revocation" in section 205.662( d) with " notification of suspension or revocation." Certification cannot be suspended or revoked without due process. Accordingly, the issuance of a written notification of proposed suspension or revocation is necessary to provide the certified operation with information regarding the alleged noncompliance( s) and its right to answer the allegations. For this reason we have not accepted the commenter's recommendation. ( 4) Mediation for Certifying Agents. Several commenters recommended amending section 205.665( c)( 4) to provide for mediation between a certifying agent and the Program Manager when a proposed suspension or revocation is disputed by the certifying agent. We have not accepted the recommendation. USDA uses 7 CFR Part 1, Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes, for adjudicatory proceedings involving the denial, suspension, and revocation of accreditation. ( 5) Revocation of Accreditation. A commenter stated that revocation of accreditation for 3 years is excessive. The commenter stated that a period of 6 to 12 months might be reasonable. We have not amended section 205.665( g)( 2) because the Act requires that the period of revocation for certifying agents, who violate the Act and these regulations, be for not less than 3 years. Suspension is available to the Secretary to address less egregious noncompliances. A 304 certifying agent whose accreditation is suspended may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and these regulations. ( 6) Appeals Under SOP's. Several commenters recommended amending 205.668( b) by adding at the end thereof: " unless the State program's appeals procedures include judicial review through the State District Court." Another commenter wanted 205.668( b) amended by removing " of the State organic certification program. There shall be no subsequent rights of appeal to the Secretary. Final decisions of a State may be appealed to the United States District Court for the district in which such certified operation is located," and inserting in its place " at 7 CFR part 11 and 205.681 of this chapter." We have not accepted the recommendations because the Act at 7 U. S. C. 6520 provides that a final decision of the Secretary may be appealed to the United States District Court for the district in which the person is located. We consider an approved SOP to be the NOP for that State. As such, we consider the SOP's governing State official of such approved SOP to be the equivalent of a representative of the Secretary for the purposes of the appeals procedures under the NOP. Accordingly, the final decision of the SOP's governing State official of an approved SOP is considered the final decision of the Secretary and, as such, is appealable to the United States District Court for the district in which the person is located, not a State's District Court. We also disagree with the commenter who wanted all appeals to be made to the National Appeals Division under the provisions at 7 CFR Part 11 and section 205.681 of these regulations. 305 First, we believe that States with an approved SOP must be allowed to establish their own appeal procedures. Such procedures would have to comply with the Act, be equivalent to the procedures of USDA, and be approved by the Secretary. Second, as noted elsewhere in this preamble, the Act and its implementing regulations are subject to the APA for adjudication. The provisions of the APA generally applicable to agency adjudication are not applicable to proceedings under 7 CFR Part 11. Compliance ­ Clarifications Clarification is given on the following issues raised by commenters: ( 1) Complaints, Investigations, Stop Sales, and Penalties. Many commenters wanted USDA to spell out the responsibilities and authorities of States, State and private certifying agents, Federal agencies, and citizens to make complaints, investigate violations, halt the sale of products, and impose penalties. Anyone may file a complaint, with USDA, an SOP's governing State official, or certifying agent, alleging violation of the Act or these regulations. Certifying agents, SOP's governing State officials, and USDA will receive, review, and investigate complaints alleging violations of the Act or these regulations as described in item 6 above under Changes Based on Comments. Citizens have no authority under the NOP to investigate complaints alleging violation of the Act or these regulations. As noted elsewhere in this preamble, the Act does not authorize USDA to stop the sale of product. Accordingly, USDA cannot authorize stop sales by accredited certifying agents. We also believe that the certified operation's right to due process precludes a stop sale prior to full adjudication of the alleged noncompliance. However, FDA and FSIS have stop sale authority that may be used in the event of food safety concerns. Further, States may, at their discretion, be able 306 to provide for stop sale of product produced within their State. Citizens have no authority under the NOP to stop the sale of a product. The Act and these regulations provide for suspension or revocation of certification by certifying agents, SOP's governing State officials, and the Secretary. Only USDA may suspend or revoke a certifying agent's accreditation. All proposals to suspend or revoke a certification or accreditation are subject to appeal as provided in section 205.681. The Act provides at 7 U. S. C. 6519 that any person who: ( 1) knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than $ 10,000 and ( 2) makes a false statement under the Act to the Secretary, an SOP's governing State official, or a certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code. Only USDA may bring an action under 7 U. S. C. 6519. ( 2) Certifying Agent's Identifying Mark. The NOSB reaffirmed its recommendation which would allow private certifying agents to prevent the use of their service mark ( seal) upon written notification that: ( 1) certification by the private certifying agent has been terminated, and ( 2) the certifying agent has 30 days to appeal the certifying agent's decision to the Secretary of Agriculture. We will neither prohibit nor approve a certifying agent's actions to withdraw a certified operation's authority to use the certifying agent's identifying mark for alleged violations of the Act or regulations. We stand fast in our position that all certified operations are to be given due process prior to the suspension or revocation of their certification. The reader is also reminded that the certifying agent cannot terminate, suspend, or revoke a certification if the certified operation files an appeal with an SOP's governing State official, when applicable, or the Administrator as provided for in the notification of proposed suspension or revocation. The 307 certifying agent accepts full liability for any action brought as a result of the withdrawal of a certified operation's authority to use the certifying agent's identifying mark. ( 3) Loss of Certification. A commenter posed several questions regarding the loss of certification. The commenter's questions and our responses are as follows. How will consumers and affected regulatory agencies know if a grower or handler loses its certification? We will provide public notification of suspensions and revocations of certified operations through means such as the NOP website. What will the effect of a lost certification be? Suspension or revocation of a producer's or handler's certification will require that the producer or handler immediately cease its sale, labeling, and representation of agricultural products as organically produced or handled as provided in the suspension or revocation order. A production or handling operation or a person responsibly connected with an operation whose certification has been suspended may at any time, unless otherwise stated in the notification of suspension, submit a new request for certification in accordance with section 205.401. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. An operation or a person responsibly connected with an operation whose certification has been revoked will be ineligible to receive certification for a period of not more than 5 years following the date of such revocation, as determined by the Secretary. Any producer or handler who sells, labels, or represents its product as organic contrary to the provisions of the suspension or revocation order would be subject to prosecution under 7 U. S. C. 6519 of the Act. Will the certifying agent give a future effective date for loss of certification, or could the 308 loss of certification be immediate or even retroactive? Suspension or revocation will become effective as specified in the suspension or revocation order once it becomes final and effective. The operation, upon suspension or revocation, will be prohibited from selling, labeling, and representing its product as organic per the provisions of the suspension or revocation order. If organic products already on the market were grown or handled by someone whose certification is revoked or suspended, would USDA require that the products be recalled and relabeled? USDA will not, unless the noncompliance involves a food safety issue under FSIS, require the recall or relabeling of product in the channels of commerce prior to the issuance of a suspension or revocation order. First, at the time the product was produced, it may have been produced in compliance with the Act and these regulations. Second, USDA does not have the authority, under the Act, to issue a stop sale order for product sold, labeled, or represented as organic and placed in the channels of commerce prior to suspension or revocation of a certified operation's certification. The Act, however, provides at 7 U. S. C. 6519( a) for the prosecution of any person who knowingly sells or labels a product as organic, except in accordance with the Act. Such persons shall be subject to a civil penalty of not more than $ 10,000 per violation. ( 4) Investigations. A commenter suggested that we amend section 205.661( a) to require that all complaints must be investigated in accordance with the certifying agent's complaints policy. The commenter also stated that the Administrator should know which complaints were not investigated. We disagree that all complaints must be investigated since, upon review of the alleged noncompliance, some complaints may lack grounds for investigation. For example, a concerned citizen could allege that an organic producer was seen applying a pesticide to a specific field. Upon review of the allegation, the certifying agent could determine that the producer in 309 question was a split operation and that the field in question was part of the conventional side of the production operation. Accordingly, there would be no need for an investigation. However, the certifying agent will be expected to: ( 1) take each allegation seriously, ( 2) review each complaint received, ( 3) make a determination as to whether there may be a basis for conducting an investigation, ( 4) investigate all allegations when it is believed that there may be a basis for conducting the investigation, and ( 5) maintain a detailed log of all complaints received and their disposition. The actions taken by the certifying agent must be in conformance with the certifying agent's procedures for reviewing and investigating certified operation compliance. ( 5) Deadline for the Correction of a Noncompliance. Several commenters requested that 205.662( a)( 3) be amended by adding: " The deadline for correction of the noncompliance may be extended at the discretion of the certifier if substantial progress has been made to correct the noncompliance." We believe that the requested amendment is unnecessary. Section 205.662( a)( 3) requires that the notification of noncompliance include a date by which the certified operation must rebut or correct each noncompliance and submit supporting documentation of each correction when correction is possible. There is no prohibition preventing the certifying agent from extending the deadline specified when the certifying agent believes that the certified operation has made a good faith effort at correcting each noncompliance. ( 6) Compliance with SOP. Several States requested that section 205.665 be amended to clarify how States may handle a private certifying agent found to be in noncompliance with SOP's approved by the Secretary. A majority of these commenters also asked if NOP intends to suspend or revoke the accreditation of certifying agents on a State­ by­ State basis. Section 205.668( c) authorizes an SOP's governing State official to review and investigate complaints of 310 noncompliance with the Act or regulations concerning accreditation of certifying agents operating in the State. When such review or investigation reveals any noncompliance, the SOP's governing State official shall send a written report of noncompliance to the NOP Program Manager. The report shall provide a description of each noncompliance and the facts upon which the noncompliance is based. The NOP Program Manager will then employ the noncompliance procedures for certifying agents as found in section 205.665. This may include additional investigative work by AMS. Only USDA may suspend or revoke a certifying agent's accreditation. SOP's must meet the general requirements for organic programs specified in the Act and be at least equivalent to these regulations. Accordingly, noncompliances worthy of suspension or revocation would in all probability be worthy of national suspension or revocation of accreditation for one or more areas of accreditation. Therefore, USDA does not anticipate suspending or revoking accreditations, or areas of accreditation, on a State­ by­ State basis. It is possible, however, that the Secretary may decide to only suspend or revoke a certifying agent's accreditation or an area of accreditation to certify producers or handlers within a given State. Such a decision would in all probability be tied to a State's more restrictive requirements. Inspection and Testing, Reporting, and Exclusion from Sale This portion of subpart G sets forth the inspection and testing requirements for agricultural products that have been produced on organic production operations or handled through organic handling operations. Residue testing plays an important role in organic certification by providing a means for monitoring compliance with the National Organic Program ( NOP) and by discouraging the 311 mislabeling of agricultural products. This testing program provides State organic programs' ( SOP) governing State officials and certifying agents with a tool for ensuring compliance with three areas for testing: ( 1) preharvest residue testing, ( 2) postharvest residue testing, and ( 3) testing for unavoidable residual environmental contamination levels. Description of Regulations General Requirements Under the residue testing requirements of the NOP, all agricultural products sold, labeled, or represented as organically produced must be available for inspection by the Administrator, SOP's governing State official, or certifying agent. Organic farms and handling operations must be made available for inspection under subpart E, Certification. In addition, products from the aforementioned organic operations may be required by the SOP's governing State official or certifying agent to undergo preharvest or postharvest testing when there is reason to believe that agricultural inputs used in organic agriculture production or agricultural products to be sold or labeled as organically produced have come into contact with prohibited substances or have been produced using excluded methods. The cost of such testing will be borne by the applicable certifying agent and is considered a cost of doing business. Accordingly, certifying agents should make provisions for the cost of preharvest or postharvest residue testing when structuring certification fees. Preharvest and Postharvest Residue Testing The main objectives of the residue testing program are to: ( 1) ensure that certified organic production and handling operations are in compliance with the requirements set forth in this final rule and ( 2) serve as a means for monitoring drift and unavoidable residue contamination of 312 agricultural products to be sold or labeled as organically produced. Any detectable residues of a prohibited substance or a product produced using excluded methods found in or on samples during analysis will serve as a warning indicator to the certifying agent. The Administrator, SOP's governing State official, or certifying agent may require preharvest or postharvest testing of any agricultural input used in organic agricultural production or any agricultural product to be sold or labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))." It is based on the Administrator's, SOP's governing State official's, or certifying agent's belief that an agricultural product or agricultural input has come into contact with one or more prohibited substances or has been produced using excluded methods. Certifying agents do not have to conduct residue tests if they do not have reason to believe that there is a need for testing. Certifying agents must ensure, however, that certified organic operations are operating in accordance with the Act and the regulations set forth in this part. The " reason to believe" could be triggered by various situations, for example: ( 1) the applicable authority receiving a formal, written complaint regarding the practices of a certified organic operation; ( 2) an open container of a prohibited substance found on the premises of a certified organic operation; ( 3) the proximity of a certified organic operation to a potential source of drift; ( 4) suspected soil contamination by historically persistent substances; or ( 5) the product from a certified organic operation being unaffected when neighboring fields or crops are infested with pests. These situations do not represent all of the possible occurrences that would trigger an investigation. Preharvest or postharvest residue testing will occur on a case­ by­ case basis. In each case, an inspector representing the Administrator, SOP's governing State official, 313 or certifying agent or will conduct sampling. According to subpart F, Accreditation, private or State entities accredited as certifying agents under the NOP must ensure that its responsibly connected persons, employees, and contractors with inspection, analysis, and decision­ making responsibilities have sufficient expertise to successfully perform the duties assigned. Therefore, all inspectors employed by certifying agents to conduct sampling must have sufficient expertise in methods of chain­ of­ custody sampling. Moreover, testing for chemical residues must be performed in an accredited laboratory. When conducting chemical analyses, the laboratory must incorporate the analytical methods described in the most current edition of the Official Methods of Analysis of the AOAC International or other current applicable validated methodology for determining the presence of contaminants in agricultural products. Results of all analyses and tests performed under section 205.670 must be promptly provided to the Administrator, except, that, where an SOP exists, all test results and analyses should be provided to the SOP's governing State official by the applicable certifying party that requested testing. Residue test results and analyses must also be, according to section 205.403( e)( 2), provided to the owner of the certified organic operation whose product was tested. All other parities desiring to obtain such information must request it from the applicable certifying agent. OFPA requires certifying agents, to the extent of their awareness, to report violations of applicable laws relating to food safety to appropriate health agencies such as EPA and FDA. When residue testing indicates that an agricultural product contains pesticide residues or environmental contaminants that exceed either the EPA tolerance level or FDA action level, as applicable, the certifying agent must promptly report data revealing such information to the Federal agency whose regulatory tolerance or action level has been exceeded. 314 Residue Testing and Monitoring Tools When testing indicates that an agricultural product to be sold or labeled as organically produced contains residues of prohibited substances, certifying agents will compare the level of detected residues with 5 percent of the Environmental Protection Agency ( EPA) tolerance for the specific residue detected on the agricultural product intended to be sold as organically produced. This compliance measure, 5 percent of EPA tolerance for the detected prohibited residue, will serve as a standard for the Administrator, SOP's governing State officials, and certifying agents to assist in monitoring for illegal use violations. In addition, we intend to establish levels of unavoidable residual environmental contamination ( UREC) for crop­ and site­ specific agricultural commodities to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." These levels will represent limits at which USDA may take compliance action to suspend the use of a contaminated area for organic agricultural production. Currently, USDA is seeking scientifically sound principles and measures by which it can establish UREC levels to most effectively address issues of unavoidable residual environmental contamination with respect to this rule. However, in the interim, UREC will be defined as the Food and Drug Administration's ( FDA) action levels for poisonous or deleterious substances in human food or animal feed. UREC levels will be initially set for persistent prohibited substances ( aldrin, dieldrin, chlordane, DDE, etc.) in the environment. They may become more inclusive of prohibited residues as additional information becomes available. Unavoidable residual environmental contamination levels will be based on the unavoidability of the chemical substances and do not represent permissible levels of contamination where it is avoidable. 315 Analyses and test results will be available for public access unless the residue testing is part of an ongoing compliance investigation. Information relative to an ongoing compliance investigation will be confidential and restricted to the public. Detection of Prohibited Substances or Products Derived from Excluded Methods In the case of residue testing and the detection of prohibited substances in or on agricultural products to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with...," products with detectable residues of prohibited substances that exceed 5 percent of the EPA tolerance for the specific residue or UREC cannot be sold or labeled as organically produced. When such an agricultural crop is in violation of these requirements, the certification of that crop will be suspended for the period that the crop is in production. Certifying agents must follow the requirements specified in sections 205.662 and 205.663 of subpart G, Compliance. The " 5 percent of EPA tolerance" standard is considered a level above which an agricultural product cannot be sold as organic, regardless of how the product may have come into contact with a potential prohibited substance. This standard has been established to: ( 1) satisfy consumer expectations that organic agricultural products will contain minimal chemical residues and ( 2) respond to the organic industry's request to implement a standard comparable to current industry practices. However, the " 5 percent of EPA tolerance" standard cannot be used to automatically qualify agricultural products as organically produced, even if the level of chemical residues detected on an agricultural product is below 5 percent of the EPA tolerance for the respective prohibited substance. This final rule is a comprehensive set of standards and regulations that determines whether a product can or cannot be considered to carry the specified 316 organic labeling terms in subpart D, Labeling. Therefore, in addition to this section of subpart G, Administrative, all other requirements of this part must be met by certified organic operations to have an agricultural product considered " organically produced." When residue testing detects the presence of any prohibited substance, whether above or below 5 percent of the EPA tolerance for the specific pesticide or UREC, the SOP's governing State official or certifying agent may conduct an investigation of the certified organic operation to determine the cause of the prohibited substance or product in or on the agricultural product to be sold or labeled as organically produced. The same shall occur if testing detects a product produced using excluded methods. If the investigation reveals that the presence of the prohibited substance or product produced using excluded methods in or on an agricultural product intended to be sold as organically produced is the result of an intentional application of a prohibited substance or use of excluded methods, the certified organic operation shall be subject to suspension or revocation of its organic certification. In addition, any person who knowingly sells, labels, or represents an agricultural product as organically produced in violation of the Act or these regulations shall be subject to a civil penalty of not more than $ 10,000 per violation. Emergency Pest or Disease Treatment Programs When a prohibited substance is applied to an organic production or handling operation due to a Federal or State emergency pest or disease treatment program and the organic handling or production operation otherwise meets the requirements of this final rule, the certification status of the operation shall not be affected as a result of the application of the prohibited substance, except that: ( 1) any harvested crop or plant part to be harvested that has contact with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program 317 cannot be sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." and ( 2) any livestock that are treated with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program or product derived from such treated livestock cannot be sold, labeled, or represented as " 100 percent organic," " organic," or " made with..." However, milk or milk products may be labeled or sold as organically produced beginning 12 months following the last date that the dairy animal was treated with the prohibited substance. Additionally, the offspring of gestating mammalian breeder stock treated with a prohibited substance may be considered organic if the breeder stock was not in the last third of gestation on the date that the breeder stock was treated with the prohibited substance. Residue Testing ­ Changes Based on Comments This portion of subpart G differs from our proposal in several respects as follows: ( 1) Reporting Requirements. Commenters were not satisfied with the language in section 205.670( d)( 1) that required results of all analyses and tests performed under section 205.670 to be provided to the Administrator promptly upon receipt. They asked that the paragraph be amended to include that: ( 1) results of all analyses and tests performed under section 205.670 be provided by the Administrator to the appropriate SOP's governing State official and ( 2) test results be made immediately available to the owner of the material sampled. They stated that since State organic certification programs are responsible for enforcement within their State, results of residue tests conducted by certifying agents must be provided to the SOP's governing State official for routine monitoring and for investigating possible violations of the Act. We agree with the commenters and have responded to their concerns accordingly. To 318 ensure that SOP's receive results of all tests and analyses conducted under the inspection and testing requirements of subpart G, section 205.670( d) has been amended to include that the results of all analyses and residue tests must be provided to the Administrator promptly upon receipt; Except: That where an SOP exists, all test results and analyses should be provided to the SOP's governing State official. In regard to the commenters' request that certified organic operations be provided with a copy of test results from samples taken by an inspector, an additional paragraph, section 205.403( e)( 2), has been added to subpart E, Certification, that assures that such information is provided to the owners of certified organic operations by the certifying agents. ( 2) Integrity Of Organic Samples. We have modified language in section 205.670( c) to clarify our intent regarding the maintenance of sample integrity. The proposed rule stated that " sample integrity must be maintained in transit, and residue testing must be performed in an accredited laboratory." During the final rulemaking process, we did not believe that our intent was clear on this subject. Our intent is to ensure that sample integrity is maintained throughout the entire chain of custody during the residue testing process. Proposed language only suggests that sample integrity be maintained in transit. Therefore, the we have changed the second sentence in section 205.670( c) to state that " sample integrity must be maintained throughout the chain of custody, and residue testing must be performed in an accredited laboratory." ( 3) Reporting Residue and Other Food Safety Violations to Appropriate Health Agencies. In the proposed rule, section 205.671( b) under Exclusion from Organic Sale states, " If test results indicate a specific agricultural product contains pesticide residues or environmental contaminants that exceed the FDA's or the EPA's regulatory tolerances, the data must be reported promptly to 319 the appropriate public health agencies." During the final rulemaking process, a group of commenters suggested that we move section 205.671( b) into section 205.670 as paragraph ( e). They recommended that we move section 205.671( b) because it does not specifically address the sale of organically produced products, as indicated by the section heading. They recommended that section 205.671( b) be placed under section 205.670 as paragraph ( e) because it dealt with the reporting of residues that exceed Federal regulatory tolerances. The commenters further stated that, while section 205.671( b) creates a duty to report, it is not specific as to who must report. We have accepted the suggestions of the commenters and have responded accordingly. We have removed section 205.671( b) and relocated it under section 205.670 as paragraph ( e). We have also modified the regulatory text of paragraph ( e) to include language that instructs certifying agents to report, when residue testing indicates that an agricultural product contains pesticide residues or environmental contaminants that exceed either the EPA tolerance level or FDA action level, as applicable, data reveling such information to the Federal agency whose regulatory tolerance or action level has been exceeded. ( 4) Exclusion from Organic Sale. We have reviewed section 205.671( a), removed the requirement to implement the Pesticide Data Program ( pdp) estimated national mean as a compliance tool in monitoring for the presence of unacceptable levels of prohibited substances in agricultural products intended to be sold as organic, and added the " 5 percent of EPA tolerance" standard. Commenters voiced the opinion that the estimated national mean would be a difficult standard in organic agricultural production for several reasons. Some stated that the estimated national mean was a new concept that would confuse producers and handlers because they would 320 not know the exact definition of " estimated national mean" and how it would be determined. Others stated that the PDP was too limited in scope to employ an estimated national mean for all commodity/ pesticide combinations. Commenters reasoned that PDP data were limited in terms of the agricultural commodities that are sampled and tested. Another group of commenters stated that PDP data would be unfair to use in the NOP's residue testing plan. They argued PDP data should not be used to set maximum residue levels for organic agricultural products because PDP samples its products as close to the point of consumption as possible. As a result, commenters believe that PDP data may not be totally reflective of residue levels of agricultural products at the farmgate level. Since most residue testing in organic agricultural production takes place at the farmgate, these commenters argued that it would be an inappropriate standard for organic agricultural production. As a result, a large number of commenters suggested that we reconsider using the estimated national mean as a standard for the maximum allowable residues on organically produced products. Instead, commenters recommended that the NOP incorporate the National Organic Standards Board's ( NOSB) recommendation and current industry practice of using 5 percent of the EPA tolerance as a maximum level of pesticide residue on organic agricultural products. Commenters argued that using 5 percent of the EPA tolerance provides a sense of confidence to the consumers of organic agricultural products. In many respects, we agree with the commenters. We have revisited using PDP data to establish an estimated national mean for commodity/ pesticide combinations and for setting a maximum level of pesticide residue that could exclude agricultural products from being sold, labeled, or represented as organic. As a result, we have concluded that such an approach may be 321 somewhat underdeveloped to incorporate into the NOP. We have reached this conclusion based on many of the same arguments presented by commenters ( i. e., limited scope of agricultural products tested under PDP, product sampling based upon market availability, testing near the point of consumption, etc.). Also, we estimated that there would be a considerable time lag between the implementation of the NOP and defining a comprehensive list of estimated national means for all commodity/ pesticide combinations. Thus, we have decided not to use the estimated national mean as a tool for monitoring organic agricultural products for the presence of prohibited substances and as a standard to exclude agricultural products from being sold, labeled, or represented as organically produced. Instead, we have decided to follow the recommendation of the commenters by replacing the estimated national mean for specific commodity/ pesticide pairs with 5 percent of the EPA tolerance for the specific pesticide. Therefore, when residue testing detects prohibited substances at levels that are greater than 5 percent of the EPA tolerance for the specific pesticide detected on the particular product samples, the agricultural product must not be sold or labeled as organically produced. We fully understand that the EPA tolerance is defined as the maximum legal level of a pesticide residue in or on a raw or processed agricultural commodity. We also acknowledge that the EPA tolerance is a health­ based standard. We are not trying to employ the 5 percent standard in a manner similar to that of EPA. As mentioned in our proposal, the national organic standards, including provisions governing prohibited substances, are based on the method of production, not the content of the product. The primary purpose of the residue testing approach described in this final rule, then, is to provide an additional tool for SOP's' governing State 322 officials and certifying agents to use in monitoring and ensuring compliance with the NOP. ( 5) Unavoidable Residual Environmental Contamination. We have defined, as an interim measure, UREC as the FDA action levels for poisonous or deleterious substances in human food or animal feed. Section 205.671 proposed the use of UREC to serve as a residue testing tool for compliance. Commenters believed UREC levels, as prescribed in section 205.671 of the proposed rule, would be problematic as a standard because they were undefined. Commenters argued that it would be impractical and very expensive to establish UREC levels for every organic crop and region in the United States. They suggested that UREC levels be managed as a practice standard or program manual issue. They also expressed the concern that inconsistent application of UREC levels could create difficulties for certifying agents and certified operations. We agree that UREC levels should be defined. We are seeking scientifically sound principles and measures by which we can establish UREC levels to most effectively address issues of unavoidable residual contamination with respect to this rule. However, in the interim, the ability to implement an undefined standard would be difficult for certifying agents. Therefore, we have included language in the preamble that temporarily defines UREC as the FDA action levels for poisonous or deleterious substances in human food or animal feed. When residue testing detects the presence of a prohibited substance on an agricultural product greater than such levels mentioned, the agricultural product cannot be sold as organic. We have decided to use FDA action levels for UREC because they encompass many of the toxic, persistent chemicals and heavy metals that are present in the environment and may be found on food and animal feed. As mentioned earlier, the FDA action levels are being employed in this part as temporary measures 323 for compliance. We will continue to seek scientifically sound principles and measures by which to establish UREC levels that more appropriately satisfy the purposes of this part. Residue Testing ­ Changes Requested But Not Made This subpart retains from the proposed rule regulations on which we received comments as follows: ( 1) Residue Testing Responsibility. Commenters petitioned that we remove the requirement in section 205.670( b) that states residue tests must be conducted by the applicable SOP's governing State official or the certifying agent at the official's or certifying agent's own expense. The commenters expressed the opinion that we were practicing " micromanagement." They also said that there was no need for the proposal to be so detailed with respect to who pays for residue testing. Based on the commenters' responses, residue analyses are reportedly paid by producers, buyers, brokers, certifiers, and government residue testing programs. We have not adopted the suggestion of the commenters. In the proposal, we stated that conducting residue tests was considered a cost of doing business for certifying agents. Our position has not changed. Certifying agents can factor residue testing costs into certification fees. It is not our intention to " micromanage" the way that certifying agents conduct business. Section 2107( a)( 6) of the Act requires that certifying agents conduct residue testing of agricultural products that have been produced on certified organic farms and handled through certified organic handling operations. OFPA also requires, under section 2112( a) through ( c), that certifying agents enforce its provisions by implementing a system of residue testing to test products sold or labeled as organically produced. In addition, subpart E, Certification, authorizes certifying agents to conduct on­ site inspections, which may include residue testing, of certified 324 organic operations to verify that the operation is complying with the provisions in the Act and the regulations in this part. Certifying agents are responsible for monitoring organic operations for the presence of prohibited substances; we view residue testing as a cost of doing business. Therefore, we believe that certifying agents should factor monitoring costs associated with implementing the provisions in the Act and Rule into their certification fees. ( 2) Reporting to Federal Regulatory Agencies. Commenters disagree with section 205.671( b) of the proposed rule which states that if test results indicate a specific agricultural product contains pesticide residues or environmental contaminants that exceed the FDA action level or EPA tolerance, the data must be reported promptly to appropriate public health agencies. Commenters believe that since results of all analyses and tests must be provided to the Administrator, USDA should be responsible for communicating such test results to other Federal agencies such as FDA or EPA if regulatory tolerances or action levels are exceeded. They also suggested that section 205.671( b) be removed from the national regulations. Commenters expressed the view that such a requirement is not related to organic certification. We do not agree with the commenters. It is not our intent to create additional responsibility for the certifying agent. Section 205.671( b), redesignated as section 205.670( e), is a statutory requirement. Section 2107( a)( 6) of the Organic Food Production Act of 1990 requires certifying agents, to the extent of their awareness, to report violations of applicable laws relating to food safety to appropriate health agencies such as EPA and FDA. Therefore, due to section 2107 of the Act, section 205.670( e) has been included in the national regulations. ( 3) " Threshold" for Genetic Contamination. Many commenters suggested that we establish a " threshold" for the unintended or adventitious presence of products of excluded 325 methods in organic products. Some commenters argued that a threshold is necessary because, without the mandatory labeling of biotechnology­ derived products, organic operations and certifying agents could not be assured that products of excluded methods were not being used. Others argued that, without an established threshold, the regulations would constitute a " zero tolerance" for products of excluded methods, which would be impossible to achieve. We do not believe there is sufficient consensus upon which to establish such a standard at this time. Much of the basic, baseline information about the prevalence of genetically engineered products in the conventional agricultural marketplace that would be necessary to set such a threshold e. g., the effects of pollen drift where it may be a factor, the extent of mixing at various points throughout the marketing chain, the adventitious presence of genetically engineered seed in nonengineered seed lots is still largely unknown. Our understanding of how the use of biotechnology in conventional agricultural production might affect organic crop production is even less well developed. Also, as was pointed out in some comments, the testing methodology for the presence of products of excluded methods has not yet been fully validated. Testing methods for some biotechnology traits in some commodities are becoming commercially available. Without recognized methods of testing for and quantifying of all traits in a wide range of food products, however, it would be very difficult to establish a reliable numerical tolerance. There are publicly and privately funded research projects underway that may provide useful baseline information. Efforts of Federal agencies to clarify the marketing and labeling of biotechnology­ and nonbiotechnology­ derived crops may also help address these concerns. FDA, for example, is developing guidance for food producers who voluntarily chose to label 326 biotechnology­ and nonbiotechnology­ derived foods. USDA is also preparing a Federal Register Notice to seek public comment on the appropriate role, if any, that it can play in facilitating the marketing of agricultural products through the development of " quality assurance" type programs that help to preserve the identity of agricultural commodities. USDA, in cooperation with the technology providers, is also working to validate testing procedures and laboratories for some commodities. All of these efforts may help to provide information on this issue. Practices for preserving product identity, including segregating genetically engineered and nongenetically engineered products, are evolving in some conventional markets. As we discussed in the preamble to the proposed rule, we anticipate that these evolving industry best practices and standards will become the standards for implementing the provisions in this regulation relating to the use of excluded methods. As was also discussed in the proposed rule, these regulations do not establish a " zero tolerance" standard. As with other substances not approve for use in organic production systems, a positive detection of a product of excluded methods would trigger an investigation by the certifying agent to determine if a violation of organic production or handling standards occurred. The presence of a detectable residue alone does not necessarily indicate use of a product of excluded methods that would constitute a violation of the standards. ( 4) Certification Status After Emergency Pest or Disease Treatment. We have not modified language in section 205.672 that would affect the certification status of a certified organic operation if the operation had been subjected to a Federal or State emergency pest or disease treatment program. Section 205.672 states that when a prohibited substance is applied to a certified operation 327 due to a Federal or State emergency pest or disease treatment program and the certified operation otherwise meets the requirements of this part, the certification status of the operation shall not be affected as a result of the application of the prohibited substance: Provided, That, the certified operation adheres to certain requirements prescribed by the NOP. One group of commenters informed us that they did not support maintaining the organic status of an operation that has been directly treated with prohibited substances, regardless of the reason for treatment. They believe that Federal and State emergency pest or disease treatment programs should provide alternatives for organic operations whenever feasible. If no alternative measure is feasible, the organic operation should choose between voluntary surrender of their organic status on targeted parts of the operation or destruction of the crop to eliminate pest habitat. The commenters also suggested that compensation should be provided to organic producers whose crops must be destroyed to eliminate habitat. They feel that allowing the application of prohibited materials to certified organic land without affecting the certification status violates the trust consumers place in organic certification. We disagree with the position of the commenters. Historically, residues from emergency pest or disease treatment programs have been treated as drift cases by certifiers. In these cases, the specific crop may not be sold as organic, but the organic status of future crop years are not affected. We intend to handle such cases in a similar manner. We understand that commenters would like us to remove the certification of an organic operation that has been treated with a prohibited substance, but organic certification is a production claim, not a content claim. We, along with the commenters, are concerned with consumers trusting organic certification. At the same time, we are concerned with the welfare of certified organic operations. We have tried to 328 include language in section 205.672 that would address both issues. We believe that, if a certified organic grower has been a good steward of his/ her land and has managed the production of his/ her product( s) in accordance with all regulations in the Act and other requirements in this part, the certification status of the operation should not be affected. The application of a prohibited substance as part of a Federal or State emergency pest or disease treatment program is outside the control of the certified operation. We also believe that maintaining consumer trust is important. Thus, section 205.672 states that any harvested crop or plant part to be harvested that has been treated with a prohibited substance as part of a Federal or State emergency pest or disease treatment program cannot be sold as organically produced. Therefore, the certified organic operation can retain its certification status, and the consumer can be assured that a product from a certified organic operation that has been in contact with a prohibited substance as the result of a Federal or State pest or disease treatment program will not enter the organic marketplace. Accordingly, we have not made the change to section 205.672 as proposed by the commenters. ( 5) Emergency Pest or Disease Treatment Programs. Commenters suggested that the Department add a new paragraph to section 205.672 that states " the certifying agent must monitor production operations that have been subjected to a Federal or State emergency pest or disease treatment program, and may require testing of following crops, or an extended transition period for affected production sites, if residue test results indicate the presence of a prohibited substance." Commenters said the language in the proposed rule did not clearly establish that a transition period could be needed after contamination of a certified organic operation by a government­ mandated spray program. They felt that there may be a need for a case­ by­ case determination by the certifying agent as to when it would be best for a certified organic operation 329 to begin selling its products as organically produced after it has been subject to a government mandated spray program. We understand that commenters would like USDA to mandate certifying agents to monitor operations that have been subject to Federal or State emergency pest or disease treatment programs; however, we do not see a need to prescribe such a provision. Based on the responsibilities of being a USDA­ accredited certifier, it is our belief that certifying agents would monitor a certified organic operation that has been subjected to a Federal or State emergency pest or disease treatment program to make sure that product being produced for organic sale is actually being produced in accordance with the Act and the regulations in this part. Certifying agents have been granted the authority to conduct additional on­ site inspections of certified organic operations to determine compliance with the Act and national standards under subpart E, section 205.403. Commenters requested that we include language that would allow certifying agents to recommend an extended transition period for affected production sites if residue tests indicate the presence of a prohibited substance. Again, we understand the commenters' concern, but we are not aware of comprehensive soil residue data that could guide certifying agents in determining appropriate withdrawal intervals for operations that have been subjected to emergency pest or disease treatment programs. Residue Testing ­ Clarifications Clarification is given on the following issues raised by commenters as follows: ( 1) Sampling and Testing. Commenters stated that the purpose of residue testing under the Act is to assure that organically produced agricultural products that are sold as organic do not contain pesticide residues or residues of other prohibited substances that exceed levels as specified 330 by the NOP. Based on language in section 205.670( b) of the proposed rule, commenters expressed the opinion that the Agricultural Marketing Service ( AMS) was, not only requiring residue testing of organic agricultural products, but also of " any" agricultural input used or agricultural product intended to be sold as " 100 percent organic," " organic," or " made with..." when there is reason to believe that the agricultural input or product has come into contact with a prohibited substance. Commenters believe that organic certifying agents may be required to test many nonorganic agricultural inputs ( such as seeds, compost, straw, sawdust, and plastic) and nonorganic agricultural products and ingredients used in products labeled as " made with...". They also argued that such testing would be unnecessary, burdensome, and expensive because such materials are more likely to have come into contact with a prohibited substance. Therefore, commenters suggested that we amend section 205.670( b) by deleting " agricultural inputs" and replacing " agricultural product" with " organically produced agricultural product." They also recommended that we replace the second occurrence of " product" with " organic product." Thus section 205.670( b) would suggest that only organic agricultural products could be required to be tested by the certifying agent. We understand the concerns of the commenters but believe that the commenters have misinterpreted the intent of section 205.670( b). It is not our intent to mandate residue testing of all inputs and ingredients used in the production of organic agricultural products. Neither is it our intent for certifying agents to abuse residue testing responsibility by conducting residue tests of certified organic operations without reason to believe that the agricultural input or product intended to be sold as organic has come into contact with prohibited substances. Our intent is to make it clear that certifying agents have the authority to test any agricultural input used or 331 agricultural product intended to be sold as organically produced when there is reason to believe that the agricultural input or product has come into contact with a prohibited substance. Section 205.670( b) allows for testing of inputs and agricultural products, but it does not require that all inputs of a product intended to be sold as organically produced must be tested. However, certifying agents must be able to ensure that certified organic operations are operating in accordance with the Act and the regulations set forth in this part. To assure that certifying agents have established fair and effective procedures for enforcing residue testing requirements, section 205.504( b)( 6) provides that they must submit to USDA a copy of the procedures to be used for sampling and residue testing pursuant to section 205.670. ( 2) Chain Of Custody Training. A commenter suggested that section 205.670( c) address chain of custody training for inspectors that will be performing preharvest or postharvest tissue test sample collection on behalf of the Administrator, SOP's governing State official, or certifying agent. The commenter proposed that all inspectors should be trained to handle chain of custody samples in order to maintain the integrity of the samples. We agree that inspectors should be appropriately trained to handle chain­ of­ custody samples in order to maintain the integrity of the samples taken from a certified organic operation. However, we do not believe that the language in section 205.670( c) must be modified to address such an issue. As a USDA­ accredited body, a private or State entity operating as a certifying agent must ensure that its responsibly connected persons, employees, and contractors with inspection, analysis, and decision­ making responsibilities have sufficient expertise in organic production or handling techniques to successfully perform the duties assigned. The certifying agent must also submit a description of the training that has been provided or intends to be 332 provided to personnel to ensure that they comply with and implement the requirements of the Act and the regulations in this part. In addition, certifying agents must submit a copy of the procedure to be used for sampling and residue testing for approval by the Administrator. Through the accreditation process, therefore, we will be able to assess the expertise of the individuals employed by the certifying agent and provide guidance in areas where additional training is needed to comply with the requirements of the Act and the regulations in this part. ( 3) Exclusion from Organic Sale. Commenters expressed that section 205.671( a) could be easily misinterpreted. They said that section 205.671( a) did not make clear that residue testing may not be used to qualify crops to be sold as organic if a direct application of prohibited materials occurred. Commenters suggested that section 205.671( a) include: " Any crop or product to which prohibited materials have been directly applied shall not be sold, labeled, or represented as organically produced." We do not believe this additional language is necessary. Residue testing cannot be used to qualify any agricultural crop or product to which a prohibited material has been purposefully/ directly applied. The presence of any prohibited substance on an agricultural product to be sold as organic warrants an investigation as to why the detected prohibited substance is present on the agricultural product. It does not matter if the product has come into contact with a prohibited substance through means of drift or intentional application. If the outcome of the investigation reveals that the presence of the detected prohibited substance is the result of an intentional application, the certified operation will be subject to suspension or revocation of its organic certification and/ or a civil penalty of not more than $ 10,000 if he/ she knowingly sells the product as organic. The use of prohibited substances is not allowed in the Act 333 or this final rule. Residue testing is not a means of qualifying a crop or product as organic if a prohibited substance has been intentionally/ directly applied. It is a tool for monitoring compliance with the regulations set forth in the Act and in this part. ( 4) Emergency Pest or Disease Treatment Programs. Commenters requested that we make a clear distinction between crops or agricultural products that have had prohibited substances directly applied to them and those that have come into contact with prohibited substances through chemical drift. They have proposed that we amend section 205.672( a) to address this issue. Section 205.672( a) of the proposal states that any harvested crop or plant part to be harvested that has had contact with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program cannot be sold as organically produced. Commenters did not find this language acceptable because it did not distinguish between the two types of ways that products can come into contact with prohibited substances ( drift and direct/ intentional application) and how each situation would be addressed with respect to the national organic standards. Commenters believed that section 205.672( a) was fairly ambiguous and open for misinterpretation. Commenters requested that we amend language in section 205.672( a) to include that " Any harvested crop or plant part to be harvested that has contact with a prohibited substance directly applied to the crop as the result of a Federal or State emergency pest or disease treatment program cannot be sold, labeled, or represented as organically produced." We do not accept the commenters' request and believe that the commenters have misinterpreted section 205.672 of the proposed rule. Section 205.672 specifically addresses certified organic operations that have had prohibited substances applied to them due to a Federal 334 or State pest or disease treatment program. Section 205.672 does not include those organic operations that may have been drifted upon by prohibited substances that have been applied to a neighboring farm as a result of a Federal or State emergency pest or disease treatment program. Any potential drift from a mandatory pest and disease treatment program will be treated in the same manner as drift from any other source. Adverse Action Appeal Process This portion of subpart G sets forth the procedures for appealing adverse actions under the National Organic Program ( NOP). These procedures will be used by: ( 1) producers and handlers appealing denial of certification and proposed suspension or revocation of certification decisions; and ( 2) certifying agents appealing denial of accreditation and proposed suspension or revocation of accreditation decisions. The Act and the Administrative Procedure Act ( APA) ( 5 U. S. C. 553­ 559) provides affected persons with the right to appeal any adverse actions taken against their application for certification or accreditation or their certification or accreditation. The Administrator will handle certification appeals from operations in States that do not have an approved State organic program ( SOP). The Administrator will also handle appeals of accreditation decisions of the NOP Program Manager. The Administrator will issue decisions to sustain or deny appeals. If an appeal is denied, the Administrator will initiate a formal adjudicatory proceeding to deny, suspend, or revoke certification or accreditation. Such proceedings will be conducted pursuant to USDA's Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes, 7 CFR 1.130 through 1.151. Under these rules of practice, if the Administrative Law Judge denies the appeal, the appellant may appeal the Administrative Law Judge's decision to the Judicial Officer. If the 335 Judicial Officer denies the appeal, the appellant may appeal the Judicial Officer's decision to the United States District Court for the district in which the appellant is located. In States with approved SOP's, the SOP will oversee certification compliance proceedings and handle appeals from certified operations in the State. An SOP's appeal procedures and rules of procedure must be approved by the Secretary and must be equivalent to those of the NOP and USDA. The final decision on an appeal under the SOP may be appealed by the appellant to United States District Court for the district in which the appellant is located. Description of Regulations These appeal procedures provide that: ( 1) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of the NOP's Program Manager may appeal such decision to the Administrator; ( 2) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of an SOP may appeal such decision to the SOP's governing State official who will initiate handling of the appeal in accordance with the appeal procedures approved by the Secretary; and ( 3) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of a certifying agent may appeal such decision to the Administrator unless the person is subject to an approved SOP, in which case the appeal must be made to the SOP. All written communications between parties involved in appeal proceedings must be sent to the recipient's place of business by a delivery service which provides dated return receipts. All appeals filed under these procedures will be reviewed, heard, and decided by persons not involved with the decision being appealed. Certification Appeals 336 Applicants for certification may appeal a certifying agent's notice of denial of certification. Certified operations may appeal a notification of proposed suspension or revocation of their certification issued by their certifying agent. Such appeals will be made to the Administrator unless the person is subject to an approved SOP, in which case the appeal must be made to the SOP. If the Administrator or SOP sustains an appeal, the applicant or certified operation will be granted certification or continued certification, as applicable to the operation's status. The act of sustaining the appeal will not be considered an adverse action and may not be appealed by the certifying agent which issued the notice of denial of certification or notification of proposed suspension or revocation of certification. If the Administrator or SOP denies an appeal, a formal administrative proceeding will be initiated to deny, suspend, or revoke the certification. Such proceeding will be conducted in accordance with USDA's Uniform Rules of Practice or the SOP's rules of procedure. Accreditation Appeals Applicants for accreditation may appeal the Program Manager's notification of accreditation denial. Accredited certifying agents may appeal a notification of proposed suspension or revocation of their accreditation issued by the Program Manager. Such appeals will be made to the Administrator. If the Administrator sustains an appeal, the applicant or certifying agent will be granted accreditation or continued accreditation, as applicable to the operation's status. If the Administrator denies an appeal, a formal administrative proceeding will be initiated to deny, suspend, or revoke the accreditation. Such proceeding will be conducted in accordance with USDA's Uniform Rules of Practice. 337 Filing Period An appeal of a noncompliance decision must be filed within the time period provided in the letter of notification or within 30 days from the date of receipt of the notification, whichever occurs later. The appeal will be considered " filed" on the date received by the Administrator or, when applicable, the SOP. Unless appealed in a timely manner, a notification to deny, suspend, or revoke a certification or accreditation will become final. The applicant, certified operation, or certifying agent that does not file an appeal in the time period provided waives the right to further appeal of the compliance proceeding. Where and What to File Appeals to the Administrator must be filed in writing and sent to: Administrator, USDAAMS Room 3071­ S, P. O. Box 96456, Washington, DC 20090­ 6456. Appeals to the SOP must be filed in writing to the address and person identified in the letter of notification. All appeals must include a copy of the adverse decision to be reviewed and a statement of the appellant's reasons for believing that the decision was not proper or made in accordance with applicable program regulations, policies, or procedures. Appeals ­ Changes Based On Comments This portion of subpart G differs from the proposal in several respects as follows: ( 1) To Whom an Appeal Is Made. We have amended section 205.680 to clarify to whom an appeal is made when the noncompliance decision is made by the NOP's Program Manager, an SOP, or a certifying agent. Several commenters requested that we amend section 205.680 to make it consistent with the provision providing that appeals to the Administrator are not allowed in the case of an SOP decision, because such appeals have to be made to the SOP's governing 338 State official. We agree that section 205.680 did not convey sufficient explanation of to whom an appeal is made. Accordingly, we have amended the language in section 205.680 to clarify through paragraphs ( a), ( b), and ( c) that: ( 1) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of the NOP's Program Manager may appeal such decision to the Administrator; ( 2) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of an SOP may appeal such decision to the SOP's governing State official who will initiate handling of the appeal pursuant to appeal procedures approved by the Secretary; and ( 3) persons, subject to the Act, who believe they are adversely affected by a noncompliance decision of a certifying agent may appeal such decision to the Administrator unless the person is subject to an approved SOP, in which case the appeal must be made to the SOP. ( 2) Written Communications. We have added a new paragraph ( d) to section 205.680, which provides that all written communications between parties involved in appeal proceedings must be sent to the recipient's place of business by a delivery service which provides dated return receipts. We have taken this action to further clarify the appeals process. This addition to section 205.680 implements the same requirements for appeal documents as our addition of new paragraph ( d) to section 205.660 stipulates for compliance documents. ( 3) Who Shall Handle Appeals. We have added a new paragraph ( e) to section 205.680, which provides that all appeals must be reviewed, heard, and decided by persons not involved with the decision being appealed. This provision was added to section 205.680 to allay the fears of commenters that the person making the decision would be the person deciding the appeal. A couple of commenters recommended that an appeal be heard by persons other than those who 339 made the decision being appealed. Specifically, they want the appeal conducted by independent hearing officers who are not responsible for implementation or administration of the NOP. They also want the final decision­ making authority in the administrative review process placed in the hands of the Secretary. Under the NOP, once the compliance procedures are completed at the certifying agent level, the certified operation may appeal the decision of the certifying agent to the Administrator or to the SOP when the certified operation is located within a State with an approved SOP. The Administrator or the SOP will review the case and render an opinion on the appeal. When the appeal is sustained, the certified operation and certifying agent are notified and the case ends. However, if the appeal is denied the certified operation and certifying agent are notified and the certified operation is given an opportunity to appeal the decision of the Administrator or SOP. Appeals of decisions made by the Administrator will be heard by an Administrative Law Judge. If the Administrative Law Judge rules against the certified operation, the Administrative Law Judge's decision may be appealed by the certified operation to the Judicial Officer. The Judicial Officer is the USDA official delegated authority by the Secretary as the final deciding officer in adjudication proceedings. If the Judicial Officer rules against the certified operation, the Judicial Officer's decision may be appealed by the certified operation to the United States District Court for the district in which the certified operation is located. For additional information see USDA's Uniform Rules of Practice found at 7 CFR Part 1, subpart H. Appeals of decisions made by an SOP will follow procedures comparable to those just described for an appeal of a decision made by the Administrator. As with a final decision of USDA, a final decision of the State that goes against the certified operation may be appealed to 340 the United States District Court for the district in which the certified operation is located. ( 4) Filing Period. We have amended the first sentence of section 205.681( c) by replacing " at least" with " within" and by adding the words, " whichever occurs later," to the end thereof. This amendment has been made to clarify our intent that persons affected by a noncompliance proceeding decision receive not less than 30 days in which to file their appeal of the decision. ( 5) Where To File an Appeal. We have amended section 205.681( d) to clarify where appeals are to be filed. First, we have amended what is now paragraph ( 1) by removing the requirement that the appellant send a copy of the appeal to the certifying agent. This action shifts the responsibility of notifying the certifying agent of the appeal from the appellant to USDA or, when applicable, the SOP. Second, we have added language at paragraph ( 2) which clarifies that appeals to the SOP must be filed in writing to the address and person identified in the letter of notification. Finally, we have amended what is now paragraph ( 3) of section 205.681 by replacing " position" with " reasons for believing" to clarify the intended scope and purpose of the appellant's appeal statement. Clarification of section 205.681( d) was prompted by a commenter who stated that it is discriminatory to require clients of private certifying agents to appeal to USDA in Washington, when State program clients can appeal locally. There are various levels of appeal within the NOP. Clients of certifying agents ( State and private) are provided with an opportunity to rebut the noncompliance findings of the certifying agent. Once the certified operation has exhausted its options at the certifying agent level, the certified operation may appeal the decision of the certifying agent to the Administrator or to the SOP when the certified operation is located within a State with an approved SOP. The Administrator will review the case and render an opinion on the appeal. This level of 341 appeal will not require the certified operation's representative to travel to the Administrator. An appeal of a decision made by the Administrator will be heard by an Administrative Law Judge as near as possible to the certified operation's representative's place of business or residence. An appeal of a decision made by the Administrative Law Judge will be heard by the Judicial Officer. Again the certified operation's representative will not be required to travel outside of the representative's place of business or residence. If the certified operation appeals the decision of the Judicial Officer, the appeal would be heard by the United States District Court for the district in which the certified operation is located. Appeals of decisions made by an SOP will follow procedures comparable to those just described for an appeal of a decision made by the Administrator. As with a final decision of USDA, a final decision of the State that goes against the certified operation may be appealed to the United States District Court for the district in which the certified operation is located. ( 6) Appeal Reports. We will submit an annual report on appeals to the National Organic Standards Board ( NOSB), which will include nonconfidential compliance information. A commenter requested that we report quarterly to the NOSB on appeals ( number, outcome, kinds, and problems). We agree that it would be appropriate for the NOP to submit an appeals report to the NOSB. We will compile appeal data such as the number, outcome, kinds, and problems encountered. We will maintain this information under the compliance program to be developed within the NOP. We do not believe that it is necessary to put this type of detail or activity into the regulations. Further, we do not believe, at this time, that reporting more frequently than annually will be needed. The NOP, however, will work closely with the NOSB to provide it with the information it may need to recommend program amendments designed to address compliance 342 and appeal issues. ( 7) Availability of Appeal Information. We will develop and distribute appeal information. A commenter requested that section 205.680 be amended to require the distribution of an appeal information brochure to any applicant for accreditation or certification. We agree that the development and distribution of such information is a good idea. We do not believe, however, that it is necessary or appropriate to put this type of detail or activity into the regulations. We plan to provide program information, including appeals and related issues, on the NOP website. Appeals ­ Changes Requested But Not Made This portion of subpart G retains from the proposed rule, regulations on which we received comments as follows: ( 1) National Appeals Division. Several commenters recommend amending sections 205.680 and 205.681 to provide for appeals to the National Appeals Division under the provisions at 7 CFR Part 11. We disagree with the request that the NOP use the National Appeals Division Rules of Procedure. The Act and its implementing regulations are subject to the APA for rulemaking and adjudication. The provisions of the APA generally applicable to agency adjudication are not applicable to proceedings under 7 CFR Part 11, National Appeals Division Rules of Procedure. USDA uses 7 CFR Part 1, Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes, for adjudicatory proceedings involving the denial, suspension, and revocation of certification and accreditation. Appeals ­ Clarifications Clarification is given on the following issues raised by commenters: 343 ( 1) Appeals. A commenter stated that appeals of certification decisions should always be taken first to the certifying agent to provide an opportunity to rectify any possible error. Another commenter requested an appeals process that includes private certifying agents. Section 205.662( a) requires a written notification of noncompliance with opportunity to rebut or correct. When the noncompliance has been resolved due to rebuttal or correction, a written notification of noncompliance resolution is issued in accordance with section 205.662( b). When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, a written notification of proposed suspension or revocation will be issued in accordance with section 205.662( c). This notification will advise the certified operation of its right to request mediation or file an appeal with the Administrator or, when applicable, an SOP. We believe this process of providing a notification of noncompliance with opportunity to rebut or correct, followed by a notification of proposed suspension or revocation, provides ample opportunity for the certified operation to work with its certifying agent to resolve issues of noncompliance. ( 2) Timely Notification. A few commenters requested that we amend section 205.680 to include mandatory procedures for timely written notice of an adverse decision, the reasons for the decision, the person's appeal rights, and the procedures for filing an appeal. We recognize that all compliance activities need to be carried out as quickly and expeditiously as possible within the confines of due process. We believe that the commenters' concerns are addressed through various sections of these regulations. Section 205.402( a) requires review of an application upon acceptance of the application. Section 205.405, on denial of certification, requires a notification of noncompliance, followed, as applicable, by a notice of denial of certification. In accordance 344 with section 205.405( d), the notice of denial of certification will state the reasons for denial and the applicant's right to request mediation or appeal the decision. Section 205.507 on denial of accreditation requires a notification of noncompliance, followed, as applicable, by a denial of accreditation. The notification of accreditation denial will state the reasons for denial and the applicant's right to appeal the decision. Compliance sections 205.662 for certified operations and 205.665 for certifying agents require a notification of noncompliance with an opportunity to correct or rebut the noncompliance( s). Sections 205.662 and 205.665, when applicable, require the issuance of a notification of proposed suspension or revocation. Such notice must describe the noncompliance and the entity's right to an appeal. Section 205.681 provides the procedures for filling an appeal. Miscellaneous Section 205.690 provisions the Office of Management and Budget control number assigned to the information collection requirements of these regulations. Sections 205.691 through 205.699 are reserved. List of Subjects in 7 CFR Part 205 Administrative practice and procedure, Agriculture, Animals, Archives and records, Imports, Labeling, Organically produced products, Plants, Reporting and recordkeeping requirements, Seals and insignia, Soil conservation. For the reasons set forth in the preamble, it is proposed that Title 7, Chapter I of the Code of Federal Regulations be amended as follows: 1. Parts 205 through 209, which are currently reserved in subchapter K ( Federal Seed Act), are removed. 345 2. A new subchapter M consisting of part 205 through 209 is added to read as follows: SUBCHAPTER M­­ ORGANIC FOODS PRODUCTION ACT PROVISIONS PART 205 ­ NATIONAL ORGANIC PROGRAM Subpart A ­ Definitions Sec. 205.1 Meaning of words. 205.2 Terms defined. Subpart B ­ Applicability 205.100 What has to be certified. 205.101 Exemptions and exclusions from certification. 205.102 Use of the term, " organic." 205­ 103 Recordkeeping by certified operations. 205.104 [ Reserved] 205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling. 205.106­ 205.199 [ Reserved] Subpart C ­ Organic Crop, Wild Crop, Livestock, and Handling Requirements 205.200 General. 205.201 Organic production and handling system plan. 205.202 Land requirements. 205.203 Soil fertility and crop nutrient management practice standard. 205.204 Seeds and planting stock practice standard. 346 205.205 Crop rotation practice standard. 205.206 Crop pest, weed, and disease management practice standard. 205.207 Wild­ crop harvesting practice standard. 205.208­ 205.235 [ Reserved] 205.236 Origin of livestock. 205.237 Livestock feed. 205.238 Livestock health care practice standard. 205.239 Livestock living conditions. 205.240­ 205.269 [ Reserved] 205.270 Organic handling requirements. 205.271 Facility pest management practice standard. 205.272 Commingling and contact with prohibited substance prevention practice standard. 205.273­ 205.289 [ Reserved] 205.290 Temporary variances. 205.291­ 205.299 [ Reserved] Subpart D ­ Labels, Labeling, and Market Information 205.300 Use of the term, " organic." 205.301 Product composition. 205.302 Calculating the percentage of organically produced ingredients. 205.303 Packaged products labeled " 100 percent organic" or " organic." 205.304 Packaged products labeled " made with organic ( specified ingredients or food group( s))." 347 205.305 Multiingredient packaged products with less that 70 percent organically produced ingredients. 205.306 Labeling of livestock feed. 205.307 Labeling of nonretail containers used for only shipping or storage of raw or processed agricultural products labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))." 205.308 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as " 100 percent organic" or " organic." 205.309 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as " made with organic ( specified ingredients or food group( s))." 205.310 Agricultural products produced on an exempt production operation. 205.311 USDA Seal. 205.312­ 205.399 [ Reserved] Subpart E ­ Certification 205.400 General requirements for certification. 205.401 Application for certification. 205.402 Review of application. 205.403 On­ site inspections. 205.404 Granting certification. 205.405 Denial of certification. 205.406 Continuation of certification. 348 205.407­ 205.499 [ Reserved] Subpart F ­ Accreditation of Certifying Agents 205.500 Areas and duration of accreditation. 205.501 General requirements for accreditation. 205.502 Applying for accreditation. 205.503 Applicant information. 205.504 Evidence of expertise and ability. 205.505 Statement of agreement. 205.506 Granting accreditation. 205.507 Denial of accreditation. 205.508 Site evaluations. 205.509 Peer review panel. 205.510 Annual report, recordkeeping, and renewal of accreditation. 205.511­ 205.599 [ Reserved] Subpart G ­ Administrative The National List of Allowed and Prohibited Substances 205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients. 205.601 Synthetic substances allowed for use in organic crop production. 205.602 Nonsynthetic substances prohibited for use in organic crop production. 205.603 Synthetic substances allowed for use in organic livestock production. 205.604 Nonsynthetic substances prohibited for use in organic livestock production. 349 205.605 Nonagricultural ( nonorganic) substances allowed as ingredients in or on processed products labeled as " organic," or " made with organic ( specified ingredients or food group( s))." 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as " organic" or " made with organic ( specified ingredients or food group( s))." 205.607 Amending the National List. 205.608­ 205.619 [ Reserved] State Programs 205.620 Requirements of State organic programs. 205.621 Submission and determination of proposed State organic programs and amendments to approved State organic programs. 205.622 Review of approved State organic programs. 205.623­ 205.639 [ Reserved] Fees 205.640 Fees and other charges for accreditation. 205.641 Payment of fees and other charges. 205.642 Fees and other charges for certification. 205.643­ 205.649 [ Reserved] Compliance 205.660 General. 205.661 Investigation of certified operations. 350 205.662 Noncompliance procedure for certified operations. 205.663 Mediation. 205.664 [ Reserved] 205.665 Noncompliance procedure for certifying agents. 205.666­ 205.667 [ Reserved] 205.668 Noncompliance procedures under State Organic Programs. 205.699 [ Reserved] Inspection and Testing, Reporting, and Exclusion from Sale 205.670 Inspection and testing of agricultural product to be sold or labeled " organic." 205.671 Exclusion from organic sale. 205.672 Emergency pest or disease treatment. 205.673­ 205.679 [ Reserved] Adverse Action Appeal Process 205.680 General. 205.681 Appeals. 205.682­ 205.689 [ Reserved] Miscellaneous 205.690 OMB control number. 205.691­ 205.699 [ Reserved] Authority: 7 U. S. C. 6501­ 6522 Subpart A ­ Definitions § 205.1 Meaning of words. 351 For the purpose of the regulations in this subpart, words in the singular form shall be deemed to impart the plural and vice versa, as the case may demand. § 205.2 Terms defined. Accreditation. A determination made by the Secretary that authorizes a private, foreign, or State entity to conduct certification activities as a certifying agent under this part. Act. The Organic Foods Production Act of 1990, as amended ( 7 U. S. C. 6501 et seq.). Action level. The limit at or above which the Food and Drug Administration will take legal action against a product to remove it from the market. Action levels are based on unavoidability of the poisonous or deleterious substances and do not represent permissible levels of contamination where it is avoidable. Administrator. The Administrator for the Agricultural Marketing Service, United States Departure of Agriculture, or the representative to whom authority has been delegated to act in the stead of the Administrator. Agricultural inputs. All substances or materials used in the production or handling of organic agricultural products. Agricultural product. Any agricultural commodity or product, whether raw or processed, including any commodity or product derived from livestock, that is marketed in the United States for human or livestock consumption. Allowed synthetic. A substance that is included on the National List of synthetic substances allowed for use in organic production or handling. Agricultural Marketing Service ( AMS). The Agricultural Marketing Service of the United States Department of Agriculture. 352 Animal drug. Any drug as defined in section 201 of the Federal Food, Drug, and Cosmetic Act, as amended ( 21 U. S. C. 321), that is intended for use in livestock, including any drug intended for use in livestock feed but not including such livestock feed. Annual seedling. A plant grown from seed that will complete its life cycle or produce a harvestable yield within the same crop year or season in which it was planted. Area of operation. The types of operations: crops, livestock, wild­ crop harvesting or handling, or any combination thereof that a certifying agent may be accredited to certify under this part. Audit trail. Documentation that is sufficient to determine the source, transfer of ownership, and transportation of any agricultural product labeled as " 100 percent organic," the organic ingredients of any agricultural product labeled as " organic" or " made with organic ( specified ingredients)" or the organic ingredients of any agricultural product containing less than 70 percent organic ingredients identified as organic in an ingredients statement. Biodegradable. Subject to biological decomposition into simpler biochemical or chemical components. Biologics. All viruses, serums, toxins, and analogous products of natural or synthetic origin, such as diagnostics, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of diseases of animals. Breeder stock. Female livestock whose offspring may be incorporated into an organic operation at the time of their birth. Buffer zone. An area located between a certified production operation or portion of a 353 production operation and an adjacent land area that is not maintained under organic management. A buffer zone must be sufficient in size or other features ( e. g., windbreaks or a diversion ditch) to prevent the possibility of unintended contact by prohibited substances applied to adjacent land areas with an area that is part of a certified operation. Bulk. The presentation to consumers at retail sale of an agricultural product in unpackaged, loose form, enabling the consumer to determine the individual pieces, amount, or volume of the product purchased. Certification or certified. A determination made by a certifying agent that a production or handling operation is in compliance with the Act and the regulations in this part, which is documented by a certificate of organic operation. Certified operation. A crop or livestock production, wild­ crop harvesting or handling operation, or portion of such operation that is certified by an accredited certifying agent as utilizing a system of organic production or handling as described by the Act and the regulations in this part. Certifying agent. Any entity accredited by the Secretary as a certifying agent for the purpose of certifying a production or handling operation as a certified production or handling operation. Certifying agent's operation. All sites, facilities, personnel, and records used by a certifying agent to conduct certification activities under the Act and the regulations in this part. Claims. Oral, written, implied, or symbolic representations, statements, or advertising or other forms of communication presented to the public or buyers of agricultural products that relate to the organic certification process or the term, " 100 percent organic," " organic," or " made 354 with organic ( specified ingredients or food group( s))," or, in the case of agricultural products containing less than 70 percent organic ingredients, the term, " organic," on the ingredients panel. Commercially available. The ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan. Commingling. Physical contact between unpackaged organically produced and nonorganically produced agricultural products during production, processing, transportation, storage or handling, other than during the manufacture of a multiingredient product containing both types of ingredients. Compost. The product of a managed process through which microorganisms break down plant and animal materials into more available forms suitable for application to the soil. Compost must be produced through a process that combines plant and animal materials with an initial C: N ratio of between 25: 1 and 40: 1. Producers using an in­ vessel or static aerated pile system must maintain the composting materials at a temperature between 131 E F and 170 E F for 3 days. Producers using a windrow system must maintain the composting materials at a temperature between 131 E F and 170 E F for 15 days, during which time, the materials must be turned a minimum of five times. Control. Any method that reduces or limits damage by populations of pests, weeds, or diseases to levels that do not significantly reduce productivity. Crop. A plant or part of a plant intended to be marketed as an agricultural product or fed to livestock. Crop residues. The plant parts remaining in a field after the harvest of a crop, which 355 include stalks, stems, leaves, roots, and weeds. Crop rotation. The practice of alternating the annual crops grown on a specific field in a planned pattern or sequence in successive crop years so that crops of the same species or family are not grown repeatedly without interruption on the same field. Perennial cropping systems employ means such as alley cropping, intercropping, and hedgerows to introduce biological diversity in lieu of crop rotation. Crop year. That normal growing season for a crop as determined by the Secretary. Cultivation. Digging up or cutting the soil to prepare a seed bed; control weeds; aerate the soil; or work organic matter, crop residues, or fertilizers into the soil. Cultural methods. Methods used to enhance crop health and prevent weed, pest, or disease problems without the use of substances; examples include the selection of appropriate varieties and planting sites; proper timing and density of plantings; irrigation; and extending a growing season by manipulating the microclimate with green houses, cold frames, or wind breaks. Detectable residue. The amount or presence of chemical residue or sample component that can be reliably observed or found in the sample matrix by current approved analytical methodology. Disease vectors. Plants or animals that harbor or transmit disease organisms or pathogens which may attack crops or livestock. Drift. The physical movement of prohibited substances from the intended target site onto an organic operation or portion thereof. Emergency pest or disease treatment program. A mandatory program authorized by a Federal, State, or local agency for the purpose of controlling or eradicating a pest or disease. 356 Employee. Any person providing paid or volunteer services for a certifying agent. Excluded methods. A variety of methods used to genetically modify organisms or influence their growth and development by means that are not possible under natural conditions or processes and are not considered compatible with organic production. Such methods include cell fusion, microencapsulation and macroencapsulation, and recombinant DNA technology ( including gene deletion, gene doubling, introducing a foreign gene, and changing the positions of genes when achieved by recombinant DNA technology). Such methods do not include the use of traditional breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture. Feed. Edible materials which are consumed by livestock for their nutritional value. Feed may be concentrates ( grains) or roughages ( hay, silage, fodder). The term, " feed," encompasses all agricultural commodities, including pasture ingested by livestock for nutritional purposes. Feed additive. A substance added to feed in micro quantities to fulfill a specific nutritional need; i. e., essential nutrients in the form of amino acids, vitamins, and minerals. Feed Supplement. A combination of feed nutrients added to livestock feed to improve the nutrient balance or performance of the total ration and intended to be: ( 1) Diluted with other feeds when fed to livestock; ( 2) Offered free choice with other parts of the ration if separately available; or ( 3) Further diluted and mixed to produce a complete feed. Fertilizer. A single or blended substance containing one or more recognized plant nutrient( s) which is used primarily for its plant nutrient content and which is designed for use or claimed to have value in promoting plant growth. 357 Field. An area of land identified as a discrete unit within a production operation. Forage. Vegetative material in a fresh, dried, or ensiled state ( pasture, hay, or silage), which is fed to livestock. Governmental entity. Any domestic government, tribal government, or foreign governmental subdivision providing certification services. Handle. To sell, process, or package agricultural products, except such term shall not include the sale, transportation, or delivery of crops or livestock by the producer thereof to a handler. Handler. Any person engaged in the business of handling agricultural products, including producers who handle crops or livestock of their own production, except such term shall not include final retailers of agricultural products that do not process agricultural products. Handling operation. Any operation or portion of an operation ( except final retailers of agricultural products that do not process agricultural products) that receives or otherwise acquires agricultural products and processes, packages, or stores such products. Immediate family. The spouse, minor children, or blood relatives who reside in the immediate household of a certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent. For the purpose of this part, the interest of a spouse, minor child, or blood relative who is a resident of the immediate household of a certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent shall be considered to be an interest of the certifying agent or an employee, inspector, contractor, or other personnel of the certifying agent. Inert ingredient. Any substance ( or group of substances with similar chemical structures if 358 designated by the Environmental Protection Agency) other than an active ingredient which is intentionally included in any pesticide product ( 40 CFR 152.3( m)). Information panel. That part of the label of a packaged product that is immediately contiguous to and to the right of the principal display panel as observed by an individual facing the principal display panel, unless another section of the label is designated as the information panel because of package size or other package attributes ( e. g., irregular shape with one usable surface). Ingredient. Any substance used in the preparation of an agricultural product that is still present in the final commercial product as consumed. Ingredients statement. The list of ingredients contained in a product shown in their common and usual names in the descending order of predominance. Inspector. Any person retained or used by a certifying agent to conduct inspections of certification applicants or certified production or handling operations. Inspection. The act of examining and evaluating the production or handling operation of an applicant for certification or certified operation to determine compliance with the Act and the regulations in this part. Label. A display of written, printed, or graphic material on the immediate container of an agricultural product or any such material affixed to any agricultural product or affixed to a bulk container containing an agricultural product, except for package liners or a display of written, printed, or graphic material which contains only information about the weight of the product. Labeling. All written, printed, or graphic material accompanying an agricultural product at any time or written, printed, or graphic material about the agricultural product displayed at 359 retail stores about the product. Livestock. Any cattle, sheep, goat, swine, poultry, or equine animals used for food or in the production of food, fiber, feed, or other agricultural­ based consumer products; wild or domesticated game; or other nonplant life, except such term shall not include aquatic animals or bees for the production of food, fiber, feed, or other agricultural­ based consumer products. Lot. Any number of containers which contain an agricultural product of the same kind located in the same conveyance, warehouse, or packing house and which are available for inspection at the same time. Manure. Feces, urine, other excrement, and bedding produced by livestock that has not been composted. Market information. Any written, printed, audiovisual, or graphic information, including advertising, pamphlets, flyers, catalogues, posters, and signs, distributed, broadcast, or made available outside of retail outlets that are used to assist in the sale or promotion of a product. Mulch. Any nonsynthetic material, such as wood chips, leaves, or straw, or any synthetic material included on the National List for such use, such as newspaper or plastic that serves to suppress weed growth, moderate soil temperature, or conserve soil moisture. Narrow range oils. Petroleum derivatives, predominately of paraffinic and napthenic fractions with 50 percent boiling point ( 10 mm Hg) between 415 E F and 440 E F. National List. A list of allowed and prohibited substances as provided for in the Act. National Organic Program ( NOP). The program authorized by the Act for the purpose of implementing its provisions. National Organic Standards Board ( NOSB). A board established by the Secretary under 7 360 U. S. C. 6518 to assist in the development of standards for substances to be used in organic production and to advise the Secretary on any other aspects of the implementation of the National Organic Program. Natural resources of the operation. The physical, hydrological, and biological features of a production operation, including soil, water, wetlands, woodlands, and wildlife. Nonagricultural substance. A substance that is not a product of agriculture, such as a mineral or a bacterial culture, that is used as an ingredient in an agricultural product. For the purposes of this part, a nonagricultural ingredient also includes any substance, such as gums, citric acid, or pectin, that is extracted from, isolated from, or a fraction of an agricultural product so that the identity of the agricultural product is unrecognizable in the extract, isolate, or fraction. Nonsynthetic ( natural). A substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process as defined in section 6502( 21) of the Act ( 7 U. S. C. 6502( 21)). For the purposes of this part, nonsynthetic is used as a synonym for natural as the term is used in the Act. Nontoxic. Not known to cause any adverse physiological effects in animals, plants, humans, or the environment. Nonretail container. Any container used for shipping or storage of an agricultural product that is not used in the retail display or sale of the product. Organic. A labeling term that refers to an agricultural product produced in accordance with the Act and the regulations in this part. Organic matter. The remains, residues, or waste products of any organism. Organic production. A production system that is managed in accordance with the Act and 361 regulations in this part to respond to site­ specific conditions by integrating cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity. Organic system plan. A plan of management of an organic production or handling operation that has been agreed to by the producer or handler and the certifying agent and that includes written plans concerning all aspects of agricultural production or handling described in the Act and the regulations in subpart C of this part. Pasture. Land used for livestock grazing that is managed to provide feed value and maintain or improve soil, water, and vegetative resources. Peer review panel. A panel of individuals who have expertise in organic production and handling methods and certification procedures and who are appointed by the Administrator to assist in evaluating applicants for accreditation as certifying agents. Person. An individual, partnership, corporation, association, cooperative, or other entity. Pesticide. Any substance which alone, in chemical combination, or in any formulation with one or more substances is defined as a pesticide in section 2( u) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136( u) et seq). Petition. A request to amend the National List that is submitted by any person in accordance with this part. Planting stock. Any plant or plant tissue other than annual seedlings but including rhizomes, shoots, leaf or stem cuttings, roots, or tubers, used in plant production or propagation. Practice standard. The guidelines and requirements through which a production or handling operation implements a required component of its production or handling organic system 362 plan. A practice standard includes a series of allowed and prohibited actions, materials, and conditions to establish a minimum level performance for planning, conducting, and maintaining a function, such as livestock health care or facility pest management, essential to an organic operation. Principal display panel. That part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for sale. Private entity. Any domestic or foreign nongovernmental for­ profit or not­ for­ profit organization providing certification services. Processing. Cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, extracting, slaughtering, cutting, fermenting, distilling, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing and includes the packaging, canning, jarring, or otherwise enclosing food in a container. Processing aid. ( a) substance that is added to a food during the processing of such food but is removed in some manner from the food before it is packaged in its finished form; ( b) a substance that is added to a food during processing, is converted into constituents normally present in the food, and does not significantly increase the amount of the constituents naturally found in the food; and ( c) a substance that is added to a food for its technical or functional effect in the processing but is present in the finished food at insignificant levels and does not have any technical or functional effect in that food. Producer. A person who engages in the business of growing or producing food, fiber, feed, and other agricultural­ based consumer products. Production lot number/ identifier. Identification of a product based on the production 363 sequence of the product showing the date, time, and place of production used for quality control purposes. Prohibited substance. A substance the use of which in any aspect of organic production or handling is prohibited or not provided for in the Act or the regulations of this part. Records. Any information in written, visual, or electronic form that documents the activities undertaken by a producer, handler, or certifying agent to comply with the Act and regulations in this part. Residue testing. An official or validated analytical procedure that detects, identifies, and measures the presence of chemical substances, their metabolites, or degradations products in or on raw or processed agricultural products. Responsibly connected. Any person who is a partner, officer, director, holder, manager, or owner of 10 percent or more of the voting stock of an applicant or a recipient of certification or accreditation. Retail food establishment. A restaurant; delicatessen; bakery; grocery store; or any retail outlet with an in­ store restaurant, delicatessen, bakery, salad bar, or other eat­ in or carry­ out service of processed or prepared raw and ready­ to­ eat­ food. Routine use of parasiticide. The regular, planned, or periodic use of parasiticides. Secretary. The Secretary of Agriculture or a representative to whom authority has been delegated to act in the Secretary's stead. Sewage sludge. A solid, semisolid, or liquid residue generated during the treatment of domestic sewage in a treatment works. Sewage sludge includes but is not limited to: domestic septage; scum or solids removed in primary, secondary, or advanced wastewater treatment 364 processes; and a material derived from sewage sludge. Sewage sludge does not include ash generated during the firing of sewage sludge in a sewage sludge incinerator or grit and screenings generated during preliminary treatment of domestic sewage in a treatment works. Slaughter stock. Any animal that is intended to be slaughtered for consumption by humans or other animals. Split operation. An operation that produces or handles both organic and nonorganic agricultural products. Soil and water quality. Observable indicators of the physical, chemical, or biological condition of soil and water, including the presence of environmental contaminants. State. Any of the several States of the United States of America, its territories, the District of Columbia, and the Commonwealth of Puerto Rico. State certifying agent. A certifying agent accredited by the Secretary under the National Organic Program and operated by the State for the purposes of certifying organic production and handling operations in the State. State organic program ( SOP). A State program that meets the requirements of section 6506 of the Act, is approved by the Secretary, and is designed to ensure that a product that is sold or labeled as organically produced under the Act is produced and handled using organic methods. State organic program's governing State official. The chief executive official of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of the agricultural operations of the State, such official who administers a State organic certification program. Synthetic. A substance that is formulated or manufactured by a chemical process or by a 365 process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes. Tolerance. The maximum legal level of a pesticide chemical residue in or on a raw or processed agricultural commodity or processed food. Transplant. A seedling which has been removed from its original place of production, transported, and replanted. Unavoidable residual environmental contamination ( UREC). Background levels of naturally occurring or synthetic chemicals that are present in the soil or present in organically produced agricultural products that are below established tolerances. Wild crop. Any plant or portion of a plant that is collected or harvested from a site that is not maintained under cultivation or other agricultural management. Subpart B ­ Applicability § 205.100 What has to be certified. ( a) Except for operations exempt or excluded in § 205.101, each production or handling operation or specified portion of a production or handling operation that produces or handles crops, livestock, livestock products, or other agricultural products that are intended to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must be certified according to the provisions of subpart E of this part and must meet all other applicable requirements of this part. ( b) Any production or handling operation or specified portion of a production or handling operation that has been already certified by a certifying agent on the date that the certifying agent 366 receives its accreditation under this part shall be deemed to be certified under the Act until the operation's next anniversary date of certification. Such recognition shall only be available to those operations certified by a certifying agent that receives its accreditation within 18 months from the effective date of this final rule. ( c) Any operation that: ( 1) Knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than $ 10,000 per violation. ( 2) Makes a false statement under the Act to the Secretary, a governing State official, or an accredited certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code. § 205.101 Exemptions and exclusions from certification. ( a) Exemptions. ( 1) A production or handling operation that sells agricultural products as " organic" but whose gross agricultural income from organic sales totals $ 5,000 or less annually is exempt from certification under subpart E of this part and from submitting an organic system plan for acceptance or approval under § 205.201 but must comply with the applicable organic production and handling requirements of subpart C of this part and the labeling requirements of § 205.310. The products from such operations shall not be used as ingredients identified as organic in processed products produced by another handling operation. ( 2) A handling operation that is a retail food establishment or portion of a retail food establishment that handles organically produced agricultural products but does not process them is exempt from the requirements in this part. 367 ( 3) A handling operation or portion of a handling operation that only handles agricultural products that contain less than 70 percent organic ingredients by total weight of the finished product ( excluding water and salt) is exempt from the requirements in this part, except: ( i) The provisions for prevention of contact of organic products with prohibited substances set forth in § 205.272 with respect to any organically produced ingredients used in an agricultural product; ( ii) The labeling provisions of § § 205.305 and 205.310; and ( iii) The recordkeeping provisions in paragraph ( c) of this section. ( 4) A handling operation or portion of a handling operation that only identifies organic ingredients on the information panel is exempt from the requirements in this part, except: ( i) The provisions for prevention of contact of organic products with prohibited substances set forth in § 205.272 with respect to any organically produced ingredients used in an agricultural product; ( ii) The labeling provisions of § § 205.305 and 205.310; and ( iii) The recordkeeping provisions in paragraph ( c) of this section. ( b) Exclusions. ( 1) A handling operation or portion of a handling operation is excluded from the requirements of this part, except for the requirements for the prevention of commingling and contact with prohibited substances as set forth in § 205.272 with respect to any organically produced products, if such operation or portion of the operation only sells organic agricultural products labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" that: 368 ( i) Are packaged or otherwise enclosed in a container prior to being received or acquired by the operation; and ( ii) Remain in the same package or container and are not otherwise processed while in the control of the handling operation. ( 2) A handling operation that is a retail food establishment or portion of a retail food establishment that processes, on the premises of the retail food establishment, raw and ready­ toeat food from agricultural products that were previously labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" is excluded from the requirements in this part, except: ( i) The requirements for the prevention of contact with prohibited substances as set forth in § 205.272; and ( ii) The labeling provisions of § 205.310. ( c) Records to be maintained by exempt operations. ( 1) Any handling operation exempt from certification pursuant to paragraph ( a)( 3) or ( a)( 4) of this section must maintain records sufficient to: ( i) Prove that ingredients identified as organic were organically produced and handled; and ( ii) Verify quantities produced from such ingredients. ( 2) Records must be maintained for no less than 3 years beyond their creation and the operations must allow representatives of the Secretary and the applicable State organic programs' governing State official access to these records for inspection and copying during normal business hours to determine compliance with the applicable regulations set forth in this part. 369 § 205.102 Use of the term, " organic." Any agricultural product that is sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must be: ( a) Produced in accordance with the requirements specified in § 205.101 or § § 205.202 through 205.207 or § § 205.236 through 205.239 and all other applicable requirements of part 205; and ( b) Handled in accordance with the requirements specified in § 205.101 or § § 205.270 through 205.272 and all other applicable requirements of this part 205. § 205.103 Recordkeeping by certified operations. ( a) A certified operation must maintain records concerning the production, harvesting, and handling of agricultural products that are or that are intended to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))." ( b) Such records must: ( 1) Be adapted to the particular business that the certified operation is conducting; ( 2) Fully disclose all activities and transactions of the certified operation in sufficient detail as to be readily understood and audited; ( 3) Be maintained for not less than 5 years beyond their creation; and ( 4) Be sufficient to demonstrate compliance with the Act and the regulations in this part. ( c) The certified operation must make such records available for inspection and copying during normal business hours by authorized representatives of the Secretary, the applicable State program's governing State official, and the certifying agent. 370 § 205.104 [ Reserved] § 205.105 Allowed and prohibited substances, methods, and ingredients in organic production and handling. To be sold or labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))," the product must be produced and handled without the use of: ( a) Synthetic substances and ingredients, except as provided in § 205.601 or § 205.603; ( b) Nonsynthetic substances prohibited in § 205.602 or § 205.604; ( c) Nonagricultural substances used in or on processed products, except as otherwise provided in § 205.605; ( d) Nonorganic agricultural substances used in or on processed products, except as otherwise provided in § 205.606; ( e) Excluded methods, except for vaccines, Provided, That, the vaccines are approved in accordance with § 205.600( a); ( f) Ionizing radiation, as described in Food and Drug Administration regulation, 21 CFR 179.26; and ( g) Sewage sludge. § § 205.106­ 205.199 [ Reserved] Subpart C ­ Organic Production and Handling Requirements § 205.200 General. The producer or handler of a production or handling operation intending to sell, label, or represent agricultural products as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must comply with the applicable provisions of 371 this subpart. Production practices implemented in accordance with this subpart must maintain or improve the natural resources of the operation, including soil and water quality. § 205.201 Organic production and handling system plan. ( a) The producer or handler of a production or handling operation, except as exempt or excluded under § 205.101, intending to sell, label, or represent agricultural products as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must develop an organic production or handling system plan that is agreed to by the producer or handler and an accredited certifying agent. An organic system plan must meet the requirements set forth in this section for organic production or handling. An organic production or handling system plan must include: ( 1) A description of practices and procedures to be performed and maintained, including the frequency with which they will be performed; ( 2) A list of each substance to be used as a production or handling input, indicating its composition, source, location( s) where it will be used, and documentation of commercial availability, as applicable; ( 3) A description of the monitoring practices and procedures to be performed and maintained, including the frequency with which they will be performed, to verify that the plan is effectively implemented; ( 4) A description of the recordkeeping system implemented to comply with the requirements established in § 205.103; ( 5) A description of the management practices and physical barriers established to prevent commingling of organic and nonorganic products on a split operation and to prevent contact of 372 organic production and handling operations and products with prohibited substances; and ( 6) Additional information deemed necessary by the certifying agent to evaluate compliance with the regulations. ( b) A producer may substitute a plan prepared to meet the requirements of another Federal, State, or local government regulatory program for the organic system plan: Provided, That, the submitted plan meets all the requirements of this subpart. § 205.202 Land requirements. Any field or farm parcel from which harvested crops are intended to be sold, labeled, or represented as " organic," must: ( a) Have been managed in accordance with the provisions of § § 205.203 through 205.206; ( b) Have had no prohibited substances, as listed in § 205.105, applied to it for a period of 3 years immediately preceding harvest of the crop; and ( c) Have distinct, defined boundaries and buffer zones such as runoff diversions to prevent the unintended application of a prohibited substance to the crop or contact with a prohibited substance applied to adjoining land that is not under organic management. § 205.203 Soil fertility and crop nutrient management practice standard. ( a) The producer must select and implement tillage and cultivation practices that maintain or improve the physical, chemical, and biological condition of soil and minimize soil erosion. ( b) The producer must manage crop nutrients and soil fertility through rotations, cover crops, and the application of plant and animal materials. ( c) The producer must manage plant and animal materials to maintain or improve soil 373 organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. Animal and plant materials include: ( 1) Raw animal manure, which must be composted unless it is: ( i) Applied to land used for a crop not intended for human consumption; ( ii) Incorporated into the soil not less than 120 days prior to the harvest of a product whose edible portion has direct contact with the soil surface or soil particles; or ( iii) Incorporated into the soil not less than 90 days prior to the harvest of a product whose edible portion does not have direct contact with the soil surface or soil particles; ( 2) Composted plant and animal materials produced though a process that ( i) established an initial C: N ratio of between 25: 1 and 40: 1; and ( ii) maintained a temperature of between 131 E F and 170 E F for 3 days using an in­ vessel or static aerated pile system; or ( iii) maintained a temperature of between 131 E F and 170 E F for 15 days using a windrow composting system, during which period, the materials must be turned a minimum of five times. ( 3) Uncomposted plant materials. ( d) A producer may manage crop nutrients and soil fertility to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances by applying: ( 1) A crop nutrient or soil amendment included on the National List of synthetic substances allowed for use in organic crop production; 374 ( 2) A mined substance of low solubility; ( 3) A mined substance of high solubility, Provided, That, the substance is used in compliance with the conditions established on the National List of nonsynthetic materials prohibited for crop production; ( 4) Ash obtained from the burning of a plant or animal material, except as prohibited in paragraph ( e) of this section: Provided, That, the material burned has not been treated or combined with a prohibited substance or the ash is not included on the National List of nonsynthetic substances prohibited for use in organic crop production; and ( 5) A plant or animal material that has been chemically altered by a manufacturing process: Provided, That, the material is included on the National List of synthetic substances allowed for use in organic crop production established in § 205.601. ( e) The producer must not use: ( 1) Any fertilizer or composted plant and animal material that contains a synthetic substance not included on the National List of synthetic substances allowed for use in organic crop production; ( 2) Sewage sludge ( biosolids) as defined in 40 CFR Part 503; and ( 3) Burning as a means of disposal for crop residues produced on the operation: Except, That, burning may be used to suppress the spread of disease or to stimulate seed germination. § 205.204 Seeds and planting stock practice standard. ( a) The producer must use organically grown seeds, annual seedlings, and planting stock: Except, That, ( 1) Nonorganically produced, untreated seeds and planting stock may be used to produce 375 an organic crop when an equivalent organically produced variety is not commercially available, Except, That, organically produced seed must be used for the production of edible sprouts; ( 2) Nonorganically produced seeds and planting stock that have been treated with a substance included on the National List of synthetic substances allowed for use in organic crop production may be used to produce an organic crop when an equivalent organically produced or untreated variety is not commercially available; ( 3) Nonorganically produced annual seedlings may be used to produce an organic crop when a temporary variance has been granted in accordance with § 205.290( a)( 2); ( 4) Nonorganically produced planting stock to be used to produce a perennial crop may be sold, labeled, or represented as organically produced only after the planting stock has been maintained under a system of organic management for a period of no less than 1 year; and ( 5) Seeds, annual seedlings, and planting stock treated with prohibited substances may be used to produce an organic crop when the application of the materials is a requirement of Federal or State phytosanitary regulations. § 205.205 Crop rotation practice standard. The producer must implement a crop rotation including but not limited to sod, cover crops, green manure crops, and catch crops that provide the following functions that are applicable to the operation: ( a) Maintain or improve soil organic matter content; ( b) Provide for pest management in annual and perennial crops; ( c) Manage deficient or excess plant nutrients; and ( d) Provide erosion control. 376 § 205.206 Crop pest, weed, and disease management practice standard. ( a) The producer must use management practices to prevent crop pests, weeds, and diseases including but not limited to: ( 1) Crop rotation and soil and crop nutrient management practices, as provided for in § § 205.203 and 205.205; ( 2) Sanitation measures to remove disease vectors, weed seeds, and habitat for pest organisms; and ( 3) Cultural practices that enhance crop health, including selection of plant species and varieties with regard to suitability to site­ specific conditions and resistance to prevalent pests, weeds, and diseases. ( b) Pest problems may be controlled through mechanical or physical methods including but not limited to: ( 1) Augmentation or introduction of predators or parasites of the pest species; ( 2) Development of habitat for natural enemies of pests; ( 3) Nonsynthetic controls such as lures, traps, and repellents. ( c) Weed problems may be controlled through: ( 1) Mulching with fully biodegradable materials; ( 2) Mowing; ( 3) Livestock grazing; ( 4) Hand weeding and mechanical cultivation; ( 5) Flame, heat, or electrical means; or ( 6) Plastic or other synthetic mulches: Provided, That, they are removed from the field at 377 the end of the growing or harvest season. ( d) Disease problems may be controlled through: ( 1) Management practices which suppress the spread of disease organisms; or ( 2) Application of nonsynthetic biological, botanical, or mineral inputs. ( e) When the practices provided for in paragraphs ( a) through ( d) of this section are insufficient to prevent or control crop pests, weeds, and diseases, a biological or botanical substance or a substance included on the National List of synthetic substances allowed for use in organic crop production may be applied to prevent, suppress, or control pests, weeds, or diseases: Provided, That, the conditions for using the substance are documented in the organic system plan. ( f) The producer must not use lumber treated with arsenate or other prohibited materials for new installations or replacement purposes in contact with soil or livestock. § 205.207 Wild­ crop harvesting practice standard. ( a) A wild crop that is intended to be sold, labeled, or represented as organic must be harvested from a designated area that has had no prohibited substance, as set forth in § 205.105, applied to it for a period of 3 years immediately preceding the harvest of the wild crop. ( b) A wild crop must be harvested in a manner that ensures that such harvesting or gathering will not be destructive to the environment and will sustain the growth and production of the wild crop. § § 205.208 ­ 205.235 [ Reserved] § 205.236 Origin of livestock. ( a) Livestock products that are to be sold, labeled, or represented as organic must be from livestock under continuous organic management from the last third of gestation or hatching: 378 Except, That, ( 1) Poultry. Poultry or edible poultry products must be from poultry that has been under continuous organic management beginning no later than the second day of life; ( 2) Dairy animals. Milk or milk products must be from animals that have been under continuous organic management beginning no later than 1 year prior to the production of the milk or milk products that are to be sold, labeled, or represented as organic, Except, That, when an entire, distinct herd is converted to organic production, the producer may: ( i) For the first 9 months of the year, provide a minimum of 80­ percent feed that is either organic or raised from land included in the organic system plan and managed in compliance with organic crop requirements; and ( ii) provide feed in compliance with § 205.237 for the final 3 months. ( iii) Once an entire, distinct herd has been converted to organic production, all dairy animals shall be under organic management from the last third of gestation. ( 3) Breeder stock. Livestock used as breeder stock may be brought from a nonorganic operation onto an organic operation at any time: Provided, That, if such livestock are gestating and the offspring are to be raised as organic livestock, the breeder stock must be brought onto the facility no later than the last third of gestation. ( b) The following are prohibited: ( 1) Livestock or edible livestock products that are removed from an organic operation and subsequently managed on a nonorganic operation may be not sold, labeled, or represented as organically produced. ( 2) Breeder or dairy stock that has not been under continuous organic management since the last third of gestation may not be sold, labeled, or represented as organic slaughter stock. 379 ( c) The producer of an organic livestock operation must maintain records sufficient to preserve the identity of all organically managed animals and edible and nonedible animal products produced on the operation. § 205.237 Livestock feed. ( a) The producer of an organic livestock operation must provide livestock with a total feed ration composed of agricultural products, including pasture and forage, that are organically produced and, if applicable, organically handled: Except, That, nonsynthetic substances and synthetic substances allowed under § 205.603 may be used as feed additives and supplements. ( b) The producer of an organic operation must not: ( 1) Use animal drugs, including hormones, to promote growth; ( 2) Provide feed supplements or additives in amounts above those needed for adequate nutrition and health maintenance for the species at its specific stage of life; ( 3) Feed plastic pellets for roughage; ( 4) Feed formulas containing urea or manure; ( 5) Feed mammalian or poultry slaughter by­ products to mammals or poultry; or ( 6) Use feed, feed additives, and feed supplements in violation of the Federal Food, Drug, and Cosmetic Act. § 205.238 Livestock health care practice standard. ( a) The producer must establish and maintain preventive livestock health care practices, including: ( 1) Selection of species and types of livestock with regard to suitability for site­ specific conditions and resistance to prevalent diseases and parasites; 380 ( 2) Provision of a feed ration sufficient to meet nutritional requirements, including vitamins, minerals, protein and/ or amino acids, fatty acids, energy sources, and fiber ( ruminants); ( 3) Establishment of appropriate housing, pasture conditions, and sanitation practices to minimize the occurrence and spread of diseases and parasites; ( 4) Provision of conditions which allow for exercise, freedom of movement, and reduction of stress appropriate to the species; ( 5) Performance of physical alterations as needed to promote the animal's welfare and in a manner that minimizes pain and stress; and ( 6) Administration of vaccines and other veterinary biologics. ( b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a producer may administer synthetic medications: Provided, That, such medications are allowed under § 205.603. Parasiticides allowed under § 205.603 may be used on ( 1) Breeder stock, when used prior to the last third of gestation but not during lactation for progeny that are to be sold, labeled, or represented as organically produced; and ( 2) Dairy stock, when used a minimum of 90 days prior to the production of milk or milk products that are to be sold, labeled, or represented as organic. ( c) The producer of an organic livestock operation must not: ( 1) Sell, label, or represent as organic any animal or edible product derived from any animal treated with antibiotics, any substance that contains a synthetic substance not allowed under § 205.603, or any substance that contains a nonsynthetic substance prohibited in § 205.604. ( 2) Administer any animal drug, other than vaccinations, in the absence of illness; ( 3) Administer hormones for growth promotion; 381 ( 4) Administer synthetic parasiticides on a routine basis; ( 5) Administer synthetic parasiticides to slaughter stock; ( 6) Administer animal drugs in violation of the Federal Food, Drug, and Cosmetic Act; or ( 7) Withhold medical treatment from a sick animal in an effort to preserve its organic status. All appropriate medications must be used to restore an animal to health when methods acceptable to organic production fail. Livestock treated with a prohibited substance must be clearly identified and shall not be sold, labeled, or represented as organically produced. § 205.239 Livestock living conditions. ( a) The producer of an organic livestock operation must establish and maintain livestock living conditions which accommodate the health and natural behavior of animals, including: ( 1) Access to the outdoors, shade, shelter, exercise areas, fresh air, and direct sunlight suitable to the species, its stage of production, the climate, and the environment; ( 2) Access to pasture for ruminants; ( 3) Appropriate clean, dry bedding. If the bedding is typically consumed by the animal species, it must comply with the feed requirements of § 205.237; ( 4) Shelter designed to allow for: ( i) Natural maintenance, comfort behaviors, and opportunity to exercise; ( ii) Temperature level, ventilation, and air circulation suitable to the species; and ( iii) Reduction of potential for livestock injury; ( b) The producer of an organic livestock operation may provide temporary confinement for an animal because of: ( 1) Inclement weather; 382 ( 2) The animal's stage of production; ( 3) Conditions under which the health, safety, or well being of the animal could be jeopardized; or ( 4) Risk to soil or water quality. ( c) The producer of an organic livestock operation must manage manure in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, heavy metals, or pathogenic organisms and optimizes recycling of nutrients. § § 205.240 ­ 205.269 [ Reserved] § 205.270 Organic handling requirements. ( a) Mechanical or biological methods, including but not limited to cooking, baking, curing, heating, drying, mixing, grinding, churning, separating, distilling, extracting, slaughtering, cutting, fermenting, eviscerating, preserving, dehydrating, freezing, chilling, or otherwise manufacturing, and the packaging, canning, jarring, or otherwise enclosing food in a container may be used to process an organically produced agricultural product for the purpose of retarding spoilage or otherwise preparing the agricultural product for market. ( b) Nonagricultural substances allowed under § 205.605 and nonorganically produced agricultural products allowed under § 205.606 may be used: ( 1) In or on a processed agricultural product intended to be sold, labeled, or represented as " organic," pursuant to § 205.301( b), if not commercially available in organic form. ( 2) In or on a processed agricultural product intended to be sold, labeled, or represented as " made with organic ( specified ingredients or food group( s))," pursuant to § 205.301( c). ( c) The handler of an organic handling operation must not use in or on agricultural 383 products intended to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))," or in or on any ingredients labeled as organic: ( 1) Practices prohibited under paragraphs ( e) and ( f) of § 205.105. ( 2) A volatile synthetic solvent or other synthetic processing aid not allowed under § 205.605, Except, That, nonorganic ingredients in products labeled " made with organic ( specified ingredients or food group( s))" are not subject to this requirement. § 205.271 Facility pest management practice standard. ( a) The producer or handler of an organic facility must use management practices to prevent pests, including but not limited to: ( 1) Removal of pest habitat, food sources, and breeding areas; ( 2) Prevention of access to handling facilities; and ( 3) Management of environmental factors, such as temperature, light, humidity, atmosphere, and air circulation, to prevent pest reproduction. ( b) Pests may be controlled through: ( 1) Mechanical or physical controls including but not limited to traps, light, or sound; or ( 2) Lures and repellents using nonsynthetic or synthetic substances consistent with the National List. ( c) If the practices provided for in paragraphs ( a) and ( b) of this section are not effective to prevent or control pests, a nonsynthetic or synthetic substance consistent with the National List may be applied. ( d) If the practices provided for in paragraphs ( a), ( b), and © of this section are not 384 effective to prevent or control facility pests, a synthetic substance not on the National List may be applied, Provided, That, the handler and certifying agent agree on the substance, method of application, and measures to be taken to prevent contact of the organically produced products or ingredients with the substance used. ( e) The handler of an organic handling operation who applies a nonsynthetic or synthetic substance to prevent or control pests must update the operation's organic handling plan to reflect the use of such substances and methods of application. The updated organic plan must include a list of all measures taken to prevent contact of the organically produced products or ingredients with the substance used. ( f) Notwithstanding the practices provided for in paragraphs ( a), ( b), ( c), and ( d) of this section, a handler may otherwise use substances to prevent or control pests as required by Federal, State, or local laws and regulations, Provided, That, measures are taken to prevent contact of the organically produced products or ingredients with the substance used. § 205.272 Commingling and contact with prohibited substance prevention practice standard. ( a) The handler of an organic handling operation must implement measures necessary to prevent the commingling of organic and nonorganic products and protect organic products from contact with prohibited substances. ( b) The following are prohibited for use in the handling of any organically produced agricultural product or ingredient labeled in accordance with subpart D of this part: ( 1) Packaging materials, and storage containers, or bins that contain a synthetic fungicide, preservative, or fumigant; 385 ( 2) The use or reuse of any bag or container that has been in contact with any substance in such a manner as to compromise the organic integrity of any organically produced product or ingredient placed in those containers, unless such reusable bag or container has been thoroughly cleaned and poses no risk of contact of the organically produced product or ingredient with the substance used. § § 205.273 ­ 205.289 [ Reserved] § 205.290 Temporary variances. ( a) Temporary variances from the requirements in § § 205.203 through 205.207, 205.236 through 205.239, and 205.270 through 205.272 may be established by the Administrator for the following reasons: ( 1) Natural disasters declared by the Secretary; ( 2) Damage caused by drought, wind, flood, excessive moisture, hail, tornado, earthquake, fire, or other business interruption; and ( 3) Practices used for the purpose of conducting research or trials of techniques, varieties, or ingredients used in organic production or handling. ( b) A State organic program's governing State official or certifying agent may recommend in writing to the Administrator that a temporary variance from a standard set forth in subpart C of this part for organic production or handling operations be established: Provided, That, such variance is based on one or more of the reasons listed in paragraph ( a) of this section. ( c) The Administrator will provide written notification to certifying agents upon establishment of a temporary variance applicable to the certifying agent's certified production or handling operations and specify the period of time it shall remain in effect, subject to extension as 386 the Administrator deems necessary. ( d) A certifying agent, upon notification from the Administrator of the establishment of a temporary variance, must notify each production or handling operation it certifies to which the temporary variance applies. ( e) Temporary variances will not be granted for any practice, material, or procedure prohibited under § 205.105. § § 205.291­ 205.299 [ Reserved] Subpart D ­ Labels, Labeling, and Market Information § 205.300 Use of the term, " organic." ( a) The term, " organic," may only be used on labels and in labeling of raw or processed agricultural products, including ingredients, that have been produced and handled in accordance with the regulations in this part. The term, " organic," may not be used in a product name to modify a nonorganic ingredient in the product. ( b) Products for export, produced and certified to foreign national organic standards or foreign contract buyer requirements, may be labeled in accordance with the organic labeling requirements of the receiving country or contract buyer: Provided, That, the shipping containers and shipping documents meet the labeling requirements specified in § 205.307( c). ( c) Products produced in a foreign country and exported for sale in the United States must be certified pursuant to subpart E of this part and labeled pursuant to this subpart D. ( d) Livestock feeds produced in accordance with the requirements of this part must be labeled in accordance with the requirements of § 205.306. § 205.301 Product composition. 387 ( a) Products sold, labeled, or represented as " 100 percent organic." A raw or processed agricultural product sold, labeled, or represented as " 100 percent organic" must contain ( by weight or fluid volume, excluding water and salt) 100 percent organically produced ingredients. If labeled as organically produced, such product must be labeled pursuant to § 205.303. ( b) Products sold, labeled, or represented as " organic." A raw or processed agricultural product sold, labeled, or represented as " organic" must contain ( by weight or fluid volume, excluding water and salt) not less than 95 percent organically produced raw or processed agricultural products. Any remaining product ingredients must be organically produced, unless not commercially available in organic form, or must be nonagricultural substances or nonorganically produced agricultural products produced consistent with the National List in subpart G of this part. If labeled as organically produced, such product must be labeled pursuant to § 205.303. ( c) Products sold, labeled, or represented as " made with organic ( specified ingredients or food group( s))." Multiingredient agricultural product sold, labeled, or represented as " made with organic ( specified ingredients or food group( s))" must contain ( by weight or fluid volume, excluding water and salt) at least 70 percent organically produced ingredients which are produced and handled pursuant to requirements in subpart C of this part. No ingredients may be produced using prohibited practices specified in paragraphs ( 1), ( 2), and ( 3) of § 205.301( f). Nonorganic ingredients may be produced without regard to paragraphs ( 4), ( 5), ( 6), and ( 7) of § 205.301( f). If labeled as containing organically produced ingredients or food groups, such product must be labeled pursuant to § 205.304. ( d) Products with less than 70 percent organically produced ingredients. The organic 388 ingredients in multiingredient agricultural product containing less than 70 percent organically produced ingredients ( by weight or fluid volume, excluding water and salt) must be produced and handled pursuant to requirements in subpart C of this part. The nonorganic ingredients may be produced and handled without regard to the requirements of this part. Multiingredient agricultural product containing less than 70 percent organically produced ingredients may represent the organic nature of the product only as provided in § 205.305. ( e) Livestock feed: ( 1) A raw or processed livestock feed product sold, labeled, or represented as " 100 percent organic" must contain ( by weight or fluid volume, excluding water and salt) not less than 100 percent organically produced raw or processed agricultural product. ( 2) A raw or processed livestock feed product sold, labeled, or represented as " organic" must be produced in conformance with § 205.237. ( f) All products labeled as " 100 percent organic" or " organic" and all ingredients identified as " organic" in the ingredient statement of any product must not: ( 1) Be produced using excluded methods, pursuant to § 201.105( e); ( 2) Be produced using sewage sludge, pursuant to § 201.105( f); ( 3) Be processed using ionizing radiation, pursuant to § 201.105( g); ( 4) Be processed using processing aids not approved on the National List of Allowed and Prohibited Substances in subpart G of this part: Except, That, products labeled as " 100 percent organic," if processed, must be processed using organically produced processing aids; ( 5) Contain sulfites, nitrates, or nitrites added during the production or handling process, Except, That, wine containing added sulfites may be labeled " made with organic grapes"; 389 ( 6) Be produced using nonorganic ingredients when organic ingredients are available; or ( 7) Include organic and nonorganic forms of the same ingredient. § 205.302 Calculating the percentage of organically produced ingredients. ( a) The percentage of all organically produced ingredients in an agricultural product sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))," or that include organic ingredients must be calculated by: ( 1) Dividing the total net weight ( excluding water and salt) of combined organic ingredients at formulation by the total weight ( excluding water and salt) of the finished product. ( 2) Dividing the fluid volume of all organic ingredients ( excluding water and salt) by the fluid volume of the finished product ( excluding water and salt) if the product and ingredients are liquid. If the liquid product is identified on the principal display panel or information panel as being reconstituted from concentrates, the calculation should be made on the basis of singlestrength concentrations of the ingredients and finished product. ( 3) For products containing organically produced ingredients in both solid and liquid form, dividing the combined weight of the solid ingredients and the weight of the liquid ingredients ( excluding water and salt) by the total weight ( excluding water and salt) of the finished product. ( b) The percentage of all organically produced ingredients in an agricultural product must be rounded down to the nearest whole number. ( c) The percentage must be determined by the handler who affixes the label on the consumer package and verified by the certifying agent of the handler. The handler may use information provided by the certified operation in determining the percentage. 390 § 205.303 Packaged products labeled " 100 percent organic" or " organic." ( a) Agricultural products in packages described in § 205.301( a) and ( b) may display, on the principal display panel, information panel, and any other panel of the package and on any labeling or market information concerning the product, the following: ( 1) The term, " 100 percent organic" or " organic," as applicable, to modify the name of the product; ( 2) For products labeled " organic," the percentage of organic ingredients in the product; ( The size of the percentage statement must not exceed one­ half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style, and color without highlighting.) ( 3) The term, " organic," to identify the organic ingredients in multiingredient products labeled " 100 percent organic"; ( 4) The USDA seal; and/ or ( 5) The seal, logo, or other identifying mark of the certifying agent which certified the production or handling operation producing the finished product and any other certifying agent which certified production or handling operations producing raw organic product or organic ingredients used in the finished product: Provided, That, the handler producing the finished product maintain records, pursuant to this part, verifying organic certification of the operations producing such ingredients, and: Provided further, That, such seals or marks are not individually displayed more prominently than the USDA seal. ( b) Agricultural products in packages described in § 205.301( a) and ( b) must: ( 1) For products labeled " organic," identify each organic ingredient in the ingredient 391 statement with the word, " organic," or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic. ( 2) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, " Certified organic by...," or similar phrase, identify the name of the certifying agent that certified the handler of the finished product and may display the business address, Internet address, or telephone number of the certifying agent in such label. § 205.304 Packaged products labeled " made with organic ( specified ingredients or food group( s))." ( a) Agricultural products in packages described in § 205.301( c) may display on the principal display panel, information panel, and any other panel and on any labeling or market information concerning the product: ( 1) The statement: ( i) " Made with organic ( specified ingredients)": Provided, That, the statement does not list more than three organically produced ingredients; or ( ii) " Made with organic ( specified food groups)": Provided, That, the statement does not list more than three of the following food groups: beans, fish, fruits, grains, herbs, meats, nuts, oils, poultry, seeds, spices, sweeteners, and vegetables or processed milk products; and, Provided Further, That, all ingredients of each listed food group in the product must be organically produced; and ( iii) Which appears in letters that do not exceed one­ half the size of the largest type size on the panel and which appears in its entirety in the same type size, style, and color without 392 highlighting. ( 2) The percentage of organic ingredients in the product. The size of the percentage statement must not exceed one­ half the size of the largest type size on the panel on which the statement is displayed and must appear in its entirety in the same type size, style, and color without highlighting. ( 3) The seal, logo, or other identifying mark of the certifying agent that certified the handler of the finished product. ( b) Agricultural products in packages described in § 205.301( c) must: ( 1) In the ingredient statement, identify each organic ingredient with the word, " organic," or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced. Water or salt included as ingredients cannot be identified as organic. ( 2) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, " Certified organic by...," or similar phrase, identify the name of the certifying agent that certified the handler of the finished product: Except, That, the business address, Internet address, or telephone number of the certifying agent may be included in such label. ( c) Agricultural products in packages described in § 205.301( c) must not display the USDA seal. § 205.305 Multiingredient packaged products with less than 70 percent organically produced ingredients. ( a) An agricultural product with less than 70 percent organically produced ingredients 393 may only identify the organic content of the product by: ( 1) Identifying each organically produced ingredient in the ingredient statement with the word, " organic," or with an asterisk or other reference mark which is defined below the ingredient statement to indicate the ingredient is organically produced, and ( 2) If the organically produced ingredients are identified in the ingredient statement, displaying the product's percentage of organic contents on the information panel. ( b) Agricultural products with less than 70 percent organically produced ingredients must not display: ( 1) The USDA seal; and ( 2) Any certifying agent seal, logo, or other identifying mark which represents organic certification of a product or product ingredients. § 205.306 Labeling of livestock feed. ( a) Livestock feed products described in § 205.301( e)( 1) and ( e)( 2) may display on any package panel the following terms: ( 1) The statement, " 100 percent organic" or " organic," as applicable, to modify the name of the feed product; ( 2) The USDA seal; ( 3) The seal, logo, or other identifying mark of the certifying agent which certified the production or handling operation producing the raw or processed organic ingredients used in the finished product, Provided, That, such seals or marks are not displayed more prominently than the USDA seal; ( 4) The word, " organic," or an asterisk or other reference mark which is defined on the 394 package to identify ingredients that are organically produced. Water or salt included as ingredients cannot be identified as organic. ( b) Livestock feed products described in § 205.301( e)( 1) and ( e)( 2) must: ( i) On the information panel, below the information identifying the handler or distributor of the product and preceded by the statement, " Certified organic by...," or similar phrase, display the name of the certifying agent that certified the handler of the finished product. The business address, Internet address, or telephone number of the certifying agent may be included in such label. ( ii) Comply with other Federal agency or State feed labeling requirements as applicable. § 205.307 Labeling of nonretail containers used for only shipping or storage of raw or processed agricultural products labeled as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))." ( a) Nonretail containers used only to ship or store raw or processed agricultural product labeled as containing organic ingredients may display the following terms or marks: ( 1) The name and contact information of the certifying agent which certified the handler which assembled the final product; ( 2) Identification of the product as organic; ( 3) Special handling instructions needed to maintain the organic integrity of the product; ( 4) The USDA seal; ( 5) The seal, logo, or other identifying mark of the certifying agent that certified the organic production or handling operation that produced or handled the finished product. ( b) Nonretail containers used to ship or store raw or processed agricultural product 395 labeled as containing organic ingredients must display the production lot number of the product if applicable. ( c) Shipping containers of domestically produced product labeled as organic intended for export to international markets may be labeled in accordance with any shipping container labeling requirements of the foreign country of destination or the container labeling specifications of a foreign contract buyer: Provided, That, the shipping containers and shipping documents accompanying such organic products are clearly marked " For Export Only" and: Provided further, That, proof of such container marking and export must be maintained by the handler in accordance with recordkeeping requirements for exempt and excluded operations under § 205.101. § 205.308 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as " 100 percent organic" or " organic." ( a) Agricultural products in other than packaged form may use the term, " 100 percent organic" or " organic," as applicable, to modify the name of the product in retail display, labeling, and display containers: Provided, That, the term, " organic," is used to identify the organic ingredients listed in the ingredient statement. ( b) If the product is prepared in a certified facility, the retail display, labeling, and display containers may use: ( 1) The USDA seal; and ( 2) The seal, logo, or other identifying mark of the certifying agent that certified the production or handling operation producing the finished product and any other certifying agent which certified operations producing raw organic product or organic ingredients used in the 396 finished product: Provided, That, such seals or marks are not individually displayed more prominently than the USDA seal. § 205.309 Agricultural products in other than packaged form at the point of retail sale that are sold, labeled, or represented as " made with organic ( specified ingredients or food group( s))." ( a) Agricultural products in other than packaged form containing between 70 and 95 percent organically produced ingredients may use the phrase, " made with organic ( specified ingredients or food group( s))," to modify the name of the product in retail display, labeling, and display containers. ( 1) Such statement must not list more than three organic ingredients or food groups, and ( 2) In any such display of the product's ingredient statement, the organic ingredients are identified as " organic." ( b) If prepared in a certified facility, such agricultural products labeled as " made with organic ( specified ingredients or food group( s))" in retail displays, display containers, and market information may display the certifying agent's seal, logo, or other identifying mark. § 205.310 Agricultural products produced on an exempt or excluded operation. ( a) An agricultural product organically produced or handled on an exempt or excluded operation must not: ( 1) Display the USDA seal or any certifying agent's seal or other identifying mark which represents the exempt or excluded operation as a certified organic operation, or ( 2) Be represented as a certified organic product or certified organic ingredient to any buyer. 397 ( b) An agricultural product organically produced or handled on an exempt or excluded operation may be identified as an organic product or organic ingredient in a multiingredient product produced by the exempt or excluded operation. Such product or ingredient must not be identified or represented as " organic" in a product processed by others. ( c) Such product is subject to requirements specified in paragraph ( a) of § 205.300, and paragraphs ( f)( 1) through ( f)( 7) of § 205.301. § 205.311 USDA Seal. ( a) The USDA seal described in paragraphs ( b) and ( c) of this section may be used only for raw or processed agricultural products described in paragraphs ( a), ( b), ( e)( 1), and ( e)( 2) of § 205.301. ( b) The USDA seal must replicate the form and design of the example in figure 1 and must be printed legibly and conspicuously: ( 1) On a white background with a brown outer circle and with the term, " USDA," in green overlaying a white upper semicircle and with the term, " organic," in white overlaying the green lower half circle; or ( 2) On a white or transparent background with black outer circle and black " USDA" on a white or transparent upper half of the circle with a contrasting white or transparent " organic" on the black lower half circle. ( 3) The green or black lower half circle may have four light lines running from left to right and disappearing at the point on the right horizon to resemble a cultivated field. 398 § § 205.312­ 205.399 [ Reserved] Subpart E ­ Certification § 205.400 General requirements for certification. A person seeking to receive or maintain organic certification under the regulations in this part must: ( a) Comply with the Act and applicable organic production and handling regulations of this part; ( b) Establish, implement, and update annually an organic production or handling system plan that is submitted to an accredited certifying agent as provided for in § 205.200; ( c) Permit on­ site inspections with complete access to the production or handling operation, including noncertified production and handling areas, structures, and offices by the certifying agent as provided for in § 205.403; ( d) Maintain all records applicable to the organic operation for not less than 5 years beyond their creation and allow authorized representatives of the Secretary, the applicable State organic program's governing State official, and the certifying agent access to such records during normal business hours for review and copying to determine compliance with the Act and the regulations in this part, as provided for in § 205.104; 399 ( e) Submit the applicable fees charged by the certifying agent; and ( f) Immediately notify the certifying agent concerning any: ( 1) Application, including drift, of a prohibited substance to any field, production unit, site, facility, livestock, or product that is part of an operation; and ( 2) Change in a certified operation or any portion of a certified operation that may affect its compliance with the Act and the regulations in this part. § 205.401 Application for Certification. A person seeking certification of a production or handling operation under this subpart must submit an application for certification to a certifying agent. The application must include the following information: ( a) An organic production or handling system plan, as required in § 205.200; ( b) The name of the person completing the application; the applicant's business name, address, and telephone number; and, when the applicant is a corporation, the name, address, and telephone number of the person authorized to act on the applicant's behalf; ( c) The name( s) of any organic certifying agent( s) to which application has previously been made; the year( s) of application; the outcome of the application( s) submission, including, when available, a copy of any notification of noncompliance or denial of certification issued to the applicant for certification; and a description of the actions taken by the applicant to correct the noncompliances noted in the notification of noncompliance, including evidence of such correction; and ( d) Other information necessary to determine compliance with the Act and the regulations in this part. 400 § 205.402 Review of application. ( a) Upon acceptance of an application for certification, a certifying agent must: ( 1) Review the application to ensure completeness pursuant to § 205.401; ( 2) Determine by a review of the application materials whether the applicant appears to comply or may be able to comply with the applicable requirements of subpart C of this part; ( 3) Verify that an applicant who previously applied to another certifying agent and received a notification of noncompliance or denial of certification, pursuant to § 205.405, has submitted documentation to support the correction of any noncompliances identified in the notification of noncompliance or denial of certification, as required in § 205.405( e); and ( 4) Schedule an on­ site inspection of the operation to determine whether the applicant qualifies for certification if the review of application materials reveals that the production or handling operation may be in compliance with the applicable requirements of subpart C of this part. ( b) The certifying agent shall within a reasonable time: ( 1) Review the application materials received and communicate its findings to the applicant; ( 2) Provide the applicant with a copy of the on­ site inspection report, as approved by the certifying agent, for any on­ site inspection performed; and ( 3) Provide the applicant with a copy of the test results for any samples taken by an inspector. ( c) The applicant may withdraw its application at any time. An applicant who withdraws its application shall be liable for the costs of services provided up to the time of withdrawal of its application. An applicant that voluntarily withdrew its application prior to the issuance of a notice 401 of noncompliance will not be issued a notice of noncompliance. Similarly, an applicant that voluntarily withdrew its application prior to the issuance of a notice of certification denial will not be issued a notice of certification denial. § 205.403 On­ site inspections. ( a) On­ site inspections. ( 1) A certifying agent must conduct an initial on­ site inspection of each production unit, facility, and site that produces or handles organic products and that is included in an operation for which certification is requested. An on­ site inspection shall be conducted annually thereafter for each certified operation that produces or handles organic products for the purpose of determining whether to approve the request for certification or whether the certification of the operation should continue. ( 2) ( i) A certifying agent may conduct additional on­ site inspections of applicants for certification and certified operations to determine compliance with the Act and the regulations in this part. ( ii) The Administrator or State organic program's governing State official may require that additional inspections be performed by the certifying agent for the purpose of determining compliance with the Act and the regulations in this part. ( iii) Additional inspections may be announced or unannounced at the discretion of the certifying agent or as required by the Administrator or State organic program's governing State official. ( b) Scheduling. ( 1) The initial on­ site inspection must be conducted within a reasonable time following a determination that the applicant appears to comply or may be able to comply with the requirements of subpart C of this part: Except, That, the initial inspection may be 402 delayed for up to 6 months to comply with the requirement that the inspection be conducted when the land, facilities, and activities that demonstrate compliance or capacity to comply can be observed. ( 2) All on­ site inspections must be conducted when an authorized representative of the operation who is knowledgeable about the operation is present and at a time when land, facilities, and activities that demonstrate the operation's compliance with or capability to comply with the applicable provisions of subpart C of this part can be observed, except that this requirement does not apply to unannounced on­ site inspections. ( c) Verification of information. The on­ site inspection of an operation must verify: ( 1) The operation's compliance or capability to comply with the Act and the regulations in this part; ( 2) That the information, including the organic production or handling system plan, provided in accordance with § § 205.401, 205.406, and 205.200, accurately reflects the practices used or to be used by the applicant for certification or by the certified operation; ( 3) That prohibited substances have not been and are not being applied to the operation through means which, at the discretion of the certifying agent, may include the collection and testing of soil; water; waste; seeds; plant tissue; and plant, animal, and processed products samples. ( d) Exit interview. The inspector must conduct an exit interview with an authorized representative of the operation who is knowledgeable about the inspected operation to confirm the accuracy and completeness of inspection observations and information gathered during the onsite inspection. The inspector must also address the need for any additional information as well as 403 any issues of concern. ( e) Documents to the inspected operation. ( 1) At the time of the inspection, the inspector shall provide the operation's authorized representative with a receipt for any samples taken by the inspector. There shall be no charge to the inspector for the samples taken. ( 2) A copy of the on­ site inspection report and any test results will be sent to the inspected operation by the certifying agent. § 205.404 Granting certification. ( a) Within a reasonable time after completion of the initial on­ site inspection, a certifying agent must review the on­ site inspection report, the results of any analyses for substances conducted, and any additional information requested from or supplied by the applicant. If the certifying agent determines that the organic system plan and all procedures and activities of the applicant's operation are in compliance with the requirements of this part and that the applicant is able to conduct operations in accordance with the plan, the agent shall grant certification. The certification may include requirements for the correction of minor noncompliances within a specified time period as a condition of continued certification. ( b) The certifying agent must issue a certificate of organic operation which specifies the: ( 1) Name and address of the certified operation; ( 2) Effective date of certification; ( 3) Categories of organic operation, including crops, wild crops, livestock, or processed products produced by the certified operation; and ( 4) Name, address, and telephone number of the certifying agent. ( c) Once certified, a production or handling operation's organic certification continues in 404 effect until surrendered by the organic operation or suspended or revoked by the certifying agent, the State organic program's governing State official, or the Administrator. § 205.405 Denial of certification. ( a) When the certifying agent has reason to believe, based on a review of the information specified in § 205.402 or § 205.404, that an applicant for certification is not able to comply or is not in compliance with the requirements of this part, the certifying agent must provide a written notification of noncompliance to the applicant. When correction of a noncompliance is not possible, a notification of noncompliance and a notification of denial of certification may be combined in one notification. The notification of noncompliance shall provide: ( 1) A description of each noncompliance; ( 2) The facts upon which the notification of noncompliance is based; and ( 3) The date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. ( b) Upon receipt of such notification of noncompliance, the applicant may: ( 1) Correct noncompliances and submit a description of the corrective actions taken with supporting documentation to the certifying agent; ( 2) Correct noncompliances and submit a new application to another certifying agent: Provided, That, the applicant must include a complete application, the notification of noncompliance received from the first certifying agent, and a description of the corrective actions taken with supporting documentation; or ( 3) Submit written information to the issuing certifying agent to rebut the noncompliance described in the notification of noncompliance. 405 ( c) After issuance of a notification of noncompliance, the certifying agent must: ( 1) Evaluate the applicant's corrective actions taken and supporting documentation submitted or the written rebuttal, conduct an on­ site inspection if necessary, and ( i) When the corrective action or rebuttal is sufficient for the applicant to qualify for certification, issue the applicant an approval of certification pursuant to § 205.404; or ( ii) When the corrective action or rebuttal is not sufficient for the applicant to qualify for certification, issue the applicant a written notice of denial of certification. ( 2) Issue a written notice of denial of certification to an applicant who fails to respond to the notification of noncompliance. ( 3) Provide notice of approval or denial to the Administrator, pursuant to § 205.501( a)( 14). ( d) A notice of denial of certification must state the reason( s) for denial and the applicant's right to: ( 1) Reapply for certification pursuant to § § 205.401 and 205.405( e); ( 2) Request mediation pursuant to § 205.663 or, if applicable, pursuant to a State organic program; or ( 3) File an appeal of the denial of certification pursuant to § 205.681 or, if applicable, pursuant to a State organic program. ( e) An applicant for certification who has received a written notification of noncompliance or a written notice of denial of certification may apply for certification again at any time with any certifying agent, in accordance with § § 205.401 and 205.405( e). When such applicant submits a new application to a certifying agent other than the agent who issued the 406 notification of noncompliance or notice of denial of certification, the applicant for certification must include a copy of the notification of noncompliance or notice of denial of certification and a description of the actions taken, with supporting documentation, to correct the noncompliances noted in the notification of noncompliance. ( f) A certifying agent who receives a new application for certification, which includes a notification of noncompliance or a notice of denial of certification, must treat the application as a new application and begin a new application process pursuant to § 205.402. ( g) Notwithstanding paragraph ( a) of this section, if a certifying agent has reason to believe that an applicant for certification has willfully made a false statement or otherwise purposefully misrepresented the applicant's operation or its compliance with the certification requirements pursuant to this part, the certifying agent may deny certification pursuant to paragraph ( c)( 1)( ii) of this section without first issuing a notification of noncompliance. § 205.406 Continuation of certification. ( a) To continue certification, a certified operation must annually pay the certification fees and submit the following information, as applicable, to the certifying agent: ( 1) An updated organic production or handling system plan which includes: ( i) A summary statement, supported by documentation, detailing any deviations from, changes to, modifications to, or other amendments made to the previous year's organic system plan during the previous year; and ( ii) Any additions or deletions to the previous year's organic system plan, intended to be undertaken in the coming year, detailed pursuant to § 205.200; ( 2) Any additions to or deletions from the information required pursuant to § 205.401( b); 407 ( 3) An update on the correction of minor noncompliances previously identified by the certifying agent as requiring correction for continued certification; and ( 4) Other information as deemed necessary by the certifying agent to determine compliance with the Act and the regulations in this part. ( b) Following the receipt of the information specified in paragraph ( a) of this section, the certifying agent shall within a reasonable time arrange and conduct an on­ site inspection of the certified operation pursuant to § 205.403: Except, That, when it is impossible for the certifying agent to conduct the annual on­ site inspection following receipt of the certified operation's annual update of information, the certifying agent may allow continuation of certification and issue an updated certificate of organic operation on the basis of the information submitted and the most recent on­ site inspection conducted during the previous 12 months: Provided, That, the annual on­ site inspection, required pursuant to § 205.403, is conducted within the first 6 months following the certified operation's scheduled date of annual update. ( c) If the certifying agent has reason to believe, based on the on­ site inspection and a review of the information specified in § 205.404, that a certified operation is not complying with the requirements of the Act and the regulations in this part, the certifying agent shall provide a written notification of noncompliance to the operation in accordance with § 205.662. ( d) If the certifying agent determines that the certified operation is complying with the Act and the regulations in this part and that any of the information specified on the certificate of organic operation has changed, the certifying agent must issue an updated certificate of organic operation pursuant to § 205.404( b). § § 205.407­ 205.499 [ Reserved] 408 Subpart F ­ Accreditation of Certifying Agents § 205.500 Areas and duration of accreditation. ( a) The Administrator shall accredit a qualified domestic or foreign applicant in the areas of crops, livestock, wild crops, or handling or any combination thereof to certify a domestic or foreign production or handling operation as a certified operation. ( b) Accreditation shall be for a period of 5 years from the date of approval of accreditation pursuant to § 205.506. ( c) In lieu of accreditation under paragraph ( a) of this section, USDA will accept a foreign certifying agent's accreditation to certify organic production or handling operations if: ( 1) USDA determines, upon the request of a foreign government, that the standards under which the foreign government authority accredited the foreign certifying agent meet the requirements of this part; or ( 2) The foreign government authority that accredited the foreign certifying agent acted under an equivalency agreement negotiated between the United States and the foreign government. § 205.501 General requirements for accreditation. ( a) A private or governmental entity accredited as a certifying agent under this subpart must: ( 1) Have sufficient expertise in organic production or handling techniques to fully comply with and implement the terms and conditions of the organic certification program established under the Act and the regulations in this part; ( 2) Demonstrate the ability to fully comply with the requirements for accreditation set 409 forth in this subpart; ( 3) Carry out the provisions of the Act and the regulations in this part, including the provisions of § § 205.402 through 205.406 and § 205.670; ( 4) Use a sufficient number of adequately trained personnel, including inspectors and certification review personnel, to comply with and implement the organic certification program established under the Act and the regulations in subpart E of this part; ( 5) Ensure that its responsibly connected persons, employees, and contractors with inspection, analysis, and decision­ making responsibilities have sufficient expertise in organic production or handling techniques to successfully perform the duties assigned. ( 6) Conduct an annual performance evaluation of all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services; ( 7) Have an annual program review of its certification activities conducted by the certifying agent's staff, an outside auditor, or a consultant who has expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part that are identified in the evaluation; ( 8) Provide sufficient information to persons seeking certification to enable them to comply with the applicable requirements of the Act and the regulations in this part; ( 9) Maintain all records pursuant to § 205.510( b) and make all such records available for inspection and copying during normal business hours by authorized representatives of the Secretary and the applicable State organic program's governing State official; 410 ( 10) Maintain strict confidentiality with respect to its clients under the applicable organic certification program and not disclose to third parties ( with the exception of the Secretary or the applicable State organic program's governing State official or their authorized representatives) any business­ related information concerning any client obtained while implementing the regulations in this part, except as provided for in § 205.504( b)( 5); ( 11) Prevent conflicts of interest by: ( i) Not certifying a production or handling operation if the certifying agent or a responsibly connected party of such certifying agent has or has held a commercial interest in the production or handling operation, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification; ( ii) Excluding any person, including contractors, with conflicts of interest from work, discussions, and decisions in all stages of the certification process and the monitoring of certified production or handling operations for all entities in which such person has or has held a commercial interest, including an immediate family interest or the provision of consulting services, within the 12­ month period prior to the application for certification; ( iii) Not permitting any employee, inspector, contractor, or other personnel to accept payment, gifts, or favors of any kind, other than prescribed fees, from any business inspected, Except, That, a certifying agent that is a not­ for­ profit organization with an Internal Revenue Code tax exemption or, in the case of a foreign certifying agent, a comparable recognition of notfor profit status from its government, may accept voluntary labor from certified operations; ( iv) Not giving advice or providing consultancy services, to certification applicants or certified operations, for overcoming identified barriers to certification; 411 ( v) Requiring all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent to complete an annual conflict of interest disclosure report; and ( vi) Ensuring that the decision to certify an operation is made by a person different from those who conducted the review of documents and on­ site inspection. ( 12) ( i) Reconsider a certified operation's application for certification and, if necessary, perform a new on­ site inspection when it is determined, within 12 months of certifying the operation, that any person participating in the certification process and covered under § 205.501( a)( 11)( ii) has or had a conflict of interest involving the applicant. All costs associated with a reconsideration of application, including onsite inspection costs, shall be borne by the certifying agent. ( ii) Refer a certified operation to a different accredited certifying agent for recertification and reimburse the operation for the cost of the recertification when it is determined that any person covered under § 205.501( a)( 11)( i) at the time of certification of the applicant had a conflict of interest involving the applicant. ( 13) Accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to § 205.500; ( 14) Refrain from making false or misleading claims about its accreditation status, the USDA accreditation program for certifying agents, or the nature or qualities of products labeled as organically produced; 412 ( 15) Submit to the Administrator a copy of: ( i) Any notice of denial of certification issued pursuant to § 205.405, notification of noncompliance, notification of noncompliance correction, notification of proposed suspension or revocation, and notification of suspension or revocation sent pursuant to § 205.662 simultaneously with its issuance and ( ii) A list, on January 2 of each year, including the name, address, and telephone number of each operation granted certification during the preceding year; ( 16) Charge applicants for certification and certified production and handling operations only those fees and charges for certification activities that it has filed with the Administrator; ( 17) Pay and submit fees to AMS in accordance with § 205.640; ( 18) Provide the inspector, prior to each on­ site inspection, with previous on­ site inspection reports and notify the inspector of its decision regarding certification of the production or handling operation site inspected by the inspector and of any requirements for the correction of minor noncompliances; ( 19) Accept all production or handling applications that fall within its area( s) of accreditation and certify all qualified applicants, to the extent of its administrative capacity to do so without regard to size or membership in any association or group; and ( 20) Demonstrate its ability to comply with a State's organic program to certify organic production or handling operations within the State. ( 21) Comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary. ( b) A private or governmental entity accredited as a certifying agent under this subpart may establish a seal, logo, or other identifying mark to be used by production and handling 413 operations certified by the certifying agent to indicate affiliation with the certifying agent: Provided, That, the certifying agent: ( 1) Does not require use of its seal, logo, or other identifying mark on any product sold, labeled, or represented as organically produced as a condition of certification and ( 2) Does not require compliance with any production or handling practices other than those provided for in the Act and the regulations in this part as a condition of use of its identifying mark: Provided, That, certifying agents certifying production or handling operations within a State with more restrictive requirements, approved by the Secretary, shall require compliance with such requirements as a condition of use of their identifying mark by such operations. ( c) A private entity accredited as a certifying agent must: ( 1) Hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of the Act and the regulations in this part; ( 2) Furnish reasonable security, in an amount and according to such terms as the Administrator may by regulation prescribe, for the purpose of protecting the rights of production and handling operations certified by such certifying agent under the Act and the regulations in this part; and ( 3) Transfer to the Administrator and make available to any applicable State organic program's governing State official all records or copies of records concerning the person's certification activities in the event that the certifying agent dissolves or loses its accreditation; Provided, That, such transfer shall not apply to a merger, sale, or other transfer of ownership of a certifying agent. ( d) No private or governmental entity accredited as a certifying agent under this subpart 414 shall exclude from participation in or deny the benefits of the National Organic Program to any person due to discrimination because of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, or marital or family status. § 205.502 Applying for accreditation. ( a) A private or governmental entity seeking accreditation as a certifying agent under this subpart must submit an application for accreditation which contains the applicable information and documents set forth in § § 205.503 through 205.505 and the fees required in § 205.640 to: Program Manager, USDA­ AMS­ TMP­ NOP, Room 2945­ South Building, PO Box 96456, Washington, DC 20090­ 6456. ( b) Following the receipt of the information and documents, the Administrator will determine, pursuant to § 205.506, whether the applicant for accreditation should be accredited as a certifying agent. § 205.503 Applicant information. A private or governmental entity seeking accreditation as a certifying agent must submit the following information: ( a) The business name, primary office location, mailing address, name of the person( s) responsible for the certifying agent's day­ to­ day operations, contact numbers ( telephone, facsimile, and Internet address) of the applicant, and, for an applicant who is a private person, the entity's taxpayer identification number; ( b) The name, office location, mailing address, and contact numbers ( telephone, facsimile, and Internet address) for each of its organizational units, such as chapters or subsidiary offices, and the name of a contact person for each unit; 415 ( c) Each area of operation ( crops, wild crops, livestock, or handling) for which accreditation is requested and the estimated number of each type of operation anticipated to be certified annually by the applicant along with a copy of the applicant's schedule of fees for all services to be provided under these regulations by the applicant; ( d) The type of entity the applicant is ( e. g., government agricultural office, for­ profit business, not­ for­ profit membership association) and for: ( 1) A governmental entity, a copy of the official's authority to conduct certification activities under the Act and the regulations in this part, ( 2) A private entity, documentation showing the entity's status and organizational purpose, such as articles of incorporation and by­ laws or ownership or membership provisions, and its date of establishment; and ( e) A list of each State or foreign country in which the applicant currently certifies production and handling operations and a list of each State or foreign country in which the applicant intends to certify production or handling operations. § 205.504 Evidence of expertise and ability. A private or governmental entity seeking accreditation as a certifying agent must submit the following documents and information to demonstrate its expertise in organic production or handling techniques; its ability to fully comply with and implement the organic certification program established in § § 205.100 and 205.101, § § 205.201 through 205.203, § § 205.300 through 205.303, § § 205.400 through 205.406, and § § 205.661 and 205.662; and its ability to comply with the requirements for accreditation set forth in § 205.501: ( a) Personnel. ( 1) A copy of the applicant's policies and procedures for training, 416 evaluating, and supervising personnel; ( 2) The name and position description of all personnel to be used in the certification operation, including administrative staff, certification inspectors, members of any certification review and evaluation committees, contractors, and all parties responsibly connected to the certifying agent; ( 3) A description of the qualifications, including experience, training, and education in agriculture, organic production, and organic handling, for: ( i) Each inspector to be used by the applicant and ( ii) Each person to be designated by the applicant to review or evaluate applications for certification; and ( 4) A description of any training that the applicant has provided or intends to provide to personnel to ensure that they comply with and implement the requirements of the Act and the regulations in this part. ( b) Administrative policies and procedures. ( 1) A copy of the procedures to be used to evaluate certification applicants, make certification decisions, and issue certification certificates; ( 2) A copy of the procedures to be used for reviewing and investigating certified operation compliance with the Act and the regulations in this part and the reporting of violations of the Act and the regulations in this part to the Administrator; ( 3) A copy of the procedures to be used for complying with the recordkeeping requirements set forth in § 205.501( a)( 9); ( 4) A copy of the procedures to be used for maintaining the confidentiality of any business­ related information as set forth in § 205.501( a)( 10); 417 ( 5) A copy of the procedures to be used, including any fees to be assessed, for making the following information available to any member of the public upon request: ( i) Certification certificates issued during the current and 3 preceding calender years; ( ii) A list of producers and handlers whose operations it has certified, including for each the name of the operation, type( s) of operation, products produced, and the effective date of the certification, during the current and 3 preceding calender years; ( iii) The results of laboratory analyses for residues of pesticides and other prohibited substances conducted during the current and 3 preceding calender years; and ( iv) Other business information as permitted in writing by the producer or handler; and ( 6) A copy of the procedures to be used for sampling and residue testing pursuant to § 205.670. ( c) Conflicts of interest. ( 1) A copy of procedures intended to be implemented to prevent the occurrence of conflicts of interest, as described in § 205.501( a)( 11). ( 2) For all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and all parties responsibly connected to the certifying agent, a conflict of interest disclosure report, identifying any food­ or agriculturerelated business interests, including business interests of immediate family members, that cause a conflict of interest. ( d) Current certification activities. An applicant who currently certifies production or handling operations must submit: ( 1) A list of all production and handling operations currently certified by the applicant; 418 ( 2) Copies of at least 3 different inspection reports and certification evaluation documents for production or handling operations certified by the applicant during the previous year for each area of operation for which accreditation is requested; and ( 3) The results of any accreditation process of the applicant's operation by an accrediting body during the previous year for the purpose of evaluating its certification activities. ( e) Other information. Any other information the applicant believes may assist in the Administrator's evaluation of the applicant's expertise and ability. § 205.505 Statement of agreement. ( a) A private or governmental entity seeking accreditation under this subpart must sign and return a statement of agreement prepared by the Administrator which affirms that, if granted accreditation as a certifying agent under this subpart, the applicant will carry out the provisions of the Act and the regulations in this part, including: ( 1) Accept the certification decisions made by another certifying agent accredited or accepted by USDA pursuant to section 205.500; ( 2) Refrain from making false or misleading claims about its accreditation status, the USDA accreditation program for certifying agents, or the nature or qualities of products labeled as organically produced; ( 3) Conduct an annual performance evaluation of all persons who review applications for certification, perform on­ site inspections, review certification documents, evaluate qualifications for certification, make recommendations concerning certification, or make certification decisions and implement measures to correct any deficiencies in certification services; ( 4) Have an annual internal program review conducted of its certification activities by 419 certifying agent staff, an outside auditor, or a consultant who has the expertise to conduct such reviews and implement measures to correct any noncompliances with the Act and the regulations in this part; ( 5) Pay and submit fees to AMS in accordance with § 205.640; and ( 6) Comply with, implement, and carry out any other terms and conditions determined by the Administrator to be necessary. ( b) A private entity seeking accreditation as a certifying agent under this subpart must additionally agree to: ( 1) Hold the Secretary harmless for any failure on the part of the certifying agent to carry out the provisions of the Act and the regulations in this part; ( 2) Furnish reasonable security, in an amount and according to such terms as the Administrator may by regulation prescribe, for the purpose of protecting the rights of production and handling operations certified by such certifying agent under the Act and the regulations in this part; and ( 3) Transfer to the Administrator and make available to the applicable State organic program's governing State official all records or copies of records concerning the certifying agent's certification activities in the event that the certifying agent dissolves or loses its accreditation; Provided, That such transfer shall not apply to a merger, sale, or other transfer of ownership of a certifying agent. § 205.506 Granting accreditation. ( a) Accreditation will be granted when: ( 1) The accreditation applicant has submitted the information required by § § 205.503 through 205.505; 420 ( 2) The accreditation applicant pays the required fee in accordance with § 205.640( c); and ( 3) The Administrator determines that the applicant for accreditation meets the requirements for accreditation as stated in § 205.501, as determined by a review of the information submitted in accordance with § § 205.503 through 205.505 and, if necessary, a review of the information obtained from a site evaluation as provided for in § 205.508. ( b) On making a determination to approve an application for accreditation, the Administrator will notify the applicant of the granting of accreditation in writing, stating: ( 1) The area( s) for which accreditation is given; ( 2) The effective date of the accreditation; ( 3) Any terms and conditions for the correction of minor noncompliances; and ( 4) For a certifying agent who is a private entity, the amount and type of security that must be established to protect the rights of production and handling operations certified by such certifying agent. ( c) The accreditation of a certifying agent shall continue in effect until such time as the certifying agent fails to renew accreditation as provided in § 205.510( c), the certifying agent voluntarily ceases its certification activities, or accreditation is suspended or revoked pursuant to § 205.665. § 205.507 Denial of accreditation. ( a) If the Program Manager has reason to believe, based on a review of the information specified in § § 205.503 through 205.505 or after a site evaluation as specified in § 205.508, that an applicant for accreditation is not able to comply or is not in compliance with the requirements 421 of the Act and the regulations in this part, the Program Manager shall provide a written notification of noncompliance to the applicant. Such notification shall provide: ( 1) A description of each noncompliance; ( 2) The facts upon which the notification of noncompliance is based; and ( 3) The date by which the applicant must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. ( b) When each noncompliance has been resolved, the Program Manager will send the applicant a written notification of noncompliance resolution and proceed with further processing of the application. ( c) If an applicant fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, fails to file a rebuttal of the notification of noncompliance by the date specified, or is unsuccessful in its rebuttal, the Program Manager will provide the applicant with written notification of accreditation denial. An applicant who has received written notification of accreditation denial may apply for accreditation again at any time in accordance with § 205.502, or appeal the denial of accreditation in accordance with § 205.681 by the date specified in the notification of accreditation denial. ( d) If the certifying agent was accredited prior to the site evaluation and the certifying agent fails to correct the noncompliances, fails to report the corrections by the date specified in the notification of noncompliance, or fails to file a rebuttal of the notification of noncompliance by the date specified, the Administrator will begin proceedings to suspend or revoke the certifying agent's accreditation. A certifying agent who has had its accreditation suspended may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary 422 for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. A certifying agent whose accreditation is revoked will be ineligible for accreditation for a period of not less than 3 years following the date of such determination. § 205.508 Site evaluations. ( a) Site evaluations of accredited certifying agents shall be conducted for the purpose of examining the certifying agent's operations and evaluating its compliance with the Act and the regulations of this part. Site evaluations shall include an on­ site review of the certifying agent's certification procedures, decisions, facilities, administrative and management systems, and production or handling operations certified by the certifying agent. Site evaluations shall be conducted by a representative( s) of the Administrator. ( b) An initial site evaluation of an accreditation applicant shall be conducted before or within a reasonable period of time after issuance of the applicant's " notification of accreditation." A site evaluation shall be conducted after application for renewal of accreditation but prior to the issuance of a notice of renewal of accreditation. One or more site evaluations will be conducted during the period of accreditation to determine whether an accredited certifying agent is complying with the general requirements set forth in § 205.501. § 205.509 Peer review panel. The Administrator shall establish a peer review panel pursuant to the Federal Advisory Committee Act ( FACA) ( 5 U. S. C. App. 2 et seq.). The peer review panel shall be composed of not less than 3 members who shall annually evaluate the National Organic Program's adherence to 423 the accreditation procedures in subpart F of these regulations and ISO/ IEC Guide 61, General requirements for assessment and accreditation of certification/ registration bodies, and the National Organic Program's accreditation decisions. This shall be accomplished through the review of accreditation procedures, document review and site evaluation reports, and accreditation decision documents or documentation. The peer review panel shall report its finding, in writing, to the National Organic Program's Program Manager. § 205.510 Annual report, recordkeeping, and renewal of accreditation. ( a) Annual report and fees. An accredited certifying agent must submit annually to the Administrator, on or before the anniversary date of the issuance of the notification of accreditation, the following reports and fees: ( 1) A complete and accurate update of information submitted pursuant to § § 205.503 and 205.504; ( 2) Information supporting any changes being requested in the areas of accreditation described in § 205.500; ( 3) A description of the measures implemented in the previous year and any measures to be implemented in the coming year to satisfy any terms and conditions determined by the Administrator to be necessary, as specified in the most recent notification of accreditation or notice of renewal of accreditation; ( 4) The results of the most recent performance evaluations and annual program review and a description of adjustments to the certifying agent's operation and procedures implemented or to be implemented in response to the performance evaluations and program review; and ( 5) The fees required in § 205.640( a). 424 ( b) Recordkeeping. Certifying agents must maintain records according to the following schedule: ( 1) Records obtained from applicants for certification and certified operations must be maintained for not less than 5 years beyond their receipt; ( 2) Records created by the certifying agent regarding applicants for certification and certified operations must be maintained for not less than 10 years beyond their creation; and ( 3) Records created or received by the certifying agent pursuant to the accreditation requirements of this subpart F, excluding any records covered by § § 205.510( b)( 2), must be maintained for not less than 5 years beyond their creation or receipt. ( c) Renewal of accreditation. ( 1) The Administrator shall send the accredited certifying agent a notice of pending expiration of accreditation approximately 1 year prior to the scheduled date of expiration. ( 2) An accredited certifying agent's application for accreditation renewal must be received at least 6 months prior to the fifth anniversary of issuance of the notification of accreditation and each subsequent renewal of accreditation. The accreditation of certifying agents who make timely application for renewal of accreditation will not expire during the renewal process. The accreditation of certifying agents who fail to make timely application for renewal of accreditation will expire as scheduled unless renewed prior to the scheduled expiration date. Certifying agents with an expired accreditation must not perform certification activities under the Act and these regulations. ( 3) Following receipt of the information submitted by the certifying agent in accordance with paragraph ( a) of this section and the results of a site evaluation, the Administrator will 425 determine whether the certifying agent remains in compliance with the Act and the regulations of this part and should have its accreditation renewed. ( d) Notice of renewal of accreditation. Upon a determination that the certifying agent is in compliance with the Act and the regulations of this part, the Administrator will issue a notice of renewal of accreditation. The notice of renewal will specify any terms and conditions that must be addressed by the certifying agent and the time within which those terms and conditions must be satisfied. ( e) Noncompliance. Upon a determination that the certifying agent is not in compliance with the Act and the regulations of this part, the Administrator will initiate proceedings to suspend or revoke the certifying agent's accreditation. ( f) Amending accreditation. Amendment to scope of an accreditation may be requested at any time. The application for amendment shall be sent to the Administrator and shall contain information applicable to the requested change in accreditation, a complete and accurate update of the information submitted pursuant to § § 205.503 and 205.504, and the applicable fees required in § 205.640. § § 205.511­ 205.599 [ Reserved] Subpart G Administrative The National List of Allowed and Prohibited Substances § 205.600 Evaluation criteria for allowed and prohibited substances, methods, and ingredients. The following criteria will be utilized in the evaluation of substances or ingredients for the organic production and handling sections of the National List: 426 ( a) Synthetic and nonsynthetic substances considered for inclusion on or deletion from the National List of allowed and prohibited substances will be evaluated using the criteria specified in the Act ( 7 U. S. C. 6517 and 6518). ( b) In addition to the criteria set forth in the Act, any synthetic substance used as a processing aid or adjuvant will be evaluated against the following criteria: ( 1) The substance cannot be produced from a natural source and there are no organic substitutes; ( 2) The substance's manufacture, use, and disposal do not have adverse effects on the environment and are done in a manner compatible with organic handling; ( 3) The nutritional quality of the food is maintained when the substance is used, and the substance, itself, or its breakdown products do not have an adverse effect on human health as defined by applicable Federal regulations; ( 4) The substance's primary use is not as a preservative or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where the replacement of nutrients is required by law; ( 5) The substance is listed as generally recognized as safe ( GRAS) by Food and Drug Administration ( FDA) when used in accordance with FDA's good manufacturing practices ( GMP) and contains no residues of heavy metals or other contaminants in excess of tolerances set by FDA; and ( 6) The substance is essential for the handling of organically produced agricultural products. ( c) Nonsynthetics used in organic processing will be evaluated using the criteria specified 427 in the Act ( 7 U. S. C. 6517 and 6518). § 205.601 Synthetic substances allowed for use in organic crop production. In accordance with restrictions specified in this section, the following synthetic substances may be used in organic crop production: ( a) As algicide, disinfectants, and sanitizer, including irrigation system cleaning systems ( 1) Alcohols ( i) Ethanol ( ii) Isopropanol ( 2) Chlorine materials ­ Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. ( i) Calcium hypochlorite ( ii) Chlorine dioxide ( iii) Sodium hypochlorite ( 3) Hydrogen peroxide ( 4) Soap­ based algicide/ demisters ( b) As herbicides, weed barriers, as applicable. ( 1) Herbicides, soap­ based ­ for use in farmstead maintenance ( roadways, ditches, right of ways, building perimeters) and ornamental crops ( 2) Mulches ( i) Newspaper or other recycled paper, without glossy or colored inks. ( ii) Plastic mulch and covers ( petroleum­ based other than polyvinyl chloride ( PVC)) ( c) As compost feedstocks 428 Newspapers or other recycled paper, without glossy or colored inks ( d) As animal repellents Soaps, ammonium ­ for use as a large animal repellant only, no contact with soil or edible portion of crop ( e) As insecticides ( including acaricides or mite control) ( 1) Ammonium carbonate ­ for use as bait in insect traps only, no direct contact with crop or soil ( 2) Boric acid ­ structural pest control, no direct contact with organic food or crops ( 3) Elemental sulfur ( 4) Lime sulfur ­ including calcium polysulfide ( 5) Oils, horticultural ­ narrow range oils as dormant, suffocating, and summer oils. ( 6) Soaps, insecticidal ( 7) Sticky traps/ barriers ( f) As insect attractants Pheromones ( g) As rodenticides ( 1) Sulfur dioxide ­ underground rodent control only ( smoke bombs) ( 2) Vitamin D3 ( h) As slug or snail bait < None> ( i) As plant disease control ( 1) Coppers, fixed ­ copper hydroxide, copper oxide, copper oxychloride, includes 429 products exempted from EPA tolerance, Provided, That, copper­ based materials must be used in a manner that minimizes accumulation in the soil and shall not be used as herbicides. ( 2) Copper sulfate ­ Substance must be used in a manner that minimizes accumulation of copper in the soil. ( 3) Hydrated lime ­ must be used in a manner that minimizes copper accumulation in the soil. ( 4) Hydrogen peroxide ( 5) Lime sulfur ( 6) Oils, horticultural, narrow range oils as dormant, suffocating, and summer oils. ( 7) Potassium bicarbonate ( 8) Elemental sulfur ( 9) Streptomycin, for fire blight control in apples and pears only ( 10) Tetracycline ( oxytetracycline calcium complex), for fire blight control only ( j) As plant or soil amendments. ( 1) Aquatic plant extracts ( other than hydrolyzed) ­ Extraction process is limited to the use of potassium hydroxide or sodium hydroxide; solvent amount used is limited to that amount necessary for extraction. ( 2) Elemental sulfur ( 3) Humic acids ­ naturally occurring deposits, water and alkali extracts only ( 4) Lignin sulfonate ­ chelating agent, dust suppressant, floatation agent ( 5) Magnesium sulfate ­ allowed with a documented soil deficiency ( 6) Micronutrients ­ not to be used as a defoliant, herbicide, or desiccant. Those made 430 from nitrates or chlorides are not allowed. Soil deficiency must be documented by testing. ( i) Soluble boron products ( ii) Sulfates, carbonates, oxides, or silicates of zinc, copper, iron, manganese, molybdenum, selenium, and cobalt, ( 7) Liquid fish products ­ can be pH adjusted with sulfuric, citric or phosphoric acid. The amount of acid used shall not exceed the minimum needed to lower the pH to 3.5 ( 8) Vitamins, B1, C, and E ( k) As plant growth regulators Ethylene ­ for regulation of pineapple flowering ( l) As floating agents in postharvest handling ( 1) Lignin sulfonate ( 2) Sodium silicate ­ for tree fruit and fiber processing ( m) As synthetic inert ingredients as classified by the Environmental Protection Agency ( EPA), for use with nonsynthetic substances or synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances. ( 1) EPA List 4 ­ Inerts of Minimal Concern ( n)­( z) [ Reserved] § 205.602 Nonsynthetic substances prohibited for use in organic crop production. The following nonsynthetic substances may not be used in organic crop production: ( a) Ash from manure burning ( b) Arsenic ( c) Lead salts 431 ( d) Sodium fluoaluminate ( mined) ( e) Strychnine ( f) Tobacco dust ( nicotine sulfate) ( g) Potassium chloride ­ unless derived from a mined source and applied in a manner that minimizes chloride accumulation in the soil. ( h) Sodium nitrate ­ unless use is restricted to no more than 20% of the crop's total nitrogen requirement. ( i)­( z) [ Reserved] § 205.603 Synthetic substances allowed for use in organic livestock production. In accordance with restrictions specified in this section the following synthetic substances may be used in organic livestock production: ( a) As disinfectants, sanitizer, and medical treatments as applicable ( 1) Alcohols ( i) Ethanol ­ disinfectant and sanitizer only, prohibited as a feed additive ( ii) Isopropanol ­ disinfectant only ( 2) Aspirin ­ approved for health care use to reduce inflammation ( 3) Chlorine materials ­ disinfecting and sanitizing facilities and equipment. Residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act ( i) Calcium hypochlorite ( ii) Chlorine dioxide ( iii) Sodium hypochlorite 432 ( 4) Chlorohexidine ­ Allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/ or physical barriers have lost their effectiveness ( 5) Electrolytes ­ without antibiotics ( 6) Glucose ( 7) Glycerin ­ Allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils ( 8) Iodine ( 9) Hydrogen peroxide ( 10) Magnesium sulfate ( 11) Oxytocin ­ use in postparturition therapeutic applications ( 12) Parasiticides Ivermectin ­ prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan­ approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for in subpart D of this part for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period of breeding stock. ( 13) Phosphoric acid ­ allowed as an equipment cleaner, Provided, That, no direct contact with organically managed livestock or land occurs. ( 14) Biologics Vaccines 433 ( b) As topical treatment, external parasiticide or local anesthetic as applicable. ( 1) Iodine ( 2) Lidocaine ­ as a local anesthetic. Use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals ( 3) Lime, hydrated ­ ( bordeaux mixes), not permitted to cauterize physical alterations or deodorize animal wastes. ( 4) Mineral oil ­ for topical use and as a lubricant ( 5) Procaine ­ as a local anesthetic, use requires a withdrawal period of 90 days after administering to livestock intended for slaughter and 7 days after administering to dairy animals ( 6) Copper sulfate ( c) As feed supplements Milk replacers ­ without antibiotics, as emergency use only, no nonmilk products or products from BST treated animals ( d) As feed additives ( 1) Trace minerals, used for enrichment or fortification when FDA approved, including: ( i) Copper sulfate ( ii) Magnesium sulfate ( 2) Vitamins, used for enrichment or fortification when FDA approved ( e) As synthetic inert ingredients as classified by the Environmental Protection Agency ( EPA), for use with nonsynthetic substances or a synthetic substances listed in this section and used as an active pesticide ingredient in accordance with any limitations on the use of such substances. 434 EPA List 4 ­ Inerts of Minimal Concern. ( f)­( z) [ Reserved] § 205.604 Nonsynthetic substances prohibited for use in organic livestock production. The following nonsynthetic substances may not be used in organic livestock production: ( a) Strychnine ( b)­( z) [ Reserved] § 205.605 Nonagricultural ( nonorganic) substances allowed as ingredients in or on processed products labeled as " organic" or " made with organic ( specified ingredients or food group( s))." The following nonagricultural substances may be used as ingredients in or on processed products labeled as " organic" or " made with organic ( specified ingredients or food group( s))" only in accordance with any restrictions specified in this section. ( a) Nonsynthetics allowed: ( 1) Acids ( i) Alginic ( ii) Citric ­ produced by microbial fermentation of carbohydrate substances ( iii) Lactic ( 2) Bentonite ( 3) Calcium carbonate ( 4) Calcium chloride ( 5) Colors, nonsynthetic sources only ( 6) Dairy cultures 435 ( 7) Diatomaceous earth ­ food filtering aid only ( 8) Enzymes ­ must be derived from edible, nontoxic plants, nonpathogenic fungi, or nonpathogenic bacteria ( 9) Flavors, nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative. ( 10) Kaolin ( 11) Magnesium sulfate, nonsynthetic sources only ( 12) Nitrogen ­ oil­ free grades ( 13) Oxygen ­ oil­ free grades ( 14) Perlite ­ for use only as a filter aid in food processing ( 15) Potassium chloride ( 16) Potassium iodide ( 17) Sodium bicarbonate ( 18) Sodium carbonate ( 19) Waxes ­ nonsynthetic ( i) Carnauba wax ( ii) Wood resin ( 20) Yeast ­ nonsynthetic, growth on petrochemical substrate and sulfite waste liquor is prohibited ( i) Autolysate ( ii) Bakers ( iii) Brewers 436 ( iv) Nutritional ( v) Smoked ­ nonsynthetic smoke flavoring process must be documented. ( b) Synthetics allowed: ( 1) Alginates ( 2) Ammonium bicarbonate ­ for use only as a leavening agent ( 3) Ammonium carbonate ­ for use only as a leavening agent ( 4) Ascorbic acid ( 5) Calcium citrate ( 6) Calcium hydroxide ( 7) Calcium phosphates ( monobasic, dibasic, and tribasic) ( 8) Carbon dioxide ( 9) Chlorine materials ­ disinfecting and sanitizing food contact surfaces, Except, That, residual chlorine levels in the water shall not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act. ( i) Calcium hypochlorite ( ii) Chlorine dioxide ( iii) Sodium hypochlorite ( 10) Ethylene ­ allowed for postharvest ripening of tropical fruit ( 11) Ferrous sulfate ­ for iron enrichment or fortification of foods when required by regulation or recommended ( independent organization) ( 12) Glycerides ( mono and di) ­ for use only in drum drying of food ( 13) Glycerin ­ produced by hydrolysis of fats and oils 437 ( 14) Hydrogen peroxide ( 15) Lecithin ­ bleached ( 16) Magnesium carbonate ­ for use only in agricultural products labeled " made with organic ( specified ingredients or food group( s))," prohibited in agricultural products labeled " organic" ( 17) Magnesium chloride ­ derived from sea water ( 18) Magnesium stearate ­ for use only in agricultural products labeled " made with organic ( specified ingredients or food group( s))," prohibited in agricultural products labeled " organic" ( 19) Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality Guidelines For Foods ( 20) Ozone ( 21) Pectin ( low­ methoxy) ( 22) Phosphoric acid ­ cleaning of food­ contact surfaces and equipment only ( 23) Potassium acid tartrate ( 24) Potassium tartrate made from tartaric acid ( 25) Potassium carbonate ( 26) Potassium citrate ( 27) Potassium hydroxide ­ prohibited for use in lye peeling of fruits and vegetables ( 28) Potassium iodide ­ for use only in agricultural products labeled " made with organic ( specified ingredients or food group( s))," prohibited in agricultural products labeled " organic" ( 29) Potassium phosphate ­ for use only in agricultural products labeled " made with 438 organic ( specific ingredients or food group( s))," prohibited in agricultural products labeled " organic" ( 30) Silicon dioxide ( 31) Sodium citrate ( 32) Sodium hydroxide ­ prohibited for use in lye peeling of fruits and vegetables ( 33) Sodium phosphates ­ for use only in dairy foods ( 34) Sulfur dioxide ­ for use only in wine labeled " made with organic grapes," Provided, That, total sulfite concentration does not exceed 100 ppm. ( 35) Tocopherols ­ derived from vegetable oil when rosemary extracts are not a suitable alternative ( 36) Xanthan gum ( c)­( z) [ Reserved] § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as organic or made with organic ingredients. The following nonorganically produced agricultural products may be used as ingredients in or on processed products labeled as " organic" or " made with organic ( specified ingredients or food group( s))" only in accordance with any restrictions specified in this section. Any nonorganically produced agricultural product may be used in accordance with the restrictions specified in this section and when the product is not commercially available in organic form. ( a) Cornstarch ( native) ( b) Gums ­ water extracted only ( arabic, guar, locust bean, carob bean) 439 ( c) Kelp ­ for use only as a thickener and dietary supplement ( d) Lecithin ­ unbleached ( e) Pectin ( high­ methoxy) § 205.607 Amending the National List. ( a) Any person may petition the National Organic Standard Board for the purpose of having a substance evaluated by the Board for recommendation to the Secretary for inclusion on or deletion from the National List in accordance with the Act. ( b) A person petitioning for amendment of the National List should request a copy of the petition procedures from the USDA at the address in § 205.607( c). ( c) A petition to amend the National List must be submitted to: Program Manager, USDA/ AMS/ TMP/ NOP, Room 2945, South Building, P. O. Box 96456, Washington, DC 20090­ 6456. State Organic Programs § 205.620 Requirements of State organic programs. ( a) A State may establish a State organic program for production and handling operations within the State which produce and handle organic agricultural products. ( b) A State organic program must meet the requirements for organic programs specified in the Act. ( c) A State organic program may contain more restrictive requirements because of environmental conditions or the necessity of specific production or handling practices particular to the State or region of the United States. ( d) A State organic program must assume enforcement obligations in the State for the 440 requirements of this part and any more restrictive requirements approved by the Secretary. ( e) A State organic program and any amendments to such program must be approved by the Secretary prior to being implemented by the State. § 205.621 Submission and determination of proposed State organic programs and amendments to approved State organic programs. ( a) A State organic program's governing State official must submit to the Secretary a proposed State organic program and any proposed amendments to such approved program. ( 1) Such submission must contain supporting materials that include statutory authorities, program description, documentation of the environmental conditions or specific production and handling practices particular to the State which necessitate more restrictive requirements than the requirements of this part, and other information as may be required by the Secretary. ( 2) Submission of a request for amendment of an approved State organic program must contain supporting materials that include an explanation and documentation of the environmental conditions or specific production and handling practices particular to the State or region, which necessitates the proposed amendment. Supporting material also must explain how the proposed amendment furthers and is consistent with the purposes of the Act and the regulations of this part. ( b) Within 6 months of receipt of submission, the Secretary will: Notify the State organic program's governing State official of approval or disapproval of the proposed program or amendment of an approved program and, if disapproved, the reasons for the disapproval. ( c) After receipt of a notice of disapproval, the State organic program's governing State official may submit a revised State organic program or amendment of such a program at any time. § 205.622 Review of approved State organic programs. 441 The Secretary will review a State organic program not less than once during each 5­ year period following the date of the initial program approval. The Secretary will notify the State organic program's governing State official of approval or disapproval of the program within 6 months after initiation of the review. Fees § 205.640 Fees and other charges for accreditation. Fees and other charges equal as nearly as may be to the cost of the accreditation services rendered under the regulations, including initial accreditation, review of annual reports, and renewal of accreditation, shall be assessed and collected from applicants for initial accreditation and accredited certifying agents submitting annual reports or seeking renewal of accreditation in accordance with the following provisions: ( a) Fees­ for­ Service. ( 1) Except as otherwise provided in this section, fees­ for­ service shall be based on the time required to render the service provided calculated to the nearest 15­ minute period, including the review of applications and accompanying documents and information, evaluator travel, the conduct of on­ site evaluations, review of annual reports and updated documents and information, and the time required to prepare reports and any other documents in connection with the performance of service. The hourly rate shall be the same as that charged by the Agricultural Marketing Service, through its Quality Systems Certification Program, to certification bodies requesting conformity assessment to the International Organization for Standardization " General Requirements for Bodies Operating Product Certification Systems" ( ISO Guide 65). ( 2) Applicants for initial accreditation and accredited certifying agents submitting annual 442 reports or seeking renewal of accreditation during the first 18 months following the effective date of subpart F of this part shall receive service without incurring an hourly charge for service. ( 3) Applicants for initial accreditation and renewal of accreditation must pay at the time of application, effective 18 months following the effective date of subpart F of this part, a nonrefundable fee of $ 500.00 which shall be applied to the applicant's fees­ for­ service account. ( b) Travel charges. When service is requested at a place so distant from the evaluator's headquarters that a total of one­ half hour or more is required for the evaluator( s) to travel to such place and back to the headquarters or at a place of prior assignment on circuitous routing requiring a total of one­ half hour or more to travel to the next place of assignment on the circuitous routing, the charge for such service shall include a mileage charge administratively determined by the U. S. Department of Agriculture and travel tolls, if applicable, or such travel prorated among all the applicants and certifying agents furnished the service involved on an equitable basis or, when the travel is made by public transportation ( including hired vehicles), a fee equal to the actual cost thereof. Travel charges shall become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F of this part. The applicant or certifying agent will not be charged a new mileage rate without notification before the service is rendered. ( c) Per diem charges. When service is requested at a place away from the evaluator's headquarters, the fee for such service shall include a per diem charge if the employee( s) performing the service is paid per diem in accordance with existing travel regulations. Per diem charges to applicants and certifying agents will cover the same period of time for which the evaluator( s) receives per diem reimbursement. The per diem rate will be administratively 443 determined by the U. S. Department of Agriculture. Per diem charges shall become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F of this part. The applicant or certifying agent will not be charged a new per diem rate without notification before the service is rendered. ( d) Other costs. When costs, other than costs specified in paragraphs ( a), ( b), and ( c) of this section, are associated with providing the services, the applicant or certifying agent will be charged for these costs. Such costs include but are not limited to equipment rental, photocopying, delivery, facsimile, telephone, or translation charges incurred in association with accreditation services. The amount of the costs charged will be determined administratively by the U. S. Department of Agriculture. Such costs shall become effective for all applicants for initial accreditation and accredited certifying agents on the effective date of subpart F of this part. § 205.641 Payment of fees and other charges. ( a) Applicants for initial accreditation and renewal of accreditation must remit the nonrefundable fee, pursuant to § 205.640( a)( 3), along with their application. Remittance must be made payable to the Agricultural Marketing Service, USDA, and mailed to: Program Manager, USDA­ AMS­ TMP­ NOP, Room 2945­ South Building, P. O. Box 96456, Washington, DC 20090­ 6456 or such other address as required by the Program Manager. ( b) Payments for fees and other charges not covered under paragraph ( a) of this section must be: ( 1) Received by the due date shown on the bill for collection; ( 2) Made payable to the Agricultural Marketing Service, USDA; and ( 3) Mailed to the address provided on the bill for collection. 444 ( c) The Administrator shall assess interest, penalties, and administrative costs on debts not paid by the due date shown on a bill for collection and collect delinquent debts or refer such debts to the Department of Justice for litigation. § 205.642 Fees and other charges for certification. Fees charged by a certifying agent must be reasonable, and a certifying agent shall charge applicants for certification and certified production and handling operations only those fees and charges that it has filed with the Administrator. The certifying agent shall provide each applicant with an estimate of the total cost of certification and an estimate of the annual cost of updating the certification. The certifying agent may require applicants for certification to pay at the time of application a nonrefundable fee which shall be applied to the applicant's fees­ for­ service account. The certifying agent may set the nonrefundable portion of certification fees; however, the nonrefundable portion of certification fees must be explained in the fee schedule submitted to the Administrator. The fee schedule must explain what fee amounts are nonrefundable and at what stage during the certification process fees become nonrefundable. The certifying agent shall provide all persons inquiring about the application process with a copy of its fee schedule. § § 205.643­ 205.659 [ Reserved] Compliance § 205.660 General. ( a) The National Organic Program's Program Manager, on behalf of the Secretary, may inspect and review certified production and handling operations and accredited certifying agents for compliance with the Act or regulations in this part. ( b) The Program Manager may initiate suspension or revocation proceedings against a 445 certified operation: ( 1) When the Program Manager has reason to believe that a certified operation has violated or is not in compliance with the Act or regulations in this part; or ( 2) When a certifying agent or a State organic program's governing State official fails to take appropriate action to enforce the Act or regulations in this part. ( c) The Program Manager may initiate suspension or revocation of a certifying agent's accreditation if the certifying agent fails to meet, conduct, or maintain accreditation requirements pursuant to the Act or this part. ( d) Each notification of noncompliance, rejection of mediation, noncompliance resolution, proposed suspension or revocation, and suspension or revocation issued pursuant to § 205.662, § 205.663, and § 205.665 and each response to such notification must be sent to the recipient's place of business via a delivery service which provides dated return receipts. § 205.661 Investigation of certified operations. ( a) A certifying agent may investigate complaints of noncompliance with the Act or regulations of this part concerning production and handling operations certified as organic by the certifying agent. A certifying agent must notify the Program Manager of all compliance proceedings and actions taken pursuant to this part. ( b) A State organic program's governing State official may investigate complaints of noncompliance with the Act or regulations in this part concerning organic production or handling operations operating in the State. § 205.662 Noncompliance procedure for certified operations. ( a) Notification. When an inspection, review, or investigation of a certified operation by 446 a certifying agent or a State organic program's governing State official reveals any noncompliance with the Act or regulations in this part, a written notification of noncompliance shall be sent to the certified operation. Such notification shall provide: ( 1) A description of each noncompliance; ( 2) The facts upon which the notification of noncompliance is based; and ( 3) The date by which the certified operation must rebut or correct each noncompliance and submit supporting documentation of each such correction when correction is possible. ( b) Resolution. When a certified operation demonstrates that each noncompliance has been resolved, the certifying agent or the State organic program's governing State official, as applicable, shall send the certified operation a written notification of noncompliance resolution. ( c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the certifying agent or State organic program's governing State official shall send the certified operation a written notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation of certification may be combined in one notification. The notification of proposed suspension or revocation of certification shall state: ( 1) The reasons for the proposed suspension or revocation; ( 2) The proposed effective date of such suspension or revocation; ( 3) The impact of a suspension or revocation on future eligibility for certification; and ( 4) The right to request mediation pursuant to § 205.663 or to file an appeal pursuant to 447 § 205.681. ( d) Willful violations. Notwithstanding paragraph ( a) of this section, if a certifying agent or State organic program's governing State official has reason to believe that a certified operation has willfully violated the Act or regulations in this part, the certifying agent or State organic program's governing State official shall send the certified operation a notification of proposed suspension or revocation of certification of the entire operation or a portion of the operation, as applicable to the noncompliance. ( e) Suspension or revocation. ( 1) If the certified operation fails to correct the noncompliance, to resolve the issue through rebuttal or mediation, or to file an appeal of the proposed suspension or revocation of certification, the certifying agent or State organic program's governing State official shall send the certified operation a written notification of suspension or revocation. ( 2) A certifying agent or State organic program's governing State official must not send a notification of suspension or revocation to a certified operation that has requested mediation pursuant to § 205.663 or filed an appeal pursuant to § 205.681, while final resolution of either is pending. ( f) Eligibility. ( 1) A certified operation whose certification has been suspended under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its certification. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. ( 2) A certified operation or a person responsibly connected with an operation whose 448 certification has been revoked will be ineligible to receive certification for a period of 5 years following the date of such revocation, Except, That, the Secretary may, when in the best interest of the certification program, reduce or eliminate the period of ineligibility. ( g) Violations of Act. In addition to suspension or revocation, any certified operation that: ( 1) Knowingly sells or labels a product as organic, except in accordance with the Act, shall be subject to a civil penalty of not more than $ 10,000 per violation. ( 2) Makes a false statement under the Act to the Secretary, a State organic program's governing State official, or a certifying agent shall be subject to the provisions of section 1001 of title 18, United States Code. § 205.663 Mediation. Any dispute with respect to denial of certification or proposed suspension or revocation of certification under this part may be mediated at the request of the applicant for certification or certified operation and with acceptance by the certifying agent. Mediation shall be requested in writing to the applicable certifying agent. If the certifying agent rejects the request for mediation, the certifying agent shall provide written notification to the applicant for certification or certified operation. The written notification shall advise the applicant for certification or certified operation of the right to request an appeal, pursuant to § 205.681, within 30 days of the date of the written notification of rejection of the request for mediation. If mediation is accepted by the certifying agent, such mediation shall be conducted by a qualified mediator mutually agreed upon by the parties to the mediation. If a State organic program is in effect, the mediation procedures established in the State organic program, as approved by the Secretary, will be followed. The 449 parties to the mediation shall have no more than 30 days to reach an agreement following a mediation session. If mediation is unsuccessful, the applicant for certification or certified operation shall have 30 days from termination of mediation to appeal the certifying agent's decision pursuant to § 205.681. Any agreement reached during or as a result of the mediation process shall be in compliance with the Act and these regulations. The Secretary may review any mediated agreement for conformity to the Act and these regulations and may reject any agreement or provision not in conformance with the Act or these regulations. § 205.664 [ Reserved] § 205.665 Noncompliance procedure for certifying agents. ( a) Notification. When an inspection, review, or investigation of an accredited certifying agent by the Program Manager reveals any noncompliance with the Act or regulations in this part, a written notification of noncompliance shall be sent to the certifying agent. Such notification shall provide: ( 1) A description of each noncompliance; ( 2) The facts upon which the notification of noncompliance is based; and ( 3) The date by which the certifying agent must rebut or correct each noncompliance and submit supporting documentation of each correction when correction is possible. ( b) Resolution. When the certifying agent demonstrates that each noncompliance has been resolved, the Program Manager shall send the certifying agent a written notification of noncompliance resolution. ( c) Proposed suspension or revocation. When rebuttal is unsuccessful or correction of the noncompliance is not completed within the prescribed time period, the Program Manager shall 450 send a written notification of proposed suspension or revocation of accreditation to the certifying agent. The notification of proposed suspension or revocation shall state whether the certifying agent's accreditation or specified areas of accreditation are to be suspended or revoked. When correction of a noncompliance is not possible, the notification of noncompliance and the proposed suspension or revocation may be combined in one notification. The notification of proposed suspension or revocation of accreditation shall state: ( 1) The reasons for the proposed suspension or revocation; ( 2) The proposed effective date of the suspension or revocation; ( 3) The impact of a suspension or revocation on future eligibility for accreditation; and ( 4) The right to file an appeal pursuant to § 205.681. ( d) Willful violations. Notwithstanding paragraph ( a) of this section, if the Program Manager has reason to believe that a certifying agent has willfully violated the Act or regulations in this part, the Program Manager shall send a written notification of proposed suspension or revocation of accreditation to the certifying agent. ( e) Suspension or revocation. When the accredited certifying agent fails to file an appeal of the proposed suspension or revocation of accreditation, the Program Manager shall send a written notice of suspension or revocation of accreditation to the certifying agent. ( f) Cessation of certification activities. A certifying agent whose accreditation is suspended or revoked must: ( 1) Cease all certification activities in each area of accreditation and in each State for which its accreditation is suspended or revoked. ( 2) Transfer to the Secretary and make available to any applicable State organic 451 program's governing State official all records concerning its certification activities that were suspended or revoked. ( g) Eligibility. ( 1) A certifying agent whose accreditation is suspended by the Secretary under this section may at any time, unless otherwise stated in the notification of suspension, submit a request to the Secretary for reinstatement of its accreditation. The request must be accompanied by evidence demonstrating correction of each noncompliance and corrective actions taken to comply with and remain in compliance with the Act and the regulations in this part. ( 2) A certifying agent whose accreditation is revoked by the Secretary shall be ineligible to be accredited as a certifying agent under the Act and the regulations in this part for a period of not less than 3 years following the date of such revocation. § § 205.666 and 205.667 [ Reserved] § 205.668 Noncompliance procedures under State organic programs. ( a) A State organic program's governing State official must promptly notify the Secretary of commencement of any noncompliance proceeding against a certified operation and forward to the Secretary a copy of each notice issued. ( b) A noncompliance proceeding, brought by a State organic program's governing State official against a certified operation, shall be appealable pursuant to the appeal procedures of the State organic program. There shall be no subsequent rights of appeal to the Secretary. Final decisions of a State may be appealed to the United States District Court for the district in which such certified operation is located. ( c) A State organic program's governing State official may review and investigate complaints of noncompliance with the Act or regulations concerning accreditation of certifying 452 agents operating in the State. When such review or investigation reveals any noncompliance, the State organic program's governing State official shall send a written report of noncompliance to the Program Manager. The report shall provide a description of each noncompliance and the facts upon which the noncompliance is based. § 205.669 [ Reserved] Inspection and Testing, Reporting, and Exclusion from Sale § 205.670 Inspection and testing of agricultural product to be sold or labeled " organic." ( a) All agricultural products that are to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" must be made accessible by certified organic production or handling operations for examination by the Administrator, the applicable State organic program's governing State official, or the certifying agent. ( b) The Administrator, applicable State organic program's governing State official, or the certifying agent may require preharvest or postharvest testing of any agricultural input used or agricultural product to be sold, labeled, or represented as " 100 percent organic," " organic," or " made with organic ( specified ingredients or food group( s))" when there is reason to believe that the agricultural input or product has come into contact with a prohibited substance or has been produced using excluded methods. Such tests must be conducted by the applicable State organic program's governing State official or the certifying agent at the official's or certifying agent's own expense. ( c) The preharvest or postharvest tissue test sample collection pursuant to paragraph ( b) of this section must be performed by an inspector representing the Administrator, applicable State 453 organic program's governing State official, or certifying agent. Sample integrity must be maintained throughout the chain of custody, and residue testing must be performed in an accredited laboratory. Chemical analysis must be made in accordance with the methods described in the most current edition of the Official Methods of Analysis of the AOAC International or other current applicable validated methodology determining the presence of contaminants in agricultural products. ( d) Results of all analyses and tests performed under this section: ( 1) Must be promptly provided to the Administrator; Except, That, where a State organic program exists, all test results and analyses shall be provided to the State organic program's governing State official by the applicable certifying party that requested testing; and ( 2) Will be available for public access, unless the testing is part of an ongoing compliance investigation. ( e) If test results indicate a specific agricultural product contains pesticide residues or environmental contaminants that exceed the Food and Drug Administration's or the Environmental Protection Agency's regulatory tolerences, the certifying agent must promptly report such data to the Federal health agency whose regulatory tolerance or action level has been exceeded. § 205.671 Exclusion from organic sale. When residue testing detects prohibited substances at levels that are greater than 5 percent of the Environmental Protection Agency's tolerance for the specific residue detected or unavoidable residual environmental contamination, the agricultural product must not be sold, labeled, or represented as organically produced. The Administrator, the applicable State organic 454 program's governing State official, or the certifying agent may conduct an investigation of the certified operation to determine the cause of the prohibited substance. § 205.672 Emergency pest or disease treatment. When a prohibited substance is applied to a certified operation due to a Federal or State emergency pest or disease treatment program and the certified operation otherwise meets the requirements of this part, the certification status of the operation shall not be affected as a result of the application of the prohibited substance: Provided, That: ( a) Any harvested crop or plant part to be harvested that has contact with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program cannot be sold, labeled, or represented as organically produced; and ( b) Any livestock that are treated with a prohibited substance applied as the result of a Federal or State emergency pest or disease treatment program or product derived from such treated livestock cannot be sold, labeled, or represented as organically produced: Except, That: ( 1) Milk or milk products may be sold, labeled, or represented as organically produced beginning 12 months following the last date that the dairy animal was treated with the prohibited substance; and ( 2) The offspring of gestating mammalian breeder stock treated with a prohibited substance may be considered organic: Provided, That, the breeder stock was not in the last third of gestation on the date that the breeder stock was treated with the prohibited substance. § § 205.673­ 205.679 [ Reserved] Adverse Action Appeal Process § 205.680 General. 455 ( a) Persons subject to the Act who believe they are adversely affected by a noncompliance decision of the National Organic Program's Program Manager may appeal such decision to the Administrator. ( b) Persons subject to the Act who believe that they are adversely affected by a noncompliance decision of a State organic program may appeal such decision to the State organic program's governing State official who will initiate handling of the appeal pursuant to appeal procedures approved by the Secretary. ( c) Persons subject to the Act who believe that they are adversely affected by a noncompliance decision of a certifying agent may appeal such decision to the Administrator, Except, That, when the person is subject to an approved State organic program, the appeal must be made to the State organic program. ( d) All written communications between parties involved in appeal proceedings must be sent to the recipient's place of business by a delivery service which provides dated return receipts. ( e) All appeals shall be reviewed, heard, and decided by persons not involved with the decision being appealed. § 205.681 Appeals. ( a) Certification appeals. An applicant for certification may appeal a certifying agent's notice of denial of certification, and a certified operation may appeal a certifying agent's notification of proposed suspension or revocation of certification to the Administrator, Except, That, when the applicant or certified operation is subject to an approved State organic program the appeal must be made to the State organic program which will carry out the appeal pursuant to the State organic program's appeal procedures approved by the Secretary. 456 ( 1) If the Administrator or State organic program sustains a certification applicant's or certified operation's appeal of a certifying agent's decision, the applicant will be issued organic certification, or a certified operation will continue its certification, as applicable to the operation. The act of sustaining the appeal shall not be an adverse action subject to appeal by the affected certifying agent. ( 2) If the Administrator or State organic program denies an appeal, a formal administrative proceeding will be initiated to deny, suspend, or revoke the certification. Such proceeding shall be conducted pursuant to the U. S. Department of Agriculture's Uniform Rules of Practice or the State organic program's rules of procedure. ( b) Accreditation appeals. An applicant for accreditation and an accredited certifying agent may appeal the Program Manager's denial of accreditation or proposed suspension or revocation of accreditation to the Administrator. ( 1) If the Administrator sustains an appeal, an applicant will be issued accreditation, or a certifying agent will continue its accreditation, as applicable to the operation. ( 2) If the Administrator denies an appeal, a formal administrative proceeding to deny, suspend, or revoke the accreditation will be initiated. Such proceeding shall be conducted pursuant to the U. S. Department of Agriculture's Uniform Rules of Practice, 7 CFR Part 1, Subpart H. ( c) Filing period. An appeal of a noncompliance decision must be filed within the time period provided in the letter of notification or within 30 days from receipt of the notification, whichever occurs later. The appeal will be considered " filed" on the date received by the Administrator or by the State organic program. A decision to deny, suspend, or revoke 461 certification or accreditation will become final and nonappealable unless the decision is appealed in a timely manner. ( d) Where and what to file. ( 1) Appeals to the Administrator must be filed in writing and addressed to Administrator, USDA­ AMS, Room 3071­ S, P. O. Box 96456, Washington, DC 20090­ 6456. ( 2) Appeals to the State organic program must be filed in writing to the address and person identified in the letter of notification. ( 3) All appeals must include a copy of the adverse decision and a statement of the appellant's reasons for believing that the decision was not proper or made in accordance with applicable program regulations, policies, or procedures. § § 205.682­ 205.689 [ Reserved] Miscellaneous § 205.690 OMB control number. The control number assigned to the information collection requirements in this part by the Office of Management and Budget pursuant to the Paperwork Reduction Act of 1995, 44 U. S C. Chapter 35, is OMB number 0581­ 0181. § § 205.691­ 205.699 [ Reserved] PARTS 206­ 209 [ Reserved] Dated: December 13, 2000 Kathleen A. Merrigan Administrator Agricultural Marketing Service Appendixes to Preamble 462 Appendix A.­­ Regulatory Impact Assessment for Final Rule Implementing the Organic Foods Production Act of 1990 The following regulatory assessment is provided to fulfill the requirements of Executive Order 12866. This assessment consists of a statement of the need for national organic standards, a description of the baseline for the analysis, a summary of the provisions of the final U. S. Department of Agriculture ( USDA) rule and the alternative approaches that were examined, and an analysis of the benefits and costs. Much of the analysis is necessarily descriptive of the anticipated effects of the final rule. Because basic market data on the prices and quantities of organic goods and the costs of organic production are limited, it is not possible to provide quantitative estimates of all benefits and costs of the final rule. The cost of fees and recordkeeping in the final USDA rule are quantified, but the anticipated benefits and other costs are not. Consequently, the analysis does not estimate the magnitude or the direction ( positive or negative) of net benefits. Under the final rule, USDA will implement a program of uniform standards of production and certification, as mandated by the Organic Foods Production Act of 1990 ( OFPA). The primary benefits from implementation of USDA's National Organic Program ( NOP) are standardizing the definitions and the manner in which organic product information is presented to consumers, which may reduce the cost associated with enforcement actions in consumer fraud cases, and improved access to domestic and international markets from harmonizing the various State and private organic standards and elevating reciprocity negotiations to the national level. The costs of this rule are the direct costs for accreditation and the costs of complying with the specific standards in the proposal, including the reporting and recordkeeping requirements. 463 Certifiers will be charged fees based on the actual costs of the accreditation work done by USDA staff. Smaller certifiers with less complex programs are expected to pay somewhat lower fees. Organic farmers, ranchers, wild­ crop harvesters, and handlers will have to pay fees for organic certification from a State or private certifier but will not be charged any additional fees by USDA. The direct accreditation costs to an estimated 59 certifying agents ( including all 49 current U. S. certifiers and an estimated 10 foreign agents) during the first 18 months following the final rule are estimated to be approximately $ 92,000 to $ 124,000 and are being subsidized with appropriated funds derived from the taxpayers. In addition, USDA will use appropriated funds to cover approximately $ 270,000­$ 448,000 in hourly charges for site evaluation during this period and for other costs associated with starting up the NOP. The magnitude of other compliance costs for adhering to this regulation including the costs of becoming familiar with and adopting the national standards have not been measured. For organic farmers who adhere to State regulations or undergo third­ party inspection and certification, the compliance cost may not be large. For those who don't, the costs may be more substantial. The impact of this regulation on small certifying agents and other small businesses has also not been measured but may be significant. To account for significant rule changes from the proposal and to reflect more up­ to­ date information, we revised some estimates of benefits and costs. We have raised our estimates of current certification fees and USDA accreditation fees. Also, we now project higher USDA accreditation fees after the 18­ month implementation period. We revised our estimates of the certification fees charged by a representative set of public and private certifiers in the U. S. based on new data, and our new estimates are about 25 percent higher for small and midsized farmers. 464 Small and midsized farmers are now estimated to pay $ 579 and $ 1,414 for their first­ year certification, respectively. Accreditation costs after the 18­ month implementation period are substantially above those estimated in the proposed rule, reflecting a slight increase in the government per diem travel allowance since the proposed rule was published and a change in the projected number of reviewers needed for site evaluations and renewals after the 18­ month implementation period. In the proposed rule, USDA had projected that only one reviewer would be needed for site evaluations and renewals that took place after the 18­ month implementation period but has changed that projection to two reviewers based on additional experience with the International Organization for Standardization ( ISO Guide 65) program. We estimate that initial accreditation costs after the 18­ month implementation period will range from $ 6,120 to $ 9,700, approximately double our estimate in the March 2000 proposed rule. Marginal changes have been made in the final rule, in response to comments on the March 2000 proposal, which generally clarify or add flexibility to producer and handler provisions or make them better reflect current industry standards. One key change was to raise the threshold for labeling products as " made with organic ingredients" from 50 percent organic content to 70 percent to be consistent with international industry standards. Although not quantified, we believe that this will increase the cost of the rule. Another key change was to reduce the transition period for a dairy operation to make a whole­ herd conversion to organic production in order to make conversion affordable for a wider range of dairy farms, including smaller operations. Although not quantified, we believe that this will decrease the cost of the rule. The Need for National Standards 465 Over the last several decades, as market demand has grown from a handful of consumers bargaining directly with farmers to millions of consumers acquiring goods from supermarket shelves as well as market stalls, a patchwork of State and private institutions has evolved to set standards and verify label claims. Organically produced food cannot be distinguished visually from conventional food and cannot necessarily be distinguished by taste; therefore, consumers must rely on labels and other advertising tools for product information. Farmers, food handlers, and other businesses that produce and handle organically grown food have a financial incentive to advertise that information because consumers have been willing to pay a price premium for these goods. However, consumers face difficulties in discerning the organic attributes of a product, and many producers and handlers have sought third­ party certification of organic claims. State and private initiatives have resulted in a fairly robust system of standards and certification, and the difficulties in consumer verification have been partially overcome by these initiatives. Private organizations, mostly nonprofits, began developing certification standards in the early 1970' s as a way to support organic farming, as well as to strengthen legitimate product claims. The first organization to offer third­ party certification, California Certified Organic Farmers, was formed in the early 1970' s, and the first State regulations and laws on organic labeling were also passed in the 1970' s. Currently, 13 State and 36 private certification programs are operating in the United States, and about half the States currently have some form of regulation. While most States still do not mandate third­ party certification and many organic producers still market goods without certification, large food processors, grain traders, and retailers are increasingly requiring certification, and many growers have turned to certification as a marketing tool. 466 However, even with increasing pressure for growers to use third­ party certification services and increasing availability of these services from State and private certifiers, the discrepancies between the certifiers on organic standards and between the States on certification requirements have resulted in several impediments to market development. The patchwork of variable standards has made producer access to organic markets, international and domestic, uneven. The recent emergence of the industry­ developed standards may have mitigated some domestic access problems, but two important impediments remain. They are: multiingredient certification disputes and barriers to foreign markets. Difficulty Certifying Multiingredient Products Although the State and private organic standards that have developed over the last several decades have many areas of overlap, particularly for crop production, the differences have caused disagreements among certifying agents over whose standards apply to multiingredient organic processed products. These disagreements have created sourcing problems for food. Disagreements about standards also create sourcing problems for handlers of these multiingredient products. Certifying agents are able to negotiate and maintain reciprocity agreements at some cost. These reciprocity agreements specify the conditions under which certifying agents recognize each other's standards. Although new organic product offerings have emerged at a fast pace during the 1990' s, this pace could eventually slow, assuming that the need for costly reciprocity agreements will continue to persist in the absence of national standards. Barriers to Foreign Organic Markets In the absence of a national standard, U. S. producers have taken on costs of private accreditation or shipment­ by­ shipment certification required to gain access to some foreign 467 markets such as the European Union ( EU). However, even with these actions, U. S. organic products may have had some difficulties entering other foreign markets due to high information and search costs on the part of foreign buyers. Some foreign buyers of U. S. organic products may incur costs to determine the compatibility of standards. Such costs may have discouraged purchases of U. S. organic products. Congress passed the OFPA Title XXI of the Food, Agriculture, Conservation and Trade Act of 1990, U. S. C. Title 7 largely to address these marketing problems. The OFPA mandates that the Secretary of Agriculture develop a national organic program, and USDA's statutory responsibility is the primary reason why USDA has carried out this rulemaking process. The OFPA requires the Secretary to establish an organic certification program for farmers, wild­ crop harvesters, and handlers of agricultural products that have been produced using organic methods as provided for in the OFPA. This legislation requires the Secretary to establish and implement a program to accredit a State program official or any private person who meets the requirements of the Act as a certifying agent to certify that farm, wild­ crop harvesting, or handling operations are in compliance with the standards set out in the regulation. As stated by the OFPA in section 6501, the regulations are for the following purposes: ( 1) to establish national standards governing the marketing of certain agricultural products as organically produced products, ( 2) to assure consumers that organically produced products meet a consistent standard, and ( 3) to facilitate interstate commerce in fresh and processed food that is organically produced. Baseline After struggling to build market recognition and supply capacity for many decades, the organic farming industry became one the fastest growing segments of U. S. agriculture during the 468 last decade. Certified organic cropland more than doubled in the United States between 1992 and 1997, and two organic livestock sectors eggs and dairy grew even faster ( Greene, 2000a). USDA's Economic Research Service estimates that over 1.3 million acres of U. S. farmland were certified in 1997, and more recent data from some of the certifiers indicate that this momentum is continuing ( Greene, 2000b). Although national estimates of the amount of uncertified organic acreage are not available, data from California, the largest U. S. producer of organic specialty crops, indicates that most of the State's organic acreage and about half of the growers were certified during the 1997/ 98 crop year ( Klonsky et al., 2000). Growth in U. S. sales of organic products during the 1990' s mirrors the growth in acreage devoted to producing these goods. According to industry data, total organic product sales more than doubled between 1992 and 1996 to $ 3.5 billion in sales ( table 1). More recent industry data on organic sales through natural product stores, the largest outlet for organic products, show annual sales growth continuing in the general range of 20­ 25 percent annually. The recent growth in organic production and sales has taken place in the absence of national organic standards but with industry expectation that these standards were forthcoming. While the U. S. organic industry is characterized by an array of certification, production, processing, and marketing practices, there are commonalities throughout the industry. Certification The number of U. S. certification groups has fluctuated between 40 and 50 during the last decade. Currently, 49 organizations 36 private and 13 State are advertising that they provide certification services to farmers, handlers ( a category that USDA defines to include processors), retailers, or other segments of the food industry. Some certifiers provide services to multiple 469 segments of the food industry. Private certifying agents range from small nonprofit associations that certify only a few growers to large for­ profit businesses operating in numerous States and certifying hundreds of producers. Typically, certifying agents review organic production plans, inspect the farm fields and facilities to be certified, periodically reinspect, and may conduct soil tests and tests for residues of prohibited substances. In some cases, certifying agents negotiate reciprocity agreements with other agents. State laws vary widely on organic certification and registration. Some States, such as California, require only that an organic producer register and make certification voluntary. Other States, including Texas, require certification by the State's own agents, while Minnesota and others accept certification by a private certifying agent. Approximately half of the States have laws that regulate organic production and processing. In many States producers may claim their product is organic but operate without certification or well­ defined standards. Many organic producers in States with no State programs voluntarily secure third­ party certification to welldefined standards. Certification costs vary with farm size and across certifying agents. Illustrative certification costs are presented in tables 2A and 2B. Very few certifying agents operate with an external accreditation for the following reasons. There is no law which requires them to be accredited: the price may be unacceptably high in relation to expected benefits; the certifying agent may be unable to find an accrediting party willing to accredit the particular organic program the certifying agent is marketing; and State programs may believe that their status as a government entity obviates the need for external accreditation. In 1999, USDA began accrediting certifying agents as meeting ISO Guide 65. It is a 470 valuable recognition that the certifying entity satisfies the business capacity standards of ISO Guide 65. EU authorities have accepted verification of certifying agents to ISO Guide 65 as an interim measure to facilitate exports pending the establishment of a national organic program. Organic Crop and Livestock Production In 1997, farmers in 49 States used organic production systems and third­ party organic certification services on over a million acres of farmland and were raising certified organic livestock production in nearly half the States, according to USDA data ( Greene, 2000a). Twothirds of the farmland was used for growing crops, with Idaho, California, North Dakota, Montana, Minnesota, Wisconsin, Iowa, and Florida as the top producers. Colorado and Alaska had the most organic pasture and rangeland. California overwhelmingly had the most certified organic fruit and vegetable acreage in 1997, but farmers were growing small plots of certified organic vegetables for direct marketing to consumers in over half the States. About 2 percent of the U. S. apple, grape, lettuce, and carrot crops were certified organic in 1997, while only onetenth of 1 percent of the U. S. corn and soybean crops were grown under certified organic farming systems. USDA has not estimated the amount of acreage devoted to organic production systems that has not been certified, although data from California suggest that a large number of farmers, mostly those with small operations, produce and market organic goods without third­ party certification. Key production practices followed by certified organic producers include: abstaining from use of certain crop chemicals and animal drugs; ecologically based pest and nutrient management; segregation of organic fields and animals from nonorganic fields and animals; following an organic system plan with multiple goals, including sustainability; and recordkeeping to document practices 471 and progress toward the plan's goals. Specific elements of organic production vary, but organic systems generally share a core set of practices. For example, the certification standards of virtually all State and private U. S. certifying agents prohibit the use of synthetic chemical pesticides or animal growth hormones. And most certification standards include a 3­ year ban on the use of prohibited substances on cropland before production can be certified as organic. On the other hand, certification standards for organic livestock production have been more variable for pasture, feed, and other practices. Until 1999, the USDA Food Safety and Inspection Service ( FSIS) withheld approval for the use of organic labels on meat and poultry products pending the outcome of this rulemaking. However, the Secretary announced a change in policy in January 1999. Meat and poultry products may be labeled " certified organic by ( name of the certifying agent)" if handlers obtain prior label approval from FSIS and the claim meets certain basic criteria. Organic labels have been permitted on eggs and dairy products which are regulated by the Food and Drug Administration ( FDA) throughout the 1990' s, but most certifiers have not yet offered certification services for these products. We provide a summary of the New Hampshire organic program to highlight the similarities in the core set of practices. It is important to note that this discussion is intended to highlight the conceptual similarities between State and private programs and is not intended to suggest that these programs are identical to each other or to the NOP. Production standards include: a written rotation plan; tillage systems that incorporate organic matter wastes into the topsoil; compliance with limits on the sources of manure and the timing of its application; prohibitions on the use of certain substances ( e. g., sewage sludge, synthetic sources of nitrates, synthetic growth regulators, and anhydrous ammonia); a list of accepted and prohibited weed and 472 pest control practices; segregation of organic and nonorganic production; recordkeeping regarding fertilization, cropping, and pest management histories; separate sales records for organic and nonorganic production; and records of all laboratory analyses. Residue testing may be required if USDA believes that the products or soil used for producing certified products may have become contaminated with prohibited substances. The New Hampshire program requires growers to pay a $ 100 annual inspection fee and to provide a written description of their farm operation, including the size of the farm; a field map; a 3­ year history of crop production, pest control, and fertilizer use; a crop rotation and a soil management plan; and a description of postharvest storage and handling methods. Applicants for certification must also agree to comply with regulations controlling the use of the New Hampshire certified organic logo. Organic Food Handling In addition to growers, who actually produce and harvest products to be marketed as organic, there are handlers who transform and resell the organic products. Not all certifiers have standards for handling organic products. And some certifiers have standards for parts of the food marketing system, such as restaurants, which are not explicitly covered by the OFPA nor encompassed by this final regulation. Definitions of processing and handling differ across certifying agents and State laws. Some States, such as Washington, distinguish between a processor and a handler, specifying 21 actions which constitute processing and defining a handler as anyone who sells, distributes, or packs organic products. Other States do not distinguish between food processors and handlers. Under the final rule, the term, " handler," includes processors but not final retailers of agricultural 473 products that do not process agricultural products. Organic Product Marketing The two largest marketing outlets for organically produced goods are natural foods stores and direct markets which include farmers markets, roadside stands, and ` community supported agriculture' arrangements according to industry data. USDA does not have official national level statistics on organic retail sales, but an industry trade publication, the Natural Foods Merchandiser ( NFM), reported estimates of total retail sales of organic foods for years 1990­ 96 and continues to report estimates of natural product stores sales ( table 1). The last NFM estimate of total organic sales through all marketing outlets was $ 3.5 billion in 1996 ($ 3.7 billion in 1999 dollars), less than one percent of total food expenditures by families and individuals that year. Natural foods stores increased in size and presence in the United States during the 1990' s many are now the size of conventional supermarkets and about two­ thirds of estimated total organic sales during the 1990' s were through this outlet ( table 1). Natural foods supermarkets, which are similar to conventional in the breadth of supermarket offerings and amount of total sales, accounted for close to 1 percent of total supermarket sales by 1997 ( Kaufman 1998). Organic product sales through the natural foods stores outlet, alone, in 1999 were estimated at $ 4 billion, and sales through this outlet increased about 20­ 25 percent annually through the 1990' s. Direct­ to­ consumer market sales ranged from $ 270 to $ 390 million during the early 1990' s, accounting for between 17 and 22 percent of total organic sales during this period, according to NFM estimates ( table 1). Conventional food stores ( mass markets) accounted for 6­ 7 percent of total sales during this period, and export sales accounted for 3­ 8 percent of the total. 474 A draft report on the U. S. organic export market, partly funded by USDA, indicates that current U. S. export sales are under 5 percent of total organic product sales ( Fuchshofen and Fuchshofen 2000). The United States is both an importer and an exporter of organic foods. The United States does not restrict imports of organic foods. In fact, U. S. Customs accounts do not distinguish between organic and conventional products. The largest markets for organic foods outside the United States are in Europe, Japan, and Canada. There is increasing pressure, particularly in Europe and Japan, for U. S. exports to demonstrate that they meet a national standard rather than a variety of private and State standards. France, for example, has indicated to USDA that it prefers to negotiate with a single national organic program, rather than the dozens of different State and private certifying programs currently operating in the U. S. The EU is the largest market for organic food outside the United States. The organic food market in the EU was estimated to be worth $ 5.2 billion in 1997 ( International Trade Centre UNCTAD/ WTO 1999). The largest organic retail sales markets in the EU in 1997 were Germany ($ 1.8 billion), France ($ 720 million), and Italy ($ 750 million). Large organic markets outside the EU include Canada and Australia, with approximately $ 60 million and $ 68 million, respectively, in organic retail sales in 1997 ( Lohr 1998). Import share of the organic food market in Europe ranged from 10 percent in France to 70 percent in the United Kingdom, was 80 percent in Canada, and varied from 0 to 13 percent in various Australian States. Japan is another important market for U. S. organic products. Currently, Japan has voluntary labeling guidelines for 6 categories of nonconventional agricultural products: organic, transitional organic, no pesticide, reduced pesticide, no chemical fertilizer, and reduced chemical 475 fertilizer. Total sales, including foods marketed as " no chemical" and " reduced chemical," are forecast to jump 15 percent in 1999 to almost $ 3 billion. Imports of organic agricultural products were valued at $ 90 million in 1998. Given Japan's limited agricultural acreage, imports will likely provide an increasingly significant share of Japan's organic food supply ( USDA FAS 1999a). Recently, these markets have adopted or are considering adoption of procedures that may impede the importing of organic food. The EU regulations establishing the basis for equivalency in organic production among EU members and for imports from outside the EU were adopted in 1991 ( Council Regulation 2092/ 91). The EU regulations only allow imports from non­ EU countries whose national standards have been recognized as equivalent to the EU standards ( Commission Regulation 94/ 92). The Ministry of Agriculture, Forestry, and Fisheries ( MAFF) in Japan recently announced proposed standards and third­ party certification requirements. Under Japan's proposed standards, certifying agents from countries without national organic standards administered by a federal government will face additional financial and administrative costs. Requirements of the Final Rule The final rule follows the structure established in the OFPA. By adopting this alternative, the Department is following the legislative direction in the OFPA. All products marketed as organic will have to be produced and handled as provided in the OFPA and these regulations. Compared to current organic practices, the final rule sets a somewhat more stringent system of requirements. Among many alternatives, two alternatives to the final rule are discussed in this section: continuation of the status quo and use of industry­ developed standards. Given the statutory 476 responsibility, USDA is implementing the requirements of the OFPA. However, under the status quo alternative, there would be no national standard or national program of accreditation and certification. No Federal funds would be used, there would be no transfer from Federal taxpayers at large to organic market participants, and there would be no Federal regulatory barriers to entry into organic production and handling. However, growers and handlers would still not have level access, under uniform standards, to the domestic market, and there may be significant enforcement gaps at the State level. International pressure for additional verification would continue to build and would be likely to lead to an increased use of public and private verification and accreditation services, which are provided on a user­ fee basis with full cost recovery. Establishing reciprocity between certifying agents in the domestic organic market would continue to be costly and may stifle growth in trade of organic products, although the magnitude of these costs and their effects on growth are unknown. Without further analysis that includes quantification and monetization of benefits and costs, it is not clear whether the net benefits associated with this alternative are greater or less than those associated with the final rule. Under the other industry­ developed standards alternative, USDA could eliminate the costs associated with establishing reciprocity in the domestic market and establish equivalency for access to international markets, but it would be difficult for industry to develop consensus standards. For example, the industry­ developed standards recently proposed by the Organic Trade Association were developed with significant industry input but with little public comment. In contrast, several hundred thousand comments have been submitted in the course of the USDA rulemaking process. In addition, the OFPA mandated an advisory role for a 15­ member National Organic Standards Board ( NOSB), which has wide representation from the organic community 477 and includes members who are farmers, handlers, retailers, environmentalists, consumers, scientists, and certifiers. The NOSB has assisted in developing the standards promulgated in this final rule and will play an advisory role for the NOP even after the final rule is in place. Without further analysis that includes quantification and monetization of benefits and costs, it is not clear whether the net benefits associated with this alternative are greater or less than those associated with the final rule. USDA's final rule will be implemented by the NOP staff in the Agricultural Marketing Service ( AMS). Major features of the NOP include: Accreditation and Certification The rule specifies the accreditation and certification process. Persons providing certification services for organic production and handling must be accredited by USDA through the NOP. Applicants for accreditation must document their abilities to certify according to the national standards and to oversee their client's compliance with the requirements of the OFPA and NOP regulations. Producers and handlers of organic products must be certified by an accredited certifying agent. Producers and handlers are required to document their organic plans and procedures to ensure compliance with the OFPA. All certifying agents would have to be accredited, and certification by producers and handlers would be mandatory. The exceptions are: ( 1) growers and handlers with gross organic sales of $ 5,000 or less would be exempt from certification, and ( 2) a handling operation may be exempt or excluded from certification according to provisions described in the rule's subpart B, Applicability. USDA will charge applicants for accreditation and accreditation renewal ( required every 5 478 years) a $ 500 fee at the time of application. USDA will also charge applicants for costs over $ 500 for site evaluation of the applicant's business. The applicant would be charged for travel costs, per diem expenses, and any miscellaneous costs incurred with a site evaluation. USDA will also charge accredited certifiers at an hourly rate to review their annual reports. Producers and handlers will not pay certification fees to USDA. Certification fees will be established by the accredited certifying agents. USDA will not set fees. The rule requires certifying agents to submit a copy of their fee schedules to USDA, post their fees, and provide applicants estimates of the costs for initial certification and for renewal of certification. Production and Handling The rule establishes standards for organic production of crops and livestock and handling of organic products. These standards were developed from specific requirements in the OFPA, recommendations from the NOSB, review of existing organic industry practices and standards, public comments received on the 1997 proposal and subsequent issue papers, public meetings, and comments received on the 2000 proposal. The final rule establishes a number of requirements for producers and handlers of organic food. These requirements will affect farming operations, packaging operations, processing operations and retailers. Some of the major provisions are: ( 1) land requirements, ( 2) crop nutrient requirements, ( 3) crop rotation requirements, ( 4) pest management requirements, ( 5) livestock management requirements, ( 6) processing and handling requirements, and ( 7) commingling requirements. National List The National List lists allowed synthetic substances and prohibited nonsynthetic 479 substances that may or may not be used in organic production and handling operations. The list identifies those synthetic substances, which would otherwise be prohibited, that may be used in organic production based on the recommendations of the NOSB. Only those synthetic substances on the National List may be used. The National List also identifies those natural substances that may not be used in organic production, as determined by the Secretary based on the NOSB recommendations. Testing When certifying agents have reason to believe organic products contain a prohibited substance, they may conduct residue tests. Labeling The rule also states how organic products may be labeled and permitted uses of the USDA organic seal. In addition to the USDA seal and the certifying agent's seal, information on organic food content may be displayed. Small businesses that are certified may use the USDA seal. Recordkeeping The rule requires certifying agents, producers, and handlers to keep certain records. Certifying agents are required to file periodic reports with USDA. Producers and handlers are required to notify and submit reports to their certifying agent. While recordkeeping is a standard practice in conventional and organic farming, the final rule adds recordkeeping and reporting requirements that do not exist for growers and handlers operating without certification. Similarly, certifying agents would face additional recordkeeping and reporting requirements, particularly those certifying agents operating without external accreditation. The rule permits certifying agent logos and requires the name of the certifying agent on processed organic foods. 480 Enforcement Organic operations that falsely sell or label a product as organic will be subject to civil penalties of up to $ 10,000 per violation. The provisions of the final regulation apply to all persons who sell, label, or represent their agricultural product as organic, including operations that aren't certified, and the civil penalties of up to $ 10,000 apply to these operations as well. Certifying agents, State organic programs' governing State officials, and USDA will receive complaints alleging violations of the Act or these regulations. In States where there is no State organic program, USDA will investigate allegations of violations of the Act. Number of Affected Parties and Projections In assessing the impacts of the rule, we have attempted to determine the number of certifying agents, private and State, that are currently operating and considered the factors likely to affect the number of certifying agents after the rule is implemented. We have attempted to determine the number of currently operating producers and handlers that would be affected. And, we have considered the factors that might affect the number of producers and handlers after the program has been implemented. For the analysis, USDA assumes the following: 1. Forty­ nine domestic certifying agents and ten foreign certifying agents will be affected by the regulation. 2. Approximately 13,650 certified and noncertified organic producers will be affected by the regulation. With the assumed growth rate of 14 percent for certified organic producers and approximately 8 percent for noncertified organic producers, the number of organic producers will grow to 17,150 in 2002. 481 3. Approximately 1,600 handlers of organic food will be affected by the regulation. This number will grow to 2,250 by 2002. Certifying Entities We place the number of certifying agents currently operating at 49, including 13 State programs. The number of certifying agents has remained fairly stable, between 40 and 50, for some years, with entries and exits tending to offset each other. For purposes of estimating the paperwork burden described elsewhere, we assume no growth in the number of domestic certifying agents but project 10 foreign certifying agents will seek and receive USDA accreditation in the first 3 years of the program. Organic Producers While some USDA data on the number of certified organic producers in the United States exist, no national data have been collected on the number of producers that produce and market organic goods without third­ party certification. Organic farming was not distinguished from conventional agriculture in the last Census of Agriculture in 1997. USDA and Organic Farming Research Foundation ( OFRF) data were used in the Regulatory Impact Analysis ( RIA) of the March 2000 proposed rule to help estimate the number of certified U. S. growers affected by the regulation. California Department of Food and Agriculture ( CDFA) data were used to help estimate the number of uncertified U. S. growers affected by the regulation. All three of these data sources have updated their estimates of the number of certified and uncertified organic producers since the RIA of the proposed rule was published earlier this year. However, the updated numbers do not indicate trends that would fundamentally alter the assumptions used in the RIA of the proposed rule to calculate the number of affected growers, and the estimates made 482 for the March 2000 RIA are retained in this assessment of the final rule. USDA datum indicates the average annual growth rate in the number of U. S. certified organic growers between 1991 and 1994 was about 14 percent ( Dunn 1995b). In April 2000, USDA's Economic Research Service estimated that 5,021 certified organic growers operated 1.347 million acres of U. S. farmland in 1997, indicating that the increase in acreage had outpaced the increase in growers, and showing only an 8 percent annual growth rate in growers between 1994 and 1997 ( Greene, 2000b). However, USDA's study indicated that the pace of growth in certified acreage had quickened considerably since 1997, with the amount of certified acreage increasing 38 to 150 percent between 1997 and 1999 by several large certifying organizations across the U. S. And a nonprofit organic research foundation, OFRF, estimates that the number of certified organic producers in the certification organizations that they track the ones that will release data to them grew over 20 percent annually between 1997 and 1999, from 4,638 to 6,600 ( OFRF 2000). Also, one certifier, Washington State, responded to our request for data on the growth rate, indicating that the number of certified organic producers has increased an average of 17 percent per year between 1994 and 1999 in that State and noting that certification became mandatory by State law in 1993. In the March 2000 RIA, USDA estimated that the number of certified U. S. organic producers potentially affected by this legislation is approximately 9,350 in 2000 and will be approximately12,150 in 2002, based on a straight line projection of the 14­ percent annual growth rate trend shown by USDA data for 1991­ 1994. The period, 2000­ 2002, was chosen for analysis because it encompasses both the period of final rulemaking and the 18­ month implementation period. Congress passed the OFPA in 1990, and the 14­ percent growth rate in certified growers 483 during the 1991­ 1994 period reflects their expectation that national organic regulations were forthcoming. Since the recent estimates of industry growth during the 1990' s are uneven and the actual growth rate in the number of growers who will become certified after this legislation is implemented is uncertain, the March 2000 estimates are retained in this assessment of the final rule. The March 2000 RIA also estimated the number of producers who are practicing organic agriculture but who are currently uncertified that would be affected by the rule. In California, where organic growers are required to register with the State but not to be certified, a large proportion of growers are uncertified. The most recent State data, for the 1997/ 98 crop year, indicate that 1,526 growers registered as organic, but only 41 percent of them obtained thirdparty certification ( Klonsky et al., 2000). While only a small percentage of growers in the lowest organic sales category ( 0­$ 10,000), where the largest number of growers were clustered, obtained certification, three­ quarters or more of the growers earning at least $ 50,000 obtained certification, and all of the growers in the highest sales class were certified. USDA did not use the California ratios of certified to uncertified growers in the March 2000 RIA to estimate the number of uncertified growers because the farming structure of California may not be representative of the Nation. For example, California sells at least three times more specialty crops that any other State in the United States and has an unusual registration program that many growers use instead of certification. USDA made two assumptions about uncertified production for the March 2000 estimate. The first assumption was that the rate of growth in uncertified production is less than the rate for certified farms because certification has value and organic producers would be expected to take 484 advantage of the marketing advantages of certification. This assumption is consistent with California data that showed an increase in the percent of organic farmers obtaining certification between 1996/ 97 and 1997/ 98 in virtually every sales class ( Klonsky et al. 2000). Second, the emergence of State certification programs with lower certification fees than private certification entities may have encouraged more organic producers to be certified. Based on these assumptions, USDA assumed that the number of uncertified organic producers is about 4,300 in 2000 and will be about 5,000 in 2002, making the total number of farms potentially affected by the rule about 13,650 in 2000 and 17,150 in 2002. Organic Handlers Little information exists on the number of organic product handlers, such as organic soup manufacturers, organic food packaging operations, organic food wholesalers, and feed millers. USDA has estimated that there were 600 entities in this category in 1994 ( Dunn 1995b). AMS estimated that the growth rate was 11 percent from 1990 through 1994 ( Dunn 1995b). More recent data from CDFA registration records suggest a growth rate of about 28 percent ( California Department of Health Services 1999). For projection purposes, we use a growth rate of 20 percent and estimate there are about 1,600 in 2000 and there will be about 2,250 handlers in 2002. Reasons for growth include the general increase in organic production and growth in the market for processed organic foods, including multiingredient products. Again, these projections are based on limited data from the early 1990' s, and growth may have slowed or increased. These estimates of organic product handlers are slightly higher that the estimates made in the March 2000 RIA because they include about 100 feed millers that were not included in the earlier calculation. 485 Retail Food Establishments Retailers of organic food are grocery stores, bakeries and other establishments that process or prepare raw and ready­ to­ eat food. Most are not currently subject to either voluntary practices or mandatory standards of the organic industry. Although they are excluded from the certification requirements under the final rule, they are subject to other processing, handling, and other production related requirements of the final rule. Some of the grocery stores in the United States, particularly the natural foods stores, sell processed or prepared organic foods and will be affected by the these requirements. USDA does not have an estimate of the number of entities affected. Foreign Entities In addition to domestic certifying agents, foreign certifying agents may also apply for accreditation under the NOP. At this time, we have no information regarding the number of foreign certifying agents that may seek USDA accreditation. Foreign applicants will face the same base costs for accreditation as domestic applicants but the overall levels of cost are expected to be higher due to the generally higher costs of foreign travel and per diem expenses for site evaluation and miscellaneous costs such as for translation of documents. For purposes of estimating the paperwork burden described elsewhere, we assume 10 foreign certifying agents will seek and obtain accreditation during the first 3 years of the program. Benefits of the Final Rule The benefits of implementing national uniform standards of production and certification include: ( 1) providing a common set of definitions on organic attributes and standardizing the manner in which the product information is presented, which may reduce the cost associated with 486 enforcement actions in consumer fraud cases; ( 2) reduced administrative costs; and ( 3) improved access to organic markets. Not all benefits that may arise from the rule are quantifiable. Where economic data are available, they may relate to costs and are generally not adequate to quantify economic benefits. The regulatory changes in the final rule are not expected to reduce the benefits from those described under the March 2000 proposed rule. Information Potential benefits to consumers as a result of the final rule include providing a common set of definitions on organic attributes and standardizing the manner in which the product information is presented. This standardization may reduce the cost associated with enforcement actions in consumer fraud cases. Organic products cannot be distinguished from conventionally produced products by sight inspection, and consumers rely on verification methods such as certification to ensure that organic claims are true. Self­ policing by certifiers of growers and handlers that are certified has been difficult because some certifiers have been under pressure to use weak standards and lax enforcement procedures in order to keep their producer and processor clients from taking their business to other certifiers ( Scowcroft 1998). Anecdotal evidence suggests that consumer fraud involving organic food does occur, and several States successfully pursued civil and criminal prosecution of these cases during the 1990' s. The Attorney General of Minnesota successfully prosecuted felony charges in 1997 against the president of Glacial Ridge Foods, a wholesale supplier of beans and grains, for repackaging conventionally produced product and selling approximately $ 700,000 worth labeled as certified organic ( Mergentime 1997). The San Diego City Attorney's office successfully prosecuted felony 487 charges against Petrou Foods, Inc., an organic oil and vinegar distributor, for misbranding conventional product, based on an investigation by the California Department of Health Services ( Scott 1997). Also the California Department of Food and Agriculture conducted spot checks of 51 uncertified organic growers during the mid­ 1990' s, based on complaints, and found 32 violations of California's organic standards ( Farmers Market Outlook). However, only about half of the States have any organic legislation, and few of those States have laws with enough teeth to permit prosecution of organic fraud. In States without similar laws, the costs associated with remedies via the tort system may be high. The NOP established in this final rule is expected to fill in important State and regional gaps in enforcement in organic fraud cases. The USDA organic seal will also provide consumers a quick tool to verify that goods offered for sale as organic are in fact organic. Reduced Administrative Costs The rule addresses the problem of existing certifying agents using different standards and not granting reciprocity to other certifying agents. By accrediting certifying agents, the rule establishes the requirements and enforcement mechanisms that would reduce inconsistent certification services and lack of reciprocity between certifying agents. In the current system, the certifying agent of a final product is not required to recognize the certification of an intermediate product. Both primary farmers and food handlers may face a risk of being unable to sell a certified organic product when more than one certifying agent is involved. By imposing a uniform standard of certification and production, the costs associated with establishing reciprocity between certifying agents will be eliminated, and the market dampening effects that these costs impose will be eliminated. Industry­ wide training costs may also decrease. USDA's uniform 488 standards of production and certification should enable organic inspectors to move more easily from one certifying agent to another than under the current system. Domestic and International Markets The final rule is expected to improve access to domestic and foreign markets for organically produced goods. The current patchwork of differing State certification requirements and variable State and private standards has given producers and handlers uneven access to the domestic organic market and to the price premiums associated with this market. Livestock producers, in particular, may have limited their organic production because they lacked access to a State or private organic livestock certification program or were uncertain about the standards that would be implemented under the NOP. The final rule could also improve access to EU and other foreign markets for U. S. organic products. For example, the EU may determine that the NOP is acceptable vis­ a­ vis EU regulation 2092/ 91. Article 11 of EU Reg. 2092/ 91 establishes the conditions under which organic products may be imported from third countries and addresses the framework for equivalency. The NOP is a national program that should be acceptable to the EU and other governments. Foreign acceptance of the U. S. national standard would reduce costs of negotiating and documenting shipment by shipment. Reducing these transaction costs may reduce entry costs for U. S. producers to foreign organic markets. These benefits would not accrue until after negotiations for an equivalency agreement have been held and completed successfully, which could be a lengthy process. An estimated 5 percent of total U. S. sales are from exports. Currently, despite restricted access to the European market, the United States is the most important non­ EU supplier of 489 organic products to EU countries ( Foreign Agriculture Service ( FAS), 1995). Import authorizations have been granted for a number of raw and processed commodities, including sunflowers, buckwheat, beans, sugar, and apples. Demand is strong throughout the European market, and the organic market share was 1­ 2 percent of total food sales in 1997 ( Collins 1999). Medium­ term growth rate forecasts range from 5­ 10 percent for Germany to 30­ 40 percent for Denmark, and is 20­ 30 percent in most of the EU countries, according to the International Trade Centre UNCTAD/ WTO. However, most analysts are basing their projected future growth rates on straight­ line extrapolations of current sales and growth rates without understanding the underlying market mechanisms and price elasticities ( Lohr 1998). Costs of the Final Rule The costs of the regulation are the direct costs of complying with the specific standards. It is important to note that while some costs associated with accreditation and certification are quantified, costs stemming from other provisions of the final regulations are not. In addition, this is a short­ run analysis. The analysis examines the costs that may be incurred through 2002. It is not possible at this time to conduct a longer run analysis because we do not know enough about the fundamental supply and demand relationships to make economically sound long­ run projections. Accreditation Costs USDA has identified 36 private certifying agents and 13 State programs providing certification in the United States. These 49 entities are considered likely applicants during the first 18 months during which USDA will not charge application fees or hourly fees for accreditation. An unknown number of new entrants to the certifying business may also apply. 490 However, over the last 10 years, the number of certifying agents does not appear to have grown significantly, with the net effect of entries and exits maintaining a population of certifying agents at about 40­ 50. The final rule allows USDA to collect fees from certifying agents for USDA accreditation. The first proposal would have permitted USDA to collect fees from producers and handlers as well, but USDA decided that it would be administratively simpler to collect fees only from certifiers and would enable State programs that want to keep client costs low to be able to do so. Applicants for accreditation will be required to submit a nonrefundable fee of $ 500 at the time of application, which will be applied to the applicant's fees for service account. This means that the $ 500 fee paid at the time of application is credited against any subsequent costs of accreditation arising from the initial review and the site evaluation. The $ 500 fee is the direct cost to applicants who are denied accreditation based on the initial review of the information submitted with their application. Charges for the site evaluation visit will cover travel costs from the duty station of USDA employees, per diem expenses for USDA employees performing the site evaluation, an hourly charge ( per each employee) for services during normal working hours ( higher hourly rates will be charged for overtime and for work on holidays), and other costs associated with providing service to the applicant or certifying agent. At present, the base per diem for places in the United States is $ 85 ($ 55 for lodging and $ 30 for meals and incidental expenses). Per diem rates are higher than $ 85 in most large cities and urbanized places, but over half of the current U. S. certifiers are located in places that have an $ 85 per diem rate, and that is the rate used to calculate average certifier expenses in table 3. A review of domestic travel by USDA staff during fiscal year 1999 indicates transportation costs 491 ranging from $ 500 to $ 600 per person. Miscellaneous costs are estimated to add another $ 50 to each site visit. The hourly rate that USDA anticipates charging for accreditation is the rate that USDA currently charges for services under the Quality Systems Certification Program ( QSCP). Our preliminary estimate that this rate will be no more than $ 95 per hour is presented to give the public some indication of the rate that will be charged following the 18­ month transition period. QSCP is an audit­ based program administered by AMS, which provides meat producers, handlers ( packers and processors), and other businesses in the livestock and meat trade with the opportunity to have special processes or documented quality management systems verified. The procedures for accreditation evaluation are similar to those used to certify other types of product or system certification programs under QSCP. Accreditation will include verification of adherence to ISO Guide 65 and the regulations. Although much of the site evaluation for accreditation will involve comparisons against ISO Guide 65, additional hours will be required because USDA will be evaluating additional aspects of the applicant's operation to determine if the applicant is qualified to perform as an accredited agent for the NOP. Based on experience with the QSCP and more limited experience performing audits verifying that certifying agents meet ISO Guide 65, we project that a site evaluation visit for small applicants with a simple business structure will require 3 days of review, and for those large applicants with more complex business structure will require 5 days of review. USDA will use two reviewers for each site evaluation visit during the 18­ month implementation period, as well as for new applicants after that period. One reviewer will come from the QSCP audit staff and will be familiar with the ISO Guide 65 verification; the other 492 reviewer will come from the NOP staff and will be familiar with requirements of the organic program. The two will conduct the site evaluation jointly. Two reviewers will also be needed for the site evaluation visits for the accreditation renewals, which will take place every 5 years. In the proposed rule, USDA had projected that only one reviewer would be needed for site evaluations and renewals that took place after the 18­ month implementation period but has changed that projection based on additional experience with the ISO Guide 65 program. During the 18­ month implementation period, applicants will be charged for travel and per diem costs for two persons and for miscellaneous expenses but will not be charged application fees or hourly fees. The estimated expenditures for these initial accreditations is $ 1,560­$ 2,100, with $ 510­$ 850 for per diem expenses, $ 1,000­$ 1,200 for travel expenses, and $ 50 for miscellaneous expenses ( table 3). The cost of initial site evaluation visits will vary with the cost of travel from the USDA reviewer's duty station to the applicant's place of business. In general, more distant and remote locations will involve higher travel costs. USDA estimates the costs of a site evaluation visit after the transition period may average $ 6,120­$ 9,700, depending on the characteristics of the applicant, including $ 4,500­$ 7,600 for the hourly site evaluation charges that are not billed to the certifier during the first 18 months ( table 3). USDA has received appropriated funds to pay for the hourly site evaluation charges only during the first 18 months of the program. Currently, few private certifying agents are operating with third­ party accreditation. Fetter ( 1999) reports that in a sample of 18 certification programs, four programs were accredited, and one had accreditation pending. All of these were large, private certifying agents. Those certifying agents currently accredited by third parties will likely pay less for USDA 493 accreditation. In its first proposal, USDA stated at FR 62: 65860, " We are aware that certifiers currently may pay in excess of $ 15,000 for accreditation by a private organization." Commenters thought this figure was too high. One commenter, which operates the International Federation of Organic Agriculture Movements ( IFOAM) Accreditation Programme under license to IFOAM, stated, " It is possible that the largest programme operating a chapter system with activities in many countries ( which is included in their IFOAM evaluation) paid this amount in their first year. On the other hand the average cost to a medium sized certifier works out at around $ 3000 to $ 4000 per year." Another commenter stated, " At the present time IFOAM accreditation costs less than $ 10,000/ year for the largest certifier and $ 3­ 5,000 for smaller certifiers." The 18­ month NOP implementation period affects the distribution of program costs between the organic industry and the taxpayer. Some of the costs of accreditation would be absorbed by the NOP operation budget appropriated by Congress. In effect, the taxpayers are subsidizing the organic industry. Without this subsidy, the total cost of accreditation would approach $ 1 million. The direct accreditation costs to an estimated 59 certifying agents ( including all 49 current U. S. certifiers and an estimated 10 foreign certifiers) during the first 18 months following the final rule, are approximately $ 92,000 to $ 124,000. This figure is derived from the per­ firm costs in table 3. In addition, USDA will use appropriated funds to cover approximately $ 270,000­ $ 448,000 in hourly charges for site evaluation. USDA will also use appropriated funds to cover the costs of producing and publishing an accreditation handbook in several languages, translating USDA reports to foreign clients, and developing and funding a peer review panel to evaluate NOP's adherence to its accreditation procedures. And if more than the estimated 59 certifiers 494 apply for accreditation during the first 18 months of the program, USDA will use appropriated funds to cover additional hourly charges for site evaluation. Private certifying agents and State programs that do not mirror the regulation may incur additional costs to change their programs to adopt the national standards. The discussion on the effect of the regulation on existing State programs is in " State Program Costs." The cost associated with changing existing private certifying programs is not quantified. Also, certifying agents who have been operating without third party accreditation will face new costs. For certifying agents who currently obtain third­ party accreditation, the direct costs of USDA accreditation, which are only incurred every 5 years, may be lower on an annual basis compared to the direct costs for third­ party certification of $ 3,000­$ 5,000 per year indicated by the commenters. The direct costs for certifying agents obtaining accreditation during the first 18 months, when USDA will not impose an application fee or hourly charges, will be limited to travel, per diem, and miscellaneous expenses. A national accreditation program may shrink the market for a third­ party accreditation. Certifying agents will have little incentive to maintain or seek a second accreditation by a private organization unless that accreditation sufficiently enhances the market value of the certifying agent's services. Thus, the market will determine whether other accrediting entities continue to have a U. S. market for their services. Training programs are currently offered by the Independent Organic Inspectors Association ( IOIA), an organization of approximately 165 organic certification inspectors, and by some of the larger certifying agents ( IOIA). Costs to existing certifying agents to provide additional training to other staff are difficult to measure in the absence of information on current 495 staff skill levels or the existence of formal training other than inspector training. Some agencies rely on volunteer staff who may have had no formal training, but the extent of this practice is unknown. AMS intends to offer assistance to certifying agents, producers, and handlers by providing accreditation training for certification agents and other printed material that would enable participants to better understand the regulations. In addition, AMS intends to continue open and frequent communication with certifying agents and inspectors to provide as much information as possible to aid them in fulfilling the requirements of the regulations. The OFPA requires that private certifying agents furnish reasonable security for the purpose of protecting the rights of participants in the organic certification program. It is expected that there will be costs to certifying agents from these requirements. Implementation of the final rule will also impose a less tangible cost on some certifiers. Some private certifiers have advertised their program and logo as representing higher standards than other programs. The brand value associated with the logos of these certifiers will be lost when uniform standards are implemented as part of the national program. However, certifiers will still be able to distinguish themselves to clients based on the quality of their services and other characteristics. A key change was made in the final rule, based on comments to the March 2000 proposal, to make the standard used by certifiers to determine maximum allowable pesticide residues ( the level above which a product could not be called organic) consistent with the current industry standard and with NOSB recommendations. In the final rule, the standard will be set at 5 percent of the pesticide residue tolerances calculated by the Environmental Protection Agency ( EPA). This change could conceptually reduce costs, but the magnitude of this reduction is uncertain. 496 Certification Costs Under the final rule, USDA will not impose any direct fees on producers and handlers. Certifying agents will establish a fee schedule for their certification services that will be filed with the Secretary. Certifying agents will provide all persons inquiring about the application process with a copy of their fees. The certifying agent will provide each applicant with an estimate of the total cost of certification and an estimate of the annual costs of updating the certification. Under the proposed rule, certifiers could charge a maximum of $ 250 at the time of application, but under the final rule, certifiers are not limited in the amount of certification fees that they may charge at the time of application. Some States charge minimal fees for certification by subsidizing operating costs from general revenues. The majority of certifying agents structure their fee schedules on a sliding scale based on a measure of size, usually represented by the client's gross sales of organic products but sometimes based on the acres operated ( Fetter 1999 and Graf and Lohr 1999). Some certifying agents charge an hourly rate for inspection and audit services. Graf and Lohr have applied fee schedules provided by ten certifying agents to four hypothetical farms, small, medium, large, and a super farm. Tables 2A and 2B summarizes the fees that Graf and Lohr found by applying schedules of each certifying agent to hypothetical farms. Total first­ year costs and subsequent­ year ( renewal) costs for certification are shown. The average cost for each size class should be interpreted with care because it is not weighted by the number of clients certified. In their study, the Texas Department of Agriculture program is the low­ cost certifying agent for all­ size operations. The high­ cost certifying agent differs across farm sizes. None of these certification programs mentions costs for residue testing, which the 497 NOP will require in the form of preharvest testing when there is reason to believe that agricultural products have come into contact with prohibited substances. Preharvest testing is expected to be infrequent. Some certifying agents currently require soil nutrient testing and water quality testing. The estimated total initial costs for a producer or handler to become certified are presented in table 3. We have not extended the average costs reported in Tables 2A and 2B to aggregate certification costs for all organic farms because the number of organic farms is not known with precision, nor is their geographic location, and there are no data to distribute the population of organic farms across size classes. The data from California suggest that a large number of small farmers produce and market organic goods without third­ party certification, but those data may not be representative of the national trend. Although many of the smallest farms would qualify for the small farm exemption from certification, if consumers accept the labeling practices required by this final rule, small farmers may obtain certification to stay in the organic market, which may involve some cost. In response to comments, the March 2000 proposal was changed to provide that if a conflict of interest is identified within 12 months of certification, the certifying agent must reconsider the application and may reinspect the operation if necessary. Additionally, if a conflict of interest is identified, the certifying agent must refer the operation to a different accredited certifying agent. These provisions would likely increase costs to certifiers; however, the magnitude of this increase is unknown. Production and Handling Costs Producers and handlers currently active in the organic industry may bear costs under the 498 national standards. We believe that while most provisions of the program mirror current industry practices, there are some differences. In addition to the cost associated with becoming familiar with the national program, any adjustments stemming from these differences will result in costs. These costs were qualitatively discussed in the March 2000 RIA for major provisions of the rule and are described below. The March 2000 proposal adhered closely to recommendations from the NOSB and largely reflected current industry standards. Marginal changes have been made in the final rule in response to comments on the March 2000 proposal. These changes have been made in concert with NOSB recommendations and, in general, have been made to clarify or add flexibility to producer and handler provisions or to make them better reflect current industry standards. Producers Producers of organic food will face numerous provisions that will regulate their production methods. As indicated in the Baseline section, many of the requirements are currently followed by certified organic farmers. Farming operations that are not certified but are registered with a State government, such as California, receive copies of the State laws to which they must comply. The costs associated with adjusting to provisions in the final rule may be minimal for certified and State­ registered growers but may be more substantial for noncertified organic producers that do not follow a specific set of guidelines or regulations. Some organic producers are neither certified nor registered and, therefore, may not practice the requirements in the final rule. Major provisions of the final rule the withdrawal period required for land to be free of prohibited substances, National List, animal drug use, and residue tests are discussed to illustrate costs; other provisions may also impose additional costs. 499 A 3­ year withdrawal period, during which prohibited materials cannot be applied to a field to be certified as organic, is currently required by most private and State organic standards, and the final rule also specifies a 3­ year period. The effect of this provision on the currently certified organic farming operations may be minimal, but the effect on farming operations that are neither certified nor registered may be significant. Farming operations that have completed a 3­ year withdrawal period will not be affected by this requirement. To stay in the organic industry, those who have not completed the 3­ year period must comply with this requirement. They may incur the cost of organic production for a significant length of time, yet not be allowed to sell their products as organic. Hence, some small organic operations may exit the industry. The impact of the National List, which lists allowed synthetic substances and prohibited nonsynthetic substances that may or may not be used in organic production and handling operations, will be determined by how the national standards differ from current certification standards and from actual practice. Lists of approved synthetic materials, including soil amendments and pesticides, vary from one certification program to another, but a detailed analysis of specific differences in the various existing materials lists shows them to be overlapping in most cases with each other and with the National List. The degree of overlap should mitigate the costs for certified operations, but farming operations, particularly those that aren't certified, may need to make some adjustments to comply with the list. These adjustments will impose costs on these operations. The magnitude of the costs resulting from these adjustments is not quantified. Where livestock standards have been adopted by existing State programs and by private certifying agents, most prohibit the use of animal drugs except for the treatment of a specific disease condition, and use of animal drugs is generally prohibited within 90 days prior to the sale 500 of milk or eggs as organic. Some State and private certifiers allow the use of animal drugs in animals for slaughter under certain conditions, while others prohibit the use of animal drugs. The standards in the final rule would prohibit the sale as organic of edible products derived from an animal treated with antibiotics or other unapproved substances. The standards may not differ from existing State or private standards in prohibiting the use of drugs on healthy animals. However, the effect of this provision may differ among certified and registered organic farms. The effect on the certified farming operations is unknown. We assume that this provision may have costs, but the magnitude of these costs is not quantified. Additional costs may be imposed by several further changes to the March 2000 proposal. These changes involve the use of treated lumber, confinement requirements, and the commercial availability of ingredients in products labeled " organic." The replacement of lumber treated with prohibited substances that comes into contact with soil, crops, or livestock under organic management with treated lumber is now specifically prohibited in organic systems. Since the use of lumber treated with prohibited substances for the purpose of preventing degradation is not a common practice in livestock production, this prohibition is not expected to increase producer costs substantially. The exact magnitude of any increase is uncertain and mainly dependent upon the number of producers seeking organic certification that currently use treated lumber in their operations and are planning to replace that lumber. The confinement provisions in the March 2000 proposal have been slightly modified. Access to the outdoors is now an explicitly required element for all organically raised livestock. We expect this change to have a minor impact on overall producer costs, since we assume most 501 producers raising organic livestock already provide access to the outdoors. Additionally, the term, " pasture," has been defined to emphasize that livestock producers must manage their land to provide nutritional benefit to grazing animals while maintaining or improving soil, water, and vegetative resources of the operation. To the extent producers desiring to raise organic livestock do not currently manage pasture in this manner, we expect livestock production costs to increase. The organic plan now requires using organically produced minor agricultural ingredients unless not commercially available. This applies to the previously allowed 5­ percent nonorganic agricultural and other ingredients in products labeled " organic." Handlers of organically produced minor ingredients, especially herbs and spices, are likely to benefit from this market incentive, while producers of nonorganic minor ingredients will likely be adversely affected. Producers will also realize a burden associated with providing the documentation of commercial availability for ingredients in the 5­ percent component. Since the criteria to determine commercial availability will be developed after additional comments and information are considered, the magnitude of the cost and benefit implications from this standard are currently unquantifiable but will likely be largely dependent upon the stringency of the developed criteria. Producers will also have administrative costs for reporting and recordkeeping, although producers who currently are active in the organic industry already perform most of these administrative functions, and additional costs to them would depend upon the extent to which their current practices are different from the requirements of the final rule. The annual reporting and recordkeeping burden on producers is estimated at 24 hours for certified producers and 1 hour of recordkeeping for small producers who choose to operate as exempt entities and is valued at $ 23 per hour. 502 Other provisions of the final rule, such as those on residue testing, livestock housing and feed, and health care practices, may vary enough from those followed by some growers that they may impose costs due to the variability in current housing, feed, and health care practices, but lacking information, we have not quantified these costs. There were also several key changes made in the final rule, based on comments to the March 2000 proposal, that will add flexibility to producer standards. A specific type of production facility was required for composting manure in the proposal, and this provision has been modified to ensure that manure is adequately composted while allowing variation in the type of facility that is used. Also, the transition period of a dairy operation to make a whole­ herd conversion to organic production has been reduced in order to make conversion affordable for a wider range of dairy farms, including smaller operations. Finally, the requirement that slaughter stock sold, labeled, or represented as organic be under continuous organic management from birth was changed to require continuous organic management from the last third of gestation. This change is also expected to provide possible cost savings and added flexibility for producers. Handlers Handlers of organic food are defined and regulated differently across different certifying agents and States. Due to this variability, handlers may incur some cost associated with complying with the requirements of the regulation. Several key changes were made in the final rule, based on comments to the March 2000 proposal, to make handler standards more consistent with current industry standards. The proposal prohibited the addition of sulfites to wine as required by OFPA. The statute has been changed since March, and the final rule will permit added sulfites in wine labeled " made with organic grapes," consistent with industry standards and 503 NOSB recommendations. Also, the March proposal required products labeled " made with organic ingredients" to have ingredients that were at least 50 percent organic, and this threshold has been raised to 70 percent in the final rule. Some certifiers set their thresholds at 50 percent, others at 70 percent, while others restrict labeling to individual ingredients only. The international industry standard outside the United States is set at 70 percent. The threshold is set at 70 percent in the final rule inresponese to comments received on the proposal and to be consistent with international standards, which will help ease export of U. S. organic product into those markets. Alternatively, to the extent handlers do not currently meet the 70­ percent threshold to label products " made with organic ingredients," handlers may incur additional costs to reach the threshold or exit the industry. The magnitude of those effects is unknown. In addition to the labeling requirement, a handler's current use of nonsynthetic and synthetic substances may change in response to the final rule. The March 2000 proposal provided for the use of any prohibited substance to prevent or control pests. This provision has been changed to first limit the use of nonsynthetic and synthetic substances to substances which are on the National List before allowing the use of any synthetic substance. To the extent to which handlers are now required to consider substances on the National List before using a prohibited substance and these substances on the National List are priced differently from the substance otherwise used, handlers may incur a change in production costs. This requirement may increase costs on handlers, but the magnitude of this increase is unknown. In addition, the commercial availability requirement in the final rule, described in the producer costs section, may also create a burden on handlers to consistently apply the standard. 504 To the extent to which sourcing organically produced ingredients in excess of 95 percent of the finished product is more expensive than sourcing nonorganically produced ingredients, handlers seeking the " organic" label for their products will incur additional costs. As previously described, the magnitude of the cost implications from this standard is currently unquantifiable but will likely be largely dependent upon the stringency of the standard that is developed. Handlers will also have administrative costs for reporting and recordkeeping, although handlers who currently are active in the organic industry already perform most of these administrative functions, and additional costs to them would depend upon the extent to which their current practices are different from the requirements of the final rule. The annual reporting and recordkeeping burden on handlers is estimated at 63 hours for certified handlers and 1 hour of recordkeeping for small handlers who choose to operate as exempt entities and is valued at $ 23 per hour. Retail Food Establishments Most retailers are not currently subject to either voluntary practices or mandatory standards of the organic industry. Retailers that have organic processing operations, such as organic food delis and bakeries, are not required to be certified in the final rule. However, retailers will be subject to requirements such as prevention of contamination of organic products with prohibited substances, and commingling organic with nonorganic products. Obtaining certification and complying with these provisions will incur some cost. Labeling Costs Certified handlers will have to comply with requirements regarding the approved use of labels. In addition, any producers, handlers, and retailers who are not currently certified but who 505 package organic products are also subject to the labeling requirements. The estimated annual cost for handlers to determine the composition of 20 products to be reported on labels is $ 1,647,000. This figure is based on an average of 1 hour per product per handler and an hourly cost of $ 27. Similarly, certified handlers will have to design their labels to comply with the regulation. This is expected to take 1 hour per label at $ 27 per hour for a compliance cost of $ 1,647,000. Total label costs for handlers are $ 3.3 million. Any changes to existing labels and new labels that need to conform to the regulation will incur a cost. The costs associated with these activities are not quantified. Hence, the lower bound on the labeling cost is approximately $ 4 million. State Program Costs The national program may impose additional costs on States by requiring changes in their existing programs. The rule encompasses most of the principles of existing State programs. However, there are also departures. Where State standards are below Federal standards or where elements of the Federal standards are missing from a State program, these States would be required to make changes in their programs that they might otherwise not make. Where State programs have standards in addition to the Federal standards and they are not approved by the Secretary, States also would be required to make changes in their programs. States without organic standards or whose current standards either would conform to those of the national program or would be approved by the Secretary would not incur additional costs resulting from required changes. Currently, USDA cannot predict which States may be required to adjust their existing programs. States that conduct certification activities will be charged for accreditation, something none of them pay for now. The cost associated with this provision is discussed in the 506 Accreditation section. Enforcement costs Enforcement costs will fall upon USDA's NOP, States operating State organic programs, and on State and private certifying agents. Certifying agents will review clients' operations and will notify clients of deficiencies. Certifying agents can initiate suspension or revocation of certification. Certifying agents will be aware of these overhead costs, and we assume that they will establish fee schedules that will cover these costs. Actual costs to certifying agents for enforcement activities will depend on the number of clients, how well informed clients are of their obligations, and client conduct. State certifying agents will face the same obligations and types of costs as private certifying agents. In States operating State organic programs ( SOP), State enforcement costs are costs associated with ensuring that certified operations fulfill their obligations. These States will bear the costs of investigating complaints, monitoring use of the State organic seal and organic labeling, and taking corrective action when needed. These States will bear costs related to reviewing an applicant's or certified operation's appeal and for administrative proceedings. Many of these activities are already a routine part of the certification program in States that have programs, and USDA will fill in gaps in enforcement in States that choose not to have programs. USDA's enforcement costs are costs associated with ensuring that certifying agents fulfill their obligations. In States without an organic program, USDA will bear the costs of investigating complaints, monitoring use of the USDA organic seal and organic labeling, and taking corrective action when needed. USDA will bear costs related to reviewing an applicant's or certified or accredited operation's appeal and for administrative proceedings. USDA expects 507 to effectively carry out its enforcement responsibilities using funds that are already allocated for operating the NOP. To the extent to which we did not estimate the likely noncompliance rate, the cost associated with enforcement remains unknown. Reporting and Recordkeeping Costs The Paperwork Reduction Act of 1995 requires an estimate of the annual reporting and recordkeeping burden of the NOP. The estimated annual reporting and recordkeeping burden reported is approximately $ 13 million. This figure should be understood within the context of the requirements of the Paperwork Reduction Act. The Paperwork Reduction Act requires the estimation of the amount of time necessary for participants to comply with the regulation in addition to the burden they currently have. Information gathered by AMS in auditing activities in conjunction with ISO Guide 65 verifications leads us to believe that the paperwork burden on current certifying agents and certified operators will be 10 to 15 percent greater than their current business practices as a result of this final rule. Certifying Agents. The regulation will impose administrative costs on certifying agents for reporting and recordkeeping. The actual amount of the additional administrative costs that would be imposed by the rule is expected to be different for those entities that would begin their activities only after the national program is implemented. Certifying agents that currently are active in the organic industry already perform most of these administrative functions; therefore, the additional costs to them would depend upon the extent to which their current practices are different from the requirements of the regulation. An estimate of the cost of compliance is the annual reporting and recordkeeping burden documented in the Paperwork Reduction Act of 1995 analysis. Table 4 shows the estimated annual costs for certifying agents. Certifying agencies each 508 have an estimated burden of 1,068 hours valued at roughly $ 27,729. The following list describes several of the most significant administrative requirements or optional submissions and the probable resources required for compliance. Details on the reporting and recordkeeping burdens estimated for each item are in the paperwork analysis. 1. A list of farmers, wild­ crop harvesters, and handlers currently certified. This information can be compiled from existing records. After implementation, certifying agents will be required to submit on a quarterly basis a list of operations certified during that quarter. 2. A copy of procedures used for certification decisions, complying with recordkeeping requirements, maintaining confidentiality of client's business­ related information, preventing conflicts of interest, sampling and residue testing, training and supervising personnel, and public disclosure of prescribed information concerning operations they have certified and laboratory analyses. These policies may have to be created or modified to conform to the regulation. 3. Documentation on the qualifications of all personnel used in the certification operation, annual performance appraisals for each inspector and personnel involved in the certification, and an annual internal program evaluation. Existing certifying agents may already perform these operations. New certifying agents will have to establish procedures to achieve these things. 4. Documentation on the financial capacity and compliance with other administrative requirements ( e. g., fee structure, reasonable security to protect the rights of the certifying agent's clients as provided in the NOP, and business relationships showing absence of conflicts of interest). Some of this information can be compiled from existing records, e. g., fee schedules, and some may be generated from other sources. 5. Copies must be submitted to USDA of all notices that are issued on certification denial, 509 noncompliance, and suspension or revocation of certification. This requirement will be fulfilled simultaneously with sending notices to applicants or clients. 6. An annual report to the Administrator including an update of previously submitted business information, information supporting any requested changes in the areas of accreditation, and steps taken to respond to previously identified concerns of the Administrator regarding the certifying agent's suitability for continued accreditation. The annual report requirement will draw on records created in the normal course of business. 7. Retention of records created by the certifying agent regarding applicants and certified operations for not less than 10 years, retention of records obtained from applicants and certified operations for not less than 5 years, and retention of other records created or received for USDA accreditation for not less than 5 years. This activity requires records, database management capabilities, and resources ( storage space, file cabinets, electronic storage, etc.). In an informal inquiry, AMS found that most existing certifying agents currently retain records for at least 10 years and use both electronic and paper storage. We believe that this requirement will not pose an additional burden on existing certifying agents. 8. Public access to certification records, such as a list of certified farmers and handlers, their dates of certification, products produced, and the results of pesticide residue tests. This requirement will have minimal impact given the requirements for retaining records. 9. Providing program information to certification applicants. To comply with this requirement, certifying agents may need to modify existing standards and practices. The criteria for qualified personnel in the rule may likely result in an increase in labor costs for some existing certifying agents and, initially, an increase in training costs. The amount of additional costs to 510 these certifying agents would depend on the level of expertise among current certification agency staff, the extent to which certifying agents currently rely on volunteers, and the current costs of training certification staff. Producers and Handlers. The regulation will impose administrative costs on producers and handlers for reporting and recordkeeping. The actual amount of the additional administrative costs that would be imposed by the final rule is expected to be different for those entities that would begin their activities only after the national program is implemented. Producers and handlers who currently are active in the organic industry already perform most of these administrative functions; therefore, the additional costs to them would depend upon the extent to which their current practices are different from the requirements of the final regulation. An estimate of the cost of compliance is the annual reporting and recordkeeping burden documented in the Paperwork Reduction Act of 1995 analysis. The following list describes several administrative requirements or optional submissions and the probable resources required for compliance. 1. Establish, implement, and update annually an organic production or handling plan. Organic plans are a standard feature in the organic industry and are required by certifying agents. Thus, producers and handlers who are already involved in organics can rely on their current plan with revisions as needed to meet elements of the national program which are new to them or differ from their current practice. Although producers and handlers are generally aware of the goals of organic plans, current practice may fall short of the rigor that will be required by the national program. New producers and handlers will have higher costs because they will have to prepare a plan from scratch. 511 2. Maintain records pertaining to their organic operation for at least 5 years and allow authorized representatives of the Secretary, the applicable State organic program's governing State official, and the certifying agent access to records. Existing organic producers and handlers maintain records. New producers and handlers will have to develop records systems. Access is expected to be infrequent, will require little time of the certified entity, and will not require buildings or equipment other than what is required for storing records. 3. Notify the certifying agent as required ( e. g., when drift of a prohibited substance may have occurred) and complete a statement of compliance with the provisions of the NOP. Notifications are expected to be infrequent. The total reporting burden includes creation and submission of documents. It covers the greatest amount of reporting burden that might occur for any single creation or submission of a document during any one of the first 3 years following program implementation; i. e., 2000, 2001, and 2002. The total estimated reporting burden reflects the average burden for each reporting activity that might occur in 1 year of this 3­ year period. The total recordkeeping burden is the amount of time needed to store and maintain records. For the purpose of measuring the recordkeeping burden, the year 2002 is used as the reporting year for which the largest number of records might be stored and maintained. The annual reporting and recordkeeping burden on producers, handlers, and certifying agents is summarized in table 4. The annual burden on certified producers is estimated at 24 hours and $ 552. Certified handlers have an estimated burden of 63 hours valued at $ 1,449. The burden on small producers and handlers who choose to operate as exempt entities is minimal, 1 hour of recordkeeping valued at $ 23. If this cost is applied to the total estimated number of 512 affected producers, the reporting and recordkeeping cost would be $ 5,260,100 in 2000 and $ 6,835,554 in 2002. By applying this cost figure to the estimated total number of affected handlers, the reporting and recordkeeping cost would be $ 2,143,002 in 2000 and $ 3,013,552 in 2002. Barriers to Entry ­ Importers of Organic Products Currently, there are no Federal restrictions on importing organic products to the United States in addition to those regulations applying to conventional products. If the imposition of the NOP decreases the importation of organic food into the United States, then this regulatory action may result in some cost. Small Business Ramifications USDA's final rule has an 18­ month period during which applicants for accreditation would not be billed for hourly services. The rationale for this transition period is to reduce the costs to certifying agents and, thus, increase the prospect that certifying agents, producers, and handlers will be able to afford to participate in the national program. The choice of 18 months is intended to provide sufficient time for parties desiring accreditation to submit their application and prepare for a site evaluation. USDA will operate the program partially with appropriated funds, in effect sharing the cost of the program between taxpayers and the organic industry, to respond to public concerns regarding the effects of the regulation on small businesses. Thousands of comments were received opposing the first proposal's fee provisions with most focusing on the substantial impact on small certifying agents. Congress has expressed public policy concern with the impacts of regulations on small 513 entities generally and with the impacts on the NOP regulations on small entities particularly. The Small Business Regulatory Enforcement Fairness Act of 1996 and the Regulatory Flexibility Act express Congressional concern regarding regulatory burden on small businesses. The Report from the Committee on Appropriations regarding the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2000, includes the following language ( U. S. Senate 1999): " The Committee continues to recognize the importance of organic markets for small farmers and fishermen. The Committee expects the Secretary to construct a national organic program that takes into consideration the needs of small farmers and fishermen. ... Furthermore, the Committee expects that of the funding available for the National Organic Program, necessary funds should be used to offset the initial costs of accreditation services, a subsidy necessary due to the lack of expertise in the Department of Agriculture in the areas of organic accreditation and insufficient data on the industry." Certifying agents applying for accreditation during the first 18 months following the final regulation will face lower direct costs than subsequent applicants. The cost for later applicants for accreditation will be higher because they will have to pay a $ 500 application fee and hourly charges for completing their site evaluation. The requirement for accreditation was established in the OFPA in 1990 and the accreditation program was part of the 1997 proposal. Because in this final rule, USDA is using appropriated funds to cover some of the costs of initial accreditation during the first 18 months of the program, certifying agents may set lower fees initially benefiting the producers and handlers who are certified during this period. It is important to note that many small organic operations may not be certified currently. 514 In California, for example, many small farms are registered but not certified. Even if certifying agents pass on the cost savings of the 18­ month period provision to applicants for certification, the cost of certification may be higher than the cost of registration. Hence, becoming a certified operation for small organic producers and handlers may be more costly than the current practices. The costs imposed on small operations may be mitigated by a $ 5000 certification exemption to aid the smallest organic operations. However, these operations are still subject to other requirements of the regulation. To the extent that these requirements differ from their current practices, complying with the national standards may be costly for exempt operations. In addition, the certification exemption allowed under the regulation includes limits on what an exempt operation may do. Without the certification, small organic operations may not display the USDA seal and may not use a certifying agent's seal. If the consumers of organic food view the seals as important information tools on organic food; that is, if consumers of organic products insist on only certified organic products, the inability of small operations to display these seals may prevent them from realizing the price premiums associated with certified organic products. Industry Composition The imposition of the national standards may change the composition of the organic industry. Even with the small business exemptions, some small organic operations may choose to exit the industry, and small organic operations may also be discouraged from entering the industry, resulting in a higher concentration of larger firms. On the other hand, it may be easier for small operations to comply with certain NOP standards, such as the livestock standards that prohibit confinement production systems and require 100 percent organic feed. And State and 515 Federal certification and conservation cost­ share programs and other government programs may help lower the impact on small producers. References Byng, John. 1994. UK and European Community ( EC) Legislation. In Handbook of Organic Food Processing and Production. Simon Wright ( ed.). pp. 17­ 30. Glasgow: Blackie Academic and Professional. California Department of Health Services ( DHS). 1999. Report on the Registration of California Organic Processed Food Firms. Sacramento: State of California. September 1999. Figures obtained via personal communication with DHS. California Department of Health Services. 1995. Report on the Registration of California Organic Processed Food Firms. Sacramento: State of California. Collins, Shane. 1999. " Rosy future forecast for Europe's organic market," Eurofruit Magazine, September. Dunn, Julie Anton. 1995a. Organic Food and Fiber: An Analysis of 1994 Certified Production in the United States. U. S. Department of Agriculture, Agricultural Marketing Service. Dunn, Julie Anton. 1995b. " Organic Foods Find Opportunity in Natural Foods Industry," Food Review, Vol. 18, Issue 3, Sep.­ Dec. Dunn, Julie Anton. 1997. AgriSystems International Reports Certified Organic production in the United States: Half a Decade of Growth. AgriSystems International: Wind Gap, PA. Emerich, Monica. 1996. Industry Growth: 22.6%. Natural Foods Merchandiser ( June): 1­ 39. Farmers Market Outlook. 1996. " Waiting for Organic Inspections," September­ October issue. Farmers Market Outlook. Various issues. www. seasonalchef. com/ orgnews1. htm. 516 Fetter, Robert T. 1999. Economic Impacts of Alternative Scenarios of Organic Products Regulation. Senior Honors Thesis. University of Massachusetts, Amherst, MA. Fuchshofen, Winfried and Silke Fuchshofen. 2000. " Export Study for U. S. Organic Products into Asia and Europe," Draft Report, Organic Insights, Inc. Graf, Anita and Luanne Lohr. 1999. " Analysis of certification program costs," Working Paper, Fund for Rural America project, Market Development for Organic Agriculture Products, Grant No. 97­ 36200­ 5. Greene, Catherine. 2000a. " U. S. Organic Farming," USDA, Economic Research Service Issues Center, www. ers. usda. gov. Greene, Catherine. 2000b. " U. S. Organic Agriculture Gaining Ground," Economic Research Service, U. S. Department of Agriculture, Agricultural Outlook, AGO­ 270, April. Hammitt, James K. 1990. Risk Perceptions and Food Choice: An Exploratory Analysis of Organic ­ Versus Conventional­ Produce Buyers. Risk Analysis, Vol. 10, No. 3: 367­ 374. Hammitt, James K. 1993. Consumer Willingness to Pay to Avoid Pesticide Residues. Statistica Sinica, 3. Independent Organic Inspectors Association. 1996. IOIA 1996 Membership Directory. Winona, MN. International Trade Centre UNCTAD/ WTO. 1999. Organic Food and beverages: World Supply and Major European Markets. Geneva: ITC, xiv, 271 p. Jolly, Desmond A., Howard G. Schutz, Katherine V. Diaz­ Knauf, and Jagjeet Johal. 1989. Organic Foods: Consumer Attitudes and Use. Food Technology ( November): 60­ 66. Jolly, Desmond A. 1991. Differences Between Buyers and Nonbuyers of Organic Produce and 517 Willingness to Pay Organic Price Premiums. Journal of Agribusiness ( Spring): 97­ 111. Kaufman, Phil. 1998. " Natural Foods Supermarkets Gaining in Popularity," Economic Research Service, U. S. Department of Agriculture, FoodReview, Volume 21, Issue 3, September­ December. Klonsky, Karen and Laura Tourte. 1995. Statistical Review of California's Organic Agriculture, 1992­ 93. Report prepared for the California Department of Food and Agriculture Organic Program. Cooperative Extension, Department of Agricultural Economics, University of California, Davis. Klonsky, Karen and Laura Tourte. 1998a. Statistical Review of California's Organic Agriculture, 1992­ 95. Report prepared for the California Department of Food and Agriculture Organic Program. Cooperative Extension, Department of Agricultural Economics, University of California, Davis. Klonsky, Karen and Laura Tourte. 1998b. Organic Agricultural Production in the United States: Debates and Directions. Amer. J. Agr. Econ. Vol. 80, No. 5: 1119­ 1124. Klonsky, Karen, Laura Tourte, Robin Kozloff, and Benjamin Shouse. 2000. Statistical Review of California Organic Agriculture, 1995­ 98, forthcoming. Lohr, Luanne. 1998. Implications of Organic Certification for Market Structure and Trade. Amer. J. Agr. Econ. Vol. 80, No. 5: 1125­ 1129. Mergentime, Ken. 1997. " Organic Fraud Case Deepens; Possible Link Causes OCIA Turmoil," the Natural Foods Merchandiser, March. Mergentime, Ken and Monica Emerich. 1995. Organic Sales Jump Over $ 2 Billion Mark in 1994. Natural Foods Merchandiser ( June): 74­ 76. 518 Mergentime, Ken and Monica Emerich. 1996. Widening Market Carries Organic Sales to $ 2.8 Billion in 1995. Natural Foods Merchandiser ( June): 36­ 38. Misra, Sukant, Chung L. Huang, and Stephen L. Ott. 1991. Georgia Consumers' Preference for Organically Grown Fresh Produce. Journal of Agribusiness ( Fall): 53­ 65. National Commission on Small Farms. 1998, A Time to Act: A Report of the USDA National Commission on Small Farms, Miscellaneous Publication 1545, January. Natural Foods Merchandiser. 1995. Organic Update: Reciprocity Controversies Intensify, Exacerbating Certifier/ Manufacturer Tensions. April. Organic Farming Research Foundation. 1999. Final Results of the Third Biennial National Organic Farmers' Survey. E. Walz, Program Coordinator. Santa Cruz, CA. Organic Farming Research Foundation. 2000. " Organic Certifiers Directory," on­ line publication, www. ofrf. org. Park, Timothy A. and Luanne Lohr. 1996. Supply and Demand Factors for Organic Produce. American Journal of Agricultural Economics, Vol. 78 ( August): 647­ 655. Scott, Mary. 1997. " Olive Oil Company Accused of Fraud," Natural Foods Merchandiser, December. Scott, Mary. 1997. " OFMA Activists Urge States to Enact Organic Laws," Natural Foods Merchandiser, May. Scowcroft, Bob. 1998. " Organic Standards and Enforcement: The Public's Right to Know," Organic Farming Research Foundation, Information Bulletin Newsletter, Number 5, Summer Issue. Thompson, Gary D. 1998. Consumer Demand for Organic Foods: What We Know and What 515 We Need to Know. Amer. J. Agr. Econ. Vol. 80, No. 5: 1113­ 1118. Underhill, S. E. and E. E. Figueroa. 1993. Consumer Preferences for Non­ Conventionally Grown Produce. Paper presented at the Valuing Food Safety and Nutrition Conference, organized by the NE­ 165 Regional Research Project. Alexandria, VA, June 2­ 4. USDA Foreign Agricultural Service. 1995. Agricultural Situation: Agricultural Highlights, Winter 1995. Report from Austria. Code 24, Sequence No. 007. USDA Foreign Agricultural Service. 1995. Agricultural Situation: Organic Food. Report from Germany. Code 24, Sequence No. 011. USDA Foreign Agricultural Service. 1996. Agricultural Situation: Organic Food Market Potential and Regulations. Report from France. Code 24, Sequence No. 002. USDA Foreign Agricultural Service. 1999a. Report on organic agriculture in Japan. Attache report JA91234. October 5. USDA Foreign Agricultural Service. 1999b. Report on organic agriculture in France. Attache report FR9070. October 18. U. S. Senate. 1999. Report 106­ 80. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Bill 2000. Committee on Appropriations. Page 56. Weaver, Robert D., David J. Evans, and A. E. Luloff. 1992. Pesticide Use in Tomato Production: Consumer Concerns and Willingness­ to­ Pay. Agribusiness, Vol. 8 No. 2: 131­ 142. Table 1. 516 TABLE 1. U. S. ORGANIC PRODUCT SALES, 1990­ 99 ($ billions) Year Export Direct Export/ Mass Natural Natural Total Total Direct Market Foods Foods Sales Sales Subtotal Stores ( 1999 $) Stores ( 1999 $) 1990 ­­ ­­ ­­ ­­ ­­ ­­ 1 1.27 1991 0.04 0.27 0.31 0.09 0.85 1.04 1.25 1.53 1992 0.07 0.32 0.39 0.12 1.03 1.22 1.54 1.83 1993 0.11 0.36 0.47 0.14 1.29 1.49 1.90 2.19 1994 0.20 0.39 0.60 0.17 1.54 1.73 2.31 2.60 1995 1/ 1/ 0.71 0.21 1.87 2.04 2.79 3.05 1996 ­­ ­­ 1/ 1/ 1/ 1/ 3.5 3.72 1997 ­­ ­­ ­­ ­­ 2/ ­­ ­­ ­­ 1998 ­­ ­­ ­­ ­­ 3.28 3.35 ­­ ­­ 1999 ­­ ­­ ­­ ­­ 4.00 4.00 ­­ ­­ Source: Natural Foods Merchandiser, New Hope Communications . ­­ = Not reported. 1/ New Hope Communications reported a combined estimate for export and direct sales in 1995 and reported a different set of subcategories in 1996 and has reported only on sales in natural foods stores since 1996. 2/ New Hope Communications did not estimate natural product store sales in 1997, but the Hartman Group estimated these sales at $ 4.9 billion. 517 TABLE 2A. FIRST­ YEAR CERTIFICATION COSTS, FROM GRAF AND LOHR ANALYSIS ( dollars) Certifying agent Small farm Medium farm Large farm Super farm CCOF 850 1,750 4,850 51,250 FVO 698 1,737 5,214 51,550 FOG 810 1,860 4,860 51,210 NOFA­ VT 335 535 585 585 NC/ SCS 700 900 1,000 2,000 OGBA 1,290 3,300 12,300 33,296 OTCO­ In 608 1,603 2,517 150,300 OTCO­ Out 768 1,698 2,852 12,052 OCIA­ WI 315 1,590 6,090 75,090 OCIA­ VA 258 320 495 1,745 TDA 90 155 200 575 WSDA 480 1,555 3,040 12,480 Average cost 579 1,414 3,623 33,276 Notes: CCOF California Certified Organic Farmers FVO Farm Verified Organic FOG Florida Certified Organic Growers & Consumers NOFA­ VT Northeast Organic Farming Association Vermont NC/ SCS NutriClean/ Scientific Certification Systems OBBA Organic Growers and Buyers Association OTCO­ In Oregon Tilth Certified Organic, inside Oregon OTCO­ Out Oregon Tilth Certified Organic, outside Oregon OCIA­ WI Organic Crop Improvement Association, Wisconsin chapter OCIA­ VA Organic Crop Improvement Association, Virginia chapter TDA Texas Department of Agriculture WSDA Washington State Department of Agriculture Small farm 25 acres with annual sales of $ 30,000. Medium farm 150 acres with annual sales of $ 200,000. Large farm 500 acres with annual sales of $ 800,000. Super farm 3,000 acres with annual sales of $ 10,000,000. 518 TABLE 2B. SUBSEQUENT­ YEAR CERTIFICATION COSTS, FROM GRAF AND LOHR ANALYSIS ( dollars) Certifying agent Small farm Medium farm Large farm Super farm CCOF 425 1,300 4,350 50,550 FVO 510 1,499 4,851 51,187 FOG 325 845 2,525 25,525 NOFA­ VT 300 500 550 550 OTCO­ In 454 1,611 2,362 11,363 OTCO­ Out 424 1,353 2,207 11,208 OCIA­ WI 290 1,565 6,065 75,065 OCIA­ VA 233 295 470 1,720 TDA 90 155 200 515 WSDA 330 1,375 2,800 12,000 NC/ SCS 700 900 1,000 2,000 Average cost 371 1,036 2,489 21,971 Notes: CCOF California Certified Organic Farmers FVO Farm Verified Organic FOG Florida Certified Organic Growers & Consumers NOFA­ VT Northeast Organic Farming Association Vermont NC/ SCS NutriClean/ Scientific Certification Systems OBBA Organic Growers and Buyers Association OTCO­ In Oregon Tilth Certified Organic, inside Oregon OTCO­ Out Oregon Tilth Certified Organic, outside Oregon OCIA­ WI Organic Crop Improvement Association, Wisconsin chapter OCIA­ VA Organic Crop Improvement Association, Virginia chapter TDA Texas Department of Agriculture WSDA Washington State Department of Agriculture Small farm 25 acres with annual sales of $ 30,000. Medium farm 150 acres with annual sales of $ 200,000. Large farm 500 acres with annual sales of $ 800,000. Super farm 3,000 acres with annual sales of $ 10,000,000. 519 TABLE 3. COSTS OF ACCREDITATION AND CERTIFICATION Estimated costs to certifying agents during first 18 months Application fee $ 0 1 Site evaluation costs ( two person team) Per diem ( 3 to 5 days at $ 85/ day) Travel ( domestic) Hourly charges ( not billed during the first 18 months) Miscellaneous charges ( copying, phone, and similar costs) $ 510 to $ 850 $ 1,000 to $ 1,200 $ 0 $ 50 Total $ 1,560 to $ 2,100 Estimated costs to certifying agents for initial accreditation after first 18 months Site evaluation costs ( two person team) Per diem ( 3 to 5 days) $ 510 to $ 850 Travel ( domestic) $ 1,000 to $ 1,200 Hourly charges ( 24 to 40 hours at $ 95/ hour)) $ 4,560 to $ 7,600 Miscellaneous charges ( copying, phone, and similar costs) $ 50 Total $ 6,120 to $ 9,700 Annual review fees for certifying agents ( 2 to 8 hours at $ 95/ hour) 2 $ 190 to $ 760 Estimated costs to producers for certification 3 Certification fee ( renewals) $ 730 520 Estimated costs to handlers for certification 4 Certification fee ( initial certification) $ 2,337 Certification fee ( renewals) $ 1,665 Nonrefundable fee that will be applied to the applicant's fee­ for­ service account. 1 Certifying agents are required to submit annual reports to USDA. Review of these 2 reports is expected to range from 2 to 8 hours at an approximate rate of $ 95 per hour. Estimated certification fees are calculated from Graf and Lohr 1999 which, for a 3 selection of certification agents, provides certification costs for four hypothetical farm sizes: ( 1) small farm ( family farm): 25 acres, $ 30,000 annual sales, 5 hours to certify; ( 2) medium farm ( cottage industry): 150 acres, $ 200,000 annual sales, 6 hours to certify; ( 3) large farm ( commercial farm): 500 acres, $ 800,000 annual sales, 8 hours to certify; and ( 4) super farm: 3,000 acres, $ 10,000,000 annual sales, 16 hours to certify. Our estimated certification fees only include those charged for small and medium farms because most organic producers fall into these categories as defined by Graf and Lohr. In the 1997 OFRF survey, 90 percent of respondents had gross organic farming income of less than $ 250,000, with 82 percent less than $ 100,000. The average current certification cost for most organic producers is about $ 1,025 for the first year of certification ($ 579 for small and $ 1,414 for medium farms) and about $ 705 for subsequent years ($ 371 for small and $ 1,036 for medium farms). Approximately $ 25 is added to cover the costs associated with the National Organic Program for an estimated first­ year certification fee of $ 1,000 and subsequent­ year certification fee of $ 730 for producers. Larger producers could expect higher fees. 521 Because Graf and Lohr do not estimate certification fees for handlers, we estimate these 4 fees by applying a ratio of handler­ to­ producer certification fees from the regulatory impact assessment from 1997. The ratio is 2: 28 and results in estimated fees of $ 2,337 and $ 2,665, respectively. TABLE 4. ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN Type of respondent Annual hours per Hourly rate Annual cost respondent Certified producer 24 $ 23 $ 552 Certified handler 63 $ 23 $ 1,449 Exempt producers and handlers 1 $ 23 $ 23 Certifying agency 1,068 $ 27 $ 27,729 Note: Estimates derived from Paperwork Reduction Act of 1995 analysis. Appendix B.­­ Unfunded Mandates Reform Act This rule has been reviewed under the Unfunded Mandates Reform Act ( P. L. 104­ 4). The Act requires that agencies prepare a qualitative and quantitative assessment of the anticipated costs and benefits before issuing any rule that may result in annual expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of $ 100 million ( adjusted annually for inflation) in any 1 year. According to the Act, the term, " Federal mandate," means any provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments or the private sector, except a duty arising from participation in a voluntary Federal program. 522 The National Organic Foods Production Act ( OFPA) of 1990 mandates that the Secretary develop a national organic program to accredit eligible governing State officials or private persons as certifying agents who would certify producers or handlers of agricultural products that have been produced using organic methods as provided for in the OFPA. The OFPA also permits a governing State official to voluntarily establish a State organic program ( SOP) if the program is approved by the Secretary and meets the requirements of the OFPA. The OFPA does not require that States establish their own SOP's or that State, local, or tribal governments or the private sector become accredited; therefore, the OFPA is not subject to the Unfunded Mandates Reform Act because it is a voluntary program. Although the U. S. Department of Agriculture has determined that this rule is not subject to the Unfunded Mandates Reform Act, USDA has sought to consider the rule's impact on various entities. USDA prepared a Regulatory Impact Assessment ( RIA) that is discussed in the section entitled " Executive Order 12866" ( also attached as an appendix to this regulation). The RIA consists of a statement of the need for the action, an examination of alternative approaches, and an analysis of the benefits and costs. Much of the analysis is necessarily descriptive of the anticipated impacts of the rule. Because basic market data on the prices and quantities of organic goods and services and the costs of organic production are limited, it is not possible to provide quantitative estimates of all benefits and costs of the rule. The cost of fees and recordkeeping required by USDA are quantified, but the anticipated benefits are not. Consequently, the analysis does not contain an estimate of net benefits. The analysis employed in reaching a determination that this rule is the least costly and least burdensome to the regulated parties is discussed in the sections entitled " The Regulatory 523 Flexibility Act and the Effects on Small Businesses" and " Paperwork Reduction Act of 1995." The rule has been designed to be as consistent as possible with existing industry practices, while satisfying the specific requirements of the OFPA. We have had numerous occasions during which to communicate with various entities during the development of the rule; States, for example. Currently, there are 32 States with some standards governing the production or handling of organic food and 13 States with organic certifying programs. Representatives of State governments have participated in public meetings with the National Organic Standards Board, while the NOP staff has made presentations, received comments, and consulted with States and local and regional organic conferences, workshops, and trade shows. States have been actively involved in training sessions for organic inspectors; public hearings concerning standards for livestock products during 1994; a national Organic Certifiers meeting on July 21, 1995; a USDA­ hosted meeting on February 26, 1996; a State certifiers meeting in February 1999; and an International Organization for Standardization ( ISO) 65 assessment training session for certifiers in April­ May 1999. More detail about contact with States regarding this rule is in the Federalism section. It is unknown at this time how many States, if any, might voluntarily establish their own SOP's pursuant to the OFPA and the regulations. Appendix C.­­ Final Regulatory Flexibility Analysis The Regulatory Flexibility Act ( 5 U. S. C. 601 et seq.) requires agencies to consider the economic impact of each rule on small entities and evaluate alternatives that would accomplish the objectives of the rule without unduly burdening small entities or erecting barriers that would restrict their ability to compete in the market. The purpose is to fit regulatory actions to the scale 524 of businesses subject to the action. 1. Need for and objectives of the National Organic Rule Currently, organic certification is voluntary and self­ imposed. Members of organic industries across the United States have experienced numerous problems marketing their organically produced and handled agricultural products. Inconsistent and conflicting organic production standards may have been an obstacle to the effective marketing of organic products. There are currently 36 private and 13 State organic certification agencies ( certifying agents) in the United States, each with its own standards and identifying marks. Some existing private certifying agents are concerned that States might impose registration or licensing fees which would limit or prevent private certification activities in those States. Labeling problems have confronted manufacturers of multiingredient organic food products containing ingredients certified by different certifying agents because reciprocity agreements have to be negotiated between certifying agents. Consumer confusion may exist because of the variety of seals, labels, and logos used by certifying agents and State programs. Also, there is no industrywide agreement on an accepted list of substances that should be permitted or prohibited for use in organic production and handling. Finally, a lack of national organic standards may inhibit organic producers and handlers in taking full advantage of international organic markets and may reduce consumer choices in the variety of organic products available in the marketplace. To address these problems in the late 1980' s, the organic industry attempted to establish a national voluntary organic certification program. At that time, the industry could not develop consensus on the standards that should be adopted, so Congress was petitioned by the Organic 525 Trade Association to establish national standards for organic food and fiber products. In 1990, Congress enacted the Organic Foods Production Act of 1990, as amended ( 7 U. S. C. 6501 et seq.) ( OFPA). The OFPA requires all agricultural products labeled as " organically produced" to originate from farms or handling operations certified by a State or private agency that has been accredited by USDA. The purposes of the OFPA, set forth in section 2102 ( 7 U. S. C. 6501), are to: ( 1) establish national standards governing the marketing of certain agricultural products as organically produced products; ( 2) assure consumers that organically produced products meet a consistent standard; and ( 3) facilitate commerce in fresh and processed food that is organically produced. The National Organic Program ( NOP) is the result of the OFPA. Recently, the Organic Trade Association published American Organic Standards, Guidelines for the Organic Industry ( AOS). However, not all participants in the organic industry elected to participate in developing the AOS. Many certifying agents preferred to wait for implementation of the national standards, and some certifying agents disagree with portions of the AOS. For these reasons, USDA will implement a regulation for the NOP. . 2. Summary of the significant issues raised by public comments in response to the Initial Regulatory Flexibility Analysis ( IRFA), a summary of agency assessment of such issues, and a statement of any changes made in the final rule as a result of such comments. Although we received many individual comments in reference to the proposed rule's IRFA, they were, for the most part, variations of several form letters. Most of the concern on the part of commenters regarded the fees that small certifying agents would be subject to under the rule. Comments Accepted: 526 ( 1) We received numerous comments to the effect that the fees, recordkeeping, and paperwork requirements for producer and handler certification must be kept as low as possible while still offering a quality certification program. We believe that we have made every effort in this rule to minimize the cost and paperwork burden to certifiers and certified operations as much as possible. We have permitted certifiers and certified operations to develop their own recordkeeping and reporting systems so long as they conform to the needs of the program. For the most part, the paperwork and recordkeeping requirements for certified operations conform to the requirements that they presently face under existing certification programs. In order to minimize the cost to the industry of transitioning to a system where certifying agents are accredited ( assuming that there will be a learning curve as agents familiarize themselves with the requirements of accreditation), we have waived the per­ hour cost that USDA will charge to conduct an accreditation review for the first 18 months of the program. ( 2) In the proposed rule, we requested comment on the benefits of an exemption for small certifiers similar to that for small producers. We received comments in opposition to such an exemption because commenters wanted to maintain documented verification of standards that is afforded by certification and accreditation. They felt that exemptions weakened the organic system in its ability to assure consumers of products that meet a consistent standard. We concurred with this comment and have not developed an exemption for certifiers in the final rule. Comments Rejected: ( 3) We received comments suggesting that, in order to lower the direct cost of accreditation to smaller certifier applicants, we should eliminate on­ site visits during accreditation or extend the time beyond the initial on­ site visit for a subsequent visit. Although eliminating the 527 on­ site visits would certainly lower the applicant's costs, we have not made the change to reduce or eliminate on­ site visits. We did not see how USDA could make an informed decision about whether or not to continue to accredit a certifying agent without complete access to the relevant records documenting the agent's business practices. This can only be efficiently done through a site visit. ( 4) We received numerous comments that the fees proposed by USDA will result in certification fees that are excessive for small farming operations. The commenters suggested that USDA impose fees on a sliding scale based on a farmer's income so as not to drive these farmers out of business and deprive consumers of the benefits of these operations. We received a similar comment to the Fees section of the proposed rule, and our response is the same. Although one of our top priorities is assisting the small farmer, AMS is primarily a user­ fee­ based Federal agency. We are aware that our accreditation fees will figure into the fees that certifiers charge their clients. However, the fee we will charge to accredit an applicant is based not on earning profits, but on recovery of costs. In addition, our waiver of the hourly service charges for accreditation during the first 18 months of the program should help to keep the cost of accreditation to certifying agents down. We believe the requirements that fees charged by a certifying agent must be reasonable and that certifiers must file a fee schedule for approval by the Administrator will help to keep costs under control. Since certifiers are required to provide their approved fee schedules to applicants for certification, the applicants will be able to base their selection of certifying agent on price if the applicants so choose. In addition, nothing in the regulations precludes certifying agents from pricing their services on a sliding scale so long as their fees are consistent and nondiscriminatory and are approved during the accreditation process. 528 ( 5) Other commenters were concerned that in the rule USDA neglects to establish " reasonable fees" annually for farm/ site/ wild crop production and handling operation certification. Commenters did not believe that a valid Regulatory Flexibility Act analysis could be made without the annual farm and handling operation fee projection. We have not established guidelines for what constitutes a " reasonable fee" in the final rule. Accredited certifying agents will be required to submit a proposed fee schedule as a part of their application. At that time, we will work with applicants for accreditation to ensure that their fees are appropriate. In addition, certifying agents will be required to send a copy of their fee schedule to anyone who requests one. This will allow operations that wish to be certified to shop around and will provide a disincentive for accredited agents to price themselves out of the market. 3. Description of and an estimate of the number of small entities to which the rule will apply. Small business size standards, Standard Industrial Code ( SIC) ( 13 CFR part 121), are developed by an interagency group, published by the Office of Management and Budget, and used by the Small Business Administration ( SBA) to identify small businesses. These standards represent the number of employees or annual receipts constituting the largest size that a for­ profit enterprise ( together with its affiliates) may be and remain eligible as a small business for various SBA and other Federal Government programs. There are three categories of operations that contain small business entities that would be affected by this rule: certifying agents, organic producers, and/ or organic handlers. The term, " certifying agent," means the chief executive officer of a State or, in the case of a State that provides for the statewide election of an official to be responsible solely for the administration of 529 the agricultural operations of a State, such official and any person ( including private entities) who is accredited by the Secretary as a certifying agent for the purpose of certifying a farm or handling operation as a certified organic farm or handling operation. According to the most complete data available to USDA's Agricultural Marketing Service ( AMS), there are 49 certifying agents ( 36 private and 13 State) in the United States. More than half of the private and State certifying agents certify both producers and handlers, while the others certify only producers. Over three­ fourths of private and State certifying agents each certify fewer than 150 producers and 20 handlers. The number of certifying agents has remained fairly stable, between 40 and 50, for some years, with entries and exits tending to offset each other. The NOP staff anticipates that, in addition to the 49 domestic certifying agents, 10 foreign certifying agents may seek accreditation during the initial phase of the program. Small businesses in the agricultural services sector, such as certifying agents, include firms with average annual revenues of less than $ 5 million ( SIC Division A Major Group 7). Based on SBA's small business size standards for the agricultural services sector, it is not likely that many, if any, of the 49 domestic certifying agents have annual revenue greater than $ 5 million. All private, nonprofit certifying agents would be considered small by SBA's standards. Based on anecdotal information, only a few private, for­ profit, certifying agents might be categorized as large businesses. In addition, the 13 State certifying agents, although not exceeding the revenue threshold, would not be considered to be small entities under the Act as only government jurisdictions with populations under 50,000 are considered to be small entities under section 601( 5). Therefore, at least 30 certifying agents would qualify as a small business. The term, " producer," means a person who engages in the business of growing or 530 producing food or feed. It is more difficult to establish the number of organic producers. Organic farming was not distinguished from conventional agriculture in the 1997 Census of Agriculture. There are sources which give insight into the number of producers. The Organic Farming Research Foundation ( OFRF), a California­ based nonprofit organization, has conducted three nationwide surveys of certified organic producers from lists provided by cooperating certifying agents. The most recent survey applies to the 1997 production year ( 1). OFRF sent its 1997 survey to 4,638 names and received 1,192 responses. Because OFRF did not obtain lists from all certifying organizations or their chapters ( 55 out of a total of 64 identified entities provided lists), its list count is likely an understatement of the number of certified organic producers. Note that the estimated number of organic producers includes only certified organic farms. Comments filed in response to the first proposal and studies indicate that the total number of organic farms is higher. Dunn has estimated the number of certified organic producers in the United States ( 2, 3) Dunn's 1995 work, a USDA study, estimated the number of certified producers at 4,060 in 1994; this estimate was used in the first proposal. Dunn's 1997 work reported 4,060 certified organic farms in 1994 and 4,856 in 1995. Data collected by AMS indicate that the number of organic farmers increased about 12 percent per year during the period 1990 to 1994. OFRF survey efforts indicate that growth has continued, although it is not clear whether the growth rate has changed. Similarly, growth in retail sales, the addition of meat and poultry to organic production, and the possibility of increased exports suggest that the number of operations has continued to increase. Lacking an alternative estimate of the growth rate for the number of certified organic producers, we use the average 531 growth rate of about 14 percent from Dunn's 1997 study. The true rate of growth could be higher or lower. Applying the 14­ percent growth rate to Dunn's estimate of certified producers in 1995 gives an estimate of 8,200 organic producers for 1999. An adjustment is needed to account for the number of producers who are practicing organic agriculture but who are not certified and who would be affected by this regulation. We assume that the number of organic but not certified producers in 1999 is about 4,000. This assumption is based on very limited information about the number of registered but not certified organic producers in California in 1995. Thus, the total number of certified organic producers used in assessing the impact of the rule is 12,176. Producers with crop production ( SIC Division A Major Group 1) and annual average revenues under $ 500,000 are small businesses. Producers with livestock or animal specialities are also considered small if annual average revenues are under $ 500,000 ( SIC Division A Major Group 2), with the exception of custom beef cattle feedlots and chicken eggs, which are considered small if annual average revenues are under $ 1,500,000. Based on SBA's small business size standards for producers, it is likely that almost all organic producers would be considered small. The OFRF survey asked for the producer's total gross organic farming income during 1997. Only 35 ( less than 3 percent) of the survey respondents reported gross income greater than $ 500,000, the SBA's cutoff between small and large businesses. Over 70 percent reported gross income of less than $ 50,000. The OFRF survey does caution readers about potential survey " errors." It is particularly important to emphasize potential " non­ response error"; that is, it is unknown if those who responded to the survey accurately represent the entire population of certified organic growers. Also, some producers 532 combine organic and conventional production on the same operation, some with total sales that may exceed $ 500,000. However, it is likely that a majority of organic producers would be considered small. We have estimated that there would be 12,176 producers certified in the first year and of those 97 percent, or 11,811, based on OFRF's survey results, would qualify as a small business. The term, " handler," means any person engaged in the business of handling agricultural products, excluding final retailers of agricultural products that do not process agricultural products. Little information exists on the numbers of handlers and processors. USDA has estimated that there were 600 entities in this category in 1994. In California, there were 208 registered organic processed food firms in 1995 and 376 in 1999, a growth rate of 20 percent ( 4). We assume that this growth rate is applicable to the U. S. and project 2,077 certified handlers in 2001. This figure includes 100 livestock feed handlers who would become certified organic. Again, the rate of growth could be higher or lower. In handling operations, a small business has fewer than 500 employees ( SIC Division D Major Group 20). It is also likely that the vast majority of handlers would be considered small, based on SBA's small business size standards for handlers. Based on informal conversations with organic certifying agents, currently, about 25 ( about 2 percent) of the estimated 1,250 organic handlers in 1999 had more than 500 employees. This includes firms that handle or process both organic and conventional foods. We have estimated that 2,077 handlers would be certified organic in the first year. Based on this information, 98 percent or 2,035 would qualify as a small business. 4. An estimate of the projected reporting, recordkeeping, and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject 533 to the requirement and the type of professional skills necessary for preparation of the report or record. The reporting, recordkeeping, and compliance requirements of the rule will directly affect three sectors of the organic industry that contain small business entities: accredited certifying agents, organic producers, and organic handlers. We have examined the requirements of the rule as it pertains to each of these entities, however several requirements to complete this Regulatory Flexibility Analysis ( RFA) overlap with the Regulatory Impact Assessment ( RIA) and the Paperwork Reduction Act ( PRA) section. In order to avoid duplication, we combine some analyses as allowed in section 605( b) of the Act. This RFA provides information specific to small entities, while the RIA or PRA should be referred to for more detail. For example, the RFA requires an analysis of the rule's costs to small entities. The RIA provides an analysis of the benefits and costs of this regulation. This RFA uses the RIA information to estimate the impact on small entities. Likewise, the RFA requires a description of the projected reporting, recordkeeping, and other compliance requirements of the final rule. The PRA section estimates the reporting and recordkeeping ( information collection) requirements that would be required by this rule from individuals, businesses, other private institutions, and State and local governments. The burden of these requirements is measured in terms of the amount of time required of program participants and its cost. This RFA uses the PRA information to estimate the burden on small entities. Certifying Agents We have identified 36 private certifying agents and 13 State programs providing certification. These 49 domestic entities are considered likely applicants during the first 12 months, as are an estimated 10 foreign certifying agents. An unknown number of new entrants to 534 the certifying business may also apply. However, over the last 10 years, the number of certifying agents does not appear to have grown significantly, with the net effect of entries and exits maintaining a population of U. S.­ based certifying agents at about 40 to 50. Of the 49 domestic certifying agents, based on information discussed previously, we estimate that 30 of the 36 private certifying agents are small businesses. The recordkeeping and paperwork requirements are outlined in the Paperwork Reduction Act section. The requirements for small and large certifying agents are identical. The recordkeeping and paperwork requirements for accreditation will be a new burden to most agents as the majority of them have not been accredited in the past. However, the actual amount of the additional administrative costs that would be imposed by the final rule is expected to be different for those entities that would begin their activities only after the national program is implemented. Certifying agents that currently are active in the organic industry already perform most of these required administrative functions; therefore, the additional costs to them would depend upon the extent to which their current practices are different from the requirements of the final regulation. Because the rule does not require any particular system or technology, it does not discriminate against small businesses. The ability of an agent to carry out the paperwork and recordkeeping sections of the rule will be more dependant on the administrative skill and capacity of their particular organization than their size. We did not receive significant comments about the paperwork requirements of the proposed rule that would indicate that they will be onerous for small certifying agents. Certifying agents will be the front line in monitoring and ensuring that certified operations stay in compliance with the Act and the regulations. However, most of the compliance 535 requirements, with the exception of some reporting requirements, are consistent with what certifiers are currently expected to do. Like the paperwork and reporting requirements, the additional costs to an agent will depend on how different their current practices are from the final regulation. The final, and probably most significant, area in which certifying agents are affected by the rule is in the fees that they must pay for accreditation. Certifying agents will be assessed for the actual time and travel expenses necessary for the NOP to perform accreditation services, including initial accreditations, 5­ year renewals of accreditation, review of annual reports, and changes to accreditation. Although the fees have not been set yet, we are using as a starting point the hourly fees that are charged for the voluntary, fee­ for­ service program provided by AMS to certification bodies requesting conformity assessment to the ISO Guide 65, " General Requirements for Bodies Operating Product Certification Systems." We expect that at the time the NOP's final rule is implemented, the fees will be approximately $ 95 per hour with higher overtime and holiday rates. Certifying agents will also be charged for travel, per diem, and other related costs associated with accreditation. To ease the financial burden of accreditation during the 18 month transition period after the NOP has been implemented, USDA will not impose hourly charges on certifying agents. The direct costs for certifying agents to obtain accreditation will be limited to per diem and transportation costs to the site evaluation. Review of the certifying agent's annual report is anticipated to range from 2 to 8 hours at the ISO Guide 65 hourly rate. Also, if certifying agents wish to become accredited in additional areas for which they were not accredited previously, a site evaluation ( with associated fees) will be necessary. Detail about the expected costs of accreditation can be found in the RIA. 536 Several factors will influence the amount of time needed to complete an accreditation audit. An operation in which documents are well organized and that has few nonconformities within the quality system will require less time for an audit than an organization in which documents are scattered and there are many nonconformities ( 7). Similarly, in a followup audit, operations that lack organization in their documents and that had a large number of nonconformities during previous audits will require a greater amount of time. The scope of a followup audit is to verify the correction of nonconformities and to evaluate the effectiveness of the corrections. Certifying agents are able to control these cost factors by making certain that documents are well organized and by educating themselves about quality systems. The complexity of a certification agency's organization also will affect the time needed to complete an audit. An agency with a central office in which all certification activities take place will require less time for document review and site evaluation than a chapter organization or a business structured so that responsibility for making certification decisions is delegated outside of the central office. In the latter cases, the auditors' document review would require additional time and site evaluation that would extend from the central office to one or more of the chapters or to the site to which the certification decision making is delegated. Other factors determine the amount of time needed to complete an accreditation audit. For an agency with numerous clients, auditors may need to spend more time reviewing client files or examining business operations than they would have to spend for a smaller agency. Audit of an agency with a large number of processor clients may require an extended amount of time to follow audit trails, confirm that organic ingredients remain segregated from nonorganic ingredients, and establish that foreign­ produced ingredients originate from approved entities. Finally, the 537 complexity of the agricultural practices certified could influence the amount of time necessary to complete an accreditation audit. An agency whose certification covers only producers who grow and harvest one crop per field per year, such as wheat or sugar beets, could quickly be audited. An agency whose producers grow several different crops per field per year or an agency that certifies producers of crops and livestock as well as handlers would require a greater amount of time. All of these factors will affect both small and large certifying agents. A small certifying agent could be assumed to have a less complex organization or have fewer clients, and, thus, potentially less time would be necessary for review. However, other factors, such as the degree of paperwork organization or the complexity of the agricultural practices certified, may influence the time needed for review for any size of business. Currently, relatively few certifying agents have third­ party accreditation because accreditation of certifying agents is voluntary. Fetter reports that in a sample of 18 certification programs, selected to include six large, private programs, six smaller private programs, and six State programs, four programs were accredited and one had accreditation pending ( 8). All of these were large private certifying agents. Three of the certifying agents identified by Fetter as accredited requested ISO Guide 65 assessments by USDA and have been approved for selling organic products into the international market. Those certifying agents currently accredited by third parties will likely pay less for USDA accreditation because their documents are organized and they have fewer nonconformities. It is expected that all certifying agents will set their fee schedule to recover costs for their certification services, including the costs of accreditation. The larger the number of clients per certifying agent, the more fixed costs can be spread out. It is possible, however, that small 538 certifying agents could be significantly affected by this final rule and may not be able to continue in business from a financial standpoint. Costs to Producers and Handlers The OFPA established a small farmer exemption from certification and submission of organic plans for small producers with a maximum of $ 5,000 in gross sales of organic products. For purposes of the exemption, the OFPA defines a " small farmer" as those who sell no more than $ 5,000 annually in value of agricultural products. In this rule, we have clarified that the exemption applies to producers and handlers who sell no more than $ 5,000 annually in value of organic products ( 9). In addition, handling operations are exempt if they: are a retail food establishment that handles organically produced agricultural products but does not process them; handles agricultural products that contain less than 70 percent organic ingredients by weight of finished product; or does not use the word, " organic," on any package panel other than the information panel if the agricultural product contains at least 70 percent organic ingredients by weight of finished product. A handling operation or specific portion of a handling operation is excluded from certification if it handles packaged certified organic products that were enclosed in their packages or containers prior to being acquired and remain in the same package and are not otherwise processed by the handler, or it is a retail food establishment that processes or prepares on its own premises raw and ready­ to­ eat food from certified organic products. According to the OFRF survey, 27 percent of currently certified farms that responded to the survey would fall under the producer exemption. This percentage does not take into account those organic farms that are not currently certified by a private or State certifying agent. A study 539 of California organic farms found that, of all organic farms ( 10) in 1994­ 95, about 66 percent have revenues less than $ 10,000 ( 11). If California is representative and the distribution within the sub­ $ 10,000 category is uniform, then a third of the farms would be classified as small for purposes of the statutory exemption with annual sales less than $ 5,000. Based on the California study and the OFRF survey results, we estimate that between 25 and 33 percent of organic producers are small and would qualify for exemption from the certification requirements. We have estimated that there are 4,801 small organic producers and 173 handlers that will be exempt from certification ( this figure does not include excluded operations). These operations would be required to comply with the production and handling standards and labeling requirements set forth under the NOP. They do not have to meet the paperwork requirements of certification and they must only keep records that document compliance with the law for 3 years ( rather than 5 for certified operations. We anticipate that this exemption will be used primarily by small market gardeners and hobbyists who grow and process produce and other agricultural products for sale at farmers markets and roadside stands to consumers within their communities. Exempt producers will be allowed to market their products as organically produced without being certified by a certifying agent. Products marketed by exempt producers cannot be represented as certified organic or display the USDA organic seal. Products produced or handled on an exempt operation may be identified as organic ingredients in a multiingredient product produced by the exempt operation, but they may not be identified as organic in a product processed by others. These limitations may discourage some small producers from seeking exemption, who instead may choose to become certified. In this case, the costs of certification would apply. The value associated with having organic certification may outweigh the costs of 540 certification. As with accredited certifying agents, the regulation will impose administrative costs on certified producers and handlers for reporting, recordkeeping, residue testing, and other compliance requirements. The actual amount of the additional administrative costs that would be imposed by the final rule is expected to be different for those entities that become certified only after the national program is implemented. Producers and handlers who currently are active in the organic industry already perform most of these administrative functions; therefore, the additional costs to them would depend upon the extent to which their current practices differ from the requirements of the final regulation. Projected reporting, recordkeeping, and other compliance requirements of certifying agents are discussed in greater detail in the PRA and the RIA. The only distinction made in the final rule between large and small entities for reporting, recordkeeping, and compliance is for operators who produce less than $ 5000 per year in organic products as stated above. As with the certifying agents, most of the concern this rule generated for small certified operations revolves around fees. Under this rule, USDA will not impose any direct fees on producers and handlers. Certifying agents will establish a fee schedule for their certification services that will be filed with the Secretary and posted in a place accessible to the public. Certifying agents will provide all persons inquiring about the application process with a copy of their fees. The certifying agent may only charge those fees that it has filed with the Secretary. Furthermore, the certifying agent will provide each applicant with an estimate of the total cost of certification and an estimate of the annual costs of updating the certification. Currently, supply and demand for certification services determine the fees charged in most 541 areas. Some States charge minimal fees for certification and instead subsidize operating costs from general revenues. According to separate studies by Fetter, and Graf and Lohr, the majority of certifying agents structure their fee schedules on a sliding scale based on a measure of size, usually represented by the client's gross sales of organic products but sometimes based on the acres operated. Some certifying agents charge an hourly rate for inspection and audit services. Graf and Lohr's study indicates that even small farms require significant time for the certification process, and this time does not increase proportionately as farm size increases. None of the existing certification programs mention costs for residue testing, which the NOP will require in the form of preharvest testing when there is reason to believe that agricultural products have come into contact with prohibited substances. Preharvest testing is expected to be infrequent. Certifiers will recover the costs of preharvest testing through explicit charges to the producer whose crop is tested or through a generally higher fee structure that spreads the expected costs of tests over all clients. This rule imposes no requirements that would cause certifying agents that are presently using a sliding­ scale type fee schedule to abandon their current fee system. Certifying agents could recover their net additional costs by increasing their flat­ fee component, their incremental charges, or both. Because accreditations are renewed only every 5 years, certifying agents will have 5 years to recover their net new costs. Certifying agents who become accredited during the first year of the program would have fewer direct costs to recover because they will not be charged the application fee and hourly charges for accreditation services. Those currently receiving voluntary certification will likely see a modest increase as the certifying agent passes on its cost incurred under the NOP. Those not currently receiving 542 certification and producing over $ 5,000 annually in organic products will be required to become certified, and they will incur the actual costs of certification. Some States, such as Texas and Washington, charge producers and handlers nominal fees for certification, and it is possible that more States might provide certification services as the NOP is implemented. Other States, such as Minnesota, have cost­ share programs to help offset costs for organic producers. Conclusion This rule will primarily affect small businesses. We have, therefore, attempted to make the paperwork, recordkeeping, and compliance provisions as flexible as possible without sacrificing the integrity of the program. We are not requiring specific technologies or practices and with the 18­ month phase­ in of the program we are attempting to give both certifying agents and certified operators an opportunity to adapt their current practices to conform with the rule. Because we have attempted to make the rule conform with existing industry standards, including ISO guide 65 for certification and ISO guide 61 for accreditation, the changes for most organizations and operations should be relatively straightforward. The fees required for accreditation will be the most significant change faced by most operations and this was apparent in the comments received. While we understand the concerns of the affected organizations, in order to administer an accreditation program, it is necessary that we recover our costs. We are hoping that the elimination of the hourly charges in the first round of accreditation will help to alleviate some of this burden. 1. Organic Farming Research Foundation. 1999. Final Results of the Third Biennial National Organic Farmers' Survey. Santa Cruz, CA. 543 2. Dunn, Julie Anton. 1995. Organic Food and Fiber: An Analysis of 1994 Certified Production in the United States. U. S. Department of Agriculture, Agricultural Marketing Service. 3. Dunn, Julie Anton. 1997. AgriSystems International Reports Certified Organic Production in the United States: Half a Decade of Growth. AgriSystems International: Wind Gap, PA. 4. California Department of Health Services ( DHS). 1995. Report on the Registration of California Organic Processed Food Firms. Sacramento: State of California. September 1999 figures obtained via personal communication with California DHS. 5. Graf, Anita and Luanne Lohr. 1999. Analysis of certification program costs. Working Paper, Fund for Rural America project, Market Development for Organic Agriculture Products, Grant No. 97­ 36200­ 5. 6. During the first 18 months, site evaluation for initial accreditation will be conducted jointly by two reviewers. Two reviewers offers: ( 1) anticipated faster turn­ around; ( 2) different areas of expertise ­ one reviewer would come from the Quality Systems Certification Program audit staff and would be familiar with ISO Guide 65 verification, while the other reviewer would come from the NOP staff and would be familiar with the requirements of the program; and ( 3) consistency with the organic industry's desire to have reviewers from both areas of expertise during ISO Guide 65 assessments. AMS would consider sending one reviewer, rather than two, for the site evaluation of small certification agents if an individual possessing both reviewing skill and knowledged of the NOP is available. We anticipate only one reviewer would be required after the 18­ month transition period. 7. Adequate advance notice will be given to certifying agents to allow them the opportunity 544 to organize their records prior to the audit and minimize the costs of accreditation. 8. Fetter, Robert T. 1999. Economic Impacts of Alternative Scenarios of Organic Products Regulation. Senior Honors Thesis. University of Massachusetts, Amherst, MA. 9. We asked for comments on the first proposal as to whether the current statutory limitation of $ 5,000 for exemption from certification should be raised to $ 10,000 or to another amount and why such an increased monetary limitation for exemption from certification would be appropriate. Few commenters offered recommendations as to a maximum sales volume to exempt producers. Amounts ranged from $ 2,000 to $ 50,000, with a few suggesting $ 10,000 and $ 20,000 exemptions. These proposed exemption levels and justifications in comments received are not sufficiently consistent enough for us to recommend changing the statute requirement of the $ 5,000 maximum sales volume exemption. 10. California State law requires organic farmers to register with the State. Certification is voluntary at the current time. 11. Klonsky, Karen, and Laura Tourte. 1998. Statistical Review of California's Organic Agriculture, 1992­ 95. Report prepared for the California Department of Food and Agriculture Organic Program. Cooperative Extension, Department of Agricultural Economics, University of California, Davis. Appendix D.­­ Executive Order 12988, Civil Justice Reform Executive Order 12988, Civil Justice Reform, instructs each executive agency to adhere to certain requirements in the development of new and revised regulations in order to avoid unduly burdening the court system. The revised proposal was reviewed under this Executive Order. No comments were received on that review, and no additional related information has been obtained 545 since then. This rule is not intended to have retroactive effect. States and local jurisdictions are preempted under section 2115 of the Organic Foods Production Act ( OFPA) ( 7 U. S. C. 6514) from creating programs of accreditation for private persons or State officials who want to become certifying agents of organic farms or handling operations. A governing State official would have to apply to USDA to be accredited as a certifying agent, as described in section 2115( b) of the OFPA ( 7 U. S. C. 6514( b)). States also are preempted under sections 2104 through 2108 of the OFPA ( 7 U. S. C. 6503 through 6507) from creating certification programs to certify organic farms or handling operations unless the State programs have been submitted to, and approved by, the Secretary as meeting the requirements of the OFPA. Pursuant to section 2108( b)( 2) of the OFPA ( 7 U. S. C. 6507( b)( 2)), a State organic certification program may contain additional requirements for the production and handling of organically produced agricultural products that are produced in the State and for the certification of organic farm and handling operations located within the State under certain circumstances. Such additional requirements must: ( a) further the purposes of the OFPA, ( b) not be inconsistent with the OFPA, ( c) not be discriminatory toward agricultural commodities organically produced in other States, and ( d) not be effective until approved by the Secretary. Pursuant to section 2120( f) of the OFPA ( 7 U. S. C. 6519( f)), this regulation would not alter the authority of the Secretary under the Federal Meat Inspection Act ( 21 U. S. C. 601 et seq.), the Poultry Products Inspections Act ( 21 U. S. C. 451 et seq.), or the Egg Products Inspection Act ( 21 U. S. C. 1031 et seq.), concerning meat, poultry, and egg products, nor any of the authorities of the Secretary of Health and Human Services under the Federal Food, Drug and Cosmetic Act ( 21 546 U. S. C. 301 et seq.), nor the authority of the Administrator of the Environmental Protection Agency ( EPA) under the Federal Insecticide, Fungicide and Rodenticide Act ( 7 U. S. C. 136 et seq.). Section 2121 of the OFPA ( 7 U. S. C. 6520) provides for the Secretary to establish an expedited administrative appeals procedure under which persons may appeal an action of the Secretary, the applicable governing State official, or a certifying agent under this title that adversely affects such person or is inconsistent with the organic certification program established under this title. The Act also provides that the U. S. District Court for the district in which a person is located has jurisdiction to review the Secretary's decision. Appendix E.­­ Executive Order 13132, Federalism This final rule has been reviewed under Executive Order 13132, Federalism. This Order requires that regulations that have federalism implications provide a federalism impact statement that: ( 1) demonstrates the Agency consulted with the State and local officials before developing the final rule, ( 2) summarizes State concerns, ( 3) provides the Agency's position supporting the need for the regulation, and ( 4) describes how the concerns of State officials have been met. The Order indicates that, where National standards are required by Federal statutes, Agencies shall consult with appropriate State and local officials in developing those standards. The Organic Foods Production Act ( OFPA) of 1990 ( 7 U. S. C. 6501 et seq.) establishes national standards regarding the marketing of agricultural products as organically produced, assures consumers that organically produced products meet a consistent standard, and facilitates interstate commerce in fresh and processed food that is organically produced. There has been a great deal of support for this law and these regulations from the organic community. 547 OFPA and these regulations do preempt State statutes and regulations related to organic agriculture. OFPA establishes national standards regarding the marketing of agricultural products as organically produced, assures consumers that organically produced products meet a consistent standard, and facilitates interstate commerce in fresh and processed food that is organically produced. Currently, 32 States have organic statutes on their books and have implemented them to various degrees. However, the Act contemplates a significant role for the States and, in fact, envisions a partnership between the States and the Federal Government in meeting the requirements of the Statute. The Act allows the States to determine the degree to which they are involved in the organic program. States may choose to: ( 1) carry out the requirements of the Act by establishing a State organic program ( SOP) and becoming accredited to certify operations, ( 2) establish an SOP but utilize private accredited certifying agents, ( 3) become accredited to certify and operate under the National Organic Program ( NOP) as implemented by the Secretary, or ( 4) not play an active role in the NOP. 7 U. S. C. 6507 provides that States may establish an SOP consistent with the national program. SOP's may contain more restrictive requirements than the NOP established by the Secretary of Agriculture. To be more restrictive, SOP's must: further the purposes of the Act, be consistent with the Act, not discriminate against organic products of another State, and be approved by the Secretary. Because implementation of OFPA will have a significant effect on many States' existing State statutes and programs, the U. S. Department of Agriculture ( USDA) has reached out to States and actively sought their input throughout the entire process of developing the organic rule. On publication of the first proposal on December 16, 1997, an announcement and information packet summarizing the proposal was sent to more than 1,000 interested parties, including State 548 governors and State department of agriculture secretaries, commissioners, or directors. Over a period of 6 years, numerous meetings were held to provide States an opportunity to provide information and feedback to the rule. In 1994, States were invited to participate in four public hearings held in Washington, DC; Rosemont, IL; Denver, CO; and Sacramento, CA, to gather information to guide development of standards for livestock products. States were also provided the opportunity to comment specifically on State issues at a National Organic Certifiers meeting held on July 21, 1995. They were invited to discuss accreditation issues at a meeting held on February 26, 1996. Following the publication of the first proposal, State and local jurisdictions had the opportunity to provide input at four listening sessions held in February and March 1998 in Austin, TX; Ames, IA; Seattle, WA; and New Brunswick, NJ. A meeting to discuss the role of States in the NOP was held in February 1999. A State organic certifiers meeting to discuss State issues was held at a March 2000 meeting with the National Association of State Organic Programs. USDA also drew extensively on the expertise of States and the organic industry by working closely with the National Organic Standards Board. The Board met 12 times before publication of the proposed rule on December 16, 1997, and met five times during 1998 and 1999 and two times in 2000. States were invited to attend each of these meetings, and official State certifier representatives participated in Board deliberations in meetings held in July 1998, July 1999, and March 2000. Public input sessions were held at each meeting to gather information from all interested persons, including State and local jurisdictions. NOP staff also received comments and consulted with States at public events. They made presentations, received comments, and consulted with 549 States at local and regional organic conferences and workshops and at national and international organic and natural food shows. States were consulted in training sessions held for organic inspectors, as well as numerous question and answer sessions at speaking engagements of the Agricultural Marketing Service ( AMS) Administrator, the NOP Program Manager, and NOP staff. In addition, during August and September 2000, the Administrator and NOP staff engaged in extensive efforts to discuss the proposed rule. While many organizations declined opportunities for these briefings, AMS staff did meet with the National Conference of State Legislatures ( NCSL) and, at their request, in lieu of a meeting, provided information to the National Governor's Association ( NGA). NGA and NCSL representatives stated they were aware of the development of the final rule but offered no comments during these consultations beyond those submitted by the individual States during the proposed rule's comment period. In addition, between August and October 2000, NOP staff had telephone or e­ mail contact with the State organic program directors or other State department of agriculture representatives in 25 States to determine the scope and status of each State's organic program in the context of the issuance of the final rule. These State representatives stated that they were eagerly awaiting the publication of the final rule and had already begun adjusting their programs to conform with the March 2000 proposed rule in anticipation of the publication of the final rule. Finally, States have had the opportunity to comment on two proposed rules. More than 275,000 comments were received on the first proposal, and 40,000 on the second proposed rule including extensive comments from twelve State departments of agriculture, one State legislator, two members of Congress, and the National Association of State Organic Programs. 550 Through this outreach and consultation process, States have both provided general feedback to the rule and expressed several specific concerns about how this rule will affect State programs. Overwhelmingly, States were extremely supportive of the March 2000 proposed rule. With a few exceptions, most notably who should bear the cost of enforcement of an SOP, States are supportive of the Federal legislation. We did not receive a single comment from a State that indicated that there should not be a national organic program. The most prevalent issues they raised regarding the March 2000 proposed rule as to how this rule will affect organic programs in their States, along with USDA's response, are described below. We received no direct comments from States on the Federalism section in the proposed rule. Many of these concerns and others are addressed in more detail in the relevant sections of the rule. Applicability Regarding section 205.100( b), five States currently offer a " transition to organic" label for producers who are in the process of becoming certified. Many of these States would like to continue to offer this label. However, OFPA does not authorize a " transition to organic" label. Although the States ( or private certifiers) are free to come up with a different label for these farmers, they cannot utilize the term, organic," in any seal or labeling associated with the conversion period. There is no change in this provision from the proposed rule. Accreditation Regarding section 205.501( a), many States wanted the NOP to add an additional subsection to the Accreditation section requiring certifiers to prove that they can carry out a 551 State's more restrictive standards in order to be accredited to certify in that State. AMS concurs with this suggestion and has added a new paragraph 205.502( a)( 20) requiring the certifying agent to demonstrate its ability to comply with a State's additional requirements. Regarding section 205.501( b), there was strong support by all of the States for the provision that States with SOP's are able to have higher standards than the NOP for operations within their State. However, there was not consensus among the States on the prohibition on private certifiers requiring more stringent standards. Although most supported the prohibition on private certifiers imposing additional requirements as a condition of certification because they perceived that it lowered barriers to farmers and processors in their States, three States were strongly opposed to this provision. Because having a consistent national standard is one of the primary purposes of the legislation, there is no change in this provision from the proposed rule. State Programs There was general confusion about what is the difference between a State organic certification program and an SOP. In addition, some States wanted the scope of the NOP's oversight for State organic activities to be limited to certification. A State organic certification program is equivalent to a private or foreign certification program. States wishing to certify operations in their State must apply to the NOP for accreditation. An SOP, on the other hand, requires the State to submit a plan to the NOP for approval to, in effect, administer the NOP within their State. Included in this is the opportunity to include requirements that differ from the NOP. In creating an SOP, a State is also agreeing to take on enforcement activities that would otherwise be the responsibility of the NOP. One exception to a 552 State's enforcement authority is that States with SOP's do not have jurisdiction over the accreditation of certifying agents and cannot revoke accreditation. They can investigate and report accreditation violations to the NOP. States with only an accredited certification program are only responsible for the level of enforcement that all accredited certifying agents, State, private, or foreign, are required to take on. Regarding section 205.620( c), several States want broader language than " unique environmental conditions" to be the basis for a State to have the right to establish more restrictive requirements under an SOP. AMS does not concur. There is no change to this language in the final rule. It is the opinion of AMS that the current language is broad enough to cover the scope of more restrictive requirements as authorized by OFPA. Regarding section 205.620( d), many States want it to be optional for States with SOP's to take on enforcement obligations; several want funding from USDA for enforcement activities. AMS does not concur with this change. AMS does not envision that participation under the NOP will impose additional fiscal costs on States with existing organic programs, other than the costs of accreditation. Regarding section 205.621( b), several States commented that States with SOP's should not be required to publish proposed changes to their programs in the Federal Register for public comment. AMS concurs with this comment. This language was an oversight from the first proposed rule. Fees A few States commented that the proposed fees for accreditation could cost more than some States could afford to pay. They made some suggestions for reducing accreditation fees, 553 ranging from no fees ( a completely federally funded program) to charging reduced rates for travel or eliminating hourly charges. AMS has no plans to change the fee structure. As in the proposed rule, hourly charges for accreditation will be waived for all applicants in the first 18 months of the program to facilitate the conversion to a national accreditation system. Compliance Regarding section 205.665, several States wanted to know what their authority was to revoke the accreditation of private certifiers in their State who do not meet additional State standards under an SOP. An SOP's governing State official is authorized to review and investigate complaints of noncompliance with the Act or regulations concerning accreditation of certifying agents operating in their State. If they discover a noncompliance, they shall send a written report to the NOP program manager. Because accreditation is a Federal license, States do not have the authority to revoke a certifying agent's accreditation. There is no change in this section from the proposed rule Appeals Regarding section 205.668( b), several State commenters want appeals from SOP's to go to State district court rather than Federal district court. AMS disagrees. The Act provides that a final decision of the Secretary may be appealed to the U. S. District Court for the district in which the person is located. AMS considers an approved SOP to be the NOP for that State. As such, AMS considers the governing State official of such State program to be the equivalent of a representative of the Secretary for the purpose of the appeals procedures under the NOP. Because the final decision of the governing State official is considered the final decision of the Secretary, under the Act it is then appealable to the U. S. District Court, not the State district court. 554 Regarding section 205.680, State commenters want a process by which people who feel they were adversely affected by the organic program in a State with an SOP may appeal to the SOP's governing State official, rather than the Administrator. AMS has amended the language in section 205.680 to clarify to whom an appeal is made under various situations. If persons believe that they were adversely affected by a decision made by the NOP Program Manager, they appeal to the Administrator. If they were adversely affected by a decision made by a certifying agent ( State, private, or foreign), they appeal to the Administrator unless they are in a State with an SOP, in which case, they appeal to the SOP's governing State official. If persons believe that they were adversely affected by a decision made by a representative of an SOP, they appeal such decision to the SOP's governing State official or such official's designee.

epa

2024-06-07T20:31:44.330720

regulations

EPA-HQ-OPP-2002-0306-0001

Notice

The Association of American Pesticide Control Officials (AAPCO) State FIFRA Issues Research and Evaluation Group SFIREG; Notice of Public Meeting

70072 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Notices to review reports from some of its Committees/ Subcommittee, most likely including the following: ( a) Executive Committee Subcommittee Scientific and Technological Achievement Awards Subcommittee ( STAA) Recommendations on the Agency's FY2001 Scientific and Technological Achievement Awards Program: An SAB Report ( see 67 FR 44200 ( July 1, 2002), for further details). ( b) Environmental Economics Advisory Committee ( EEAC) Affordability: An SAB Report ( see 67 FR 46506 ( July 15, 2002), for further details). Please check with Ms. Diana Pozun ( see contact information below) prior to the meeting to determine which reports will be on the agenda as last minute changes can take place. Availability of Review Materials: Drafts of the SAB reports that will be reviewed at the meeting will be available to the public at the SAB website under the heading for the Executive Committee Public Teleconference, December 5, 2002, ( http:// www. epa. gov/ sab/ whatsnew. htm) approximately two weeks prior to the meeting. Charge to the Executive Committee: The focus of the EC review of these reports will be on the following questions: ( a) Has the SAB adequately responded to the questions posed in the Charge? ( b) Are the statements and/ or responses in the draft report clear? And ( c) Are there any errors of fact in the report? ( Note: In the case of the STAA report, the charge to the committee was to review over 100 scientific papers and make recommendations for awards. The draft report that will be available for comment at this meeting will only contain the description of the overall process and recommendations on that process. The actual award recommendations are embargoed until approved and processed by the Office of Research and Development. The final report that will be posted on the SAB website, once awards are announced, will include the complete list of recommended awards.) In accord with the Federal Advisory Committee Act ( FACA), the public and the Agency are invited to submit written comments on these three questions that are the focus of the review. Written comments should be received in the SAB Staff Office by November 27, 2002. Forward comments to Ms. Diana Pozun ( see contact information below). The SAB will have a brief period available for applicable public comment. Therefore, anyone wishing to make oral comments on the three focus questions above, but that are not duplicative of the written comments, should contact the Designated Federal Officer for the Executive Committee, Mr. A. Robert Flaak ( see contact information below). For Further Information Any member of the public wishing further information concerning this meeting or wishing to submit brief oral comments ( 3 minutes or less) must contact Mr. A. Robert Flaak, Designated Federal Officer, EPA Science Advisory Board ( 1400A), U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone ( 202) 564 4546; FAX ( 202) 501 0582; or via e­ mail at flaak. robert@ epa. gov. Requests for oral comments must be in writing ( e­ mail, fax or mail) and received by Mr. Flaak no later than noon eastern standard time on November 27, 2002. Written comments should be sent to: Ms. Diana Pozun, EPA Science Advisory Board, Mail Code 1400A, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460 ( Telephone ( 202) 564 4544, FAX ( 202) 501 0323; or via e­ mail at: pozun. diana@ epa. gov. Submission by e­ mail to Ms. Pozun will maximize the time available for review by the Executive Committee. Providing Oral or Written Comments at SAB Meetings It is the policy of the EPA Science Advisory Board to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA Science Advisory Board expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face­ to­ face meeting will be limited to a total time of 10 minutes ( unless otherwise indicated above). For teleconference meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than 15 minutes total. Deadlines for getting on the public speaker list for a meeting are given above. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the reviewers and public at the face­ toface meetings. Written Comments: Although the SAB accepts written comments until the date of the meeting ( unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the committee for their consideration. Comments should be supplied to the appropriate DFO at the address/ contact information noted above in the following formats: one hard copy with original signature, and one electronic copy via e­ mail ( acceptable file format: WordPerfect, Word, or Rich Text files ( in IBM PC/ Windows 95/ 98 format). Those providing written comments and who attend face­ to­ face meeting are also asked to bring 35 copies of their comments for public distribution. General Information Additional information concerning the EPA Science Advisory Board, its structure, function, and composition, may be found on the SAB Website ( http:// www. epa. gov/ sab) and in The FY2001 Annual Report of the Staff Director which is available from the SAB Publications Staff at ( 202) 564 4533 or via fax at ( 202) 501 0256. Committee rosters, draft Agendas and meeting calendars are also located on our website. Meeting Access Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Mr. Flaak at least five business days prior to the meeting so that appropriate arrangements can be made. Dated: November 13, 2002. Vanessa Vu, Director, EPA Science Advisory Board Staff Office. [ FR Doc. 02 29478 Filed 11 19 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPPT 2002 0306; FRL 7280 2] The Association of American Pesticide Control Officials ( AAPCO) State FIFRA Issues Research and Evaluation Group SFIREG; Notice of Public Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: The State Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA), Issues Research and Evaluation Group ( SFIREG) will hold a 2 day meeting, beginning on December 9, 2002 and ending December 10, 2002. This notice announces the location and times for the meeting, and sets forth the tentative agenda topics. DATES: The meeting will be held on Monday, December 9, 2002, from 8: 30 a. m. until 4 p. m. ( A CLOSED SESSION 4 p. m. until 5 p. m.) and Tuesday, December 10, 2002 from 8: 30 a. m. until noon. VerDate 0ct< 31> 2002 16: 46 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20NON1. SGM 20NON1 70073 Federal Register / Vol. 67, No. 224 / Wednesday, November 20, 2002 / Notices ADDRESSES: The meeting will be held at Doubletree Hotel, 300 Army Navy Drive, Arlington, VA FOR FURTHER INFORMATION CONTACT: Georgia McDuffie, Field and External Affairs Division ( 7506c), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 605 0195; fax number: ( 703) 308 1850; email address: mcduffie. georgia@ epa. gov. or Philip H. Gray, SFIREG Executive Secretary, P. O. Box 1249, Hardwick, VT 05843 1249; telephone number: ( 802) 472 6956; fax ( 802) 472 6957; e­ mail address: aapco@ plainfield. bypass. com. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to `` those persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug and Cosmetic Act ( FFDCA), or the FIFRA''. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP 2002 0306. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Tentative Agenda: 1. Committee Business Issues. 2. Regional Reports & Introduction of Issue Papers/ Action Items. 3. Comments to the Committee/ Open Discussion with EPA Senior Managers ( To be determined). 4. Worker Protection Standard ( WPS) Program Element Review Update. 5. Non­ English/ Multiple Language Labels. 6. Tribal Pesticide Program Council ( TPPC)/ Section 18s & other Tribal Issues. 7. Update on Current OPP & OECA Activities. 8. SFIREG Issue Paper Status Report. 9. Closed Session. 10. Pesticide Regulatory Education Program ( PREP) Briefing/ Issues. 11. Soybean Rust Pest/ Section 18s Requests. 12. Status ( SLA) Label Improvement Project Proposals i. e. Mosquito Products/ West Nile virus Issues 13. States Label Issue Tracking System ( SLITS) Update 14. Certification Training Assessment Group ( CTAG) Update & Discussion 15. Issue Papers/ Past & Present List of Subjects Environmental protection, Pesticide and pests. Dated: November 6, 2002. Jay Ellenberger, Associate Director, Field and External Affairs Division, Office of Pesticide Programs. [ FR Doc. 02 29171 Filed 11 19 02; 8: 45 a. m.] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0126; FRL 7184 7] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0126, must be received on or before December 20, 2002. ADDRESSESS: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0126 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Registration Division, Office of Pesticide Programs, ( 7505C) Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 6224; e­ mail address: miller. joanne@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop productionmption 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing VerDate 0ct< 31> 2002 16: 46 Nov 19, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 20NON1. SGM 20NON1

epa

2024-06-07T20:31:44.697419

regulations

EPA-HQ-OPP-2002-0307-0001

Notice

Organophosphate Pesticide; Availability of Naled Interim Risk Management Decision Document

77783 Federal Register / Vol. 67, No. 244 / Thursday, December 19, 2002 / Notices [ FR Doc. 02 31901 Filed 12 18 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ FRL 7423 6] EPA Science Advisory Board, Notification of Public Advisory Committee Meeting; Contaminated Sediment Science Plan Review Panel Pursuant to the Federal Advisory Committee Act, Public Law 92 463, notice is hereby given that the Contaminated Sediment Science Plan Review Panel ( CSSP Review Panel) of the U. S. Environmental Protection Agency's ( EPA) Science Advisory Board ( SAB) will meet via teleconference on January 6, 2003, from 3 p. m. to 5 p. m. eastern time. This teleconference meeting will be hosted out of Conference Room 6013, USEPA, Ariel Rios Building North, 1200 Pennsylvania Avenue, NW., Washington, DC 20004. The meeting is open to the public, but, due to limited space, seating will be on a first­ come basis. The public may also attend via telephone, however, lines may be limited. Information on how to participate is given below. Background The background for this review and the charge to the CSSP Review Panel were published in the Federal Register ( 67 FR 49336, July 30, 2000). The notice also included a draft charge to the CSSP Review Panel, a call for nominations for members of the CSSP Review Panel in certain technical expertise areas needed to address the charge and described the process to be used in forming the CSSP Review Panel. Subsequently, notice was published ( 67 FR 61622, October 1, 2002) of three meetings that have since been convened: a teleconference on October 17, 2002, a meeting in Washington, DC on October 30 and 31, 2002, and another teleconference on November 22, 2002. Details on the activities of the CSSP Review Panel can be found on our Web site at: http:// www. epa. gov/ sab/ panels/ cssprpanel. html. Purpose of this Meeting The purpose of this public teleconference meeting is for the CSSP Review Panel to: ( a) Review and revise the panel's draft report as necessary; and ( b) approve the report as revised for delivery to the SAB Executive Committee. For Further Information To inquire about public participation in the meeting identified above please contact Mr. Lawrence Martin, Designated Federal Officer, CSSP Review Panel, USEPA Science Advisory Board ( 1400A), Suite 6450DD, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone/ voice mail at ( 202) 564 6497; fax at ( 202) 501 0323; or via e­ mail at martin. lawrence@ epa. gov. Members of the public desiring additional information about the meeting locations or the call­ in number for the teleconference, must contact Mr. Martin at the addresses and numbers identified above. Submitting Public Comments The SAB will have a brief period ( no more than 10 minutes) available during the Teleconference meeting for applicable public comment. For the Teleconference, the oral public comment period will be divided among the speakers who register. Registration is on a first come basis. Speakers who have been granted time on the agenda may not yield their time to other speakers. Those wishing to speak but who are unable to register in time may provide their comments in writing. Requests for oral comments must be in writing ( e­ mail, fax or mail) and received by Mr. Martin at the address above no later than noon eastern time on December 30, 2002. Availability of Review Material There is one primary document that is the subject of the review. This review document is available electronically at the following site http:// www. epa. gov/ sab/ panels/ cssprpanel. html. For questions and information pertaining to the review document, please contact Dr. Lee Hofmann, Office of Solid Waste and Emergency Response ( OSWER), Mail Code 5103T, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460 at telephone number 202 566 1928, or by e­ mail at: hofmann. lee@ epa. gov. The Panel's draft report, which will be the topic for the January 6 teleconference, will be available on December 20 at the following site: http:// www. epa. gov/ sab/ panels/ cssprpanel. html. Providing Oral or Written Comments at SAB Meetings It is the policy of the EPA Science Advisory Board to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA Science Advisory Board expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face­ to­ face meeting will be limited to a total time of 10 minutes ( unless otherwise indicated above). For teleconference meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than 15 minutes total ( unless otherwise indicated above). Deadlines for getting on the public speaker list for a meeting are given above. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the reviewers and public at the meeting. Written Comments: Although the SAB accepts written comments until the date of the meeting ( unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the review panel for their consideration. Comments should be supplied to the appropriate DFO at the address/ contact information noted above in the following formats: One hard copy with original signature, and one electronic copy via e­ mail ( acceptable file format: Adobe Acrobat, WordPerfect, Word, or Rich Text files ( in IBM PC/ Windows 95/ 98 format). Those providing written comments and who attend the meeting are also asked to bring 35 copies of their comments for public distribution. Meeting Access Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Mr. Martin at least five business days prior to the meeting so that appropriate arrangements can be made. General Information Additional information concerning the EPA Science Advisory Board, its structure, function, and composition, may be found on the SAB Web site ( http:// www. epa. gov/ sab) and in the Science Advisory Board FY2001 Annual Staff Report which is available from the SAB Publications Staff at ( 202) 564 4533 or via fax at ( 202) 501 0256. Dated: November 9, 2002. A. Robert Flaak, Acting Director, EPA Science Advisory Board Staff Office. [ FR Doc. 02 31905 Filed 12 1 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0307; FRL 7281 1] Organophosphate Pesticide; Availability of Naled Interim Risk Management Decision Document AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the availability of the interim risk VerDate 0ct< 31> 2002 20: 06 Dec 18, 2002 Jkt 200001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19DEN1. SGM 19DEN1 77784 Federal Register / Vol. 67, No. 244 / Thursday, December 19, 2002 / Notices management decision ( IRED) document for the organophosphate pesticide naled. This decision document has been developed as part of the public participation process that EPA and the U. S. Department of Agriculture ( USDA) are now using for involving the public in the reassessment of pesticide tolerances under the Food Quality Protection Act ( FQPA), and the reregistration of individual organophosphate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). DATES: The interim risk management decision document is available in the OPP Docket under docket ID number OPP 2002 0307. FOR FURTHER INFORMATION CONTACT: Tom Myers, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8589; e­ mail address: myers. tom@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, nevertheless, a wide range of stakeholders will be interested in obtaining the interim risk management decision document for naled, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides on food. Since other entities also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP 2002 0307. The official public docket consists of the document specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. For questions on the IRED in this document, contact the Chemical Review Manager listed under FOR FURTHER INFORMATION CONTACT. III. What Action is the Agency Taking? EPA has assessed the risks of naled and reached an IRED for this organophosphate pesticide. Provided that risk mitigation measures are adopted, naled fits into its own risk cup its individual, aggregate risks are within acceptable levels. Used mainly to control mosquitos and to control insects on a variety of agricultural crops, naled residues in food and drinking water do not pose risk concerns. Naled may no longer be used in and around the home by residents or professional applicators. However, residents can be exposed as bystanders from wide­ area mosquito control applications. With mitigation limiting homeowners' and children's exposure, naled fits into its own `` risk cup.'' With other mitigation measures, naled's worker and ecological risks are also below levels of concern for reregistration. The interim risk management decision document for naled was made through the organophosphate pesticide pilot public participation process, which increases transparency and maximizes stakeholder involvement in EPA's development of risk assessments and risk management decisions. The pilot public participation process was developed as part of the EPA USDA Tolerance Reassessment Advisory Committee ( TRAC), which was established in April 1998, as a subcommittee under the auspices of EPA's National Advisory Council for Environmental Policy and Technology. A goal of the pilot public participation process is to find a more effective way for the public to participate at critical junctures in the Agency's development of organophosphate pesticide risk assessments and risk management decisions. EPA and USDA began implementing this pilot process in August 1998, to increase transparency and opportunities for stakeholder consultation. EPA worked extensively with affected parties to reach the decisions presented in this interim risk management decision document, which conclude, the pilot public participation process for naled. As part of the pilot public participation process, numerous opportunities for public comment were offered as this interim risk management decision document was being developed. The naled interim risk management decision document, therefore, is issued without a formal public comment period concluding review of the individual organophosphate pesticide. The docket remains open, however, and any comments submitted in the future will be placed in the public docket. The risk assessments for naled were released to the public through notices published in the Federal Register on August 12, 1998 ( 63 FR 43175) ( FRL 6024 3), and October 6, 1999 ( 64 FR 54298) ( FRL 6387 6). EPA's next step under FQPA is to complete a cumulative risk assessment and risk management decision for the organophosphate pesticides, which share a common mechanism of toxicity. This interim risk management decision document on naled cannot be considered final until this cumulative assessment is complete. When the cumulative risk assessment for the organophosphate pesticides has been completed, EPA will issue its final tolerance reassessment decision for naled and further risk mitigation measures may be needed. List of Subjects Environmental protection, Chemicals, Pesticides and pests. Dated: December 7, 2002. Betty Shackleford, Acting Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02 31907 Filed 12 18 02; 8: 45 am] BILLING CODE 6560 50 S VerDate 0ct< 31> 2002 21: 31 Dec 18, 2002 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 19DEN1. SGM 19DEN1

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EPA-HQ-OPP-2002-0309-0004

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 5, 2002 MEMORANDUM SUBJECT: SUBJECT: OXADIAZON. Response to the 30­ day Error Only Comments on the HED Chapter of the Reregistration Eligibility Decision Document ( RED). PC Code: 109001, Case # 819425, Submission No. S610158, DP Barcode D280876 FROM: Nancy E. McCarroll, Toxicologist/ Risk Assessor Toxicology Branch Health Effects Division ( 7509C) THRU: Alberto Protzel, Ph. D., Branch Senior Scientist Toxicology Branch Health Effects Division ( 7509C) TO: Veronique La Capra, Chemical Review Manager Reregistration Branch II Special Review and Reregistration Division ( 7508W) Error only comments received from the registrant, Aventis on the preliminary Human Health Risk Assessment for the reregistration of Oxadiazon have been addressed in the revised HED Chapter of the RED. The revised document is attached and the revisions are as follows: Actions in Response to Aventis 30­ Day Error Only Comments ( Letter dated October 31, 2001) CBI Executive Summary The percent usages of Oxadiazon in the Executive Summary have been removed. Although not mentioned by the Registrant, percent usage items have also been removed from Section 4, 4.1 ( Exposure Assessment, Summary of Registered Uses, p. 21). Document Errors i) At the request of the Registrant, the name " Aventis Crop Science" ( Exec. Sum, para 1) has been changed and now reads Aventis Environmental Science. Although not mentioned by the Registrant, the name has also been changed on pp. 9, 21 and 43. ii) Aventis states that the reference to use areas of oxadiazon as being apartment / condo lawns was an error on the part of Aventis and requests that it be removed. This information has not been deleted because apartment/ condo lawn usage appears on labels other than those prepared by Aventis. iii) Aventis states that the commercial landscape use making­ up the 12% is non­ residiential and requests that this statement be removed. Within the category, HED considers " residential outdoors" as possibly including apartment/ condo lawns, parks, playing fields and cemeteries. The sentence has been revised as follows to reflect this consideration: In addition, oxadiazon may be applied by commercial operators to landscapes ( which could include residential landscapes such as apartment/ condo lawns, parks, playing fields and cemeteries), and these use patterns indicate a potential non­ occupational exposure for adults and children. cc: Margaret Stasikowski Lois Rossi Elizabeth Doyle Tom Myer HUMAN HEALTH RISK ASSESSMENT FOR OXADIAZON PC Code No. 109001 U. S. Environmental Protection Agency Office of Pesticide Programs Health Effects Division ( 7509C) Nancy McCarroll, Risk Assessor 2 OXADIAZON RISK ASSESSMENT TABLE OF CONTENTS 1.0 Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 2.0 Physical/ Chemical Properties Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 3.0 Hazard Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.1 Hazard Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 3.2 FQPA Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 3.3 Dose Response Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 4.0 Exposure Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.1 Summary of Registered Uses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 4.2 Dietary Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.2.1 Food Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.2.2 Water Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.2.2.1 Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.2.2.2 Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 4.3 Occupational Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.3.1 Handler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.3.1.1 Noncancer Handler Exposures/ Risks . . . . . . . . . . . . . . . . . . . . . 24 4.3.1.2 Cancer Handler Exposures/ Risks . . . . . . . . . . . . . . . . . . . . . . . . 27 4.3.2 Occupational Postapplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 4.3.2.1 Data Sources and Assumptions for Scenarios Considered . . . . . 31 4.3.2.2 Postapplication Exposure Risk Estimates . . . . . . . . . . . . . . . . . . 32 4.3.3 Non­ Occupational Postapplication Exposures with Risk . . . . . . . . . . . . . 32 4.3.3.1 Non­ occupational Postapplication Dermal Exposure ( Adults and Toddlers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 4.3.3.1.1 Data Sources and Assumptions for Scenarios Considered . . . . . . . . . . . . . . . . . . . 34 4.3.3.1.2 Non­ occupational Postapplication Dermal Exposure Risk Estimates . . . . . . . . . . . . . . . . . . 34 4.3.3.2 Incidental Oral Exposure for Toddlers . . . . . . . . . . . . . . . . . . . . 35 4.3.4 Incident Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 5.0 Aggregate Risk Assessments and Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 5.1 DWLOCs for Acute Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 5.2 DWLOCs for Chronic Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 5.3 DWLOCs for Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 5.4 Aggregate Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 3 6.0 Cumulative Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 7.0 Endocrine Disruption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 8.0 Data Needs/ Label Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 8.1 Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 8.2 Product and Residue Chemistry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 8.3 Occupational and Residential Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 9.0 Attachments. . . . . . . . . . . . . . . . . . . . . . . . . . .......................................................................... 45 1 No Observable Adverse Effect Level 4 1.0 EXECUTIVE SUMMARY The Agency has conducted a human health risk assessment for the active ingredient oxadiazon, [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ delta 2­ 1,3,4­ oxadiazolin­ 5­ one], for the purpose of making a reregistration eligibility decision. Oxadiazon is a selective pre­ emergent and early post emergence herbicide registered to control annual grasses and broadleaf weeds. The trade name for oxadiazon in the U. S. is Ronstar ® . The Registrant, Aventis Environmental Science is supporting use of oxadiazon on turf ( e. g., golf courses, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries) and ornamentals ( Gorrell, 2001). Like other oxadiazoles, it displays light­ dependent phytotoxicity through the inhibition of protoporphyrinogen oxidase, an enzyme critical in the biosynthesis of chlorophyl and heme. Accumulation of protoporphyrin IX following exposure to oxadiazon has been demonstrated in plants, yeast and mouse liver mitochondria. Aventis is not supporting any tolerances for oxadizon in the United States ( Gorrell, 2001). There is also no CODEX ( Canadian or Mexican tolerances) for oxadiazon ( Piper, 2001a). The request for revocation of tolerances for residues of oxadiazon on food and feed has been granted and tolerances will be revoked ( Piper, 2001b). Since only the non­ food uses of oxadiazon on turf and ornamentals will be retained, it has been determined that a Food Quality Protection Act ( FQPA) assessment was not required. Based on the current and anticipated use patterns, dietary risk assessments are also not required. Oxadiazon is applied via hand held sprayers, manual spreaders and tractor­ drawn equipment. Aerial application was voluntarily canceled by the Registrant. This pesticide can be applied at a frequency of 1 to 3 applications per season and at an application rate of 2.0 to 4.0 pounds ai/ acre. Use sites include golf courses, roadsides and nurseries. In addition, oxadiazon may be applied by commercial operators to landscapes ( which could include residential landscapes such as apartment/ condo lawns, parks, playing fields and cemeteries), and these use patterns indicate a potential non­ occupational exposure for adults and children. Two formulations are available: wettable powder and granular. Oral toxicity is well characterized for oxadiazon but dermal and inhalation toxicity are not. Accordingly, the short and intermediate­ term toxicological endpoints selected for the dermal and inhalation risk assessments were based on an oral endpoint from a rat developmental study. In this study, a NOAEL1 of 12 mg/ kg/ day was selected based on an increased incidence of fetal loss. A dermal absorption rate of 9% was applied to the dermal risk assessments and a 100% absorption rate was applied to the inhalation risk assessments. In both subchronic and chronic studies, the major target organ of oxadiazon is the liver. Effects were consistent among the species tested ( rat, dog, mouse) and typically included enlarged livers along with increases in serum clinical chemistry parameters associated with hepatotoxicity. The hematopoietic system also appeared to be a target of oxadiazon in all three species, based on mild 2 Metabolism Assessment Review Committee 3 Health Effects Division 4 Margin of Exposure 5 Personal Protective Equipment 5 anemia ( reductions in RBC, hematocrit and/ or hemoglobin). This is consistent with its ability to inhibit protoporphyrinogen oxidase. In a rat metabolism/ pharmacokinetic study, oxadiazon was extensively metabolized, primarily via hydroxylation and glucuronide conjugation. The MARC2 concluded, however, that the only residue of concern is the parent compound, oxadiazon because major degradates would only be minor components in the enviroment and are not likely to be significantly more toxic than the parent ( Piper, 2001b). The Office of Pesticide Programs ( OPP) Carcinogenicity Peer Review Committee ( CARC) has classified oxadiazon as " likely to be carcinogenic to humans" based on the combined incidence of male mouse liver adenoma and/ or carcinoma rates in the ICR­ JCL mouse strain. A quantitative risk ( Q1*) of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents was used for the human health risk assessments. Findings from reproduction and developmental toxicity studies indicate that there is no quantitative evidence of increased susceptibility of rats or rabbits following in utero or postnatal exposure to oxadiazon. Similarly, there is no evidence of neurobehavioral alterations, neuropathological effects or neurodevelopmental potential in any of the available toxicity studies. HED3 has determined that there are potential exposures to occupational mixers, loaders, applicators, or other occupational handlers during standard use­ patterns associated with oxadiazon. Fourteen major exposure scenarios were identified for occupational exposure of handlers. These scenarios include mixing, loading and applying through the use of ground spray, granular and lawn application methods. The exposure scenarios are of short­ term ( 1­ 7 days) and intermediate­ term ( 1 week to several weeks); use patterns do not indicate any long­ term use. The target MOE4 of 100 for occupational exposure scenarios was selected based on the uncertainty factors of 10x for intraspecies variation and a 10x for interspecies extrapolation. Since the effects from dermal and inhalation exposure are based on the same oral study ( i. e., rat developmental study), the doses for these routes and durations were aggregated. Calculation of non­ cancer occupational risk based on combined dermal and inhalation exposure indicates that with the exception of one scenario [ i. e., low pressure handwand ­ wettable powder formulations ( with the feasible level of mitigation)], all other potential exposure scenarios provide at least one application rate with total MOEs 100 at baseline or with PPE5 or engineering controls. Dermal exposure, rather than inhalation exposure, appears to be the main contributor to the total MOE for the low pressure handwand ­ wettable powder formulation scenario as well as the majority of occupational exposures. 6 Turf Transferable Residue 6 Cancer risks for occupational dermal and inhalation exposures range from 1.65E­ 2 to 4.66E­ 7 at baseline, 1.05E­ 3 to 1.38E­ 7 with PPE or 4.92E­ 5 to 1.10E­ 8 with engineering controls. Overall, these data suggest that none of the evaluated scenarios have cancer risks that exceed 1.00E­ 4 ( the Agency's level of concern for occupational cancer risk begins at
1.00E­ 4 with all attempts to mitigate risks to
1.00E­ 6, when possible). Postapplication contact of workers with oxadiazon is generally minimal because of the use sites ( turf, conifer nurseries, sod farms, landscape­ industrial sites or herbaceous ornamental crops early in the season, either pre­ plant or before weeds) and the mechanization ( machine harvesting and mowing) utilized in cultivating these crops reduces the postapplication contact of workers with oxadiazon. Nevertheless, the Agency has ascertained that there are potential postapplication exposures to individuals re­ entering treated areas associated with the following scenarios: mowing roadsides, Bermuda grass right­ of­ ways, sod farms and golf courses as well as harvesting sod farms. Since oxadiazon is not volatile ( has a low vapor pressure of 1.0x10­ 6 mm Hg) and is used outdoors, the inhalation component of postapplication exposure is anticipated to be negligible. Hence, the dermal route is the route of consequence. For short and intermediate­ term occupational non­ cancer risks, transplanting and/ or harvesting weeds either manually or mechanically, had MOEs ( 30) that failed to meet the target MOE of 100. All other occupational postapplication activities had MOEs of 1000. Cancer risks for occupational postapplication scenarios were estimated not to exceed HED's level of concern ( i. e.,
1.00E­ 4). The oxadiazon labels indicate that use of this pesticide is limited to licensed operators and the product is not available to homeowners. However, there are potential postapplication dermal exposures to adults and toddlers entering oxadiazon­ treated lawns and potential postapplication risks to toddlers from incidental ingestion of turfgrass and/ or " hand­ to­ mouth" exposure when entering lawns treated with the granular and wettable powder formulations. For these assessments, the duration of postapplication dermal exposure is expected to be either short­ term or intermediate­ term, based on oxadiazon turf residue dissipation data. The short­ term and intermediate­ term MOEs for dermal exposures were calculated using a NOAEL of 12 mg/ kg/ day; this value was derived from the same developmental rat study used for the occupational handler noncancer exposures. For the cancer risk estimates, the Q1* of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents was used. Results show that all non­ cancer dermal scenarios developed for adults and toddlers had short­ term and intermediate­ term dermal MOEs greater than 100. The cancer risks for all adult residential dermal postapplication exposures fell between 1.59x 10­ 5 to 7.51 x 10­ 7. Estimated incidental oral exposure (" hand­ to­ mouth") for toddlers had an MOE of 100 using the TTR6 default values from the residential SOP. When the TTR data from the submitted oxadiazon study were used, however, the MOEs were 90 to 240. The former MOE does not exceed the target 7 Estimated Drinking Water Concentrations 8 Drinking Water Levels of Concern 9 Risk Assessment Committee 7 value of 100; nonetheless, the TTR data from the submitted study were for the wettable powder formulation and the major use of oxadiazon is with the granular formulation. It is probable, therefore, that the risk indicated when the TTR data from the submitted study were applied, is an overestimate and not likely to be a cause for concern. MOEs were not calculated for the incidental ingestion of oxadiazon granules because an acute RfD was not selected for this non­ food use pesticide. Additionally, there is no indication from the studies in the guideline database that a single oral exposure to oxadiazon presents a hazard. This statement is also supported by the high rat acute oral LD50 for oxadiazon (> 5,000 mg/ kg). It is thought, therefore, that the incidental ingestion of granules is not likely to be a cause for concern. Monitoring data for oxadiazon residues in surface and ground water were not available. Consequently, potential exposures and risks from oxadiazon residues in unfinished drinking water were assessed using Tier 1 FIRST ( surface waters) and SCI­ GROW ( ground water) modeling estimates. For risk assessment purposes, surface water EDWCs7 of oxadiazon were an acute ( peak) value of 246 ppb (  g/ L) and an average annual value of 100 ppb (  g/ L). These values generally depict worst­ case scenarios, and represent the upper­ bound estimates of the concentration that might be found in surface water and ground water due to the use of oxadiazon on turf. These model estimates were compared to DWLOCs8, the theoretical concentration of pesticide in drinking water that would be an acceptable upper limit in light of the aggregate exposure to the pesticide from other sources. Results for acute DWLOC calculations show that acute exposure of each population ( U. S. population, females 13­ 50 years, children 1­ 6 years and infants) to residues of oxadiazon in surface and ground water are of no concern. For chronic DWLOCs, the U. S. population as a whole had a DWLOC value that exceeded the surface and ground water targets. The chronic DWLOC values derived for infants and children exceeded the EDWCs for ground water but not for surface water. Hence, the Agency has concerns for children chronically exposed to oxadiazon in drinking water derived from surface waters. In addition, EDWCs for both surface and ground water were higher than the cancer DWLOC; therefore, the cancer risk exceeds HED's level of concern for lifetime exposure to oxadiazon in surface and ground water. It should be noted, however, that EDWC values derived from the FIRST and SCI­ GROW models represent the compounding of several worst case scenarios. Similarly, the SCI­ GROW model used for the ground water analysis, is based on high concentrations observed in shallow ground water after agricultural treatment of permeable soils. Since this combination of conditions is encountered in only 1% of the agricultural use area in the U. S., it is not likely that oxadiazon would pose a potential cancer concern for exposure to oxadiazon in ground water ( Barrett, 1998). The RARC9 recommended that an aggregate risk assessment not be conducted on oxadiazon because the DWLOC values are based on conservative default values since no monitoring data were available on oxadiazon and the refined model for turf analysis is not completed at this time. 10 National Pesticide Telecommunication Network 8 In addition, data used to develop residential exposure estimates ( dermal exposure values) were also conservative because the highest mean postapplication TTR residue value from the submitted study along with the data from the wettable powder formulation were used . Thus, any aggregation of a conservative water number with a conservative residential exposure estimate would result in an even more conservative expression of aggregate risk. The RARC also noted that guidance from management on this issue is forthcoming. Oxadiazon has not been reported to cause life­ threatening illness or death in humans. Most of the cases appear to be related to irritation to the skin, eyes and mucous membranes. Some cases may be related to an allergic reaction. On the list of the top 200 chemicals for which NPTN10 received calls from 1984­ 1991 inclusively, oxadiazon was ranked 192nd with 12 incidents in humans reported and 5 incidents in animals ( mostly pets). In summary, the potential risks from occupational exposure to oxadiazon are generally below HED's level of concern. However, even with the feasible level of mitigation, there is one occupational exposure scenario ( i. e., low pressure handwand­ wettable powder formulations) and there are postapplication occupational exposures associated with transplanting and/ or harvesting weeds manually or mechanically that are of concern. HED also had concerns for chronic and lifetime exposure to oxadiazon in drinking water derived from surface and/ or ground water. 9 2.0 PHYSICAL/ CHEMICAL PROPERTIES CHARACTERIZATION Oxadiazon [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ delta­ 2­ 1,3,4­ oxadiazolin­ 5­ one] is a preemergence, early postemergence herbicide registered to control annual grasses and broadleaf weeds. Oxadiazon Empirical formula: C15H18Cl 2N2O 3 Molecular weight: 345.2 CAS Registry No.: 19666­ 30­ 9 PC Code: 109001 Oxadiazon is an odorless white crystalline powder with a melting point of 90 C, a density of 1.3 gm/ mL and it has a low solubility in water ( 0.0007 g/ L at 20 C). It is stable at normal and elevated temperatures ( at 55 C), stable in the presence of metals ( aluminum, iron and tin) and metal ions ( ferric chloride), and has a low vapor pressure ( 1.0x10­ 6 mm Hg). A single manufacturing use product ( MP) registered under the PC Code 109001 was identified as Aventis Environmental Science USA LP 94% technical ( T); only this Aventis 94% T is subject to the RED ( Dockter, 2001; Piper, 2001). The Registrant lists oxadiazon as not leaching and persistent in soil ( Dockter, 2001). Both the Product Chemistry and the Residue Chemistry databases for oxadiazon are complete. 10 3.0 HAZARD CHARACTERIZATION 3.1 Hazard Profile Oxadiazon is a selective pre­ emergent herbicide of the oxadiazole class. Like other oxadiazoles, it displays light­ dependent phytotoxicity through the inhibition of protoporphyrinogen oxidase. Accumulation of protoporphyrin IX following exposure to oxadiazon has been demonstrated in plants, yeast and mouse liver mitochondria. Details of the hazard assessment of oxadiazon can be found in the HED's Toxicology Disciplinary Chapter ( Hansen and McCarroll, 2001); major features of the toxicology profile are presented below. In acute studies, oxadiazon is only slightly toxic ( Toxicity Categories III or IV) with an oral LD 50 > 5000 mg/ kg, a dermal LD 50 > 2000 mg/ kg and an inhalation LC 50 > 1.94 mg/ L. Oxadiazon is mildly irritating to ocular tissue and negligibly irritating to the skin ( both Toxicity Category III) and is not a dermal sensitizer ( Table 1). Table 1. Acute Toxicity Data on Oxadiazon Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity ( rat) 41866501 ( 97.5% a. i.) LD50 > 5000 mg/ kg ,
combined IV 870.1200 Acute dermal toxicity ( rabbit) 41866502 ( 97.5% a. i.) LD50 > 2000 mg/ kg, ,
combined III 870.1300 Acute inhalation toxicity ( rat) 41866503 ( 93.7% a. i.) LC50 > 1.94 mg/ L ,
combined III 870.2400 Acute eye irritation ( rabbit) 41866504 ( 97.5% a. i.) Mild irritant to ocular tissues III 870.2500 Acute dermal irritation ( rabbit) 41866505 ( 97.5% a. i.) Negligibly irritating to skin III 870.2600 Skin sensitization ( guinea pig) 41230401 ( 93.7% a. i.) Not a dermal sensitizer ( Buehler test) ­­ 870.6200a Acute neurotoxicity screening battery ( rat) ND ­­ ­­ ND No data ­ not required for oxadiazon. The major target organ of oxadiazon is the liver. Effects were consistent among the species tested ( rat, dog, mouse) in both subchronic and chronic studies and typically included enlarged livers along with increases in serum clinical chemistry parameters associated with hepatotoxicity such as alkaline phosphatase and serum aspartate or alanine aminotransferase. Findings in rats and mice 11 Cancer Assessment Review Committee 11 included fatty changes, pigmented Kupffer cells and bile canaliculi and bile duct proliferation, periacinar swelling and pallor, increased acidophilic cells, hyperplasia and hepatocellular necrosis. No treatment­ related microscopic lesions were observed in the subchronic dog study and findings in the chronic study were only observed at the highest dose tested ( 200 mg/ kg/ day), where only two animals/ sex were assigned and one female was sacrificed in moribund condition. These findings included increased liver weight and hepatocellular histopathology ( centriacinar vacuolation, periacinar apoptosis and inflammation). The hematopoietic system also appeared to be a target of oxadiazon in all three species, based on mild anemia [ reductions in red blood cells ( RBC), hematocrit and/ or hemoglobin]. This is consistent with its its ability to inhibit protopotphyrinogen oxidase, an enzyme involved in the synthesis of both heme and chlorophyll. In addition to effects on the liver, increased pigmentation in the kidney was observed in rats, along with increased blood urea nitrogen ( BUN) and kidney weights. Although a dose­ dependent increase in thyroid weight was observed in the dog subchronic oral toxicity study and at the highest dose tested of the chronic dog studies, treatment­ related changes in thyroid weights or gross/ microscopic observations were not observed in other studies ( thyroid hormones were not evaluated). In general, males appeared to be slightly more sensitive to oxadiazon than females. Oxadiazon is not readily absorbed by the skin. In a rat dermal absorption study, up to
9% of the applied dose of technical oxadiazon was absorbed after 10 hours of exposure, this includes 2.65% absorbed and 6.07% which could be potentially absorbed. The 21­ day rabbit dermal toxicity study supports low dermal absorption: no toxicity was observed at the limit dose of 1000 mg/ kg/ day. Following long­ term dietary administration, oxadiazon caused an increased incidence of hepatocellular adenoma and carcinoma in rats and mice. Consistent findings were reported in a total of four acceptable studies in two species ( 2 mouse and 2 rat studies). A third mouse study was unacceptable, although increased hepatocellular tumors were also observed in mice of both sexes. In CD­ 1 mice, statistically significant increases of hepatocellular adenoma and combined adenoma/ adenocarcinoma were observed at all dose levels tested (  100 ppm) in both males and females. The incidence of hepatocellular carcinoma was increased at all doses in males but only at the two highest doses in females. The highest dose tested exceeded the maximum tolerated dose ( MTD) for males, based on excessive mortality. In ICR­ JCL mice, adenomas, carcinomas and combined adenomas/ carcinomas were increased in males at the two highest doses but only at the highest dose in females. In SPF Wistar rats, the incidence of hepatocellular adenomas, carcinomas and combined adenomas/ carcinomas was increased in males only. A second study in F344 rats showed a treatment­ related increase in the incidence of hepatocellular carcinoma and combined adenoma/ carcinoma only in males. A classification of " likely to be carcinogenic to humans" was assigned by the CARC11 using the EPA Draft Guidelines for Carcinogen Risk Assessment of July 1999 ( Diwan, 2001). A quantitative risk ( Q1*) of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 was calculated as the most potent unit risk, based on the incidence of male mouse liver adenoma and/ or carcinoma combined tumor rates in the ICR­ JCL mouse ( Brunsman, 2001). 12 Mechanism of Toxicity Assessment Review Committee 13 Hazard Identification Assessment Review Committee 12 In a special submitted mechanistic study in rats and a published study in rats, mice and dogs, oxadiazon induced peroxisomal proliferation ( based on liver enlargement, peroxisomal enzyme induction and electron microscopy) after a 14­ day dietary administration. Some peroxisomal proliferator compounds are known to be liver carcinogens, but the HED MTARC12 determined that there are insufficient data available to support this as a mechanism of carcinogenicity for oxadiazon due to insufficient data showing hepatocellular proliferation, lack of concordance between the enzyme induction dose­ response and tumor formation and an unexplained decrease in catalase, which is normally significantly increased by peroxisomal proliferator compounds ( McCarroll, 2001a). Oxadiazon did not show mutagenic potential in any in vitro assays with bacteria ( S. typhimurium and E. coli) or mammalian cells ( TK +/­ mouse lymphoma cells), did not show clastogenic potential in the in vitro Chinese hamster ovary cell chromosomal aberration assays and did not induce unscheduled DNA synthesis in cultured primary rat hepatocytes. However, a dose­ related increase in transformation frequencies was observed in an in vitro Syrian hamster kidney BHK21 C13/ HRC1 cell transformation assay. Significant fetal toxicity ( fetal loss due to resorptions and post­ implantation loss, decreased fetal weight, skeletal variations) was observed in developmental toxicity studies in both rats and rabbits. These fetal effects occurred at the same dose levels at which slight maternal toxicity ( decreased weight gain/ weight loss) were observed. Offspring survival effects were also observed in the rat two­ generation reproduction study. No toxicity was reported at the lowest dose tested; however, in the range­ finding phase of the reproduction study at higher dose levels, fetal and neonatal survival were also sharply reduced. The decreased neonatal survival was due at least in part to effects on lactation, based on findings of inactive mammary glands in the dams at necropsy. It is likely that neonatal loss may have resulted from starvation and would, therefore, be an effect of direct maternal toxicity. Inactivity of the mammary tissue as a possible effect of endocrine disruption was considered by the HIARC13 but was not found to be likely since there was no evidence from any other study in the database suggesting endocrine disruption ( McCarroll, 2001 b). No fetal malformations were observed in the rat or rabbit developmental toxicity studies; however, some skeletal variations ( delayed ossification, asymmetric pelvis) were reported. The above findings indicate that there is no quantitative evidence of increased susceptibility of rats or rabbits following in utero or postnatal exposure to oxadiazon. Neurotoxicity studies are not required for oxadiazon because no clinical signs of toxicity suggestive of neurobehavioral alterations nor evidence of neuropathological effects were observed in any of the available toxicity studies. There was no evidence for neurodevelopmental potential of oxadiazon in the rat and rabbit developmental toxicity studies, nor in the rat two­ generation reproductive toxicity study. 13 In a rat metabolism/ pharmacokinetic study, oxadiazon was extensively metabolized, primarily via hydroxylation and glucuronide conjugation. Eighteen ( 18) metabolites were identified in the urine and feces, of which 4 urinary and 5 fecal metabolites were present at levels greater than 1% of the dose. After 7 days,  83% of the administered dose was excreted in the urine and feces ( total recovery  94%) for all dose groups. Females excreted more radioactivity in the urine than males. The excretion of radioactivity into the urine and the feces was sex dependent and the tissue residues were very low in all tissues except liver and fat. Low doses ( 5 mg/ kg, single or multiple) of oxadiazon were completely absorbed, metabolized and excreted in the urine and feces and virtually no free oxadiazon was found in the urine. At this dose, the rates and routes of excretion of radioactivity were similar. At high dose ( 500 mg/ kg), the rate of excretion was affected but the route was not. Intact oxadiazon was present in feces only and was dose­ related: at the high dose, more than 53% of the administered radioactivity was intact oxadiazon in the feces; at 5 mg/ kg, not more than 4.8% of the dose was intact oxadiazon in the feces. Based on the available data, the MARC concluded that the only residue of concern is the parent compound, oxadiazon because major degradates would only be minor components in the enviroment and are not likely to be significantly more toxic than the parent ( Piper 2001b). Subchronic, chronic and other types of toxicity studies are summarized in Table 2. The only data gap that has been identified at this time is a 28­ day inhalation study ( OPPTS No. 870.3465). This study is not a guideline requirement for oxadiazon, but has been requested by the Agency because some currently registered products of oxadiazon include spray formulations ( McCarroll, 2001 b) which could result in exposure via the inhalation route. 3.2 FQPA Considerations From the available data, it was concluded that there is no quantitative evidence of increased susceptibility of rats or rabbits following in utero or postnatal exposure to oxadiazon. However, it has been determined that an FQPA assessment is not required because oxadiazon has no food or feed uses; the request for revocation of tolerances for residues of oxadiazon on food and feed has been granted and tolerances will be revoked ( Piper, 2001b). 14 Table. 2 Subchronic, Chronic and Other Toxicity Tables Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results SUBCHRONIC TOXICITY STUDIES 870.3100 90­ Day oral toxicity ( CD rat) 00111804 ( 1970) Acceptable/ guideline 0, 25, 100 or 1000 mg/ kg/ d ( diet) NOAEL = 25 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased body weight, increased liver weight, hematological changes and clinical chemistry and pathological changes associated with liver damage. 870.3150 90­ Day oral toxicity in ( Beagle dog) 00111805 ( 1970) Acceptable/ guideline 0, 25, 100 or 1000 mg/ kg/ d ( capsule) NOAEL < 25 mg/ kg/ day LOAEL 25 mg/ kg/ day based on increased thyroid weights in males. 870.3200 21­ Day dermal toxicity ( NZW rabbit) 41863602 ( 1991 ) Acceptable/ guideline 0, 100, 500 or 1000 mg/ kg/ day NOAEL
1000 mg/ kg/ day. LOAEL > 1000 mg/ kg/ day. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES 870.3700a Prenatal developmental ( SD rat) 40470202 ( 1987) Acceptable/ guideline 0, 3, 12 or 40 mg/ kg/ day ( gavage) Maternal NOAEL = 12 mg/ kg/ day. LOAEL = 40 mg/ kg/ day based on decreased body weight/ weight gain. Developmental NOAEL = 12 mg/ kg/ day LOAEL = 40 mg/ kg/ day based on increased fetal resorptions/ implantation loss, decreased pup weight and increased incidence of incomplete ossification. 870.3700b Prenatal developmental ( NZW rabbit) 40470201 ( 1987) Acceptable/ guideline 0, 20, 60 or 180 mg/ kg/ day ( gavage) Maternal NOAEL = 20 mg/ kg/ day LOAEL = 60 mg/ kg/ day based on transient weight loss during the first week of treatment. Developmental NOAEL = 60 mg/ kg/ day LOAEL = 180 mg/ kg/ day based on increased postimplantation loss and late resorptions, decreased fetal weight and increased bilateral hind­ limb flexure. 870.3800 Reproduction and fertility effects ( CD rat) 41239801 ( 1988) Acceptable/ guideline 0, 20, 60 or 200 ppm ( M/ F 0, 1.5/ 1.84, 4.65/ 5.63 or 15.50/ 18.20 mg/ kg/ day, premating) Parental/ Systemic NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( decreased gestational weight gain in RF study at 38 mg/ kg/ day). Reproductive NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( inactive mammary tissue, fetal/ neonatal mortality in the RF study at 38 mg/ kg/ day). Offspring NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( fetal/ neonatal mortality in the RF study at 38 mg/ kg/ day). Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 15 CHRONIC TOXICITY AND CARCINOGENICITY STUDIES 870.4100a Chronic toxicity ( rat) See 870.4300, Combined chronic toxicity/ carcinogenicity 870.4100b Chronic toxicity ( Beagle dog) 41326401( 1989) Acceptable/ guideline 0, 5, 20 or 60 mg/ kg/ day ( capsule) NOAEL = 5 mg/ kg/ day LOAEL = 20 mg/ kg/ day based on increased absolute and relative female liver weight accompanied by similar changes in liver weight for both sexes at 60 mg/ kg/ day. 870.4200 Carcinogenicity ( CD­ 1 mouse) 00044322 ( 1980) Unacceptable/ guideline 0, 300, 1000 or 2000 ppm ( M/ F 0, 48/ 62, 153/ 201 or 319/ 417 mg/ kg/ day), in diet NOAEL < 48 mg/ kg/ day LOAEL 48 mg/ kg/ day based on increased liver weight, serum enzymes related to liver damage and microscopic pathology in the liver of both sexes. Evidence of carcinogenicity­ increased incidence of hepatocellular carcinoma, both sexes at
48/ 62 mg/ kg/ day. 870.4200 Carcinogenicity ( CD­ 1 mouse) 00115733 ( 1982) Acceptable/ guideline 0, 100, 300, 1000 or 2000 ppm ( M/ F 0, 12/ 14, 37/ 44, 122/ 143 or 254/ 296 mg/ kg/ day), in diet NOAEL 12 mg/ kg/ day LOAEL < 12 mg/ kg/ day based on clinical signs, increased liver weights in males and increased microscopic pathology in the liver of both sexes. Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms ( adenoma, combined adenoma/ carcinoma) in both sexes at all doses tested ( carcinoma alone increased in all male groups and at
143 mg/ kg/ day in females). 870.4200 Carcinogenicity ( ICR­ JCL mouse) 40993301 ( 1987) Acceptable/ guideline 0, 3, 10, 100 or 1000 ppm ( M/ F 0, 0.315/ 0.278, 1.09/ 0.92, 10.6/ 9.3 or 113/ 99 mg/ kg/ day), in diet NOAEL = 1.09 mg/ kg/ day LOAEL = 10.6 mg/ kg/ day based on anemia and microscopic lesions in the liver and kidneys ( all in males). Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms ( adenomas, carcinomas and combined adenomas/ carcinomas in males at
10.6 mg/ kg/ day and in females at 99 mg/ kg/ day). 870.4300 Combined chronic toxicity/ carcinogenicity ( F344 rat) 00149003, 00157780 ( 1982, 1986) Acceptable/ guideline 0, 10, 100, 1000 or 3000 ppm ( M/ F 0, 0.5/ 0.6, 5.9/ 4.8, 50.9/ 60.9 or 163.1/ 192.7 mg/ kg/ day, in diet NOAEL = 0.5 mg/ kg/ day LOAEL = 4.8 mg/ kg/ day based on increased liver weights in both sexes and increased total serum protein in females. Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms in males ( adenomas and combined adenomas/ carcinomas in males at
50.9 mg/ kg/ day). Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 16 870.4300 Combined chronic toxicity/ carcinogenicity ( Wistar rat) 40993401 ( 1987) Acceptable/ guideline 0, 3, 10, 100 or 1000 ppm ( M/ F 0, 0.106/ 0.131, 0.36/ 0.44, 3.5/ 4.2 or 39/ 44 mg/ kg/ day) NOAEL = 0.36 mg/ kg/ day LOAEL = 3.5 mg/ kg/ day based on increased incidence of hepatocellular centrilobular swelling in males. Evidence of carcinogenicity­ increased incidence of hepatocellular neoplasms in males ( adenomas and combined adenomas/ carcinomas at
4.2 mg/ kg/ day and carcinomas at 39 mg/ kg/ day). MUTAGENICITY AND CELL TRANSFORMATION STUDIES 870.5100 Gene Mutation Bacterial reverse gene mutation assay and 870.5500 Bacterial DNA Repair Assay 00069893 ( 1976) Acceptable/ guideline S. typhimurium and E. coli 100­ 2500 and 10­ 1000  g/ plate w/ o S9 and 10­ 1000  g/ plate w/ S9. B. subtilis 20­ 2000  g/ plate w/ o S9. Negative in S. typhimurium strains TA1535, TA1437, TA1538, TA98 and TA100; E. coli strain WP2 hcr­ and B. subtilis strains H17 and M45 ( cytotoxicity not observed ). 870.5100 Gene Mutation Bacterial reverse gene mutation assay 41871701 ( 1991) Acceptable/ guideline 50­ 5000  g/ plate w/ o or w/ S9. Negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 ( cytotoxicity observed at
3330  g/ plate w/ o S9 but not w/ S9). Insoluble at
500  g/ plate. 870.5300 Gene Mutation In vitro mammalian cell forward gene mutation assay 00115726 ( 1982) Acceptable/ guideline 15.6­ 1000  g/ mL ( Trial 1), 50­ 1000  g/ mL ( Trial 2), both w/ o S9; 3.91­ 62.5 ( Trial 1), 20­ 100 ( Trial 2) and 100­ 200  g/ mL ( Trial 3), all w/ S9. Negative in L5178Y TK+ mouse lymphoma cells ( cytotoxicity observed at 1000  g/ mL w/ o S9 and
200  g/ mL w/ S9). Insoluble at
62.5  g/ mL. 870.5300 Gene Mutation In vitro mammalian cell forward gene mutation assay 00115729 ( 1982) Acceptable/ guideline 31.3­ 1000  g/ mL w/ o S9 and 15.6­ 250  g/ mL w/ S9 Negative in L5178Y TK+ mouse lymphoma cells ( cytotoxicity observed at 1000  g/ mL w/ o S9 and 250  g/ mL w/ S9). Insoluble at 250  g/ mL. 870.5375 Cytogenetics In vitro mammalian cell chromosomal aberration assay 00115728 ( 1982) Acceptable/ guideline 2­ 2000  g/ mL w/ o S9; 0.667­ 2000  g/ mL ( Trial 1) and 200­ 600  g/ mL ( Trial 2), both w/ S9. Negative in Chinese hamster ovary ( CHO) cells ( cytotoxicity observed at 200  g/ mL w/ o S9 and 500  g/ mL w/ S9). Insoluble at 667  g/ mL w/ o S9 and 200  g/ mL w/ S9. Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 17 870.5375 Cytogenetics In vitro mammalian cell chromosomal aberration assay 00115730 ( 1982) Acceptable/ guideline 0.416­ 125  g/ mL ( Trial 1) and 12.5­ 75  g/ mL ( Trial 2), both w/ o S9; 1.25­ 125  g/ mL w/ S9 ( trial 2). Negative in Chinese hamster ovary ( CHO) cells ( cytotoxicity at 75  g/ mL w/ o S9 and 41.6  g/ mL w/ S9). Insoluble at 416  g/ mL. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 0073288 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg 100% oxadiazon Negative up to limit dose of 2000 mg/ kg, but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. No signs of toxicity were observed. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 0073289 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg Negative up to limit dose of 2000 mg/ kg , but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. No signs of toxicity were observed. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 00732890 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg 24865 RP ( 99%), an oxadiazon impurity Negative up to limit dose of 2000 mg/ kg, but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. Clinical signs of toxicity observed at
1000 mg/ kg including 2 deaths at 2000 mg/ kg. 870.5550 Other Effects Unscheduled DNA synthesis assay 00115723 ( 1982) Acceptable/ guideline 1.0 to 1000  g/ mL Negative in primary rat hepatocytes after 18 hrs ( cytotoxicity observed at 100­ 500  g/ mL). 870.5550 Other Effects Unscheduled DNA synthesis assay 00115727 ( 1982) Acceptable/ guideline 0.5 to 50  g/ mL Negative in primary rat hepatocytes after 18 hrs ( cytotoxicity observed at 50  g/ mL). Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 18 Nonguideline Other Effects In vitro cell transformation 00115703 ( 1982) Acceptable/ nonguideline 12.5­ 200  g/ mL w/ and w/ o S9 for technical oxadiazon; 25­ 400  g/ mL for recrystallized oxadiazon ( 100%) w/ S9 or w/ o S9. Positive, dose­ related induction of cell transformation above background levels observed w/ S9 and w/ o S9 activation in Syrian hamster kidney cells ( BHK21 C13/ HRC1 cells) for both technical and recrystallized oxadiazon. METABOLISM, DERMAL PENETRATION AND SPECIAL MECHANISTIC STUDIES 870.7485 Metabolism and pharmacokinetics ( Crl: CD( SD) BR rat) 42324701, 42663601 ( 1992, 1993) Acceptable/ guideline 5 mg/ kg 14C­ oxadiazon ( single dose), 5 mg/ kg ( 14­ day dose of oxadiazon + 1 dose of 14C­ oxadiazon, day 15) or 500 mg/ kg 14Coxadiazon ( gavage) At 5 mg/ kg, oxadiazon is completely absorbed, metabolized and excreted in urine and feces ( no parent compound in urine; < 5% in feces). At 500 mg/ kg, 53% of administered dose was excreted in feces as parent compound. For both groups,
83% of administered dose was excreted in urine and feces ( total recovery
94%) by 7 days' post­ dosing. Females tended to excrete more radioactivity in urine than males. Oxadiazon was metabolized primarily by hydroxylation and glucuronide conjugation, but benzene and pyrozolidine rings were not metabolized. A total of 18 metabolites were identified in urine and feces ( 4 urinary, 5 fecal metabolites present at > 1% of administered dose). 870.7600 Dermal penetration ( SD rat) 44588101( 1996) Acceptable/ guideline 5.45, 39.2 or 523  g/ cm2 ( exposure times of 0.5, 1, 2, 4, 10 or 24 hrs) Total absorption  9% of administered dose ( 96% a. i.) following 10 hr exposure ( 2.65% absorbed and 6.05% potentially absorbed by skin). Absorption but not dermal uptake saturated at 39.2 and 523  g/ cm2. Special studies ( nonguideline) ­ Peroxisomal proliferation ( SD rat) 42310001 ( 1991) Acceptable/ nonguideline 0, 20, 200 or 500 mg/ kg/ day in diet for 14 days NOAEL < 20 mg/ kg/ day. LOAEL = 20 mg/ kg/ day, based on increased peroxisomal enzyme ( palmitoyl CoA and acetylcarnitine transferase) activities. At 200 mg/ kg/ day, liver enlargement and at 500 mg/ kg/ day, ultrastructural changes ( peroxisomal proliferation and microsomal alterations) were also observed. However, catalase was decreased by treatment. NOAEL No Observable Adverse Effect Level LOAEL Lowest Observable Adverse Effect Level 3.3 Dose Response Assessment On December 7, 2000, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for oxadiazon with regard to the toxicological endpoint selection for use as appropriate in occupational/ residential 19 exposure risk assessments. Based on these deliberations, the HIARC concluded that neither an acute nor a chronic reference dose was required because there are no food or feed or anticipated food or feed uses for oxadiazon. The HIARC report, nevertheless, indicated that there are toxicological endpoints of concern for oxadiazon. A short­ term oral endpoint was selected for incidental oral exposure in children, using a No Observed Adverse Effect Level ( NOAEL) of 12 mg/ kg/ day based on a statistically significant decrease in maternal body weight gains at 40 mg/ kg/ day ( LOAEL) in a developmental study in rats ( McCarroll, 2001 b). For short­ term and intermediate dermal exposure, an oral endpoint was selected using a NOAEL of 12 mg/ kg/ day based on a statistically significant decrease in maternal body weight gains at 40 mg/ kg/ day ( LOAEL) in a developmental study in rats. For the long­ term dermal exposure, an oral endpoint was also selected using a NOAEL of 0.036 mg/ kg/ day, based on an increased incidence of hepatocellular centrilobular swelling in males at 3.5 mg/ kg/ day ( LOAEL) in a combined chronic/ oncogenicity feeding study in rats. The HIARC recommended that a dermal absorption factor of 9% ( rounded up from 8.7%) be used in the calculations, based on a dermal penetration study. Due to a lack of inhalation studies, the HIARC selected an endpoint from oral studies for inhalation risk assessments. For short and intermediate­ term inhalation exposure, the same oral study was chosen as for dermal exposure of this duration, with a NOAEL of 12 mg/ kg/ day. The same chronic/ oncogenicity feeding study in rats chosen for dermal exposure of this duration was selected for the long­ term inhalation exposure, with a NOAEL of 0.036 mg/ kg/ day. An absorption factor of 100% was applied for inhalation exposures. The target MOE of 100 for occupational and residential exposure scenarios was selected based upon 10x for intraspecies variation and 10x for interspecies extrapolation. Because the effects from dermal and inhalation exposure are the same, the doses for these routes and duration were combined. Dermal and incidental oral exposures for toddlers were also combined to reflect a total exposure burden. Since 1987, the Agency's decision on the carcinogenic potential of oxadiazon has been in concurrence with the Scientific Advisory Panel's ( SAP) classification of oxadiazon as a Group C carcinogen and the Q1* has been set at 1.4 x 10­ 1( mg/ kg/ day)­ 1 in human equivalents. Since that time, new chronic/ carcinogenicity data have been submitted and reviewed by the CARC. Based on this revisit, CARC has reclassified oxadiazon as a " Likely To Be Carcinogenic To Humans" ( Diwan, 2001). For the purpose of the lifetime cancer risk assessment by the Agency, the most potent unit risk, Q 1 *, is that for male mouse liver adenoma and/ or carcinoma combined tumor rates at 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents. All unit risks have been converted from animals to humans by use of the 3/ 4' s scaling factor ( Brunsman, 2001). The endpoints that were selected for this risk assessment are summarized in Table 3. 20 Table 3: Endpoints Selected by HIARC for Assessing Occupational and Residential Risks for Oxadiazon EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Incidental Oral, Short­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Incidental Oral, Intermediate­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Short­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Intermediate­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Long­ Term NOAEL= 0.36 Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Inhalation, Short­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, route­ to­ route extrapolation and a 100% absorption rate are applied Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Intermediate­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, route­ to­ route extrapolation and a 100% absorption rate are applied. Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). Route­ to­ route extrapolation and a 100% absorption rate aplied. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Cancer Q 1* of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 Significant increase ( pair­ wise and trend, p< 0.01) in liver adenomas and adenomas and/ or carcinomas combined in males at 9.3 mg/ kg/ day). Combined Chronic Feeding/ Carcinogenicity ­ Mouse MRID Nos. 40993301 21 4.0 EXPOSURE ASSESSMENT 4.1 Summary of Registered Uses Oxadiazon is applied as a pre­ plant or pre­ emergent herbicide on non­ food/ outdoor crops. The Registrant, Aventis Environmental Science is supporting use of oxadiazon on turf ( e. g., golf courses, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries) and ornamentals ( Gorrell, 2001). Aventis is not supporting any tolerances for oxadiazon in the United States ( Gorrell, 2001). There is also no CODEX ( Canadian or Mexican tolerances) for oxadiazon ( Piper, 2001a). The request for revocation of tolerances for residues of oxadiazon on food and feed has been granted and tolerances will be revoked ( Piper, 2001b). Occupational applications ( i. e., to turf and ornamentals) are made to established areas such as lawns or golf course greens prior to the emergence of the target plant species. The oxadiazon labels indicate that use of this pesticide is limited to licenced operators and the product is not available to homeowners. Residential/ non­ occupational applications by commercial operators are made to residential lawns, parks, cemeteries, schools, athletic fields and golf courses. The frequency of application ranges from 1 to 3 applications per season. Oxadiazon can be applied at a minimum application rate of 2.0 pounds of active ingredient ( ai) per acre up to a maximum application rate of 4.0 pounds ai/ acre to turf and ornamentals. Oxadiazon use sites are classified as nonfood sites ( i. e., primarily golf course greens), residential outdoor use, roadside and nurseries. The granular formulations account for the majority of oxadiazon that is used on turf. Occupational­ use sites include: Oxadiazon is registered for occupational­ use only on conifer nurseries, landscape ­ industrial sites, ornamental, roadside landscape planting, woody ornamental shrubs, vines and trees, herbaceous ornamental, and turf grass for lawns, fairways, and sod production. Residential/ Non­ occupational­ use sites include: Oxadiazon is registered for commercial use on lawns and turf grown in parks, playgrounds, athletic fields, cemeteries, schools and other residential ( i. e., residential buildings) areas. It is also used on sod farms and golf courses. Methods and types of equipment used: Chemigation, groundboom, rights­ of­ way sprayer, handgun sprayer, tractor drawn spreader, backpack sprayer, low pressure handwand, high pressure handwand, lawn handgun, belly grinder and push type spreader are examples of the application equipment associated with the use patterns for oxadiazon. ( Aerial application was voluntarily canceled by the registrant). 14 Estimated Environmental Concentrations 22 4.2 Dietary Exposure 4.2.1 Food Exposure There are no food or feed or anticipated food or feed uses for oxadiazon. The Registrant is not supporting any tolerances for oxadiazon in the United States ( Gorrell, 2001). There is also no CODEX ( Canadian or Mexican tolerances) for oxadiazon ( Piper, 2001a). The request for revocation of tolerances for residues of oxadiazon on food and feed has been granted and tolerances will be revoked ( Piper, 2001a). Consequently, dietary exposure is not a concern for this product. 4.2.2 Water Exposure The Enviromental Fate and Effects Division ( EFED) has provided a surface and groundwater analysis for oxadiazon ( Melendez, 2001). The MARC concluded that the only residue of concern is the parent compound, oxadiazon because major degradates would only be minor components in the enviroment and are not likely to be significantly more toxic than the parent ( Piper, 2001b). Thus, they are not likely to be a concern in surface or ground water. Based on environmental fate characteristics, potential exposures and risks from oxadiazon residues in unfinished drinking water were assessed using Tier 1 FIRST ( surface waters) and SCIGROW ( ground water) modeling estimates. For risk assessment purposes, surface water EDWCs14 of oxadiazon were an acute ( peak) value of 246 ppb (  g/ L) and an average annual value of 100 ppb (  g/ L). These values generally depict worse­ case scenarios, and represent the upper­ bound estimates of the concentration that might be found in surface and ground water due to the use of oxadiazon on turf. In the absence of oxadiazon monitoring data, unique turf characteristics ( i. e., turf offers a vegetation interception layer that prevents rapid deposition of pesticides onto the surface of soil and promotes runoff) have been considered in the rationale for developing EDWCs. 4.2.2.1 Surface Water For drinking water originating in surface water bodies, an acute concentration of 246  g/ L was used to evaluate the risk to human health. This amount represents the high­ end value that might be found in a small drinking water reservoir. A chronic value of 100.0  g/ L was used to evaluate the chronic and cancer risk to human health. 4.2.2.2 Ground Water For drinking water originating in ground water, the SCI­ GROW model provided a value of 0.59  g/ L to evaluate the risk to human health. This value represents the ground water concentration of oxadiazon at the maximum allowable rate ( 2 applications/ year of 4lb. ai/ acre). It also assumes that the ground water is exceptionally vulnerable to contamination. This estimate is applied to all exposure 15 Outdoor Residential Exposure Task Force 16 Lawn Care Operator 23 scenarios regardless of the duration of exposure since SCI­ GROW calculates only the 90­ day average value. 4.3 Occupational Exposure HED has determined that there are potential exposures to mixers, loaders, applicators, or other handlers during standard use­ patterns associated with oxadiazon. Although postapplication contact of workers with oxadiazon is minimal, the Agency has ascertained that there are potential postapplication exposures to individuals re­ entering treated areas associated with mowing and harvesting. 4.3.1 Handler The Agency has found that occupational exposure to oxadiazon via the dermal and inhalation routes of exposure may occur during mixing, loading and applying through the use of ground spray, granular and other lawn application methods. Based on the use patterns, 14 major occupational exposure scenarios were identified for oxadiazon: ( 1a) mixing/ loading wettable powders for chemigation application; ( 1b) mixing/ loading wettable powders for groundboom application; ( 1c) mixing/ loading wettable powders for rights­ of­ way sprayer; ( 2) loading granular formulations; ( 3) applying with a groundboom; ( 4) applying with a rights­ of­ way sprayer; ( 5) applying wettable powders for handgun applicators ( ORETF) 15; ( 6) applying granular with a tractor drawn spreader; ( 7) backpack sprayer ( LCO) 16; ( 8) low pressure handwand­ wettable powder formulations ( LCO); ( 9) high pressure­ handwandwettable powder formulations ( LCO); ( 10) lawn handgun­ wettable powder formulations ( ORETF); ( 11) granulars with a push type spreader ( ORETF) and ( 12) granulars with a bellygrinder ( LCO). Typical application rates for oxadiazon range from 3 to 4 lb. ai/ acre, with the higher rate being applied to golf courses, roadside turf, lawns, parks, recreational areas and woody ornamentals. Since the use patterns for oxadiazon do not suggest any long term use, exposure scenarios of a longer duration were not considered. The exposure scenarios are of short­ term ( 1­ 7 days) and intermediate­ term ( 1 week to several months). The estimated exposures considered baseline protection ( long pants, long shirts and no gloves ­ dermal; no respirator ­ inhalation), additional PPE ( long pants, long shirts and chemical resistant gloves and/ or double layer of clothing ­ dermal; all of the dermal protection plus 80% protection from dust/ mist respirator ­ inhalation), and engineering controls ( use of water soluble packages). Handler exposure assessments were completed by EPA using baseline exposure scenarios previously noted and, if required, increasing levels of risk mitigation ( PPE and engineering controls) to achieve an MOE of 100 for non­ cancer risks. For cancer, there is a concern for risk estimates > 1.0x 10­ 4. 17 Pesticide Handlers Exposure Database 24 Chemical­ specific data for assessing human exposures during pesticide handling activities were not submitted to the Agency in support of the reregistration of oxadiazon. In such instances, it is the policy of the HED to use data from the PHED17 Version 1.1 to assess handler exposures for regulatory actions when chemical­ specific monitoring data are not available. HED's level of confidence in these data are shown in the occupational and residential exposure assessment and recommendations for oxadiazon ( Tadayon, 2001). 4.3.1.1 Noncancer Handler Exposure/ Risks The short­ term and intermediate­ term MOEs for dermal and inhalation exposures were calculated using an oral NOAEL of 12 mg/ kg/ day for both exposure durations ( see Section 3.3 Dose Response Assessment). The Agency also used route­ to­ route extrapolations from this oral study for both exposure assessments. A dermal absorption rate of 9% was applied to the dermal exposure assessments and an inhalation absorption rate of 100% was applied to the inhalation exposure assessments. The results of the short and intermediate­ term handler assessments are presented in Table 5 and indicate that all potential non­ cancer exposure scenarios provide at least one application rate with a total MOE( s) greater than or equal to 100 at either the baseline ( i. e., long pants, long sleeved shirts, no gloves) using open systems, PPE ( i. e., long pants, long sleeved shirts, and chemical resistant gloves while using open systems) or using engineering controls ( i. e., closed systems). The only exception, with the feasible level of mitigation, is scenario 8 ( low pressure handwand­ wettable powder formulations). As further shown, dermal exposure rather than inhalation exposure drives the total MOE for scenario 8 as well as the majority of cases. Total MOEs for all scenarios range from 2 to 3000 and 37 MOEs were calculated for the various application rates. The data show that baseline or mitigation measures raised the MOEs to values greater than or equal to 100 for all scenarios except scenario 8. 25 Table 5: Exposure Variables ( Noncancer), MOEs for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop Type App Rates ( lb ai/ acre) Daily Acres Treated Dermal MOEs Inhalation MOEs Total MOEs Base line PPE Eng. Control Base line PPE Eng. Control Base line PPE Eng. Control Mixer/ Loader Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3 350 2 59 780 16 80 2900 2 35 610 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 4 40 14 380 NA 100 520 NA 12 220 NA herbaceous ornamentals 3 40 18 510 NA 140 700 NA 16 300 NA sod farms 3 80 9 260 NA 70 350 NA 8 150 NA golf courses 4 40 14 380 NA 100 520 NA 12 220 NA Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 4 40 14 380 NA 100 520 NA 12 220 NA Loading Granular formulations ( 2) sod farms, conifers forest 4 80 3000 NA NA 1300 NA NA 920 NA NA golf course turf, parks, recreational areas 4 40 6000 NA NA 2600 NA NA 1800 NA NA woody ornamentals 4 40 6000 NA NA 2600 NA NA 1800 NA NA Applicator Applying with a Groundboom ( 3) sod farms 3 80 2400 NA NA 4100 NA NA 1500 NA NA herbaceous ornamentals 3 40 4800 NA NA 8100 NA NA 3000 NA NA golf courses 40 3600 NA NA 6100 NA NA 2300 NA NA conifer nurseries, woody ornamentals 4 40 3600 NA NA 6100 NA NA 2300 NA NA Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 4 40 38 130 NA 1200 1200 NA 37 120 NA Table 5: Exposure Variables ( Noncancer), MOEs for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop Type App Rates ( lb ai/ acre) Daily Acres Treated Dermal MOEs Inhalation MOEs Total MOEs Base line PPE Eng. Control Base line PPE Eng. Control Base line PPE Eng. Control 26 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 4 5 See PPE 550 NA 36000 3600 0 NA See PPE 540 NA Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 4 80 2500 NA NA 1900 NA NA 1100 NA NA golf courses 4 40 5100 NA NA 3800 NA NA 2200 NA NA Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l awn s , gol f c o u r s e s , ornamentals nurseries 4 5 See PPE 160 NA 1200 1200 NA See PPE 140 NA Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 4 5 14 65 NF 33 160 NF 10 46 NF High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 4 5 See PPE 160 NA 300 300 NA See PPE 100 NA Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 4 5 560 NA NA 580 NA NA 280 NA NA Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, rec r ea t iona l areas, ornamentals 4 5 1100 NA NA 4800000 NA NA 1100 NA NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 4 1 200 NA NA 2900 NA NA 190 NA NA Baseline dermal unit exposure scenarios includes long pants, long shirts and no gloves. Baseline inhalation unit exposure represents no respirator PPE dermal unit exposure includes long pants, long shirts and gloves for scenarios 5, 7, and 9. PPE dermal unit exposure includes long pants, long shirts gloves and double layer ( 50% protection) for scenarios 1a, 1b, 1c, and 8. PPE inhalation unit exposure represents dust/ mist respirator ( 80 % protection) for scenarios 1a, 1b, 1c, and 8. Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages for scenario 1a. Engineering inhalation unit exposure represents no respirator. NA = Not applicable NF = Not Feasible 18 The Agency has defined a range of acceptable cancer risks based on a policy memorandum dated August 14, 1996, by then Office of Pesticide Programs Director Dan Barolo. This memo refers to a predetermined quantified " level of concern" for occupational carcinogenic risk. Occupational carcinogenic risks that are 1 x 10­ 6 or lower require no risk management action. For those chemicals subject to reregistration, the Agency is carefully examining uses with estimated risks in the 10­ 6 to 10­ 4 range to seek ways of cost­ effectively reducing risks. If carcinogenic risks are in this range for occupational handlers, increased levels of personal protection are warranted as is commonly applied with noncancer risk estimates ( e. g., additional PPE or engineering controls). Carcinogenic risks that remain above 1.0 x 10­ 4 at the highest level of mitigation appropriate for that scenario remain a concern. 19 Lifetime Average Daily Dose 27 4.3.1.2 Cancer Handler Exposure/ Risks The cancer risk assessments for handlers used baseline exposure scenarios and, as needed, increasing levels of risk mitigation ( PPE and engineering) to achieve cancer risks that would be considered of no concern. According to Agency policy18, acceptable cancer risks for occupational exposure to pesticides varies from 1 x 10­ 4 to 1 x 10­ 6, depending on the course of action taken by the Agency as outlined in the policy memo on this subject. The Q 1* used in this risk assessment is 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents ( see Section 3.3 Dose Response Assessment). Potential cancer risks ( LADD19) to handlers were assessed using the following assumptions: The average body weight of 70 kg is used, representing a typical adult. Career duration is assumed to be 35 years. This represents a typical working lifetime. Lifetime is assumed to be 70 years. Dermal absorption is assumed to be 9%, and inhalation absorption is assumed to be 100% of the oral dose. The dermal and inhalation doses were added together to represent total daily dose. In addition, two exposure frequencies were used in the calculations, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). The results of the short and intermediate­ term handler cancer assessments presented in Table 6 indicate that values range from 1.65E­ 2 to 4.66E­ 7 at the baseline ( long pants, long shirts and no gloves), 2.56E­ 3 to 4.11E­ 7 at PPE1 ( long pants, long shirts, gloves and no respirator), 2.40E­ 3 to 3.51 E­ 7 at PPE2 ( long pants, long shirts, double layer, gloves and no respirator), 1.05E­ 3 to 1.98E­ 7 at PPE3 28 Table 6: Exposure Variables for Handlers with Baseline Exposure Scenarios and Increasing Levels of Risk Mitigation ( Cancer) for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop/ Target Appl Rates ( lb ai/ acre) Daily Acres Treated Cancer Base line PPE 1 PPE 2 PPE 3 PPE 4 Eng. Control Mixer/ Loader Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3 350 1.65e­ 03/ 1.65e­ 02 2.56e­ 04/ 2.56e­ 03 2.40e­ 04/ 2.40e­ 03 1.05e­ 04/ 1.05e­ 03 8.90e­ 05/ 8.90e­ 04 4.92e­ 06/ 4.92e­ 05 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 herbaceous ornamentals 3 40 1.88e­ 04/ 1.88e­ 03 2.92e­ 05/ 2.92e­ 04 2.74e­ 05/ 2.74e­ 04 1.20e­ 05/ 1.20e­ 04 1.02e­ 05/ 1.02e­ 04 5.62e­ 07/ 5.62e­ 06 sod farms 3 80 3.77e­ 04/ 3.77e­ 03 5.84e­ 05/ 5.84e­ 04 5.48e­ 05/ 5.48e­ 04 2.39e­ 05/ 2.39e­ 04 2.03e­ 05/ 2.03e­ 04 1.12e­ 06/ 1.12e­ 05 golf courses 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 Loading Granular formulations ( 2) sod farms, conifers forest 4 80 3.28e­ 06/ 3.28e­ 05 3.10e­ 06/ 3.10e­ 05 2.68e­ 06/ 2.68e­ 05 1.28e­ 06/ 1.28e­ 05 8.63e­ 07/ 8.63e­ 06 2.20e­ 08/ 2.20e­ 07 golf course turf, parks, recreational areas 4 40 1.64e­ 06/ 1.64e­ 05 1.55e­ 06/ 1.55e­ 05 1.34e­ 06/ 1.34e­ 05 6.42e­ 07/ 6.42e­ 06 4.31e­ 07/ 4.31e­ 06 1.10e­ 08/ 1.10e­ 07 woody ornamentals 4 40 1.64e­ 06/ 1.64e­ 05 1.55e­ 06/ 1.55e­ 05 1.34e­ 06/ 1.34e­ 05 6.42e­ 07/ 6.42e­ 06 4.31e­ 07/ 4.31e­ 06 3.29e­ 08/ 3.29e­ 07 Applicator Applying with a Groundboom ( 3) sod farms 3 80 2.00e­ 06/ 2.00e­ 05 2.00e­ 06/ 2.00e­ 05 1.73e­ 06/ 1.73e­ 05 1.41e­ 06/ 1.41e­ 05 1.14e­ 06/ 1.14e­ 05 4.94e­ 07/ 4.94e­ 06 Table 6: Exposure Variables for Handlers with Baseline Exposure Scenarios and Increasing Levels of Risk Mitigation ( Cancer) for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop/ Target Appl Rates ( lb ai/ acre) Daily Acres Treated Cancer Base line PPE 1 PPE 2 PPE 3 PPE 4 Eng. Control 29 herbaceous ornamentals 3 40 1.00e­ 06/ 1.00e­ 05 1.00e­ 06/ 1.00e­ 05 8.67e­ 07/ 8.67e­ 06 7.06e­ 07/ 7.06e­ 06 5.71e­ 07/ 5.71e­ 06 2.47e­ 07/ 2.47e­ 06 golf courses 40 1.34e­ 06/ 1.34e­ 05 1.34e­ 06/ 1.34e­ 05 1.16e­ 06/ 1.16e­ 05 9.42e­ 07/ 9.42e­ 06 7.61e­ 07/ 7.61e­ 06 3.29e­ 07/ 3.29e­ 06 conifer nurseries, woody ornamentals 4 40 1.34e­ 06/ 1.34e­ 05 1.34e­ 06/ 1.34e­ 05 1.16e­ 06/ 1.16e­ 05 9.42e­ 07/ 9.42e­ 06 7.61e­ 07/ 7.61e­ 06 3.29e­ 07/ 3.29e­ 06 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 4 40 8.07e­ 05/ 8.07e­ 04 2.60e­ 05/ 2.60e­ 04 2.00e­ 05/ 2.00e­ 04 2.40e­ 05/ 2.40e­ 04 1.80e­ 05/ 1.80e­ 04 NA Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 4 5 See PPE 5.57e­ 06/ 5.57e­ 05 2.94e­ 06/ 2.94e­ 05 5.50e­ 06/ 5.50e­ 05 2.87e­ 06/ 2.87e­ 05 NA Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 4 80 9.31e­ 07/ 9.31e­ 06 8.23e­ 07/ 8.23e­ 05 7.03e­ 07/ 7.03e­ 06 3.95e­ 07/ 3.95e­ 06 2.75e­ 07/ 2.75e­ 06 1.82e­ 07/ 1.82e­ 06 golf courses 4 40 4.66e­ 07/ 4.66e­ 06 4.11e­ 07/ 4.11e­ 06 3.51e­ 07/ 3.51e­ 06 1.98e­ 07/ 1.98e­ 06 1.38e­ 07/ 1.38e­ 06 9.11e­ 08/ 9.11e­ 07 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l awn s , g o l f c o u r s e s , ornamentals nurseries 4 5 See PPE 2.13e­ 05/ 2.13e­ 04 1.45e­ 05/ 1.45e­ 04 1.93e­ 05/ 1.93e­ 04 1.25e­ 05/ 1.25e­ 04 NA Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 4 5 3.10e­ 04/ 3.10e­ 03 1.56e­ 04/ 1.56e­ 03 1.38e­ 04/ 1.38e­ 03 8.30e­ 05/ 8.30e­ 04 6.50e­ 05/ 6.50e­ 04 NA High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 4 5 See PPE 1.88e05/ 1.88e­ 04 1.20e­ 05/ 1.20e­ 04 1.98e­ 05/ 1.98e­ 04 1.31e­ 05/ 1.31e­ 04 NA Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 4 5 1.06e­ 05/ 1.06e­ 04 1.06e­ 05/ 1.06e­ 04 8.03e­ 06/ 8.03e­ 05 6.44e­ 06/ 6.44e­ 05 3.89e­ 06/ 3.89e­ 05 NA Table 6: Exposure Variables for Handlers with Baseline Exposure Scenarios and Increasing Levels of Risk Mitigation ( Cancer) for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop/ Target Appl Rates ( lb ai/ acre) Daily Acres Treated Cancer Base line PPE 1 PPE 2 PPE 3 PPE 4 Eng. Control 30 Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, r ec r eat ional ar eas , ornamentals 4 5 2.33e­ 06/ 2.33e­ 05 1.80e­ 06/ 1.80e­ 05 No data 1.80e­ 06/ 1.80e­ 05 No data NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 4 1 1.61e­ 05/ 1.61e­ 04 1.50e­ 05/ 1.50e­ 04 9.60e­ 06/ 9.60e­ 05 1.42e­ 05/ 1.42e­ 04 8.77e­ 06/ 8.77e­ 05 NA Baseline dermal unit exposure scenarios includes long pants, long shirts and no gloves. PPE 1 cancer risk includes long pants, long shirts, gloves and no respirator. PPE 2 cancer risk includes long pants, long shirts, double layer, gloves and no respirator. PPE 3 cancer risk includes long pants, long shirts, gloves and respirator. PPE 4 cancer risk includes long pants, long shirts, double layer, gloves and respirator. Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages. Engineering inhalation unit exposure represents no respirator. 31 ( long pants, long shirts, gloves and respirator), 8.90E­ 4 to 1.38E­ 07 at PPE4 ( long pants, long shirts, double layer, gloves and respirator) and 4.92E­ 5 to 1.10E­ 8 at engineering control. Overall, these data show that none of the evaluated scenarios have cancer risks that exceed 1.00E­ 4 at the highest feasible level of mitigation. 4.3.2 Occupational Postapplication HED uses the term " post­ application" to describe those individuals who can be exposed to pesticides after entering areas previously treated with pesticides and performing certain jobs, tasks or activities ( also often referred to as reentry exposure). Most of the oxadiazon used in agriculture is applied either pre­ plant or when the crops are quite small ( early post­ emergence). This information together with the degree of mechanization minimizes the postapplication contact of workers with oxadiazon. Nevertheless, the Agency has determined that there are potential postapplication exposures to individuals re­ entering oxadiazon treated areas for the purpose of: iv) Roadsides: mowing v) Bermuda grass rights­ of­ way: mowing vi) Sod farms: mowing and harvesting vii) Golf­ course turfgrass: mowing 4.3.2.1 Data Sources and Assumptions for Scenarios Considered Based on data submitted for reregistration, it can be assumed that the most common postapplication exposures will occur for workers on turf. Based on label restrictions and patterns of use, oxadiazon is applied early in the season, either pre­ plant or before weeds emerge ( pre­ emergence). Mowing would be a common postapplication activity after either spraying method. Treated turf or grasses will routinely require reentry activities, such as mowing and watering, and eventually harvesting in the case of sod farms. Although two transferable turf residue ( TTR) studies and one Jazzercize study ( MRID No. 43517801) were submitted in support of the reregistration of oxadiazon, only the Jazzercize study was found to be acceptable for this assessment because the TTR values obtained from the two TTR studies were less than 1%. TTR values less than 1% are not considered acceptable by HED since the submitted studies were performed with a modified California Cloth Roller sampling device, which has been replaced with new equipment accredited by ORETF. TTR values derived from a modified California Cloth Roller sampling device can be used if accompanied by concurrent transfer coefficient measurements. This was not the case for oxadiazon. The TTR value from the Jazzercise study utilized a wettable powder formulation which by far has a higher potential for exposure than the oxadiazon granular formulations. Since a majority of the total use involves granular formulations, using wettable powder TTR values is a conservative approach and can be considered the upper level estimates of exposure. A linear regression to calculate a dissipation rate ( T ½ ) for oxadiazon TTR from irrigated and non­ irrigated test sites was performed, using all non­ zero, uncorrected, averaged data point from DAT­ 0 20 Agricultural Reentry Task Force 32 through DAT­ 7. Calculated dissipation half­ lives for the irrigated plot was 1.7days ( R2= 0.64) and for the non­ irrigated plot was 1.4 days ( R2= 0.64) Because oxadiazon has a low vapor pressure ( 1.0 x 10­ 6mm Hg) and is only used outdoors, the inhalation component of postapplication exposure is anticipated to be negligible. Therefore, all calculations of postapplication risk estimates have been done for dermal exposure only, and there was no need to aggregate postapplication exposure routes for workers. 4.3.2.2 Postapplication Exposure Risk Estimates For turf or sod mowing and harvesting, transfer coefficients of 500 and 16,500 cm2/ hr were used, based on the ARTF 20 data. The TTR values are assumed to be 5% of the application rate on Day 0 for turfgrass application ( the 5% rate for turfgrass in the high end of the values observed in the studies of Hurto and Prinster, 1993; Goh et al., 1986 and Cowell et al., 1993). As shown in Table 7, short and intermediate­ term exposures for noncancer risks had estimated MOEs of 300­ 10,000, which exceed the target value of 100. Similarly, occupational postapplication cancer risks were estimated to fall within the acceptable range of 1 x 10­ 4 to 1 x 10­ 6. 4.3.3 Non­ Occupational Postapplication Exposures and Risk The Agency has determined that there are potential postapplication exposures to residents entering oxadiazon treated lawns, either as a result of commercial or private application. The scenarios likely to result in postapplication exposures are: ° dermal postapplication risks to adults and toddlers ( defined as 5< 12 years old and considered by HED to be the most sensitive subpopulation of children) when entering oxadiazon­ treated turf and lawns; ° oral postapplication risks to toddlers from " hand­ to­ mouth" ( i. e., ingestion of grass, soil, granular pellets, or hand­ to­ mouth contact) exposure when reentering lawns treated with granular and wettable powder formulations. Representative turf reentry activities include, but are not limited to: ( 1) Adults involved in a low exposure activity, such as golfing or walking on treated turf. ( 2) Toddlers involved in a low exposure activity, such as walking on treated turf. ( 3) Adults mowing or other moderate contact activity, for 1­ 2 hours. ( 4) Adults involved in a high exposure activity, such as heavy yard work ( doses similar to occupational scenarios for cutting and harvesting sod). ( 5) Toddlers involved in high exposure activities on turf. 33 Table 7: Occupational Short­ and Intermediate­ Term Postapplication Risks for Oxadiazon at Day 0 Crop/ Use Pattern Application Rate ( lb ai/ acre) Postapplication Activity Transfer Coefficienta Short Term and Intermediate Term Risks Cancer Risk TTRb ( g/ cm2) MOEc LADDd mg/ kg/ day Riske Golf Course Turf 4 Mow, seed, scout, mechanical weed, aerate, fertilize, prune 500 0.2 ( 5% of application rate) 10,000 4.23e­ 6 3.01e­ 7 Transplant, hand weed 16,500 300 1.39e­ 4 9.92e­ 6 Sod Farms 4 Mow, scout, mechanical weed, irrigate 500 10,000 4.23e­ 6 3.01e­ 7 Transplant, hand weed, harvest ( hand or mechanical) 16,500 300 1.39e­ 4 9.92e­ 6 Bermuda Grass Rights of Way 4 Mow, seed, scout, mechanical weed, aerate, fertilize 500 10,000 4.23e­ 6 3.01e­ 7 a Transfer coefficient from Science Advisory Council for Exposure: Policy Memo # 003 .1 " Agricultural Transfer Coefficients," Revised ­ August 7, 2000. b TTR source: 5% of application rate, " Residential SOP Revised February 2001 " was used for determination of MOE's. c MOE = Short­ term NOAEL ( 12 mg/ kg/ day; based on a dermal study) / dermal dose where absorbed dose = TTR ( g/ cm2) x TC ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time( 8hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg; adult). d Absorbed dermal dose where absorbed dose = TTR ( g/ cm2) x TC ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 8 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime e Cancer Risk = LADD ( mg/ kg/ day) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. Note: TTR ­ Turf Transferable Residue 34 4.3.3.1 Non­ occupational Postapplication Dermal Exposure ( Adults and Toddlers) 4.3.3.1.1 Data Sources and Assumptions for Scenarios Considered A turf re­ entry exposure study ( Jazzercise study), using a spray application, was mentioned in the Occupational Postapplication section ( see Section 4.3.2, Occupational Postapplication). As the study was found to be acceptable for the risk assessment, the highest mean residues were also used to estimate short­ term ( DAT 0­ 1) for irrigated and non­ irrigated plots evaluated for these scenarios. The duration of postapplication dermal exposure is expected to be either short­ term or intermediate­ term, based on oxadiazon turf residue dissipation data. The short­ term and intermediateterm MOEs for dermal exposures were calculated using an oral NOAEL of 12 mg/ kg/ day with a dermal absorption rate of 9%; this value was derived from the same study used for the occupational handler noncancer exposures ( see 4.3.1.1, Noncancer Handler Exposure/ Risks). For the cancer risk estimates, the Q 1* of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents ( see 4.3.1.2, Cancer Handler Exposure/ Risks) was used. As calculated from the previously discussed Jazzercise study, oxadiazon has a half­ life on turf of up to 1.4 days ( irrigated) and 1.7 days ( non­ irrigated) after spraying, requiring several days to dissipate to non detectable levels of transferable residues. Because the label prohibits application more than 3 times per year, and even with the slow dissipation rates, it is not expected that individual residential exposure duration would exceed 30 days in duration. Exposure on a residential lawn would diminish continuously with time, while exposure through recreation turf contact would more likely be random, intermittent events of varying doses, all less than the dose predicted in this assessment. Residential postapplication exposure assessments assumed residents wear the following attire: short sleeved shirt, short pants, shoes and socks, and no gloves or respirator. As stated earlier, negligible oxadiazon inhalation exposure is anticipated for non­ handlers, due to the low chemical vapor pressure and the dilution of the vapor outdoors. Other assumptions and all equations used for the assessment of each exposure scenario can be found in the occupational and residential exposure assessment and recommendations for oxadiazon document ( Tadayon, 2001). Dermal postapplication exposure estimates were conducted using the highest mean postapplication residue to estimate short­ term DAT 0­ 1 for irrigated and non­ irrigated plots from the previously discussed Jazzercise study ( wettable powder formulations). The dermal transfer coefficients from the Jazzercize study ( MRID No. 43517801) and the revised residential SOPs were also used. As the study was found to be acceptable for the risk assessment. 4.3.3.1.2 Non­ occupational Postapplication Dermal Exposure Risk Estimates Utilizing the Jazzercize wettable powder application study residue data and revised residential SOPs, all of the non­ cancer risks scenario developed for adults and toddlers had short­ term and intermediate­ term dermal MOEs greater than 100. The cancer risks for all adult residential \ 35 dermal postapplication exposure were between 6.22x 10­ 6 to 7.51 x 10­ 8 . The resulting risk estimates are summarized in Tables 8 and 9. 4.3.3.2 Incidental Oral Exposure for Toddlers Only limited information was received regarding the size and distribution of granular formulations. This information would help to refine or characterize the estimate of potential risk from episodic incidental ingestion of granules beyond the current screening level. If the particles are very fine, individual grains would be difficult to pick up, or even to see when applied on a lawn. If used according to label directions, it is unlikely that oxadiazon granules would be accessible to a child. However, larger granules or pellets of a few millimeters diameter might be attractive and easily picked up by a toddler. An intermediate­ term ( 7­ 30 days) MOE was not calculated since exposure by this route for weeks is considered less likely to occur than short­ term ( 1­ 7days) exposure. Similarly, there was no indication from the studies in the database that toxic effects observed over the short­ term would be any different over a longer term exposure. Estimated incidental oral short­ term exposures (" hand­ tomouth for toddlers had an MOE of 100 using the TTR default values from the residential SOP; when the TTR data from submitted oxadiazon study were used, the MOEs were 90 and 240 ( Table 10). The former MOE of 90 does not exceed the target value, however, the submitted study TTR data were from the wettable powder formulation and the major formulation used is granular oxadiazon. It is probable, therefore, that the risk indicated for irrigated dormant grass is an overestimate and not likely to be a cause for concern ( also see Section 4.3.3.1, Data Sources and Assumptions for Scenarios Considered). MOEs were not calculated for the incidental ingestion of oxadiazon granules because an acute RfD was not selected for this non­ food use pesticide. Additionally, there is no indication from the studies in the guideline database that a single oral administration of oxadiazon presents a hazard. This statement is also supported by the high rat acute LD 50 for oxadiazon (> 5000 mg/ kg). It is thought, therefore, that the incidental ingestion of granules is not likely to be a cause for concern. It is considered reasonably likely that dermal and oral incidental exposures may occur in the same day for children playing on an oxadiazon­ treated lawn. However, these exposures were not aggregated due to the short­ term hand­ to­ mouth exposures having MOEs less than or equal to the target MOE of 100. Because an exposure just mets or exceeds the level of concern by a single route, that route must be mitigated prior to aggregating exposures by other routes otherwise, the reported risk is only increased. 36 Table 8. Residential Dermal Postapplication Non­ Cancer Risks for Oxadiazon Dermal Scenarios Application Rate ( lb ai/ acre) Exposure Time ( hours/ day) Short Term and Intermediate Term Risks Transfer Coefficient ( cm2/ hr) a Transfer Coefficient ( cm2/ hr) Irrigatedb Transfer Coefficient ( cm2/ hr) Non­ Irrigatedc TTRd ( ug/ cm2) DAT 0­ 1 Dermal Dose ( mg/ kg/ day) e Dermal Dose ( mg/ kg/ day) Irrigatedf Dermal Dose ( mg/ kg/ day) Non­ Irrigatedg MOEsh MOEs i Irrigated MOEsj Non­ Irrigated Adult dermal turf contact 4 2 14500 4300 7,400 1.53 NA 1.97e­ 2 3.40e­ 2 NA 610 350 2.0 8.70e­ 2 NA NA 140 NA NA Toddler dermal turf contact 2 5200 1600 2,700 0.87 NA 1.67e­ 2 2.82e­ 2 NA 720 430 2.0 3.12e­ 2 NA NA 390 NA NA Adult walking, playing golf 4 500 NA NA 2.0 6.0e­ 3 NA NA 2000 NA NA Adult push mowing lawn 2 500 NA NA 2.0 3.0e­ 3 NA NA 4000 NA NA a Transfer coefficient from the Residential SOP's ( 2/ 01) used for fresh grass b Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass c Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass d TTR source: wettable powder from turf studies MRID # 435178­ 01, DAT 0­ 1 residue or residential SOP ( 5% application rate) e Dermal dose ( mg/ kg/ day) = TTR ( 5% application rate) ( g/ cm2) x TC ( from residential SOP, s) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 or 4hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg adult or 15 kg toddler). f Dermal dose ( mg/ kg/ day) irrigated = TTR ( from MRID # 435178­ 01) ( g/ cm2) x TC ( MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %)/ body weight ( 60 kg adult or 15 kg toddler). g Dermal dose ( mg/ kg/ day) non­ irrigated = TTR ( from MRID # 435178­ 01) ( g/ cm2) x TC ( MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg adult or 15 kg toddler). h MOE = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) i MOE ( irrigated) = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) j MOE ( non­ irrigated) = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) Note: TTR ­ Turf Transferable Residue rounded to 2.0 ug/ cm2 37 Table 9. Residential Dermal Postapplication Cancer Risks for Oxadiazon Dermal Scenarios Application Rate ( lb ai/ acre) Exposure Time ( hours/ day) Transfer Coefficient ( cm2/ hr) a Transfer Coefficient ( cm2/ hr) Irrigatedb Transfer Coefficient ( cm2/ hr) Non­ Irrigatedc TTRd ( ug/ cm2) DAT 0­ 1 LADDe mg/ kg/ day LADDf mg/ kg/ day irrigated LADDg mg/ kg/ dayf Non­ Irrigated Cancer Riskh Cancer Risk Irrigatedj Cancer Risk Nonirrigatedj Adult dermal turf contact 4 2 14500 4300 7400 1.53 NA 6.95e­ 5 1.2e­ 4 NA 3.62e­ 6 6.22e­ 6 2.0 3.06e­ 04 NA NA 1.59e­ 5 NA NA Toddler dermal turf contact 2 5200 1600 2700 0.87 NF NF NF NF NF NF 2.0 NF NF NF NF NF NF Adult walking, playing golf 4 500 NA NA 2.0 2.11e­ 5 NA NA 1.50e­ 6 NA NA Adult push mowing lawn 2 500 NA NA 2.0 1.06e­ 5 NA NA 7.51e­ 7 NA NA a Transfer coefficient from the Residential SOP's ( 2/ 01) used for fresh grass b Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass c Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass d TTR source: wettable powder and granular turf studies MRID # 435178­ 01, DAT 0­ 1 residue e LADD ( mg/ kg/ day) = TTR ( g/ cm2)( 5% of application rate) x TC( residential SOP) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 or 4 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime f LADD ( mg/ kg/ day)( irrigated) = TTR ( g/ cm2) ( from MRID # 435178­ 01) x TC ( cm2/ hr)( from MRID # 435178­ 01) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime g LADD ( mg/ kg/ day)( non­ irrigated) = TTR ( g/ cm2)( from MRID # 435178­ 01) x TC( from MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime h Cancer Risk = LADD ( mg/ kg/ day) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. i Cancer Risk ( irrigated) = LADD ( mg/ kg/ day) ( irrigated) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. j Cancer Risk ( non­ irrigated) = LADD ( mg/ kg/ day)( non­ irrigated) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. NA= Not applicable NF= Not Feasible Note: TTR ­ Turf Transferable Residue rounded to 2.0 ug/ cm2 38 Table 10 Residential Oral Nondietary Postapplication Risks to Toddlers from " Hand­ to­ Mouth" and Ingestion Exposure When Reentering Lawns Treated with Granular or wettable powder Oxadiazon Formulations Type of Exposure Application Ratea ( lb ai/ acre) Ingestion Rate or Other Assumptionsb Short­ Term TTRc ( g/ cm2) DAT 0­ 1 Oral Dosed ( mg/ kg/ day) MOEe Hand to Mouth Activity 4 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; fresh grass 5% of ai dislodgeable with potentially wet hands 2.0 1.19e­ 01 100 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; 2.1% of ai dislodgeable with potentially wet hands ( dormant grass, non­ irrigated) 1.0 5.02e­ 02 240 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; 5.5% of ai dislodgeable with potentially wet hands ( dormant grass, irrigated) 2.5 1.31e­ 01 90 Incidental Turfgrass Ingestion 25 cm2/ day of turf 20% application rate ( residential SOP) fresh grass 9.0 1.49e­ 02 805 25 cm2/ day of turf Irrigated ( MRID # 435178­ 01) used for dormant grass 0.87 2.60e­ 03 4700 25 cm2/ day of turf Non­ Irrigated( MRID # 435178­ 01) used for dormant grass 1.53 1.45e­ 03 8300 Incidental Ingestion of Soil 100 mg/ day ingestion; 0.67 cm3/ gm soil NA 2.12e­ 04 57000 a Application rates represent maximum label rates from current EPA registered labels. b Assumptions from Residential SOP's ( February, 2001). fresh grass c TTR source: wettable powder and granular oxadiazon turf studies MRID Nos. 43517801. Short­ term risks assessed using DAT 0­ 1 residue values. d Oral doses calculated using formulas presented in the Residential SOPs ( February, 2001). Short­ term and intermediate­ term doses were calculated using the following formulas. Intermediate term doses were each multiplied by the estimated fraction of oxadiazon residue remaining on DAT 7 after application. Hand­ to­ mouth oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [ application rate ( lb ai/ acre) x fraction of residue dislodgeable from potentially wet hands ( see assumptions) x 11.2 ( conversion factor to convert lb ai/ acre to g/ cm2)] x median surface area for 1­ 3 fingers ( 20 cm2/ event) x hand­ to­ mouth rate ( ST: 20 events/ hour ) x exp. time ( 2 hr/ day) x 0.001 mg/ µ g] / bw ( 15 kg toddler). Grass ingestion oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [ TTR ( g/ cm2) x ingestion rate of grass ( 25 cm2/ day) x0.001 mg/ µ g] / bw ( 15 kg toddler). Soil ingestion oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [( application rate ( lb ai/ acre) x fraction of residue retained on uppermost 1 cm of soil ( 100% or 1.0/ cm) x 4.54E+ 08 g/ lb conversion factor x 2.47E­ 08 acre/ cm2 conversion factor x 0.67 cm3/ g soil conversion factor) x 100 mg/ day ingestion rate x 1.0E­ 06 g/ g conversion factor] / bw ( 15 kg; toddler). Short term dose based residue on the soil on day of application. NA= Not applicable Note: TTR ­ Turf Transferable Residue 39 4.3.4 Incident Data Oxadiazon has not been reported to cause life­ threatening illness or death in humans. Most of the cases appear to be related to irritation to the skin, eyes and mucous membranes. Some cases may be related to an allergic reaction On the list of the top 200 chemicals for which NPTN received calls from 1984­ 1991 inclusively, oxadiazon was ranked 192nd with 12 incidents in humans reported and 5 incidents in animals ( mostly pets). 21 Drinking Water Levels of Comparison 22 acute Population Adjusted Dose 40 5.0 AGGREGATE RISK ASSESSMENTS AND RISK CHARACTERIZATION 5.1 DWLOCs21 for Acute Exposure An aggregate risk assessment is defined as the evaluation of the likelihood of the occurrence of an adverse health effect resulting from exposure to a single substance via all relevant routes. As part of the aggregate risk assessment, short­ and intermediate­ term risk assessments require the incorporation of drinking water exposure and the calculation of DWLOC values to estimate the total exposure from all sources. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water that are used to determine how much of the acceptable exposure is available for exposure through drinking water. OPP uses DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water. DWLOC values are not regulatory standards for drinking water; however, they do have regulatory impact through aggregate exposure and risk assessments. DWLOCs were calculated for oxadiazon based on an oral NOAEL of 12 mg/ kg/ day from a developmental study, which was selected by HIARC for the short­ term ( 1­ 7 day) incidental oral exposure ( McCarroll, 2001b). An acute RfD was not selected for oxadiazon because there are no food uses ( McCarroll, 2001b). However, in accordance with the Updated Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments ( Stasikowski, 1999), this NOAEL was used to calculate the acute DWLOCs. An uncertainty factor of 100 was applied based on a 10x for intraspecies variation and a 10x for interspecies extrapolation. Therefore, the theoretical acute RfD or the theoretical aPAD22 would be 0.12 mg/ kg/ day. The default body weights and daily water consumption values were applied for each target population ( i. e., U. S. population, children 1­ 6, and infants). Default body weights and consumption values for calculation of the DWLOCs were: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female) and 1L/ 10 kg ( children and infants), respectively. Based on a comparison of DWLOCs to the corresponding FIRST and SCIGROW values, which show higher values for the DWLOCs, acute exposure to residues of oxadiazon in surface and ground water is not a concern ( Table 11a). 5.2 DWLOCs for Chronic Exposure A chronic RfD was also not selected by the HIARC because of the lack of food or feed uses ( McCarroll, 2001b). Using the line of reasoning developed for the acute DWLOC calculations and put forth in the interim guidance document, a combined chronic/ oncogenicity feeding study was selected by HIARC for the dermal and inhalation risk assessments ( see Section 3.3). Accordingly, this 23 chronic Population Adjusted Dose 41 Table 11a. Summary of Acute DWLOC Calculations for Oxadiazon Population Subgroup1 Acute Scenario Theoretical aPAD mg/ kg/ day Acute Food Exp mg/ kg/ day Max Acute Water Exp mg/ kg/ day2 FIRST Surface Water EDWC ( g/ L) SCIGROW Ground Water EDWC ( g/ L) Acute DWLOC ( g/ L) 3 U. S. Population 0.12 0.00 0.12 246 0.59 4200 Females 13­ 50 years old 0.12 0.00 0.12 246 0.59 3600 Infants < 1 year old 0.12 0.00 0.12 246 0.59 1200 Children 1­ 6 years old 0.12 0.00 0.12 246 0.59 1200 1 Default body weights and consumption values for calculation of the DWLOCs were: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female) and 1L/ 10 kg ( child), respectively. 2 Maximum acute water exposure ( mg/ kg/ day) = [( acute PAD ( mg/ kg/ day) ­ acute food exposure ( mg/ kg/ day)] 3 Acute DWLOC( g/ L) = [ maximum chronic water exposure ( mg/ kg/ day) x body weight ( kg)] [ water consumption ( L) x 10­ 3 mg/ g] NOAEL of 0.36 mg/ kg/ day, based on adverse liver effects, was used to calculate the chronic DWLOCs ( DWLOC chronic). An uncertainty factor of 100 was applied ( 10x for intraspecies and a 10x for interspecies variation). Therefore, the theoretical chronic RfD or the theoretical cPAD23 would be 0.0036 mg/ kg/ day. Residential exposures were not factored into the DWLOCchronic since no long­ term residential exposures ( handlers or postapplication) are expected. As shown in Table 11b, only the adult male and female populations as a whole had DWLOC values that exceeded the surface and ground water targets; consequently, the Agency concludes with reasonable certainty that there is no drinking water risk of concern for these populations exposure to oxadiazon. DWLOCs values derived for infants and children also exceeded the EDWCs for ground water and are, also of no concern to the Agency. On the other hand, the EDWCs for surface water ( 100 g/ mL) were higher than the DWLOCs calculated for infants and children. Since the EDWCs were higher than the chronic values derived for surface and ground water, the Agency concludes that there is a drinking water risk of concern for infants and children chronically exposed to oxadiazon via drinking water. 5.3 DWLOCs for Cancer For the cancer ( Q 1*) exposure calculations, the Agency used multi­ year mean water concentration values. The DWLOC cancer is the concentration in drinking water as a part of the aggregate chronic exposure that results in a negligible cancer risk ( 10­ 6). 42 No residential exposures were factored into the equation since no long­ term residential exposures ( handlers or postapplication) are expected. As shown in Table 11c, EFED's EDWC for Table 11b. Summary of Chronic DWLOC Calculations for Oxadiazon Population Subgroup1 Chronic Scenario Theoretical cPAD mg/ kg/ day Chronic Food Exp mg/ kg/ day Max Chronic Water Exp mg/ kg/ day2 FIRST Surface Water EDWC ( g/ mL) SCIGROW Ground Water EDWC ( g/ mL) Chronic DWLOC ( g/ L) U. S. Population 0.0036 0.00 0.0036 100 0.59 126 Females 13­ 50 years old 0.0036 0.00 0.0036 100 0.59 108 Infants < 1year old 0.0036 0.00 0.0036 100 0.59 36 Children 1­ 6 years old 0.0036 0.00 0.0036 100 0.59 36 1 Default body weights and consumption values for calculation of the DWLOCs were: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female) and 1L/ 10 kg ( child), respectively. 2 Maximum Chronic Water Exposure ( mg/ kg/ day) = [ Chronic PAD ( mg/ kg/ day) ­ Chronic Dietary Exposure ( mg/ kg/ day)] 3 Chronic DWLOC( g/ L) = [ maximum chronic water exposure ( mg/ kg/ day) x body weight ( kg)] [ water consumption ( L) x 10­ 3 mg/ g] Table 11c. Summary of Cancer DWLOC Calculations for Oxadiazon Population Q* Negligible Risk Level1 Target Max Exposure2 mg/ kg/ day Chronic Food Exposure mg/ kg/ day Max Water Exposure3 mg/ kg/ day FIRST Surface Water EDWC ( g/ mL) SCIGROW Ground Water EDWC ( g/ mL) Cancer DWLOC4 ( g/ L) U. S. Pop 7.11e­ 02 0.000001 0.000014 0.000000 0.00001400 100 0.59 0.490000 1 DWLOC CANCER was calculated for U. S. population only. Default body weights and consumption values for calculation of the DWLOCs were: 2L/ 70 kg 2 Target Maximum Exposure ( mg/ kg/ day) = [ negligible risk/ Q*] 3 Maximum Water Exposure ( mg/ kg/ day) = [ Target Maximum Exposure ­ ( Chronic Food Exposure + Residential Exposure ( Lifetime Average Daily Dose))] 4 Cancer DWLOC( g/ L) = [ maximum water exposure ( mg/ kg/ day) x body weight ( kg)] [ water consumption ( L) x 10­ 3 mg/ g] 2 oxadiazon residues in surface and ground water are lower than the Agency's calculated DWLOCs for the adult U. S. population. Therefore, the cancer risk exceeds HED's level of concern for lifetime exposure to oxadiazon in drinking water derived from surface and ground water. It should be noted, however, that EDWC values derived from the SCI­ GROW model for the ground water analysis, are based on high concentrations observed in shallow ground water after agricultural treatment of permeable soils. Since this combination of conditions is encountered in only 1% of the agricultural use area in the U. S., it is not likely that oxadiazon would pose a potential cancer concern for exposure to oxadiazon in ground water ( Barrett, 1998). 43 5.4 Aggregrate Risk Assessments HED did not perform an aggregate risk assessment as part of this reregistration review for oxadiazon because the calculated DWLOC values are based on conservative default values since no monitoring data were available on oxadiazon and the refined model for turf analysis is not completed at this time. In addition, data used to develop residential exposure estimates ( dermal exposure values) were also conservative because the highest mean postapplication TTR residue value from the Jazzercize study ( MRID No. 43517801) along with the data from the wettable powder formulation instead of the the major formulation ( granular) were used. Thus, any aggregation of a conservative water number with a conservative residential exposure estimate would result in an even more conservative expression of aggregate risk. The RARC also noted that guidance from management on this issue is forthcoming. 6.0 CUMULATIVE RISK FQPA of 1996 stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other non­ occupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the other substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe. HED did not perform a cumulative risk assessment as part of this reregistration review for oxadiazon because HED has not yet initiated a comprehensive review to determine if there are any other chemical substances that have a mechanism of toxicity common with that of oxadiazon. For purposes of this reregistration decision, EPA has assumed that oxadiazon does not have a common mechanism of toxicity with other substances. On this basis, the Registrant, Aventis Environmental Science, must submit, upon EPA's request and according to a schedule determined by the Agency, such information as the Agency directs to be submitted in order to evaluate issues related to whether oxadiazon shares a common mechanism of toxicity with any other substance and, if so, whether any tolerances for oxadiazon need to be modified or revoked. If HED identifies other substances that share a common mechanism of toxicity with oxadiazon, HED will perform aggregate exposure assessments on each chemical, and will begin to conduct a cumulative risk assessment once the final guidance HED will use for conducting cumulative risk assessments is available. HED has recently developed a framework that it proposes to use for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued for 44 public comment on June 30, 2000 ( 65 FR 40644­ 40650) and is available from the OPP Website at: http:// www. epa. gov/ fedrgstr/ EPA­ PEST/ 2000/ June/ Day­ 30/ 6049. pdf . In the draft guidance, it is stated that a cumulative risk assessment of substances that cause a common toxic effect by a common mechanism will not be conducted until an aggregate exposure assessment of each substance has been completed. The proposed guidance on cumulative risk assessment of pesticide chemicals that have a common mechanism of toxicity is expected to be finalized by the summer of 2001. Before undertaking a cumulative risk assessment, HED will follow procedures for identifying chemicals that have a common mechanism of toxicity as set forth in the " Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity" ( 64 FR 5795­ 5796, February 5, 1999). 7.0 ENDOCRINE DISRUPTION EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency's EDSP have been developed, oxadiazon may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. 8.0 DATA NEEDS/ LABEL REQUIREMENTS 8.1 Toxicology 28­ day Inhalation Study ( 870.3465) 45 8.2 Product and Residue Chemistry Current Confidential Statement of Formula containing nominal concentration, upper limits for all components and lower limits for the a. i. 8.3 Occupational and Residential Exposure Concurrent Transfer Coefficient measurements along with TTR studies. 9.0 BIBILOGRAPHY Litt, B. D. ( 1984). Carcinogenicity Risk Assessment for Oxadiazon, dated November 21, 1984 ( HED Document No. 004097). Farber, T ( 1987). Classification of Oncogenic Potential of Oxadiazon, dated August 27, 1987 ( HED Document No. 007798). Quest, J. ( 1987). Second Peer Review of Oxadiazon, dated August 14, 1987 ( HED Document No. 007798). Barrett, M. ( 1998). Updated Documentation on the SCI­ GROW Method to Determine Screening Concentration Estimates for Drinking Water Derived from Ground Water Sources, dated May 29, 1998. Brunsman, L. ( 2001). REVISED Oxadiazon Qualitative Risk Assessment ( Q 1 *) Based on SPF Wistar Rat and ICR_ JCL Mouse Dietary Studies with 3/ 4' s interspecies Scaling Factor, dated February 1, 2001 ( HED Document No. 014465). Diwan, S. ( 2001). Cancer Assessment Document Evaluation of the Carcinogenic Potential of Oxadiazon ( Third Review), dated May 1, 2001 ( HED Document No. 014555). Hansen, L and McCarroll, N. ( 2001). Oxadiazon: Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document, dated July 7, 2001 ( HED Document No. 014614). Dockter, K. ( 2001). Oxadiazon. List B Registration Case 2485. PC Code 109001. Product Chemistry Chapter for the Reregistration Eligibility Decision [ RED] Document, dated March 2, 2001. D273104. Gorrell. M. ( 2001). Revocation Letter for Oxadiazon Tolerances March 12, 1991. Letter from Mike Gorrell, Manager, Registrations, Aventis Environmental Science USA to Veronique La Capra, SRRD, USEPA, dated January 24, 2001. McCarroll, N. ( 2001a). Oxadiazon: Assessment of Mode of Action on Liver Carcinogenicity, dated February 28, 2001. D266361. 46 McCarroll, N. ( 2001b). Oxadiazon: Report of the Hazard Identification Assessment Review Committee ( HIARC), dated February 8, 2001 ( HED Document No. 014469) D266361. Melendez, J. L. ( 2001). Tier I Estimated Environmental Concentrations of Oxadiazon, dated May 8, 2001. Piper, S. ( 2001a). Oxadiazon: List B Registration Case 2485. PC Code 109001. Product Chemistry and Residue Chemistry Chapter for the Registration Eligibility Decision [ RED] Document, dated March 27, 2001. DP Barcode D273740. Piper, S. ( 2001b). Oxadiazon: ( List B, Case No. 2485) The Outcome of the HED Metabolism Assessment Review Committee Meeting Held on 01/ 31/ 01, dated February 13, 2001. D272425. Piper, S. and McCarroll, N. ( 2001). Oxadiazon: ( List B, Case No. 2485) Issues to be Presented to the HED Metabolism Assessment Review Committee ( MARC), dated January 10, 2001. D271728. Stasikowski, M. ( 1999). Updated " Interim Guidance for Incorporating Drinking Water Exposure into Aggregate Risk Assessments", dated August 1, 1999. Tadayon, S. ( 2001). Occupational and Residential Exposure Assessment and Recommendationsfor the Reregistration Eligibility Decision Document for Oxadiazon, dated May 7, 2001. DP Barcode D273742. 47 SignOff Date: 7/ 20/ 01 DP Barcode: D266361 HED DOC Number: 014629 Toxicology Branch: TOX1

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2024-06-07T20:31:44.853711

regulations

EPA-HQ-OPP-2002-0309-0005

Supporting & Related Material

1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES March 05, 2002 PC Code: 109001 DP Barcode D280320 MEMORANDUM Subject: EFED Risk Assessment for the Reregistration Eligibility Decision of Oxadiazon To: Margaret Rice, Branch Chief Veronique LaCapra, Chemical Review Manager Reregistration Branch II Special Review and Reregistration Division ( 7508C) From: Miachel Rexrode, Ph. D., Aquatic Biologist José Luis Meléndez, Chemist Rodolfo Pisigan, Jr., Ph. D., Chemist Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) Through: Mah Shamim, Ph. D., Chief Jean Holmes, Risk Assessment Process Leader Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) This memo provides a summary of the EFED Environmental Risk Assessment for the Oxadiazon Reregistration Eligibility Document ( RED). Oxadiazon is registered for use on terrestrial non­ food crop sites, including golf courses, landscape ( turf and ornamentals), nurseries, and roadside areas. Based on laboratory and field data, oxadiazon is a persistent, lipophilic compound that has a low mobility in most soils, and may be susceptible to aqueous photolysis. Oxadiazon is also a light­ dependent peroxidizing herbicide ( LDPH) that has the potential for the induction of phototoxicity. Our risk assessment shows that oxadiazon use has the potential for chronic exposure to aquatic organisms that could result in reproductive effects to estuarine/ marine fish and aquatic invertebrates. Other aquatic issues of concern include oxidiazon's ability to bind and accumulate in the sediment thus resulting in possible toxic exposure to aquatic organisms that live in or near the benthos. Since oxadiazon exposure to light has the potential for free radical generation, phototoxicity may be another issue of toxic concern for aquatic organisms. 2 Acute exposure of oxadiazon ( emulsifiable concentrate and granular) to birds and mammals should not present short term toxic risk. However, the potential for chronic risk to mammals and birds may result in reproductive effects. EFED also has a concern that acute exposure of oxadiazon to aquatic and terrestrial systems may result in the potential for risk to endangered species that include mammals, birds, fish and aquatic invertebrates. Since this compound is a herbicide, there can be an assumption of potential risk to nontarget plants ( terrestrial, semi­ aquatic and aquatic). The studies that have been submitted show that this compound is potentially a toxic risk to aquatic vascular and nonvascular plants. However, this possible risk to nontarget terrestrial plants cannot be fully assessed at this time due to the lack of acceptable data. Outstanding Data Requirements Environmental Fate: The environmental fate data base is largely complete. EFED will not require additional studies at this time. Ecological Effects: 72­ 4 ( a) Early­ Life Stage Estuarine Fish 72­ 4 ( b) Life Cycle Estuarine Invertebrate 123­ 1 Seedling Emergence and Vegetative Vigor­ using a liquid TEP to represent both granular and liquid formulations ( note in the case that liquid formulations are not supported for reregistration, only seedling emergence testing would be required; vegetative vigor testing is not required for granular formulations) 123­ 2 Aquatic plant testing ( TierII) is required because oxadiazon has outdoor nonresidential terrestrial uses that may move off­ site by runoff and/ or aerial spray drift. The following species should be tested at Tier II: Kirchneria subcapitata ( Selenastrum capricornutum), Skeletonema costatum, and Anabaena flos­ aquae. 70­ 1 Acute and Chronic Sediment Toxicity Testing ­ Oxadiazon shows a high K OC, combined with a high persistence exhibited in the aerobic soil metabolism, and the anaerobic aquatic metabolism (> 10 days). These fate properties indicate that there may be risk to benthicdwelling aquatic invertebrates, however the potential for risk cannot be assessed until data have been submitted. The Chronic Sediment Toxicity Testing data requirement is triggered, with Chironomus tentans and the Acute Chronic Sediment Toxicity Testing data requirement is triggered, with both Hyalella azteca, and Chironomus tentans. 70­ 1 Phototoxicity studies on fathead minnow. A subchronic exposure duration would be adequate for proof of concept. Behavioral observations should be conducted in addition to 3 mortality, growth, and morphology. All studies should be conducted under defined light conditions. Endangered Species The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA puts basic toxicity and exposure data developed for REDs into context for individual listed species and their locations by evaluating important ecological parameters, pesticide use information, the geographic relationship between specific pesticide uses and species locations, and biological requirements and behavioral aspects of the particular species. This analysis will take into consideration any regulatory changes recommended in this RED that are being implemented at this time. A determination that there is a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/ or the National Marine Fisheries Service as necessary. The Endangered Species Protection Program as described in a Federal Register notice ( 54 FR 27984­ 28008, July 3, 1989) is currently being implemented on an interim basis. As part of the interim program, the Agency has developed County Specific Pamphlets that articulate many of the specific measures outlined in the Biological Opinions issued to date. The Pamphlets are available for voluntary use by pesticide applicators on EPA's website at www. epa. gov/ espp. A final Endangered Species Protection Program, which may be altered from the interim program, is scheduled to be proposed for public comment in the Federal Register before the end of 2001. Endocrine Disruption EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally­ occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). 4 When the appropriate screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, oxadiazon, may be subjected to additional screening and or testing to better characterize effects related to endocrine disruption. Issues that have raised this concern include fish reproduction effects ( larval and embryo survival, egg hatchability) and invertebrate reproduction effects ( reduced neonate production) also suggest endocrine disruption. Uncertainties Environmental Fate and Exposure: There is some uncertainty in using the FIRST and GENEEC2 models respectively for drinking water and aquatic assessment. These two models are typically used for Tier I screening purposes for pesticides applied to soils. In turf environments, the fate characteristics and transport behavior of oxadiazon may be different than those in soils. Whether the difference is significant is not known at the present. Hence, it is difficult to estimate the magnitude of uncertainty. The turf scenario for PRZM/ EMAMS Tier II modeling is not available at this time so turf EECs can not be further refined.. Ecological Effects: Since oxadiazon is a herbicide, there is a potential for risk to nontarget plants. Lack of adequate data represents an uncertainty with regards to the risk, which may be further clarified through the submission of data. In the absence of data on chronic effects of oxadiazon to estuarine aquatic organisms, chronic testing results from freshwater fish and invertebrates species were extrapolated, representing an uncertainty which may be satisfied through the submission of appropriate data. The high persistence and lipophilicity of this chemical and its likelihood to accumulate in the sediment suggest that there may be risk to benthic and epibenthic aquatic life ( fish and aquatic invertebrates). However the potential for risk cannot be further refined until additional data ( sediment toxicity tests) have been submitted. Enhanced toxicity of oxadiazon to aquatic organisms after light exposure is an uncertainty. The inhibition of protoporphyrinogen oxidase, the rapid accumulation of protoporphyrin IX with the resulting generation of singlet oxygen ( free radicals) and eventual cell membrane destruction suggest that exposure to this compound may increase toxicity to aquatic organisms Label Recommendations: EFED recommends that the labels for all oxadiazon products carry the following statements: 5 Environmental Hazards i. Manufacturing Use Product: This pesticide is toxic to fish and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System ( NPDES) permit and the permitting authority has been notified in writing prior to discharge. For guidance, contact your State Water Board or Regional Office of the EPA. ii. End­ Use Product: This pesticide is toxic to fish and aquatic invertebrates. Do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not contaminate water when disposing of equipment washwaters or rinsate. Do not apply when weather conditions favor drift from treated areas. Runoff and drift from treated areas may be hazardous to aquatic organisms in neighboring areas. Do not allow this product to drift. 6 SUPPLEMENT Possible Risk Mitigation Measures: To reduce risk to plants and aquatic organisms, possible risk mitigation measures may include, but are not limited to: The addition of a well maintained buffer zone can also mitigate the risk. It is known that buffer zones can decrease the amount of spray drift reaching bodies of water. The current label suggests that to improve the efficacy, prior to application, the turf should be mowed and after application it should be irrigated if rain is not expected shortly. Making this suggestion compulsory would assure that most of the chemical reaches the soil surface, where it is less prone to runoff. 7 N N O Cl Cl O CH O C CH 3 CH 3 CH 3 C H 3 C H 3 Environmental Fate and Ecological Risk Assessment for the Reregistration Eligibility Decision Oxadiazon; Ronstar ® 2­ tert­ Butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ delta2­ 1,3,4­ oxadiazoline­ 5­ one and 3­[ 2,4­ Dichloro­ 5­( 1­ methylethoxy) phenyl]­ 5­( 1,1­ dimethyl­ ethyl)­ 1,3,4­ oxadiazol­ 2( 3H)­ one Shaughnessy Number: 109001 CAS Number: 19666­ 30­ 9 Prepared by: Miachel Rexrode, Ph. D. José L. Meléndez Environmental Risk Branch V Reviewed by: Environmental Fate and Effects Division Rodolfo Pisigan Jr., Ph. D. Mah T. Shamim, Ph. D. 8 TABLE OF CONTENTS CHAPTER 1: ENVIRONMENTAL RISK CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 CHAPTER 2: INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 CHAPTER 3: INTEGRATED ENVIRONMENTAL RISK CHARACTERIZATION . . . . . . . . . . . . . 15 CHAPTER 4: ENVIRONMENTAL FATE AND TRANSPORT ASSESSMENT . . . . . . . . . . . . . . . . 19 CHAPTER 5: DRINKING WATER ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 CHAPTER 6: AQUATIC EXPOSURE AND RISK ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . 21 CHAPTER 7: TERRESTRIAL EXPOSURE AND RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 CONCLUSIONS......................................................................................................................................... 32 APPENDIX A: REFERENCES CITED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 APPENDIX B: FATE SUMMARIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 APPENDIX C: ECOLOGICAL TOXICITY DATA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 APPENDIX D: FATE TERRESTRIAL MODEL RUNS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 APPENDIX E: DRINKING WATER CONCENTRATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 APPENDIX F: EXPOSURE AND RISK CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 APPENDIX G: ENVIRONMENTAL FATE AND ECOLOGICAL EFFECTS DATA REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 APPENDIX H: QUALITATIVE USE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 APPENDIX I: GENEEC 2.0 INPUT PARAMETERS, RESULTS, AND OUTPUTS . . . . . . . . . . . . . 75 APPENDIX J: REQUEST for PHOTOTOXICITY STUDY PROTOCOL for LIGHT­ DEPENDENT PEROXIDIZING HERBICIDES........................................................................................... 80 ATTACHMENT I........................................................................................................................................ 83 9 CHAPTER 1: ENVIRONMENTAL RISK CONCLUSIONS a. Registered Uses Oxadiazon is a selective pre­ emergent and early post­ emergent herbicide used to control grassy and broadleaf weeds in turf and ornamentals. Application rates range from 2 to 4 lbs ai/ A, with usually only one application made per season. Most of the products are in granular form. The herbicide's primary use is on golf courses, turf farms and ornamental plantings. The registrant, Aventis, is supporting a maximum yearly use of eight pounds of active ingredient per acre. Aerial applications are not being supported ( SRRD communication). . Table 1. Oxadiazon Registered Use on Turf ( Golf Courses), Nursery and Roadsides. Usage Maximum Application Rate ( lbs ai/ A) Number of Applications Minimum Application Interval ( days) Maximum Application Rate per Season ( lbs ai/ A) Turf ( Ground Spray) 4.0 2 182 8.0 4.0 1 NA 4.0 3.0 1 NA 3.0 2.0 1 NA 2.0 Turf ( Ground Spray) Split Application 1.0 8 42 8.0 1.3 6 56 8.0 Turf ( Granular) 4.0 2 182 8.0 4.0 1 NA 4.0 3.0 1 NA 3.0 2.0 1 NA 2.0 b. Major Risk Concerns Our assessment shows that oxadiazon exposure in the aquatic environment can present significant chronic risk to freshwater fish and aquatic invertebrates. The chronic Level of Concern ( LOC) was exceeded by up to 132­ fold for fish and 37­ fold for aquatic invertebrates. Although this Tier I risk assessment suggests that acute exposure of oxadiazon to aquatic systems should result in relatively lower short term risk to non endangered fish and aquatic invertebrates there is uncertainty regarding possible phototoxicity. Since oxadiazon is an LDPH compound, enhanced toxicity through exposure to high levels of solar radiation is a possible concern that could impact aquatic organisms that inhabit small, shallow water bodies. Oxadiazon is also a lipophilic compound that has the capacity to strongly bind to particulates and organic carbon. This binding can result in accumulation in the sediment raising concerns for toxic risk to benthic and epibenthic aquatic organisms ( aquatic insects, amphipods, crustaceans, mollusks, bivalves, 10 etc). Since sediment act as a reservoir for lipophilic persistent compounds, sediment bound oxadiazon presents a high risk potential for aquatic life because of direct contact with various organisms through respiration, ingestion, dermal contact, or indirectly through alterations of the food chain. The herbicidal properties of this compound also strongly suggest that there is a potential for toxic risk to aquatic plants ( monocots and dicots) which may result in an indirect impact on aquatic systems through habitat alteration. Endangered species concerns have also been triggered for fish, aquatic invertebrates and plants. Terrestrial exposure of this compound to mammals and birds can result in potential chronic risk while the acute risk to terrestrial organisms ( birds, mammals, and honey bees) from the registered use of oxadiazon appears low. However, information on the herbicidal mode of action of oxadiazon strongly suggests that there is a potential for acute risk to nontarget aquatic and terrestrial plants. The limited plant data for oxadiazon shows that this compound can present a toxic risk to nontarget plants ( EC 25 values reported in the seedling emergence/ vegetative vigor tests were as low as about a tenth of a pound per acre). Although there does not appear to be an acute risk to endangered birds and mammals there may be chronic concerns as reflected in the two­ fold LOC exceedences for non endangered terrestrial animals. Therefore, our assessment suggests that endangered terrestrial species ( birds, mammals, and terrestrial plants) may be at risk. c. Oxadiazon Incident History There are no confirmed incidents associated with the use of oxadiazon in the Environmental Fate and Effects Division EIIS Database. However, this data base is compiled through voluntary submissions that may only capture a small fraction of actual incidents. d. Likelihood of Water Contamination The potential impact to water quality from the use of oxadiazon on turf is essentially due to the parent ( as opposed to possible degradates). Oxadiazon appears to be very persistent under most environmental conditions making the chemical available for surface runoff. Moreover, the remaining important factor which affects the impact of oxadiazon on water quality is its mobility. A soil column leaching study, and supplemental batch equilibrium studies indicated that oxadiazon has low mobility in the various soils tested. Ordinarily this would mean that the chemical would remain soil bound and would be transported to a water body on eroded soil. Turf scenarios, however, offer different challenges than other conventional crops. The turf itself offers a vegetative interception layer ( including thatch) that prevents rapid deposition of the oxadiazon on the surface of the soil. Both liquid and granular formulations labels of oxadiazon specify that the chemical's effectiveness is improved if it is wetted in after application. Furthermore, both labels recommend mowing the grass prior to application. Oxadiazon is expected to bind to soil particles, but turf scenarios offer vegetation interception. The models used for the determination of the water exposures were FIRST, GENEEC 2.0 for surface waters, and SCIGROW for ground waters. The models are screening models designed to provide upper­ bound estimates of the concentrations that might be found due to the use of oxadiazon. For drinking water worst case scenario ( 4 lb a. i./ A applied at 6­ months interval) was used. Further refinements of our 11 computer models were not possible at this time. The EFED is currently developing a turf scenario, which is expected to be ready in the near future. Surface water monitoring data for oxadiazon is very limited and cannot be used to represent possible concentrations of oxadiazon in surface waters. The chemical is not included in the NAWQA monitoring studies. The STORET database contained only two samples taken from the same location within an interval of only four days. The estimated recommended acute, and long term drinking water concentrations are detailed in Chapter 6. Oxadiazon has a high affinity to soils and sediments K OC
2357, combined with the high persistence exhibited in the aerobic soil metabolism (>> 1year), as well as the anaerobic aquatic metabolism (
1 year studies). It appeared that oxadiazon would be a persistent chemical in sediment environments. Although oxadiazon exhibits high affinity to soils and a relatively high bioconcentration factor ( K ow = 63100; BCF's of 368X, 2239X, and 1111X for muscle, viscera, and whole fish, respectively), the rate of depuration was relatively rapid ( half­ life of about one day). e. Recommended Drinking Water Concentrations for HED As per HED's request, the drinking water assessment for oxadiazon is as follows: the peak untreated surface water concentration is 246 ppb, and the annual average untreated water concentration is 100 ppb . These values represent upper­ bound estimates of the concentrations of oxadiazon that might be found in surface water due to the use of oxadiazon on turf at the maximum application rate of 8.0 lb a. i./ A/ season. The recommended oxadiazon ground water concentration is 0.6 ppb. Recently EFED validated a new turf scenario that can be used to model golf courses. Additionally, new PCA's have been developed for golf courses ( tees, greens and fairways). EFED will model Tier II drinking water concentrations accordingly. These calculations will be performed during the revisions of the 60­ days comments period. f. Monitoring and Modeling As shown in Table 3, the groundwater concentration estimated from SCIGROW is 0.6 ppb which is about two orders of magnitude lower than those of surface water. This concentration may be used for both acute and chronic values. The low concentration is consistent with both laboratory and field studies that indicate the low mobility of oxadiazon, and subsequently, its reduced potential to reach groundwater. 12 CHAPTER 2: INTRODUCTION a. Mode of Action Oxadiazon is a selective pre­ emergent and early post­ emergent herbicide used to control grassy weeds ( e. g., crabgrass and goosegrass) and broadleaf weeds. The primary mode of action of oxadiazon is inhibition of protoporphyrinogen oxidase ( Protex), a critical enzyme in the biosynthesis of chlorophyll and heme ( Matringe et al., 1989). Consistent with protoporphyrinogen oxidase­ inhibiting herbicides, tissue exposed in darkness accumulate protoporphyrin IX, which can lead to a photodynamic loss of cell membrane integrity ( free radical development) upon exposure to light. b. Use Characterization The formulation types include granular ( 39 products; predominant formulation), wettable powder ( 2 products), soluble concentrate ( 1 product) and emulsifiable concentrate ( 1 product). Aventis is the sole technical registrant. Oxadiazon is registered for use on terrestrial non­ food crop sites, including golf courses; landscape ( turf and ornamentals); nursery; and roadside. An annual estimate of oxadiazon's total usage is 249,000 pounds of active ingredient on 52,000 acres. Most of the use is on golf courses, which accounts for about 65% of all use. Application rates range from two to four pounds active ingredient per acre. According to SRRD, Aventis is supporting a maximum application of 4.0 lb ai/ A per six month period, equivalent to 8.0 lbs ai/ year and aerial applications are not being supported. Since efficacy ( pre emergent control) is based on oxadiazon reaching and remaining in the soil, product labels may specify to mow, if necessary, before application, and to irrigate, if rain is not expected shortly. Oxadiazon may also be used for early post­ emergent control, but this is to a much lesser extent. ( usage information was obtained from BEAD's Qualitative Use Assessment, Appendix K). Oxadiazon is classified as an oxadiazole herbicide. The chemical name is: 5­ tert­ Butyl­ 3­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 1,3,4­ oxadiazol­ 2( 3H)­ one. Other chemical names are: ( IUPAC). 2­ tert­ Butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ delta2­ 1,3,4­ oxadiazoline­ 5­ one and 3­[ 2,4­ Dichloro­ 5­( 1­ methylethoxy) phenyl]­ 5­( 1,1­ dimethyl­ ethyl)­ 1,3,4­ oxadiazol­ 2( 3H)­ one. Trade names include Ronstar, RP­ 17623, and G 315. c. Approach to Risk Assessment In order to conduct an ecological risk assessments on this compound, EFED used dosage rate information obtained from SRRD and BEAD. The evaluation of the potential risk to aquatic and terrestrial organisms from the use of oxadiazon, was assessed through the calculation of risk quotients ( RQs) that were derived from the ratio of estimated environmental concentrations ( EECs) to ecotoxicity values ( see Appendix F). EECs were based on the maximum and typical application rate of oxadiazon to turf. These RQs are then compared to the Levels of Concern ( LOC) ( Appendix F) criteria used by EFED for determining potential risk to nontarget organisms and the subsequent need for possible regulatory action. 1EFED examined two DER's that provide data ( 2­ 7 day half­ life) on the decay of transferable residues of oxadiazon from turf surfaces to a cotton cloth, EFED chose not to use these studies because one study was conducted on a granular formulation and the other study presented a quantitative concern. 13 Terrestrial exposure was evaluated using EECs generated from ELL­ FATE spreadsheet­ based model that calculates the decay of a chemical applied to foliar surfaces for single and multiple applications. The model assumes initial concentrations on plant surfaces based on Kenaga predicted maximum residues as modified by Fletcher et al. ( 1994) and assumes 1st order dissipation. Kenaga estimates and an explanation of the model with sample output are presented in Appendix F. In the absence of foliar dissipation half­ life data for oxadiazon a 35­ day half­ life was used. The selection of this half­ life was based on the upper limit of pesticide, foliar dissipation half­ lives provided in the half­ life listing of Willis and McDowell, 1987. EFED uses this value as a default equivalent when the foliar dissipation for a particular pesticide is unknown or in question1. The terrestrial and aquatic risk assessment was also based on the three maximum application rates of 4.0, 3.0, and 2.0 lbs ai/ A at 2 applications each and a 4.0 lbs ai/ A for granular, at 2 applications. Additional exposure scenarios for split application ( 1.0 and 1.3 lbs ai/ A, at 6 and 8 week intervals, respectively) were conducted for terrestrial exposure. Aquatic exposure was evaluated using EECs generated from the Tier I GENEEC2 model. 14 Aquatic and terrestrial risk assessments were conducted by using worst case ecotoxicity endpoints ( i. e., LD50 and LC50 values, NOAEC values). The toxicity endpoints chosen for use in the ecological risk assessment are summarized below. Table 2. Selection of Toxicological Endpoints Used to Determine Risk Quotients ( RQs) Type Of Toxicity Organism Species Toxicological Endpoint Oral Acute Bird Mallard 1040 mg/ kg Dietary Bobwhite/ Mallard > 5000 ppm Chronic Bobwhite 500 ppm 1 Oral Acute Mammal Rat > 5000 mg/ kg Chronic Rat 200 ppm 2 Acute Freshwater Fish Rainbow trout/ Bluegill 0.88 ppm Chronic Rainbow trout 0.88 ppb 3 Acute Freshwater Invertebrates Daphnid 2.18 ppm Chronic Daphnid 0.03 ppm Acute Estuarine Fish Sheepshead Minnow 1.5 ppm Chronic Sheepshead Minnow 0.0015 ppm 4 Acute Estuarine Invertebrates Mysid 0.27 ppm Chronic Mysid 0.0037ppm4 Acute Aquatic Plants ( vascular) ( Nonvascular) duckweed marine diatom EC50 = 41 ppb; NOAEC = < 8 ppb EC50 = 5.2 ppb 1 No effects on any reproductive parameter or viability of of F1 offspring at the highest dose tested, 1000 ppm; however due to excessive mortality ( 33%) of adult female birds in that dose level, a NOAEC for chronic effects was set at 500 ppm. 2 LOAEL of > 38 mg/ kg/ day for inactive mammary tissue and fetal/ pup death observed in the one year range­ finding test of a rat reproduction study. NOAEC > 200 ppm. 3 Rainbow trout was more sensitive than the fathead minnow ( fathead minnow NOAEC= 33 ppb). 4 Extrapolation from acute/ chronic ratio. 15 CHAPTER 3: INTEGRATED ENVIRONMENTAL RISK CHARACTERIZATION Oxadiazon is a persistent, lipophilic compound that has low mobility in most soils ( not expected to move to ground water), and may be susceptible to aqueous photolysis. Oxadiazon is also a light­ dependent peroxidizing herbicide ( LDPH) that has the potential for the induction of phototoxicity ( exposure to light results in the development of free radicals that can destroy cell membranes). Our risk assessment shows that chronic exposure of this compound to aquatic organisms ( estuarine/ marine fish and aquatic invertebrates) can result in significant reproductive effects ( EFED's runoff and drift exposure scenarios). Aquatic risk is further compounded by oxadiazon's ability to bind and accumulate in the sediment. As a contrast, terrestrial concerns for this compound are mixed. The potential for chronic risk to mammals appears very high and could result in significant reproductive effects. However, chronic risk to birds appeared to be a relatively lower concern although values still exceed EFED's level of concern ( LOC). Our analysis also noted that acute exposure of oxadiazon ( emulsifiable concentrate and granular) to birds and mammals should not present significant short term toxic risk. EFED also has a concern that exposure of oxadiazon to aquatic and terrestrial systems may result in a potential risk to endangered species that can include mammals, birds, fish and aquatic invertebrates. Since this compound is a herbicide, there is the potential for impact to nontarget plants ( terrestrial, semi­ aquatic and aquatic). However, this possible risk to nontarget plants cannot be fully assessed at this time due to the lack of acceptable data. The focus of this risk assessment is based on toxicity and exposure values ( risk quotients or RQs as the ratio of exposure/ toxicity), the disposition ( fate) of oxadiazon in the environment, and its mode of action as a phototoxic compound. In order to evaluate the potential for risk to non target organisms, our assessment is divided into aquatic and terrestrial exposure scenarios. The aquatic component was evaluated through GENEEC2 pond scenario while terrestrial impact was assessed through the ELL­ FATE model. Since oxadiazon is primarly used as a herbicide on turf, especially golf courses, EFED has evaluated the proximity of these areas to estuarine/ marine environments, and the ecological significance of application timing. Oxadiazon is a stable and persistent compound. However, direct aqueous photolysis half­ life of about 3 days suggests that in clear and shallow surface water bodies where sunlight penetration can be significant, photolytic degradation of oxadiazon is possible. However, this photolytic effect may also substantially diminish in turbid and deeper water bodies. Soil photolysis and hydrolysis under acidic and basic conditions do not appear to be an important dissipation mechanism. Microbial metabolism in soil and aquatic environments under either aerobic and anaerobic condition is not expected to cause any significant transformation of oxadiazon. Studies on equilibrium sorption and aged/ unaged oxadiazon indicate that the pesticide has low environmental mobility ( K d's ranged from 8.17 to 22.83; K oc's ranged from 1409 to 3268). Thus, oxadiazon can be transported on erodible soil particles via runoff events to nearby surface water bodies. Leaching from surficial soils to groundwater is expected to be low or negligible, unless the soil is very porous or has some cracks that favor preferential flow. Oxadiazon exhibited slow dissipation in two field terrestrial studies conducted in California and North Carolina. Our review has found that golf courses can represent about 2,300,000 acres in the USA. About half of this acreage is located in counties that are considered coastal and close to estuarine/ marine environments 16 and tributaries. Because of the proximity to these aquatic habitats to golf courses, EFED has a concern for any persistent compound that has the potential for runoff and toxicity to aquatic systems that include estuaries. Many of these aquatic areas have significant fisheries that can account for over 65% of the commercial catches for the USA. ( e. g. Chesapeake Bay, Long Island Sound, The Gulf of Mexico, San Diego Bay, San Francisco Bay, Puget Sound, etc.). Impact to this resource could effect not only the ecological value but the livelihood of fishing communities and markets at a local and national level. Since oxadiazon is stable to hydrolysis and persistent in the environment, the results from our Tier I ( GENEEC2) pond scenario model suggest that chronic exposure of oxadiazon can result in significant long term risk to freshwater and estuarine/ marine fish and aquatic invertebrates. Our screening level assessment shows that the RQ values that were generated exceeded the LOC by significant amounts of 4 ­ 132 fold ( application rates of 2.0 ­ 4.0 lbs ai/ A EC and granular formulation). The issue of chronic toxicity is compounded by the lipophilic nature of oxadiazon. Since this stable compound can be absorbed to particulate and organic carbon, oxadiazon residues can accumulate in sediments and increase the potential for chronic risk to benthic and epibenthic organisms ( aquatic organisms that live in or on the sediment). Acting as a repository for lipophilic compounds, sediments can impact aquatic organisms through respiration, ingestion, dermal contact, and/ or indirect impact through alterations of the food chain. This can present a significant risk to aquatic organisms because about 80% of all aquatic life in estuaries is in contact with the benthos. Therefore, in order to better understand this potential risk, EFED is requiring appropriate sediment toxicity testing ( acute and chronic) on this compound. Another issue of concern is the uncertainty regarding the degree of phototoxicity of this compound to aquatic organisms. Since oxadiazon is a lightdependent peroxidizing herbicide ( LDPH), enhanced toxicity through exposure to high levels of solar radiation may increase toxic risk to aquatic organisms that inhabit small, shallow water bodies ( toxicity is increased through the production of free radicals which actively destroy cell membranes). This can be very critical to several species of aquatic organisms ( fish, crabs, etc) whose early life stages are dependent upon these relatively shallow areas for their development. The herbicidal properties of oxadiazon also suggest the potential for acute toxicity to aquatic plants and the possibility of aquatic habitats alterations. This can potentiate an indirect effect to aquatic populations through a decrease in plant cover. In addition to toxic risk to non target aquatic organisms, oxadiazon may also impact endangered species ( fish and invertebrates). The potential for birds and mammals to be exposed to pesticides through a turf use has been documented ( e. g. chlorpyrifos, lindane). The application of oxadiazon in the spring as noted from the label, can coincide with several avian and mammalian reproductive cycles, as well as spring migrations ( avian). In order to evaluate the potential for risk to terrestrial organisms, EFED has conducted a Tier I assessment by using the ELL­ FATE model. In order to evaluate possible toxic risk to terrestrial organisms, three application rates ( 4.0, 3.0, and 2.0 lbs ai/ A, at 2 applications/ 6 months) and two split applications ( 1.0 lbs ai/ A applied 4 times/ 6 month and 1.3 lbs ai/ A applied 3 times/ 6 month) were run. Our objective was to find not only the highest rate that may cause toxic risk, but the rate that might result in lower risk. Our assessment noted that acute risk to birds and mammals was minimal and should not present any short term toxic concern to these organisms. However, all application scenarios showed that chronic exposure could result in significant risk to mammalian herbivores and insectivores ( 15g, 35g, and 1000g) with RQ exceedences of 1.5 ­ 9.9 fold. In contrast to mammalian chronic risk, our assessment also noted that 17 chronic exposure to birds could result in relatively lower RQ values that showed exceedence of about 1 to 2 fold the LOC. This could be interpreted as potentially low toxic risk ( chronic) to birds that feed on plants and grass ( e. g. ducks, geese). A reduction in chronic risk to birds was noted with the split application scenarios ( RQ = < 1), but chronic risk to mammals was still very high even with this scenario. Exposure from the granular formulation was evaluated because birds may be exposed to granular pesticides through ingestion when foraging for food or grit. RQ values were calculated for three weight classes of birds ( 1000g waterfowl, 180g upland game bird, and 20g songbird). All scenarios for the granular resulted in no acute risk to birds ( EFED does not conduct a chronic assessment from granular exposure). The potential for chronic risk ( high for mammals but relatively low for birds) that has been noted for terrestrial organisms suggests that oxadiazon may present a risk to both avian and mammalian endangered species ( RQ > 0.1), even though the acute LOC values were not exceeded. Although, risk to terrestrial plants could not be conducted at this time ( lack of data), oxadiaxon's herbicidal mode of action suggests that there is a potential for risk to nontarget terrestrial plants, as well as endangered plants. Since oxadiazon is practically non­ toxic to the honey bee, minimal risk to these organisms is anticipated. The Agency is currently engaged in a Proactive Conservation Review with FWS and the National Marine Fisheries Service under section 7( a)( 1) of the Endangered Species Act. The objective of this review is to clarify and develop consistent processes for endangered species risk assessments and consultations. Subsequent to the completion of this process, the Agency will reassess the potential effects of oxadiazon use to federally listed threatened and endangered species. At that time the Agency will also consider any regulatory changes recommended in the RED that are being implemented. Until such time as this analysis is completed, the overall environmental effects mitigation strategy articulated in this document and any County Specific Pamphlets which address oxadiazon, will serve as interim protection measures to reduce the likelihood that endangered and threatened species may be exposed to oxadiazon at levels of concern. The endangered species LOCs for liquid and granular formulations of oxadiazon are exceeded for chronic risks to birds and mammals and acute/ chronic risk to freshwater and estuarine fish and invertebrates and aquatic vascular plants. Although the terrestrial plant data are outstanding, it is assumed that endangered terrestrial plants are at risk since oxadiazon is an herbicide. Although the endangered species LOC for estuarine invertebrates has been exceeded, there are no listed species in this group. EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally­ occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen­ and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). 18 When the appropriate screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, oxadiazon, may be subjected to additional screening and or testing to better characterize effects related to endocrine disruption. Issues that have raised this concern include fish reproduction effects ( larval and embryo survival, egg hatchability) and invertebrate reproduction effects ( reduced neonate production). 19 CHAPTER 4: ENVIRONMENTAL FATE AND TRANSPORT ASSESSMENT Basic Physicochemical Parameters The important properties of oxadiazon are summarized below. Oxadiazon is a high­ molecularweight compound with fairly low solubility in water and high solubility in organic solvents. It has a low vapor pressure and Henry's Law Constant (<< 1 x 10­ 3 atm­ m­ 3/ mol) suggesting that volatilization from soil and surface water environments is not important. Its high Kow value tends to indicate that bioconcentration in aquatic organisms such as fish is possible. Nevertheless, the high bioconcentration factors observed in studies using bluegill sunfish can be offset by fast depuration rate. Molecular formula: C 15 H 18 Cl 2 N 2 O 3. Molecular weight: 345.2. Physical state: Colorless crystals. Vapor pressure ( 20  C): 1.00x10­ 6 mm Hg Henry's Constant: 4.51x10­ 7 Atm$ m3/ mol Solubility ( 20  C): 1 ppm water ( 25  C) 600 g/ L acetone, acetophenone, anisole 1 kg/ L benzene, chloroform, toluene 100 g/ L ethanol, methanol K ow: 63,100 log 10 K ow: 4.8 Fate and Transport Processes ­ Summary Based on fate studies reviewed, oxadiazon would be stable and persistent under typical natural environment. However, direct aqueous photolysis half­ life of about 3 days ( summer sunlight conditions in Florida) suggests that in clear and shallow surface water bodies where sunlight penetration can be significant, photolytic degradation of oxadiazon is possible. The photolytic effect though may substantially diminish in turbid and deeper water bodies. Soil photolysis and hydrolysis under acidic and basic conditions do not appear to be an important dissipation mechanism. Microbial metabolism in soil and aquatic environments under either aerobic and anaerobic condition is not expected to cause any significant transformation of oxadiazon. A number of degradates have been reported from the different chemical and biological fate studies. The nomenclature of these degradates are summarized in Appendix 3 ( move nomenclauture on page to 20 to this Appendix 3). Studies on equilibrium sorption and aged/ unaged oxadiazon indicate that the pesticide has low environmental mobility ( K d's ranged from 8.17 to 22.83; K oc's ranged from 1409 to 3268). Thus, oxadiazon can be transported as sorbed species to erodible soil particles via surface runoff to nearby surface water bodies. Leaching from surficial soils to groundwater is expected to be low or negligible, unless the soil is very porous or has some cracks that favor preferential flow. Oxadiazon exhibited slow dissipation in two field terrestrial studies conducted in California and North Carolina. Details of all the fate and transport studies are discussed in Appendix B. 20 CHAPTER 5: DRINKING WATER ASSESSMENT a. Estimated Environmental Concentrations and Drinking Water Concentration Estimates TierI screening models, FIRST and SCIGROW, were used to determine estimated environmental concentrations ( EECs) of oxadiazon in surface water and groundwater associated with the ground spray application of 4.0 lbs a. i./ A ( applied two times a year) in turf. FIRST estimates surface water concentrations resulting from runoff of applied pesticides from a treated area to an adjacent index water reservoir in which the percent or fraction of cropped area ( 0.87) is taken into account. SCIGROW predicts groundwater concentrations after leaching of pesticides from the surficial soils and/ or subsurface horizons to the aquifer. The screening concentrations derived from the two models are used in the evaluation of human exposure to contaminated drinking water. Details about the two models, including the input parameters and computer output printouts for turf scenario, are presented in Appendix E ( Drinking Water Memo). Surface Water The results of FIRST modeling for the acute and chronic surface water EECs are summarized in the table below. The acute ( 246 ppb) and chronic ( 100 ppb) values represent the peak and annual average concentrations predicted by the model. These values generally represent upper bound estimates. The values are relatively higher than the two similar oxadiazon detections ( 0.05 ug/ L) in Larue, KY reported in the 1997 surface water monitoring data of the STORET system. Therefore, based on the data available, EFED conservatively recommends to use the model­ predicted values for surface derived drinking water concentrations. Table 3. Estimated Tier I concentrations of oxadiazon in drinking water Chemical Surface Water ( ug/ L) Groundwater ( ug/ L) Acute Chronic Acute and Chronic Oxadiazon 246 100 0.6 Groundwater As shown in Table 3, the groundwater concentration estimated from SCIGROW is 0.6 ppb which is about two orders of magnitude lower than those of surface water. This concentration may be used for both acute and chronic values. The low concentration is consistent with both laboratory and field studies that indicate the low mobility of oxadiazon, and subsequently, its reduced potential to reach groundwater. 21 CHAPTER 6: AQUATIC EXPOSURE AND RISK ASSESSMENT a. Aquatic ( Acute/ Chronic Hazard Summary) Oxadiazon is considered to be moderately toxic on an acute basis to freshwater fish ( LC 50 = 0.88­ 1.2 ppm) and estuarine/ marine fish ( LC 50 = 1.5 ppm). However, chronic NOAEC/ LOAEC were determined for freshwater fish at 0.88/ 1.7 ppb with egg hatchability as the endpoint effected. Oxadiazon has the potential for high acute toxicity to estuarine/ marine invertebrates ( EC 50 = 0.27 ­ 0.7 ppb) but appears to be moderately toxic to freshwater invertebrates ( LC 50 = 2.18 ­ 2.4 ppm). Chronic toxicity to freshwater invertebrates shows reproductive effects ( mean time to first brood, # young/ adult/ reproductive day, survival, growth) with a NOAEC/ LOAEC = 30.0/ 35.0 ppb. The limited data on plant toxicity shows that oxadiazon is toxic to non­ vascular aquatic plants ( marine diatom EC 50 = 5.2 ppb) and vascular aquatic plants ( duckweed EC 50 = 41 ppb). b. Risk to Aquatic Organisms ( Acute/ Chronic) Tables 4 and 5 provide acute and chronic RQ values for oxadiazon exposure to freshwater and estuarine/ marine species relative to turf use patterns ( application rates for EC at 2.0 ­ 4.0 lbs ai/ A and 4.0 lbs ai/ A for granular). Our Tier I ( GENEEC) risk assessment suggests that chronic exposure of this compound can result in significant chronic risk to freshwater and estuarine/ marine fish ( RQ = 39.3 ­ 131.8) and aquatic invertebrates ( RQ = 3.9 ­ 36.7). Although our assessment further suggests that oxadiazon acute exposure may result in low acute risk to fish ( RQ = 0.1 ­ 0.2) and invertebrates ( RQ = 0.3 ­ 0.5), there is uncertainty regarding the potential for enhanced risk that may occur through phototoxicity. Since oxadiazon is a light­ dependent peroxidizing herbicide ( LDPH), enhanced toxicity through exposure to high levels of solar radiation is a possible concern regarding aquatic organisms that inhabit small, shallow water bodies. Endangered species concerns are also suggested with RQ = 0.1. Aquatic plant acute high risk levels of concern are exceeded ( Table 6 and 7) for both vascular and nonvascular plants. The exceedences range 1 ­ 4 fold for vascular plants and 8.5 ­ 33 fold for non­ vascular plants. The acute plant high risk level of concern is exceeded for vascular plants with an exceedence range of 5.5 ­ 22 fold. Currently, EFED does not perform assessments for chronic risk to aquatic plants. 22 Table 4. Acute and chronic RQ's for evaluating toxic risk of oxadiazon exposure to fish ( freshwater and estuarine/ marine). RQ's are based on the bluegill ( Lepomis macrochirus) LC50 = 0.88 ppm, rainbow trout ( Oncorhynchus mykiss) NOAEC = 0.00088 ppm and sheepshead minnow ( Cyprinodon variegatus) LC50 = 1.5 ppm., NOAEC = 0.0015 ppm1. EEC values are generated from GENEEC and reflect three of the highest proposed EC application rates, and the maximum granular use rate ( 4.0, 3.0, and 2.0 lbs ai/ A, 2 applications each; 4.0 lbs ai/ A, 2 applications, respectively) for turf use. Crop App. Rate ( lbs ai/ A; # App.) Organism LC50 ( ppm) NOAEC ( ppm) EEC Peak ( ppm) EEC 60­ Day Ave. ( ppm) Acute RQ ( EEC/ LC50) Chronic RQ ( EEC/ NOAEC) Turf ( EC) 4.0 ( 2) Freshwater 0.88 0.00088 0.143 0.116 0.22 131.83 Estuarine/ Marine 1.5 0.00151 0.143 0.116 0.12 77.33 Turf ( EC) 3 ( 2) Freshwater 0.88 0.00088 0.130 0.122 0.12 139.03 Estuarine/ Marine 1.5 0.00151 0.130 0.122 0.12 81.33 Turf ( EC) 2 ( 2) Freshwater 0.88 0.00088 0.088 0.083 0.12 94.33 Estuarine/ Marine 1.5 0.00151 0.088 0.083 0.0 55.33 Turf ( Granular) 4.0 ( 2) Freshwater 0.88 0.00088 0.122 0.099 0.12 112.53 Estuarine/ Marine 1.5 0.00151 0.122 0.099 0.12 66.03 1 Extrapolated chronic value using acute/ chronic freshwater toxicity ratio 2 Acute restrictive use (> 0.1), acute species 3 Chronic concern (> 1.0) 23 Table 5. Acute and chronic risk RQ's for evaluating toxic risk of oxadiazon exposure to aquatic invertebrates ( freshwater and estuarine / marine). RQ's are based on Daphnia ( Daphnia magna) EC50 = 2.18 ppm, NOAEC = 0.03 ppm and the Mysid shrimp ( Americamysis bahia) EC50 = 0.27 ppm, NOAEC = 0.0037 ppm1. EEC values are generated from GENEEC and reflect three of the highest proposed EC application rates, and the maximum granular use rate ( 4.0, 3.0, and 2.0 lbs ai/ A, 2 applications each; 4.0 lbs ai/ A, 2 applications, respectively) for turf use. Crop App. Rate ( lbs ai/ A) # App. ( days) Organism EC50 ( ppm) NOAEC ( ppm) EEC Peak ( ppm) EEC 21­ Day Ave. ( ppm) Acute RQ ( EEC/ LC50) Chronic RQ ( EEC/ NOAEC) Turf ( EC) 4.0 ( 2) Freshwater 2.18 0.03 0.143 0.136 0.12 4.51 Estuarine/ Marine 0.27 0.0037 0.143 0.136 0.52 36.71 Turf ( EC) 3.0 ( 2) Freshwater 2.18 0.03 0.130 0.127 0.52 4.21 Estuarine/ Marine 0.27 0.0037 0.130 0.127 0.52 34.33 Turf ( EC) 2.0 ( 2) Freshwater 2.18 0.03 0.088 0.086 0.0 2.93 Estuarine/ Marine 0.27 0.0037 0.088 0.086 0.32 23.23 Turf ( Granular) 4.0 ( 2) Freshwater 2.18 0.03 0.122 0.116 0.0 3.91 Estuarine/ Marine 0.27 0.0037 0.122 0.116 0.42 31.31 1 Extrapolated chronic value using acute/ chronic freshwater toxicity ratio 2 Acute restrictive use (> 0.1) 3 Chronic concern (> 1.0) 24 Exposure and Risk to Aquatic Plants Exposure to nontarget aquatic plants may occur through runoff or spray drift from adjacent treated sites. An aquatic plant risk assessment for acute high risk is usually made for aquatic vascular plants from the surrogate duckweed Lemna gibba. Non­ vascular acute high aquatic plant risk assessments are performed using either algae or a diatom, whichever is the most sensitive species. Runoff and drift exposure are computed from GENEEC2 and the risk quotient is determined by dividing the pesticide's initial or peak concentration in water by the plant EC 50 value. Acute risk quotients for vascular and non­ vascular plants are tabulated in Table 6. Table 6. Acute Risk Quotients for Aquatic Plants based upon a duckweed ( Lemna gibba) EC50 of 41 ppb and a nonvascular plant ( marine diatom) EC50 of 5.2 ppb. Turf/ Rate of Application in lbs ai/ A ( Number of Applications). Species EC50 ( ppm) EEC ( ppm) Non­ target plant RQ ( EEC/ EC50) 4 ( 1) duckweed 0.041 0.173 4.2 4 ( 1) " 0.041 0.089 2.2 3 ( 1) " 0.041 0.067 1.6 2 ( 1) " 0.041 0.044 1.1 4 ( 2) diatom 0.0052 0.173 33.3 4 ( 1) " 0.0052 0.089 17.1 3 ( 1) " 0.0052 0.067 12.9 2 ( 1) " 0.0052 0.044 8.5 The acute high risk levels of concern for aquatic plants are exceeded for both vascular and nonvascular plants. The exceedences range 1 ­ 4 fold for vascular plants and 8.5 ­ 33 fold for non­ vascular plants. Currently, EFED does not perform assessments for chronic risk to aquatic plants. 25 Table 7. Species Risk Quotients on turf for aquatic plants based upon a duckweed ( Lemna gibba) NOAEC of < 8 ppb. Rate of Application in lbs ai/ A ( Number of Applications). Species EC50 ( ppm) EEC ( ppm) Non­ target plant RQ ( EEC/ EC50) 4 ( 2) duckweed 0.008 0.173 21.6 4 ( 1) 0.008 0.089 11.1 3 ( 1) 0.008 0.067 8.4 2 ( 1) 0.008 0.044 5.5 An analysis of the results indicate that the plant acute high risk level of concern is exceeded for vascular plants with exceedences ranging 5.5 ­ 22 fold. 26 CHAPTER 7: TERRESTRIAL EXPOSURE AND RISK a. Terrestrial Hazard Summary The available toxicity data are listed in Appendix D. Oxadiazon appears to be practically non­ toxic to avian species on an subacute basis ( Northern Bobwhite quail and mallard duck LC 50 > 5,000 ppm) and slightly to practically non­ toxic to birds on an acute basis ( Bobwhite quail LD 50 > 2,150 mg/ kg; mallard LD 50 = 1,040 mg/ kg). Chronic testing showed no reproductive effects at 500 ppm.. At greater than 1,000 ppm mortality was noted for adult females ( Bobwhite quail). Mammalian toxicity data suggest that this compound is practically non­ toxic to small mammals on an acute basis ( rat LD 50 > 5,000 mg/ kg). Reproductive effects were noted at > 200 ppm that resulted in inactive mammary tissue and fetal/ neonatal death. Acute toxicity studies to honey bees show that oxadiazon was practically non­ toxic ( LD 50 > 25 ug/ bee). b. Risk to Avian Species ( Acute/ Chronic) Table 8 provides avian acute and chronic RQs from exposure to multiple applications of oxadiazon EC to turf for the maximum three application rates ( 4.0, 3.0 and 2.0 lbs ai/ A) and two split applications ( 1.0 lb ai/ A, 4 times/ 6 months; 1.3 lbs ai/ A, 3 times/ 6 months). The maximum three applications have the potential for chronic exposure to birds that feed on plants and grass ( e. g. ducks, geese) and may result in toxic risk to these birds ( RQ = 1.0 ­ 2.0). The split application appears to lower this chronic exposure and risk ( RQ = < 1). Exposure from the granular formulation was evaluated ( Appendix F) because birds may be exposed to granular pesticides through ingestion when foraging for food or grit. RQ values were calculated for three weight classes of birds ( 1000g waterfowl, 180g upland game bird, and 20g songbird). All scenarios for the granular resulted in no acute risk to birds ( RQ < 1.5 ­ 2.0). However, the potential chronic concern noted for non endangered birds suggest that oxadiazon may present a risk to endangered species ( RQ > 0.1) The estimated environmental concentration ( EEC) values used for foliar terrestrial exposure are derived from the Kenega nomograph, as modified by Fletcher et al. ( 1994), based on a large set of actual field residue data. The upper limit values from the nomograph represent the 95th percentile of residue values from actual field measurements ( Hoerger and Kenega, 1972). The Fletcher et al., ( 1994) modifications to the Kenega nomograph are based on measured field residues from 249 publications, including information on 118 species of plants, 121 pesticides, and 17 chemical classes. These modifications represent the 95th percentile of the expanded data set. Risk quotients are based on the most sensitive LC 50 and NOAEC for birds. EFED also used the ELL­ FATE model for multiple applications, incorporating the appropriate dissipation half­ life to generate EECs. Single application EECs reflect day zero maximum Fletcher residue values ( lbs ai/ A x 240; 110; 135; 15 ppm). Current EFED policy assumes that pesticide dissipation from foliar surfaces is primarily due to degradation or dissipation by one or more processes including, photolysis, hydrolysis, microbial 27 degradation and volatilization. If adequate foliar dissipation data are not available then a half­ life not to exceed 35 days will be used in the EEC calculations. Table 8. Avian acute and chronic risk quotients ( RQ's) as generated through ELL­ FATE for broadcast ground spray applications for oxadiazon. RQ's are based on mallard duck LC50 > 5,000 ppm and NOAEC = 500 ppm. The EEC reflects the turf use with the three highest use rate ( 4.0, 3.0 and 2.0 lbs ai/ A, 2 applications) and two split applications ( 1.0 lb ai/ A, 4 times/ 6 months; 1.3 lbs ai/ A, 3 times/ 6 months). Site Application Rate lbs ai/ A (# appl) Food Item Maximum EECs ( ppm) Acute RQ ( EEC/ LC50) Chronic RQ ( Max. EEC/ NOAEC) Turf ( EC) 4.0 ( 2) Short grass Tall grass Broadleaf plants/ insects Seeds 984.1 451.1 553.6 61.5 < 0.2 < 0.1 < 0.1 < 0.0 2.0 1.0 0.1 0.1 Turf ( EC) 3.0 ( 2) Short grass Tall grass Broadleaf plants/ insects Seeds 739.6 339.0 416.0 46.2 < 0.1 0.0 < 0.1 0.0 1.5 1.0 1.0 0.1 Turf ( EC) 2.0 ( 2) Short grass Tall grass Broadleaf plants/ insects Seeds 493.1 226.0 277.3 30.8 < 0.1 0.0 0.0 0.0 1.0 0.4 0.5 0.1 Turf ( EC) 1.0 ( split 4 applications/ 6 months) Short grass Tall grass Broadleaf plants/ insects Seeds 424.4 194.5 238.7 26.5 < 0.1 0.0 0.0 0.0 1.0 0.4 0.5 0.1 Turf ( EC) 1.3 ( split 3 applications/ 6 months) Short grass Tall grass Broadleaf plants/ insects Seeds 257.0 117.8 144.6 16.1 < 0.1 0.0 0.0 0.0 1.0 0.4 0.5 0.1 28 c. Risk to Mammalians ( Acute, Chronic) Our assessment ( Table 9 and 10) suggests that the proposed use rates ( 4.0, 3.0 and 2.0 lbs ai/ A), as well as the split use rates ( 1.0 and 1.3 lbs ai/ A) should not result in acute risk to mammals ( RQ < 0.2). However, these application scenarios can result in significant chronic exposure and risk to mammalian herbivores and insectivores ( 15g, 35g, and 1000g) with RQ values ranging from 1.5 ­ 9.9. This chronic risk to non endangered mammalian species also suggests the potential for impact to endangered species. Estimating the potential for adverse effects to wild mammals is based upon EFED's draft 1995 SOP of mammalian risk assessments and methods used by Hoerger and Kenaga ( 1972) as modified by Fletcher et al., ( 1994). The concentration of oxadiazon in the diet is expected to be acutely toxic to 50% of the test organisms is determined by dividing the LD 50 value ( usually the rat LD 50 ) by the per cent body weight consumed. A risk quotient is then determined by dividing the EEC by the acute toxicity value. RQ = EEC ( ppm) LD 50 ( mg/ kg)/ % Body weight consumed RQ values are calculated for four different kinds of food ( short grass, tall grass, forage/ insects, and seeds) that are expected to be consumed by mammalian herbivores, insectivores, and granivores. The per cent body weight consumed for herbivores and insectivores corresponding to the three weight categories ( 15, 35, and 1000 g) is assumed to be 95%, 66%, and 15%, respectively. Granivores are expected to have a different per cent body weight consumption for the same weight categories ( 21%, 15%, and 3%, respectively). Chronic toxicity values were based on the NOAEC from a rat reproductive study. In order to evaluate chronic concerns, a maximum EEC was generated through the ELL­ FATE model that takes into consideration pesticide half­ life, application rate, number of applications, and intervals between applications ( first order kinetics model). In order to evaluate possible toxic risk to terrestrial organisms, three application rates ( 4.0, 3.0, and 2.0 lbs ai/ A, at 2 applications/ 6 months) and two split applications ( 1.0 lbs ai/ A applied 4 times/ 6 month and 1.3 lbs ai/ A applied 3 times/ 6 month) were run. Our objective was to find not only the highest rate that may cause toxic risk, but the lowest rate that might result in lower risk. 29 Table 9. Mammalian acute risk quotients as generated through ELL­ FATE for ground application of oxadiazon ( EC). RQ's are based on rat ( Rattus norvegicus) LD50 > 5,000 mg/ kg,. The EEC reflects the three highest use rate ( 4.0, 3.0 and 2.0 lbs ai/ A, 2 applications) and two split applications ( 1.0 lb ai/ A, 4 times/ 6 months; 1.3 lbs ai/ A, 3 times/ 6 months). Crop Application Rate lbs ai/ A ( # of applications) Body Wt. ( g) % Body Wt. Consumed Acute RQ Short Grass Acute RQ Forage and Small Insects Acute RQ Large Insects Acute RQ Seeds Turf ( EC) 4.0 ( 2) 15 35 1000 95/ 21 66/ 15 15/ 3 < 0.2 < 0.1 0.0 < 0.1 < 0.1 0.0 < 0.1 < 0.1 0.0 0.0 0.0 0.0 Turf ( EC) 3.0 ( 2) 15 35 1000 95/ 21 66/ 15 15/ 3 < 0.1 < 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Turf ( EC) 2.0 ( 2) 15 35 1000 95/ 21 66/ 15 15/ 3 < 0.1 < 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Turf ( EC) 1.0 ( split 4 applications/ 6 months) 15 35 1000 95/ 21 66/ 15 15/ 3 < 0.1 < 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 Turf ( EC) 1.3 ( split 3 applications/ 6 months) 15 35 1000 95/ 21 66/ 15 15/ 3 < 0.1 < 0.1 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 1 Acute species concerns (> 0.1) 2 Acute restricted use (> 0.2) 30 Table 10. Mammalian chronic risk quotients as generated through ELL­ FATE for ground application of oxadiazon are based on rat ( Rattus norvegicus) NOAEC = 100 ppm. The EEC reflects the three highest use rate ( 4.0, 3.0 and 2.0 lbs ai/ A, 2 applications) and two split applications ( 1.0 lb ai/ A, 4 times/ 6 months; 1.3 lbs ai/ A, 3 times/ 6 months). Crop Application Rate lbs ai/ A ( # of applications) Food Items Max. EEC ( ppm) Chronic RQ ( Max. EEC/ NOAEC) Turf ( EC) 4.0 ( 2) Short Grass Tall Grass Broadleaf plant/ Insects Seeds 986.1 452.0 554.7 61.6 9.91 4.51 5.51 1.01 Turf ( EC) 3.0 ( 2) Short Grass Tall Grass Broadleaf plant/ Insects Seeds 739.6 339.0 416.0 46.2 7.41 3.41 4.21 0.5 Turf ( EC) 2.0 ( 2) Short Grass Tall Grass Broadleaf plant/ Insects Seeds 493.1 226.0 227.3 30.8 4.91 2.31 2.81 0.3 Turf ( EC) 1.0 ( split 4 applications/ 6 months) Short Grass Tall Grass Broadleaf plant/ Insects Seeds 424.4 194.5 238.7 26.5 3.21 1.51 1.81 0.2 Turf ( EC) 1.3 ( split 3 applications/ 6 months) Short Grass Tall Grass Broadleaf plant/ Insects Seeds 257.0 117.8 144.6 16.1 4.71 2.21 2.71 0.3 1 Chronic risk ( LOC > 1) d. Risk to Non­ target Insects EFED does not do risk assessments on insects. However, it appears that oxadiazon exposure to honeybees should present low risk. e. Risk to Terrestrial Plants The risk assessment of oxadiazon to terrestrial plants and aquatic plants ( vascular and nonvascular) cannot be completed because of an inadequate data base. It should be noted that the assessment for nonvascular plants provided here is incomplete in that the assessment is based on a supplemental study and additional nonvascular plant species testing is being recommended. 31 f. Endocrine Disruption EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally­ occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen­ and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, oxadiazon, may be subjected to additional screening and or testing to better characterize effects related to endocrine disruption. Issues that have raised this concern include the findings from fish reproduction effects ( larval and embryo survival, egg hatchability) and invertebrate reproduction effects ( reduced neonate production) also suggest endocrine disruption. 32 CONCLUSIONS The Tier I GENEEC calculated RQ values for the use of oxadiazon on turf suggests that chronic exposure of this compound has the potential for toxic risk to freshwater and estuarine/ marine fish ( RQ = 39.3 ­ 131.8) and aquatic invertebrates ( RQ = 3.9 ­ 36.7). The chronic Level of Concern ( LOC) was exceeded by up to 132­ fold for fish and 37­ fold for aquatic invertebrates. Although our initial risk assessment suggests that acute exposure of oxadiazon to aquatic systems should result in relatively lower short term risk to non endangered fish and aquatic invertebrates ( RQ = 0.1 ­ 0.5) there is uncertainty regarding possible risk enhancement through phototoxicity. Since oxadiazon is a light­ dependent peroxidizing herbicide ( LDPH), enhanced toxicity through exposure to high levels of solar radiation is a possible concern regarding aquatic organisms that inhabit small, shallow water bodies. Oxadiazon is also a lipophilic, persistent compound that can be absorbed to particulate and sediment. This combination of chemical/ physical attributes and the relatively high toxicity profile to fish and invertebrates suggest concern for accumulation in the sediments. Since sediments can act as a repository for lipophilic compounds, there can be direct impact to aquatic organisms through respiration, ingestion, dermal contact, and/ or indirect impact through alterations of the food chain. The herbicidal properties of this compound also suggest toxicity to aquatic plants and the resulting alteration of habitats. Our terrestrial risk assessment for the oxadiazon EC use on turf was conducted by using the ELLFATE model. An evaluation of EECs generated for each of the three application rates ( 4.0, 3.0, and 2.0 lbs ai/ A) and split applications ( 1.0 and 1.3 lbs ai/ A) showed that oxadiazon chronic exposure to mammals ( RQ = 1.5 ­ 9.9) has the potential for toxic risk. Chronic risk to mammalians can be upto 10 fold greater than the LOC with the potential to impact herbivores, granivores and insectivores. Relative to mammalian effects, chronic risk to avian species ( RQ = 1.0 ­ 2.0) appears lower but still exceeds EFEDs LOC ( RQ = 1). This exposure may result in impact to herbivorous birds which feed on grass, broadleaf plants, etc. Although acute exposure of this compound should not present a toxic risk to non endangered avian or mammalian species ( RQ < 0.1), the potential for chronic risk suggests a possible endangered avian species concern. Exposure from the granular formulation was evaluated ( Appendix F) because birds may be exposed to granular pesticides through ingestion when foraging for food or grit. RQ values were calculated for three weight classes of birds ( 1000g waterfowl, 180g upland game bird, and 20g songbird). The maximum use rate scenarios for the granular resulted in acute risk to small songbirds ( RQ = 1.5 ­ 2.0). Since oxadiazon is practically non­ toxic to the honey bee, minimal risk to these organisms is anticipated. However, since oxadiazon is a herbicide, risk to non­ nontarget aquatic and terrestrial plants can be anticipated. RQ's generated for Tier I testing of aquatic plants ( vascular RQ = 1.1 ­ 4.2 and nonvascular RQ = 8.5 ­ 33.3) show the potential for toxic risk to aquatic plants. Although there does not appear to be an acute risk to endangered birds and mammals there may be chronic concerns as reflected in the two­ fold LOC exceedences for non endangered terrestrial animals. Therefore, our assessment suggests that endangered terrestrial species ( birds, mammals, and terrestrial plants) may be at risk. Aquatic studies that showed fish reproduction effects ( larval and embryo survival, egg hatchability) and invertebrate reproduction effects ( reduced neonate production) suggest that oxadiazon may be subject to additional screening or testing to better characterize effects related to possible endocrine disruption. 33 APPENDIX A: REFERENCES CITED Supplemental and Core Ecotoxicity Studies Cited MRID 111806 Posner, S.; McGee, G.; Freeman, L. ( 1971) Acute Toxicity ( LD50) in Mallard Ducks: [ RP­ 17623 Technical Assay 99.1]: Experimental Reference No. A­ 408. ( Unpublished study received Aug 23, 1972 under 359­ 658; prepared by Biometric Testing, Inc., submitted by Rhone­ Poulenc, Inc., Monmouth Junction, NJ; CDL: 003179­ B) MRID 111807 Posner, S.; McGee, G.; Freeman, L. ( 1971) Acute Toxicity ( LD50) in Bobwhite Quail: [ RP­ 17623 Technical Assay 99.1]: Experimental Reference No. A­ 408. ( Unpublished study received Aug 23, 1972 under 359­ 658; prepared by Biometric Testing, Inc., submitted by Rhone­ Poulenc, Inc., Monmouth Junction, NJ; CDL: 003179­ C) MRID 112622 Posner, S.; McGee, G.; Freeman, L. ( 1971) Acute Toxicity ( LD50) in Bobwhite Quail: Experimental Reference No. A­ 408. ( Unpublished study received Oct 14, 1972 under 2F1269; prepared by Biometric Testing, Inc., submitted by Rhodia, Inc., New Brunswick, NJ; CDL: 091824­ D) MRID 41610101 Pedersen, C. ( 1990) Oxadiazon Technical: 21­ Day Acute Oral LD50 Study in Bobwhite Quail: Lab Project Number: BLAL/ NO/ 89 QD 139. Unpublished study prepared by Bio­ Life Associates, Ltd. 35 p. MRID 41610102 Pedersen, C. ( 1990) Oxadiazon Technical: 8­ Day Acute Dietary LC50 Study in Bobwhite Quail: Lab Project Number: BLAL/ NO/ 89 QC 141. Unpublished study prepared by Bio­ Life Associates, Ltd. 82 p. MRID 41610103 Pedersen, C. ( 1990) Oxadiazon Technical: 8­ Day Acute Dietary LC50 Study in Mallard Ducklings: Lab Project Number: BLAL/ NO/ 89 DC 137. Unpublished study prepared by Bio­ Life Associates, Ltd. 80 p. MRID 41610105 Giddings, J. ( 1990) Oxadiazon Technical­ Toxicity to the Marine Diatom Skeletonema costatum: Lab Project Number: 90­ 7­ 3384: 10566­ 1089­ 6137­ 450. Unpublished study prepared by Springborn Laboratories, Inc. 55 p. MRID 41610106 Giddings, J. ( 1990) Oxadiazinon Technical­ Toxicity to the Freshwater Diatom Navicula pelliculosa: Lab Project Number: 90­ 8­ 3423; 10566­ 1089­ 6137­ 440. Unpublished study prepared by Springborn Laboratories, Inc. 52 p. MRID 41610108 Giddings, J. ( 1990) Oxadiazon Technical­ Toxicity to the Freshwater Green Alga Selenastrum capricornutum: Amended Report: Lab Project Number: 90­ 8­ 3422; 10566.1089.6137.437. Unpublished study prepared by Springborn Laboratories, Inc. 52 p. 34 MRID 41610107 Giddings, J. ( 1990) Oxadiazon Technical­ Toxicity to the Duckweed Lemma gibba G3: Final Report: Lab Project Number: 90­ 7­ 3389; 10566.1089.6137.410. Unpublished study prepared by Springborn Laboratories, Inc. 48 p. MRID 41784301 Blakemore, G.; Burgess, D. ( 1991) Chronic Toxicity of Oxadiazon Technical to Daphnia magna under Flow­ thru Conditions: Final Reort: Lab Project Number: 38369. Unpublished study prepared by Analytical Bio­ Chemistry Labs., Inc. 349 p. MRID 41898001 Hoberg, J. ( 1991) Oxadiazon Technical­­ Determination of Effects on Seed Germination, Seedling Emergence and Vegetative Vigor of Ten Plant Species: Final Report: Lab Project Number: 90­ 11­ 3547: 10566­ 0790­ 6165­ 610. Unpublished study prepared by Springborn Laboratories, Inc. 164 p. MRID 41993201 Fletcher, D.; Pedersen, C. ( 1991) Oxadiazon Technical: Toxicity and Reproduction Study in Mallard Ducks: Lab Project Number: 89 DR 35. Unpublished study prepared by Bio­ Life Associates, Ltd. 138 p. MRID 41993202 Fletcher, D.; Pedersen, C. ( 1991) Oxadiazon Technical: Toxicity and Reproduction Study in Bobwhite Quail: Lab Project Number: 89 QR 39. Unpublished study prepared by Bio­ Life Associates, Ltd. 145 p. MRID 42330401 Sword, M.; Northup, R. ( 1992) Acute Flow­ Through Toxicity of Oxadiazon to Rainbow Trout ( Oncorhynchus mykiss): Lab Project Number: 39729. Unpublished study prepared by ABC Laboratories, Inc. 211 p. MRID 42331801 Blasberg, J.; Bowman, J. ( 1992) Acute Toxicity of Oxadiazon to Daphnia magna under Flow­ through Conditions: Amended Final Report: Lab Project Number: 39730. Unpublished study prepared by ABC Labs, Inc. 254 p. MRID 42350601 Sword, M.; Northup, R. ( 1992) Acute Flow­ through Toxicity of Oxadiazon to Bluegill ( Lepomis macrochirus): Final Report: Lab Project Number: 39728. Unpublished study prepared by ABC Labs., Inc. 194 p. MRID 42468301 Beevers, M. ( 1992) Acute Contact Toxicity of Oxadiazon Technical to Honey Bees ( Apis mellifera L.): Lab Project Number: CAR 160­ 92. Unpublished study prepared by California Agricultural Research, Inc. 14 p. 42570301 Dionne, E. ( 1992) Oxadiazon Technical­­ Acute Toxicity to Eastern Oyster ( Crassostrea virginica) under Flow­ through Conditions: Final Report: Lab Project Number: 92­ 7­ 4329: 10566.0392.6238.504. Unpublished study prepared by Springborn Labs, Inc. 63 p. MRID 42615801 Machado, M. ( 1992) Oxadiazon Technical­­ Acute Toxicity to Sheepshead Minnow ( Cyprinodon variegatus) under Flow­ through Conditions: Final Report: Lab Project Number: 92­ 8­ 4383 10566.0392.6237.505. Unpublished study prepared by Springborn Labs, Inc. 66 p. MRID 42615802 Machado, M. ( 1992) Oxadiazon Technical­­ Acute Toxicity to Mysid Shrimp ( Mysidopsis 35 bahia) under Flow­ through Conditions: Final Report: Lab Project Number: 92­ 7­ 4348: 10566.0392.6236.515. Unpublished study prepared by Springborn Labs, Inc. 65 p. MRID 42659001 Mihaich, E. ( 1993) Response to EPA Review of Oxadiazon Anabaena flos­ aquae Study ( MRID 41610104) and Selenastrum caprocornutum ( sic) Study ( MRID 41610108): Lab Project No. NS/ EMM­ 93­ 03. Unpublished study prepared by Rhone­ Poulenc Ag Co. and Springborn Labs., Inc. 10 p. MRID 42921601 Rhodes, J. ( 1993) Early Life­ Stage Toxicity of Oxadiazon Technical to the Fathead Minnow ( Pimephales promelas) Under Flow­ Through Conditions: Lab Project Number: 40024. Unpublished study prepared by ABC Labs. Inc., Environmental Toxicology. 432 p. Literature Citation, Ecotoxicity Study Guardigli, A, et. al., " Residue Uptake and Depletion Measurements of Dietary Oxadiazon in Mammalian and Avian Species." Archives of Environmental Contamination and Toxicology Vol. 4, 145­ 154 ( 1976) Supplemental and Core Environmental Fate Studies Cited ( MRID# 42226701; DP Barcode D192825) Armstrong, K., B. D. Cameron, S. A. Chapleo, B. E. Hall, and A. Haswell. 1991. Oxadiazon: Bioaccumulation test in bluegill sunfish. IRI Project No. 381195; Report No. 8385. Unpublished study performed by Inversk Research International, Tranent, Scotland, and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC Manley, J. D., I. A. J. Hardy, and E. A. Savage. 1992. Herbicides: Oxadiazon spectroscopic investigation of metabolites from a [ 14C]­ oxadiazon bioaccumulation test in bluegill sunfish. IRI Project No. 381195. Unpublished study performed by Rhône­ Poulenc Agriculture Limited, Ongar, United Kingdom, and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC ( No Study ID) ( MRID# 41898201; DP Barcode D165559) Das, Y. T. 1991. Photodegradation of [ Phenyl( U)­ 14C] Oxadiazon on Soil under Artificial Sunlight. Unpublished study performed by Innovative Scientific Services, Inc. Piscataway, N. J., and sponsored and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC ( MRID# 41897201; DP Barcode D192825) Corgier, M. M. C., and A. P. Plewa. 1991. 14Coxadiazon photodegradation in aqueous solution. Study No. 90­ 29. Filing Reference AG/ CRLD/ AN/ 9115609. Unpublished study performed by Rhône­ Poulenc Secteur Agro, Lyon, France, and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC ( MRID# 41863603; DP Barcode D165559) Corgier, M. M. C., and Robin, J. M. 1991. 14COxadiazon Hydrolysis at 25  C. Unpublished study performed by Rhône­ Poulenc, Lyon, France, and submitted by Rhône­ Poulenc, Research Triangle Park, NC ( MRID# 41898202, DP Barcode D165559) Dykes, J. 1991. Soil Adsorption/ Desorption with 14C­ 36 Oxadiazon. An unpublished study performed by Analytical Bio­ Chemistry Laboratories, Inc., Columbia, MO, nad submitted by Rhône Poulenc Ag Company, Research Triangle Park, NC ( MRID# 41767401; DP Barcode D192825) Norris, F. A. 1991. A terrestrial field soil dissipation study with oxadiazon. Study No. EC/ P­ 89­ 0014. File No. 40642. Unpublished study performed and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC ( MRID# 41889501; DP Barcode D165559) Priestley, D. B., Lowden, P., and Savage, E. A. 1991. Oxadiazon­ 14C: Leaching Study with Four Soils. Unpublished study performed by Rhône­ Poulenc Agriculture Limited, Essex, England, and submitted by Rhône­ Poulenc Ag Company, Research Triangle Park, NC ( MRID# 42772801; DP Barcode D192825) Waring, A. R. 1993a. [ 14C] Oxadiazon: Aerobic soil metabolism. HUK Study No. 68/ 111; Report No. 7218. Unpublished study performed by Hazleton UK, Harrogate, North Yorkshire, England, and submitted by Rhône­ Poulenc Agriculture Company, Research Triangle Park, NC ( MRID# 42773802; DP Barcode D192825) Waring, A. R. 1993b. [ 14C] Oxadiazon: Anaerobic aquatic metabolism. HUK Study No. 68/ 112; Report No. 7214. Unpublished study performed by Hazleton UK, Harrogate, North Yorkshire, England, and submitted by Rhône­ Poulenc Agriculture Company, Research Triangle Park, NC Supplemental HED Study, for Environmental Fate Use MRID# 44995501 Howell, C., and Wedekind, W. 1999. " Oxadiazon: Determination of Transferable Turf Residues on Turf Treated with CHIPCO ® G." An unpublishded study sponsored by Rhône Poulenc Corporation, NC, and performed by ABC Laboratories, Inc., MO, Test Guideline 875.2100, ABC Study Number 44951. MRID# 44995502 Howell, C. 1999. " Oxadiazon: Determination of Transferable Turf Residues on Turf Treated with CHIPCO ® RONSTAR ® 50WSP." An unpublishded study sponsored by Rhône Poulenc Ag Company, NC, and performed by ABC Laboratories, Inc., MO, Test Guideline 875.2100, ABC Study Number 44952. 37 APPENDIX B: FATE SUMMARIES 161­ 1 Hydrolysis ( MRID# 41863603; Core) [ 14C]­ Oxadiazon ( phenyl ring­ labeled), at 0.48 mg/ L, was stable in pH 4, 5, and 7 sterile aqueous buffered solutions incubated in the dark at 25  C for 31 days. At pH 9, oxadiazon was hydrolyzed with a calculated half­ life of 38 days. Oxadiazon averaged 93.64% of the applied at 5 days, and 49.98% at 31 days. The main degradate found was ! 1­ trimethyl acetyl­ 2­( 2,4­ dichloro­ 5­ isopropoxyphenyl) hydrazine ( RP26123), which increased to 45% of the applied at 31 days. All other metabolites were present at < 10% of the applied. 161­ 2 Photodegradation in Water ( MRID# 41897201; Core) [ 14C] oxadiazon ( phenyl ring­ labeled), at 0.5 mg/ L, photodegraded with a half­ life of 21.2 hours ( or the equivalent of 2.75 days of summer sunlight in Florida) in pH 5 buffered solutions that were continuously irradiated with a xenon arc lamp at 25 + 1  C for up to 42 hours. Oxadiazon declined from an average of 98.68% of the recovered immediately posttreatment, to 42.46% at 26 hours. In the dark controls, no degradation was observed for 42 hours. The degradates identified were RP36939 and RP37084, present at up to 4.8% and 11.5% of the applied radioactivity, respectively. Up to 20 degradates were isolated, present at < 8% of the applied radioactivity. The registrant did not provide the chemical names for RP36939 and RP37084. The later one was a maximum of 11.5% of the applied at 42 hours ( last test interval), when the level of oxadiazon had decreased to < 28% of the applied. It is not likely that RP37084 would be formed in significantly higher quantities. 161­ 3 Photolysis on Soil ( MRID# 41898201; Core) [ 14C] oxadiazon ( phenyl ring­ labeled), at 9.4­ 11.3 ppm, degraded slowly with a calculated half­ life of 165 days on a sandy loam soil irradiated with xenon arc lamp intermitently at 25  C. There was no significant breakdown of the parent under non­ irradiated conditions. In the irradiated samples, oxadiazon averaged 90.2% of the applied at day 0 posttreatment, and averaged 86.6% at day 30. In the dark samples, oxadiazon averaged 90.2% of the applied at day 0, and 90.8% at day 30. The following minor degradates were observed in small quantities. ! 2­ tertiobutyl­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP25496), and ! 3­( 2,4­ dichloro­ 5­ methoxyphenyl)­ 5­ tertiobutyl­ 1,3,4­  4­ oxadiazolin­ 2­ one ( RP17272). 38 161­ 4 Photodegradation in Air ( Waived) 163­ 2 Laboratory Volatility ( Waived) 163­ 3 Field Volatility ( Waived) All three data requirements were waived, based on the relatively low vapor pressure ( 1.0x10­ 6 mm Hg) and Henry's Law Constant ( calc. 4.51x10­ 7 Atm · m3/ mol) of oxadiazon. EFED believes that this value is relatively low and that volatility of oxadiazon may not be an important route of dissipation for oxadiazon. This conclusion is further confirmed by the results of the Aerobic Soil Metabolism study ( MRID# 42772801), which shows only a small fraction of the applied was volatilized after 1 year ( see below). 162­ 1 Aerobic Soil Metabolism ( MRID# 42772801; Core) [ 14C]­ Oxadiazon ( uniformly ring labeled) degraded slowly in sandy loam soil that was incubated aerobically in the dark at about 25  C and approximately 75% of soil water capacity at 0.33 bar for 1 year. The registrant­ calculated initial half­ life was well beyond the experimental time frame ( t ½ = 841 days). Oxadiazon comprised 98.87­ 92.33% of the applied immediately posttreatment and decreased slowly to 72.11­ 76.47% of the applied after 365 days. Unextracted [ 14C] residues, and volatilized [ 14C] residues comprised 4.82% and 2.95% of the applied at 365 days, respectively. Five degradates were identified: ! 3­( 2,4­ dichloro­ 5­ methoxyphenyl)­ 5­ tertiobutyl­ 1,3,4­  4­ oxadiazolin­ 2­ one ( RP17272) ! 2­( carboxy­ 2­ propyl)­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP26471) ! 2­ tertiobutyl­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP25496) ! 2­( 2­ carboxy­ 2­ propyl)­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP26449) and ! 1­ trimethylacetyl­ 2­( 2,4­ dichloro­ 5­ isopropoxyphenyl) hydrazine ( RP26123). These degradates were present at concentrations  1.51% of the applied throughout the study. Three other areas of radioactivity were isolated, but not identified, at  1% of the applied. 162­ 3 Anaerobic Aquatic Metabolism ( MRID# 42773802: Supplemental) [ 14C] Oxadiazon ( uniformly ring labeled) degraded slowly with an observed half­ life of approximately 1 year in anaerobic ( flooded plus nitrogen atmosphere) sandy loam soil that was incubated in the dark at about 25  C for 1 year; oxadiazon comprised 91.7­ 91.8% of the applied immediately posttreatment and decreased to 47.3­ 47.9% of the applied at 366 days. At 366 days, unextracted [ 14C] residues were 2.47% of the applied and [ 14C] volatiles totaled 0.02% of the applied. Five degradates were identified: ! 2­( carboxy­ 2­ propyl)­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP26471) ! 2­ tertiobutyl­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP25496) ! 2­( 2­ carboxy­ 2­ propyl)­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP26449) 39 ! 2,4­ dichloroisopropoxybenzene ( RP36227) and ! 1­ trimethylacetyl­ 2­( 2,4­ dichloro­ 5­ isopropoxyphenyl) hydrazine ( RP26123). All the degradates were present at concentrations  3.76% of the applied througout the experiments. In addition, one " cluster" of [ 14C] residues was isolated from the floodwater at a maximum of 18.2% of the applied, and one was isolated from the soil at a maximum of 20.8% of the applied at 181 day. These [ 14C] residues were not further characterized. 163­ 1 Mobility in Soil ( MRID# 41889601; Core) [ 14C]­ Oxadiazon ( phenyl ring labeled), at 4 ppm showed a low mobility in soil leaching columns containing sand, loam, and two sandy loam soils. The material was either freshly applied ( parent pesticide), or applied after 30 days of aerobic incubation. A similar profile was observed in the aged and unaged soil columns. The majority of the radioactivity (  80.5%) remained in the upper 0­ 6 inches of the 36 inches long columns, indicating a low mobility for parent oxadiazon in these soil. The amount of radiaoctivity recovered from the leachate was small (  0.2%). Solvent extracts were shown to contain only parent compound. The total recoveries of radioactivity were 92.6­ 102.4%. 163­ 1 Mobility ­ Leaching and Adsorption/ Desorption ( MRID# 41898202; Supplemental) Based on batch equilibrium studies, at nominal concentrations of 0.1­ 0.3 ppm and 25  C, [ 14C] Oxadiazon demonstrated slight mobility in sand and sandy loam, and low mobility in a clay and silt loam. The Kd and Koc constants obtained from the Freundlich isotherms were as follows: Table 1. Mobility of Oxadiazon adsorption. desorption Soil type % OC Kd Koc Kd Koc silt loam 1.2 16.91 1409 21.35 1779 clay 1.2 22.83 1903 51.72 4310 sandy loam 0.4 11.39 2848 41.00 10250 sand 0.25 8.17 3268 10.34 4136 The soil treatment included grinding in a grist mill. It is not known what is the particle size distribution. The particle size of the soil is a determinant of its adsortivity. A cursory revision of the DER for this study indicates that 1/ n values were not reported for any soil type. 40 164­ 1 Terrestrial Field Dissipation ( MRID# 41767401; Core) Oxadiazon slowly dissipated from two field plots located in San Juan Bautista, California ( sandy loam soil) and Clayton, North Carolina ( loamy sand) and planted with Junipers and Azaleas, respectively. The plots were treated with oxadiazon at 4.48 kg ai/ ha ( 4.06 lb ai/ A). The registrant­ calculated initial half­ life of oxadiazon in the California site was 65 days, and 40 days in the North Carolina site. The dissipation rate was near zero during the winter season in both locations. Oxadiazon appears to persist over time. In the 0­ to 15­ cm soil depth of the California site, oxadiazon was 1.80­ 3.60 ppm immediately posttreatment and decreased to 0.08­ 0.18 ppm at 12­ 16 months. In the North Carolina site oxadiazon was 1.08­ 2.05 ppm immediately posttreatment and decreased to 0.02­ 0.43 ppm at 12­ 16 months. In the 15­ to 30­ cm soil depth of both plots, oxadiazon was  0.12 ppm through 2 months and  0.01 ppm thereafter. Generally, oxadiazon residues were detected only in the upper 30 cm of the soil, with occasional small detections in the 15­ to 30­ cm soil depth. The degradates ! 3­( 2,4­ Dichloro­ 5­ methoxyphenyl)­ 5­ tertiobutyl­ 1,3,4­  4­ oxadiazolin­ 2­ one ( RP­ 17272) and ! 2­( 2­ Carboxy­ 2­ propyl)­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 5­ oxo­ 1,3,4­ oxadiazolin ( RP­ 26449) were each present at < 0.02 ppm in the 0­ to 15­ cm soil depth, and were not detected in the deeper soil layers. Total irrigation plus rainfall during the study period was 14.03 cm in the California site, and 20.03 cm in the North Carolina site. 165­ 4 Bioaccumulation in Fish ( MRID# 42226701; Core) Oxadiazon residues accumulated in bluegill sunfish continuously exposed to 8.8 ug/ L of oxadiazon, with average bioconcentration factors of 368x for the edible tissues ( muscle), 2239x for the nonedible tissues ( viscera), and 1111x for the whole fish. Maximum mean [ 14C] residue concentrations were 4.26 ug/ g for the edible tissues, 26.83 ug/ g for the nonedible tissues, and 11.94 ug/ g for whole fish. Steady state concentrations were observed within 3 days of exposure. Depuration was rapid, with an observed half­ life of about 1 day; by day 3 of the depuration period, 83% of the accumulated [ 14C] residues had been eliminated from whole fish, and by day 14, > 97% were eliminated. Parent [ 14C] oxadiazon was detected only once in the fish inedible tissues on day 14; three degradates were identified in the fish samples: ! 5­( 1­ hydroxymethyl­ 1­ methylethyl)­ 3­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 1,3,4­ oxadiazol­ 2( 3H)­ one ( M8), which was 15.8­ 24.6% of the [ 14C] residues extracted from the edible fish; ! An ether glucuronide conjugate of M8 ( chemical name not provided), which was 25.8­ 31.6% of the [ 14C] residues extracted from the edible fish; and ! 5­( 1­ hydroxymethyl­ 1­ methylethyl)­ 3­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 1,3,4­ oxadiazol­ 2( 3H)­ one ( M10), which was 8.5­ 13.4% of the [ 14C] residues extracted from the edible fish. 41 875.2100 Transferable Oxadiazon Residues on Turf Treated with the Product in the Granular Formulation ( MRID# 44995501; supplemental) EFED had available a review by Versar, Inc., a contractor for HED studies. This study and the review were prepared as a requirement of the Health Effects Division. Only some highlights of the study are mentioned here for information only, since EFED investigated the usefulness of the study for modeling purposes. This test was performed with the granular formulation of oxadiazon. Samples were taken with cotton cloth sheets, which were exposed to a large turf area. These samples were taken at various test intervals, starting from prior to application, from three geographical locations. It appears that the registrant did not intend to compare the actual amount of oxadiazon residues present on and in turf, compared to the amount present in the cotton cloth. The registrant may have developed that information, but it was not available to EFED at this time. The reported LOQ was 25 µ g/ sample, while the LOD was not provided. Several results were less than the LOQ. The authors intended also to report the degradates RP25496+ RP17272 ( together), and RP26449. These degradates, however, were not detected in any sampling interval through the study. Half­ life of the transferable residues may be around 2­ 7 days for the granular formulation. By no means that would definitely mean that 7 days would be representative of the half­ life of oxadiazon in the turf because there is no evidence that the methodology used was in some way quantitatively measuring the total levels of oxadiazon in the foliage. For the purpose of running EFED models, this study can only be regarded at best as supplemental. 875.2100 Transferable Oxadiazon Residues on Turf Treated with the Product in the Liquid Formulation ( MRID# 44995502; supplemental) EFED had available a review by Versar, Inc., a contractor for HED studies. This study and the review were prepared as a requirement of the Health Effects Division. Only some highlights of the study are mentioned here for information only, since EFED investigated the usefulness of the study for modeling purposes. The product was formulated in Wettable Soluble Packets ( of powder containing oxadiazon at about 2% of a. i.). The product was applied at 3 lb a. i./ A. Samples were taken in triplicate with cotton cloth sheets, which were exposed to a large turf area. These samples were taken at various test intervals, starting from prior to application, from two geographical locations. Sampling occurred between March 26 and April 8, 1999. It appears that the registrant did not intend to compare the actual amount of oxadiazon residues present on turf and in turf, compared to the amount present in the cotton cloth. The registrant may have developed that information, but it was not available to EFED at this time. 42 The reported LOQ was 25 µ g/ sample, while the LOD was not provided. Several results were less than the LOQ. In addition, the authors intended also to report the degradates RP25496+ RP17272 ( together), and RP26449. It appears, however, that these degradates were not detected in any sampling interval through the study. In the California site, the data was very variable, and it was judged unreliable by the authors of the study. The review does not offer the author's detailed rationale with respect to this invalidation. On the other hand, a study conducted in Georgia, yielded most samples at > LOQ, although the range of the actual results was several orders of magnitude larger than range of the fortified samples. Based on the results of the 27 samples available, the half­ life was about 2.3 days, with a correlation coefficient ( R2) of 0.7. By no means that would definitely mean that 2 days would be representative of the half­ life of oxadiazon in the turf because there is no evidence that the methodology used was in some way quantitatively measuring the total levels of oxadiazon in the foliage. Furthermore, out of two studies conducted with the liquid formulation, only one produced results with acceptable concentrations above the LOQ. EFED believes that for the purpose of running EFED models, this study can only be regarded at best as informative, and, for the safety of the public, the default value of 35 days should be used. 43 APPENDIX C: ECOLOGICAL TOXICITY DATA Toxicity testing reported in this section is not representative of the wide diversity of terrestrial and aquatic organisms in the United States. Two surrogate bird species, the bobwhite quail and the mallard duck, are used for the 680 plus species of birds found in this country. For mammals, acute studies are usually limited to the Norway rat or the house mouse. Reptiles are not tested, as these are assumed to be subject to similar toxicological effects as birds. Of approximately 100,000 species of insects, spiders, and other terrestrial arthropods, toxicity tests are usually required only for the honey bee. Only two surrogate fish species ( rainbow trout and bluegill sunfish) are used to represent the over 2,000 species of freshwater fish found in this country. Amphibians are not tested, as these are assumed to be subject to similar toxicological effects as fish. One crustacean, the water flea, is used to represent all freshwater invertebrates. Estuarine/ marine animal acute toxicity testing is usually limited to a crustacean, a mollusk, and a fish. Testing on aquatic plants is limited to one species of vascular plant ( duckweed) and four species of algae and diatoms. Toxicity to Terrestrial Organisms Birds, Acute, Subacute and Chronic An acute oral toxicity study using the technical grade of the active ingredient ( TGAI) is required to establish the toxicity of oxadiazon to birds. The avian oral LD 50 is an acute, single­ dose laboratory study designed to estimate the quantity of toxicant required to cause 50% mortality in a test population of birds. The preferred test species is either the Mallard Duck, a waterfowl, or Bobwhite quail, an upland gamebird. The TGAI is administered by oral intubation to adult birds, and the results are expressed as LD 50 milligrams ( mg) active ingredient ( a. i.) per kilogram ( kg). Toxicity category descriptions are as follows: If the LD50 is less than 10 mg a. i./ kg, then the test substance is very highly toxic. If the LD50 is 10­ to­ 50 mg a. i./ kg, then the test substance is highly toxic. If the LD50 is 51­ to­ 500 mg a. i./ kg, then the test substance is moderately toxic. If the LD50 is 501­ to­ 2,000 mg a. i./ kg, then the test substance is slightly toxic. If the LD50 is greater than 2,000 mg a. i./ kg, then the test substance is practically nontoxic. 44 Study results are in the table below. Table C. 1. Avian Acute Oral Toxicity Species % ai LD50 ( mg/ kg) Toxicity Category MRID/ Lab/ Year Classification Northern Bobwhite ( Colinus virginianus) 99.1 6000 practically nontoxic 111807 ( also under 112622) Biometric Testing, Inc. 1971 Supplemental1 Mallard ( Anas platyrhynchos) 99.1 1040 slightly toxic 111806 Biometric Testing, Inc. 1971 Supplemental1 Northern bobwhite ( Colinus virginianus) 97.49 > 2150 ( no bird mortality) practically nontoxic 41610101 Bio­ Life Associates, Ltd 1990 Core 1 studies are scientifically sound; although deemed satisfactory for registration of oxadiazon in the early 1970' s, EFED required a new study in 1991under Phase IV Reregistration. Based on results of the above studies, oxadiazon may be categorized slightly to practically nontoxic to birds on an acute oral basis. The guideline 71­ 1( a ) is fulfilled ( MRID 41610101). Two dietary studies using the TGAI are required to establish the toxicity of oxadiazon to birds. These avian dietary LC 50 tests, using the Mallard Duck and Bobwhite Quail, are acute, eight­ day dietary laboratory studies designed to estimate the quantities of toxicant required to cause 50% mortality in the two respective test populations of birds. The TGAI is administered by mixture to juvenile birds' diets for five days followed by three days of " clean" diet, and the results are expressed as LC 50 parts per million ( ppm) active ingredient ( a. i.) in the diet. Toxicity category descriptions are as follows: If the LC50 is less than 50 ppm a. i., then the test substance is very highly toxic. If the LC50 is 50­ to­ 500 ppm a. i., then the test substance is highly toxic. If the LC50 is 501­ to­ 1,000 ppm a. i., then the test substance is moderately toxic. If the LC50 is 1001­ to­ 5,000 ppm a. i., then the test substance is slightly toxic. If the LC50 is greater than 5,000 ppm a. i., then the test substance is practically nontoxic. Study results are tabulated below. Table C. 2. Avian Subacute Dietary Toxicity Species % ai LC50 ( ppm) Toxicity Category MRID/ Lab/ Year Study Classification Bobwhite Quail ( Colinus virginianus) 97.49 > 5,000 ( no bird mortality) practically nontoxic 41610102 Bio­ Life Associates, Ltd 1990 Core Mallard Duck ( Anas platyrhynchos) 97.49 > 5000 ( no bird mortality) practically nontoxic 41610103 Bio­ Life Associates, Ltd 1990 Core 45 Based on results of the above studies, oxadiazon may be characterized practically nontoxic to birds on a subacute basis. The guideline 71­ 2( a) for bobwhite ( MRID 41610102) and 71­ 2( b) for mallard duck ( MRID 41610103) are fulfilled. Avian reproduction tests are designed to estimate the quantity of toxicant required to adversely affect the reproductive capabilities of a test population of birds. The TGAI is administered by mixture to breeding birds' diets throughout their breeding cycle. Test birds are approaching their first breeding season and, generally, are 18­ to­ 23 weeks old. The onset of the exposure period is at least 10 weeks prior to egg laying. Exposure period during egg laying is generally 10 weeks with a withdrawal period of three additional weeks if reduced egg laying is noted. Results are expressed as No Observed Adverse Effect Concentration ( NOAEC) and various observable effect levels, such as the Lowest Observable Adverse Effect Concentration ( LOAEC), quantified in units of parts per million of active ingredient ( ppm) in the diet. Study results are tabulated below . Table C. 3. Avian Chronic Toxicity Species/ Study Duration % ai NOAEC/ LOAEC ( ppm) LOAEC Endpoints MRID/ Lab/ Year Classification Mallard Duck ( Anas platyrhynchos) 20 weeks 97.49 > 1000 ( highest dose tested)/ LOAEC not determined not determined 41993201 Bio­ Life Associates, Ltd 1991 Supplemental1 Northern Bobwhite ( Colinus virginianus) 21 weeks 97.49 500/ 1000 mortality among adult females 41993202 Bio­ Life Associates, Ltd 1991 Core 1 study was classified supplemental because a NOAEC was not established. Based on the results of the Bobwhite reproduction study, the ingestion of oxadiazon at levels up to 1,000 ppm, the highest dose concentration tested, had no effect on any reproductive parameter or viability of F 1 the offspring ( reproductive NOAEC > 1000 ppm). However, mortality among females at that level was quite high ( 33%). The study authors stated that due to the inconsistency and lack of dose­ related pathology observations in birds found dead or sacrificed at study termination, the pathology observations were attrbuted to factors other than the test substance. EFED, in the absence of information on the cause of the deaths, considered the mortality attributable to treatment. The chronic NOAEC was set at 500 ppm. The guideline 71­ 4( a) is fulfilled ( MRID 41993202). The avian reproduction study using mallard resulted in a NOAEC greater than 1000 ppm, the highest dose tested. This study was classified supplemental because a NOAEC was not established. Although the study is classified supplemental, it does not have to be repeated because ( 1) the Bobwhite was more sensitive in testing, and ( 2) the highest dose tested is greater than the highest estimated environmental concentration for the highest application rate ( turf; 4 lb ai/ A; maximum Fletcher value 240 x 4 = 960 ppm). The guidelines 71­ 4( a) for the Bobwhite ( MRID 41993202) and 71­ 4( b) for the mallard ( MRID 41993201) are considered fulfilled. 46 Mammals, Acute and Chronic Wild mammal testing is required on a case­ by­ case basis, depending on the results of lower tier laboratory mammalian studies, intended use pattern and pertinent environmental fate characteristics. In most cases, rat or mouse toxicity values obtained from the Agency's Health Effects Division ( HED) substitute for wild mammal testing. The acute toxicity values below were taken from HED's Tox One­ Liners. Chronic toxicity information was obtained from the Health Effects Division Hazard Identification Assessment Review Committee ( HIARC report HED DOC. NO. 014469; February 8, 2001). Table C. 4. Mammalian Acute Toxicity Species % ai Test Type LD50 ( mg/ kg) Toxicity Category) MRID laboratory rat ( Rattus norvegicus) 97.5 oral ­ single dose > 5,000 ( combined sexes) practically nontoxic 41866501 Table C. 5. Mammalian Chronic Toxicity Species % ai Test Type NOAEC/ LOAEC ( ppm) Affected Endpoints MRID laboratory rat ( Rattus norvegicus) 96.6 Three generation reproduction study ( feeding) 100/ 200 Fewer and lighter pups at birth With a rat LD50 > 5,000 mg / kg, oxadiazon may be characterized practically nontoxic to mammals on an acute oral basis. The rat reproduction study showed a NOAEC/ LOAEC of 100/ 200 ppm. Chronic effects included fewer and lighter pups at birth. Insect Acute Contact A honey bee acute contact study using the TGAI is required to support outdoor uses. The acute contact LD 50, using the honey bee, Apis mellifera, is an acute contact, single­ dose laboratory study designed to estimate the quantity of toxicant required to cause 50% mortality in a test population of bees. The TGAI is administered by one of two methods: whole body exposure to technical pesticide in a nontoxic dust diluent; or, topical exposure to technical pesticide via micro­ applicator. The median lethal dose ( LD 50) is expressed in micrograms of active ingredient per bee ( ug a. i./ bee). Toxicity category descriptions are as follows: If the LD50 is less than 2 µ g a. i./ bee, then the test substance is highly toxic. If the LD50 is 2 to less than 11 µ g a. i./ bee, then the test substance is moderately toxic. If the LD50 is 11 µ g a. i./ bee or greater, then the test substance is practically nontoxic 47 Study results are tabulated below. Table C. 6. Nontarget Insect Acute Contact Toxicity Species % ai LD50 ( g/ bee) Toxicity Category MRID/ Lab/ Year Study Classification Honey bee ( Apis mellifera) 95.9 > 25 practically nontoxic 42468301 California Agricultural Research Inc. 1992 Core The LD 50 for oxadiazon is greater than 25 ug per bee, characterizing oxadiazon practically nontoxic to bees. The guideline ( 141­ 1) is fulfilled ( MRID 42468301). Insect Residual Contact Honey bee toxicity of residues on foliage study is required on an end­ use product for any pesticide intended for outdoor application when the proposed use pattern indicates that honey bees may be exposed to the pesticide and when the formulation contains one or more active ingredients having an acute contact honey bee LD 50 which falls in the moderately toxic or highly toxic range. Since oxadiazon is practically nontoxic to honey bees a honey bee toxicity of residues on foliage ( Guideline 141­ 2) is not required. Terrestrial Plant Testing The data were deemed inadequate for determining the EC 25/ NOAEC values of the most sensitive species ( Reference: D166982; 1995 memo to SRRD requesting repeat of all ten species due to very poor study with numerous deficiencies and guideline deviations). To date, the studies have not been submitted to EFED. Aquatic Organism Toxicity Toxicity to Freshwater Organisms Freshwater Fish, Acute Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity of oxadiazon to fish. The preferred test species are rainbow trout ( a coldwater fish) and bluegill sunfish ( a warmwater fish). Toxicity category descriptions are as follows: If the LC50 is less than 0.1 ppm a. i., then the test substance is very highly toxic. If the LC50 is 0.1­ to­ 1.0 ppm a. i., then the test substance is highly toxic. If the LC50 is greater than 1 and up through 10 ppm a. i., then the test substance is moderately toxic. If the LC50 is greater than 10 and up through 100 ppm a. i., then the test substance is slightly toxic. If the LC50 is greater than 100 ppm a. i., then the test substance is practically nontoxic. 48 Study results are tabulated below. Table C. 7. Freshwater Fish 96­ hr Acute Toxicity Species/ Flow­ through or Static % ai LC50 ( ppm) Toxicity Category MRID / Lab/ Year Study Classification Bluegill sunfish ( Lepomis macrochirus) / static 97.4 0.88 ( nominal) highly toxic McCann / 1977 Supplemental1 Bluegill sunfish ( Lepomis macrochirus / flow­ through 95.9 1.2 ( measured) moderately toxic 42350601 ABC Labs., Inc. 1992 Core Rainbow Trout ( Oncorhynchus mykiss)/ static 97.4 1.05 ( nominal) moderately toxic McCann / 1977 Supplemental1 Rainbow Trout ( Oncorhynchus mykiss) / flow­ through 95.9 1.2 ( measured) moderately toxic 42330401 ABC Labs, Inc. 1992 Core 1 EFED considers McCann studies as scientifically sound and useful for risk assessment purposes, even though studies do not follow current protocols and raw data are not available for verification of results. Based on the above studies, oxadiazon may be characterized moderately to highly toxic to freshwater warmwater fish on an acute basis. The guideline 72­ 1( a) for bluegill is fulfilled ( MRID 42350601 and McCann study). Oxadiazon may be characterized as moderately toxic to freshwater coldwater fish on an acute basis. The guideline 72­ 1( c) for rainbow trout is fulfilled ( MRID 42350401 and McCann study). Freshwater Fish, Chronic A freshwater fish early life­ stage test using the TGAI is required for oxadiazon because the end­ use product may be transported to water from the intended use site, and an acute aquatic toxicity value is less than 1 ppm. Acceptable freshwater test species are rainbow trout, brook trout, coho salmon, chinook, bluegill, brown trout, lake trout, northern pike, fathead minnow, white sucker and channel catfish. The fish early life­ stage is a laboratory test designed to estimate the quantity of toxicant required to adversely effect the reproductive capabilities of a test population of fish. The TGAI is administered into water containing the test species, providing exposure throughout a critical life­ stage, and the results are expressed as a No Observed Adverse Effect Concentration ( NOAEC) and LOAEC ( Lowest Observed Adverse Effect Concentration). Testing results are summarized below. 49 Table C. 8. Freshwater Fish Chronic Toxicity Species/ Static or Flow­ through Study Duration % ai NOAEC/ LOAEC ( ppb)/ ( measured/ nominal) Endpoints Affected MRID/ Lab/ Year Study Classification Rainbow trout ( Oncorhynchus mykiss) > 98% Radiopurity 0.88/ 1.7 ( measured) egg hatch ability 41811601 Analytical Biochemistry Labs, Inc. 1991 Supplemental1 Fathead minnow ( Pimephales promelas) / flowthrough 48 days > 98.5 Radiopurity 33 / 84 ( measured) growth ( length of fry) 42921601 Analytical Biochemistry Labs, Inc. 1993 Core 1 individual growth data were not included in report and were requested so statistics could not be verified. The rainbow trout was found to be more sensitive than the fathead minnow in fish early life stage testing. The study results of the rainbow trout study could not be verified, because individual growth data were not included in the report. Although this information was requested ( Reference: D165510; 1/ 13/ 97 asking for raw data, and also informing the registrant that the study was acceptable for use in a risk assessment), the information has not been submitted. The guideline 72­ 4( a) for early life­ stage fish testing is fulfilled. Freshwater Invertebrates, Acute A freshwater aquatic invertebrate toxicity test using the TGAI is required to establish the toxicity of oxadiazon to aquatic invertebrates. The preferred test organism is Daphnia magna, but early instar amphipods, stoneflies, mayflies, or midges may also be used Study results are tabulated below. Table C. 9. Freshwater Invertebrate Acute Toxicity ( 48­ hour) Species/ Static or Flowthrough % ai EC50 ( ppm)/ ( nominal/ measured) Toxicity Category MRID/ Lab/ Year Study Classification Daphnid ( Daphnia magna)/ static 97.4 2.18 ( nominal) moderately toxic McCann / 1977 Supplemental1 Daphnid ( Daphnia magna) / flow­ through 95.9 > 2.4 ( measured) moderately toxic 42331801 Analytical biochemistry Labs., Inc. 1992 Core 1 EFED considers McCann studies as scientifically sound and useful for risk assessment purposes. Based on results of the above studies, oxadiazon may be categorized moderately toxic to freshwater aquatic invertebrates on an acute basis. The guideline 72­ 2( a) is fulfilled ( MRID 42331801 and McCann study). 50 Freshwater Invertebrate, Chronic A freshwater aquatic invertebrate life­ cycle test using the TGAI is required because the end­ use product is expected to be transported to water from the intended use site, and an aquatic acute LC 50 is less than 1.0 ppm. The preferred test species is Daphnia magna. Table C. 10. Freshwater Invertebrate Chronic Species/ Static or Flowthrough Duration % ai NOAEC/ LOAEC ppb ( nominal/ measured) Endpoints Affected MRID/ Lab/ Year Study Classification Daphnid ( Daphnia magna)/ flow­ through/ 21­ day 97.49 30 / 55 ( measured) survival; adult mean length; mean time in days to first brood and young/ adult/ reproduction day 41784301 Analytical Biochemistry Labs., 1991 Core Based on the results of a 21­ day daphnid chronic test survival with effects on adult growth, time in days to first brood and number of young/ adult/ reproduction day at a LOAEL of 55 ppb , the NOAEC is 30 ppb. The guideline 72­ 4( b) for invertebrate life­ cycle testing is fulfilled ( MRID 41784301). Toxicity to Estuarine and Marine Organisms Estuarine and Marine Fish, Acute Acute toxicity testing with estuarine and marine fish using the TGAI is required for oxadiazon because the end­ use product may reach the marine/ estuarine environment. The preferred test organism is the sheepshead minnow. Study results are tabulated below. Table C. 11. Estuarine/ Marine Fish Acute Toxicity Species/ static or flowthrough % a. i. LC50) ppm/ ( measured/ nominal) Toxicity Category MRID/ Lab/ Year Classification Sheepshead minnow/ ( Cyprinodon variegatus)/ flowthrough 95.9 1.5 ( measured) moderately toxic 42615801 Springborn Labs, Inc. 1992 Core Based on results of the above study, oxadiazon may be categorized moderately toxic to estuarine fish on an acute basis. The guideline 72­ 3( a) is fulfilled ( MRID 42615801). Estuarine and Marine Fish, Chronic No data are available. 51 Estuarine and Marine Invertebrates, Acute Acute toxicity testing with estuarine/ marine invertebrates using the TGAI is required for oxadiazon because the end­ use product may reach the marine/ estuarine environment. The preferred test species are mysid shrimp and eastern oyster. Study results are tabulated below. Table C. 12 . Estuarine/ Marine Invertebrate Acute Toxicity Species/ Static or Flow­ through % a. i. 96­ hour EC50 ( ppm)/ ( measured/ nominal) Toxicity Category MRID/ Lab/ Year Study Classification Eastern oyster ( Crassostrea virginica)/ flowthrough ( shell deposition) 95.9 0.7 ( measured) highly toxic 42570301 Springborn 1992 Supplemental1 Mysid ( Americamysis bahia)/ flowthrough 95.9 0.27 ( measured) highly toxic 42615802 Springborn 1992 Core 1 classified supplemental because average growth in controls was less than 2 mm. Based on the results of the above studies, oxadiazon is considered to be highly toxic to estuarine invertebrates on an acute basis. Although the oyster study is classified supplemental, the study does not need to be repeated, since the mysid was the more sensitive of the two species, and will be used for risk assessment purposes ( Reference: D182582; 3/ 16/ 95). The guideline 72­ 3( b) for the oyster is considered fulfilled ( MRID. 42570301). The guideline 72­ 3( c) for the mysid is fulfilled ( MRID 42615802). Estuarine and Marine Invertebrate, Chronic No data are available. The guideline 72­ 4( b) for the estuarine/ marine invertebrate life cycle is not fulfilled. Aquatic Plants Tier I or Tier II aquatic plant growth testing using the TEP is required for fungicides. The recommendation is for five species: freshwater green alga ( Selenastrum capricornutum), duckweed ( Lemna gibba), marine diatom ( Skeletonema costatum), blue­ green algae ( Anabaena flos­ aquae), and a freshwater diatom. Results of testing with the TGAI are below. 52 Table C. 13. Nontarget Aquatic Plant Toxicity ( Tier II) Species/ duration % A. I. EC50/ NOAEC ( ppb) MRID No. Author/ year Classification1 duckweed ( Lemna gibba)/ 14 day 97.49 41 / < 8 ( measured) 41610107 Springborn Laboratories Inc. 1990 Supplemental1 freshwater green algae ( Selenastrum capricornutum) / 120 hrs. 97.49 8 / 5.6 ( measured) 41610108 Springborn Laboratories Inc. 1990 Core marine diatom ( Skeletonema costatum)/ 120 hrs. 97.49 5.2 / 1.4 ( measured) 41610105 Springborn Laboratories Inc. 1990 Core freshwaterr diatom ( Navicula pelliculosa)/ 120 hrs. 97.49 126 / 27 ( measured) 41610106 Springborn Laboratories Inc. 1990 Core 1 the study was classified supplemental primarily because the exposure concentrations used in the test were too high to establish a NOAEC. 2 study deemed invalid because EC50 not established; registrant was asked to repeat study ( Reference: D188355; 4/ 7/ 95). With an EC50 of 5.2 ppb, the marine diatom appears to be the most sensitive non­ vascular aquatic plant species tested. Guideline 123­ 2 ( Tier II) is fulfilled for four of the five species required ( MRIDs 41610195 through 41610108). Although the duckweed study was classified supplemental, it does not have to be repeated since adequate information was provided for risk assessment purposes ( Reference: D182582; 3/ 16/ 95). A data gap exists for freshwater blue­ green algae ( Anabaena flos­ aquae). 53 APPENDIX D: TERRESTRIAL MODEL RUNS ELL­ Fate Version 1.2 July 19, 2001 Developed by Laurence Libelo. February, 1999 This spreadsheet based model calculates the decay of a chemical applied to foliar surfaces for single or multiple applications. It uses the same principle as the batch code models FATE and TERREEC for calculating terrestrial estimates exposure ( TEEC) concentrations on plant surfaces following application. A first order decay assumption is used to determine the concentration at each day after initial application based on the concentration resulting from the initial and additional applications. The decay is calculated by from the first order rate equation: CT = Cie­ kT or in integrated form: ln ( CT/ Ci) = kT Where CT = concentration at time T = day zero. Ci = concentration, in parts per million ( PPM) present initially ( on day zero) on the surfaces. Ci is calculated based on Kenaga and Fletcher by multiplying the Ci is calculated based on the Kanaga nomogram ( Hoerger and Kenaga, ( 1972) as modified Fletcher ( 1994). For maximum concentration the application rate, in pounds active ingredient per acre, is multiplied by 240 for Short Grass, 110 for Tall Grass, and 135 for Broad leafed plants/ insects and 15 for Seeds. Additional applications are converted from pounds active ingredient per acre to PPM on the plant surface and the additional mass added to the mass of the chemical still present on the surfaces on the day of application. k = degradation rate constant determined from studies of hydrolysis, photolysis, microbial degradation etc. Since degradation rate is generally reported in terms of half­ life the rate constant is calculated from the input half­ life ( k = ln 2/ T1/ 2) instead of being input directly. Choosing which processes controls the degradation rate and which half­ life to use in terrestrial exposure calculations is open for debate and should be done by a qualified scientist. T = time, in days, since the start of the simulation. The initial application is on day 0. The simulation is hardwired to run for 365 days. The program calculates concentration on each type of surface on a daily interval for one year. 54 The maximum concentration during the year and the average concentration during the first 56 days are calculated. The inputs used to calculate the amount of the chemical present are in highlighted in yellow on the spread sheet. Outputs are in blue. The inputs required are: Application Rate: The maximum label application rate ( in pounds ai/ acre) Half­ life: The degradation half­ life for the dominate process( in days) Frequency of Application: The interval between repeated applications, from the label ( in days) Maximum # Application per year: From the label The calculated concentrations are used to calculate Avian and Mammalian RQ values. The maximum calculated concentration is divided by user input values of Chronic No Observable Adverse Effects Level and acute LC50 to give RQs for each plant type. The rat LC 50 is calculated by dividing the mammalian LD 50 by 0.05 ( to correct for actual food consumption) For 15g, 35g and 1000 g mammals the RQ values are calculated by dividing the maximum concentration for each surface by the LD 50 or NOAEL corrected for consumption ( 0.95, 0.66 and .15 body wt. for herbivores and insectivores and 0.21, 0.15 and 0.3 body wt. for granivore) The number of days that the input value of Chronic No Observable Adverse Effects Level and acute LC50 are exceeded in the first 56 days is calculated by comparing the input value to the calculated concentration. A graph of concentration on each plant surface vs time is plotted and a " level of concern" line can be added at a user specified level. The maximum single application which can be applied and not exceed the toxicity input values if calculated by dividing the input value by the Kenaga maximum concentration for Short Grass ( 240). 55 Oxadiazon Chemical Name: turf Use EC Formulation Inputs lbs a. i./ acre 4 Application Rate days 35 Half­ life days 182 Frequency of Application 2 Maximum # Apps./ Year Outputs 56 day Average Maximum Concentration Concentration ( PPM) ( PPM) 585.83 986.12 Short Grass # days 268.51 451.97 Tall Grass Exceeded 329.53 554.69 Broadleaf plants/ Insects on short grass 36.61 61.63 Seeds ( in first 56) 0 5000 Acute LC 50 ( ppm) Avian Max Single Application 33 500 Chronic NOAEC ( ppm) which does NOT exceed 20.833 Avian Acute Chronic RQ Acute RQ ( lb a. i.) 2.083 Avian Chronic ( Max. res. mult. apps.) 1.97 0.20 Short Grass 138.89 Mammalian Acute # days 0.90 0.09 Tall Grass 0.42 Mammalian Chronic Exceeded 1.11 0.11 Broadleaf plants/ Insects on short grass 0.12 0.01 Seeds ( in first 56) 100000 Rat Calculated LC 50 ( ppm) 0 5000 Acute LD 50 ( mg/ kg) Mammalian 56 100 Chronic NOAEL ( mg/ kg) 1000 g mammal 35 g mammal 15 g mammal Rat Chronic Rat Acute Dietary Dietary Acute RQ Acute RQ Acute RQ RQ RQ ( mult. apps) ( mult. apps) ( mult. apps) 9.86 0.01 0.03 0.13 0.19 Short Grass 4.52 0.00 0.01 0.06 0.09 Broadleaf plants/ insects 5.55 0.01 0.02 0.07 0.11 Large Insects 0.62 0.00 0.00 0.00 0.00 Seeds ( granivore) 56 Oxadiazon Chemical Name: turf Use EC Formulation Inputs lbs a. i./ acre 3 Application Rate days 35 Half­ life days 182 Application Interval 2 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 439.37 739.59 Short Grass # days 201.38 338.98 Tall Grass Exceeded 247.15 416.02 Broadleaf plants/ Insects on short grass 27.46 46.22 Seeds ( in first 56) 0 5000 Acute LC50 ( ppm) Avian Max Single Application 19 500 Chronic NOAEC ( ppm) which does NOT exceed 20.833 Avain Acute Chronic RQ Acute RQ ( lb a. i.) 2.083 Avian Chronic ( Max. res. mult. apps.) 1.48 0.15 Short Grass 138.89 Mammalian Acute # days 0.68 0.07 Tall Grass 2.78 Mammalian Chronic Exceeded 0.83 0.08 Broadleaf plants/ Insects on short grass 0.09 0.01 Seeds ( in first 56) 100000 Rat Calculated LC 50 ( ppm) 0 5000 Acute LD50 ( mg/ kg) Mammalian 56 100 Chronic NOAEL ( mg/ kg) 1000 g mammal 35 g mammal 15 g mammal Rat Chronic Rat Acute Chronic RQ Chronic RQ Chronic RQ Dietary Dietary ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ RQ RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 7.40 0.01 1.11 0.02 4.88 0.10 7.03 0.14 Short Grass 3.39 0.00 0.51 0.01 2.24 0.04 3.22 0.06 Tall Grass 4.16 0.00 0.62 0.01 2.75 0.05 3.95 0.08 Broadleaf plants/ Insects 0.46 0.00 0.07 0.00 0.31 0.01 0.44 0.01 Seeds 57 Oxadiazon Chemical Name: turf Use EC Formulation Inputs lbs a. i./ acre 2 Application Rate days 35 Half­ life days 182 Application Interval 2 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 292.92 493.06 Short Grass # days 134.25 225.99 Tall Grass Exceeded 164.77 277.35 Broadleaf plants/ Insects on short grass 18.31 30.82 Seeds ( in first 56) 0 5000 Acute LC50 ( ppm) Avian Max Single Application 0 500 Chronic NOAEC ( ppm) which does NOT exceed 20.833 Avain Acute Chronic RQ Acute RQ ( lb a. i.) 2.083 Avian Chronic ( Max. res. mult. apps.) 0.99 0.10 Short Grass 138.89 Mammalian Acute # days 0.45 0.05 Tall Grass 2.78 Mammalian Chronic Exceeded 0.55 0.06 Broadleaf plants/ Insects on short grass 0.06 0.01 Seeds ( in first 56) 100000 Rat Calculated LC 50 ( ppm) 0 5000 Acute LD50 ( mg/ kg) Mammalian 56 100 Chronic NOAEL ( mg/ kg) 1000 g mammal 35 g mammal 15 g mammal Rat Chronic Rat Acute Chronic RQ Chronic RQ Chronic RQ Dietary Dietary ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ RQ RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 4.93 0.00 0.74 0.01 3.25 0.07 4.68 0.09 Short Grass 2.26 0.00 0.34 0.01 1.49 0.03 2.15 0.04 Tall Grass 2.77 0.00 0.42 0.01 1.83 0.04 2.63 0.05 Broadleaf plants/ Insects 0.31 0.00 0.05 0.00 0.20 0.00 0.29 0.01 Seeds units = weeks not days 58 Oxadiazon Chemical Name: turf Use EC Formulation Inputs lbs a. i./ acre 1.33 Application Rate days 5 Half­ life days 8 Application Interval 6 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 257.05 475.72 Short Grass # days 117.82 218.04 Tall Grass Exceeded 144.59 267.59 Broadleaf plants/ Insects on short grass 16.07 29.73 Seeds ( in first 56) 0 5000 Acute LC 50 ( ppm) Avian Max Single Application 0 500 Chronic NOAEC ( ppm) which does NOT exceed 20.833 Avain Acute Chronic RQ Acute RQ ( lb a. i.) 2.083 Avian Chronic ( Max. res. mult. apps.) 0.95 0.10 Short Grass 138.89 Mammalian Acute # days 0.44 0.04 Tall Grass 2.78 Mammalian Chronic Exceeded 0.54 0.05 Broadleaf plants/ Insects on short grass 0.06 0.01 Seeds ( in first 56) 100000 Rat Calculated LC 50 ( ppm) 0 5000 Acute LD 50 ( mg/ kg) Mammalian 52 100 Chronic NOAEL ( mg/ kg) 1000 g mammal 35 g mammal 15 g mammal Rat Chronic Rat Acute Chronic RQ Chronic RQ Chronic RQ Dietary Dietary ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ RQ RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 4.76 0.00 0.71 0.01 3.14 0.06 4.52 0.09 Short Grass 2.18 0.00 0.33 0.01 1.44 0.03 2.07 0.04 Tall Grass 2.68 0.00 0.40 0.01 1.77 0.04 2.54 0.05 Broadleaf plants/ Insects 0.30 0.00 0.04 0.00 0.20 0.00 0.28 0.01 Seeds units = weeks not days 59 Oxadiazon Chemical Name: turf Use EC Formulation Inputs lbs a. i./ acre 1 Application Rate days 5 Half­ life days 8 Application Interval 8 Maximum # Apps./ Year Outputs 56 Day Average Maximum Concentration Concentration ( PPM) ( PPM) 66.16 358.09 Short Grass # days 30.32 164.13 Tall Grass Exceeded 37.21 201.43 Broadleaf plants/ Insects on short grass 4.13 19.95 Seeds ( in first 56) 0 5000 Acute LC50 ( ppm) Avian Max Single Application 0 500 Chronic NOAEC ( ppm) which does NOT exceed 20.833 Avain Acute Chronic RQ Acute RQ ( lb a. i.) 2.083 Avian Chronic ( Max. res. mult. apps.) 0.64 0.06 Short Grass 138.89 Mammalian Acute # days 0.29 0.03 Tall Grass 2.78 Mammalian Chronic Exceeded 0.36 0.04 Broadleaf plants/ Insects on short grass 0.04 0.00 Seeds ( in first 56) 100000 Rat Calculated LC 50 ( ppm) 0 5000 Acute LD50 ( mg/ kg) Mammalian 16 100 Chronic NOAEL ( mg/ kg) 1000 g mammal 35 g mammal 15 g mammal Rat Chronic Rat Acute Chronic RQ Chronic RQ Chronic RQ Dietary Dietary ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ ( Max. res. ) Acute RQ RQ RQ mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) mult. apps.) ( mult. apps) 3.19 0.00 0.48 0.01 2.11 0.04 3.03 0.06 Short Grass 1.46 0.00 0.22 0.00 0.97 0.02 1.39 0.03 Tall Grass 1.80 0.00 0.27 0.01 1.18 0.02 1.71 0.03 Broadleaf plants/ Insects 0.20 0.00 0.03 0.00 0.13 0.00 0.19 0.00 Seeds 60 APPENDIX E: DRINKING WATER CONCENTRATIONS The Tier I Estimated Environmental Concentrations were calculated using the computer models FIRST ( surface waters) and SCIGROW ( ground waters). A copy from the electronic document generated by EFED appears next. Drinking Water Memo: U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 . OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 8, 2001 DPBarcode: D273599 PC Code 109001 MEMORANDUM SUBJECT: Tier I Estimated Environmental Concentrations of Oxadiazon FROM: José Luis Meléndez, Chemist Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) THROUGH: Mah T. Shamim, Ph. D., Chief Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) TO: Margaret Rice, Acting Branch Chief Veronique LaCapra, CRM and Tom Myers, Team Leader Special Review and Reregistration Division ( 7508C) This memo presents the Tier I Estimated Environmental Concentrations ( EECs) for oxadiazon, calculated using FIRST ( surface water) and SCIGROW ( ground water) for use in the human health risk assessment. For surface water, the acute ( peak) value is 246 ppb and the annual average value is 100 ppb. The groundwater screening concentration is 0.6 ppb. These values generally represent upper­ bound estimates of the concentrations that might be found in surface water and groundwater due to the use of oxadiazon on turf, which is the major use of the chemical. Background Information on FIRST: FIRST is a new screening model designed to estimate the pesticide concentrations found in water for use in 61 drinking water assessments. It provides high­ end values on the concentrations that might be found in a small drinking water reservoir due to the use of pesticide. Like GENEEC, the model previously used for Tier I screening level, FIRST is a single­ event model ( one run­ off event), but can account for spray drift from multiple applications. FIRST takes into consideration the so called Index Drinking Water Reservoir by representing a larger field and pond than the standard GENEEC scenario. The FIRST scenario includes a 427 acres field immediately adjacent to a 13 acres reservoir, 9 feet deep, with continuous flow ( two turnovers per year). The pond receives a spray drift event from each application plus one runoff event. The runoff event moves a maximum of 8% of the applied pesticide into the pond. This amount can be reduced due to degradation on field and the effect of binding to soil. Spray drift is equal to 6.4% of the applied concentration from the ground spray application and 16% for aerial applications. FIRST also makes adjustments for the percent crop area. While FIRST assumes that the entire watershed would not be treated, the use of a PCA is still a screen because it represents the highest percentage of crop cover of any large watershed in the US, and it assumes that the entire crop is being treated. Various other conservative assumptions of FIRST include the use of a small drinking water reservoir surrounded by a runoffprone watershed, the use of the maximum use rate, no buffer zone, and a single large rainfall Background Information on SCIGROW: SCIGROW provides a groundwater screening exposure value to be used in determining the potential risk to human health from drinking water contaminated with the pesticide. Since the SCIGROW concentrations are likely to be approached in only a very small percentage of drinking water sources, i. e., highly vulnerable aquifers, it is not appropriate to use SCIGROW for national or regional exposure estimates. SCIGROW estimates likely groundwater concentrations if the pesticide is used at the maximum allowable rate in areas where groundwater is exceptionally vulnerable to contamination. In most cases, a large majority of the use area will have groundwater that is less vulnerable to contamination than the areas used to derive the SCIGROW estimate. Modeling Inputs and Results: Tables 1 and 2 summarize the input values used in the model runs for FIRST 1.0 and SCIGROW, respectively. The lowest non­ sand K D was used in FIRST 1.0. The median K OC value was used in SCIGROW. The available aerobic soil metabolism half­ life for oxadiazon was extremely high. For FIRST, stability was assumed, while the extrapolated value of 841 days was used in SCIGROW. The modeling results associated with maximum allowable rate per year ( 4 lb ai/ A applied twice at 6 months interval) are presented in Table 3. Attached to this memo are copies of the original printouts generated from FIRST and SCIGROW runs. cc: Nancy McCarroll ( HED) 62 Table 1. Environmental Fate and Other Input Parameters for the Estimation of Oxadiazon using FIRST Parameter Value Source Water Solubility ( 25  C) 1 ppm One­ Liner Hydrolysis Half­ Life ( pH 7) stable MRID 41863603 Aerobic Soil Metabolism Half­ Life ( from 6 values) essentially stable MRID 42772801 Aerobic Aquatic Metabolism Half­ life not available N/ A Aqueous Photolysis Half­ Life 2.75 days MRID 41897201 Soil/ Water Partition Coefficient ( Lowest non­ sand K d) 16.9 MRID 41898202 Pesticide is Wetted­ In Yes Labels PCA ( turf) 0.87 Default Depth of Incorporation ( Broadcast) 0.0 inch Labels Table 2. Environmental Fate Input Parameters for the Estimation of Oxadiazon using SCIGROW. Parameter Value Source Organic Carbon Partition Coefficient ( median K OC) 2376 MRID 41898202 Aerobic Soil Metabolism Half­ Life ( median) 841 days MRID 42772801 Table 3. Modeling Results for Use of Oxadiazon on ( Turf) Golf Courses Parameter Value Source Application Method Ground Spray Labels Application Rate 4.0 lb a. i./ A Registrant Applications Permitted per Year 2 Registrant*** Application Interval ( days) 182 Registrant FIRST 1.0 Peak Untreated Water Concentration 246 ppb N/ A FIRST 1.0 Annual Average Untreated Water Concentration 100 ppb N/ A SCIGROW Ground Water Concentration 0.6 ppb N/ A *** The Registrant supports multiple applications, at lower application rates. 63 RESULTS OBTAINED USING FIRST RUN No. 1 FOR OXADIAZON ON Turf ( Golf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) AREA ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000( 8.000) 2 182 16.9 1.0 GROUND( 6.4) 87.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES.­ EFF) ( RESER.) ( RESER.) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 MAY 1, 2001 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 246.388 100.013 RESULTS OBTAINED USING SCIGROW RUN No. 1 FOR OXADIAZON INPUT VALUES ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000 2 8.000 2376.0 841.0 GROUND­ WATER SCREENING CONCENTRATIONS IN PPB ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .592986 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ A= 836.000 B= 2381.000 C= 2.922 D= 3.377 RILP= 1.821 F= ­ 1.130 G= .074 URATE= 8.000 GWSC= .592986 64 APPENDIX F: EXPOSURE AND RISK CHARACTERIZATION Risk characterization integrates the results of the exposure and ecotoxicity data to evaluate the likelihood of adverse ecological effects. The means of this integration is called the quotient method. Risk quotients ( RQs) are calculated by dividing exposure estimates by acute and chronic ecotoxicity values: RQ = exposure/ toxicity. To evaluate the potential risk to aquatic and terrestrial organisms from the use of Oxadiazon, risk quotients ( RQs) are calculated from the ratio of estimated environmental concentrations ( EECs) to ecotoxicity values. For risk assessments, EFED used dosage rate information obtained from SRRD and BEAD. Since most of the use is on golf courses, turf was chosen to represent all sites. Terrestrial and aquatic risk assessments were based on: ­ 4 lb ai/ A liquid and granular product at 1 and 2 applications per year with a six month reapplication interval ­ 2.4 lb ai/ A liquid product at 2 application per year with a six month reapplication interval ( NOTE: aquatic risk assessments did not include granular formulations) RQs are then compared to levels of concern ( LOC) criteria used by OPP for determining potential risk to nontarget organisms and the subsequent need for possible regulatory action. The criteria indicate that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms. LOCs currently address the following risk presumption categories: ( 1) acute high ­­ potential for acute risk is high; regulatory action may be warranted in addition to restricted use classification, ( 2) acute restricted use ­­ the potential for acute risk is high, but it may be mitigated through restricted use classification, ( 3) acute species ­ the potential for acute risk to species is high, and regulatory action may be warranted, and ( 4) chronic risk ­ the potential for chronic risk is high, and regulatory action may be warranted. Currently, EFED does not perform assessments for chronic risk to plants, acute or chronic risks to nontarget insects, or chronic risk from granular/ bait formulations to birds or mammals. The ecotoxicity test values ( measurement endpoints) used in the acute and chronic risk quotients are derived from required studies. Examples of ecotoxicity values derived from short­ term laboratory studies that assess acute effects are: ( 1) LC 50 ( fish and birds), ( 2) LD 50 ( birds and mammals), ( 3) EC 50 ( aquatic plants and aquatic invertebrates) and ( 4) EC 25 ( terrestrial plants). Examples of toxicity test effect levels derived from long­ term laboratory studies that assess chronic effects are: ( 1) LOAEC ( birds, fish, and aquatic invertebrates) and ( 2) NOAEC ( birds, fish and aquatic invertebrates). Generally, the most sensitive species tested are used. The NOAEC is used as the ecotoxicity test value in assessing chronic effects to birds, mammals, fish, and aquatic invertebrates. Risk presumptions and the corresponding RQs and LOCs, are tabulated in Table 1. 65 Table 1. Risk presumptions for terrestrial organisms Risk Presumption RQ LOC Birds Acute High Risk EEC1/ LC50 or LD50/ sqft2 or LD50/ day3 0.5 Acute Restricted Use EEC/ LC50 or LD50/ sqft or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Species EEC/ LC50 or LD50/ sqft or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 Wild Mammals Acute High Risk EEC/ LC50 or LD50/ sqft or LD50/ day 0.5 Acute Restricted Use EEC/ LC50 or LD50/ sqft or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Species EEC/ LC50 or LD50/ sqft or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft2 3 mg of toxicant consumed/ day LD50 * wt. of bird LD50 * wt. of bird Risk presumptions for aquatic organisms Risk Presumption RQ LOC Acute High Risk EEC1/ LC50 or EC50 0.5 Acute Restricted Use EEC/ LC50 or EC50 0.1 Acute Species EEC/ LC50 or EC50 0.05 Chronic Risk EEC/ NOAEC 1 1 EEC = ( ppm or ppb) in water 66 Risk presumptions for plants Risk Presumption RQ LOC Plant Inhabiting Terrestrial and Semi­ Aquatic Areas Acute High Risk EEC1/ EC25 1 Acute Species EEC/ EC05 or NOAEC 1 Aquatic Plants Acute High Risk EEC2/ EC50 1 Acute Species EEC/ EC05 or NOAEC 1 1 EEC = lbs a. i./ A 2 EEC = ( ppb or ppm) in water 67 Table 2. Selection of Toxicological Endpoints Used to Determine Risk Quotients ( RQs) Type Of Toxicity Organism Species Toxicological Endpoint Oral Acute Bird Mallard 1040 mg/ kg Dietary Bobwhite/ Mallard > 5000 ppm Chronic Bobwhite 500 ppm 1 Oral Acute Mammal Rat > 5000 mg/ kg Chronic Rat 100 ppm 2 Acute Freshwater Fish Rainbow trout/ Bluegill 0.88 ppm Chronic Rainbow trout 0.88 ppb 3 Acute Freshwater Invertebrates Daphnid 2.18 ppm Chronic Daphnid 0.03 ppm Acute Estuarine Fish Sheepshead Minnow 1.5 ppm Chronic Sheepshead Minnow 0.0015 ppm4 Acute Estuarine Invertebrates Mysid 0.27 ppm Chronic Mysid 0.0037 ppm4 Acute Aquatic Plants ( vascular) Aquatic Plants ( Nonvascular) duckweed marine diatom EC50 = 41 ppb; NOAEC = < 8 ppb EC50 = 5.2 ppb 1 No effects on any reproductive parameter or viability of of F1 offspring at the highest dose tested, 1000 ppm; however due to excessive mortality ( 33%) of adult female birds in that dose level, a NOAEC for chronic effects was set at 500 ppm. 2 Based on LOAEL of > 38 mg/ kg/ day for inactive mammary tissue and fetal/ pup death observed in the one year range­ finding test of a rat reproduction study. NOAEC > 100 ppm. 3 Rainbow trout was more sensitive than the fathead minnow ( fathead minnow NOAEC= 33 ppb). 4 Extrapolation from acute/ chronic ratio. 68 Table 6. Environmental Fate Input Parameters for GENEEC 2.0. Chemical Oxadiazon PC Code 109001 Water Solubility ( 25 C) 1 ppm Hydrolysis Half­ Life ( pH 7) stable Aerobic Soil Metabolism Half­ Life stable Aerobic Aquatic Metabolism Half­ life not available Photolysis Half­ Life 2.75 days Soil/ Water Equilibrium Partition Coefficient ( Kd) 16.91 Depth of Incorporation ( Broadcast) 0.0 in. Wetted­ In Yes Table 7. Modeling Results for Use on Turf Ground spray1 granular Application Rate 2.0 3.0 4.0 4.0 4.0 Application Frequency 1 1 1 2 2 Application Interval ( days) N/ A N/ A 182 182 182 GENEEC 2.0 Peak EEC 44 67 89 173 150 21­ Day EEC 43 65 87 170 147 60­ Day EEC 42 63 84 163 142 3. Low boom ground sprayer with fine spray quality ( EFED defaults), no buffer ( no spray zone). 69 APPENDIX G: ENVIRONMENTAL FATE AND ECOLOGICAL EFFECTS DATA REQUIREMENTS Table of Data Requirements of Ecological Effects for Oxadiazon Guideline # Data Requirement Is Data Requirement Satisfied? MRID #' s Study Classification 71­ 1 850.2100 Avian Oral LD50 yes 41610101 core 71­ 2 850.2200 Avian Dietary LC50 yes 41610102 41610103 core core 71­ 4 850.2300 Avian Reproduction yes 41993201 41993202 supplemental core 72­ 1 850.1075 Freshwater Fish LC50 yes 42350601 42330401 core core 72­ 2 850.1010 Freshwater Invertebrate Acute LC50 yes 41784301 core 72­ 3( a) 850.1075 Estuarine/ Marine Fish LC50 yes 42615801 core 72­ 3( b) 850.1025 Estuarine/ Marine Mollusk EC50 yes 42570301 core 72­ 3( c) 850.1035 850.1045 Estuarine/ Marine Shrimp EC50 yes 42615802 core 72­ 4( a) 850.1400 Estuarine Fish Early Life­ Stage no 72­ 4( b) 850.1300 850.1350 Estuarine/ Marine Invertebrate Life­ Cycle no 72­ 5 850.1500 Freshwater Fish Full Life­ Cycle na ­ ­ 122­ 1( a) 850.4100 Seed Germ./ Seedling Emergence no ­ ­ 122­ 1( b) 850.4150 Vegetative Vigor no ­ ­ 70 122­ 2 850.4400 Aquatic Plant Growth partially ­ ­ 123­ 1( a) 850.4225 Seed Germ./ Seedling Emergence no 123­ 1( b) 850.4250 Vegetative Vigor no 123­ 2 850.4400 Aquatic Plant Growth partially 5 41610105 41610106 41610106 41610108 core 141­ 1 850.3020 Honey Bee Acute Contact LD50 yes 4268301 core 141­ 2 850.3030 Honey Bee Residue on Foliage not required 70­ 1 Acute and Chronic Sediment Toxicity Testing no6 70­ 1 Aquatic Phototoxicity Studies no 1 Although the mallard study was supplemental since a NOAEC was not established, the study does not have to be repeated; the bobwhite was more sensitive and was used for risk assessment purposes. 2 Early­ life stage fish testing with an estuarine species is required. The raw data for the rainbow trout study MRID 41811601 must be submitted. This information was requested in 1997 under D165510. 4 The rates used should be low enough to elicit an NOAEC or allow for accurate estimation of the EC05 for all measured parameters. The measured endpoints should include: shoot length, root length and/ or height, and a phytotoxic rating of the visible effects. Testing must be conducted with a liquid typical end­ use product, rather than technical product, due to the insolubility of the material and since historically, plant species have been found to be more sensitive to the end­ use product, than technical. Concentrations must be measured, and results must be based on measured concentrations. The nominal concentrations used in statistical analyses most likely did not represent actual exposure. This information was requested in 1995 under D166982. 5 A freshwater blue­ green algae ( Anabaena flos­ aquae) is required; the study submitted ( MRID 41610104) was invalid. 6 The high KOC of oxadiazon, combined with the high persistance exhibited in the aerobic soil metabolism, as well as the anaerobic aquatic metabolism (>> 10 days) trigger the requirement of a Chronic Sediment Toxicity Testing with both Hyalella azteca and Chironomus tentans. 2 Waived due to the relatively low vapor pressure for oxadiazon ( 1.00x10­ 6 mm Hg). 3Satisfied by submission of an Anaerobic Aquatic Metabolism study. 71 Table of Data Requirements of Environmental Effects for Oxadiazon Guideline # Data Requirement Is Data Requirement Satisfied? MRID #' s Study Classificatio n 161­ 1 835.2120 Hydrolysis Yes 41863603 acceptable 161­ 2 835.2240 Photodegradation in Water Yes 41897201 acceptable 161­ 3 835.2410 Photodegradation on Soil Yes 41898201 acceptable 161­ 4 835.2370 Photodegradation in Air waived2 N/ A N/ A 162­ 1 835.4100 Aerobic Soil Metabolism Yes 42772801 acceptable 162­ 2 835.4200 Anaerobic Soil Metabolism Yes3 NA N/ A 162­ 3 835.4400 Anaerobic Aquatic Metabolism Yes 42773802 supplemental 162­ 4 835.4300 Aerobic Aquatic Metabolism not required N/ A N/ A 163­ 1 835.1240 835.1230 Leaching­ Adsorption/ Desorption Yes 44555608 , 41898202 acceptable, supplemental 163­ 2 835.1410 Laboratory Volatility waived1 N/ A N/ A 163­ 3 835.8100 Field Volatility waived1 N/ A N/ A 164­ 1 835.6100 Terrestrial Field Dissipation Yes 41767401 acceptable 164­ 2 835.6200 Aquatic Field Dissipation not required N/ A N/ A 164­ 3 835.6300 Forestry Dissipation not required N/ A N/ A 72 164­ 4 835.6400 Combination Products and Tank Mixes Dissipation not required N/ A N/ A 165­ 4 850.1730 Accumulation in Fish Yes 42226701 acceptable 165­ 5 850.1950 Accumulation­ aquatic non­ target not required N/ A N/ A 166­ 1 835.7100 Ground Water­ small prospective not required N/ A N/ A 201­ 1 840.1100 Droplet Size Spectrum reserved N/ A N/ A 202­ 1 840.1200 Drift Field Evaluation reserved N/ A N/ A 73 APPENDIX H: QUALITATIVE USE ASSESSMENT Case No.: 2485 PC Code: 109001 Date: 01­ 10­ 01 Analyst: Stephen Smearman Oxadiazon is a selective preemergence and early post emergence herbicide used primarily to control annual grasses and broadleaf weeds. The tradename for Oxadiazon in the US is Ronstar ( formerly Chipco Ronstar) and formulations are available as emulsifiable concentrates, granules, flowable and wetable powders. Based upon the available EPA data and other pesticide usage survey information for Oxadiazon on all sites for the years 1989 through 1999, an annual estimate of Oxadiazon's total usage on all sites averaged 249,000 pounds of active ingredient ( a. i.) on an average of 52,000 acres treated over the last 10 years. Most of the acreage is treated with up to 2.4 pounds of a. i. per acre owing most of the usage applies to golf courses which based on reported usage has higher application rates than other uses. Oxadiazon's largest markets in terms of total pounds of active ingredient is allocated to golf courses ( 65%). The remaining usage is primarily for horticultural/ nursery uses and on processed tomatoes ( 22%). Other reported uses include potatoes and barley which accounts for an respective 1.5% and less than 1% of the total pounds a. i. annually. However, there are no tolerances nor labeled uses for these site and therefore should not be considered during risk assessment. However, there is international reported use of Oxadiazon on rice in China and on cotton in Mexico and Sudan. Additional estimates of total acres grown and total acres treated for the non­ crop sites of road right of ways ( ROW), landscape maintenance, horticultural/ nursery and park uses are not currently available although there is estimates of pounds of a. i. applied. The following table illustrates the usage of Oxadiazon. 74 USAGE OF OXADIAZON Site Acres Grown ( 000) Acres Treated ( 000) % of Crop Treated LB AI Applied ( 000) Average Application Rate Wtd Avg Est Max Wtd Avg Est Max Wtd Avg Est Max lb ai/ acre/ yr # appl / yr lb ai/ A/ appl * Potatoes 1,373 2 4 0% 0% 4 8 2.0 1.0 2.0 * Barley 7,326 0 1 0% 0% 0 1 1.0 1.0 1.0 Lots/ Farmsteads/ etc 56,000 1 3 0% 0% 1 4 1.3 1.0 1.3 Golf Courses 1,618 49 98 3% 6% 160 235 2.4 1.0 2.4 Landscape Mainten ­ ­ ­ ­ ­ 12 24 3.0 ­ ­ Rights of Way ­ ­ ­ ­ ­ 5 10 ­ ­ ­ Parks ­ ­ ­ ­ ­ 11 22 ­ ­ ­ Horticultural Nurseries ­ ­ ­ ­ ­ 56 112 4.0 ­ ­ Total 51.915 106 249.03 416 COLUMN HEADINGS Wtd Avg = Weighted average­­ the most recent years and more reliable data are weighted more heavily. Est Max = Estimated maximum, which is estimated from available data. Average application rates are calculated from the weighted averages. NOTES ON TABLE DATA Usage data primarily covers 1988 ­ 1998. Calculations of the above numbers may not appear to agree because they are displayed as rounded to the nearest 1000 for acres treated or lb. a. i. ( Therefore 0 = < 500) to the nearest whole percentage point for % of crop treated. ( Therefore 0% = < 0.5%) * = Available EPA sources indicate that usage is observed for potatoes and barley in the reported data for this site. However, there are no tolerances or labeled uses for these site. Reason for reported usage is undetermined and therefore usage for these sites should not be used for risk assessment. ­ = missing information or lack of confidence in the data to determine an accurate estimate of usage. However, these sites were included in the table because of indicated usage. SOURCES: EPA data, 1988­ 98; USDA, NASS, 1999 75 APPENDIX I. GENEEC 2.0 INPUT PARAMETERS, RESULTS, AND OUTPUTS Environmental Fate Input Parameters for GENEEC 2.0. Chemical Oxadiazon PC Code 109001 Water Solubility ( 25  C) 1 ppm Hydrolysis Half­ Life ( pH 7) stable Aerobic Soil Metabolism Half­ Life stable Aerobic Aquatic Metabolism Half­ life not available Photolysis Half­ Life 2.75 days Soil/ Water Equilibrium Partition Coefficient ( K d) 16.91 Depth of Incorporation ( Broadcast) 0.0 in. Wetted­ In Yes Table 2. Modeling Results for Use on Turf Ground spray1 granular Application Rate 2.0 3.0 4.0 4.0 4.0 Application Frequency 1 1 1 2 2 Application Interval ( days) N/ A N/ A 182 182 182 GENEEC 2.0 Peak EEC 44 67 89 173 150 21­ Day EEC 43 65 87 170 147 60­ Day EEC 42 63 84 163 142 4. Low boom ground sprayer with fine spray quality ( EFED defaults), no buffer ( no spray zone). 76 RUN No. 1 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000( 8.000) 2 182 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 173.14 172.44 169.50 163.00 158.23 RUN No. 2 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 2.000( 4.000) 2 42 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 88.20 87.84 86.34 83.03 80.60 77 RUN No. 3 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 3.000( 6.000) 2 182 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 129.85 129.33 127.12 122.25 118.67 RUN No. 4 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000( 8.000) 2 182 16.9 1.0 GRANUL( .0) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 150.41 149.80 147.25 141.60 137.46 78 RUN No. 1 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 2.000( 2.000) 1 1 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 44.39 44.21 43.46 41.79 40.57 RUN No. 1 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 3.000( 3.000) 1 1 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 66.59 66.32 65.19 62.69 60.85 79 RUN No. 1 FOR Oxadiazon ON Turf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE NO­ SPRAY INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) ( FT) ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000( 4.000) 1 1 16.9 1.0 GRHIFI( 6.6) .0 .0 FIELD AND STANDARD POND HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( POND) ( POND­ EFF) ( POND) ( POND) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 GENERIC EECs ( IN MICROGRAMS/ LITER ( PPB)) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 88.79 88.43 86.92 83.59 81.14 4Matringe, M., J.­ M. Camadro, P. Labbe, and R. Scalla. 1989. Protoporphyrinogen oxidase as a molecular target for diphenyl ether herbicides. Biochem. J. 260: 231­ 235. 5Birchfield, N. B., and J. E. Casida. 1997. Protoporphyrinogen oxidase of mouse and maize: Target site selectivity and thiol effects on peroxidizing herbicide action. Pesticide Biochemistry and Physiology 57, 36­ 43. 6Halling, B. P., D. A. Yuhas, V. F. Fingar, and J. W. Winkleman. 1994. " Protoporphyrinogen oxidase inhibitors for tumor therapy" in Porphyric Pesticides: Chemistry, Toxicology, and Pharmaceutical Applications, ( S. O. Duke and C. A. Rebeiz, Eds.) pp. 280­ 290, American Chemical Society Symposium Series 559, Am. Chem. Soc., Washington, D. C., 1994. 7Birchfield, N. B. Protoporphyrinogen Oxidase as a Herbicide Target: Characterization of the [ 3H] Desmethylflumipropyn Binding Site. Dissertation. University of California, Berkeley. 1996. 80 APPENDIX J. PHOTOXICITY STUDY PROTOCOL for LIGHT­ DEPENDENT PEROXIDIZING HERBICIDES The light­ dependent peroxidizing herbicides ( LDPHs) are a growing class of weed control chemicals ( see partial listing attached). They act in plants by inhibiting the enzyme protoporphyrinogen oxidase ( protox), which is the last common enzyme in the heme and chlorophyll biosynthetic pathways. 4 Protox exists in both plants and animals and the enzyme from both sources has been shown to be highly sensitive to many LDPHs. 5 LDPH protox inhibition in plants results in a rapid accumulation of protoporphyrin IX, a phototoxic heme and chlorophyll precursor. In the presence of light, protoporphyrin IX is a powerful generator of singlet oxygen which in plants causes lipid membrane peroxidation leading to a rapid loss of turgidity and foliar burns. LDPH exposure in mammals has been shown to result in excretion of porphyrins in urine ( porphynuria) and feces, increased liver weight, elevated blood porphyrin levels, developmental abnormalities, and cancer. Humans with a hereditary protox disorder ( variegate porphyria) which results in lowered protox activity exhibit many symptoms similar to LDPH exposure in addition to photosensitivity. However, photosensitivity is not a commonly reported symptom of LDPH exposure in animals. An LDPH­ induced occurrence of phototoxicity in rats6 and increased cytotoxicity to human skin cells grown in culture in the presence of light and an LDPH7 have been reported but many other LDPH toxicity studies make no mention of phototoxicity in animals. The scarcity of phototoxicity data in animals could result from physiological or biochemical distinctions from plants. For instance, animals exposed to LDPHs may not normally accumulate protoporphyrin IX in their epidermis. However, phototoxicity may not be reported in many LDPH toxicity tests because of relatively low light conditions in laboratories and/ or protection afforded by the animals' fur or feathers. Animals without fur or feathers existing in sunny environments would be expected to be at highest risk for potential phototoxic effects. The Aquatic Biology Tech Team ( ABTT) recommends that phototoxicity studies be conducted on 8American Society for Testing and Materials. 1994. Standard guide for conducting the frog embryo teratogenesis assay­ Xenopus. E 1439­ 91. In Annual Book of ASTM Standards, Vol 11.5, pp. 825­ 835. Philadelphia, PA. 81 herbicides with this mode of action to determine if animals exposed to LDPHs and intense light ( similar to sunlight) show increased toxicity relative to controls exposed to LDPHs and low intensity light. The results of these studies will help to determine if animals that are exposed to sunlight in LDPH use areas are at higher risk than guideline toxicity studies suggest. The ABTT is requesting that a LDPH phototoxicity protocol be submitted for review and agreement by EFED and the registrant prior to study initiation. Protocols for standard toxicity tests have also been published. 8 In nature, fish and other aquatic organisms are expected to be exposed to LDPHs through run­ off and spray drift. Aquatic organisms inhabiting small, shallow water bodies, exposed to high levels of solar radiation would be expected to be at greatest risk for potential phototoxic effects. Therefore, the ABTT is requesting a small fish species be used in a phototoxicity assay to assess the potential of light to increase LDPH toxicity. The ABTT requests that the study adequately address the following issues and suggests the paper, " Photoenhanced Toxicity of a Carbamate Insecticide to Early Life Stage Anuran Amphibians", 5 and other studies in the peer­ reviewed scientific literature serve as sources of additional guidance: Species The fathead minnow may be an appropriate test species because of existing toxicity protocols which may be adapted for this study. Exposure duration A subchronic exposure duration would be adequate for proof of principle. A single exposure may not allow adequate time for porphyrin accumulation, however, a life­ cycle is not necessary to identify a phototoxic effect. Dosing A range finding study should be conducted under defined low light conditions to identify an LC 50 value and lower dose levels expected to be similar to controls. Doses used in the phototoxicity study should not be expected to result in significant mortality in low light controls. Dissolved concentrations of the test chemical should be confirmed by an appropriate analytical method. Endpoints Behavioral observations should be made in addition to measurements of mortality, growth, weight, morphology, and appearance. Ideally, measurements of protoporphyrin and heme concentrations in the blood and protox activity in the liver of each test organisms should be made. Light sources Artificial light may be preferred to natural light that will vary in different regions and seasons as well as 82 with weather. If artificial light is used, the light should resemble full, natural sunlight as closely as possible, particularly around 400 nm. The most important wavelength for porphyrin induced phototoxicity in ~ 400 nm. No matter what the light source, the duration and intensity of UV and visible light should be reported at all wavelengths ( 200­ 800 nm). At this point EFED does not have a specific recommendation for an artificial light source. Dark, light, and positive controls As this study is intended to identify potential effects of light on LDPH toxicity, an appropriate study protocol should include a dark, or low light, control group. Another group not exposed to chemicals but exposed to full light should be included ( a full light control). In addition to the dark and light controls, a positive control group using protoporphyrin IX may be useful. Exposure chambers and light filters Light intensity should be measured inside test chambers if glass or any other material is placed between the light source and the test animals. Any filters should be cured under the study light for 72­ hours prior to study initiation to ensure consistent transmittance. 83 ATTACHMENT 1. The following list of herbicides are believed to act by inhibiting protoporphyringen oxidase in the heme and chlorophyll biosynthetic pathway. acifluorfen azafenidin carfentrazone­ ethyl flumiclorac­ pentyl flumioxazin fluthiacet­ methyl fomesafen lactofen oxadiargyl oxadiazon oxyfluorfen sulfentrazone thidiazimin

epa

2024-06-07T20:31:44.881678

regulations

EPA-HQ-OPP-2002-0309-0006

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: July 15, 2001 MEMORANDUM SUBJECT: REVISED OCCUPATIONAL AND RESIDENTIAL EXPOSURE ASSESSMENT AND RECOMMENDATIONS FOR THE REREGISTRATION ELIGIBILITY DECISION DOCUMENT FOR OXADIAZON FROM: Seyed Tadayon, Chemist Chemistry Exposure Branch I Health Effect Division ( 7509C) THRU: Francis Suhre, Senior Scientist Chemistry Exposure Branch I Health Effects Division ( 7509C) TO: Nancy McCarroll, Geneticist Toxicology Branch I Health Effects Division ( 7509C) Please find the review of oxadiazon. DP Barcode: D276360 PC Codes: 109001 EPA Reg Nos: 264­ 450, 264­ 502, 432­ 886, 432­ 887, 432­ 893, 432­ 898, 538­ 143, 538­ 146, 538­ 147, 538­ 164, 538­ 241, 538­ 257, 961­ 340, 961­ 371, 961­ 379, 961­ 380, 961­ 382, 8660­ 17, 8660­ 35, 8660­ 36, 9198­ 75, 9198­ 154, 9198­ 155, 10404­ 63, 10404­ 93, 34704­ 771, 35512­ 43, 35512­ 44, 48234­ 1, 48234­ 2, 48234­ 10, 48234­ 14, 48234­ 15, 52287­ 1, 52287­ 2, 52287­ 3, 55615­ 4, 55615­ 5, 67508­ 1, CA97001800, FL82004500, HI97000100. EPA MRID No: 449955­ 01, 449955­ 02, 435178­ 01 LUIS Report: 05/ 04/ 99 PHED: Yes, Version 1.1 2 CONTENTS EXECUTIVE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.0 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.1 Summary of Toxicity Concerns Relating to Agricultural Exposures . . . . . . . . . . . . 6 1.2 Summary of Use Pattern and Formulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 1.3 Method and Types of Equipment Used for Mixing/ Loading/ Applying . . . . . . . . . 10 1.4 Incident Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2.0 OCCUPATIONAL EXPOSURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2.1 Handler Exposures & Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2.1.1 Summary of Occupational Handler Exposures . . . . . . . . . . . . . 14 2.1.2 Summary of Uncertainties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 2.1.3 Calculations of Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 2.1.4 Calculations of Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 2.2 Risk From Handler Exposures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 2.2.1 Risk From Handler Exposures . . . . . . . . . . . . . . . . . . . . . . . . . 20 2.2.2 Summary of MOEs and cancer . . . . . . . . . . . . . . . . . . . . . . . . . 22 3.0 POSTAPPLICATION EXPOSURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.1 Postapplication Exposures & Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 3.1.1 Data Source and Assumptions For Scenario Considered . . . . . . 27 3.1.2 Assumptions Used in Postapplication Exposure . . . . . . . . . . . . 28 3.1.3 Exposure and Risk Calculation . . . . . . . . . . . . . . . . . . . . . . . . . 28 3.1.4 Postapplication Exposure Risk estimates . . . . . . . . . . . . . . . . . . 29 3.2 Non­ occupational Postapplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 3.2.1 Postapplication Exposure Scenarios . . . . . . . . . . . . . . . . . . . . . 30 3.2.2 Data Sources for Scenarios Considered . . . . . . . . . . . . . . . . . . 30 3.2.3 Assumptions Used in Postapplication Exposure Calculations . . 31 3.2.4 Postapplication Exposure Risk Estimates . . . . . . . . . . . . . . . . . 36 3.2.5 Data Gaps and Uncertainties . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 APPENDIX A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 APPENDIX B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 APPENDIX C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 EXECUTIVE SUMMARY 3 Purpose This is a revision of the original Occupational and Residential Exposure Assessment and Recommendations Document for Oxadiazon, ( S. Tadayon June 12, 2001). This chapter has been revised to address comments made by the Risk Assessment Review Committee ( RARC). This document addresses the exposures and risks associated with the use of the oxadiazon, that occur through non­ dietary exposure. These exposures can occur as a result of applying oxadiazon or by entering areas that have been previously treated with oxadiazon. Exposures can occur as a part of one's job or through uses of oxadiazon on residential lawns and other areas that are frequented by the general public. Occupational and residential exposures are addressed separately in this document. Oxadiazon, 2­ tert­ butyl­ 4­ ( 2,4­ dichloro­ 5­ isopropoxyphenyl­ 1,3,4­ oxadiazolin­ 5­ one), is a selective pre emergence and early post emergence herbicide used primarily to control annual grasses and broadleaf weeds. The occupational use sites include golf course turf, ornamental turf, conifer nursery, landscape ­ industrial sites, ornamental noncroplands, roadside landscape plantings, sod farms, woody ornamental shrubs, vines and trees and herbaceous ornamental crops. The outdoor residential use site include cemeteries, athletic fields, residential condominiums and school ground. A wide variety of application techniques have been identified that could potentially be used to apply oxadiazon such as groundboom sprayers, handheld sprayers ( low and high pressure devices and low pressure/ high volume sprayguns commonly used on turf), backpack sprayers, tractor­ drawn granular spreaders, push­ type granular lawn spreaders, and bellygrinders. Oxadiazon is formulated as a manufacturing product ( 94.0% active ingredient), several granular formulations ( up to 50.0% active ingredient) and three wettable powders ( 50.0% active ingredient). Hazard Identification The Report of the Hazard Identification Assessment Review Committee ( HIARC) for oxadiazon, dated December 21, 2000, indicates that there are toxicological endpoints of concern for oxadiazon. A short­ term ( 1­ 7 days) to intermediate­ term ( one week to several months) oral endpoint was selected for incidental oral exposure in children, using a NOAEL of 12 mg/ kg/ day based on a statistically significant decrease in maternal body weight gains at 40 mg/ kg/ day ( LOAEL) in a developmental study in rats. For short­ term and intermediate dermal exposure, an oral endpoint was selected using a NOAEL of 12 mg/ kg/ day based on a statistically significant decrease in maternal body weight gains at 40 mg/ kg/ day ( LOAEL) in a developmental study in rats. The committee recommended a dermal absorption factor of 9% ( rounded up from 8.7%) based on a dermal penetration study to be used in the calculation. Due to a lack of inhalation studies, the HIARC selected an endpoint from oral studies for 4 inhalation risk assessments. For short and intermediate­ term inhalation exposure, the same oral study was chosen as for dermal exposure of this duration, with a NOAEL of 12 mg/ kg/ day. An absorption factor of 100% is applied for inhalation exposures. The target margin of exposure ( MOE) of 100 or more for occupational exposure scenarios was selected based upon 10x for intraspecies and 10x for interspecies variation. Because the effects from dermal and inhalation exposure are the same, the doses for these routes and duration may be aggregated. Since 1987, the Agency's decision on the carcinogenic potential of oxadiazon concurred with the Scientific Advisory Panel's ( SAP) classification of oxadiazon as a Group C carcinogen and the Q 1* had been set at 1.4 x 10­ 1( mg/ kg/ day)­ 1 in human equivalents. Since that time, new chronic/ carcinogenicity data have been submitted and reviewed by the Cancer Assessment Review Committee ( CARC). Based on this revisit, CARC has reclassified oxadizon as a " Likely To Be Carcinogenic To Humans". For the purpose of the lifetime cancer risk assessment by the Agency, the most potent unit risk, Q 1 *, is that for male mouse liver adenoma and/ or carcinoma combined tumor rates at 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 in human equivalents. All unit risks have been converted from animals to humans by use of the 3/ 4' s scaling factor. Oxadiazon has not been reported to cause life­ threatening illness or death. Most of the cases appear to be related to irritation to the skin, eyes and mucous membranes. Some cases may be related to an allergic reaction On the list of the top 200 chemicals for which NPTN ( National Pesticide Telecommunications Network) received calls from 1984­ 1991 inclusively, oxadiazon was ranked 192nd with 12 incidents in humans reported and 5 incidents in animals ( mostly pets). Occupational Handler Exposure and Risk Estimates HED has determined that there are potential exposures to mixers, loaders, applicators, and other handlers during usual use­ patterns associated with oxadiazon. Fourteen major exposure scenarios were identified for oxadiazon, including mixing, loading, and applying using ground spray, granular, and lawn application methods. Handler Scenarios with Risk Concerns The results of the short and intermediate­ term handler assessments indicate that all potential exposure scenarios provide at least one application rate with a total MOE( s) greater than or equal to 100 at either the baseline ( i. e., long pants, long sleeved shirts, no gloves) using open systems, PPE ( i. e., long pants, long sleeved shirts, and chemical resistant gloves while using open systems) or using engineering controls ( i. e., closed systems). In the majority of cases, it is dermal exposure rather than the inhalation exposure driving the total MOEs. In total, 37 MOEs were calculated for the various application rates. The total MOEs for all the scenarios range from 2 to 3000. The results of the Cancer Risk indicate that the values range from 1.65E­ 2 to 4.66E­ 7 at the baseline ( i. e. long pants, long shirts and no gloves), 2.56E­ 3 to 4.11E­ 7 at PPE1 ( i. e. long 5 pants, long shirts, gloves and no respirator), 2.40E­ 3 to3.51E­ 7 at PPE2 ( i. e. long pants, long shirts, double layer, gloves and no respirator), 1.05E­ 3 to 1.98E­ 7 at PPE3 ( i. e. long pants, long shirts, gloves and respirator), 8.90E­ 4 to 1.38E­ 07 at PPE4 ( i. e. long pants, long shirts, double layer, gloves and respirator) and 4.92E­ 5 to 1.10E­ 8 at engineering control. Postapplication Worker Exposure and Risk Estimates Most of the oxadiazon used on golf course turf ( 71%), ornamental turf, conifer nursery, landscape ­ industrial sites, ornamental non­ croplands, roadside landscape planting, sod farms, woody ornamental shrubs, vines and trees and herbaceous ornamental crops is applied early in the season, either pre­ plant or before weeds emerge ( pre­ emergence). This fact, and the degree of mechanization in cultivating these crops, minimizes the postapplication contact of workers with the chemical on these crops. Three chemical­ specific studies, were submitted to the Agency for consideration. Theses studies were reviewed and only the re­ entry study found to be acceptable for use in the oxadiazon risk assessment. Using the revised residential SOP postapplication short­ and intermediate­ term dermal risk estimates for occupational workers are between 30 and 1,000. The cancer risk for all occupational handlers is between 9.92 x 10­ 5 to 3.01 x 10­ 6. Residential Postapplication Exposure and Risk Estimates Dermal postapplication exposure estimates were conducted using the highest mean postapplication residue from the Jazzercise study ( wettable powder formulations). The dermal transfer coefficients from the Jazzercize study and the revised residential SOPs were used. Using the Jazzercize wettable powder application study residue data and revised residential SOPs , all of the scenario had short­ term and intermediate dermal MOEs greater than 100. The cancer risks for all residential dermal postapplication is between 6.22x 10­ 6 to 7.51 x 10­ 7 . The Residential SOPs and submitted Jazzercize study data were used to estimate incidental oral exposure for toddlers on treated turf. The short­ term MOE was100 for the toddler hand­ to­ mouth using residential SOPs and between 90 to 240 for the submitted study. The intermediate­ term MOE was not calculated since exposure by this route for weeks to months is considered less likely to occur than short­ term exposure. Incidental turfgrass mouthing and soil ingestion had MOEs greater than 100 for short­ term exposures. Uncertainties in Risk Assessment and Data Gaps Residential handler exposure and risk estimates were conducted using a set of surrogate chemical data: the ORETF study data and the Residential SOPs. Dermal postapplication exposures to oxadiazon were based on the highest residues from the chemical­ specific re­ entry study data and are of fairly high confidence. Oral ingestion scenarios are based on standard assumptions and formulae ( Residential SOPs) which are designed to be screening level. Granular 6 ingestion is considered episodic in nature. 1.0 BACKGROUND Purpose In this document, which is for use in EPA's development of the oxadizon. Reregistration Eligibility Decision Document ( RED), EPA presents the results of its review of the potential human health effects of occupational and residential exposure to oxadiazon. Criteria for Conducting Exposure Assessments An occupational and/ or residential exposure assessment is required for an active ingredient if ( 1) certain toxicological criteria are triggered and ( 2) there is potential exposure to handlers ( mixers, loaders, applicators, etc.) during use or to persons entering treated sites after application is complete. For oxadiazon, both criteria are met. 1.1 Summary of Toxicity Concerns Relating to Agricultural Exposures Acute Toxicology Categories Table 1 presents the acute toxicity categories as outlined in the Hazard Identification Document ( Dec 21, 2000). 1 Table 1: Acute Toxicity Categories For Oxadiazon Guideline No. Study Type MRID #( S). Results Toxicity Category 81­ 1 Acute Oral­ Rat 41866501 LD50 = > 5000 mg/ kg (
, combined) IV 81­ 2 Acute Dermal­ Rabbit 41866502 LD50 = > 2000 mg/ kg (
, combined) III 81­ 3 Acute Inhalation­ Rat 41866503 LC50 = > 1.94 mg/ L (
, combined) III 81­ 4 Primary Eye Irritation­ Rabbit 41866504 Mild irritant to ocular tissue III 81­ 5 Primary Skin Irritation­ Rabbit 41866505 Negligibly irritating to skin III 81­ 6 Dermal Sensitization­ Guinea Pig 41230401 Not a dermal sensitizer ( Buehler test) ­­ 81­ 8 Acute Neurotoxicity ND Other Endpoints of Concern The report of the Hazard Identification Assessment Review Committee ( HIARC) for oxadiazon, dated Dec 21, 20001, identified toxicological endpoints of concern for oxadiazon. 7 All calculations completed in this document are based on the most current toxicity information available for oxadiazon. The endpoints that were used to complete this assessment are summarized below in Table 2: Table 2: Endpoints selected by HIARC for Assessing Occupational and Residential Risks for Oxadiazon EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Incidental Oral, Short­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Incidental Oral, Intermediate­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Short­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Intermediate­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Long­ Term NOAEL= 0.36 Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption rate of 9% is applied. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Inhalation, Short­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, route­ to­ route extrapolation and a 100% absorption rate are applied Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Intermediate­ Term NOAEL= 12 Maternal effects/ Developmental effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) / Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, route­ to­ route extrapolation and a 100% absorption rate are applied. Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). Route­ to­ route extrapolation and a 100% absorption rate aplied. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Cancer Q 1* of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 Significant increase ( pair­ wise and trend, p< 0.01) in liver adenomas and adenomas and/ or carcinomas combined in males at 9.3 mg/ kg/ day). Combined Chronic Feeding/ Carcinogenicity ­ Mouse MRID Nos. 40993301 1.2 Summary of Use Patterns and Formulations At this time, products containing oxadiazon are intended for both occupational and residential uses. 8 Type of pesticide/ target pests Oxadiazon, 2­ tert­ butyl­ 4­ ( 2,4­ dichloro­ 5­ isopropoxyphenyl­ 1,3,4­ oxadiazolin­ 5­ one), is a selective pre­ emergence and early post emergence herbicide used primarily to control annual grasses and broadleaf weeds. Table 3 presents a list of oxadiazons ' s active products. The annual grasses and broadleaves controlled by oxadiazon include the following: 1. Annual grasses: annual blugrass, barnyardgrass, crabgrass, fall panicum, giant foxtail ( yellow and green), goosegrass, junglerice, signalgrass, sprangletop, Texas panicum and hophornbeam copperleaf $ Broadleaves: Florida beggarweed, carpet weed, cudweed, dayflower, ducksalad, filaree, groundsel, jimsonweed, lambersquarters, mustards, pigweed, prickly sida, prostrate knotweed, purslane, purslane, redmaids, smartweed, sowthistle, velvetleaf, morningglory and black night shade Formulation types and percent active ingredient Oxadiazon is formulated as a manufacturing product ( 94.0% active ingredient), several granular formulations ( up to 50.0% active ingredient) and three wettable powders ( 50.0% active ingredient). Wettable powders are marketed in bags and water soluble bags. Registered use sites, application rates and frequency of application Oxadiazon is applied as a pre­ plant or pre­ emergent herbicide on non­ food/ outdoor crops. occupational applications ( i. e., to turf and ornamentals) are made to established areas such as lawns or golf course greens prior to the emergence of the target plant species. Residential/ nonoccupational applications are made to residential lawns, parks, cemeteries, schools, athletic fields and golf courses. The frequency of application ranges from 1 to 3 applications per season. Oxadiazon can be applied at a minimum application rate of 2.0 pounds of active ingredient per acre up to a maximum application rate of 4.0 pounds active ingredient per acre to turf and ornamentals. Oxadiazon use sites are non­ food crops ( primarily golf course greens, 77% of all use), residential outdoor use ( approximately 12% of all use), roadside ( approximately 3% of all use) and nurseries ( approximately 8% of all use). The granular formulations account for 91% of the total oxadiazon use ( turf use). Table 3 represents information on registered use sites, products name, application rates, percent active ingredient and frequency of application per growing season for oxadiazon2. Application rate covers various type of equipment used to apply oxadiazon. Table 3: Use Patterns, Application Rate, and Frequency of Application for Oxadiazon Reg No A. I % Product Name Crop Type Max Appl rate No of Appl per/ y 10404­ 63 0.95 Lesco Turfic for Crabgrass with Ronstar G turf: golf course 4 lb ai/ acre 3 10404­ 63 0.95 Lesco Turfic for Crabgrass with RonstarG turf: ornamental 4 lb ai/ acre 3 10404­ 93 0.63 Ronstar Weed and Feed 63 G nursery: woody ornamental shrubs, vines and trees 4 lb ai/ acre 3 9 10404­ 93 0.63 Ronstar Weed and Feed 63 G nursery: woody ornamental shrubs, vines and trees 4 lb ai/ acre 3 10404­ 93 0.63 Ronstar Weed and Feed 63 G turf: golf course 4 lb ai/ acre 3 10404­ 93 0.63 Ronstar Weed and Feed 63 G turf: ornamental ( parks, athletic fields, recreational) 4 lb ai/ acre 3 10404­ 93 0.63 Ronstar Weed and Feed 63 G turf: sod farms 4 lb ai/ acre 3 264­ 445 2 Chipco Ronstar G nursery: conifer 4 lb ai/ acre 1 264­ 445 2 Chipco Ronstar G nursery: woody ornamentals, shrubs, vines and trees 4 lb ai/ acre 1 264­ 445 2 Chipco Ronstar G turf: golf course 4 lb ai/ acre 1 264­ 445 2 Chipco Ronstar G turf: lawns 4 lb ai/ acre 1 264­ 445 2 Chipco Ronstar G turf: ornamental ( parks) 4 lb ai/ acre 1 264­ 450 94 oxadiazon technical Formulating use only 264­ 502 50 Ronstar 50% Intermediate Formulating use only 264­ 538 50 Chipco Ronstar 50 WSP landscape: woody ornamental shrubs, vines and trees 2 lb ai/ acre 1 264­ 538 50 Chipco Ronstar 50 WSP nursery: conifer 4 lb ai/ acre 1 264­ 538 50 Chipco Ronstar 50 WSP nursery: woody ornamental shrubs, vines and trees 4 lb ai/ acre 1 264­ 538 50 Chipco Ronstar 50 WSP turf: golf course ( no tees and greens) 3 lb ai/ acre 3 264­ 538 50 Chipco Ronstar 50 WSP turf: ornamental ( parks) 3 lb ai/ acre 3 264­ 538 50 Chipco Ronstar 50 WSP turf: sod farms in HI 3 lb ai/ acre 3 34704­ 771 2 Napropamide­ Oxadiazon 4­ 2 Granules landscape: woody ornamental shurbs vines and trees 3 lb ai/ acre 34704­ 771 2 Napropamide­ Oxadiazon 4­ 2 Granules nursery: conifer 3 lb ai/ acre 34704­ 771 2 Napropamide­ Oxadiazon 4­ 2 Granules nursery: woody ornamental shurbs vines and trees 3 lb ai/ acre 35512­ 43 1 Turf Pride Fertilizer with Ronstar 5­ 20G turf: golf course 4 lb ai/ acre 1 35512­ 43 1 Turf Pride Fertilizer with Ronstar 5­ 20G turf: ornamental ( parks, athletic fields, recreational) 4 lb ai/ acre 1 35512­ 43 1 Turf Pride Fertilizer with Ronstar 5­ 20G turf: sod farms 4 lb ai/ acre 1 35512­ 44 1 RegalstarG turf: established 2 lb ai/ acre 1 35512­ 44 1 RegalstarG turf: golf course 2 lb ai/ acre 1 48234­ 1 1 RegalstarG turf: established 2 lb ai/ acre 1 48234­ 1 1 RegalstarG turf: golf course ( not greens) 2 lb ai/ acre 1 48234­ 10 1 Regal­ O­ Herbicide G landscape: woody ornamental shrubs, vines and trees 3 lb ai/ acre 48234­ 10 1 Regal­ O­ Herbicide G nursery: woody ornamentals shrubs, trees, vines 3 lb ai/ acre 48234­ 10 1 Regal Ronstar Plus I G nursery: woody ornamentals shrubs, trees, vines 4 lb ai/ acre 3 48234­ 10 1 Regal Ronstar Plus I G turf: golf course 4 lb ai/ acre 1 48234­ 10 1 Regal Ronstar Plus I G turf: ornamental 4 lb ai/ acre 1 48234­ 15 1 RegalStar II G landscape: woody ornamentals shrubs, trees, vines 2 lb ai/ acre 1 48234­ 15 1 RegalStar II G nursery: woody ornamentals shrubs, trees, vines 2 lb ai/ acre 1 48234­ 15 1 RegalStar II G turf: golf course 2 lb ai/ acre 1 48234­ 15 1 RegalStar II G turf: sod farms 2 lb ai/ acre 1 48234­ 2 2 Regal Ronstar Plus G landscape: woody ornamental shrubs, vines and trees 4 lb ai/ acre 1 48234­ 2 2 Regal Ronstar Plus G nursery: conifer 4 lb ai/ acre 1 48234­ 2 2 Regal Ronstar Plus G nursery: woody ornamental shrubs, vines and trees 4 lb ai/ acre 3 48234­ 2 2 Regal Ronstar Plus G turf: golf course 4 lb ai/ acre 1 48234­ 2 2 Regal Ronstar Plus G turf: ornamental ( parks) 4 lb ai/ acre 1 52287­ 1 0.95 Harrells Crabgrass Control with Ronstar G turf: golf course 4 lb ai/ acre 3 52287­ 1 0.95 Harrells Crabgrass Control with Ronstar G turf: ornamental 4 lb ai/ acre 3 52287­ 2 1.5 Harrells Ronstar 1.5 G turf: golf course 4 lb ai/ acre 3 52287­ 2 1.5 Harrells Ronstar 1.5 G turf: ornamental 4 lb ai/ acre 3 52287­ 3 0.67 Harrells Ronstar 0.67 with Fertilizer G turf: golf course 4 lb ai/ acre 3 52287­ 3 0.67 Harrells Ronstar 0.67 with FertilizerG turf: ornamental 4 lb ai/ acre 3 538­ 164 1.31 Scotts ProTurf Goosegrass/ Crabgrass Control 8656 turf: golf course ( fairways and greens) 0.75 538­ 164 1.31 Scotts ProTurf Goosegrass/ Crabgrass Control 8656 turf: golf course ( fairways and tees) 1.5 538­ 164 1.31 Scotts ProTurf Goosegrass/ Crabgrass Control 8656G turf: golf course ( greens) 1.5 538­ 164 1.31 Scotts ProTurf Goosegrass/ Crabgrass Control 8656 turf: ornamental 0.75 538­ 241 ~ 1 Scotts Turf Starter Plus G turf: golf course fairways 4 lb ai/ acre 1 538­ 241 ~ 1 Scotts Turf Starter Plus G turf: ornamental 4 lb ai/ acre 1 538­ 257 0.2 Scotts ­ ProTurf Fertilizer Plus Preemergent Weed Control II turf: golf course 4 lb ai/ acre 2 538­ 257 0.2 Scotts ­ ProTurf Fertilizer Plus Preemergent Weed Control II turf: ornamental 4 lb ai/ acre 2 55615­ 4 0.75 Wilbro Fertilizer with 0.75% Ronstar G turf: golf course 4 lb ai/ acre 1 55615­ 4 0.75 Wilbro Fertilizer with 0.75% Ronstar G turf: ornamental 4 lb ai/ acre 1 557­ 1966 0.69 ParEx Plus Ronstar G turf: golf course 4 lb ai/ acre 1 557­ 1966 0.69 ParEx Plus Ronstar G turf: ornamental ( parks) 4 lb ai/ acre 1 557­ 1974 1.5 ParEx Fertilizer Plus 1.5% RonstarG turf: golf course ( fairways) 4 lb ai/ acre 1 557­ 1974 1.5 ParEx Fertilizer Plus 1.5% Ronstar G turf: lawns ( but not home lawns) 4 lb ai/ acre 1 557­ 1974 1.5 ParEx Fertilizer Plus 1.5% Ronstar G turf: ornamental ( parks) 4 lb ai/ acre 1 557­ 2026 1 ParEx Fertilizer Plus 1% Ronstar G turf: golf course 4 lb ai/ acre 1 557­ 2026 1 ParEx Fertilizer Plus 1% Ronstar G turf: lawns 4 lb ai/ acre 1 10 557­ 2026 1 ParEx Fertilizer Plus 1% Ronstar G turf: ornamental 4 lb ai/ acre 1 67508­ 1 1 Ronstar 1% with Fertilizer G turf: golf course 4 lb ai/ acre 1 67508­ 1 1 Ronstar 1% with Fertilizer G turf: ornamental 4 lb ai/ acre 1 8660­ 17 1 Sta­ Green G turf: golf course 2.5 1 8660­ 17 1 Sta­ Green G turf: lawns 2.5 1 8660­ 36 1 Vertagreen Fertilizer with Ronstar G turf: golf course 4 lb ai/ acre 3 8660­ 36 1 Vertagreen Fertilizer with Ronstar G turf: ornamental 4 lb ai/ acre 3 9198­ 154 1 Andersons Fertilizer with 1% Ronstar and 0.125% Dimension G turf: golf course ( fairways and roughs) 4 lb ai/ acre 3 9198­ 154 1 Andersons Fertilizer with 0.125% Dimension and 1.0% Ronstar G turf: golf course ( fairways) 2 lb ai/ acre 3 9198­ 154 1 Andersons Fertilizer with 0.125% Dimension and 1.0% Ronstar G turf: golf course ( roughs) 1.5 3 9198­ 154 1 Andersons Fertilizer with 1% Ronstar and 0.125% Dimension G turf: lawns 4 lb ai/ acre 3 9198­ 154 1 Andersons Fertilizer with 1% Ronstar and 0.125% Dimension G turf: ornamental 4 lb ai/ acre 3 9198­ 75 1.38 Andersons Fertilizer with 1.38% Ronstar G turf: golf course ( fairways, tees) 4 lb ai/ acre 9198­ 75 1.38 Andersons Fertilizer with 1.38% Ronstar G turf: golf course( fairways and tees) 4 lb ai/ acre 9198­ 75 1.38 Andersons Fertilizer with 1.38% Ronstar G turf: lawns 4 lb ai/ acre 9198­ 75 1.38 Andersons Fertilizer with 1.38% Ronstar G turf: ornamental 4 lb ai/ acre 9198­ 75 1.38 Andersons Fertilizer with 1.38% Ronstar G turf: ornamental 4 lb ai/ acre 961­ 340 1.73 Lebanon Country Club with Ronstar G landscape: woody ornamentals, shrubs, vines 4 lb ai/ acre 3 961­ 340 1.73 Lebanon Country Club with Ronstar G nursery: conifer 4 lb ai/ acre 3 961­ 340 1.73 Lebanon Country Club with Ronstar G nursery: woody ornamentals shrubs, trees, vines 4 lb ai/ acre 3 961­ 340 1.73 Lebanon Country Club with Ronstar G turf: golf course 4 lb ai/ acre 1 961­ 340 1.73 Lebanon Country Club with Ronstar G turf: ornamental ( parks and gardens) 4 lb ai/ acre 1 961­ 371 0.5 Lebanon Country Club with Ronstar G turf: golf course 4 lb ai/ acre 961­ 371 0.5 Lebanon Country Club with Ronstar G turf: ornamental 4 lb ai/ acre CA­ 970018 50 Chipco Ronstar 50 WSP landscape: specific ornamental crops 3 lb ai/ acre NS CA­ 970018 50 Chipco Ronstar 50 WSP nursery: specific ornamental crops 3 lb ai/ acre NS FL­ 820045 2 Chipco Ronstar G leatherleaf ferns 2 lb ai/ acre NS HI­ 970001 2 Chipco Ronstar G turf: Lalo 3 lb ai/ acre 1 1.3 Methods and Types of Equipment Used for Mixing/ Loading/ Applying The following use patterns are associated with the application equipment: chemigation, groundboom, rights­ of­ way sprayer, handgun sprayer, tractor drawn spreader, backpack sprayer, low pressure handwand, high pressure handwand lawn handgun, belly grinder and push type spreader. ( aerial application was voluntarily canceled by the registrant) 1.4 Incident reports The following data bases have been consulted for the poisoning incident data on the active ingredient oxadiazon3. I. Incident Data System Please note that the following cases from the IDS do not have documentation confirming exposure or health effects unless otherwise noted. Incident# 6920­ 2 A pesticide incident occurred in 1998, when a man applied oxadiazon on a wet lawn. He reported nausea, headache, and difficulty breathing. No further information on the disposition of the case was reported. Incident# 7424­ 1 11 A pesticide incident occurred in 1998, when oxadiazon was sprayed onto landscaping at a large apartment complex. Several individuals reported congestion, sore throat, running eyes, and hoarseness. No further information on the disposition of the case was reported. Incident# 8383­ 1 A pesticide incident occurred in 1998, when a man used oxadiazon for two weeks on the landscape of several properties. He reported hives over his entire body area, itching, and a swollen face. He experienced a rash that lasted for twenty­ four hours. However, these effects only occurred on the last two days of use and may, instead, be a reaction to ibuprofen. He was seen by a physician. No further information on the disposition of the case was reported. Incident# 8383­ 2 A pesticide incident occurred in 1997, when an unknown person applied the product to grass around a home. A year and a half later, a man who has chronic fatigue syndrome, reported malaise. He now lives with his brother and reports developing acute symptoms whenever he returns to his home. No further information on the disposition of the case was reported. Incident# 8476­ 1 A pesticide incident occurred in 1999, when a golf course was treated. Several months later, a female employee reported respiratory irritation and muscle weakness. No further information on the disposition of the case was reported. Incident# 9413­ 1 A pesticide incident occurred in 1999, when a man mixed the product in his home and reported a seizure the next morning. Two days later he poured the chemical into a spreader and ten minutes later reported a seizure. This individual has a history of ongoing seizure and is taking medication for his condition. Physicians treating this case did not believe that the seizure were related to the pesticide exposure. No further information on the disposition of the case was reported. Incident# 10179­ 10 A pesticide incident occurred in 1996, when a teacher and his daughter reported headaches, dizziness, burning eyes and skin, coughing, sore throat and hoarseness after oxadiazon was applied to a school campus. No further information on the disposition of the case was reported. This same case is reported in the California data summary. No consistent pattern of ill effects was seen in this relatively small number of incidents. There was some evidence of irritative and allergic effects to the skin and respiratory system. II. Poison Control Center Data ­ 1993 through 1998 Results for the years 1993 through 1998 were acquired for 37 exposures to oxadiazon reported to Poison Control Centers. Cases involving exposures to multiple products are 12 excluded. Only 4 cases were reported among children under six years of age and six cases among older children and adults exposed at their workplace. This was too few cases to warrant detailed analysis. None of these cases reported a serious outcome and only one of the occupational cases had a moderate outcome. There were 27 non­ occupationally exposed cases among older children and adults. III. California Data ­ 1982 through 1996 Detailed descriptions of 31 cases submitted to the California Pesticide Illness Surveillance Program ( 1982­ 1996) were reviewed. In 26 of these cases, oxadiazon was used alone or was judged to be responsible for the health effects. Only cases with a definite, probable or possible relationship were reviewed. Oxadiazon ranked 84th as a cause of systemic poisoning in California based on data for 1982 through 1994. Category includes cases where skin, eye, or respiratory effects were also reported. IV. National Pesticide Telecommunications Network On the list of the top 200 chemicals for which NPTN received calls from 1984­ 1991 inclusively, oxadiazon was ranked 192nd with 12 incidents in humans reported and 5 incidents in animals ( mostly pets). 2.0 OCCUPATIONAL EXPOSURES 2.1 Handler Exposures & Assumptions iii. Handler Exposure Scenarios Exposure scenarios can be thought of as ways of categorizing the kinds of exposures that occur related to the use of a chemical. The use of scenarios as a basis for the exposure assessment is described in the U. S. EPA Guidelines For Exposure Assessment ( U. S. EPA; Federal Register Volume 57, Number 104; May 29, 1992). HED uses the term " Handlers" to describe those individuals who are involved in the pesticide application process. HED believes that there are distinct job functions or tasks related to applications and that exposures can vary depending on the specifics of each task. Job requirements ( e. g., amount of chemical to be used in an application), the kinds of equipment used, the crop or target being treated, and the circumstances of the user ( e. g., the level of protection used by an applicator) can cause exposure levels to differ in a manner specific to each scenario. HED has developed a series of general descriptions for tasks that are associated with pesticide applications. Tasks associated with pesticide use ( i. e., for " handlers") can generally be categorized using one of the following terms: 13 Occupational Mixer/ loaders: these individuals perform tasks in preparation for an application. For example, they would prepare dilute spray solutions and/ or load/ transfer solid materials ( e. g., granulars) or dilute spray solutions into application equipment such as a groundboom tractor or planter prior to application. Occupational Applicators: these individuals operate application equipment during the application of oxadiazon to registered sites. These individuals can make applications using equipment such as groundboom sprayers or tractor­ drawn spreaders for granular materials. Occupational Mixer/ loader/ applicators: these individuals are involved in the entire pesticide application process ( i. e., they do all job functions related to a pesticide application event). These individuals would prepare a dilute spray solution and then also apply the solution. HED always considers some exposures to be mixer/ loader/ applicator exposures because of the equipment used and the logistics associated with such applications. For example, if one uses a small handheld device such as a 1 gallon low pressure handwand sprayer it is anticipated that one individual will mix a spray solution and then apply the solution because of labor and logistical considerations. HED has determined that there are potential exposures to mixers, loaders, applicators, or other handlers during usual use­ patterns associated with oxadiazon. Based on the use patterns and potential exposures described above, 14 major exposure scenarios are identified in this document to represent the extent of oxadiazon uses. These scenarios include: mixing/ loading wettable powders for chemigation application ( 1a), mixing/ loading wettable powders for groundboom application ( 1b), mixing/ loading wettable powders for rights­ of­ way sprayer ( 1c), loading granular formulations ( 2), applying with a groundboom ( 3), applying with a rights­ of­ way sprayer ( 4), applying wettable­ powders for handgun applicators ( ORETF) ( 5), applying granular with a tractor drawn spreader ( 6), backpack sprayer ( LCO) ( 7), low pressure handwand­­ wettable powder formulations ( LCO) ( 8), high pressure handwand ­­ ( wettable powder formulations) ( 9), lawn handgun ( wettable powder formulations) ( ORETF) ( 10), granulars with a push type spreader ( ORETF) ( 11), granulars with a bellygrinder ( LCO) ( 12). In most cases, HED assesses the exposure and risk to mixer/ loaders and applicators separately for tractor drawn applications ( i. e. granular spreaders) in the RED chapter. This practice has evolved, not because it is believed that there are always separate job functions, but rather because of the limited amount of information regarding these practices along with limited exposure data. For occupational RED chapters process, HED has adopted a methodology to present the risks separately for some scenarios and combine others. Most of the hand­ held equipment such as backpack sprayers, and push type granular spreaders are assessed as a combined function. With these types of small operations the mixing, loading, and applying are almost always carried out by the same individual and there are data available to estimate exposure from these activities. 14 For equipment such as groundboom tractors, the applications is assessed separately from the individual who mixes and loads the formulated product. By separating the two job functions, HED can determine the most appropriate PPE or engineering control without requiring the handler to wear PPE throughout the entire workday or engineering controls that are not needed. 2.1.1 Summary of Occupational Handler Exposures Table 4 presents the exposure scenarios, application rates, and area ( i. e., acres ) potentially treated that have been used in the exposure calculations. Oxadiazon labels include a multitude of uses and a range of application rates. Chemical­ specific data for assessing human exposures during pesticide handling activities were not submitted to the Agency in support of the reregistration of oxadiazon. Consequently it is the policy of the HED to use data from the Pesticide Handlers Exposure Database ( PHED) 4 Version 1.1 to assess handler exposures for regulatory actions when chemical­ specific monitoring data are not available. PHED was designed by a task force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide regulation, and member companies of the American Crop Protection Association. PHED is a software system consisting of two parts ­­ a database of measured exposure values for workers involved in the handling of pesticides under actual field conditions and a set of computer algorithms used to subset and statistically summarize the selected data. Currently, the database contains values for over 1,700 monitored individuals ( i. e., replicates) Users select criteria to subset the PHED database to reflect the exposure scenario being evaluated. The subsetting algorithms in PHED are based on the central assumption that the magnitude of handler exposures to pesticides are primarily a function of activity ( e. g., mixing/ loading, applying), formulation type ( e. g., wettable powders, granulars), application method ( e. g., groundboom), and clothing scenarios ( e. g., gloves, double layer clothing). Once the data for a given exposure scenario have been selected, the data are normalized ( i. e., divided by) by the amount of pesticide handled resulting in standard unit exposures ( milligrams of exposure per pound of active ingredient handled). Following normalization, the data are statistically summarized. The distribution of exposure values for each body part ( e. g., chest upper arm) is categorized as normal, lognormal, or " other" ( i. e., neither normal nor lognormal). A central tendency value is then selected from the distribution of the exposure values for each body part. These values are the arithmetic mean for normal distributions, the geometric mean for lognormal distributions, and the median for all " other" distributions. Once selected, the central tendency values for each body part are composited into a " best fit" exposure value representing the entire body. The unit exposure values calculated by PHED generally range from the geometric mean to 15 the median of the selected data set. To add consistency and quality control to the values produced from this system, the PHED Task Force has evaluated all data within the system and has developed a set of grading criteria to characterize the quality of the original study data. The assessment of data quality is based on the number of observations and the available quality control data. These evaluation criteria and the caveats specific to each exposure scenario are summarized in TableA4. While data from PHED provide the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. HED has developed a series of tables of standard unit exposure values for many occupational scenarios that can be utilized to ensure consistency in exposure assessments. The method of risk assessment for adult non­ occupational/ residential handlers was essentially the same as that for occupational workers with similar application methods. The Residential SOPs ( 1997) and the Outdoor Residential Exposure Task Force ( ORETF ) study data were both used to estimate exposure and compared. After preliminary review by the Agency, the ORETF data was found to be equal or superior in quality to the data set from the Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( revised December 1999) currently used by the Agency. Some of these data may be combined, but they are used separately for this assessment. Table 4: Exposure Variables for Uses ofOxadiazon Exposure Scenario ( Scenario #) Crop Type Application Rates ( lb ai/ acre) a Daily Acres Treatedb Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3 350 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 4 40 herbaceous ornamentals 3 40 sod farms 3 80 golf courses 4 40 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 4 40 Loading Granular formulations ( 2) sod farms, conifers forest. 4 80 golf course turf, parks, recreational areas 4 40 woody ornamentals 4 40 Applicator Table 4: Exposure Variables for Uses ofOxadiazon Exposure Scenario ( Scenario #) Crop Type Application Rates ( lb ai/ acre) a Daily Acres Treatedb 16 Applying with a Groundboom ( 3) sod farms 3 80 herbaceous ornamentals 3 40 golf courses 4 40 conifer nurseries, woody ornamentals 4 40 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 4 40 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 4 5 Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 4 80 golf courses 4 40 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l a w n s , g o l f c o u r s e s , ornamentals nurseries 4 5 Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 4 5 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 4 5 Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 4 5 Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, r e c r e a t i o n a l a r e a s , ornamentals 4 5 Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 4 1 a Application rates are the maximum or range found on oxadiazon labels b Daily acres treated are based on HED's estimates of acreage that would be reasonably expected to be treated in a single day for each exposure scenario of concern. LCO = lawn care operators 2.1.2 Summary of Uncertainties The handler exposure assessments encompass all of the major uses of oxadiazon throughout the country. It is difficult to assess all of the " typical" uses ( i. e., actual or predominate application rates and farm sizes), and therefore, an assessment has been developed that is believed to be realistic and yet provides a reasonable certainty that the exposures are not underestimated. 17 Daily Dermal Exposure mg ai Day Dermal Unit Exposure mg ai lb ai Max. Appl. Rate lb ai Acre Max. Area Treated Acres Day Daily Inhalation Exposure mg ai day Unit Exposure g ai lb ai x Conversion Factor 1mg 1,000 g x Use Rate lb ai A x Daily Acres Treated A day The assumptions and uncertainties are identified below to be used in risk management decisions: Application Rates: The application rates are the maximum allowable that were identified on the available product labels. Amount Handled: The daily acres treated are HED standard values ( see Table 4). The values for groundboom applications in agriculture and on turf/ ornamentals vary. Groundboom applications in an agricultural setting are based on an 80 acre day because the Agency believes it would take 8 hours to complete that type of application with common equipment and that acreage estimate for various crops is reasonable. On the other hand, the value for groundboom applications on golfcourse turf is based on treating 40 acres because that is the value calculated to represent a 18 hole course ( they account for about 10% of all golf courses based on registrants comments and investigation by Agency personnel). The 40 acre value is not the maximum that can be treated on a single day given that the application equipment is likely capable of treating higher acreage. The daily limitation of 40 acres per day is based on the fact that an applicator would only treat a course a single time on any given day. 2.1.3 Calculations of Exposure Potential daily dermal exposure is calculated using the following formula: Potential daily inhalation exposure is calculated using the following formula: These calculations of potential daily exposure to oxadiazon by handlers are used to calculate the absorbed doses and total risk to those handlers ( see Occupational Risk section). 2.1.4 Calculation of Cancer Cancer risk assessments for handler used baseline exposure scenarios and, as needed, increasing levels of risk mitigation ( PPE and engineering controls) to achieve cancer risks that are not of concern. Tables B1 to B4 in Appendix B present total cancer risk calculations at baseline, with various PPE ( ie., single layer+ gloves and no respirator, double layer + gloves and no 18 Daily Dermal Exposure mg ai day Unit Exposure mg ai lb ai x Use Rate lb ai A x Daily Acres Treated A day Daily Inhalation Exposure mg ai day Unit Exposure g ai lb ai x Conversion Factor 1mg 1,000 g x Use Rate lb ai A x Daily Acres Treated A day Daily Inhalation Dose mg ai kg/ day Daily Inhalation Exposure mg ai day x 1 Body Weight ( kg) Daily Dermal Dose mg ai Kg/ Day Daily Dermal Exposure mg ai Day x 1 Body Weight ( Kg) x 0.09 Dermal Absorption Factor Total Daily Dose Daily Dermal Dose mg kg/ day
Daily Inhalation Dose mg kg/ day LADD mg kg/ day Daily Total Dose mg kg/ day x days worked 365 days per year x 35 years worked 70 year lifetime respirator, single layer+ gloves and respirator and double layer + gloves and respirator) and with engineering controls, respectively, for each exposure scenario. The calculations of daily dermal and inhalation exposure to oxadiazon by handlers were used to calculate the daily dose, and hence the risks, to those handlers. Potential daily dermal exposure was calculated using the following formula: Potential daily inhalation exposure was calculated using the following formula: The daily dermal and inhalation doses were calculated using a 70 kg body weight using the following formulas: The lifetime average daily dose ( LADD) was calculated using the following formula: T otal cancer risk was calculated using the following formula: 19 Total Cancer Risk LADD x Q1
where Q 1 * = 7.11x10­ 2 ( mg/ kg/ day)­ 1 The following assumptions and factors were used in order to complete this cancer risk assessment: The average body weight of 70 kg is used, representing a typical adult. Career duration is assumed to be 35 years. This represents a typical working lifetime. Lifetime is assumed to be 70 years. Dermal absorption is assumed to be 9 %, and inhalation absorption is assumed to be 100 percent of the oral dose. The dermal and inhalation doses were added together to represent total daily dose. The Q1* used in the cancer assessment was 7.11x10­ 2( mg/ kg/ day)­ 1 . Two exposure frequencies were used in the calculations, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). The Agency has defined a range of acceptable cancer risks based on a policy memorandum issued in 1996 by then office director, Dan Barolo. This memo refers to a predetermined quantified " level of concern" for occupational carcinogenic risk. In summary, this policy memo indicates occupational carcinogenic risks that are 1 x 10­ 6 or lower require no risk management action. For those chemicals subject to reregistration, the Agency is to carefully examine uses with estimated risks in the 10­ 6 to 10­ 4 range to seek ways of cost­ effectively reducing risks. If carcinogenic risks are in this range for occupational handlers, increased levels of personal protection would be warranted as is commonly applied with noncancer risk estimates ( e. g., additional PPE or engineering controls). Carcinogenic risks that remain above 1.0 x 10­ 4 at the highest level of mitigation appropriate for that scenario remain a concern. 2.2 Risk From Handler Exposures Using the daily dermal exposure scenarios identified in the exposure section, EPA calculated the potential risk to persons from handler exposures and post­ application exposures to oxadiazon. 20 Daily Inhalation Dose mg ai kg/ day Daily Inhalation Exposure mg ai day x 1 Body Weight ( kg)  1 ( 100%) Daily Dermal Dose mg ai kg/ Day Daily Dermal Exposure mg ai Day x 1 Body Weight ( kg)  0.09 ( 9%) MOE NOAEL mg kg/ day Dermal Daily Dose mg kg/ day MOE NOAEL mg kg/ day Inhlation Daily Dose mg kg/ day Potential dermal and inhalation daily exposures for occupational handlers were calculated using the following formulas ( 9% dermal absorption was assumed): The daily dermal and inhalation doses were calculated using a 60 kg body weight using the following formulas: The MOEs were calculated using the following formulas: A total MOE is also calculated because there is a common endpoint. The uncertainty factor of 100 is applied to all routes and exposure durations. Route specific data are available for the dermal and oral routes, and therefore, the following reciprocal MOE calculation is used: 1/(( 1/ Dermal MOE) + ( 1/ Inhalation MOE) 2.2.1 Risk From Handler Exposures Handler exposure assessments are completed by EPA using a baseline exposure scenario and, if required, increasing levels of risk mitigation ( PPE and engineering controls) to achieve a margin of exposure of 100 for dermal and inhalation exposure or cancer risk of 1.0x 10­ 4 to 1.0x 10­ 6. Appendix A presents the short­ term and intermediate term MOE calculations for baseline exposure plus the risk mitigation measures of personal protective equipment ( PPE) and engineering controls using data from PHED and ORTEF for the uses of oxadiazon. Aventis is a member of the ORETF so there are no data compensation issues associated with the use of this data. Appendix B Tables B1 to B4 presents the cancer risk calculations for baseline exposure plus the risk mitigation measures of personal protective equipment ( PPE) and engineering 21 controls. EPA calculated the baseline MOE ( short­ term and intermediate­ term) and cancer for each of the exposure scenarios using the following baseline PPE assumptions: $ all occupational handlers are wearing footwear ( socks plus shoes or boots). $ occupational mixers and loaders using open mixing techniques are wearing longsleeved shirts, long pants, and no gloves. $ occupational applicators use open cab tractor­ driven application equipment. $ occupational handlers ( mixers, loaders, and applicators) who use hand­ held application equipment are wearing long­ sleeve shirts, long pants, and no gloves. If the baseline short­ term or intermediate­ term MOE calculated using this baseline PPE was 100 or greater ( since the NOAEL is based on data from animal studies) for an exposure scenario, then no further calculations were made. If the baseline short­ term or intermediate­ term MOE was less than 100 for any exposure scenario, an additional short­ term or intermediate­ term MOE was calculated based on increasing the level of PPE over the baseline PPE. HED calculated the additional PPE short­ term or intermediate­ term MOE for each occupational exposure scenario with a baseline total MOE of less than 100, using the following additional PPE assumptions: $ all occupational handlers are wearing footwear ( socks plus shoes or boots) $ occupational mixers and loaders using open mixing techniques are wearing longsleeved shirts and long pants and gloves; this represents minimum PPE $ occupational mixers and loaders using open mixing techniques are wearing longsleeved shirts and long pants, coveralls and gloves; this represents maximum PPE $ occupational applicators who use open cab tractor­ driven application equipment $ Also, if necessary, dust/ mist respirator represented by 5­ fold protection factor or an organic vapor respirator represented by a 10­ fold protection factor are added to mitigate the risks. If the additional­ PPE short­ term or intermediate­ term MOE calculated using this additional­ PPE was 100 or greater ( the NOAEL is based on data from animal studies) for an exposure scenario, then no further calculations were made. If the additional­ PPE short­ term or intermediate­ term MOE remained less than 100 for any occupational exposure scenario, an addition short­ term or intermediate­ term MOE was calculated based on mandatory use of engineering controls where feasible. Engineering controls are not available for occupational handlers ( mixers, loaders, and applicators) who use hand­ held application equipment. HED calculated the engineering­ control short­ term or intermediate­ term MOE for each occupational exposure scenario with an additional­ PPE short­ term or intermediate­ term MOE of less than 100, using the following engineering control assumptions: $ all occupational handlers are wearing footwear ( socks plus shoes or boots). $ occupational mixers and loaders handling liquid formulations using a closed system 22 are wearing chemical­ resistant gloves plus long­ sleeved shirts and long pants. $ occupational mixers and loaders handling wettable powders using a closed system ( water­ soluble packages) are wearing long­ sleeved shirts and long pants, and chemical­ resistant gloves. $ occupational applicators who use tractor­ driven application equipment are located in enclosed cabs are wearing long­ sleeved shirts and long pants, and no gloves. 2.2.2 Summary of Handler MOEs and Cancer Table 5 summarizes the numeric MOE values for both the short­ and intermediate­ term exposure durations. The MOEs are presented for baseline, PPE and engineering controls. Cancer values also summarized in Table 6 at different levels of mitigation. Baseline for non­ cancer assessment represents long pants, long sleeved shirts and no gloves or respirator, PPE dermal unit exposure represents long pants, long shirts and gloves for scenarios 5, 7, 9 and long pants, long shirts gloves and double layer ( 50% protection) for scenarios 1a, 1b, 1c, and 8. PPE inhalation unit exposure represents dust/ mist respirator ( 80 % protection) for scenarios 1a, 1b, 1c, and 8. Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages for scenario 1a. The results of the short and intermediate­ term handler assessments indicate that all potential exposure scenarios provide at least one application rate with a total MOE( s) greater than or equal to 100 at either the baseline ( i. e., long pants, long sleeved shirts, no gloves) using open systems, PPE ( i. e., long pants, long sleeved shirts, and chemical resistant gloves while using open systems) or using engineering controls ( i. e., closed systems). In the majority of cases, it is dermal exposure rather than the inhalation exposure driving the total MOEs. In total, 37 MOEs were calculated for the various application rates. The total MOEs for all the scenarios range from 2 to 3000. The results of the Cancer Risk indicate that the values range from 1.65E­ 2 to 4.66E­ 7 at the baseline ( long pants, long shirts and no gloves), 2.56E­ 3 to 4.11E­ 7 at PPE1 ( long pants, long shirts, gloves and no respirator), 2.40E­ 3 at PPE2 ( long pants, long shirts, double layer, gloves and no respirator), 1.05E­ 3 to 1.98E­ 7 at PPE3 ( long pants, long shirts, gloves and respirator), 8.90E­ 4 to 1.38E­ 07 at PPE4 ( long pants, long shirts, double layer, gloves and respirator) and 9.92E­ 5 to 1.10E­ 8 at engineering control. Table 5: Exposure Variables, MOEs for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop Type App Rates ( lb ai/ acre) Daily Acres Treated Dermal MOEs Inhalation MOEs Base line PPE Eng. Control Base line PPE En Con Mixer/ Loader Table 5: Exposure Variables, MOEs for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop Type App Rates ( lb ai/ acre) Daily Acres Treated Dermal MOEs Inhalation MOEs Total MOEs Base line PPE Eng. Control Base line PPE Eng. Control Base line PPE Eng. Control 23 Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3 350 2 59 gl, dl 780 wsp 16 80 resp 2900 2 35 610 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 4 40 14 380 gl, dl NA 100 520 resp NA 12 220 NA herbaceous ornamentals 3 40 18 510 gl, dl NA 140 700 resp NA 16 300 NA sod farms 3 80 9 260 gl, dl NA 70 350 resp NA 8 150 NA golf courses 4 40 14 380 gl, dl NA 100 520 resp NA 12 220 NA Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) r o a d s i d e t u r f , ornamentals 4 40 14 380 gl, dl NA 100 520 resp NA 12 220 NA Loading Granular formulations ( 2) so d f a rms , coni fer s forest 4 80 3000 NA NA 1300 NA NA 920 NA NA golf course turf, parks, recreational areas 4 40 6000 NA NA 2600 NA NA 1800 NA NA woody ornamentals 4 40 6000 NA NA 2600 NA NA 1800 NA NA Applicator Applying with a Groundboom ( 3) sod farms 3 80 2400 NA NA 4100 NA NA 1500 NA NA herbaceous ornamentals 3 40 4800 NA NA 8100 NA NA 3000 NA NA golf courses 40 3600 NA NA 6100 NA NA 2300 NA NA conifer nurseries, woody ornamentals 4 40 3600 NA NA 6100 NA NA 2300 NA NA Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 4 40 38 130 NA 1200 1200 NA 37 120 NA Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) l a w n s , p a r k s , recreational areas 4 5 See PPE 550 gl NA 36000 36000 NA See PPE 540 NA Table 5: Exposure Variables, MOEs for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop Type App Rates ( lb ai/ acre) Daily Acres Treated Dermal MOEs Inhalation MOEs Total MOEs Base line PPE Eng. Control Base line PPE Eng. Control Base line PPE Eng. Control 24 Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 4 80 2500 NA NA 1900 NA NA 1100 NA NA golf courses 4 40 5100 NA NA 3800 NA NA 2200 NA NA Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l awns, gol f courses, ornamentals nurseries 4 5 See PPE 160 gl NA 1200 1200 NA See PPE 140 NA Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 4 5 14 65 gl, dl NF 33 160 resp NF 10 46 NF High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 4 5 See PPE 160 gl NA 300 300 NA See PPE 100 NA Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 4 5 560 NA NA 580 NA NA 280 NA NA Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, recreational areas, ornamentals 4 5 1100 NA NA 4800000 NA NA 1100 NA NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 4 1 200 NA NA 2900 NA NA 190 NA NA Baseline dermal unit exposure scenarios includes long pants, long shirts and no gloves. . Baseline inhalation unit exposure represents no respirator PPE dermal unit exposure includes long pants, long shirts and gloves for scenarios5, 7, and 9. PPE dermal unit exposure includes long pants, long shirts gloves and double layer ( 50% protection) for scenarios 1a, 1b, 1c, and 8. PPE inhalation unit exposure represents dust/ mist respirator ( 80 % protection) for scenarios 1a, 1b, 1c, and 8. Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages for scenario 1a. Engineering inhalation unit exposure represents no respirator NA = Not applicable NF= not feasible gl = gloves dl = double layer wsp = water soluble packages resp = dust mist respirator 25 Table 6: Exposure Variables, Cancer for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop/ Target Appl Rates ( lb ai/ acre) Daily Acres Treated Cancer Base line PPE 1 PPE 2 PPE 3 PPE 4 Eng. Control Mixer/ Loader Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3 350 1.65e­ 03/ 1.65e­ 02 2.56e­ 04/ 2.56e­ 03 2.40e­ 04/ 2.40e­ 03 1.05e­ 04/ 1.05e­ 03 8.90e­ 05/ 8.90e­ 04 4.92e­ 06/ 4.92e­ 05 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 herbaceous ornamentals 3 40 1.88e­ 04/ 1.88e­ 03 2.92e­ 05/ 2.92e­ 04 2.74e­ 05/ 2.74e­ 04 1.20e­ 05/ 1.20e­ 04 1.02e­ 05/ 1.02e­ 04 5.62e­ 07/ 5.62e­ 06 sod farms 3 80 3.77e­ 04/ 3.77e­ 03 5.84e­ 05/ 5.84e­ 04 5.48e­ 05/ 5.48e­ 04 2.39e­ 05/ 2.39e­ 04 2.03e­ 05/ 2.03e­ 04 1.12e­ 06/ 1.12e­ 05 golf courses 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 4 40 2.51e­ 04/ 2.51e­ 03 3.89e­ 05/ 3.89e­ 04 3.65e­ 05/ 3.65e­ 04 1.60e­ 05/ 1.60e­ 04 1.36e­ 05/ 1.36e­ 04 7.49e­ 07/ 7.49e­ 06 Loading Granular formulations ( 2) sod farms, conifers forest 4 80 3.28e­ 06/ 3.28e­ 05 3.10e­ 06/ 3.10e­ 05 2.68e­ 06/ 2.68e­ 05 1.28e­ 06/ 1.28e­ 05 8.63e­ 07/ 8.63e­ 06 2.20e­ 08/ 2.20e­ 07 golf course turf, parks, recreational areas 4 40 1.64e­ 06/ 1.64e­ 05 1.55e­ 06/ 1.55e­ 05 1.34e­ 06/ 1.34e­ 05 6.42e­ 07/ 6.42e­ 06 4.31e­ 07/ 4.31e­ 06 1.10e­ 08/ 1.10e­ 07 woody ornamentals 4 40 1.64e­ 06/ 1.64e­ 05 1.55e­ 06/ 1.55e­ 05 1.34e­ 06/ 1.34e­ 05 6.42e­ 07/ 6.42e­ 06 4.31e­ 07/ 4.31e­ 06 3.29e­ 08/ 3.29e­ 07 Applicator Applying with a Groundboom ( 3) sod farms 3 80 2.00e­ 06/ 2.00e­ 05 2.00e­ 06/ 2.00e­ 05 1.73e­ 06/ 1.73e­ 05 1.41e­ 06/ 1.41e­ 05 1.14e­ 06/ 1.14e­ 05 4.94e­ 07/ 4.94e­ 06 herbaceous ornamentals 3 40 1.00e­ 06/ 1.00e­ 05 1.00e­ 06/ 1.00e­ 05 8.67e­ 07/ 8.67e­ 06 7.06e­ 07/ 7.06e­ 06 5.71e­ 07/ 5.71e­ 06 2.47e­ 07/ 2.47e­ 06 golf courses 4 40 1.34e­ 06/ 1.34e­ 05 1.34e­ 06/ 1.34e­ 05 1.16e­ 06/ 1.16e­ 05 9.42e­ 07/ 9.42e­ 06 7.61e­ 07/ 7.61e­ 06 3.29e­ 07/ 3.29e­ 06 Table 6: Exposure Variables, Cancer for Uses of Oxadiazon Exposure Scenario ( Scenario #) Crop/ Target Appl Rates ( lb ai/ acre) Daily Acres Treated Cancer Base line PPE 1 PPE 2 PPE 3 PPE 4 Eng. Control 26 conifer nurseries, woody ornamentals 4 40 1.34e­ 06/ 1.34e­ 05 1.34e­ 06/ 1.34e­ 05 1.16e­ 06/ 1.16e­ 05 9.42e­ 07/ 9.42e­ 06 7.61e­ 07/ 7.61e­ 06 3.29e­ 07/ 3.29e­ 06 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 4 40 8.07e­ 05/ 8.07e­ 04 2.60e­ 05/ 2.60e­ 04 2.00e­ 05/ 2.00e­ 04 2.40e­ 05/ 2.40e­ 04 1.80e­ 05/ 1.80e­ 04 NA Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 4 5 See PPE 5.57e­ 06/ 5.57e­ 05 2.94e­ 06/ 2.94e­ 05 5.50e­ 06/ 5.50e­ 05 2.87e­ 06/ 2.87e­ 05 NA Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 4 80 9.31e­ 07/ 9.31e­ 06 8.23e­ 07/ 8.23e­ 05 7.03e­ 07/ 7.03e­ 06 3.95e­ 07/ 3.95e­ 06 2.75e­ 07/ 2.75e­ 06 1.82e­ 07/ 1.82e­ 06 golf courses 4 40 4.66e­ 07/ 4.66e­ 06 4.11e­ 07/ 4.11e­ 06 3.51e­ 07/ 3.51e­ 06 1.98e­ 07/ 1.98e­ 06 1.38e­ 07/ 1.38e­ 06 9.11e­ 08/ 9.11e­ 07 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l a w n s , g o l f c o u r s e s , ornamentals nurseries 4 5 See PPE 2.13e­ 05/ 2.13e­ 04 1.45e­ 05/ 1.45e­ 04 1.93e­ 05/ 1.93e­ 04 1.25e­ 05/ 1.25e­ 04 NA Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 4 5 3.10e­ 04/ 3.10e­ 03 1.56e­ 04/ 1.56e­ 03 1.38e­ 04/ 1.38e­ 03 8.30e­ 05/ 8.30e­ 04 6.50e­ 05/ 6.50e­ 04 NA High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 4 5 See PPE 1.88e05/ 1.88e­ 04 1.20e­ 05/ 1.20e­ 04 1.98e­ 05/ 1.98e­ 04 1.31e­ 05/ 1.31e­ 04 NA Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 4 5 1.06e­ 05/ 1.06e­ 04 1.06e­ 05/ 1.06e­ 04 8.03e­ 06/ 8.03e­ 05 6.44e­ 06/ 6.44e­ 05 3.89e­ 06/ 3.89e­ 05 NA Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, recreational areas, ornamentals 4 5 2.33e­ 06/ 2.33e­ 05 1.80e­ 06/ 1.80e­ 05 No data 1.80e­ 06/ 1.80e­ 05 No data NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 4 1 1.61e­ 05/ 1.61e­ 04 1.50e­ 05/ 1.50e­ 04 9.60e­ 06/ 9.60e­ 05 1.42e­ 05/ 1.42e­ 04 8.77e­ 06/ 8.77e­ 05 NA Baseline dermal unit exposure scenarios includes long pants, long shirts and no gloves. PPE 1 cancer risk includes long pants, long shirts, gloves and no respirator. PPE 2 cancer risk includes long pants, long shirts, double layer, gloves and no respirator. PPE 3 cancer risk includes long pants, long shirts, gloves and respirator. PPE 4 cancer risk includes long pants, long shirts, double layer, gloves and respirator. Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages. Engineering inhalation unit exposure represents no respirator. 27 Two exposure frequencies were used for cancer, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). NA= Not applicable 3.0 POSTAPPLICATION EXPOSURES 3.1 Postapplication Exposure & Assumption HED uses the term " post­ application" to describe those individuals who can be exposed to pesticides after entering areas previously treated with pesticides and performing certain tasks or activities ( also often referred to as reentry exposure). Most of the oxadiazon used in agriculture is applied either pre­ plant or when the crops are quite small ( early post­ emergence). This fact, and the degree of mechanization, minimizes the postapplication contact of workers with oxadiazon. However, The Agency has determined that there are potential postapplication exposures to individuals re­ entering oxadiazon treated areas for the purpose of: ° Roadsides: mowing ° Bermuda grass rights­ of­ way: mowing ° Sod farms: mowing and harvesting ° Golf­ course turfgrass: mowing 3.1.1 Data Source and Assumptions for Scenario Considered Although two transferable turf residues ( TTR) studies ( MRID# 449955­ 01and 449955­ 02) and one Jazzercize study ( MRID# 435178­ 01) were submitted in support of the reregistration of oxadiazon, only the Jazzercize study found to be acceptable for this assessment. The TTR studies were reviewed and found to have TTR transfer efficiencies of less than1% ( transfer efficiency = % of the application rate). TTR data generated by ORETF members rely on a modified version of the California roller ( ORETF roller) that appears to have a much lower transfer efficiency ( percent of application rate) than the original version. Many TTR data submitted by ORETF members show percent transferabilities of less than 1% of the application rate for sprayable formulations and less than 0.5% of the application rate for granular formulations. ORD has conducted a round robin test of TTR methods that included the ORETF roller ( Fortune 1997). While ORD concluded that the ORETF roller performed the best of all methods, transfer efficiency for three liquid herbicide formulations indicated a transfer efficiency of ~ 0.5%. The ORETF data was not used with the revised Transfer Coefficients referenced in current residential SOP since these revised TCs are based on TTR transfer efficiencies of ~ 1­ 5% ( transfer efficiency = % of the application rate). Therefore the TTR values from these studies are not included in this assessment. The Jazzercize study ( MRID # 435178­ 01) was reviewed and found to be acceptable for this assessment. MRID 435178­ 01. Evaluation of Turf Re­ entry Exposure to a Broadcast Application of Ronstar ® 50 WP, L. Rosenheck ( 1995). Pan­ Agricultural Labs, Inc. Number: 93293 Unpublished study prepared by Rhone Poulenc AG Company. 300 pages. 28 This study on turf­ transferable residues ( TTR) was submitted by Rhone Poulenc Ag Company, in response to an occupational/ residential exposure Data Call­ In, and in support of oxadiazon re­ registration requirements. Ronstar ® 50 WP a wettable powder product containing ~ 50 % oxadiazon, was applied to turf in North Carolina. The study was conducted in order to quantify the dermal exposure associated with re­ entry onto oxadiazon treated turf. Ronstar ® 50 WP which is labeled for use on dormant, Bermuda grass, St. Augustine grass and Zoisia turf in areas such as fairways, parks, and lawns was used at a maximum label rate of 3 .0 lb ai/ A. Two different exposure scenarios were monitored: a) Application at the maximum label rate followed by re­ entry as soon as the turf was dry. b) Application within 30 minuted by sprinkler irrigation of 1/ 10 inch of water with re­ entry occurring as soon as the turf is dry. Overall, the study met most criteria of the OPPTS Post­ application Exposure Monitoring Test Guidelines, 875.2100, Transferable Residue Dissipation: Lawn and Turf. Most of the field samples returned results that were < LOQ for oxadiazon,. No LOD value was defined in the study, however. The overall mean recovery for field fortification samples of oxadiazon ranged between 64.7 to 99.6%. On Day 0, the highest average turf­ transferable residues ( TTR) for non­ irrigated plot was 1.22 µ g per cm 2 and 0.694 µ g per cm 2 on irrigated plot. The TTR values adjusted for an application rate of 4.0 lb ai/ A. The TTR value from the above study utilized a wettable powder formulation which by far has a higher potential for exposure than the oxadiazon granular formulations. Since 91% of the total use involves granular formulations, using wettable powder TTR values is a conservative approach and can be considered the upper level estimates of exposure. A linear regression to calculate a dissipation rate ( T ½ ) for oxadiazon TTR from irrigated and non­ irrigated test sites was performed, using all non­ zero, uncorrected, averaged data point from DAT­ 0 through DAT­ 7. Calculated dissipation half­ lives for the irrigated plot was 1.7days ( R2= 0.64) and for the non­ irrigated plot was 1.4 days ( R2= 0.64) 3.1.2 Assumptions Used in Postapplication Exposure Calculations Based on data submitted for reregistration, the most common postapplication exposures will occur for workers on turf. Based on label restrictions and pattern of use, oxadiazon is applied early in the season, either pre­ plant or before weeds emerge ( pre­ emergence). Mowing would be a common postapplication activity after either spraying method. Treated turf or grasses will routinely require reentry activities, such as mowing and watering, and eventually harvesting in the case of sod farms. Because oxadiazon has a low vapor pressure ( 1.0 x 10­ 6mm Hg) and is only used outdoors, the inhalation component of postapplication exposure is anticipated to be negligible. Therefore, all calculations of postapplication risk estimates have been done for dermal exposure only. Postapplication exposure via the inhalation route is considered to be negligible. 29 Dose ( mg/ kg/ d) ( DFR ( g/ cm 2) x Tc ( cm 2/ hr) x CF 1 mg 1,000 g x Abs x ED ( hrs/ day)) BW MOE NOAEL ( mg/ kg/ day) Dose ( mg/ kg/ day) 3.1.3 Exposure and Risk Calculations Short­ and intermediate­ term daily absorbed doses and MOEs were calculated as follows: Where: DFR = daily DFR, as calculated above for the assumed average reentry day Tc = transfer coefficient; CF = conversion factor ( i. e., 1 mg/ 1,000 g) Abs = dermal absorption ( 9%) ED = exposure duration; 8 hours worked per day BW = body weight ( 60 kg) Dermal MOEs were calculated as follows: Where: NOAEL = 12 mg/ kg/ day for short­ term and intermediate­ term Dose = calculated absorbed dermal dose For the purposes of occupational risk assessments, the following residue values were chosen: ° For short­ term and intermediate­ term postapplication turf activities, the Residential SOP standard 5% of the amount ai applied is used, along with standard transfer coefficients ( updated 8/ 2000). 3.1.4 Postapplication Exposure Risk Estimates For turf or sod mowing and harvesting, transfer coefficients of 500 and 16,500 cm2/ hr were used, based on the ARTF data ( see HED Exposure SAC Policy guidance 3.1, 8/ 00). As shown in Table C1, short and intermediate ­ term exposure had an estimated MOEs of 30­ 1,000. Similarly occupational post application cancer risks were estimated to fall within the acceptable range of 1 x 10­ 4 to 1 x 10­ 6. Residential SOP standard value of 5% of application rate used.( see Appendix C, Table C1) 3.2 Non­ Occupational Postapplication Exposures and Risk Estimates 30 The Agency has determined that there are potential postapplication exposures to residents entering oxadiazon treated lawns, either as a result of commercial or private application. 3.2.1 Postapplication Exposure Scenarios The scenarios likely to result in postapplication exposures are presented below. The duration of postapplication dermal exposure is expected to be either short­ term or intermediate­ term, based on oxadiazon turf residue dissipation data. As calculated from the previously discussed Jazzercise study ( MRID # 435178­ 01), oxadiazon has a half­ life on turf of up to 1.4 days ( irrigated) and 1.7 days ( non­ irrigated) after spraying, requiring several days to dissipate to non detectable levels of transferable residues. Because the label prohibits application more than 3 times per year, and even with the slow dissipation rates, it is not expected that individual residential exposure duration would exceed 30 days in duration. Exposure on a residential lawn would diminish continuously with time, while exposure through recreation turf contact would be more like random intermittent events of varying doses, all less than the dose predicted in this assessment. The resulting risk estimates are summarized in Tables C2 ( non­ cancer) and C3 ( cancer). Residential postapplication exposure assessments assumed residents wear the following attire: short sleeved shirt, short pants, shoes and socks, and no gloves or respirator. As stated in the occupational postapplication risk section of this document, negligible oxadiazon inhalation exposure is anticipated for non­ handlers, due to low chemical vapor pressure and dilution of vapor outdoors. The scenarios likely to result in postapplication exposures are as follows: ° dermal postapplication risks to adults and toddlers when entering oxadiazon treated turf and lawns; ° oral postapplication risks to toddlers from " hand­ to­ mouth" ( i. e., ingestion of grass, soil, granular pellets, or hand­ to­ mouth contact) exposure when reentering lawns treated with granular and wettable powder formulations. Representative turf reentry activities include, but are not limited to: ( 1) Adults involved in a low exposure activity, such as golfing or walking on treated turf. ( 2) Toddlers involved in a low exposure activity, such as walking on treated turf. ( 3) Adults mowing or other moderate contact activity, for 1­ 2 hours. ( 4) Adults involved in a high exposure activity, such as heavy yard work ( doses similar to occupational scenarios for cutting and harvesting sod). ( 5) Toddlers involved in high exposure activities on turf. 3.2.2 Data Sources for Scenarios Considered A turf re­ entry exposure study ( Jazzercise study), using a spray application, was described in the Occupational Postapplication exposure section of this document. As the study was found to be acceptable for the risk assessment, the highest mean residues were also used to estimate short­ term ( DAT 0­ 1) for irrigated and non­ irrigated plots. 31 Only limited information was received regarding the size and distribution of granular formulations. This information would help to refine or characterize the estimate of potential risk from episodic incidental ingestion of granules beyond the current screening level. If the particles are very fine, individual grains would be difficult to pick up, or even to see when applied on a lawn. If used according to label directions, it is unlikely that oxadiazon granules would be accessible to a child. However, larger granules or pellets of a few millimeters diameter might be attractive and easily picked up by a toddler. 3.2.3 Assumptions Used in Postapplication Exposure Calculations Dermal Exposure to Golf Course Turfgrass According to a 1992 report from The Center For Golf Course Management, 12.2 percent of the population are golfers ( i. e., 28.5 million people). Golfing is considered a lifetime sport so individuals of all ages, excluding very small children, routinely play. Children who are 12 years of age or older are likely to represent the vast majority of the youth that play golf on any sort of routine basis. However, the popularity of golf as a recreational pastime has increased steadily over the last few years which has resulted in more and more young children ( i. e., less than 12 years old for this discussion) becoming involved in the sport. Risk assessments for these age children are more difficult to complete because of the increased uncertainties associated with any extrapolations using adult dermal exposure data and because of the increased likelihood that other behaviors that might contribute to exposure such as mouthing contaminated hands or golf balls. Dermal exposures are calculated using the standard transfer coefficient approach that is used for postapplication exposure assessments. ADD( t) ( mg/ kg/ day) = (( TTR( t) ( g/ cm2) x TC ( cm2/ hr) x ET( hr/ day) x ( 1 mg/ 1000 g) )/( BW ( kg)) Where: ADD= average daily dose ( mg/ kg/ day) at time ( t) attributable to golfing on previously treated turf ( mg/ kg/ day); TTR( t)= turf transferable residue at time ( t) ( g/ cm2); TC = transfer coefficient ( cm2/ hour); ET = exposure duration ( hours); and BW = body weight ( kg). ° Duration is 4 hours for a chemical that can be used on all parts of a course ( greens, tees, and fairways). This estimate of the average time it takes to play a round of golf which is based on the report completed by the Center For Golf Course Management [ 1992 Golf Course Operations: Cost of Doing Business/ Profitability. Library of Congress GV975. G56 1992]. ° The dose levels calculated for adult golfers can be considered upper level estimates of exposure because of several reasons including the clothing scenario considered ( i. e., shorts and short­ sleeved shirts are not worn by all golfers), combining average values across several 32 input parameters mathematically results in an upper percentile calculated product. ° Children of various ages down to the very young ( e. g., 4 or 5 years old) are currently playing golf, the agency recognize this but has not yet developed a quantitative approach for calculating their risk, based to analysis of surface area to body weight ratio it appears that the dose for these children may be as much as 1.7 times than for adults. Dermal Exposure values on each day after application were calculated based on the following equation ( see Residential 2.2 ( 1997): Postapplication dermal potential dose from pesticide residues on turf): DE( t) ( mg/ day) = ( TTR( t) ( g/ cm2) x TC ( cm2/ hr) x Hr/ Day)/ 1000 ( g/ mg) Where: DE = Dermal exposure at time ( t) attributable for activity in a previously treated area ( mg/ day); TTR = Turf Transferable Residue at time ( t) where the longest duration ( t) is dictated by the kinetics observed in the TTR study; TC = Transfer Coefficient; and Hr = Exposure duration in hours. The activities that were selected as the basis for the risk assessment are represented by the following transfer coefficients ( for short­ term and intermediate­ term endpoints): ° Transfer Coefficient = 500 cm2/ hour for adults involved in a low exposure activity on turf such as golfing or light work activities; based on Policy Memo # 003 .1 " Agricultural Transfer Coefficients," Revised ­ August 7, 2000.. ° Transfer Coefficient = 14,500 cm2/ hour for adults involved in a high exposure activity on turf such as heavy yard work; Based on the revised residential SOP ­ February 2001 ° Transfer Coefficient = 5200 cm2/ hour for toddler involved in a high exposure activity on turf such as heavy yard work; Based on the revised residential SOP ­ February 2001 ° Transfer Coefficient = 7,400 cm2/ hour ( non­ irrigated) for adults involved in a high exposure activity on turf such as heavy yard work; Based on the submitted re­ entry study ( MRID # 435178­ 01) ° Transfer Coefficient = 4,300 cm2/ hour ( irrigated) for adults involved in a high exposure activity on turf such as heavy yard work; Based on the submitted re­ entry study ( MRID # 435178­ 01) and ° Transfer Coefficient = 2,700 cm2/ hour ( non­ irrigated) for toddlers involved in a high exposure activity. Based on the submitted re­ entry study ( MRID # 435178­ 01) ° Transfer Coefficient = 1,600 cm2/ hour ( irrigated) for toddlers involved in a high exposure activity. Based on the submitted re­ entry study ( MRID # 435178­ 01) ° Transfer Coefficient = 16,500 cm2/ hour for sod harvesting ( hand or mechanical); based on Policy Memo # 003 .1 " Agricultural Transfer Coefficients," Revised ­ August 7, 2000. 33 PDR ( DFR
SA
Freq
Hr
( 1mg/ 1000 g)) The Agency's Residential SOPs contains guidance for considering children's exposure to treated turf. The dermal calculations, as noted above, were completed based on the guidance provided in the document. All nondietary exposures were also calculated using guidance from this document. Specifically, the kinds of nondietary exposures that were considered in this assessment include the following: ° Dose from hand to mouth activity calculated using Residential SOP 2.3.2: Postapplication potential dose among toddlers from incidental nondietary ingestion of pesticide residues on residential lawns from hand­ to­ mouth transfer. ° Dose from mouthing treated turf calculated using Residential SOP 2.3.3: Postapplication potential dose among toddlers from the ingestion of pesticide treated turfgrass; and ° Dose from incidental ingestion of soil calculated using Residential SOP 2.3.4: Postapplication potential dose among toddlers from the ingestion of soil in pesticide treated areas. Although incidental exposures incurred by hand­ to­ mouth exposure are included as part of the nondietary risk assessment, these type of exposures are considered episodic in nature. The hand­ licking, mouthing of turf, and eating of soil are considered more likely to co­ occur, with the hand­ licking constituting the largest incidental oral exposure component. The following demonstrates the method used to calculate exposures that are attributable to a child touching treated turf and then putting their hands in their mouth ( SOP 2.3.2): where: PDR = potential dose rate ( mg/ day) DFR( t)= Dislodgeable Residue ( 5%) on day of treatment ( g/ cm2); SA = surface area of two fingers ( cm2); Freq = frequency of hand­ to­ mouth events ( events/ hour); and Hr = exposure duration ( hours). As indicated above, the dislodgeable foliar residue represents the amount of pesticide that can be removed from turf by the ( potentially wet) hands of a child, while the turf transferable residue represents the amount of chemical on the surfaces of treated leaves that can rub off on dry skin or clothing. These observations are based on empirical data, and therefore the Residential SOP standard 5% of the amount ai applied is used, rather than the data from the TTR study. The surface area for 1­ 3 fingers used ( 20 cm2) is the median surface area for a toddler ( age 3 years) as updated by the SAP in 12/ 99. The frequency of hand­ to­ mouth events is 20 events per hour as updated in 12/ 99. The 2 hour duration value is a recommended value from the U. S. EPA Exposure Factors Handbook. This model for hand­ to­ mouth dose is based on the premise that a child puts 2­ 3 fingers in their mouths, 50% of the residues on the hands are transferred from the hands to the mouth, and that all of the dislodgeable residues available on the treated turf transfer to the child's 34 PDR ( DFR
IgR
( 1mg/ 1000 g)) hand each time they exhibit this behavior. The following illustrates the approach used to calculate exposures that are attributable to a child mouthing treated turf ( SOP 2.3.3): where: PDR = potential dose rate ( mg/ day); DFR( t)= Dislodgeable Foliar Residue ( DFR) at time ( t) where the longest duration ( t) is dictated by the kinetics observed in the TTR study ( g/ cm2); and IgR= ingestion rate for mouthing of grass per day ( cm2/ day). The ingestion rate used ( 25 cm2/ day) assumes that a child will grab a handful of turf, mouth it and remove all oxadiazon residues, and then remove it from their mouth as described in the Residential SOPs. The standard time period is 2 hours, as explained above. The surface area of ( 25 cm2/ day) is thought to approximate a handful of turf that is mouthed. The maximum average TTR values were used for this scenario. Incidental Soil Ingestion: PDR = ( SR t * IgR * CF1) where: PDR = potential dose rate ( mg/ day) SR t = soil residue on day " t" ( g/ g), assuming average day of reentry " t" is day 0 IgR = ingestion rate of soil ( mg/ day), assumed to be 100 mg/ day CF1 = weight unit conversion factor to convert the g of residues on the soil to grams to provide units of mg/ day ( 1E­ 6 g/ g) and SR t = AR * F * ( 1­ D) t * CF2 * CF3 * CF4 where: AR = application rate ( lb ai/ acre) F = fraction of ai available in uppermost cm of soil ( fraction/ cm), assumed to be 100 percent based on soil incorporation into top 1 cm of soil after application D = fraction of residue that dissipates daily ( unitless) t = postapplication day on which exposure is being assessed CF2 = weight unit conversion factor to convert the lbs ai in the application rate to g for the soil residue value ( 4.54 x 108 g/ lb) CF3 = area unit conversion factor to convert the surface area units ( ft2) in the application rate to cm2 for the SR value ( 2.47 x 10­ 8 acre/ cm2 if the application rate is per acre) 35 CF4 = volume to weight unit conversion factor to convert the volume units ( cm3) to weight units for the SR value ( 0.67 cm3/ g soil) t = postapplication day on which exposure is being assessed, assumed to be day zero The following specific assumptions and factors were used in order to complete this exposure assessment: These assessments were based on the guidance provided in the Residential SOPs. Several of the assumptions and factors used in the exposure assessment are described in that document. The TTR values are assumed to be 5 percent of the application rate at day 0 for turfgrass application ( the 5 percent rate for turfgrass is the high end of the values observed in Hurto and Prinster, 1993, Goh et al., 1986, and Cowell et al., 1993, Calculations are completed at the maximum application rates recommended by the available oxadiazon labels to bracket risk levels associated with the various use patterns and activity scenarios. Due to a lack of scenario­ specific exposure data, HED has calculated exposure values for adults using surrogate dermal transfer coefficients that represent activities such as mowing, golfing, and yard work. Most of the transfer coefficients used are based on data submitted by the ARTF and ORETF and are reflected in the revised HED exposure guidance Policy 3.1 ( 8/ 2000). ° For the short­ and intermediate­ term risk assessment, the equations and assumptions used for each of the scenarios were taken from the Residential SOPs guidance document. ° Adults were assumed to weigh 60 kg for the short and intermediate­ term postapplication dermal dose estimate. Toddlers ( 3 years old) were assumed to weigh 15 kg. ° Postapplication exposure is generally assessed on the same day the pesticide is applied because it is assumed that the resident could be exposed to turf immediately after application. ° A dermal absorption factor of 9 % was used in the calculation of short and intermediate­ term postapplication dermal dose. MOEs were calculated using the same formula ( NOAEL divided by absorbed dermal dose) described in the residential handler portion of this chapter, and are considered to be below the level of concern when results are greater than 100. 3.2.4 Postapplication Exposure Risk Estimates 36 Using the revised residential SOP postapplication short­ and intermediate­ term dermal risk estimates for occupational workers are between 30 and 1,000. The cancer risk for all occupational handlers is between 9.92 x 10­ 5 to 3.01 x 10­ 6. Dermal postapplication exposure estimates were conducted using the highest mean postapplication residue from the Jazzercise study( wettable powder formulations). The dermal transfer coefficients from the Jazzercize study and the revised residential SOPs were used. Using the Jazzercize wettable powder application study residue data and revised residential SOPs , all of the scenario had short­ term and intermediate­ term dermal MOEs greater than 100 on the application day ( i. e., day 0). The cancer risks for all residential dermal postapplication is between 6.22x 10­ 6 to 7.51 x 10­ 7 . The Residential SOPs and submitted Jazzercize study data were used to estimate incidental oral exposure for toddlers on treated turf. The short­ term MOE was100 for the toddler hand­ tomouth using residential SOPs and between 90 to 240 for the submitted Jazzercize study, however since wettable powder formulation has a higher exposure than granular formulation, therefore the MOE, s can be considered upper level estimates of exposure. The intermediate­ term MOE was not calculated since exposure by this route for weeks to months is considered less likely to occur than short­ term exposure. Incidental turfgrass mouthing and soil ingestion had MOEs greater than 100 for short­ term exposures ( see Appendix C Table C4). Under the Worker Protection Standard ( WPS), interim restricted entry intervals ( REI) for all uses within the scope of the WPS are based on the acute toxicity of the active ingredient. The toxicity categories of the active ingredient for acute dermal toxicity, eye irritation potential, and skin irritation potential are used to determine the interim WPS REI. If one or more of the three acute toxicity effects are in toxicity category I, the interim WPS REI is established at 48 hours. If none of the acute toxicity effects are in category I, but one or more of the three is classified as category II, the interim WPS REI is established at 24 hours. If none of the three acute toxicity effects are in category I or II, the interim WPS REI is established at 12 hours.( all of the three oxadiazon acute toxicity effects are in category III) 3.2.5 Data Gaps and Uncertainties The following data gap or uncertainties were associated with this assessment: ° Granular ingestion is considered episodic, rather than continuous, in nature. 37 APPENDIX A SHORT­ TERM AND INTERMEDIATE­ TERM HANDLER EXPOSURE RISK TABLES A1 THROUGH A4 38 Table A1: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at Baseline Exposure Scenario ( Scenario #) Crop type Baseline Dermal Baseline Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 3.7 5.8 2.0 43 0.75 16 2 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.89 14 0.11 100 12 herbaceous ornamentals 0.67 18 0.086 140 16 sod farms 1.3 9 0.17 70 8 golf courses 0.89 14 0.11 100 12 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.89 14 0.11 100 12 Loading Granular formulations ( 2) sod farms, conifers forest 0.0084 0.004 3000 1.7 0.0091 1300 920 golf course turf, parks, recreational areas 0.002 6000 0.0045 2600 1800 woody ornamentals 0.002 6000 0.0045 2600 1800 Applicator Applying with a Groundboom ( 3) sod farms 0.014 0.005 2400 0.74 0.003 4100 1500 herbaceous ornamentals 0.0025 4800 0.0015 8100 3000 golf courses 0.0034 3600 0.002 6100 2300 conifer nurseries, woody ornamentals 0.0034 3600 0.002 6100 2300 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 1.3 0.31 38 3.9 0.01 1200 37 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas See PPE See PPE See PPE 1 0 36000 See PPE Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 0.0099 0.0048 2500 1.2 0.0064 1900 1100 golf courses 0.0099 0.0024 5100 1.2 0.0032 3800 2200 Table A1: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at Baseline Exposure Scenario ( Scenario #) Crop type Baseline Dermal Baseline Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf 39 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries See PPE See PPE See PPE 30 0.01 1200 See PPE Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 29 0.87 14 1100 0.37 33 10 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. See PPE See PPE See PPE 120 0.04000 300 See PPE Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 0.99 0.022 560 62 0.021 580 280 Granulars with a Push Type Spreader ( ORETF) ( 11) l awn s , g o l f c o u r s e s , p a r k s , recreational areas, ornamentals 0.35 0.011 1100 0.0075 2.50e­ 06 4800000 1100 Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 10 0.06 200 62 0.0041 2900 190 a Baseline dermal unit exposure scenarios includes long pants, long shirts and no gloves. b Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day)/ Body weight ( 60 kg)* Dermal Absorption Factor ( 9%) . c Short­ term or Intermediate­ term Dermal MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Dermal Dose ( mg/ kg/ day). d Baseline inhalation unit exposure represents no respirator e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day)/ Body weight ( 60 kg). f Short­ term or Intermediate­ term Inhalation MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Inhalation Dose ( mg/ kg/ day). g Total Dermal MOE = 1/ (( 1/ Dermal MOE) + ( 1/ Inhalation MOE)). 40 Table A2: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at PPE Exposure Scenario ( Scenario #) Crop type PPE Dermal PPE Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 0.13 ( gl, dl) 0.2 59 8.6 dust/ mist respirator 0.15 80 35 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.031 380 0.023 520 220 herbaceous ornamentals 0.023 510 0.017 700 300 sod farms 0.047 260 0.034 350 150 golf courses 0.031 380 0.023 520 220 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.031 380 0.023 520 220 Loading Granular formulations ( 2) sod farms, conifers forest NA NA NA NA NA NA NA golf course turf, parks, recreational areas NA NA NA NA NA woody ornamentals NA NA NA NA NA Applicator Applying with a Groundboom ( 3) sod farms NA NA NA NA NA NA herbaceous ornamentals NA NA NA NA NA golf courses NA NA NA NA NA conifer nurseries, woody ornamentals NA NA NA NA NA Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 0.39 ( gl) 0.094 130 3.9 ( no resp) 0.01 1200 120 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 0.73 ( gl) 0.022 550 1.0 ( no resp) 0.00030 36000 540 Applying Granular with a Tractor Drawn Spreader ( 6) sod farms NA NA NA NA NA NA NA golf courses NA NA NA NA NA NA NA Table A2: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at PPE Exposure Scenario ( Scenario #) Crop type PPE Dermal PPE Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf 41 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries 2.5 ( gl) 0.075 160 30 ( no resp) 0.01 1200 140 Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 6.2 ( gl dl) 0.19 65 220 dust/ mist resp 0.073 160 46 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 2.5 ( gl) 0.075 160 120 ( no resp) 0.040 300 100 Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas NA NA NA NA NA NA NA Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, recreational areas, ornamentals NA NA NA NA NA NA NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. NA NA NA NA NA NA NA a PPE dermal unit exposure includes long pants, long shirts and gloves for scenarios 5, 7, and 9. PPE dermal unit exposure includes long pants, long shirts gloves and double layer ( 50% protection) for scenarios 1a, 1b, 1c, and 8. b Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day)/ Body weight ( 60 kg)* Dermal Absorption Factor ( 9%) . c Short­ term or Intermediate­ term Dermal MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Dermal Dose ( mg/ kg/ day). d PPE inhalation unit exposure represents dust/ mist respirator for scenarios 1a, 1b, 1c, and 8. e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day)/ Body weight ( 60 kg). f Short­ term or Intermediate­ term Inhalation MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Inhalation Dose ( mg/ kg/ day). g Total Dermal MOE = 1/ (( 1/ Dermal MOE) + ( 1/ Inhalation MOE)). NA= Not applicable 42 Table A3: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at Engineering Control Exposure Scenario ( Scenario #) Crop type PPE Dermal PPE Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf Mixer/ Loader Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 0.0098 ( water soluble Packages) 0.015 780 0.24 0.00420 2900 610 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals NA NA NA NA NA herbaceous ornamentals NA NA NA NA NA sod farms NA NA NA NA NA golf courses NA NA NA NA NA Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals NA NA NA NA NA Loading Granular formulations ( 2) sod farms, conifers forest NA NA NA NA NA NA NA golf course turf, parks, recreational areas NA NA NA NA NA woody ornamentals NA NA NA NA NA Applicator Applying with a Groundboom ( 3) sod farms NA NA NA NA NA NA herbaceous ornamentals NA NA NA NA NA golf courses NA NA NA NA NA conifer nurseries, woody ornamentals NA NA NA NA NA Applying with a Rights­ of­ Way Sprayer ( 4) roadsides NA NA NA NA NA NA NA Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas NA NA NA NA NA NA NA Applying Granular with a Tractor Drawn Spreader ( 6) sod farms NA NA NA NA NA NA NA Table A3: Occupational Handler Short­ term and Intermediate­ term Risk from Oxadiazon at Engineering Control Exposure Scenario ( Scenario #) Crop type PPE Dermal PPE Inhalation Total MOEg Unit Exposure ( mg/ lb ai) a Daily Dose ( mg/ kg/ day) b Dermal MOEc Unit Exposure ( ug/ lb ai) d Daily Dose ( mg/ kg/ day) e Inhalation MOEf 43 golf courses NA NA NA NA NA NA NA Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries NA NA NA NA NA NA NA Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock NF NF NF NF NF NF NF High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. NA NA NA NA NA NA NA Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas NA NA NA NA NA NA NA Granulars with a Push Type Spreader ( ORETF) ( 11) l awns, gol f c o u r s e s , p a rk s, recreational areas, ornamentals NA NA NA NA NA NA NA Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. NA NA NA NA NA NA NA a Engineering Control dermal unit exposure scenarios includes long pants, long shirts, gloves and water soluble packages for scenario 1a. b Daily Dermal Dose ( mg/ kg/ day) = Daily Dermal Exposure ( mg/ day)/ Body weight ( 60 kg)* Dermal Absorption Factor ( 9%) . c Short­ term or Intermediate­ term Dermal MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Dermal Dose ( mg/ kg/ day). d inhalation unit exposure represents no respirator e Daily Inhalation Dose ( mg/ kg/ day) = Daily Inhalation Exposure ( mg/ day)/ Body weight ( 60 kg). f Short­ term or Intermediate­ term Inhalation MOE = NOAEL ( 12 mg/ kg/ day)/ Daily Inhalation Dose ( mg/ kg/ day). g Total Dermal MOE = 1/ (( 1/ Dermal MOE) + ( 1/ Inhalation MOE)). NA = Not applicable NF = Not feasible 44 Table A4 : Exposure Scenario Descriptions for the Use of Oxadiazon Exposure Scenario # Data Source Standard Assumptionsa ( 8­ hr work day) Commentsb Mixer/ Loader Descriptors Mixing/ Loading Wettable Powder Formulations ( 1a/ 1b/ 1c) PHED V1.1 350 acres for chemigation, 80 acres for groundboom in sod farms, 40 acres for groundboom on golf course turf, 5 acres/ day for the turf loading scenarios Baseline: Hands, dermal and inhalation = ABC grades. Hands = 7 replicates, dermal = 22­ 45 replicates and inhalation = 44 replicates. Low confidence in dermal, hands data due to the low number of hand replicates. Medium confidence in inhalation data. PPE: Gloved data for hands = ABC grades. Hands = 24 replicates. Medium confidence in hands data. Dermal values calculated by applying a 50% protection factor to baseline values to account for an additional layer of clothing. A 5­ fold PF ( e. g. 80% PF was applied to the baseline inhalation data). Engineering Controls: Water soluble bags. Dermal = AB grades. Hands and inhalation = All grade. Inhalation = 15 replicates, dermal = 6­ 15 replicates and hands = 5 replicates. Low confidence in the dermal, hands and inhalation data. Loading Granular Formulations ( 2) PHED V1.1 80 acres for tractor drawn spreaders for most crops; 40 acres for golf course turf Baseline: Low confidence in dermal and hand data ( due to low hand replicates). High confidence in inhalation data. No protection factors were needed to define the unit exposure values. Applicator Descriptors Groundboom Application ( 3) PHED V1.1 80 acres for tractor drawn spreaders for sod farms; 40 acres for golf course turf Baseline: Dermal ( 23 to 42 replicates); hand ( 29 replicates); and inhalation ( 22 replicates) exposure values are based on AB grade data. High confidence in the unit exposure values. No protection factors were required to define the unit exposure value. Applying Liquids with Rights­ of­ Way Sprayer ( 4) PHED V1.1 40 acres Baseline: Dermal ( 4 to 20 replicates) exposure value is based on ABC grade data. Hand ( 16 replicates) exposure value based on AB grade data and inhalation ( 16 replicates) exposure value is based on A grade data. Low confidence in the dermal unit exposure value and high confidence in the inhalation data. No protection factors were needed to define the unit exposure value. PPE: The same dermal and inhalation data are used as for the baseline coupled, if needed, with a 50% protection factor to account for an additional layer of clothing and an 80% protection factor to account for the use of a dust/ mist respirator. Gloved­ hand ( 4 replicates) exposure value is based on AB grade data. Low confidence in the dermal/ hand unit exposure value. Engineering Controls: Not available for this scenario. Applying Liquids with a Handgun ( 5) ( ORTEF) ORTEF 5 acres Baseline: Inhalation ( 90 replicates) exposure value is based on B grade data. PPE: Hand ( 90 replicates) and dermal ( 90 replicates) exposure values are based on B grade data. Engineering Controls: Not available for this scenario Applying Granulars with a Tractor Drawn Spreader ( 6) PHED V1.1 40 acres for golf course turf Baseline: Low confidence in hand, dermal, and inhalation data. No protection factors were required to define the unit exposure values. Mixer/ Loader/ Applicator Descriptors Table A4 : Exposure Scenario Descriptions for the Use of Oxadiazon Exposure Scenario # Data Source Standard Assumptionsa ( 8­ hr work day) Commentsb 45 Mixing/ Loading/ Applying with a Backpack Sprayer ( 7) PHED V1.1 5 acres for occupational uses Baseline: Only low confidence inhalation data available ( no non­ gloved hand monitoring data are available, therefore the assessment was not completed). PPE: Low confidence single layer clothing dermal monitoring data available, coupled with a 50% protection factor to account for an additional layer of clothing. Inhalation data coupled with a 90% protection factor to account for the use of a respirator. Hand exposure data with gloves were monitored ( considered low confidence). Engineering Controls: Not feasible Mixing/ Loading/ Applying Liquids with a Low Pressure Handwand ( 8) PHED V1.1 5 acres for occupational uses Baseline: Dermal and inhalation data = ABC grades, and hands data = All grade. Dermal = 9­ 80 replicates; hands = 70 replicates; and inhalation = 80 replicates. Low confidence in hands, dermal data. Medium confidence in inhalation data. PPE and Engineering Controls: Not required for assessment. Mixing/ Loading/ Applying with a High Pressure Handwand ( 9) PHED V1.1 5 acres Baseline: Only low confidence inhalation data available ( no non­ gloved hand monitoring data are available, therefore the assessment was not completed). PPE: Low confidence single layer clothing dermal monitoring data available, coupled with a 50% protection factor to account for an additional layer of clothing. Inhalation data coupled with a 90% protection factor to account for the use of a respirator. Hand exposure data with gloves were monitored ( considered low confidence). Engineering Controls: Not feasible Mixing/ Loading/ Applying with a Handgun ( turf grass application) ( 10) ORTEF 5 acres for occupational uses. Data for open mixing of liquids and handgun turfgrass application were combined to generate mixer/ loader/ applicator value as this is the most likely exposure scenario. Baseline for application: Low confidence in hand, dermal, and inhalation data. Baseline dataset was based on the use of chemical­ resistant gloves. Therefore, a reverse 80% PF was used on the gloved hand data to assess baseline exposure for individuals wearing no gloves ( i. e., it is a typical use scenario demanding a baseline assessment and the exposures are generally lower compared with other handheld methods). PPE for applicator: As appropriate, the same dermal, hand, and inhalation data are used as for the baseline coupled with a 50% protection factor to account for an additional layer of clothing and a 80% protection factor to account for the use of a respirator. Hand exposure data with gloves were monitored ( considered low confidence). Engineering Controls: Not feasible. Mixing/ Loading/ Applying with a Push­ Type Granular Spreader ( 11) ORTEF 5 acres for occupational uses. Baseline: Low confidence in the dermal and hand data. High confidence in the inhalation data. No protection factors were required to define the unit exposure values ( a 50 percent protection factor was used to back calculate the homeowner exposure scenario). Mixing/ Loading/ Applying with a Bellygrinder ( 12) PHED V1.1 5 acres for occupational uses. Baseline: Medium confidence in hand and dermal data. High confidence in inhalation data. No protection factors were required to define the unit exposure values ( also applies to homeowner scenarios). a All Standard Assumptions are based on a typical work day ( the components that involve pesticide use) as estimated by HED. b All handler exposure assessments in this document are based on the " Best Available" data as defined by the PHED SOP for meeting Subdivision U Guidelines ( i. e., completing exposure assessments). Best available grades are assigned to data as follows: matrices with A and B grade data ( i. e., Acceptable Grade Data) and a minimum of 15 replicates; if not available, then grades 46 A, B and C data and a minimum of 15 replicates; if not available, then all data regardless of the quality ( i. e., All Grade Data) and number of replicates. Generic data confidence categories are assigned as follows: High = grades A and B and 15 or more replicates per body part Medium = grades A, B, and C and 15 or more replicates per body part Low = grades A, B, C, D and E or any combination of grades with less than 15 replicates. Protection factors applied to exposure data for the use of respiratory protection, protection afforded with the use of an additional layer of clothing, and protection from the use of chemical resistant gloves are as follows: 90 % ( respirator); 50 % ( layer of clothing); and 90% ( gloves). 47 APPENDIX B OCCUPATIONAL HANDLER CANCER ( Q*) RISKS TABLES B1 ­ B4 48 Table B1: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at baseline Exposure Scenario # Crop Type Total Baseline Daily Dose ( mg/ kg/ day) a Baseline Daily LADDb 3/ 30 days Baseline Riskc Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 5.600 2.30e­ 02/ 2.30e­ 01 1.65e­ 03/ 1.65­ 02 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.860 3.50e­ 03/ 3.5e­ 02 2.51e­ 04/ 2.51e­ 03 herbaceous ornamentals 0.640 2.60e­ 03/ 2.60e­ 02 1.88e­ 04/ 1.88e­ 03 sod farms 1.300 5.30e­ 03/ 5.30e­ 02 3.77e­ 04/ 3.77e­ 03 golf courses 0.860 3.50e­ 03/ 3.50e­ 02 2.51e­ 04/ 2.51e­ 03 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.860 3.50e­ 03/ 3.50e­ 02 3.14e­ 05/ 3.14e­ 04 Loading Granular formulations ( 2) sod farms, conifers forest 0.011 4.60e­ 04/ 4.60e­ 03 3.28e­ 06/ 3.28e­ 05 golf course turf, parks, recreational areas 0.0056 2.30e­ 05/ 2.30e­ 04 1.64e­ 06/ 1.64e­ 05 woody ornamentals 0.0056 2.30e­ 05/ 2.30e­ 04 1.64e­ 06/ 1.64e­ 05 Applicator Applying with a Groundboom ( 3) sod farms 0.007 2.80e­ 05/ 2.80e­ 04 2.00e­ 06/ 2.00e­ 05 herbaceous ornamentals 0.003 1.40e­ 05/ 1.40e­ 04 1.00e­ 06/ 1.00e­ 05 golf courses 0.005 1.90e­ 05/ 1.90e­ 04 1.34e­ 06/ 1.34e­ 05 conifer nurseries, woody ornamentals 0.005 1.90e­ 05/ 1.90e­ 04 1.34e­ 06/ 1.34e­ 05 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 0.280 1.10e­ 03/ 1.10e­ 02 8.07e­ 05/ 8.07e­ 04 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas See PPE See PPE See PPE/ Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 0.010 1.30e­ 05/ 1.30e­ 04 9.31e­ 07/ 9.31e­ 06 golf courses 0.005 6.50e­ 06/ 6.50e­ 05 4.66e­ 07/ 4.66e­ 06 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries See PPE See PPE See PPE Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 1.060 4.40e­ 03/ 4.40e­ 02 3.10e­ 04/ 3.10e­ 03 Table B1: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at baseline Exposure Scenario # Crop Type Total Baseline Daily Dose ( mg/ kg/ day) a Baseline Daily LADDb 3/ 30 days Baseline Riskc 49 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. See PPE See PPE See PPE Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 0.036 1.50e­ 04/ 1.50e­ 03 1.06e­ 05/ 1.06e­ 04 Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, recreational areas, ornamentals 0.008 3.30e­ 05/ 3.30e­ 04 2.33e­ 06/ 2.33e­ 05 Granulars with a Bellygrinder ( LCO) ( 12) golf courses, parks, rec areas. 0.055 2.30e­ 04/ 2.30e­ 03 1.61e­ 05/ 1.61e­ 04 a Baseline Total Daily Dose = [ Baseline Daily Dermal Exposure ( mg/ day) * Dermal absorption factor ( 9%) + Baseline Daily Inhalation Exposure ( mg/ day)]/ Body Weight ( 70 kg). b Baseline LADD ( mg/ kg/ day) = Baseline Total Daily Dose ( mg/ kg/ day) * ( Number of days exposed per year) / 365 days per year) * 35 years worked/ 70 year lifetime. c Baseline Total Cancer Risk = Baseline LADD ( mg/ kg/ day) * ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. Baseline cancer risk includes long pants, long shirts no gloves and no respirator. Two exposure frequencies were used for cancer, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). 50 Table B2: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at PPE Exposure Scenario # Crop Type Total PPE 1 Daily Dose ( mg/ kg/ day) a PPE 1 LADDb 3/ 30 days PPE 1 Riskc Total PPE 2 Daily Dose ( mg/ kg/ day) a PPE 2 LADDb 3/ 30 days PPE2 Riskc Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 0.870 3.58e­ 03/ 3.58e­ 02 2.56e­ 04/ 2.56e­ 03 0.82 3.37e­ 01/ 3.37e­ 02 2.40e­ 04/ 2.40e­ 03 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.130 5.48e­ 04/ 5.48e­ 03 3.89e­ 05/ 3.89e­ 04 0.130 5.14e­ 4/ 5.14e­ 03 3.65e­ 05/ 3.65e­ 04 herbaceous ornamentals 0.100 4.11e­ 04/ 4.11e­ 03 2.92e­ 05/ 2.92e­ 04 0.094 3.85e­ 04/ 3.85e­ 03 2.74e­ 05/ 2.74e­ 04 sod farms 0.200 8.22e­ 04/ 8.22e­ 03 5.84e­ 05/ 5.84e­ 04 0.190 7.71e­ 04/ 7.71e­ 03 5.48e­ 05/ 5.48e­ 04 golf courses 0.130 5.48e­ 04/ 5.48e­ 03 3.89e­ 05/ 3.89e­ 04 0.130 5.14e­ 04/ 5.14e­ 04 3.65e­ 05/ 3.65e­ 04 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.130 5.48e­ 04/ 5.48e­ 03 3.89e­ 05/ 3.89e­ 04 0.016 5.14e­ 04/ 5.14e­ 03 4.57e­ 06/ 4.57e­ 04 Loading Granular formulations ( 2) sod farms, conifers forest 0.011 4.36e­ 05/ 4.36e­ 04 3.10e­ 06/ 3.10e­ 05 0.009 3.77e­ 05/ 3.77e­ 04 2.68e­ 06/ 2.68e­ 05 golf course turf, parks, recreational areas 0.005 2.18e­ 05/ 2.18e­ 04 1.55e­ 06/ 1.55e­ 05 0.0046 1.88e­ 05/ 1.88e­ 04 1.34e­ 06/ 1.34e­ 05 woody ornamentals 0.005 2.18e­ 05/ 2.18e­ 04 1.55e­ 06/ 1.55e­ 05 0.0046 1.88e­ 05/ 1.88e­ 04 1.34e­ 06/ 1.34e­ 05 Applicator Applying with a Groundboom ( 3) sod farms 0.007 2.82e­ 05/ 2.82e­ 04 2.00E­ 06/ 2.00e­ 05 0.0059 2.44e­ 05/ 2.44e­ 04 1.73e­ 06/ 1.73e­ 05 herbaceous ornamentals 0.003 1.41e­ 05/ 1.41e­ 04 1.00e­ 06/ 1.00e­ 05 0.003 1.22e­ 05/ 1.22e­ 04 8.67e­ 07/ 8.67e­ 06 golf courses 0.005 1.88e­ 05/ 1.88e­ 04 1.34e­ 06/ 1.34e­ 05 0.004 1.63e­ 05/ 1.63e­ 04 1.16e­ 06/ 1.16e­ 05 conifer nurseries, woody ornamentals 0.005 1.88e­ 05/ 1.88e­ 04 1.34e­ 06/ 1.34e­ 05 0.004 1.63e­ 05/ 1.63e­ 04 1.16e­ 06/ 1.16e­ 05 Table B2: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at PPE Exposure Scenario # Crop Type Total PPE 1 Daily Dose ( mg/ kg/ day) a PPE 1 LADDb 3/ 30 days PPE 1 Riskc Total PPE 2 Daily Dose ( mg/ kg/ day) a PPE 2 LADDb 3/ 30 days PPE2 Riskc 51 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 0.890 3.66e­ 04/ 3.66e­ 03 2.60e­ 05/ 2.60e­ 04 0.069 2.82e­ 04/ 2.82e­ 03 2.00e­ 05/ 2.00e­ 04 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 0.019 7.83e­ 05/ 7.83e­ 04 5.57e­ 06/ 5.57e­ 05 0.010 4.13e­ 05/ 4.13e­ 04 2.94e­ 06/ 2.94e­ 05 Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 0.008 1.16e­ 05/ 1.16e­ 04 8.23e­ 07/ 8.23e­ 05 0.0072 9.88e­ 06/ 9.88e­ 05 7.03e­ 07/ 7.03e­ 06 golf courses 0.004 5.79e­ 06/ 5.79e­ 05 4.11e­ 07/ 4.11e­ 06 0.0036 4.94e­ 06/ 4.94e­ 05 3.51e­ 07/ 3.51e­ 06 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries 0.073 2.99e­ 04/ 2.99e­ 03 2.13e­ 05/ 2.13e­ 04 0.05 2.04e­ 04/ 2.04e­ 03 1.45e­ 05/ 1.45e­ 04 Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 0.540 2.20e­ 03/ 2.20e­ 03 1.56e­ 04/ 1.56e­ 03 0.47 1.95e­ 03/ 1.95e­ 02 1.38e­ 04/ 1.38e­ 03 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 0.064 2.64e­ 04/ 2.64e­ 03 1.88e­ 05/ 1.88e­ 04 0.041 1.69e­ 04/ 1.69e­ 03 1.20e­ 05/ 1.20e­ 04 Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 0.036 1.49e­ 04/ 1.49e­ 03 1.06e­ 05/ 1.06e­ 04 0.027 1.13e­ 04/ 1.13e­ 03 8.03e­ 06/ 8.03e­ 05 Granulars with a Push Type Spreader ( ORETF) ( 11) l a wn s , g o l f c o u r s e s , p a r k s , recreational areas, ornamentals 0.006 2.54e­ 05/ 2.54e­ 04 1.80e­ 06/ 1.80e­ 05 No Data No Data No data Granulars with a Bellygrinder ( LCO) ( 12) golfcourses, parks, rec areas. 0.051 2.11e­ 04/ 2.11e­ 03 1.50e­ 05/ 1.50e­ 04 0.033 1.35e­ 04/ 1.35e­ 03 9.60e­ 06/ 9.60e­ 05 a PPE1, 2 Total Daily Dose = [ PPE Daily Dermal Exposure ( mg/ day) * Dermal absorption Factor ( 9%) + baseline Daily Inhalation Exposure ( mg/ day)]/ Body Weight ( 70 kg). b PPE1, 2 LADD ( mg/ kg/ day) = PPE Total Daily Dose ( mg/ kg/ day) * ( Number of days exposed per year) / 365 days per year) * 35 years worked/ 70 year lifetime. C PPE1, 2 Total Cancer Risk = PPE LADD ( mg/ kg/ day) * ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. PPE 1 cancer risk includes long pants, long shirts, gloves and no respirator. PPE 2 cancer risk includes long pants, long shirts, double layer, gloves and no respirator. Two exposure frequencies were used for cancer, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). 52 Table B3: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at PPE Exposure Scenario # Crop Type Total PPE 3 Daily Dose ( mg/ kg/ day) a PPE 3 LADDb 3/ 30 days PPE 3 Riskc Total PPE 4 Daily Dose ( mg/ kg/ day) a PPE 4 LADDb 3/ 30 days PPE 4 Riskc Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 0.360 1.47e­ 03/ 1.47e­ 02 1.05E­ 04/ 1.05e­ 03 0.3 1.25e­ 03/ 1.25e­ 02 8.90e­ 05/ 8.90e­ 04 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.055 2.25e­ 04/ 2.25e­ 03 1.60e­ 05/ 1.60e­ 04 0.046 1.91e­ 04/ 1.91e­ 03 1.36e­ 05/ 1.36e­ 04 herbaceous ornamentals 0.041 1.68e­ 04/ 1.68e­ 03 1.20e­ 05/ 1.20e­ 04 0.035 1.43e­ 04/ 1.43e­ 03 1.02e­ 05/ 1.02e­ 04 sod farms 0.082 3.37e­ 04/ 3.37e­ 03 2.39e­ 05/ 2.39e­ 04 0.070 2.86e­ 04/ 2.86e­ 03 2.03e­ 05/ 2.03e­ 04 golf courses 0.055 2.25e­ 04/ 2.25e­ 03 1.60e­ 05/ 1.60e­ 04 0.046 1.91e­ 04/ 1.91e­ 03 1.36e­ 05/ 1.36e­ 04 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.055 2.25e­ 04/ 2.25e­ 03 1.60e­ 05/ 1.60e­ 04 0.046 1.91e­ 04/ 1.91e­ 03 1.36e­ 05/ 1.36e­ 04 Loading Granular formulations ( 2) sod farms, conifers forest 0.004 1.81e­ 05/ 1.81e­ 04 1.28e­ 06/ 1.28e­ 05 0.003 1.21e­ 05/ 1.21e­ 04 8.63e­ 07/ 8.63e­ 06 golf course turf, parks, recreational areas 0.002 9.03e­ 06/ 9.03e­ 05 6.42e­ 07/ 6.42e­ 06 0.0015 6.07e­ 06/ 6.07e­ 05 4.31e­ 07/ 4.31e­ 06 woody ornamentals 0.002 9.03e­ 06/ 9.03e­ 07 6.42e­ 07/ 6.42e­ 06 0.0015 6.07e­ 06/ 6.07e­ 05 4.31e­ 07/ 4.31e­ 06 Applicator Applying with a Groundboom ( 3) sod farms 0.005 1.99e­ 05/ 1.99e­ 04 1.41e­ 06/ 1.41e­ 05 0.0039 1.61e­ 05/ 1.61e­ 04 1.14e­ 06/ 1.14e­ 05 herbaceous ornamentals 0.002 9.93e­ 06/ 9.93e­ 05 7.06e­ 07/ 7.06e­ 06 0.002 8.03e­ 06/ 8.03e­ 05 5.71e­ 07/ 5.71e­ 06 golf courses 0.003 1.32e­ 05/ 1.32e­ 04 9.42e­ 07/ 9.42e­ 06 0.003 1.07e­ 05/ 1.07e­ 04 7.61e07/ 7.61e­ 06 conifer nurseries, woody ornamentals 0.003 1.32e­ 05/ 1.32e­ 04 9.42e07/ 9.42e­ 06 0.003 1.07e­ 05/ 1.07e­ 04 7.61e07/ 7.61e­ 06 Table B3: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at PPE Exposure Scenario # Crop Type Total PPE 3 Daily Dose ( mg/ kg/ day) a PPE 3 LADDb 3/ 30 days PPE 3 Riskc Total PPE 4 Daily Dose ( mg/ kg/ day) a PPE 4 LADDb 3/ 30 days PPE 4 Riskc 53 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides 0.082 3.37e­ 04/ 3.37e­ 03 2.40e­ 05/ 2.40e­ 04 0.061 2.52e­ 04/ 2.52e­ 03 1.80e­ 05/ 1.80e­ 04 Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas 0.019 7.74e­ 05/ 7.74e­ 04 5.50e06/ 5.50e­ 05 0.0098 4.04e­ 05/ 4.04e­ 04 2.87e06/ 2.87e­ 05 Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 0.004 5.56e­ 06/ 5.56e­ 05 3.95e07/ 3.95e­ 06 0.0028 3.87e­ 06/ 3.87e­ 05 2.75e07/ 2.75e­ 06 golf courses 0.002 2.78e­ 06/ 2.78e­ 05 1.98e07/ 1.98e­ 06 0.0014 1.94e­ 06/ 1.94e­ 05 1.38e07/ 1.38e­ 06 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) l a wn s , g o l f c o u r s e s , ornamentals nurseries 0.066 2.71e­ 04/ 2.71e­ 03 1.93e­ 05/ 1.93e­ 04 0.043 1.76e­ 04/ 1.76e­ 03 1.25e05/ 1.25e­ 04 Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock 0.280 1.17e­ 03/ 1.17e­ 02 8.30e05/ 8.30e­ 04 0.22 9.14e­ 04/ 9.14e­ 03 6.50e05/ 6.50e­ 04 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. 0.068 2.79e­ 04/ 2.79e­ 03 1.98e05/ 1.98e­ 04 0.045 1.84e­ 04/ 1.84e­ 03 1.31e05/ 1.31e­ 04 Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas 0.022 9.06e­ 05/ 9.06e­ 04 6.44e­ 06/ 6.44e­ 05 0.013 5.47e­ 05/ 5.47e­ 04 3.89e06/ 3.89e­ 05 Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, r e c r e a t iona l ar e a s , ornamentals 0.006 2.54e­ 05/ 2.54e­ 04 1.80e06/ 1.80e­ 05 No Data No Data No data Granulars with a Bellygrinder ( LCO) ( 12) golfcourses, pa rk s, rec areas. 0.049 1.99e­ 04/ 1.99e­ 03 1.42e05/ 1.42e­ 04 0.03 1.23e­ 04/ 1.23e­ 03 8.77e06/ 8.77e­ 05 a PPE 3,4 Total Daily Dose = [ PPE Daily Dermal Exposure ( mg/ day) * Dermal absorption Factor ( 9%)+ baseline Daily Inhalation Exposure ( mg/ day)]/ Body Weight ( 70 kg). b PPE 3, 4 LADD ( mg/ kg/ day) = PPE Total Daily Dose ( mg/ kg/ day) * ( Number of days exposed per year) / 365 days per year) * 35 years worked/ 70 year lifetime. C PPE 3, 4 Total Cancer Risk = PPE LADD ( mg/ kg/ day) * ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. PPE3 cancer risk includes long pants, long shirts, gloves and respirator. PPE 4 cancer risk includes long pants, long shirts, double layer, gloves and respirator Two exposure frequencies were used for cancer, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). 54 Table B4: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at Eengineering Control Exposure Scenario # Crop Type Total Eng. Control Daily Dose ( mg/ kg/ day) a Eng. Control LADDb 3/ 30 days Eng Control Riskc Mixer/ Loader Exposure Mixing/ Loading Wettable Powders for Chemigation Application ( 1a) sod farms 0.0170 6.92e­ 05/ 6.92e­ 04 4.92E­ 06/ 4.92e­ 05 Mixing/ Loading Wettable Powders for Groundboom Application ( 1b) conifer nurseries, woody ornamentals 0.0026 1.05e­ 05/ 1.05e­ 04 7.49E­ 07/ 7.49e­ 06 herbaceous ornamentals 0.0019 7.90e­ 06/ 7.90e­ 05 5.62E­ 07/ 5.62e­ 06 sod farms 0.0038 1.58e­ 05/ 1.58e­ 04 1.12E­ 06/ 1.12e­ 05 golf courses 0.0026 1.05e­ 05/ 1.05e­ 04 7.49E­ 07/ 7.49e­ 06 Mixing/ Loading Wettable Powders for Rights­ of­ Way Sprayer ( 1c) roadside turf, ornamentals 0.0026 1.05e­ 05/ 1.05e­ 04 7.49E­ 07/ 7.49e­ 06 Loading Granular formulations ( 2) sod farms, conifers forest 0.0002 3.09e­ 073.09e­ 06 2.20E­ 08/ 2.20e­ 07 golf course turf, parks, recreational areas 0.0001 1.54e­ 07/ 1.54e­ 06 1.10E­ 08/ 1.10e­ 07 woody ornamentals 0.0001 4.63e­ 07/ 4.63e­ 06 3.29E­ 08/ 3.29e­ 07 Applicator Applying with a Groundboom ( 3) sod farms 0.0017 6.95e­ 06/ 6.95e­ 05 4.94E­ 07/ 4.94e­ 06 herbaceous ornamentals 0.0009 3.47e­ 06/ 3.47e­ 05 2.47E­ 07/ 2.47e­ 06 golf courses 0.0011 4.63e­ 06/ 4.63e­ 05 3.29E­ 07/ 3.29e­ 06 conifer nurseries, woody ornamentals 0.0011 4.63e­ 06/ 4.63e­ 05 3.29E­ 07/ 3.29e­ 06 Applying with a Rights­ of­ Way Sprayer ( 4) roadsides NF NF NF Applying Wettable­ Powders for Handgun Applicators ( ORETF) ( 5) lawns, parks, recreational areas NF NF NF Applying Granular with a Tractor Drawn Spreader ( 6) sod farms 0.0019 2.56e­ 06/ 2.56e­ 05 1.82E­ 07/ 1.82e­ 06 golf courses 0.0009 1.28e­ 06/ 1.28e­ 05 9.11E­ 08/ 9.11e­ 07 Mixer/ Loader/ Applicator Backpack Sprayer ( LCO) ( 7) lawns, golf courses, ornamentals nurseries NF NF NF Low Pressure Handwand ­ Wettable Powder Formulations ( LCO) ( 8) lawns, golf courses, nursery stock NF NF NF Table B4: Occupational Handler, Cancer ( Q*) Risk from Oxadiazon at Eengineering Control Exposure Scenario # Crop Type Total Eng. Control Daily Dose ( mg/ kg/ day) a Eng. Control LADDb 3/ 30 days Eng Control Riskc 55 High Pressure Handwand ­­ ( Wettable Powder Formulations) ( 9) woody ornamentals, conifer nurseries. NF NF NF Lawn Handgun ( Wettable Powder Formulations) ( ORETF) ( 10) ornamentals, lawns, parks rec areas NF NF NF Granulars with a Push Type Spreader ( ORETF) ( 11) lawns, golf courses, parks, recreational areas, ornamentals NF NF NF Granulars with a Bellygrinder ( LCO) ( 12) golfcourses, parks, rec areas. NF NF NF a Eng. Control Total Daily Dose =[ Eng. Control Daily Dermal Exposure ( mg/ day)* Dermal Absorption Factor ( 9%)+ baseline Daily Inhalation Exposure ( mg/ day)]/ Body Weight ( 70 kg). b Eng. Control LADD ( mg/ kg/ day) = Eng. control Total Daily Dose ( mg/ kg/ day) * ( Number of days exposed per year) / 365 days per year) * 35 years worked/ 70 year lifetime. c Eng. Control Total Cancer Risk = Eng. Control LADD ( mg/ kg/ day) * ( Q 1*), Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. NF= Not feasible Two exposure frequencies were used for cancer, the first represented the maximum number of applications per site per season to represent private use ( 3), and the second frequency applied a factor of ten to the first frequency to represent commercial handlers making multiple applications per site per season ( 30). 56 APPENDIX C OCCUPATIONAL AND RESIDENTIAL POST APPLICATION TABLES C1 ­ C4 57 Table C1: Occupational Short­ and Intermediate­ Term Postapplication Risks for Oxadiazon Crop/ Use Pattern Application Rate ( lb ai/ acre) Postapplication Activity Transfer Coefficienta Short Term and Intermediate Term Risks Cancer Risk TTRb ( ug/ cm2) MOEc LADDd mg/ kg/ day Riske Golf Course Turf 4 Mow, seed, mechanical weed, aerate, fertilize, prune 500 2.0 ( 5% of application rate) 1,000 4.23e­ 5 3.01e­ 6 Transplant, hand weed 16,500 30 1.39e­ 3 9.92e­ 5 Sod Farms Mow, scout, mechanical weed, irrigate 500 1,000 4.23e­ 5 3.01e­ 6 Transplant, hand weed, harvest ( hand or mechanical) 16,500 30 1.39e­ 3 9.92e­ 5 Bermuda Grass Rights of Way Mow, seed, scout, mechanical weed, aerate, fertilize 500 1,000 4.23e­ 5 3.01e­ 6 a Transfer coefficient from Science Advisory Council for Exposure: Policy Memo # 003 .1 " Agricultural Transfer Coefficients," Revised ­ August 7, 2000. b TTR source: 5% of application rate, " Residential SOP Revised February 2001 " was used for determination of MOE's. c MOE = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose where absorbed dose = TTR ( g/ cm2) x TC ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 8hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg; adult). d absorbed dermal dose where absorbed dose = TTR ( g/ cm2) x TC ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 8 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime e Cancer Risk = LADD ( mg/ kg/ day) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. Note: TTR ­ Turf Transferable Residue rounded to 2.0 ug/ cm2 XXXXX 58 Table C2. Residential Dermal Postapplication Non­ Cancer Risks for Oxadiazon Dermal Scenarios Application Rate ( lb ai/ acre) Exposure Time ( hours/ day) Short Term and Intermediate Term Risks Transfer Coefficient ( cm2/ hr) a Transfer Coefficient ( cm2/ hr) Irrigatedb Transfer Coefficient ( cm2/ hr) Non­ Irrigatedc TTRd ( ug/ cm2) DAT 0­ 1 Dermal Dose ( mg/ kg/ day) e Dermal Dose ( mg/ kg/ day) Irrigatedf Dermal Dose ( mg/ kg/ day) Non­ Irrigatedg MOEsh MOEs i Irrigated MOEsj Non­ Irrigated Adult dermal turf contact 4 2 14500 4300 7,400 1.53 NA 1.97e­ 2 3.40e­ 2 NA 610 350 2.0 8.70e­ 2 NA NA 140 NA NA Toddler dermal turf contact 2 5200 1600 2,700 0.87 NA 1.67e­ 2 2.82e­ 2 NA 720 430 2.0 3.12e­ 2 NA NA 390 NA NA Adult walking, playing golf 4 500 NA NA 2.0 6.0e­ 3 NA NA 2,000 NA NA Adult push mowing lawn 2 500 NA NA 2.0 3.0e­ 3 NA NA 4,000 NA NA a Transfer coefficient from the Residential SOP's ( 2/ 01) used for fresh grass b Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass c Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass d TTR source: wettable powder from turf studies MRID # 435178­ 01, DAT 0­ 1 residue or residential SOP ( 5% application rate) e Dermal dose ( mg/ kg/ day) = TTR ( 5% application rate) ( g/ cm2) x TC ( from residential SOP, s) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 or 4hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg adult or 15 kg toddler). f Dermal dose ( mg/ kg/ day) irrigated = TTR ( from MRID # 435178­ 01) ( g/ cm2) x TC ( MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg adult or 15 kg toddler). g Dermal dose ( mg/ kg/ day) non­ irrigated = TTR ( from MRID # 435178­ 01) ( g/ cm2) x TC ( MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 60 kg adult or 15 kg toddler). h MOE = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) i MOE ( irrigated) = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) j MOE ( non­ irrigated) = Short­ term NOAEL ( 12 mg/ kg/ day; based on an oral study) / dermal dose ( mg/ kg/ day) Note: TTR ­ Turf Transferable Residue rounded to 2.0 ug/ cm2 59 Table C3. Residential Dermal Postapplication Cancer Risks for Oxadiazon Dermal Scenarios Application Rate ( lb ai/ acre) Exposure Time ( hours/ day) Transfer Coefficient ( cm2/ hr) a Transfer Coefficient ( cm2/ hr) Irrigatedb Transfer Coefficient ( cm2/ hr) Non­ Irrigatedc TTRd ( ug/ cm2) DAT 0­ 1 LADDe mg/ kg/ day LADDf mg/ kg/ day irrigated LADDg mg/ kg/ dayf Non­ Irrigated Cancerh Cancer Irrigatedj Cancerj Nonirrigated Adult dermal turf contact 4 2 14500 4300 7400 1.53 NA 6.95e­ 5 1.2e­ 4 NA 3.62e­ 6 6.22e­ 6 2.0 3.06e­ 04 NA NA 1.59e­ 5 NA NA Toddler dermal turf contact 2 5200 1600 2700 0.87 NF NF NF NF NF NF 2.0 NF NF NF NF NF NF Adult walking, playing golf 4 500 NA NA 2.0 2.11e­ 5 NA NA 1.50e­ 6 NA NA Adult push mowing lawn 2 500 NA NA 2.0 1.06e­ 5 NA NA 7.51e­ 7 NA NA a Transfer coefficient from the Residential SOP's ( 2/ 01) used for fresh grass b Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass c Transfer coefficient from turf study MRID # 435178­ 01used for dormant grass d TTR source: wettable powder and granular turf studies MRID # 435178­ 01, DAT 0­ 1 residue e LADD ( mg/ kg/ day) = TTR ( g/ cm2)( 5% of application rate) x TC( residential SOP) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 or 4 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime f LADD ( mg/ kg/ day)( irrigated) = TTR ( g/ cm2) ( from MRID # 435178­ 01) x TC ( cm2/ hr)( from MRID # 435178­ 01) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime g LADD ( mg/ kg/ day)( non­ irrigated) = TTR ( g/ cm2)( from MRID # 435178­ 01) x TC( from MRID # 435178­ 01) ( cm2/ hr) x conversion factor ( 1 mg/ 1,000 g) x exposure time ( 2 hrs/ day) x dermal absorption ( 9 %) / body weight ( 70 kg) x ( Number of days ( 3) exposure per year applicator) / 365 days per year) x 35 years worked/ 70 year lifetime h Cancer Risk = LADD ( mg/ kg/ day) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. i Cancer Risk ( irrigated) = LADD ( mg/ kg/ day) ( irrigated) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. j Cancer Risk ( non­ irrigated) = LADD ( mg/ kg/ day)( non­ irrigated) x ( Q 1*), where Q 1* = 7.11e­ 2 ( mg/ kg/ day)­ 1. NA= Not applicable NF= Not Feasible Note: TTR ­ Turf Transferable Residue rounded to 2.0 ug/ cm2 60 Table C4 Residential Oral Nondietary Postapplication Risks to Toddlers from " Hand­ to­ Mouth" and Ingestion Exposure When Reentering Lawns Treated with Granular or wettable powder Oxadiazon Formulations Type of Exposure Application Ratea ( lb ai/ acre) Ingestion Rate or Other Assumptionsb Short­ Term TTRc ( g/ cm2) DAT 0­ 1 Oral Dosed ( mg/ kg/ day) MOEe Hand to Mouth Activity 4 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; fresh grass 5% of ai dislodgeable with potentially wet hands 2.0 1.19e­ 01 100 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; 2.1% of ai dislodgeable with potentially wet hands ( dormant grass, non­ irrigated) 1.0 5.02e­ 02 240 20 cm2/ event surface area of 1­ 3 fingers; 20 events/ hr; 5.5% of ai dislodgeable with potentially wet hands ( dormant grass, irrigated) 2.5 1.31e­ 01 90 Incidental Turfgrass Ingestion 25 cm2/ day of turf 20% application rate ( residential SOP) fresh grass 9.0 1.49e­ 02 805 25 cm2/ day of turf Irrigated ( MRID # 435178­ 01) used for dormant grass 0.87 2.60e­ 03 4700 25 cm2/ day of turf Non­ Irrigated( MRID # 435178­ 01) used for dormant grass 1.53 1.45e­ 03 8300 Incidental Ingestion of Soil 100 mg/ day ingestion; 0.67 cm3/ gm soil NA 2.12e­ 04 57000 a Application rates represent maximum label rates from current EPA registered labels. b Assumptions from Residential SOP's ( February, 2001). fresh grass c TTR source: wettable powder and granular oxadiazon turf studies MRID Nos. 43517801. Short­ term risks assessed using DAT 0­ 1 residue values. d Oral doses calculated using formulas presented in the Residential SOPs ( February, 2001). Short­ term and intermediate­ term doses were calculated using the following formulas. Intermediate term doses were each multiplied by the estimated fraction of oxadiazon residue remaining on DAT 7 after application. Hand­ to­ mouth oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [ application rate ( lb ai/ acre) x fraction of residue dislodgeable from potentially wet hands ( see assumptions) x 11.2 ( conversion factor to convert lb ai/ acre to g/ cm2)] x median surface area for 1­ 3 fingers ( 20 cm2/ event) x hand­ to­ mouth rate ( ST: 20 events/ hour ) x exp. time ( 2 hr/ day) x 0.001 mg/ µ g] / bw ( 15 kg toddler). Grass ingestion oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [ TTR ( g/ cm2) x ingestion rate of grass ( 25 cm2/ day) x0.001 mg/ µ g] / bw ( 15 kg toddler). Soil ingestion oral dose to toddlers on the day of treatment ( mg/ kg/ day) = [( application rate ( lb ai/ acre) x fraction of residue retained on uppermost 1 cm of soil ( 100% or 1.0/ cm) x 4.54E+ 08 g/ lb conversion factor x 2.47E­ 08 acre/ cm2 conversion factor x 0.67 cm3/ g soil conversion factor) x 100 mg/ day ingestion rate x 1.0E­ 06 g/ g conversion factor] / bw ( 15 kg; toddler). Short term dose based residue on the soil on day of application. NA= Not applicable Note: TTR ­ Turf Transferable Residue 61 References 1) Revised Report of Hazard Identification Assessment Review Committee, Dec 21, 2001. 2) Oxadizon Labels. 2) Memorandum from J Blondell to S. Tadayon, 13 March, 2001 4) Pesticide Handler Exposure Database Version 1.1 Surrogate Exposure Table ( newly organized) and printed August 1998. cc: PP# 276360 RDI: Francis Suhre 4/ 6/ 2001 Timothy Leighton 3/ 21/ 2001 Jeff Evans 3/ 21/ 2001 S. Tadayon: 810J: CM# 2: ( 703) 305­ 5238 62

epa

2024-06-07T20:31:45.114288

regulations

EPA-HQ-OPP-2002-0309-0007

Supporting & Related Material

OXADIAZON 109001 Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document Date completed: April 4, 2001 Health Effects Division Office of Pesticide Programs U. S. Environmental Protection Agency Arlington, VA 22202 Prepared by: Linnea J. Hansen, Ph. D. __________________________ Date _________________ Nancy McCarroll, B. S. ___________________________ Date __________________ Reviewed by: Alberto Protzel, Ph. D., Toxicology Branch Senior Scientist ___________________________ Date __________________ form: FINAL June 21, 2000 EPA Reviewer: Linnea J. Hansen, Ph. D. , Date Toxicology Branch ( 7509C) Secondary EPA Reviewer: Alberto Protzel, Ph. D., Branch Sr. Scientist , Date Toxicology Branch ( 7509C) TABLE OF CONTENTS 1.0 HAZARD CHARACTERIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 2.0 REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.0 DATA GAP( S) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.0 HAZARD ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.1 Acute Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.2 Subchronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.3 Prenatal Developmental Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 4.4 Reproductive Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 4.5 Chronic Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 4.6 Carcinogenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4.7 Mutagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 4.8 Neurotoxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 4.9 Metabolism. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 4.10 Special/ Other Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 5.0 TOXICITY ENDPOINT SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 5.1 See Section 9.2 for Endpoint Selection Table. . . . . . . . . . . . . . . . . . . . . . . . . . . 29 5.2 Dermal Absorption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 5.3 Classification of Carcinogenic Potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 6.0 FQPA CONSIDERATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 6.1 Special Sensitivity to Infants and Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 6.2 Recommendation for a Developmental Neurotoxicity Study . . . . . . . . . . . . . . . 30 7.0 OTHER ISSUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 8.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 9.0 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 9.1 Toxicity Profile Summary Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 9.1.1 Acute Toxicity Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 9.1.2 Subchronic, Chronic and Other Toxicity Tables . . . . . . . . . . . . . . . . . . . 36 9.2 Summary of Toxicological Dose and Endpoints . . . . . . . . . . . . . . . . . . . . . . . . 42 OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 3 1.0 HAZARD CHARACTERIZATION Oxadiazon is a selective pre­ emergent herbicide of the oxadiazole class. Like other oxadiazoles, it displays light­ dependent phytotoxicity through the inhibition of protoporphyrinogen oxidase. Accumulation of protoporphyrin IX following exposure to oxadiazon has been demonstrated in plants, yeast and mouse liver mitochondria. At present, there are no registered food or feed uses. Aventis CropScience USA is supporting use of oxadiazon on golf courses, ornamentals, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries. The database for oxadiazon is largely complete and provides sufficient information to characterize toxicity. The only data gap that has been identified at this time is the submission of a 28­ day inhalation study ( OPPTS No. 870.3465). This study was not a guideline requirement for oxadiazon, but has been requested by the Agency because some currently registered products of oxadiazon are spray formulations. In acute studies, oxadiazon is only slightly toxic ( Toxicity Categories III or IV) with an oral LD 50 > 5000 mg/ kg, a dermal LD 50 > 2000 mg/ kg and an inhalation LC 50 > 1.94 mg/ L. Oxadiazon is mildly irritating to ocular tissue and negligibly irritating to the skin ( both Toxicity Category III) and is not a dermal sensitizer. The major target organ of oxadiazon is the liver. Effects were consistent among the species tested ( rat, dog, mouse) in both subchronic and chronic studies and typically included enlarged livers ( presumably due to the peroxisomal proliferating activity of oxadiazon), along with increases in serum clinical chemistry parameters associated with hepatotoxicity such as alkaline phosphatase and serum aspartate or alanine aminotransferase. Findings in rats and mice included fatty changes, pigmented Kupffer cells and bile canaliculi and bile duct proliferation, periacinar swelling and pallor, increased acidophilic cells, hyperplasia and hepatocellular necrosis. No treatment­ related microscopic lesions were observed in the subchronic dog study and findings in the chronic study were only observed at the HDT ( 200 mg/ kg/ day), where only 2 animals/ sex were assigned and 1 female was sacrificed in moribund condition. These findings included increased liver weight and hepatocellular histopathology ( centriacinar vacuolation, periacinar apoptosis and inflammation). The hematopoietic system also appeared to be a target of oxadiazon in all three species, based on mild anemia ( reductions in RBC, hematocrit and/ or hemoglobin). This is consistent with its ability to inhibit protoporphyrinogen oxidase, an enzyme involved in the synthesis of both heme and chlorophyll. In addition to effects on the liver, increased pigmentation in the kidney was observed in rats, along with increased BUN and kidney weights. Although a dose­ dependent increase in thyroid weight was observed in the dog subchronic oral toxicity study and at the HDT of the chronic dog studies, treatment­ related changes in thyroid weights or gross/ microscopic observations were not observed in other studies ( thyroid hormones were not evaluated). In general, males appeared to be slightly more sensitive to oxadiazon than females. Oxadiazon is not readily absorbed by the skin. In a rat dermal absorption study, up to 9% of the applied dose was absorbed after 10 hours of exposure. The 21­ day rabbit dermal toxicity study supports low dermal absorption: no toxicity was observed at the limit dose of 1000 mg/ kg/ day. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 4 Following long­ term dietary administration, oxadiazon caused an increased incidence of hepatocellular adenoma and carcinoma in rats and mice. Consistent findings were reported in a total of 4 acceptable studies in 2 species ( 2 mouse and 2 rat studies). A third mouse study was unacceptable, although increased hepatocellular tumors were also observed in mice of both sexes. In CD­ 1 mice, statistically significant increases of hepatocellular adenoma and combined adenoma/ adenocarcinoma were observed at all dose levels tested (
100 ppm) in both males and females. The incidence of hepatocellular carcinoma was increased at all doses in males but only at the two highest doses in females. The highest dose tested exceeded the MTD for males, based on excessive mortality. In ICR­ JCL mice, adenomas, carcinomas and combined adenomas/ carcinomas were increased in males at the highest 2 dose levels but only at the highest dose level in females. In SPF Wistar rats, the incidence of hepatocellular adenomas , carcinomas and combined adenomas/ carcinomas was increased in males only. A second study in F344 rats showed a treatment­ related increase in the incidence of hepatocellular carcinoma and combined adenoma/ carcinoma only in males. A classification of " likely to be carcinogenic to humans" was assigned by the HED Cancer Assessment Review Committee using the EPA Draft Guidelines for Carcinogen Risk Assessment of July, 1999. A quantitative risk ( Q 1*) of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1 was calculated as the most potent unit risk, based on the incidence of male mouse liver adenoma and/ or carcinoma combined tumor rates in the ICR­ JCL mouse. In a special mechanistic study in rats, oxadiazon induced peroxisomal proliferation ( based on liver enlargement, peroxisomal enzyme induction and electron microscopy) after a 14­ day dietary administration. Some peroxisomal proliferator compounds are known to be liver carcinogens, but the HED Mechanism of Toxicity Assessment Review Committee ( MTARC) determined that there are insufficient data available to support this as a mechanism of carcinogenicity for oxadiazon due to insufficient data showing hepatocellular proliferation, lack of concordance between the enzyme induction dose­ response and tumor formation and an unexplained decrease in catalase, which is normally significantly increased by peroxisomal proliferator compounds. Oxadiazon did not show mutagenic potential in any in vitro assays with bacteria ( S. typhimurium and E. coli) or mammalian cells ( TK +/­ mouse lymphoma cells), did not show clastogenic potential in the in vitro Chinese hamster ovary cell chromosomal aberration assays and did not induce unscheduled DNA synthesis in cultured primary rat hepatocytes. However, a dose­ related increase in transformation frequencies was observed in an in vitro Syrian hamster kidney BHK21 C13/ HRC1 cell transformation assay. Significant fetal toxicity ( fetal loss due to resorptions and post­ implantation loss, decreased fetal weight, skeletal variations) was observed in developmental toxicity studies in both rats and rabbits. These fetal effects occurred at the same dose levels at which slight maternal toxicity ( decreased weight gain/ weight loss) were observed. Offspring survival effects were also observed in the rat two­ generation reproduction study. No toxicity was reported at the lowest dose tested; however, in the range­ finding study at higher dose levels, fetal and neonatal survival were also sharply reduced. The decreased neonatal survival was due at least in part to effects on lactation, based on findings of inactive mammary glands in the dams at necropsy. It is likely that neonatal OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 5 loss may have resulted from starvation and would, therefore, be an effect of direct maternal toxicity. Inactivity of the mammary tissue as a possible effect of endocrine disruption was considered but was not found to be likely since there was no evidence from any other study in the database suggesting endocrine disruption. No fetal malformations were observed in the rat or rabbit developmental toxicity studies; however, some skeletal variations ( delayed ossification, asymmetric pelvis) were reported. The above findings indicate that there is neither qualitative nor quantitative evidence of increased susceptibility of rats or rabbits following in utero or postnatal exposure to oxadiazon. Neurotoxicity studies are not required for oxadiazon because no clinical signs of toxicity suggestive of neurobehavioral alterations nor evidence of neuropathological effects were observed in any of the available toxicity studies. There was no evidence for neurodevelopmental potential of oxadiazon in the rat and rabbit developmental toxicity studies, nor in the rat two­ generation reproductive toxicity study. In a rat metabolism/ pharmacokinetic study, oxadiazon was extensively metabolized, primarily via hydroxylation and glucuronide conjugation. However, the benzene and pyrozolidine rings were not modified. Eighteen ( 18) metabolites were identified in the urine and feces, of which 4 urinary and 5 fecal metabolites were present at levels greater than 1% of the dose. After 7 days,
83% of the administered dose was excreted in the urine and feces ( total recovery
94%) for all dose groups. Females excreted more radioactivity in the urine than males. The excretion of radioactivity into the urine and the feces was sex dependent and the tissue residues were very low in all tissues except liver and fat. Low doses ( 5 mg/ kg, single or multiple) of oxadiazon were completely absorbed, metabolized and excreted in the urine and feces and virtually no free oxadiazon was found in the urine. At this dose, the rates and routes of excretion of radioactivity were similar. At high dose ( 500 mg/ kg), the rate of excretion was affected but the route was not. Intact oxadiazon was present in feces only and was dose­ related: at the high dose, more than 53% of the administered radioactivity was intact oxadiazon in the feces; at 5 mg/ kg, not more than 4.8% of the dose was intact oxadiazon in the feces. 2.0 REQUIREMENTS The requirements ( CFR 158.340) for non food/ feed ( turf) uses for oxadiazon are shown below in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 6 Table 1. Data requirements for Reregistration of Oxadiazon Test Technical Required Satisfied 870.1100 Acute Oral Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . 870.1200 Acute Dermal Toxicity . . . . . . . . . . . . . . . . . . . . . . 870.1300 Acute Inhalation Toxicity . . . . . . . . . . . . . . . . . . . . 870.2400 Primary Eye Irritation . . . . . . . . . . . . . . . . . . . . . . . 870.2500 Primary Dermal Irritation . . . . . . . . . . . . . . . . . . . . 870.2600 Dermal Sensitization . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes yes yes 870.3100 Oral Subchronic ( rodent) . . . . . . . . . . . . . . . . . . . . . 870.3150 Oral Subchronic ( nonrodent) . . . . . . . . . . . . . . . . . . 870.3200 21­ Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3250 90­ Day Dermal . . . . . . . . . . . . . . . . . . . . . . . . . . . . 870.3465 90­ Day Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes no yes1 yes yes yes ­­ no 870.3700a Developmental Toxicity ( rodent) . . . . . . . . . . . . . . . 870.3700b Developmental Toxicity ( nonrodent) . . . . . . . . . . . . 870.3800 Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes 870.4100a Chronic Toxicity ( rodent) . . . . . . . . . . . . . . . . . . . . 870.4100b Chronic Toxicity ( nonrodent) . . . . . . . . . . . . . . . . . 870.4200a Oncogenicity ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . 870.4200b Oncogenicity ( mouse) . . . . . . . . . . . . . . . . . . . . . . . 870.4300 Chronic/ Oncogenicity . . . . . . . . . . . . . . . . . . . . . . . yes yes yes yes yes yes yes yes yes yes 870.5100 Mutagenicity C Gene Mutation ­ bacterial . . . . . . . . . 870.5300 Mutagenicity C Gene Mutation ­ mammalian . . . . . . 870.5375 Mutagenicity C Structural Chromosomal Aberrations 870.5550 Mutagenicity C Other Genotoxic Effects . . . . . . . . . . yes yes yes yes yes yes yes yes 870.6100a Acute Delayed Neurotox. ( hen) . . . . . . . . . . . . . . . . 870.6100b 90­ Day Neurotoxicity ( hen) . . . . . . . . . . . . . . . . . . . 870.6200a Acute Neurotox. Screening Battery ( rat) . . . . . . . . . 870.6200b 90 Day Neuro. Screening Battery ( rat) . . . . . . . . . . . 870.6300 Develop. Neuro . . . . . . . . . . . . . . . . . . . . . . . . . . . . no no no no no ­­ ­­ ­­ ­­ ­­ 870.7485 General Metabolism . . . . . . . . . . . . . . . . . . . . . . . . 870.7600 Dermal Penetration . . . . . . . . . . . . . . . . . . . . . . . . . yes no2 yes yes Special Studies for Ocular Effects Acute Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . . . . . Subchronic Oral ( rat) . . . . . . . . . . . . . . . . . . . . . . . . Six­ month Oral ( dog) . . . . . . . . . . . . . . . . . . . . . . . no no no ­­ ­­ ­­ 1 A 90­ day inhalation study is not a guideline requirement for oxadiazon. However, a 28­ day inhalation study has been requested by the Agency because some of the currently registered products are spray formulations. 2 This study was not required by the Agency, but was submitted as additional information for oxadiazon. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 7 3.0 DATA GAPS There are no guideline required data gaps. However, HIARC has recommended the submission of a 28­ day inhalation toxicity study in the rodent because some of the currently registered products are spray formulations. 4.0 HAZARD ASSESSMENT 4.1 Acute Toxicity Adequacy of data base for acute toxicity: The data base for acute toxicity is considered complete. No additional studies are required at this time. The acute toxicity of oxadiazon is low by all potential routes of exposure ( Toxicity Category IV, oral and III, dermal and inhalation). Primary eye irritation is mild and skin irritation is negligible ( both Category III). Oxadiazon did not show potential for dermal sensitization in a Buehler test. The acute toxicity data on oxadiazon technical is summarized in Table 2. Table 2. Acute Toxicity Data on Oxadiazon Guideline No./ Study Type MRID No. Results Toxicity Category 870.1100 Acute oral toxicity ( rat) 41866501 ( 97.5% a. i.) LD50 > 5000 mg/ kg ,
combined IV 870.1200 Acute dermal toxicity ( rabbit) 41866502 ( 97.5% a. i.) LD50 > 2000 mg/ kg, ,
combined III 870.1300 Acute inhalation toxicity ( rat) 41866503 ( 93.7% a. i.) LC50 > 1.94 mg/ L ,
combined III 870.2400 Acute eye irritation ( rabbit) 41866504 ( 97.5% a. i.) Mild irritant to ocular tissues III 870.2500 Acute dermal irritation ( rabbit) 41866505 ( 97.5% a. i.) Negligibly irritating to skin III 870.2600 Skin sensitization ( guinea pig) 41230401 ( 93.7% a. i.) Not a dermal sensitizer ( Buehler test) ­­ 870.6200a Acute neurotoxicity screening battery ( rat) ND ­­ ­­ ND No data ­ not required for oxadiazon. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 8 4.2 Subchronic Toxicity Adequacy of data base for subchronic toxicity: The data base for subchronic toxicity is considered complete with respect to the guideline requirements for a non­ food/ feed use. However, the HIARC has recommended the submission of a 28­ day inhalation toxicity study because some of the currently registered products are spray formulations. In the rat, liver effects from subchronic exposure included increased weight, increased ALT, AST, alkaline phosphatase and BUN, and microscopic findings such as increased brown pigmentation of Kupffer cells and bile canaliculi, variable hepatocyte size and staining and necrosis. In addition, decreased red blood cell parameters, increased splenic hematopoietic activity and vacuolization of cells of the adrenal gland and the kidney were observed. In the dog, increased liver and thyroid weights and serum levels of alkaline phosphatase and ALT were reported, but no liver pathology or hematological effects were observed at the doses tested. No toxicity following 21 consecutive daily dermal exposures was observed in rats exposed up to the limit dose of 1000 mg/ kg/ day. In addition to the Executive Summaries provided below, subchronic toxicity studies are summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.3100 90­ Day Oral Toxicity ­ Rat In a 90­ day subchronic oral toxicity study ( MRID 00111804), oxadiazon as RP 17623 ( tech., 98.2% a. i.) was administered to CD rats ( 10/ sex/ dose) at dietary levels of 0, 25, 100 or 1000 mg/ kg/ day) for 13 weeks. Clinical signs, body weights and food consumption were determined weekly. At 4 and 13 weeks, hematology, clinical chemistry and urinalysis determinations were performed. Cholinesterase activity was also measured in erythrocytes at 13 weeks. Necropsy, organ weights and histology examinations were performed at 13 weeks. Mortality was confined to one high­ dose male at week 10 and one high­ dose female at week 12. Other clinical signs noted at 1000 mg/ kg/ day were: hunched appearance, urine stains, rapid respiration, yellow skin pigmentation and loss of coordination ( both sexes). Body weight (­ 13 and ­ 49%) was significantly decreased in males at 100 and 1000 mg/ kg/ day; respectively, and in females (­ 21%) at 1000 mg/ kg/ day. Food consumption was significantly reduced for both sexes at the high dose. Affected hematological parameters included: slight decreases in hematocrit, hemoglobin and erythrocyte count for high­ dose males and females ( 13 weeks). ALP, total bilirubin, SGPT ( 4 and 13 weeks) BUN and SGOT ( 13 weeks) were increased in high­ dose males and females. Mid­ dose males also had increased ALP, SGOT and SGPT values. There was no effect on cholinesterase activity. Significantly increased absolute and relative liver weights were seen in males and females receiving 100 and 1000 mg/ kg/ day. Microscopic changes were also apparent for intermediate and high­ dose males and females. At 1000 mg/ kg/ day ( males and females) and 100 mg/ kg/ day ( males), the liver contained brown pigment in the Kupffer OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 9 cells and bile canaliculi, marked variability in cell size and staining properties of the hepatocytes and necrotic hepatocytes. The adrenals contained cytoplasmic vacuolation of the zona fasciculata, vacuolation and hypertrophy of cells in the zona reticularis and increased vacuolation of the zona glomerulosa ( males and females at 1000 mg/ kg/ day). Also at 1000 mg/ kg/ day, the spleen showed increased hematopoietic activity and brown pigmentation; granular pigmentation and vacuolation were reported for the kidneys. No significant effects were seen at 25 mg/ kg/ day. The LOAEL is 100 mg/ kg/ day, based on decreased body weight, increased liver weight, hematological changes and clinical chemistry and pathological changes associated with damage to the livers of males and females; the NOAEL is 25 mg/ kg/ day. This 90­ day subchronic oral toxicity study in the rat is Acceptable/ guideline and satisfies the guideline requirement for a subchronic toxicity study ( 870.3100) in rodents. 870.3100 90­ Day Oral Toxicity ­ Mouse A 90­ day oral toxicity study in the mouse was not submitted. 870.3150 90­ Day Oral Toxicity ­ Dog In a subchronic oral toxicity study ( MRID 00111805), oxadiazon ( tech., 98.2% a. i.) was administered to 4 Beagle dogs/ sex/ dose in the diet for the initial 3 weeks of the study at concentrations of 0, 1000, 4000 or 10,000 ppm. Due to unpalatability of the diets, the test material was administered via gelatin capsule from weeks 4 to 13 at 0, 25, 100 or 1000 ( limit dose) mg/ kg/ day. The high­ dose group received 250 mg/ kg/ day by gelatin capsule during week 4 instead of 1000 mg/ kg/ day. It was stated that a single high­ dose male died during week 4 due to incidental causes and was replaced with another dog; it was not specified if the replacement animal was treated or untreated prior to week 4. No statistical analyses were provided. At 25 mg/ kg/ day, increased abs/ rel thyroid weights were observed in males (+ 18/+ 34%). At 100 mg/ kg/ day, increased alkaline phosphatase during weeks 4 and 13 (+ 16 to + 41%) in the males only; increased aspartate aminotransferase during week 13 (+ 14 to + 26%) in males and females; increased abs/ rel thyroid weights in males (+ 26%/+ 35%); increased relative thyroid weights in females (+ 34%); increased abs/ rel liver weights ( males + 15%/+ 28%) and relative liver weights in females (+ 28%) were observed. At 1000 mg/ kg/ day, increased alkaline phosphatase during weeks 4 and 13 (+ 23 to + 181%) in the males; increased aspartate aminotransferase during weeks 4 and/ or 13 (+ 10 to + 80%) in males and females, increased abs/ rel liver weights (+ 24%/+ 53%, males and + 60%/+ 34%, females) and increased abs/ rel thyroid weights (+ 30%/+ 59%, males and + 23%/+ 39%, females) were observed. Large reductions in food consumption were noted in the high dose males during the first 3 weeks of treatment (­ 36 to ­ 50%). In the treated females, decreased food consumption was observed during the first 3 weeks of treatment at the low­ (­ 4 to ­ 20%), mid­ (­ 23 to ­ 44%), and high­ dose levels (­ 31 to ­ 45%). These decreases OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 10 were attributed to unpalatability of the test substance in the diet; after changing to capsule administration, food consumption did not show a clear dose­ dependent decrease. No treatment­ related changes in body weights, clinical signs of toxicity, overall body weight gains, hematology, urinalysis, erythrocyte cholinesterase levels, gross or microscopic pathological findings were observed. The systemic toxicity LOAEL for this study is 25 mg/ kg/ day, based on increased thyroid weights in males. The systemic toxicity NOAEL for this study is < 25 mg/ kg/ day. This study is classified as Acceptable/ guideline ( 870.3150) and satisfies the requirement for a subchronic oral toxicity study in dogs. Although a NOAEL was not identified in this study, a NOAEL of 5 mg/ kg/ day was identified in a subsequently conducted chronic oral study in the dog ( MRID 41326401; HED Doc. Nos. 008248 and this Doc. No.). 870.3200 21­ Day Dermal Toxicity B Rat In a 21­ day dermal toxicity study ( MRID 41863602), oxadiazon technical ( 97.49% a. i., moistened with distilled water) was applied dermally 6 hrs/ day, 7 days/ week for 3 weeks to 8 male and 8 female New Zealand White rabbits per dose at 0, 100, 500 or 1000 mg/ kg/ day. Treatment with oxadiazon technical had no effect on mortality, body weight, body weight gain, food consumption, hematology, clinical chemistry, urinalysis, organ weights or gross necropsy. Dermal irritation ( erythema, edema and eschar) was observed in treated and control rabbits. These symptoms first appeared during the second week and persisted throughout the study. Histologically, the skin lesions include acanthosis, hyperkeratosis, acute and chronic dermatitis, acute folliculitis, exudate on the dermal surface, edema and hemorrhage, which are characteristic of chronic inflammation and occlusion. Although a higher incidence of erythema and edema was noticed in the 500 and 1000 mg/ kg groups, the significance of these findings is questionable. The investigator overlooked pharmacokinetic principles in conducting the study. The approximate area of the test article treated skin was 25.9, 92.1 and 119.5 cm2 for the 100, 500 and 1000 mg/ kg/ day groups, respectively, which indicates that the administered dose ( mg/ cm2) was the same in all cases. It is appropriate to apply graded concentrations of the test material to the entire test area ( i. e., 10 % of the body surface area, rather than a fraction of the test area). Even though appropriate doses were not tested, the highest level tested reached the Limit Dose. The results suggest, therefore, that at the Limit Dose, oxadiazon Technical is not an irritant to rabbit skin. The systemic toxicity and local ( dermal irritation) LOAELs are > 1000 mg/ kg/ day and the NOAELs are
1000 mg/ kg/ day. This study is classified Acceptable/ guideline and satisfies the guideline requirement for a 21­ day dermal study ( 870.3200) in the rabbit. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 11 4.3 Prenatal Developmental Toxicity Adequacy of data base for Prenatal Developmental Toxicity: The data base for prenatal developmental toxicity of oxadiazon is considered complete. No additional studies are required at this time. Similar findings were reported in rats and rabbits, although the sensitivity of fetuses to oxadiazon was greater in rats than in rabbits. In rats, fetal toxicity ( increased resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification in skull and vertebral bones) were reported at 40 mg/ kg/ day, whereas only slightly decreased during late gestation, due at least in part to the fetal loss at that dose level. In the rabbit, developmental toxicity ( increased post­ implantation loss and late resorptions, decreased mean fetal weight and increased incidence of bilateral hind­ limb flexure) was observed at the highest dose tested ( 180 mg/ kg/ day), whereas maternal toxicity ( transient weight loss and decreased food consumption during and after treatment) was observed at mid dose ( 60 mg/ kg/ day) and higher. In addition to the Executive Summaries provided below, developmental toxicity studies are summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.3700a Prenatal Developmental Toxicity Study ­ Rat In a developmental toxicity study ( MRID 40470202), oxadiazon technical ( 96.3% a. i.) was administered daily by gavage in 10 ml 1% aqueous methylcellulose vehicle/ kg body weight from Gestation Days 6 through 15 to groups of 20 pregnant Sprague­ Dawley rats per dose at 0, 3, 12 or 40 mg/ kg/ day. Pregnant females were examined daily for signs of toxicity and body weights were measured on Gestation Days 0, 3, 6, daily through Day 16 and on Days 18 and 20. Dams were sacrificed on Day 20 and uterine contents were examined. Very little maternal toxicity was observed at any dose. Small but statistically significant decreases in body weight (­ 2% less than controls) and body weight gain (­ 10%) in the highdose females at Days 16­ 20 were possibly due to resorptions of fetuses ( decreased maternal body weights also observed at
40 mg/ kg/ day in the range­ finding study). The maternal toxicity LOAEL is 40 mg/ kg/ day, based on decreased body weight/ weight gain. The maternal toxicity NOAEL is 12 mg/ kg/ day. Treatment­ related fetal toxicity at 40 mg/ kg/ day included: slightly, not statistically significantly increased fetal resorptions ( 0.7/ dam vs. 0.4/ dam, controls) and postimplantation loss ( 12.5% vs. 8.2%, controls) and significantly decreased body weight (­ 4.5% less than controls). Developmental effects at 40 mg/ kg/ day were confined to increased incidence of incomplete ossification, primarily in skull and vertebral bones. No effects were seen at lower doses. No treatment­ related malformations were observed at the doses tested. Fetal effects seen in this study are considered treatment­ related based on the steep dose­ response curve ( for fetal loss and decreased fetal weight) between 20­ 60 mg/ kg/ day in the preliminary range­ finding study. Therefore, the effects seen at 40 mg/ kg/ day are considered a threshold response for oxadiazon under the conditions of the OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 12 main study. The developmental toxicity LOAEL ( threshold) is 40 mg/ kg/ day, based on increased fetal resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification. The developmental toxicity NOAEL ( threshold) is 12 mg/ kg/ day. This study is classified Acceptable/ guideline and satisfies the guideline requirement for a developmental toxicity study ( 870.3700a) in the rat. 870.3700b Prenatal Developmental Toxicity Study ­ Rabbit In a developmental toxicity study ( MRID 40470201), oxadiazon technical ( 95.6% a. i.) was administered daily by gavage in 5 ml 1% aqueous methylcellulose vehicle/ kg body weight from gestation days 6 through 19 to groups of 15 to 19 pregnant New Zealand White rabbits per dose at 0, 20, 60 or 180 mg/ kg/ day. Pregnant females were examined daily for signs of toxicity and body weights were measured on Gestation Days 0 and 6, on alternate days through day 20 and on days 24 and 28. Dams were sacrificed on Day 29 and uterine contents were examined. Treatment­ related maternal toxicity was observed at 60 mg/ kg/ day as transient weight loss (­ 0.01 kg vs. 0.10 kg gain, controls; p< 0.05) and slightly decreased food consumption during the first half of treatment (­ 15% less than controls, treatment days 6­ 12; not statistically significant). These effects were more pronounced at 180 mg/ kg/ day and showed statistically significant reductions in weight gain and marked reductions in food consumption during and after treatment. The maternal toxicity LOAEL is 60 mg/ kg/ day, based on transient weight loss and decreased food consumption during treatment. The maternal toxicity NOAEL is 20 mg/ kg/ day. Treatment­ related fetal toxicity at 180 mg/ kg/ day included: increased postimplantation loss and late resorptions ( 18.85% vs. 8.6%, controls; p< 0.05), decreased mean fetal weight (­ 10%) and increased incidence of bilateral hind­ limb flexure ( 4.2% of fetuses, 3 litters affected vs. 0%, controls). Marginal developmental effects at 180 mg/ kg/ day were: increased incidence of rib abnormalities, delayed/ incomplete ossification in several bones and asymmetrical pelvis. No effects were seen at lower doses and there were no treatmentrelated malformations observed at any dose tested. The developmental toxicity LOAEL is 180 mg/ kg/ day, based on increased postimplantation loss, decreased mean fetal weight, increased bilateral hind­ limb flexure and possibly delayed/ incomplete ossification of several bones. The developmental toxicity NOAEL is 60 mg/ kg/ day. This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a non­ rodent developmental toxicity study ( 870.3700b) in the rabbit. 4.4 Reproductive Toxicity OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 13 Adequacy of data base for Reproductive Toxicity: The data base for reproductive toxicity is considered complete. No additional studies are required at this time. In the rat two­ generation reproductive toxicity study, no maternal, offspring or reproductive effects were reported at any dose tested up to 200 ppm ( 15.5 mg/ kg/ day). However, in the range­ finding study at
400 ppm ( 38 mg/ kg/ day), significant toxicity to the offspring ( fetal/ neonatal mortality) and the dams ( inactive mammary tissue, decreased gestational weight, due at least in part to fetal mortality) was observed. The neonatal mortality was probably related to the mammary tissue effects in the dams. In addition to the Executive Summaries provided below, the reproductive toxicity study is summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.3800 Reproduction and Fertility Effects ­ Rat In a 2­ generation reproduction study ( MRID 41239801; range­ finding study MRID 41240301) oxadiazon ( 96.6% a. i.) was administered in the diet continuously to CD rats ( 30 rats/ sex/ dose) at 0, 20, 60 or 200 ppm ( equivalent to an average daily intake [ M/ F] of 0, 1.50/ 1.84, 4.65/ 5.63 or 15.50/ 18.20 mg/ kg/ day, average of P and F 1 generation premating food consumption). Dose levels were selected based on the results of the 1­ generation range­ finding study, which tested at 0, 50, 100, 200, 400 or 800 ppm ( 6 animals/ sex/ dose, 4 weeks premating exposure). The P animals were exposed to the test substance beginning at approximately 6 weeks of age for 14 weeks prior to mating and continuing until sacrifice after weaning ( post­ partum day 25). F 1 pups selected ( 30/ sex/ dose) to produce the F 2 generation were exposed to the same dosage as their parents beginning at postnatal day ( PND) 25 for 14 weeks premating and continuously throughout the rest of the study until weaning of the F 2 offspring ( postpartum day 25). Liver, kidneys, ovaries, uterus, prostate, epididymis, testes and seminal vesicles were weighed and examined for gross/ microscopic pathology. Mammary gland, pituitary and vagina were examined for pathological changes. The 1­ generation range­ finding study tested in 6 dams/ dose group at dietary concentrations of 0, 50, 100, 200, 400 or 800 ppm ( 0, 5/ 5, 9/ 9, 19/ 19, 36/ 38 or 67/ 75 mg/ kg/ day, respectively), administered beginning15 days prior to initiation of mating until lactation day 4. No treatment­ related findings were reported at  200 ppm; effects at 400 and 800 ppm are discussed below. There was no evidence of treatment­ related changes in clinical signs, mortality, body weights or weight gains, food consumption, food efficiency, organ weights or microscopic or macroscopic pathology observed in P or F 1 adults in the main study. Slight liver alterations in F 1 adults at 200 ppm (+ 6% relative liver weight, females, periacinar hepatocellular hypertrophy, males) were considered an adaptive response. However, at 400 ppm in the range­ finding study, markedly decreased gestational weight gain (­ 34% below controls, primarily after GD 13) was observed ( due largely to increased fetal loss). At 800 ppm, decreased maternal weight gain of ­ 38% below controls, also primarily after GD 13, blood in the urine in the cage paper of males and blood in the nares/ face/ urogenital region of 1 dam were observed. The LOAEL ( main study) for parental toxicity is > 200 ppm ( 15.5 mg/ kg/ day; HDT in main study); however, a LOAEL of 400 ppm ( 38 OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 14 mg/ kg/ day), based on decreased gestational weight gain, was observed in the rangefinding study. The parental toxicity NOAEL ( main study) is
200 ppm. No differences in reproductive parameters in P or F 1 parental animals, nor in F 1 or F 2 offspring viability, clinical signs, body weight or body weight gain, developmental landmarks, auditory or ophthalmological function or macroscopic pathology were observed in the main study. However, in the range­ finding study, pronounced reproductive/ offspring toxicity at 400 ppm in the 4 dams that littered ( 5 pregnant) included inactive/ pale mammary tissue, reduced litter size and increased gestation length (+ 1 day). Pre­/ perinatal mortality resulted in total litter losses for all dams by day 1 postpartum ( 17 offspring were examined: 20% late resorptions, 7.7% dead fetus, 73% without milk in stomach). At 800 ppm, 2 dams littered but all were late resorptions; 4 dams that failed to litter had blood in their cage on GD 23 ( implantation sites/ dam were comparable to controls). The reproductive/ offspring toxicity LOAEL ( main study) is > 200 ppm ( 15.5 mg/ kg/ day; HDT in main study); however, a LOAEL of 400 ppm ( 38 mg/ kg/ day), based on inactive mammary tissue and fetal/ pup death, was observed in the range­ finding study. The reproductive/ offspring toxicity NOAEL ( main study) is
200 ppm. This reproductive toxicity study in the rat is classified Acceptable/ guideline ( 870.3800) and satisfies the guideline requirement for a multigenerational reproductive toxicity study in rats. Although no significant effects were observed at
200 ppm in the main or rangefinding studies, pronounced reproductive/ offspring toxicity, including complete litter loss, was observed at
400 ppm. At the Hazard Identification Assessment Review Committee ( HIARC) meeting, held December 7, 2000 ( see HED Document No. 014469), it was concluded that the neonatal loss seen at 400 ppm was attributable to maternal effects ( i. e., inactive mammary tissue resulting in possible starvation of the pups which was manifested as 73% of the examined offspring without milk in their stomachs). The HIARC further concluded that the inactivity of mammary tissue may have been related to endocrine disruption. However, this finding was not considered to be likely because there was no supporting evidence of possible endocrine disruption observed in any other study in the Oxadiazon database. 4.5 Chronic Toxicity Adequacy of data base for chronic toxicity: The data base for chronic toxicity is considered complete. No additional studies are required at this time. In the Wistar rat, males were more sensitive to oxadiazon than females and the NOAEL of 10 ppm ( 0.36 mg/ kg/ day) was based on centrilobular swelling in male rat liver at 100 ppm ( 3.5 mg/ kg/ day). Oxadiazon caused hepatic toxicity, demonstrated by alterations in liver­ related blood enzymes ( males), liver enlargement and microscopic pathology ( hepatocellular swelling and increased acidophilic foci of cellular alteration, brown pigmentation and bile duct proliferation). Liver tumors were also increased by treatment ( see Section for details). Mild anemia was observed in males. In addition, oxadiazon caused renal OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 15 toxicity ( increased BUN, brown pigmentation in the proximal tubular cells and cortical interstitial tissues in both sexes and incidence of chronic nephropathy in males). F344 rats had similar treatment­ related effects, including anemia in males, increased liver­ related blood enzymes primarily in males, increased urine color and bilirubin/ urobilinogen, increased liver and kidney weights, microscopic liver effects such as hypertrophy, fatty change and necrosis and pigmented nephrosis. In the dog, the liver was also the primary target organ, as demonstrated by liver enlargement. Evidence of liver pathology and serum enzyme alterations, increased blood/ bilirubin in the urine, increased kidney and thyroid weights ( and possibly anemia in 1 female) were observed only at a relatively high dose ( 200 mg/ kg/ day) in which only 2/ sex dogs were evaluated and 1 female was sacrificed in moribund condition. In addition to the Executive Summaries provided below, chronic toxicity studies are summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.4300 Chronic Toxicity/ Carcinogenicity B Rat ( 1) In a chronic/ carcinogenicity toxicity study ( MRID Nos. 00149003 [ main study]/ MRID 00157780 [ additional data]), oxadiazon ( tech., 99.9% a. i.) was administered to Fischer 344 rats ( 76/ sex/ dose) in the diet at dose levels of 0, 10, 100, 1000 or 3000 ppm ( mean consumption per group: equivalent to 0, 0.5, 4.8, 50.9 or 163.1 mg/ kg/ day for males or 0, 0.6, 5.9, 60.9 or 192.7 mg/ kg/ day for females) for 24 months. Parameters examined included: ( 1) twice daily observations, ( 2) weekly body weights and food consumption, ( 3) ophthalmic examinations ( all animals at pretest and 10 rats/ group at 6, 12 and 24 months), ( 4) standard hematology, clinical chemistry and urinalysis ( 10 rats/ group at 6, 12 and 24 months), and ( 5) gross necropsy, organ weights and histology ( 10 rats/ group at 6 and 12 months and all survivors at 24 months). There were no effects on mortality. At 1000 and 3000 ppm, clinical signs included emaciation, anemia and brown colored urine; ophthalmic examinations revealed narrowing of the fundus vasculature ( males at 1000 ppm and both sexes at 3000 ppm). Significant decreases ( p< 0.05­ 0.001) in body weight gain were apparent in rats of both sexes receiving 1000 or 3000 ppm and significant decreases in food consumption were recorded for both sexes starting at week 3 ( males) and week 6 ( females). Consistent hematological findings indicative of anemia at 3000 ppm ( both sexes) were: significantly decreases erythrocyte counts, hematocrit, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration. Anemia was also present in males at 1000 ppm and appeared to be less severe in females. Adverse effects on urinalysis parameters were confined to the two highest dose groups ( both sexes) and included: urine color, strongly positive bilirubin and urobilinogen. Significantly affected clinical chemistry parameters included: reduced glucose levels ( males
1000 ppm at 6 and 12 months; females 3000 ppm at 6 months); increased total protein ( consistent effect only in the females at
100 ppm and generally at all sampling intervals); increased total cholesterol ( males at 1000 ppm and both sexes at 3000 ppm) and increased bilirubin ( males
1000 ppm at 6 and 12 months; females 3000 ppm at 6 months). In addition, significant increases OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 16 in GOT, GPT, AP and BUN generally correlated well with liver morphological changes at
1000 ppm ( males). Similarly, increased absolute and relative liver and kidney weights at
1000 ppm ( both sexes) correlated well with liver and kidney histopathology effects. At termination, oxadiazion also induced increased absolute and relative liver weights at 100 ppm ( females). Non­ neoplastic pathology included: hepatocyte changes consisting of progressive alterations from hypertrophy through fatty changes to necrosis were noted in males receiving 1000 and 3000 ppm and females receiving 3000 ppm. Other non­ neoplastic changes noted in both sexes were: pigmented nephrosis and fat replacement in the pancreas at 1000 ppm and basophilic changes in the adrenal glands at 3000 ppm. The LOAEL is 100 ppm ( 4.8 mg/ kg/ day) based on increased absolute liver weights in males and females and increased total serum protein in females. The NOAEL is 10 ppm ( 0.5 mg/ kg/ day). Neoplastic findings were: increased incidences of benign and malignant liver tumors in males at 1000 and 3000 ppm after prolonged exposure to hepatotoxic doses. In addition, there was no decrease in latency for liver neoplasia. Dosing was considered adequate in males and the data support a presumption that the maximum tolerated dose ( MTD) lies between 100 and 1000 ppm. This chronic/ carcinogenicity study in the rat is Acceptable/ Guideline and satisfies the guideline requirement for a combined chronic/ carcinogenicity study ( 870.4300) in the rat. ( 2) In a chronic/ oncogenicity toxicity study ( MRID 40993401), oxadiazon ( tech., 95.9% a. i.) was administered to SPF Wistar rats ( 80/ sex/ dose) in the diet at dose levels of 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.106, 0.36, 3.5 or 39 mg/ kg/ day for males or 0, 0.131, 0.44, 4.2 or 44 mg/ kg/ day for females) for 104 weeks. Clinical signs were monitored daily. Body weights were determined weekly for the first 26 weeks and biweekly, thereafter; food consumption was determined weekly for 20 rats/ group. Groups of 8 rats/ sex/ group were sacrificed at weeks 26, 52 and 78 and 10 animals/ sex/ group at 104 weeks were subjected to hematology, biochemistry and urinalysis examinations. All 80 rats/ sex/ dose were reportedly examined for histopathology. Dose selection was based on a preliminary 4­ week range finding study with 10, 100, 1000 or 3000 ppm. At 1000 and 3000 ppm, signs of toxicity included: anemia ( males­­ both groups; females­­ 3000 ppm, only), effects on biochemical parameters associated with hepato­ renal disorders ( increased GOT, GPT, ALP, BUN, total cholesterol and/ or urobilinogen), and liver and kidney weight changes accompanied by a dark color. There were no adverse effects on mortality, clinical signs or food consumption. Treatment related effects included: decreased body weight gain for high­ dose males generally throughout the study; statistically significant body weight losses (­ 8.9%) were reported for the 10­ and 1000 ppm females only at study termination. Hematological parameters significantly affected were: decreased hematocrit and hemoglobin ( high­ dose males at week 26) and decreased mean corpuscular volume and mean corpuscular hemoglobin ( high­ dose males at weeks 26, 78 and 104). There were no consistent hematological effects in the OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 17 females. The generalized changes in the blood elements of male rats are indicative of anemia which was most evident at week 26. Significantly affected clinical chemistry parameters included: increased LDH, ALT, GOT, GPT, total and direct bilirubin and total cholesterol for high­ dose males at week 26; no toxicologically significant effects were seen in the females of any dose group. At 1000 ppm, males also showed increased urobilinogen at week 26. Increased liver weights were seen in high­ dose males and females throughout the study and statistically significant increases in kidneys ( both sexes) and testis ( males) were also consistently seen at 1000 ppm. Non­ neoplastic pathology in the liver at 1000 ppm included: increased centrilobular hepatocellular swelling ( males and females); increased acidophilic foci of cellular alteration ( males); brown pigmentation in the liver ( males and females); and bile duct proliferation ( males) At 100 ppm, increased centrilobular hepatocellular swelling was also seen in the males. Brown pigmentation in the proximal tubular cells and in cortical interstitial tissue ( males and females); and chronic nephropathy ( females) were also recorded for the kidneys of high­ dose rats. The LOAEL is 100 ppm ( 3.5 mg/ kg/ day) based on centrilobular swelling in the male rat livers; the NOAEL is 10 ppm ( 0.36 mg/ kg/ day). Neoplastic findings were: increased incidence of liver adenomas in males at 100 ( p< 0.05) and 1000 ppm ( p< 0.010); liver carcinomas were also increased at 1000 ppm in both sexes but not significantly. Dosing was considered adequate in males based on signs of transient anemia, increased serum enzyme activity, bilirubin and liver weight, decreased body weight gain, and pathological changes in the liver ( centrilobular hepatocellular swelling and foci of cellular alteration). Females were considered to be tested at a dose below the maximum tolerated dose ( MTD). However, since the NOAEL and LOAEL were defined for males ( 0.36/ 3.5 mg/ kg/ day), the hypothetical values for females are expected to be higher. Hence, the NOAEL and LOAEL for males are considered to be protective for females. The pathology report for this chronic/ carcinogenicity study in the rat was considered incomplete; thus, the overall study was listed as Supplementary. At this time, no additional information is being requested because the results are consistent with an acceptable rat chronic/ carcinogenicity study ( MRID No. 0014003/ 00157780) that satisfies the guideline requirement. Similarly, the presence of liver neoplasms confirms the evidence of a carcinogenic effect seen in MRID No. 0014003/ 00157780. After review of the data from this study by the Cancer Assessment Review Committee ( CARC), however, it was concluded that this deficiency did not compromise the integrity of the study or the interpretation of the results [ see Cancer Assessment Document­­ Evaluation of the Carcinogenic Potential of Oxadiazon ( Third Review), dated April 2001]. Using this rationale, the study is now upgraded and listed as Acceptable/ guideline and satisfies the guideline requirement for a combined chronic toxicity/ carcinogenicity study in the rat ( 870.4300). 870.4100b Chronic Toxicity ­ Dog In a one­ year chronic oral toxicity study ( MRID No. 41326401), oxadiazon ( tech., 94.9% OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 18 a. i.) was administered orally via capsules once a day to five groups of Beagle dogs ( 4 males and 4females/ group dosed with 0, 5, 20 or 60 mg/ kg/ day; 2 males and 2 females dosed with 200 mg/ kg/ day). Dose selection was based on the findings of a preliminary study showing that dogs could not tolerate 360 mg/ kg/ day and that minimal changes were seen at 60 mg/ kg/ day. Parameters examined in all animals included: ( 1) daily observations; ( 2) weekly body weights and food consumption; ( 3) ophthalmic examinations at pretest and week 51; ( 4) standard hematology ( pretest and at weeks 12, 24 and 50), clinical chemistry ( pretest and at weeks 24 and 50) and urinalysis; ( 5) bone marrow analysis at week 52; and ( 6) gross necropsy, organ weights and histology. Due to the small number of animals tested ( 2/ sex, 1 female sacrificed at week 11) and that they were rejected due to lower body weight from inclusion in the range­ finding study, the findings in the 200 mg/ kg/ day dogs were considered to be supplementary information. There were no effects on mortality, clinical signs, food consumption, hematology, urinalysis or ophthalmic examinations. At 60 mg/ kg/ day, clinical biochemical changes in the males ( 3 of 4) included significant ( p< 0.05) elevations (  + 35%) in aspartate aminotransferase ( AST) at all intervals. For females, ALT and AST values were significantly decreased at week 24 (­ 32% to ­ 40%), an effect not considered of toxicological significance. No other alterations in biochemical parameters were considered to be an effect of oxadiazon. In males, significant increases in relative liver weights were seen at 60 (+ 39%) and 200 (+ 61%) mg/ kg/ day; absolute liver weights were also increased at 60 (+ 28%) and 200 (+ 41%) mg/ kg/ day but statistical significance was not attained. The response was doserelated with weight increases of + 7, + 23 or + 28% ( absolute) and + 7, + 21 and + 28% ( relative) at 5, 20 or 60 mg/ kg/ day, respectively. In females, significant increases in absolute liver weight were noted at levels
20 mg/ kg/ day (+ 35% and + 44% at 20 and 60 mg/ kg/ day, respectively); a nonsignificant + 21% increase was seen at 5 mg/ kg/ day. Relative female liver weights also showed a dose­ related response with a + 7, + 10 or + 38% increases at 5, 20 or 60 mg/ kg/ day, respectively. However, organ weight changes and increased blood levels of AST were not definitively associated with a pathological condition in the liver. At 200 mg/ kg/ day, one female was sacrificed in moribund condition. Observed effects included pallor, thinness, decreased weight gain, possible anemia ( based on hematological changes, brown urine in the sacrificed female and blood/ bilirubin in the urine of the surviving female), clinical chemistry alterations ( increased ALT, phosphorous; decreased glucose, total cholesterol, protein and potassium), increased liver, spleen, kidney and thyroid weights ( also lower testes weights) and hepatocellular histopathology ( centriacinar hepatocytic vacuolation, periacinar apoptosis and periacinar inflammation in females). The systemic toxicity LOAEL is 20 mg/ kg/ day, based on hepatic toxicity ( increased absolute and relative female liver weight accompanied by similar changes in the absolute and relative liver weights for both sexes at 60 mg/ kg/ day). The systemic toxicity NOAEL is 5 mg/ kg/ day. This study is classified Acceptable/ Guideline and satisfies the guideline requirement for a non­ rodent chronic oral toxicity study ( 870.4100b) in the dog. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 19 4.6 Carcinogenicity Adequacy of data base for Carcinogenicity: The data base for carcinogenicity is considered complete. No additional studies are required at this time. An increased incidence of hepatocellular neoplasms were observed in both rats ( F344 and Wistar) and mice ( CD­ 1 and ICR­ JCL). In mice, liver tumor incidence was increased in both sexes, whereas in rats the males were affected. In addition to the Executive Summaries provided below, carcinogenicity studies are summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.4300a Chronic Toxicity/ Carcinogenicity Study ­ rat See Section 4.5 ( Chronic Toxicity), above for the executive summaries. 870.4200b Carcinogenicity ( feeding) ­ Mouse ( 1) In a mouse oncogenicity study ( MRID No. 00115733), oxadiazon ( tech., 99.3% a. i.) was administered in the diet to CD­ 1 mice ( 70/ sex/ group) for up to 105 weeks at 0, 100, 300, 1000, or 2000 ppm ( equivalent to 0/ 0, 12/ 14, 37/ 44, 122/ 143, or 254/ 296 mg/ kg/ day [ M/ F], respectively). At 2000 ppm, significantly decreased survival ( and a dose­ related positive trend for decreased survival) were observed in males ( at termination, 43%, 24%, 36%, 27% and 4%, control to high dose) and in females ( at termination, 56%, 41%, 53%, 43% and 29%). During the first 26 weeks of treatment, 29/ 70 high­ dose males died or were sacrificed in extremis. It was stated that these animals were generally pale, inactive, weak, hypothermic and exhibited tremor and piloerection. Thoracic serosanguineous fluid was observed in these males at gross necropsy ( 15/ 29 treated vs 6/ 70 total controls affected and 1 of 2 controls that died by week 26). At histological examination, the following were also observed (# of animals): hypercellular spleens ( 18); diffuse, necrotic myocarditis ( 20); periacinar hepatocytic pallor ( 12); hepatic single cell necrosis ( 16); and pigmented Kupffer cells ( 8). An increase ( p< 0.05 or 0.01) in the total incidence of distended abdomen was observed at various intervals in all treated males ( 80­ 90% treated vs 60­ 61% controls). Pale eyes were observed in females ( 50­ 60% treated vs 31% controls). At 1000 and 2000 ppm, increased ( p< 0.05 or 0.01) incidence of pallor was observed ( 40­ 46% treated vs 21% controls) during the study. At 2000 ppm, body weights were reduced in males at week 104 (  12%, not analyzed statistically). Reductions ( p< 0.05 or 0.01) in mean body weight gain were observed in the males during weeks 1­ 13 (  13%) and for weeks 0­ 104 (  26%); during weeks 66­ 92, weight loss was greater at high dose than controls (­ 7 g vs. ­ 2 g, respectively). Slight anemia, as indicated by decreased ( p< 0.05, 0.01, or 0.001) hematocrit (­ 5 to ­ 30%), hemoglobin (­ 6 to ­ 28%), and erythrocyte count (­ 12 to ­ 32%), was observed in the 1000 ppm males and 2000 ppm males and females. Neutrophil count was slightly increased at 2000 ppm in males (­ 83%) and females (­ 117%) at termination, OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 20 possibly reflecting a mild inflammatory response. Increases ( p< 0.05, 0.01, or 0.001) with respect to concurrent controls were observed in absolute and relative ( to body weight) liver weights in all male treatment groups (+ 45%/+ 52%, + 46%/+ 57%, + 107%/+ 120% and + 86%/+ 120%) and in the 1000 and 2000 ppm female groups (+ 48/+ 53% and + 103%/+ 102%). At gross necropsy, increased incidence of hepatic pale areas/ foci and masses were observed in all male groups when excluding animals that died before week 27 ( pale areas/ foci 36%­ 59% treated vs 4% controls; masses 41%­ 47% treated vs 27% controls) and all female groups ( pale areas/ foci 11%­ 19% treated vs 7% controls; masses 10%­ 26% treated vs 3% controls). In addition, raised areas in the liver were observed in the 300, 1000, and 2000 ppm females ( 10­ 11% vs 1% control). Increases in large, eosinophilic hepatocytes were observed in all male and female groups without a clear dose­ response ( 7­ 23 treated affected vs 0­ 3 controls, N = 70, all groups). Slight to moderate hepatic amyloidosis was increased in all male treatment groups ( 9­ 22 treated affected vs. 0 controls) and in high­ dose females ( 12/ 70 treated vs 3/ 70 controls). Increased incidence of pigmented Kupffer cells ( 7/ 41 treated vs 0/ 70 controls) were observed in males that did not die by week 26. Food consumption, food efficiency, and water consumption ( visually inspected, only) for both sexes at all doses were unaffected by treatment with oxadiazon at any tested dose. The systemic toxicity LOAEL is 100 ppm for males and females ( equivalent to 12/ 14 mg/ kg/ day [ M/ F]) based on clinical signs, gross and microscopic liver lesions in both sexes, and increased liver weights in males. The systemic toxicity NOAEL is < 100 ppm. Under the conditions of this study, there was an increased incidence of hepatocellular neoplasms in males and females. Incidences of hepatocellular adenomas were increased ( p< 0.05, 0.01, or 0.001) in all groups of treated males ( 27.9%, 51.4%, 68.6%, 56.5% and 53.7%­ 68.6%, control to high dose) and females ( 4.4%, 18.8%, 25.7%, 32.9% and 41.2%) treatment groups. These were outside of historical control ranges of males ( 0­ 12%) in all groups, including controls, and of females ( 0­ 14%) for all treated groups. The incidences of adenocarcinomas were increased ( p< 0.05 or not significant) in all male treatment groups ( 7.4%, 20.0%, 24.3%, 24.6% and 24.4%, control to high dose) and in the 1000 and 2000 ppm female groups ( 12.9% and 10.3% vs 1.5%, controls). The incidences were outside of historical control ranges for males ( 0­ 8%) in all treatment groups and females ( 0­ 6%) at
1000 ppm. The incidences of combined adenomas and adenocarcinomas were increased ( p< 0.05, 0.01, or 0.001) in all male ( 29,4%, 57.1%, 74.3%, 63.8% and 68.3%) and female ( 5.9%, 18.8%, 27.1%, 38.6% and 47.1%) treatment groups ( no historical controls provided for combined neoplasms). Dosing was considered adequate based on the finding of liver toxicity at all doses. The submitted study is classified as Acceptable/ guideline ( 870.4200b) and satisfies the guideline requirements for a carcinogenicity study in mice. ( 2) In a chronic/ oncogenicity toxicity study ( MRID 40993301), oxadiazon ( tech., 95.9% a. i.) was administered to 80 ICR­ JCL mice ( 80/ sex/ dose) in the diet at 0, 3, 10, 100 or 1000 OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 21 ppm ( equivalent to 0, 0.315, 1.09, 10.6 or 113 mg/ kg/ day for males or 0, 0.278, 0.92, 9.3 or 99 mg/ kg/ day for females) for 98­ 99 weeks ( the study was scheduled to run for 104 weeks but due to deaths, it was terminated at 98­ 99 weeks). Clinical signs were monitored daily. Body weights were determined weekly for the first 26 weeks and biweekly, thereafter; food consumption was determined twice weekly for 8 cages ( 4 mice/ cage). Groups of 9­ 10 mice/ sex/ group were sacrificed at weeks 52 and 98/ 99 were subjected to hematology, biochemistry, urinalysis and pathology analysis. Dose selection was based on a preliminary 4­ week range finding study with 0, 10, 100, 1000 or 3000 ppm. Liver weights were increased in males at 100, 1000 and 3000 ppm and in females at 1000 and 3000 ppm. Signs of anemia were reported for both sexes at
1000 ppm. Elevated GOT and GPT ( indicative of hepatic toxicity) was also evident at 1000 and 3000 ppm ( males) and 3000 ppm ( females). There were no consistent adverse effects on mortality, clinical signs, body weight or food consumption. Hematological parameters significantly affected in male mice were: decreased hematocrit, hemoglobin and erythrocyte counts ( all exposure groups at week 52 but not at week 98); and decreased mean corpuscular volume and mean corpuscular hemoglobin ( high­ dose males at weeks 52 and 98). In females, significantly decreased hemoglobin, mean corpuscular volume and decreased mean corpuscular hemoglobin were observed at 1000 ppm after 52 weeks of treatment. The generalized changes in these blood elements are indicative of anemia which was most evident in the males at week 52. Significantly affected clinical chemistry parameters at 1000 ppm included: increased GLP, GOT, ALP and BUN ( males and females) and at 100 ppm were: increased GLP and GOT ( males). High­ dose males also had brownish colored urine at week 52. Significantly increased liver weights ( absolute/ relative) were seen in high­ dose males at weeks 52 and 98 and in high­ dose females at week 98. Significant increases in absolute and relative adrenal ( males, week 98) and kidney ( females, week 98) weights were also seen at 1000 ppm. Non­ neoplastic pathology at 1000 ppm included: increased centrilobular hepatocellular swelling ( females); increased diffuse hepatocellular swelling ( males); brown pigmentation in the liver and proximal tubules of the kidney ( males and females); extramedullary hematopoiesis ( females) diffuse hepatocellular necrosis ( males) and increased auricular thrombus ( males). At 100 ppm, increased diffuse hepatocellular swelling and brown pigmentation in the liver were also seen in the males. The LOAEL is 100 ppm ( 10.6 mg/ kg/ day) based on anemia, hepatocellular swelling, necrosis and the formation of brown pigment in the liver and kidneys of male mice. This latter finding is consistent with the established mechanism of action of oxadiazon in plants, ( i. e., inhibition of porphyrin biosynthesis). The NOAEL is 10 ppm ( 1.09/ 0.92 mg/ kg/ day for males/ females). Neoplastic findings were: significant increases ( p< 0.05­< 0.001) in liver adenomas and carcinomas in males and females at 1000 ppm; liver adenomas and carcinomas were also significantly increased at 100 ppm in males. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 22 The pathology report for this chronic/ carcinogenicity study in the mouse was considered incomplete; thus, the overall study was listed as Supplementary. At this time, additional information is not being requested because the results are consistent with an acceptable mouse carcinogenicity study ( MRID No. 00115733) that satisfies the guideline requirement. Similarly, the presence of liver neoplasms confirms the evidence of a carcinogenic effect seen in other mouse long­ term studies ( MRID No. 00044322 and 00115733). After review of the data from this study by the Cancer Assessment Review Committee ( CARC), however, it was concluded that this deficiency did not compromise the integrity of the study or the interpretation of the results [ see Cancer Assessment Document­­ Evaluation of the Carcinogenic Potential of Oxadiazon ( Third Review), dated April 2001]. Using this rationale, the study is now upgraded and listed as Acceptable/ guideline ( 870.4200b). ( 3) In an oral mouse oncogenicity study ( MRID 00044322), oxadiazon ( tech. 95.5% a. i.) was administered in the diet to CD­ 1 mice ( 60/ sex/ group) for up to 104 weeks at 0, 300, 1000 or 2000 ppm ( equivalent to 0/ 0, 48/ 62, 153/ 201, and 319/ 417 mg/ kg/ day [ M/ F], respectively. Actual daily dosage may have been slightly lower, based on the analytical diet concentrations). At study initiation, high­ dose animals received 3000 ppm diets. Due to high mortality, the compound was removed from the high­ dose diet for weeks 2 and 3, then dosing was re­ initiated at 2000 ppm. Animals that died during weeks 1­ 5 ( 10 males, 3 females) were replaced with parallel treated animals or control replacement animals that had not previously received the test article. No interim sacrifice was performed. Toxicity to the liver was observed at all doses. At 300 ppm, statistically significantly increased serum alkaline phosphatase (+ 60% above controls) and ALT or SGPT (+ 270%) in females, along with a non­ significant increase in AST or SGOT (+ 76%, females) and ALT (+ 75%, males), and statistically significant increases in abs/ rel liver weights in both males (+ 26%/+ 34%) and females (+ 50%/+ 60%) were observed. These parameters usually showed dose­ dependent increases at
1000 ppm. Grossly visible liver masses ( combined males/ females 38% vs. 9%, controls) and liver microscopic lesions ( bile duct proliferation, pigmented macrophages, diffuse hepatocellular hyperplasia, nodular hyperplasia, nodular hypertrophy and centrilobular hypertrophy) were increased at
300 ppm in both sexes. Some of these lesions did not show a dose­ response, but were still considered treatmentrelated At 1000 ppm, significantly increased serum alkaline phosphatase (+ 620%), AST (+ 104%), ALT (+ 218%) and cholesterol (+ 82%) were observed in males, and possibly lenticular degeneration in the eyes of males ( 10% vs. 0, controls). At 2000 ppm, most of these parameters showed additional increases and significantly increased cholesterol in females (+ 81%), increased lenticular degeneration in the eyes of males ( 25% vs. 0%, controls) and liver focal necrosis in males ( 54% vs. 35%, controls) and females ( 41% vs. 25%, controls) were also observed. A 16% decrease in hematocrit in males was considered of equivocal biological significance. Survival ( after lowering of high dose to 2000 ppm), clinical signs, body weights, food consumption/ efficiency and urine occult blood in both sexes were unaffected at all dose levels. The systemic toxicity LOAEL is 300 ppm ( approximately 48/ 62 [ M/ F] mg/ kg/ day) based on increased liver effects in both sexes. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 23 The systemic toxicity NOAEL is < 300 ppm. Under the conditions of this study, there was evidence of an increased incidence of hepatocellular carcinoma in both sexes. The increase was significant ( p< 0.01) in both sexes at 1000 ( males ­ 24/ 60 or 40% vs 5/ 60 or 8.3%, controls; females ­ 12/ 61 or 19.7% vs 1/ 60 or 1.7%, controls) and 2000 ppm ( 27/ 69 or 39.1%, males and 13/ 63 or 20.6%, females). The incidence at 300 ppm in both males ( 7/ 60 or 11.7%) and females ( 4/ 60 or 6.7%) was not significant. Dosing was considered adequate based on the finding of liver toxicity at all doses. The submitted study is classified as Unacceptable/ guideline ( 870.4200b). Although several study deficiencies were identified, the additional information is not being requested at this time because the results are consistent with an acceptable mouse carcinogenicity study ( MRID 00157780; also under MRID 00149003) that satisfies the guideline requirement. In the current study, the following were noted: ( 1) the summary tables of the gross pathology findings ( Tables 9 and 10) were illegible in the only study copy available for review and ( 2) it was unclear from the study report what system of classification of liver proliferative and neoplastic microscopic lesions were used in this study compared to current conventions of classification. Although hepatocellular carcinomas were increased in treated animals, no adenomas were reported, which are generally observed as part of the tumor progression. 4.7 Mutagenicity Adequacy of data base for Mutagenicity: The data base for mutagenicity is considered adequate based on pre­ 1991 mutagenicity guidelines. Overall, the available data indicate that oxadiazon is not mutagenic, but does cause neoplastic cell transformation in vitro. The acceptable bacterial assays conducted with 97.49% technical oxadiazon were negative. Similarly, neither 95.5% nor recrystallized oxadiazon ( 100%) were mutagenic or clastogenic in cultured mammalian cells and did not cause UDS in primary rat hepatocytes. There is, however, evidence that oxadiazon induced neoplastic transformation in Syrian hamster kidney cells both in the presence and the absence of S9 activation. This positive finding is consistent with the evidence from the mouse and rat long­ term bioassays in which the incidence of liver tumors was increased. Gene Mutation 870.5100 ­ Bacterial Reverse Gene Mutation Assay and 870.5500 ­ Bacterial DNA Repair Assay MRID 00069893 Acceptable/ guideline Doses tested: In Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2 hcr­, 100­ 2500 g/ plate and 10­ 1000 g/ plate w/ o S9 activation and 10­ 1000 g/ plate w/ S9. Bacillis subtilis strains H17 and M45, 20­ 2000 g/ plate w/ o activation. Negative. Cytotoxicity not observed. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 24 870.5100 ­ Bacterial Reverse Gene Mutation MRID 41871701 Acceptable/ guideline Doses tested: In Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100, 50­ 5000 g/ plate w/ and w/ o S9 activation. Negative up to cytotoxic doses ( 3330 g/ plate) in absence of S9 and up to 5000 g/ plate in presence of S9 ( not cytotoxic at any dose tested + S9). Insoluble at
500 g/ plate. 870.5300 ­ In Vitro Mammalian Gene Mutation Assay MRID 00115726 Acceptable/ guideline Doses tested: In L5178Y TK+/­ mouse lymphoma cells, 15.6, 31.3, 250, 500 or 1000 g/ mL ( trial 1) and 50, 300, 600, 800 or 1000 g/ mL ( trial 2) w/ o S9; 3.91, 7.81, 15.6, 31.3 or 62.5 g/ mL ( trial 1), 20, 30, 40, 60, 80 or 100 g/ mL ( trial 2) and 100, 120, 140, 160, 180 or 200 g// L ( trial 3) w/ S9. Negative up to cytotoxic levels ( 1000 g/ mL w/ S9 and 200 g/ mL w/ o S9). Insoluble at
62.5 g/ mL. 870.5300 ­ In Vitro Mammalian Gene Mutation Assay MRID 00115729 Acceptable/ guideline Doses tested: In L5178Y TK+/­ mouse lymphoma cells, oxadiazon recrystallise ( 100% a. i.) 31.3, 62.5, 125, 250, 500 or 1000 g/ mL w/ o S9 and 15.6, 31.3, 62.5, 125 or 250 g/ mL w/ S9. Negative up to cytotoxic doses ( 1000 g/ mL w/ o S9 and 250 g/ mL w/ S9). Insoluble at 250 g/ mL. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 25 Cytogenetics 870.5375 ­ In Vitro Mammalian Cell Chromosomal Aberration Assay MRID 00115728 Acceptable/ guideline Doses tested: In Chinese hamster ovary cells, oxadiazon recrystallise ( 100% a. i.) at 2.0, 6.7, 20, 66.7, 200, 667 or 2000 g/ mL w/ o S9 and 0.667, 2.0, 6.7, 20.0, 66.7, 200, 667 or 1000 g/ mL w/ S9 ( trial 1); and at 200, 300, 400, 500 or 600 g/ mL w/ S9 ( trial 2). Negative up to cytotoxic concentrations ( 200 g/ mL w/ o S9 and
500 g/ mL w/ S9). Insoluble at 667 g/ mL w/ o S9 and 200 g/ mL w/ S9. 870.5375 ­ In Vitro Mammalian Cell Chromosomal Aberration Assay MRID 00115730 Acceptable/ guideline Doses tested: oxadiazon tech. ( 95.5% a. i.) in Chinese Hamster ovary cells at 0.416, 1.25, 4.16, 12.5, 41.6 or 125 g/ mL ( trial 1) and 12.5, 25, 50 or 75 g/ ml w/ o S9 ( trial 2) and 1.25, 4.16, 41.6 or 125 g/ mL w/ S9 ( trial 2). Negative up to cytotoxic concentrations (
75 g/ mL w/ o S9 and
41.6 g/ mL w/ S9). Insoluble at 416 g/ mL. 870.5395 ­ Mammalian Erythrocyte Micronucleus Test MRID 00073288 Unacceptable/ guideline ( not upgradable) Doses tested: In CD­ 1 mice, 0, 500, 100 or 200 mg/ kg ( 2 gavage doses 24 hr apart). Harvested 6 hr after second dose. Negative; however was unacceptable because the 6 hr sampling time could have missed an effect and no evidence that target tissue was reached. 870.5395 ­ Mammalian Erythrocyte Micronucleus Test MRID 00073289 Unacceptable/ guideline ( not upgradable) Doses tested: In CD­ 1 mice, 0, 500, 1000 or 2000 mg/ kg, 2 gavage doses 24 hrs apart. Harvest 6 hrs post­ treatment. Negative; however was unacceptable because the 6 hr sampling time could have missed an effect and no evidence that target tissue was reached. 870.5395 ­ Mammalian Erythrocyte Micronucleus Test MRID 00073290 Unacceptable/ guideline ( not upgradable) Doses tested: In CD­ 1 mice, 0, 500, 1000 or 2000 mg/ kg, 2 gavage doses 24 hrs apart. Harvest 6 hrs post­ treatment. Negative; however was unacceptable because the 6 hr sampling time could have missed an effect. Clinical signs of toxicity observed at 2000 mg/ kg. Other Genotoxicity 870.5550 ­ Unscheduled DNA Synthesis MRID 00115723 Acceptable/ guideline Doses tested: In primary rat hepatocytes, 1.0, 2.5, 5.0, 10, 25, 50 250 or 1000 g/ mL, 18 hr exposure. Negative up to cytotoxic concentrations ( 100­ 500 g/ ml). 870.5550 ­ Unscheduled DNA Synthesis MRID 00115727 Acceptable/ guideline Doses tested: In primary rat hepatocytes, 0.5, 1.0, 2.0, 5.0, 10, 25 or 50 g/ mL. Negative up to cytotoxic concentrations (
100 g/ ml). OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 26 Nonguideline ­ In vitro cell transformation MRID 00115703 Acceptable/ non­ guideline Doses tested: In Syrian hamster BHK21 C13/ HRC1 cells, 12.5, 25, 50, 100 or 200 g technical oxadiazon/ mL and 25, 50, 100, 200 or 400 g recrystallized oxadiazon; both tested w/ and w/ o S9 activation. Positive in the presence and absence of S9 metabolic activation. At the LD 50 or HDT, transformation frequencies exceeded 5X solvent control w/ and w/ o S9 for both oxadiazon and recrystallized oxadiazon. 4.8 Neurotoxicity Adequacy of data base for neurotoxicity: These studies are not required at this time because there was no evidence of potential neurotoxicity in the database. 4.9 Metabolism and Dermal Penetration Adequacy of data base for metabolism and dermal penetration: The data base for metabolism is considered to be complete. No additional studies are required at this time. In rats, oxadiazon was extensively metabolized and most was excreted in both urine and feces during the 7 days following dosing. Although at the low dose ( 5 mg/ kg), only a small amount of parent compound was excreted, at high dose ( 500 mg/ kg), as much as 53% of unchanged oxadiazon was excreted in the feces. Females tended to excrete more of the administered dose in the urine than males. A total of 18 metabolites were identified in the urine and feces. Two studies not required by the guidelines were also submitted. In a dermal absorption study in the rat, penetration was shown to be less than 10% in rats exposed for up to 10 hrs. A 14­ day dietary study in the rat was also submitted in which peroxisomal proliferative effects were examined. In this study, liver enlargement, proliferation of hepatocyte peroxisomes and induction of several peroxisomal enzymes were observed. However, activity of catalase, usually induced by such compounds, was decreased by oxadiazon treatment. Hepatocellular proliferation was not evaluated. In addition to the Executive Summaries provided below, the metabolism and dermal penetration studies are summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). 870.7485 Metabolism ­ Rat In a metabolism/ pharmacokinetic study ( MRIDs 42324701, 42663601), five Crl: CD( SD) BR rats of each sex were dosed with 14C­ labeled oxadiazon at a single oral dose of 5 mg/ kg or 500 mg/ kg, and multiple doses of 5 mg/ kg unlabeled oxadiazon for 14 days followed by a single oral dose of labeled oxadiazon at 5 mg/ kg on day 15. At low doses ( 5 mg/ kg, single or multiple), oxadiazon was completely absorbed, metabolized and excreted in the urine and feces; virtually no free oxadiazon was found in the urine. At this OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 27 dose, the rates and routes of excretion of radioactivity were similar. At 500 mg/ kg, the rate of excretion was affected but the route was not. The excretion of radioactivity into the urine and the feces was sex dependent and the tissue residues were very low in all tissues except liver and fat. Over a 7­ day period, 85 to 93% of the test compound administered was excreted in the urine and feces. The radioactivity recovered in the urine, feces and tissues exceeded 94% of the dose and was sex­ related. Females excreted more radioactivity in the urine than males. The metabolism of oxadiazon in rats was extensive, but the benzene and pyrozolidine rings were not modified. Eighteen ( 18) metabolites were identified in the urine and feces. Four urinary and 5 fecal metabolites were present at levels greater than 1% of the dose. Among the 9 metabolites, U2, U7 and U10 from the urine correspond to F2, F7 and F9 of the feces. Female rats were efficient metabolizers and the urine was unique in that metabolites U4 and U5 were excreted in the urine only. In addition to 5 fecal metabolites, intact oxadiazon was present in feces only and was dose­ related. At the high dose more than 53% of the administered radioactivity was intact oxadiazon in the feces; at 5 mg/ kg, not more than 4.8% of the dose was intact oxadiazon in the feces. This observation is consistent with extensive absorption followed by excretion in the feces by way of the bile. This study is classified Acceptable/ guideline and satisfies the Guideline requirements ( 870.7385) for a metabolism study for oxadiazon in the rat. 870.7600 Dermal Absorption ­ Rat In a dermal penetration study ( MRID 44588101), 14C­ oxadiazon ( 99.6% a. i., radiochemical purity, mixed with unlabelled oxadiazon technical, 96% a. i.) in 1% aqueous carboxymethyl cellulose was administered dermally to groups of 24 male Sprague Dawley rats/ dose at 5.45, 39.2 or 523 g/ cm2 for exposure durations of 0.5, 1, 2, 4, 10 or 24 hours per dose ( 4 rats/ exposure time). Urine and feces were collected; skin was excised and blood, residual urine and carcasses were collected and analyzed. Recovery of radioactivity ranged from 83.2% to 106% of administered dose. The quantity of oxadiazon in washed skin during the exposure phase ranged from 0.06­ 0.38, 0.59­ 3.31 or 2.88­ 15.32 g/ cm2 at the low, mid or high dose, respectively. As a percentage of the administered dose, these were equivalent to 1.09%­ 6.89%, 1.50%­ 8.45% or 0.55%­ 2.93% ( low to high dose, respectively). In general, the amount of absorbed test material was not detectable during the first 2 hours of exposure. Absorption ( g/ cm2) was low throughout exposure and ranged from 0.06­ 0.6, 0.05­ 2.00 or 0.05­ 2.62 g/ cm2 ( low to high dose, respectively) at 4 to 24 hours; as a percent of the administered dose, these were equivalent to 1.11%­ 11.0%, 0.39%­ 5.11% or 0.01%­ 0.50%, respectively. The percent of test material on the skin versus the percent absorbed at 10 hours was 6.05% vs. 2.65% ( 5.45 g/ cm2), 4.71% vs. 0.63% ( 39.2 g/ cm2) and 1.03% vs. 0.05% ( 523 g/ cm2). Since the percent of dose absorbed decreased with increasing dose and the quantity absorbed was essentially the same, the results indicate that absorption but not dermal uptake was saturated at 39.2 and 523 g/ cm2. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 28 This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a dermal penetration study ( 870.7600) in the rat. 4.10 Special/ Other Studies A 14­ day dietary study evaluating peroxisomal proliferation by oxadiazon in the rat was submitted. In addition to the Executive Summary provided below, this study is summarized in capsule form in Section 9.0 ( Appendix), Table 9.1.2 ( toxicity profile table). In a special mechanistic study ( MRID No. 42310001), oxadiazon ( tech., 95.6% a. i.) was orally administered to groups of male Sprague­ Dawley rats ( 10 rats/ dose) at 0, 20, 200 or 500 mg/ kg/ day for 14 days. Clinical signs were monitored daily. Body weights, food consumption and water consumption were determined daily. After 14 days of treatment, animals were sacrificed and organ weights were determined. Livers were prepared for microscopic examination ( high­ dose only) and liver homogenates from all dose levels were assessed for protein, glucose 6­ phosphatase, catalase, palmitoyl CoA oxidation, palmitoyl carnitine transferase and acetyl carnitine transferase. There were no adverse effects on mortality, clinical signs, body weight or food and water consumption. Absolute and relative liver weights were significantly ( p< 0.05) increased at 200 and 500 mg/ kg/ day. Thyroid and kidney weights were unaffected by treatment. Significant ( p< 0.05) effects on liver biochemistry at 200 and 500 mg/ kg/ day were: decreased catalase (­ 62 and ­ 72%, respectively); increased palmitoyl CoA oxidation (+ 43 and + 98%, respectively); increased palmitoyl carnitine transferase (+ 92 and 113%, respectively); and increased acetyl carnitine transferase (+ 296 and 569%, respectively). Nonsignificant changes noted for these parameters in the 20­ mg/ kg/ day group were: increased palmitoyl CoA oxidation (+ 13%); increased palmitoyl carnitine transferase (+ 6%); and increased acetyl carnitine transferase (+ 57%). In addition, glucose 6­ phosphatase was significantly inhibited at 500 mg/ kg/ day. Data for these enzyme levels indicate dose­ dependent increases in peroxisomal enzyme activity ( in particular palmitoyl Co A and acetyl carnitine transferase as well as the mitochondrial associated palmitoyl carnitine transferase). Ultrastructural changes seen after treatment with 500 mg/ kg/ day included: peroxisome proliferation, increased lipids, sinusoidal dilation, and rough endoplasmic reticulum damage. The generalized changes in the enzyme levels indicate dose­ dependent increases in peroxisomal enzyme activity ( in particular palmitoyl Co A and acetyl carnitine transferase as well as the mitochondrial associated palmitoyl carnitine transferase). The LOAEL is 20 mg/ kg/ day ( lowest treatment level) based on increased peroxisomal enzyme activity ( in particular palmitoyl Co A and acetyl carnitine transferase) at all dose levels. This study does not define a NOAEL (< 20 mg/ kg/ day). This special peroxisome proliferation study in the rat is Acceptable/ non­ guideline for the purpose for which it was intended. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 29 5.0 TOXICITY ENDPOINT SELECTION 5.1 See Section 9.2 for Endpoint Selection Table. 5.2 Dermal Absorption Dermal Absorption Factor: 9 % The HIARC ( December 7, 2000) determined that a dermal absorption factor of 9% should be used for risk assessment. The dermal absorption factor is based on the dermal absorption observed ( 6.05% absorbed + 2.65% bound = 8.7%) after a 10 hr exposure in a rat dermal absorption study ( MRID 44588101). The dermal absorption factor is required for the short­ term, intermediate­ term and long­ term dermal risk assessments since oral doses were administered in the study selected for these exposure periods ( rat developmental toxicity study). 5.3 Classification of Carcinogenic Potential 5.3.1 Discussion of Findings Oxadiazon was evaluated for carcinogenicity for the third time by the HED Cancer Assessment Review Committee on March 7, 2001 ( HED Document No. 014555). This reevaluation was prompted by the submission of a mouse and a rat carcinogenicity study that were not previously available to the Agency for review. A treatment­ related increase in the incidence of hepatocellular benign and malignant tumors was identified in these new studies in male Wistar rats ( MRID 40993401) and in male and female ICR­ JCL mice ( MRID 40993301). The results of the new studies are consistent with those of the previously reviewed studies on F344 rats ( MRIDs 00149003, 00157780) and CD­ 1 mice ( MRIDs 00044322, 00115733). The findings of these studies are summarized above in the Hazard Assessment ( see Section 4.6). The quantitative risk [ Q 1 * ( mg/ kg/ day)­ 1 ] was also recalculated as shown below, based on evaluation of the new data ( Memorandum from L. Brunsman to N. McCarroll dated February 1, 2001). The available mechanistic data on the peroxisomal proliferative properties of oxadiazon were considered insufficient to support a threshold mechanism for hepatocellular carcinogenesis ( see Section 7.0, below). 5.3.2 Classification of Carcinogenic Potential Oxadiazon is classified as " likely to be a human carcinogen", using the classification system of the EPA Draft Guidelines for Carcinogen Risk Assessment ( July, 1999). Hepatocellular tumors were identified in two species and 2 sexes ( in mice; only males showed significant increases in rats). 5.3.3 Quantification of Carcinogenic Potential OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 30 The Q 1 * ( mg/ kg/ day)­ 1 calculated for oxadiazon is 7.11 x 10­ 2 mg/ kg/ day, based on male mouse liver adenoma and/ or carcinoma combined tumor rates from the 98­ week dietary study ( MRID 40993301). 6.0 FQPA CONSIDERATIONS 6.1 Special Sensitivity to Infants and Children In the rabbit developmental study, there was no evidence of either a quantitative or qualitative increase in the sensitivity of fetuses. However, in the rat developmental study, very little maternal toxicity ( small but significant decrease in body weight, ­ 2% and decrease in body weight gain, ­ 10%) was seen at the maternal and developmental LOAEL ( 40 mg/ kg/ day). By contrast, effects on offspring at this LOAEL were severe ( increased post­ implantation loss and late resorptions and decreased fetal weight). Neonatal effects ( LOAEL of 38 mg/ kg/ day, based on neonatal losses) in the dose rangefinding phase of the two generation reproduction study in rats were attributable to maternal effects ( i. e., inactive mammary tissue) at that dose. Based on weight­ of­ the­ evidence considerations, the Committee concluded that the overall data provide no clear evidence of either a qualitative or quantitative increase in susceptibility of rats or rabbits to in utero and/ or postnatal oxadiazon exposure. 6.2 Recommendation for a Developmental Neurotoxicity Study The HIARC recommended against requiring a developmental neurotoxicity study. This decision was based on results showing no evidence of neurotoxicity in any study in the database which included: chronic ( rats, mice, dogs), subchronic ( rat or rabbit), reproduction ( rat) or developmental ( rat or rabbit) studies. 7.0 OTHER ISSUES Many compounds that induce hepatic peroxisomal proliferation also are hepatic carcinogens. Because the special mechanistic study demonstrated that oxadiazon caused hepatocellular peroxisomal proliferation, the MTARC evaluated the complete database to determine whether it supported peroxisomal proliferation as a mechanism of action for hepatocellular carcinogenesis in rats and mice ( meeting of February 8, 2001). Based on weight­ of­ the­ evidence considerations, the MTARC determined that although oxadiazon did not show mutagenic potential and peroxisomal proliferation may be a possible mode of action for hepatocellular carcinogenesis by oxadiazon, the data were insufficient to support this mechanism. The weaknesses in the database included: ( 1) no cell proliferation data were provided for rats or mice; ( 2) a good concordance between the dose­ response for peroxisomal enzymatic activity and tumor formation was not observed and ( 3) the role of decreased catalase activity, which is generally increased by peroxisomal proliferator compounds, was not explained by the authors of the submitted mechanistic study. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 31 8.0 REFERENCES 00044322 Gunderson, G., Jefferson, N. D., Blair, M., Spicer, E. J. F. and Nelson, L. W. ( 1980) Life­ time Oncogenicity Study in Mice. International Research and Development Corp. IRDC No. 347­ 008, June 5, 1980. Unpublished study. 00069893 Shirasu, Y., Moriya, M. and Kato, K. ( 1976) Microbial Mutagenic Study on Oxadiazon. Institute of Environmental Toxicology, Nissan Chemical Industries, Ltd., Japan. No study/ report no. provided. Report dated June 4, 1976. Unpublished study. 00073288 Pasquet, J. and Fournier, E. ( 1980) Oxadiazon ( 17 623 R. P.), Batch BES 2253: Micronucleus Test in the Mouse. Rhone­ Poulenc, Centre Nicolas Grillet, France. Laboratory Report No. 20 512/ E. February 22, 1980. Unpublished study. 00073289 Pasquet, J. and Fournier, E. ( 1980) Oxadiazon ( 17 623 R. P.), Batch CA 76 204: Micronucleus Test in the Mouse. Rhone­ Poulenc, Centre Nicolas Grillet, France. Laboratory Report No. 20 513E. February 22, 1980. Unpublished study. 00073290 Pasquet, J. and Fournier, E. ( 1980) Compound 24 865 R. P.: Micronucleus Test in the Mouse. Rhone­ Poulenc, Centre Nicolas Grillet, France. Laboratory Report No. 20 533E. March 13, 1980. Unpublished study. 00111801 McGee, G.; Freeman, L.; Jolly, E. ( 1972) Subacute Dermal Toxicity Study in Rabbits. K G Laboratories Division, Parsippany, NJ. Laboratory Reference No: A­ 404. March 22, 1972. Unpublished study. 00111804 Weatherholtz, W. and Voelker, R. ( 1970) 13­ week Dietary Administration­­ Rats: RP 17623. TRW, Inc., Vienna, VA. Study No. 656­ 114. May 28, 1970. Unpublished study. 00111805 Weatherholtz, W. and Voelker, R. ( 1970) 13­ week Oral Administration­­ Dogs: RP 17623. TRW, Inc., Vienna, VA. Project No. 656­ 115. May 22, 1970. Unpublished study. 00115703 Hossack, D. J. N. and Daniel, M. R. ( 1982) Oxadiazon Lot CA 76 204 and Recrystallized Oxadiazon 17 623 RP Cell Transformation Test for Carcinogenicity. Huntingdon Research Centre, England. Laboratory report number RNP 152A/ 79368, July 29, 1982. Unpublished study. 00115723 Myhr, B. C. and McKeon, M. ( 1982) Evaluation of Oxadiazon Recristallise in the Primary Rat Hepatocyte Unscheduled DNA Synthesis Assay. Litton Bionetics, Inc., Kensington, MD. LBI Project No. 20991. June, 1982. Unpublished study. 00115726 Cifone, M. A and Balinas, V. ( 1982) Mutagenicity Evaluation of Oxadiazon in the Mouse Lymphoma Forward Mutation Assay. Litton Bionetics, Inc., Kensington, MD. LBI Project OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 32 No. 20999. Unpublished study. 00115727 Myhr, B.; McKeon, M. ( 1982) Evaluation of Oxadiazon ( Lot MAG 405) in the Primary Rat Hepatocyte Unscheduled DNA Synthesis Assay. Litton Bionetics, Inc., Kensington, MD. LBI Project No. 21001. June, 1980. Unpublished study. 00115728 Galloway, S. and Lebowitz, H. ( 1982) Mutagenicity Evaluation of Oxadiazon Recristallise, Lot BOS 2 385 in an in vitro Cytogenetic Assay Measuring Chromosome Aberration Frequencies in Chinese Hamster Ovary ( CHO) Cells. Litton Bionetics, Inc., Kensington, MD. LBI Project No. 21000. July, 1982. Unpublished study. 00115729 Cifone, M. and Balinas, V. ( 1982) Mutagenicity Evaluation of Oxadiazon Recristallise in the Mouse Lymphoma Forward Mutation Assay. Litton Bionetics, Inc., Kensington, MD. LBI Project No. 20999. April, 1982. Unpublished study. 00115730 Galloway, S. and Lebowitz, H. ( 1982) Mutagenicity Evaluation of Oxadiazon, Lot MAG 405 in an in vitro Cytogenetic Assay Measuring Chromosome Aberration Frequencies in Chinese Hamster Ovary ( CHO) Cells. Litton Bionetics, Inc., Kensington, MD. LBI Project No. 21000. July, 1982. Unpublished study. 00115733 Amyes, S. J., Macrae, S. M., King, D. J. and Whitney, J. C ( 1982) Oxadiazon: Oncogenicity in Dietary Administration to Mice for Period of 105 Weeks. Life Science Research, England. Laboratory Report No. 82/ RH0004/ 245. September 17, 1982. Unpublished study. 00149003 Kudo, S., Takeuchi, T., Hayashi, K. et al. ( 1981) Twenty­ four Month Chronic Toxicity Study of Oxiadiazon in Rats. Nippon Institute for Biological Science and Institute of Environmental Toxicology. No study/ report no. July, 1981. Unpublished study. 00157780 Nippon Institute for Biological Science ( 1986) Twenty­ four Month Chronic Toxicity Study of Oxadiazon in Rats: Revised Data Tables per EPA Request. Unpublished data. 40470201 Tesh, J. M., Ross, F. W., Bailey, G.. P., Wilby, O. K. and Tesh., S. A. ( 1987) Oxadiazon: Teratology Study in the Rabbit. Life Sciences Research, England. Laboratory Project ID 87/ RHA095/ 534. September 14, 1987. Unpublished study. 40470202 Tesh, J. M., McAnulty, P. A., Wightman, T. J., McCloskey, B. A., Wilby, O. K. and Tesh, S. A. ( 1987) Oxadiazon: Teratology Study in the Rat: Laboratory. Life Science Research, England. Project ID 87/ RHA093/ 356 ( Preliminary Study 87/ RHA092/ 040). August 3, 1987. Unpublished study. 40993301 Shirasu, Y. ( 1987) Oxadiazon­­ 23 Month Oral Chronic Toxicity and Oncogenicity Study in Mice. Institute of Environmental Toxicology, Tokyo, Japan. Study No. not listed. February, 1987. Unpublished study. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 33 40993401 Y. Shirasu ( 1987). Oxadiazon ­ 24 Month Chronic Toxicity and Oncogenicity Study in Rats. Institute of Environmental Toxicology, Tokyo, Japan; Study No. not listed. February 1987. Unpublished study. 41230401 Siglin, J. ( 1988) Delayed contact hypersensitivity study in guinea pigs with oxadiazon ( EPA). Springborn Life Sciences, Inc., Spencerville, OH. Laboratory Study No. 3147.26. December 20, 1988. Unpublished study. 41239801 Tesh, J. M., McAnulty, P. A. and Higgins, C. ( 1988) Oxadiazon: Effects of Dietary Administration Upon Reproductive Performance of Rats Treated Continuously Throughout Two Successive Generations. Life Sciences Research, England. Project ID 88/ RHA097/ 366. October 7, 1988. Unpublished study. 41240301 Tesh, J.; McAnulty, P.; Wightman, T.; et al. ( 1987) Oxadiazon: Effects of Dietary Administration Upon Reproductive Performance in the Rat: Dosage Range Finding Study. Life Sciences Research, England. Project ID 87/ RHA096/ 434. August 3, 1987. Unpublished study. 41326401 Chapman, E. A. ( 1989) Oxadiazon: Toxicity Study by Oral ( Capsule) Administration to Beagle Dogs for 52 Weeks. Life Sciences Research Ltd., England. Lab Project Number 88/ 0763. November 29, 1989. Unpublished study. 41863602 Siglin, J. C. ( 1991) 21­ Day Dermal Toxicity Study in Rabbits with Oxadiazon Technical. Springborn Labs, Inc., Spencerville, OH. Lab Project Number: 3147.86. March 20, 1991. Unpublished study. 41866501 Rush, R. E. ( 1990) Acute Oral Toxicity Study in Rats with Oxadiazon. Springborn Laboratories, Inc., Spencerville, OH. Lab Project Number 3147.84. August 14, 1990. Unpublished study 041866502 Rush, R. E. ( 1990) Acute Dermal Toxicity Study in Rabbits with Oxadiazon. Springborn Laboratories, Inc., Spencerville, OH. Lab Project Number 3147.85. August 14, 1990. Unpublished study. 41866503 Michlewicz, K. G. ( 1988) Acute Inhalation Toxicity Study of Oxadiazon in Rats­ Limit Test. Springborn Laboratories, Inc., Spencerville, OH. Lab Project Number 3147.24. December 20, 1988. Unpublished study. 41866504 Rush, R. E. ( 1991) Primary Eye Irritation Study in Rabbits with Oxadiazon. Springborn Laboratories, Inc., Spencerville, OH. Lab Project Number 3147.110. April 19, 1991. Unpublished study. 41866505 Rush, R. E. ( 1991) Primary Skin Irritation Study in Rabbits with Oxadiazon. Springborn Laboratories, Inc., Spencerville, OH. Lab Project Number 3147.111. April 11, 1991. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 34 Unpublished study. 41871701 L. F. Stankowski, Jr, ( 1991). Ames Salmonella Plate Incorporation Assay on Oxadiazon. Pharmalon Research International Inc., Waverly, PA. Study No. PH 301­ RP­ 001­ 91. April 30, 1991. Unpublished study. 42310001 Price, S. C. ( 1991) Studies on Morphological and Biochemical Changes in the Livers of Rats Treated for 14 Days with Oxadiazon. Robens Institute of Health and Safety, Surrey, England. Study Number R190/ 0312. January 9, 1991. Unpublished study. 42324701 Powles, P. ( 1992) ( 14C)­ Oxadiazon: Absorption, Distribution, Metabolism, and Excretion in the Rat: [ Final Report]. Hazleton UK, England. Study No. 7120­ 68/ 118. May 11, 1992. Unpublished study. 42663601 Powles, P. ( 1993): ( 14C)­ Oxadiazon: Absorption, Distribution Metabolism and Excretion in the Rat. [ Amendment to Final Report MRID No. 42324701] Hazleton UK, England. Study No. 7120­ 68/ 118. February 9, 1993. Unpublished study. 44588101 Cheng, T. ( 1996) Dermal Absorption of 14C­ Oxadiazon in Male Rats ( Preliminary and Definitive Phases) Corning Hazleton, Vienna, VA. Lab Project Number: CHW 6224­ 224. September 27, 1996. Unpublished study. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 35 9.0 APPENDICES Tables for Use in Risk Assessment OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 36 9.1 Toxicity Profile Summary Tables 9.1.1 Acute Toxicity Table ­ See Section 4.1 9.1.2 Subchronic, Chronic and Other Toxicity Tables Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results SUBCHRONIC TOXICITY STUDIES 870.3100 90­ Day oral toxicity ( CD rat) 00111804 ( 1970) Acceptable/ guideline 0, 25, 100 or 1000 mg/ kg/ d ( diet) NOAEL = 25 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased body weight, increased liver weight, hematological changes and clinical chemistry and pathological changes associated with liver damage. 870.3150 90­ Day oral toxicity in ( Beagle dog) 00111805 ( 1970) Acceptable/ guideline 0, 25, 100 or 1000 mg/ kg/ d ( capsule) NOAEL < 25 mg/ kg/ day LOAEL 25 mg/ kg/ day based on increased thyroid weights in males. 870.3200 21­ Day dermal toxicity ( NZW rabbit) 41863602 ( 1991 ) Acceptable/ guideline 0, 100, 500 or 1000 mg/ kg/ day NOAEL
1000 mg/ kg/ day. LOAEL > 1000 mg/ kg/ day. DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES 870.3700a Prenatal developmental ( SD rat) 40470202 ( 1987) Acceptable/ guideline 0, 3, 12 or 40 mg/ kg/ day ( gavage) Maternal NOAEL = 12 mg/ kg/ day. LOAEL = 40 mg/ kg/ day based on decreased body weight/ weight gain. Developmental NOAEL = 12 mg/ kg/ day LOAEL = 40 mg/ kg/ day based on increased fetal resorptions/ implantation loss, decreased pup weight and increased incidence of incomplete ossification. 870.3700b Prenatal developmental ( NZW rabbit) 40470201 ( 1987) Acceptable/ guideline 0, 20, 60 or 180 mg/ kg/ day ( gavage) Maternal NOAEL = 20 mg/ kg/ day LOAEL = 60 mg/ kg/ day based on transient weight loss during the first week of treatment. Developmental NOAEL = 60 mg/ kg/ day LOAEL = 180 mg/ kg/ day based on increased postimplantation loss and late resorptions, decreased fetal weight and increased bilateral hind­ limb flexure. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 37 870.3800 Reproduction and fertility effects ( CD rat) 41239801 ( 1988) Acceptable/ guideline 0, 20, 60 or 200 ppm ( M/ F 0, 1.5/ 1.84, 4.65/ 5.63 or 15.50/ 18.20 mg/ kg/ day, premating) Parental/ Systemic NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( decreased gestational weight gain in RF study at 38 mg/ kg/ day). Reproductive NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( inactive mammary tissue, fetal/ neonatal mortality in the RF study at 38 mg/ kg/ day). Offspring NOAEL
15.5 mg/ kg/ day LOAEL > 15.5 mg/ kg/ day ( fetal/ neonatal mortality in the RF study at 38 mg/ kg/ day). CHRONIC TOXICITY AND CARCINOGENICITY STUDIES 870.4100a Chronic toxicity ( rat) See 870.4300, Combined chronic toxicity/ carcinogenicity 870.4100b Chronic toxicity ( Beagle dog) 41326401( 1989) Acceptable/ guideline 0, 5, 20 or 60 mg/ kg/ day ( capsule) NOAEL = 5 mg/ kg/ day LOAEL = 20 mg/ kg/ day based on increased liver weight. 870.4200 Carcinogenicity ( CD­ 1 mouse) 00044322 ( 1980) Unacceptable/ guideline 0, 300, 1000 or 2000 ppm ( M/ F 0, 48/ 62, 153/ 201 or 319/ 417 mg/ kg/ day), in diet NOAEL < 48 mg/ kg/ day LOAEL 48 mg/ kg/ day based on increased liver weight, serum enzymes related to liver damage and microscopic pathology in the liver of both sexes. Evidence of carcinogenicity­ increased incidence of hepatocellular carcinoma, both sexes at
48/ 62 mg/ kg/ day. 870.4200 Carcinogenicity ( CD­ 1 mouse) 00115733 ( 1982) Acceptable/ guideline 0, 100, 300, 1000 or 2000 ppm ( M/ F 0, 12/ 14, 37/ 44, 122/ 143 or 254/ 296 mg/ kg/ day), in diet NOAEL 12 mg/ kg/ day LOAEL < 12 mg/ kg/ day based on clinical signs, increased liver weights in males and increased microscopic pathology in the liver of both sexes. Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms ( adenoma, combined adenoma/ carcinoma) in both sexes at all doses tested ( carcinoma alone increased in all male groups and at
143 mg/ kg/ day in females). 870.4200 Carcinogenicity ( ICR­ JCL mouse) 40993301 ( 1987) Acceptable/ guideline 0, 3, 10, 100 or 1000 ppm ( M/ F 0, 0.315/ 0.278, 1.09/ 0.92, 10.6/ 9.3 or 113/ 99 mg/ kg/ day), in diet NOAEL = 1.09 mg/ kg/ day LOAEL = 10.6 mg/ kg/ day based on anemia and microscopic lesions in the liver and kidneys ( all in males). Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms ( adenomas, carcinomas and combined adenomas/ carcinomas in males at
10.6 mg/ kg/ day and in females at 99 mg/ kg/ day). OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 38 870.4300 Combined chronic toxicity/ carcinogenicity ( F344 rat) 00149003, 00157780 ( 1982, 1986) Acceptable/ guideline 0, 10, 100, 1000 or 3000 ppm ( M/ F 0, 0.5/ 0.6, 5.9/ 4.8, 50.9/ 60.9 or 163.1/ 192.7 mg/ kg/ day, in diet NOAEL = 0.5 mg/ kg/ day LOAEL = 4.8 mg/ kg/ day based on increased liver weights in both sexes and increased total serum protein in females. Evidence of carcinogenicity ­ increased incidence of hepatocellular neoplasms in males ( adenomas and combined adenomas/ carcinomas in males at
50.9 mg/ kg/ day). 870.4300 Combined chronic toxicity/ carcinogenicity ( Wistar rat) 40993401 ( 1987) Acceptable/ guideline 0, 3, 10, 100 or 1000 ppm ( M/ F 0, 0.106/ 0.131, 0.36/ 0.44, 3.5/ 4.2 or 39/ 44 mg/ kg/ day) NOAEL = 0.36 mg/ kg/ day LOAEL = 3.5 mg/ kg/ day based on increased incidence of hepatocellular centrilobular swelling in males. Evidence of carcinogenicity­ increased incidence of hepatocellular neoplasms in males ( adenomas and combined adenomas/ carcinomas at
4.2 mg/ kg/ day and carcinomas at 39 mg/ kg/ day). MUTAGENICITY AND CELL TRANSFORMATION STUDIES 870.5100 Gene Mutation Bacterial reverse gene mutation assay and 870.5500 Bacterial DNA Repair Assay 00069893 ( 1976) Acceptable/ guideline S. typhimurium and E. coli 100­ 2500 and 10­ 1000  g/ plate w/ o S9 and 10­ 1000  g/ plate w/ S9. B. subtilis 20­ 2000  g/ plate w/ o S9. Negative in S. typhimurium strains TA1535, TA1437, TA1538, TA98 and TA100; E. coli strain WP2 hcr­ and B. subtilis strains H17 and M45 ( cytotoxicity not observed ). 870.5100 Gene Mutation Bacterial reverse gene mutation assay 41871701 ( 1991) Acceptable/ guideline 50­ 5000  g/ plate w/ o or w/ S9. Negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 ( cytotoxicity observed at
3330  g/ plate w/ o S9 but not w/ S9). Insoluble at
500  g/ plate. 870.5300 Gene Mutation In vitro mammalian cell forward gene mutation assay 00115726 ( 1982) Acceptable/ guideline 15.6­ 1000  g/ mL ( Trial 1), 50­ 1000  g/ mL ( Trial 2), both w/ o S9; 3.91­ 62.5 ( Trial 1), 20­ 100 ( Trial 2) and 100­ 200  g/ mL ( Trial 3), all w/ S9. Negative in L5178Y TK+ mouse lymphoma cells ( cytotoxicity observed at 1000  g/ mL w/ o S9 and
200  g/ mL w/ S9). Insoluble at
62.5  g/ mL. 870.5300 Gene Mutation In vitro mammalian cell forward gene mutation assay 00115729 ( 1982) Acceptable/ guideline 31.3­ 1000  g/ mL w/ o S9 and 15.6­ 250  g/ mL w/ S9 Negative in L5178Y TK+ mouse lymphoma cells ( cytotoxicity observed at 1000  g/ mL w/ o S9 and 250  g/ mL w/ S9). Insoluble at 250  g/ mL. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 39 870.5375 Cytogenetics In vitro mammalian cell chromosomal aberration assay 00115728 ( 1982) Acceptable/ guideline 2­ 2000  g/ mL w/ o S9; 0.667­ 2000  g/ mL ( Trial 1) and 200­ 600  g/ mL ( Trial 2), both w/ S9. Negative in Chinese hamster ovary ( CHO) cells ( cytotoxicity observed at 200  g/ mL w/ o S9 and 500  g/ mL w/ S9). Insoluble at 667  g/ mL w/ o S9 and 200  g/ mL w/ S9. 870.5375 Cytogenetics In vitro mammalian cell chromosomal aberration assay 00115730 ( 1982) Acceptable/ guideline 0.416­ 125  g/ mL ( Trial 1) and 12.5­ 75  g/ mL ( Trial 2), both w/ o S9; 1.25­ 125  g/ mL w/ S9 ( trial 2). Negative in Chinese hamster ovary ( CHO) cells ( cytotoxicity at 75  g/ mL w/ o S9 and 41.6  g/ mL w/ S9). Insoluble at 416  g/ mL. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 0073288 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg 100% oxadiazon Negative up to limit dose of 2000 mg/ kg, but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. No signs of toxicity were observed. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 0073289 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg Negative up to limit dose of 2000 mg/ kg , but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. No signs of toxicity were observed. 870.5395 Cytogenetics Mammalian erythrocyte micronucleus test 00732890 ( 1980) Unacceptable/ guideline ( not upgradable) 0, 500, 1000 or 2000 mg/ kg 24865 RP ( 99%), an oxadiazon impurity Negative up to limit dose of 2000 mg/ kg, but early sampling time ( 6 hr post­ dosing) may have missed peak time of mutagenic effect. Clinical signs of toxicity observed at
1000 mg/ kg including 2 deaths at 2000 mg/ kg. 870.5550 Other Effects Unscheduled DNA synthesis assay 00115723 ( 1982) Acceptable/ guideline 1.0 to 1000  g/ mL Negative in primary rat hepatocytes after 18 hrs ( cytotoxicity observed at 100­ 500  g/ mL). 870.5550 Other Effects Unscheduled DNA synthesis assay 00115727 ( 1982) Acceptable/ guideline 0.5 to 50  g/ mL Negative in primary rat hepatocytes after 18 hrs ( cytotoxicity observed at 50  g/ mL). OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 40 Nonguideline Other Effects In vitro cell transformation 00115703 ( 1982) Acceptable/ nonguideline 12.5­ 200  g/ mL w/ and w/ o S9 for technical oxadiazon; 25­ 400  g/ mL for recrystallized oxadiazon ( 100%) w/ S9 or w/ o S9. Dose­ related induction of cell transformation above background levels observed w/ S9 and w/ o S9 activation in Syrian hamster kidney cells ( BHK21 C13/ HRC1 cells) for both technical and recrystallized oxadiazon. METABOLISM, DERMAL PENETRATION AND SPECIAL MECHANISTIC STUDIES 870.7485 Metabolism and pharmacokinetics ( Crl: CD( SD) BR rat) 42324701, 42663601 ( 1992, 1993) Acceptable/ guideline 5 mg/ kg 14C­ oxadiazon ( single dose), 5 mg/ kg ( 14­ day dose of oxadiazon + 1 dose of 14C­ oxadiazon, day 15) or 500 mg/ kg 14Coxadiazon ( gavage) At 5 mg/ kg, oxadiazon is completely absorbed, metabolized and excreted in urine and feces ( no parent compound in urine; < 5% in feces. At 500 mg/ kg, 53% of administered dose was excreted in feces as parent compound. For both groups,
83% of administered dose was excreted in urine and feces ( total recovery
94%) by 7 days' post­ dosing. Females tended to excrete more radioactivity in urine than males. Oxadiazon was metabolized primarily by hydroxylation and glucuronide conjugation, but benzene and pyrozolidine rings were not metabolized. A total of 18 metabolites were identified in urine and feces ( 4 urinary, 5 fecal metabolites present at > 1% of administered dose). 870.7600 Dermal penetration ( SD rat) 44588101( 1996) Acceptable/ guideline 5.45, 39.2 or 523  g/ cm2 ( exposure times of 0.5, 1, 2, 4, 10 or 24 hrs) Total absorption 9% of administered dose following 10 hr exposure ( 6.05% in skin and 2.65% absorbed). Absorption but not dermal uptake saturated at 39.2 and 523  g/ cm2. Special studies ( nonguideline) ­ Peroxisomal proliferation ( SD rat) 42310001 ( 1991) Acceptable/ nonguideline 0, 20, 200 or 500 mg/ kg/ day in diet for 14 days NOAEL < 20 mg/ kg/ day. LOAEL = 20 mg/ kg/ day, based on increased peroxisomal enzyme ( palmitoyl CoA and acetylcarnitine transferase) activities. At 200 mg/ kg/ day, liver enlargement and at 500 mg/ kg/ day, ultrastructural changes ( peroxisomal proliferation and microsomal alterations) were also observed. However, catalase was decreased by treatment. OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 41 9.2 Summary of Toxicological Dose and Endpoints for Oxadiazon for Use in Human Risk Assessment1 EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary NOAEL= N/ A UF = N/ A This risk assessment is not required at this time because there are no food or feed uses for Oxadiazon Chronic Dietary NOAEL = N/ A UF = N/ A This risk assessment is not required at this time because there are no food or feed uses for Oxadiazon Cancer Q1* of 7.11 x 10­ 2 ( mg/ kg/ day)­ 1in human equivalentsa, based on increased incidence of combined hepatocellular adenomas/ carcinomas in male ICR­ JCL mice. " Possibly a human carcinogen", based on increased incidence of hepatocellular tumors in four of the five positive studies ( two mouse studies and two rat studies) at doses that exceeded the maximum tolerated dose. Combined Chronic Toxicity/ Carcinogenicity Studies in Rats MRID Nos. 00149003/ 00157780 and 40993401 Carcinogenicity Studies in Mice MRID Nos. 00115733 and 40993301 ( increased liver tumors also observed in both sexes in an unacceptable mouse oncogenicity study, MRID 00044322). Incidental Oral, Short­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Incidental Oral, Intermediate­ Term NOAEL= 12 Maternal effects Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Short­ Term NOAEL= 12 Developmental effects Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption factor of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 42 EXPOSURE DOSE ( mg/ kg/ day) ENDPOINT STUDY Dermal, Intermediate­ Term NOAEL= 12 Developmental effect Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption factor of 9% is applied. Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). For this risk assessment, the dermal absorption factor of 9% is applied. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Inhalation, Short­ Term NOAEL= 12 Developmental effect Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, use a route­ to­ route extrapolation and a 100% absorption rate ( default value). Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Intermediate­ Term NOAEL= 12 Developmental effect Increased fetal resorptions/ postimplantation loss, increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL). For this risk assessment, use a route­ to­ route extrapolation and a 100% absorption rate ( default value). Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL). Use a route­ toroute extrapolation and a 100% absorption rate ( default value) Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 OXADIAZON TECH. Updated April 4, 2001 RED Toxicology Chapter 43 SignOff Date: 7/ 10/ 01 DP Barcode: D266361 HED DOC Number: 014614 Toxicology Branch: TOX1

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EPA-HQ-OPP-2002-0309-0008

Supporting & Related Material

U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 . OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES May 8, 2001 DPBarcode: D273599 PC Code 109001 MEMORANDUM SUBJECT: Tier I Estimated Environmental Concentrations of Oxadiazon FROM: José Luis Meléndez, Chemist Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) THROUGH: Mah T. Shamim, Ph. D., Chief Environmental Risk Branch V Environmental Fate and Effects Division ( 7507C) TO: Margaret Rice, Acting Branch Chief Veronique LaCapra, CRM and Tom Myers, Team Leader Special Review and Reregistration Division ( 7508C) This memo presents the Tier I Estimated Environmental Concentrations ( EECs) for oxadiazon, calculated using FIRST ( surface water) and SCIGROW ( ground water) for use in the human health risk assessment. For surface water, the acute ( peak) value is 246 ppb and the annual average value is 100 ppb. The groundwater screening concentration is 0.6 ppb. These values generally represent upper­ bound estimates of the concentrations that might be found in surface water and groundwater due to the use of oxadiazon on turf, which is the major use of the chemical. Background Information on FIRST: FIRST is a new screening model designed to estimate the pesticide concentrations found in water for use in drinking water assessments. It provides high­ end values on the concentrations that might be found in a small drinking water reservoir due to the use of pesticide. Like GENEEC, the model previously used for Tier I screening level, FIRST is a single­ event model ( one run­ off event), but can account for spray drift from multiple applications. FIRST takes into consideration the so called Index Drinking Water Reservoir by representing a larger field and pond than the standard GENEEC scenario. The FIRST scenario includes a 427 acres field immediately adjacent to a 13 acres reservoir, 9 feet deep, with continuous flow ( two turnovers per year). The pond receives a spray drift event from each application plus one runoff event. The runoff event moves a maximum of 8% of the applied pesticide into the pond. This amount can be reduced due to degradation on field and the 2 effect of binding to soil. Spray drift is equal to 6.4% of the applied concentration from the ground spray application and 16% for aerial applications. FIRST also makes adjustments for the percent crop area. While FIRST assumes that the entire watershed would not be treated, the use of a PCA is still a screen because it represents the highest percentage of crop cover of any large watershed in the US, and it assumes that the entire crop is being treated. Various other conservative assumptions of FIRST include the use of a small drinking water reservoir surrounded by a runoff­ prone watershed, the use of the maximum use rate, no buffer zone, and a single large rainfall Background Information on SCIGROW: SCIGROW provides a groundwater screening exposure value to be used in determining the potential risk to human health from drinking water contaminated with the pesticide. Since the SCIGROW concentrations are likely to be approached in only a very small percentage of drinking water sources, i. e., highly vulnerable aquifers, it is not appropriate to use SCIGROW for national or regional exposure estimates. SCIGROW estimates likely groundwater concentrations if the pesticide is used at the maximum allowable rate in areas where groundwater is exceptionally vulnerable to contamination. In most cases, a large majority of the use area will have groundwater that is less vulnerable to contamination than the areas used to derive the SCIGROW estimate. Modeling Inputs and Results: Tables 1 and 2 summarize the input values used in the model runs for FIRST 1.0 and SCIGROW, respectively. The lowest non­ sand K D was used in FIRST 1.0. The median K OC value was used in SCIGROW. The available aerobic soil metabolism half­ life for oxadiazon was extremely high. For FIRST, stability was assumed, while the extrapolated value of 841 days was used in SCIGROW. The modeling results associated with maximum allowable rate per year ( 4 lb ai/ A applied twice at 6 months interval) are presented in Table 3. Attached to this memo are copies of the original printouts generated from FIRST and SCIGROW runs. cc: Nancy McCarroll ( HED) 3 Table 1. Environmental Fate and Other Input Parameters for the Estimation of Oxadiazon using FIRST Parameter Value Source Water Solubility ( 25 C) 1 ppm One­ Liner Hydrolysis Half­ Life ( pH 7) stable MRID 41863603 Aerobic Soil Metabolism Half­ Life ( from 6 values) essentially stable MRID 42772801 Aerobic Aquatic Metabolism Half­ life not available N/ A Aqueous Photolysis Half­ Life 2.75 days MRID 41897201 Soil/ Water Partition Coefficient ( Lowest non­ sand K d) 16.9 MRID 41898202 Pesticide is Wetted­ In Yes Labels PCA ( turf) 0.87 Default Depth of Incorporation ( Broadcast) 0.0 inch Labels Table 2. Environmental Fate Input Parameters for the Estimation of Oxadiazon using SCIGROW. Parameter Value Source Organic Carbon Partition Coefficient ( median K OC) 2376 MRID 41898202 Aerobic Soil Metabolism Half­ Life ( median) 841 days MRID 42772801 Table 3. Modeling Results for Use of Oxadiazon on ( Turf) Golf Courses Parameter Value Source Application Method Ground Spray Labels Application Rate 4.0 lb a. i./ A Registrant Applications Permitted per Year 2 Registrant*** Application Interval ( days) 182 Registrant FIRST 1.0 Peak Untreated Water Concentration 246 ppb N/ A FIRST 1.0 Annual Average Untreated Water Concentration 100 ppb N/ A SCIGROW Ground Water Concentration 0.6 ppb N/ A *** The Registrant supports multiple applications, at lower application rates. 4 RESULTS OBTAINED USING FIRST RUN No. 1 FOR OXADIAZON ON Turf ( Golf * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Kd ( PPM ) (% DRIFT) AREA ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000( 8.000) 2 182 16.9 1.0 GROUND( 6.4) 87.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES.­ EFF) ( RESER.) ( RESER.) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 0 N/ A 2.75­ 341.00 .00 341.00 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 MAY 1, 2001 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 246.388 100.013 RESULTS OBTAINED USING SCIGROW RUN No. 1 FOR OXADIAZON INPUT VALUES ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 4.000 2 8.000 2376.0 841.0 GROUND­ WATER SCREENING CONCENTRATIONS IN PPB ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .592986 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ A= 836.000 B= 2381.000 C= 2.922 D= 3.377 RILP= 1.821 F= ­ 1.130 G= .074 URATE= 8.000 GWSC= .592986

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regulations

EPA-HQ-OPP-2002-0309-0009

Supporting & Related Material

U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES PC Code: 1090001 DP Code: D281176 MEMORANDUM DATE: April 15, 2002 SUBJECT: Tier II Estimated Drinking Water Concentrations ( EDWCs) for Human Health Risk for oxadiazon on Florida Golf Course TO: Veronique LaCapra, Chemical Review Manager Margaret Rice, Branch Chief Special Review and Reregistration Division ( 7508C) FROM: Faruque A. Khan, Ph. D., Environmental Scientist José Luis Meléndez, Chemist Environmental Fate and Effects Division THROUGH: Mah T. Shamim, Ph. D., Chief Jean Holmes, Biologist, RAPL Environmental Risk Branch V Environmental Fate and Effects Division This memo presents the Tier II surface drinking water assessment for oxadiazon. The EDWCs for oxadiazon were based on the proposed maximum application rate ( 8.0 lbs a. i./ A, 3 applications) on golf coarse, which constitute the major use of the chemical. The mean values of EDWCs over a 36­ year period based on Florida Turf Scenario for various segments of the golf course ( green, tees, fairways, and rough ) are summarized in Table 1. Adjustments can be made to calculate cumulative EDWCs for various segments of the golf coarse by adding EECs for each segment of interest. For example, the sum of the chronic EDWCs for green, tees and , fairways would be 20.73 ( i. e. 2.10+ 18.63) µ g L­ 1. Table 1. Recommended EDWCs of Oxadiazon for human health risk assessment. Exposure Greens & Tees Fairways Roughs Golf Coarse ­­­­­­­­­­­­­­­­­­( µ g L­ 1)­­­­­­­­­­­­­­­­­­ Acute ( 1/ 10 peak value) 7.7 44.28 128.65 180.63 Non­ cancer Chronic ( 1/ 10 yearly value) 2.76 15.87 46.24 64.87 Cancer Chronic ( Mean 36­ year annual concentration) 2.10 18.63 35.22 55.95 Note: µ g L­ 1 = ppb 2 1.0 Estimation of surface water exposure concentrations The maximum application rate and relevant environmental fate parameters for oxadiazon were used in the Tier II model ( PRZM/ EXAMS) for EDWCs in the surface water. The output of the screening model represent an upper­ bound estimate of the concentrations of oxadiazon that might be found in surface water due to use of oxadiazon on golf coarse. 2.0 Background Information on PRZM/ EXAMS simulation PRZM/ EXAMS modeling using the Index Reservoir ( IR) and the Percent Crop Area ( PCA) adjustment was used to estimate concentrations in surface water used as a source of drinking water. The index reservoir represents a watershed that is more vulnerable than most used as drinking water sources. It was developed from a real watershed in western Illinois. The index reservoir is used as a standard watershed that is combined with local soils, weather, and cropping practices to represent a vulnerable watershed for each crop that could support a drinking water supply. If a community derives its drinking water from a large river, the estimated exposure would likely be higher than the actual exposure. Conversely, a community that derives its drinking water from smaller bodies of water with minimal outflow would likely get higher drinking water exposure than estimated using the index reservoir. Areas with a more humid climate that use a similar reservoir and golf coarse turf management practices would likely get more pesticides in their drinking water than predicted levels. A single steady flow has been used to represent the flow through the reservoir. Discharge from the reservoir also removes chemical from it so this assumption will underestimate removal from the reservoir during wet periods and overestimates removal during dry periods. This assumption can both underestimate or overestimate the concentration in the reservoir depending upon the annual precipitation pattern at the site. The index reservoir scenario uses the characteristic of a single soil to represent all soils in the basin. Soils can vary substantially across even small areas, thus, this variation is not reflected in these simulations. The index reservoir scenario does not consider tile drainage. Areas that are prone to substantial runoff are often tile drained. This may underestimate exposure, particularly on a chronic basis ( the watershed on which the IR is based had no documented tile drainage). Additionally, EXAMS is unable to easily model spring and fall turnover which would result in complete mixing of a chemical through the water column during these events. Because of this inability, Shipman City Lake has been simulated without stratification. There is data to suggest that Shipman City Lake does stratify in the deepest parts of the lake at least in some years. This may result in both an over and underestimation of the concentration in drinking water depending upon the time of the year and the depth the drinking water intake is drawing from. A full description of the Index Reservoir is provided in the " Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessment" from EFED upon request. Development a Percent Crop Area ( PCA), watershed­ based adjustment factor for the percent of land in production for golf coarse has not been performed. Therefore, the drinking water concentrations for oxadiazon were estimated using adjusting factors recommended in the EFED guidance document for the turf scenario ( Carleton, et. al., 2001). The predicted concentrations are multiplied by 0.04 ( fractional area analogous to PCA) for an average green and tee areas, 0.23 ( fractional area analogous to PCA) for fairways, and an average 0.67 ( fractional area analogous to PCA) for roughs ( Appendix A). These multipliers were comparable to the surveyed data conducted by the Golf Course Superintends 3 Table 2. PRZM/ EXAM Input Parameters for Oxadiazon Parameters and Units Oxadiazon Source PC Code 1090001 Molecular Weight ( g Mole­ 1) 345.2 Product Chemistry Vapor pressure ( Torr) 1.0 E­ 6 Product Chemistry Water solubility ( mg L­ 1) * 1.0 Product Chemistry Hydrolysis half­ life @ pH 5 ( Days) Stable MRID 41863603 Hydrolysis half­ life @ pH 7 ( Days) Stable MRID 41863603 Hydrolysis half­ life @ pH 9 ( Days) 38 MRID 41863603 Aerobic soil metabolism t ½ , ( Days)* 841 MRID 42772801 Aerobic aquatic metabolism ( Days)* 1682** EFED Guidence Anaerobic aquatic metabolism ( Days)* 365 MRID 42773802 Direct Aqueous Photolysis ( Days) 2.75 MRID 41897201 Soil Water Partition Coefficient ( Koc, L Kg­ 1) 2352 MRID 1898202 Florida Turf Management Pesticide Application Rates ( lbs a. i./ A) 2.0 and 4.0 SRRD Application Frequency 2X and 1X SRRD Application Interval ( days) 30 and 135 SRRD First Application Date March 15 SRRD Spray Efficiency 99% EFED Spray Drift 6.40% EFED PCA*** Green and Tees Fairways Roughs 4.00% 23.00% 67.00% EFED * = Water solubility was multiplied by 10 according to Guidance for selecting input parameters in modeling for environmental fate and transport of * = Selected input parameters were multiplied by 3 according to Guidance for selecting input parameters in modeling for environmental fate and ** = 2X of soil aerobic metabolismhalf­ life input value. *** = Fractional use area analogous to percent crop area Association of America. They reported that an average for teeing areas is 2%, putting green 2%, fairways 23%, rough/ wood/ water 70%, and building and grounds 3% and that an average of 150­ 200 acres of total land is used for an 18­ hole golf course facility. The linked PRZM and EXAM model is typically used by EFED in estimating pesticides concentrations in surface waters. PRZM is employed to evaluate runoff loading to a receiving surface body. As soon as the pesticides residues reaches the surface water, EXAMS uses algorithms to estimate the 4 pesticides concentrations by taking into account different dissipation mechanisms in the aqueous and sediment phases, weather patterns, and periodic application of pesticides for several years. 3.0 Florida Turf Scenario This scenario based on the the EFED standard citrus scenario, models a field located in Osceola County, Florida in the Adamsville sand, a hyperthermic, uncoated Aquic Quartzipsamment in MLRA 156A. The Adamsville sand is a somewhat poorly drained, rapidly permeable soil that formed in thick sandy marine sediments occurring in Central and Southern Florida on slopes of 0­ 5 percent. Adamsville sand ranges from a Hydrologic Group A soil to a Hydrologic Group C soil, depending on the water table. For the purpose of this modeling, EFED used the curve numbers from the PIC of the Adamsville sand as a Group C soil. Runoff from application on turf was modeled using the EFED standard turf scenario ( Carleton, et. al., 2001). To develop a turf scenario the citrus scenario was modified by adding a 2 cm thick layer of A thatch@ on top of the soil profile. The thatch layer has the following properties: bulk density = 0.37; field capacity = 0.47; wilting point = 0.27; organic carbon = 7.5%. Curve numbers were selected based on A good condition@ open space areas as specified in TR­ 55, that for hydrologic soil groups. A 2 cm layer of thatch is typical for golf course fairways, but is probably thicker than average for golf course greens. Turf is considered to be essentially generic, with no distinction made between sod farms, golf course fairways, greens and tees, or residential lawns. For chemicals applied to golf courses, the fraction of the total area composed of greens, tees, and fairways may, however be used to modify the results of a modeling run, somewhat in the fashion of a percent cropped area ( PCA) adjustment. The approximate average percent areas ( confirmed by Mike Kenna, USGA, personal communication) are as follows: fairways, 23%; greens, 2%; tees, 2%. Thus if a pesticide is only used on greens and tees, for example, the modeling results would be multiplied by a factor of 0.04. 4.0 Modeling Inputs and Results The weather, golf coarse management practices, and oxadiazon applications were simulated over 36 years so that the ten year excedence probability at the site could be estimated. The EDWC's generated in this analysis were estimated using PRZM 3.12 ( Pesticide Root Zone Model ) for simulating runoff and erosion from the agricultural field and EXAMS 2.97.5 ( Exposure Analysis Modeling System) for estimating environmental fate and transport in surface water. Table 2 summarizes the input values used in the Florida Golf Coarse model run for PRZM/ EXAMS. Attached to this memo is a copy of the printout generated from the PRZM/ EXAMS run ( See Appendix A). 5.0 References Carleton, J., J. Lin, and M. Corbin. 2002. Development of a modeling approach to estimate runoff of pesticide residues from managed turf grass. Memorandum issued on February 27, 2002 on the subject " PRZM Standard Crop/ Location Scenarios, Procedure to Develop and Approve New Scenarios, and PRZM Turf Modeling Scenarios to Date" by Elizabeth Leovey, Acting Director of Environmental Fate And Effect Division of the Office of Pesticides, Environmental Protection Agency, Washington D. C. EFFD Guidance document. 2001. Guidance for selecting input parameters in modeling for environmental fate and transport of pesticides. Version II. December 4, 2001. 5 Appendix A Florida Turf( 2.00 lbs X 2X and 4.00 lbs X 1X applications) Chemical: Oxadiazon PRZM environment: FLOXATRF. inp EXAMS environment: INDEXRES. EXV Metfile: met156A. met WATER COLUMN DISSOLVED CONCENTRATION ( PPB) YEAR PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY ­­­­ ­­­­ ­­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ 1948 242.000 236.000 215.000 180.000 160.000 50.980 1949 112.000 109.000 101.000 90.350 83.690 63.400 1950 74.410 72.960 68.120 58.650 53.490 38.110 1951 73.530 72.160 66.680 56.480 51.260 39.540 1952 210.000 205.000 187.000 154.000 139.000 63.590 1953 105.000 103.000 99.710 87.230 79.180 60.070 1954 92.800 91.020 85.580 77.490 71.290 53.220 1955 63.750 62.710 59.680 53.670 49.610 40.750 1956 55.700 54.680 52.380 50.060 47.080 33.150 1957 161.000 157.000 143.000 119.000 112.000 66.870 1958 169.000 166.000 151.000 129.000 115.000 66.050 1959 113.000 111.000 104.000 89.500 82.190 59.850 1960 140.000 137.000 128.000 116.000 106.000 67.850 1961 85.600 84.050 78.420 73.590 68.740 52.540 1962 68.250 67.010 62.160 56.550 56.250 42.300 1963 111.000 109.000 102.000 88.070 78.290 49.370 1964 107.000 105.000 96.260 90.100 86.820 60.240 1965 148.000 145.000 133.000 122.000 108.000 62.890 1966 109.000 107.000 100.000 94.900 87.020 71.590 1967 109.000 107.000 103.000 95.120 88.300 65.750 1968 112.000 111.000 108.000 101.000 94.220 67.920 1969 79.310 78.140 72.690 63.590 56.750 45.180 1970 98.620 96.960 90.130 76.970 69.270 50.640 1971 84.820 83.200 77.290 68.930 63.760 44.640 1972 93.450 91.590 84.920 79.580 74.520 48.020 1973 50.060 49.180 46.770 42.220 39.300 31.670 1974 63.840 62.890 58.230 49.290 46.990 34.390 1975 40.150 39.430 36.700 32.370 31.470 26.370 1976 54.370 53.310 49.600 45.990 43.700 33.380 1977 235.000 232.000 214.000 198.000 181.000 87.790 1978 67.640 66.730 63.140 56.240 52.850 40.150 1979 185.000 181.000 170.000 144.000 130.000 73.100 1980 84.110 82.580 78.420 70.970 64.470 53.390 1981 101.000 99.370 92.320 78.970 72.440 47.590 1982 107.000 105.000 102.000 96.830 92.650 59.920 1983 54.200 53.310 50.180 46.460 45.450 39.870 SORTED FOR PLOTTING ­­­­­­ ­­­ ­­­­­­­­ PROB PEAK 96 HOUR 21 DAY 60 DAY 90 DAY YEARLY ­­­­ ­­­­ ­­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­ 0.027 242.000 236.000 215.000 198.000 181.000 87.790 0.054 235.000 232.000 214.000 180.000 160.000 73.100 6 0.081 210.000 205.000 187.000 154.000 139.000 71.590 0.108 185.000 181.000 170.000 144.000 130.000 67.920 0.135 169.000 166.000 151.000 129.000 115.000 67.850 0.162 161.000 157.000 143.000 122.000 112.000 66.870 0.189 148.000 145.000 133.000 119.000 108.000 66.050 0.216 140.000 137.000 128.000 116.000 106.000 65.750 0.243 113.000 111.000 108.000 101.000 94.220 63.590 0.270 112.000 111.000 104.000 96.830 92.650 63.400 0.297 112.000 109.000 103.000 95.120 88.300 62.890 0.324 111.000 109.000 102.000 94.900 87.020 60.240 0.351 109.000 107.000 102.000 90.350 86.820 60.070 0.378 109.000 107.000 101.000 90.100 83.690 59.920 0.405 107.000 105.000 100.000 89.500 82.190 59.850 0.432 107.000 105.000 99.710 88.070 79.180 53.390 0.459 105.000 103.000 96.260 87.230 78.290 53.220 0.486 101.000 99.370 92.320 79.580 74.520 52.540 0.514 98.620 96.960 90.130 78.970 72.440 50.980 0.541 93.450 91.590 85.580 77.490 71.290 50.640 0.568 92.800 91.020 84.920 76.970 69.270 49.370 0.595 85.600 84.050 78.420 73.590 68.740 48.020 0.622 84.820 83.200 78.420 70.970 64.470 47.590 0.649 84.110 82.580 77.290 68.930 63.760 45.180 0.676 79.310 78.140 72.690 63.590 56.750 44.640 0.703 74.410 72.960 68.120 58.650 56.250 42.300 0.730 73.530 72.160 66.680 56.550 53.490 40.750 0.757 68.250 67.010 63.140 56.480 52.850 40.150 0.784 67.640 66.730 62.160 56.240 51.260 39.870 0.811 63.840 62.890 59.680 53.670 49.610 39.540 0.838 63.750 62.710 58.230 50.060 47.080 38.110 0.865 55.700 54.680 52.380 49.290 46.990 34.390 0.892 54.370 53.310 50.180 46.460 45.450 33.380 0.919 54.200 53.310 49.600 45.990 43.700 33.150 0.946 50.060 49.180 46.770 42.220 39.300 31.670 0.973 40.150 39.430 36.700 32.370 31.470 26.370 1/ 10 192.500 188.200 175.100 147.000 132.700 69.021 MEAN OF ANNUAL VALUES = 52.559 STANDARD DEVIATION OF ANNUAL VALUES = 14.081 UPPER 90% CONFIDENCE LIMIT ON MEAN = 56.034 EEC calculations: FOR Tees and Greens Acute EEC = ( 1/ 10 peak value)( Percent area for Green & Tee) = ( 192.5 µ g/ L)( 0.04) = 7.70 µ g/ L Non­ cancer Chronic EEC =( 1/ 10 yearly value)( Percent area for Green & Tee) ( 69.02 µ g/ L)( 0.04) = 2.76 µ g/ L Cancer chronic EEC = ( Mean of annual value)( Percent area for Green & Tee) ( 52.56 µ g/ L)( 0.04) = 2.10 µ g/ L 7 FOR Fairways Acute EEC = ( 1/ 10 peak value)( Percent area for Fairway) = ( 192.5 µ g/ L)( 0.23) = 44.28 µ g/ L Non­ cancer Chronic EEC =( 1/ 10 yearly value)( Percent area for FAirways) ( 69.02 µ g/ L)( 0.23) = 15.87 µ g/ L Cancer chronic EEC = ( Mean of annual value)( Percent area for Fairways) ( 52.56 µ g/ L)( 0.23) = 12.08 µ g/ L FOR Roughs Acute EEC = ( 1/ 10 peak value)( Percent area for Roughs) = ( 192.5 µ g/ L)( 0.67) = 128.65 µ g/ L Non­ cancer Chronic EEC =( 1/ 10 yearly value)( Percent area for Rough) ( 69.02 µ g/ L)( 0.67) = 46.24 µ g/ L Cancer chronic EEC = ( Mean of annual value)( Percent area for Rough) ( 52.56 µ g/ L)( 0.67) = 35.22 µ g/ L

epa

2024-06-07T20:31:45.217449

regulations

EPA-HQ-OPP-2002-0309-0010

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES HED DOC. NO. 014469 DATE: February 8, 2001 MEMORANDUM SUBJECT: Oxadiazon­ Report of the Hazard Identification Assessment Review Committee. FROM: Nancy E. McCarroll, Toxicologist Toxicology Branch 1 Health Effects Division ( 7509C) THROUGH: Jess Rowland, Co­ Chair and Elizabeth Doyle, Co­ Chair Hazard Identification Assessment Review Committee Health Effects Division ( 7509C) TO: Seyed Tadayan, Chemist Chemistry and Exposure Branch I Health Effects Division ( 7509C) PC Code: 109001 On December 7, 2000, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for Oxadiazon with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for use as appropriate in occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to Oxadiazon was also evaluated as required by the Food Quality Protection Act ( FQPA) of 1996. The conclusions drawn at this meeting are presented in this report. Page 2 Committee Members in Attendance Members present were: William Burnam, Pamela Hurley, David Nixon, Jess Rowland, Brenda Tarplee, and Yung Yang, Member( s) in absentia: Elizabeth Doyle and Elizabeth Mendez Data evaluation prepared by: Linnea Hansen/ Nancy E. McCarroll, Toxicologist Branch 1 Also in attendance were: Ayaad Assad, Mike Ioannou, Alberto Protzel, Seyed Tadayan ( HED) Jonathan Chen ( AD), Veronique La Capra ( SRRD) Data Evaluation / Report Presentation: December 7, 2000 Linnea Hansen/ Nancy E. McCarroll Toxicologists Page 3 1. INTRODUCTION On December 7, 2000, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for Oxadiazon with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for use as appropriate in occupational/ residential exposure risk assessments. The potential for increased susceptibility of infants and children from exposure to Oxadiazon was also evaluated as required by the Food Quality Protection Act ( FQPA) of 1996. Oxadiazon, 5­ term­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 1,3,4­ oxadiazol­ 2­ one, is a selective pre­ emergent and early post­ emergence herbicide that is effective primarily for the control of annual grasses and broadleaf weeds in turf. Most of the usage is allocated to golf courses. The trade name for Oxadiazon in the U. S. is Ronstar. The mechanism of action is contact inhibition by affecting young shoots as they grow through the treated zone ( pre­ emergence) and complete coverage ( postemergence Oxadiazon destroys cell membranes and inhibits photosynthesis, probably by generating oxidizing radicals in light. It is a powerful inhibitor of plant, yeast and mouse protoporphyrinogen oxidase, an enzyme critical in the biosynthesis of chlorophyll and heme ( Matringe et al., 1989). Oxadiazon has no food or feed uses. There are currently 16 tolerances in CFR 180.346; however, the registrant will delete these uses so that the tolerances can be revoked. The Registrant is now supporting use of Oxadiazon on golf courses, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries. Oxadiazon has the following structure: Empirical Formula: C 15 H 18 Cl 2 N 2 O 3 Molecular Weight: 345.22 Melting Point: 88­ 90 C Boiling Point: Not applicable ( Oxadiazon is a solid) Density: 20 C Vapor Pressure at 20 C: < 1 x 10­ 6 mm Hg Water Solubility: 0.7 mg/ L at 20 C Log Kow: 4.8 CAS Number: 19666­ 30­ 9 Page 4 2. HAZARD IDENTIFICATION 2.1 Acute Reference Dose ( RfD) Not required since there are no food or feed or anticipated food or feed uses for this pesticide. 2.2 Chronic Reference Dose ( RfD) Not required since there are no food or feed or anticipated food or feed uses for this pesticide. 2.3 Occupational/ Residential Exposure 2.3.1 Short­ Term ( 1­ 7 days) Incidental Oral Exposure Study Selected: Developmental Toxicity in Rats Guideline #: 870.3700; 83­ 3a MRID No.: 40470202 Executive Summary: In a developmental toxicity study ( MRID 40470202), Oxadiazon technical ( 96.3%) was administered daily by gavage in 10 ml 1% aqueous methylcellulose vehicle/ kg body weight from Gestation Days 6 through 15 to groups of 20 pregnant Sprague­ Dawley rats per dose at 0, 3, 12 or 40 mg/ kg/ day. Pregnant females were examined daily for signs of toxicity and body weights were measured on Gestation Days 0, 3, 6, daily through Day 16 and on Days 18 and 20. Dams were sacrificed on Day 20 and uterine contents were examined. Very little maternal toxicity was observed at any dose. Small but statistically significant decreases in body weight (­ 2% less than controls) and body weight gain (­ 10%) in the highdose females at Days 16­ 20 were possibly due to resorptions of fetuses ( decreased maternal body weights also observed at
40 mg/ kg/ day in the range­ finding study). The maternal toxicity LOAEL is 40 mg/ kg/ day, based on slightly decreased body weight/ weight gain. The maternal toxicity NOAEL is 12 mg/ kg/ day. Treatment­ related fetal toxicity at 40 mg/ kg/ day included: slightly, not statistically significantly increased fetal resorptions ( 0.7/ dam vs. 0.4/ dam, controls) and post­ implantation loss ( 12.5% vs. 8.2%, controls), and significantly decreased body weight ( 4.5% less than controls). Developmental effects at 40 mg/ kg/ day were confined to increased incidence of incomplete ossification, primarily in skull and vertebral bones. No effects were seen at lower doses. No treatment­ related malformations were observed at the doses tested. Fetal effects seen in this study are considered treatment­ related based on the steep dose­ response curve ( for fetal loss and decreased fetal weight) between 20­ 60 mg/ kg/ day in the preliminary rangefinding study. In the range­ finding study, which tested at 10, 20, 40, 60 or 80 mg/ kg/ day ( 6 dams/ dose group), no maternal or developmental toxicity was observed at 10 or 20 Page 5 mg/ kg/ day. However, at 40 mg/ kg/ day, a mean fetal resorption rate of 40% ( 53­ 100% in 3/ 6 dams) was observed, increasing to 80­ 90% at 60 and 80 mg/ kg/ day. Weights of surviving fetuses were decreased. Decreased maternal weights were also observed at
40 mg/ kg/ day and were usually correlated with the increased litter resorption. Therefore, the effects seen at 40 mg/ kg/ day in the main study are considered a threshold response for Oxadiazon under the conditions of the main study. The developmental toxicity LOAEL is 40 mg/ kg/ day, based on increased fetal resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification. The developmental toxicity NOAEL is 12 mg/ kg/ day. This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a developmental toxicity study ( 83­ 3a) in the rat. Dose and Endpoint for Risk Assessment: NOAEL for maternal effects = 12 mg/ kg/ day. LOAEL = 40 mg/ kg/ day based on slight decrease in body weight/ body weight gain at Days 16­ 20. Comments about Study/ Endpoint/ Uncertainty Factor( s): This dose and endpoint were considered appropriate because the critical effect ( body weight decrements) occurred during the treatment period ( Gestation Days 16­ 20) which encompasses the exposure period of concern ( 1­ 7 days) and is appropriate for the population of concern ( infants and children). 2.3.2 Intermediate­ Term ( 7 Days to Several Months) Incidental Oral Exposure Study Selected: Developmental Toxicity in Rats Guideline #: 870.3700; 83­ 3a MRID No.: 40470202 Executive Summary: See Short­ term ( 1­ 7 Days) Incidental Oral Exposure Dose and Endpoint for Risk Assessment: NOAEL for maternal effects = 12 mg/ kg/ day. LOAEL = 40 mg/ kg/ day based on slight decrease in body weight/ body weight gain at Days 16­ 20. Comments about Study/ Endpoint: The dose and endpoint were considered appropriate because the NOAEL in the 90­ day studies were higher than the NOAEL of this study. The NOAEL from the developmental study was selected because the lower maternal NOAEL may reflect greater sensitivity of the pregnant rat. 2.3.3 Dermal Absorption Dermal Absorption Factor: 9% from the dermal penetration study ( 10­ hour reading) MRID No.: 44588101 Page 6 Executive Summary: In a dermal penetration study ( MRID 44588101), 14C­ Oxadiazon ( Lot No. GXR 396A­­ 99.6% radiochemical purity, mixed with unlabeled Oxadiazon technical, 96% a. i.) in 1% aqueous carboxymethyl cellulose was administered dermally to groups of 24 male Sprague Dawley rats/ dose at 5.45, 39.2 or 523  g/ cm2 for exposure durations of 0.5, 1, 2, 4, 10 or 24 hours per dose ( 4 rats/ exposure time). Urine and feces were collected; skin was excised and blood, residual urine and carcasses were collected and analyzed. Recovery of radioactivity ranged from 83.2% to 106% of administered dose. The quantity of Oxadiazon in washed skin during the exposure phase ranged from 0.06­ 0.38, 0.59­ 3.31 or 2.88­ 15.32  g/ cm2 at the low, mid or high dose, respectively. As a percentage of the administered dose, these were equivalent to 1.09%­ 6.89%, 1.50%­ 8.45% or 0.55%­ 2.93% ( low to high dose, respectively). In general, the amount of absorbed test material was not detectable during the first 2 hours of exposure. Absorption (  g/ cm2) was low throughout exposure and ranged from 0.06­ 0.6, 0.05­ 2.00 or 0.05­ 2.62  g/ cm2 ( low to high dose, respectively) at 4 to 24 hours; as a percent of the administered dose, these were equivalent to 1.11%­ 11.0%, 0.39%­ 5.11% or 0.01%­ 0.50%, respectively. The percent of test material on/ or bound to the skin and the percent absorbed at 10 hours was 6.05% and 2.65% ( 5.45  g/ cm2), 4.71% and 0.63% ( 39.2  g/ cm2), and 1.03% and 0.05% ( 523  g/ cm2), respectively. Since the percent of dose absorbed decreased with increasing dose and the quantity absorbed was essentially the same, the results indicate that absorption but not dermal uptake was saturated at 39.2 and 523  g/ cm2. Consequently, the percent bound to the skin and the percent absorbed in a 10­ hour period is 6.05 and 2.65 %, respectively. For the purposes of risk assessment, the sum of both is 8.70%. This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a dermal penetration study ( 85­ 3) in the rat. Comments about Dermal Absorption: None 2.3.4 Short­ Term Dermal ( 1­ 7 days) Exposure Study Selected: Developmental Toxicity in Rats Guideline #: 870.3700; 83­ 3a MRID No.: 40470202 Executive Summary: See Short­ term ( 1­ 7 Days) Incidental Oral Exposure Dose and Endpoint for Risk Assessment: NOAEL for developmental effects = 12 mg/ kg/ day. LOAEL = 40 mg/ kg/ day based on increased fetal resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification. Comments about Study/ Endpoint: A dermal study was submitted in which no systemic effects were seen up to the limit dose. However, since dermal studies do not evaluate developmental effects and there is a concern for increased susceptibility of the fetus to the test compound, Page 7 the Committee decided that the rat developmental study was more appropriate to set the dermal endpoint in conjunction with a dermal absorption factor. 2.3.5 Intermediate­ Term Dermal ( 7 Days to Several Months) Exposure Study Selected: Developmental Toxicity in Rats Guideline #: 870.3700; 83­ 3a MRID No.: 40470202 Executive Summary: See Short­ term Incidental Oral Exposure Dose and Endpoint for Risk Assessment: See Short­ term Incidental Dermal Exposure Comments about Study/ Endpoint: See Comments for Short­ Term Dermal Study/ Endpoint. 2.3.6 Long­ Term Dermal ( Several Months to Life­ Time) Exposure Studies Selected: Combined Chronic Feeding/ Oncogenicity­ Rat Guideline 870.4300/ [ 83­ 5] MRID Nos: ( 1) 40993401 ( 2) 00149003/ 00157780 Executive Summary: In a chronic/ oncogenicity toxicity study ( MRID No. 40993401), Oxadiazon ( 95.9%) was administered to SPF Wistar rats ( 80/ sex/ dose) in the diet at dose levels of 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.106, 0.36, 3.5 or 39 mg/ kg/ day for males or 0, 0.131, 0.44, 4.2 or 44 mg/ kg/ day for females) for 104 weeks. Clinical signs were monitored daily. Body weights were determined weekly for the first 26 weeks and biweekly, thereafter; food consumption was determined weekly for 20 rats/ group. Groups of 8 rats/ sex/ group were sacrificed at weeks 26, 52 and 78 and 10 animals/ sex/ group at 104 weeks were subjected to hematology, biochemistry and urinalysis examinations. All 80 rats/ sex/ dose were reportedly examined for histopathology. Dose selection was based on a preliminary 4­ week range finding study with 10, 100, 1000 or 3000 ppm. At 1000 and 3000 ppm, signs of toxicity included: anemia ( males­­ both groups; females­­ 3000 ppm, only), effects on biochemical parameters associated with hepato­ renal disorders ( increased GOT, GPT, ALP, BUN, total cholesterol and/ or urobilinogen), and liver and kidney weight changes accompanied by a dark color. There were no adverse effects on mortality, clinical signs or food consumption. Treatment related effects included: decreased body weight gain for high­ dose males generally throughout the study; statistically significant body weight losses (­ 8.9%) were reported for the 10 and 1000 ppm females only at study termination. Hematological parameters significantly affected were: decreased hematocrit and hemoglobin ( high­ dose males at week 26) and decreased mean corpuscular volume and mean corpuscular hemoglobin ( high­ dose males at weeks 26, Page 8 78 and 104). There were no consistent hematological effects in the females. The generalized changes in the blood elements of male rats are indicative of anemia which was most evident at week 26. Significantly affected clinical chemistry parameters included: increased LDH, ALP, GOT, GPT, total and direct bilirubin and total cholesterol for high­ dose males at week 26; no toxicologically significant effects were seen in the females of any dose group. At 1000 ppm, males also showed increased urobilinogen at week 26. Increased liver weights were seen in high­ dose males and females throughout the study and statistically significant increases in kidneys ( both sexes) and testis ( males) were also consistently seen at 1000 ppm. Nonneoplastic pathology in the liver at 1000 ppm included:  centrilobular hepatocellular swelling ( and
) ;  acidophilic foci of cellular alteration ( ) ; brown pigmentation in the liver ( and
) ; and bile duct proliferation ( ) . At 100 ppm,  centrilobular hepatocellular swelling was also seen in the males. Brown pigmentation in the proximal tubular cells and in cortical interstitial tissue ( and
) ; and chronic nephropathy (
) were also recorded for the kidneys of high­ dose rats. The LOAEL is 100 ppm ( 3.5 mg/ kg/ day) based on centrilobular swelling in the male rat livers; the NOAEL is 10 ppm ( 0.36 mg/ kg/ day). Neoplastic findings were: increased incidence of liver adenomas in males at 100 ( p< 0.05) and 1000 ppm ( p< 0.010); liver carcinomas were also increased at 1000 ppm in both sexes but not significantly. The pathology report for this chronic/ carcinogenicity study in the rat was considered incomplete; thus, the overall study was listed as Supplementary. At this time, no additional information is being requested because the results are consistent with an acceptable rat chronic/ carcinogenicity study ( MRID No. 0014003/ 00157780) that satisfies the guideline requirement. Similarly, the presence of liver neoplasms confirms the evidence of a carcinogenic effect seen in MRID No. 0014003/ 00157780. Using the more recent terminology, the study is now listed as Unacceptable/ guideline ( MRID No. 40993401). Executive Summary: In a chronic/ carcinogenicity toxicity study ( 00149003/ 00157780), Oxadiazon ( 99.9%) was administered to Fischer 344 rats ( 76/ sex/ dose) in the diet at dose levels of 0, 10, 100, 1000 or 3000 ppm ( mean consumption per group: equivalent to 0, 0.5, 4.8, 50.9 or 163.1 mg/ kg/ day for males or 0, 0.6, 5.9, 60.9 or 192.7 mg/ kg/ day for females) for 24 months. Parameters examined included: ( 1) twice daily observations, ( 2) weekly body weights and food consumption, ( 3) ophthalmic examinations ( all animals at pretest and 10 rats/ group at 6, 12 and 24 months), ( 4) standard hematology, clinical chemistry and urinalysis ( 10 rats/ group at 6, 12 and 24 months), and ( 5) gross necropsy, organ weights and histology ( 10 rats/ group at 6 and 12 months and all survivors at 24 months). There were no effects on mortality. At 1000 and 3000 ppm, clinical signs included emaciation, anemia and brown colored urine; ophthalmic examinations revealed narrowing of the fundus vasculature ( at 1000 ppm and both sexes at 3000 ppm). Significant decreases ( p< 0.05­ 0.001) in body weight gain were apparent in rats of both sexes receiving 1000 or 3000 ppm and significant decreases in food consumption were recorded for both sexes Page 9 starting at week 3 ( males) and week 6 ( females). Consistent hematological findings indicative of anemia at 3000 ppm ( both sexes) were: significantly decreases erythrocyte counts, hematocrit, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration. Anemia was also present in males at 1000 ppm and appeared to be less severe in females. Adverse effects on urinalysis parameters were confined to the two highest dose groups ( both sexes) and included: urine color, strongly positive bilirubin and urobilinogen. Significantly affected clinical chemistry parameters included: reduced glucose levels (
1000 ppm at 6 and 12 months;
3000 ppm at 6 months); increased total protein ( consistent effect only in the
at
100 ppm and generally at all sampling intervals); increased total cholesterol ( at 1000 ppm and both sexes at 3000 ppm) and increased bilirubin (
1000 ppm at 6 and 12 months;
3000 ppm at 6 months). In addition, significant increases in GOT, GPT, AP and BUN generally correlated well with liver morphological changes at
1000 ppm ( ) . Similarly, increased absolute and relative liver and kidney weights at
1000 ppm ( both sexes) correlated well with liver and kidney histopathology effects. At termination, Oxadiazon also induced increased absolute and relative liver weights at 100 ppm (
) . Non­ neoplastic pathology included: hepatocyte changes consisting of progressive alterations from hypertrophy through fatty changes to necrosis were noted in males receiving 1000 and 3000 ppm and females receiving 3000 ppm. Other nonneoplastic changes noted in both sexes were: pigmented nephrosis and fat replacement in the pancreas at 1000 ppm and basophilic changes in the adrenal glands at 3000 ppm. The LOAEL is 100 ppm ( 5 mg/ kg/ day) based on increased absolute liver weights in males and females and increased total serum protein in females. The NOAEL is 10 ppm ( 0.5 mg/ kg/ day). Neoplastic findings were: increased incidences of benign and malignant liver tumors in males at 1000 and 3000 ppm after prolonged exposure to hepatotoxic doses. In addition, there was no decrease in latency for liver neoplasia. This chronic/ carcinogenicity study in the rat is Acceptable ( Guideline) and satisfies the guideline requirement for a combined chronic/ carcinogenicity study ( 83­ 5) in the rat ( MRID Nos. 00149003 [ main study]/ MRID 00157780 [ additional data]). Dose and Endpoint for Risk Assessment: NOAEL = 0.36 mg/ kg/ day. LOAEL = 3.5 mg/ kg/ day based on centrilobular swelling in the male rat livers. Comments about Study/ Endpoint: The pathology report for the selected chronic/ carcinogenicity study in the rat was considered incomplete and the overall study was listed as Supplementary ( Unacceptable). However, no additional information is being requested because the results are consistent with an acceptable rat chronic/ carcinogenicity study ( MRID No. 0014003/ 00157780). This study was chosen by IRIS in 1986 to set the chronic RfD for Oxadiazon. The NOAEL and LOAEL for this study was 0.5 and 5 mg/ kg/ day, respectively, based on increased liver weights in both sexes and increased serum protein in females. Thus, the findings from MRID No. 0014003/ 00157780 support the selected NOAEL and LOAEL. In addition, liver neoplasms in males were present in both Page 10 studies and confirms the evidence of a carcinogenic effect. While both studies were in good agreement, the study selected for this endpoint ( MRID No. 40993401) is considered Unacceptable. The HIARC concluded, however, that in combination with the Acceptable study used by IRIS and within the context of the entire database, MRID No. 40993401 was Acceptable for endpoint selection. Additionally, since an oral NOAEL was selected for this risk assessment, the dermal absorption factor should be used for route­ to­ route extrapolation. 2.3.7 Inhalation Exposure ( All Durations) Studies Selected: Short­ and Intermediate­ Term: Developmental Oral Study in Rats ( MRID No. 40470202) NOAEL = 12 mg/ kg/ day Executive Summary: See Short­ term Incidental Oral Exposure Long­ Term: Combined Chronic Feeding / Oncogenicity in Rats ( MRID Nos. 40993401 and 0014003/ 00157780) NOAEL = 0.36 mg/ kg/ day Executive Summaries: See Long­ Term Dermal ( Several Months to Life­ Time) Exposure Comments about Study/ Endpoint: With the exception of an acute inhalation study ( MRID No. 41866503) in which Oxadiazon was placed in Category III ( LC 50 > 1.94 mg/ L), no other inhalation studies are available for this risk assessment. Consequently, the HIARC recommended the submission of a 28­ day inhalation toxicity study. Until that time, the HIARC recommended using route­ to­ route extrapolation since the doses identified for the short and intermediate term and for the long term inhalation exposures are from oral studies. The following route­ to­ route extrapolation steps should be followed: Step 1: Convert the inhalation exposure (  g/ lb a. i.) using a 100% inhalation absorption rate ( default value), application rate and acres treated to an oral equivalent dose ( mg/ kg/ day). Step 2: Convert the dermal exposure ( mg/ kg/ day) using 9% as the dermal absorption rate, application rate and acres treated to an oral equivalent dose ( mg/ kg/ day). This dose should be combined with the converted oral dose in Step 1. Step 3: To calculate the MOE's, the combined dose from Step II should be compared to the oral NOAEL of 12 mg/ kg/ day for the Short­ and Intermediate­ term exposure scenarios and to the oral NOAEL of 0.36 mg/ kg/ day for the Long­ term exposure scenarios. Page 11 2.3.8 Margins of Exposure for Occupational/ Residential Risk Assessments There are no food or feed uses of Oxadiazon. For nonoccupational and occupational exposure risk assessments, a MOE of 100 is required for dermal and inhalation exposures. The Registrant is now supporting use of Oxadiazon on golf courses, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries. Many of these sites, including golf courses are considered a residential use with respect to the post­ application risk assessment. 2.4 Recommendation for Aggregate Exposure Risk Assessments Since there are no food uses, aggregate exposure will be limited to combining the dermal and inhalation exposure components since oral equivalents were selected. 3 CLASSIFICATION OF CARCINOGENIC POTENTIAL 3.1 Combined Chronic Toxicity/ Carcinogenicity Study in Rats Guideline #: 870.4300/ [ 83­ 5] MRID No.: 00149003/ 00157780 Executive Summary: In a chronic/ carcinogenicity toxicity study ( 00149003/ 00157780), Oxadiazon ( 99.9%) was administered to Fischer 344 rats ( 76/ sex/ dose) in the diet at dose levels of 0, 10, 100, 1000 or 3000 ppm ( mean consumption per group: equivalent to 0, 0.5, 4.8, 50.9 or 163.1 mg/ kg/ day for males or 0, 0.6, 5.9, 60.9 or 192.7 mg/ kg/ day for females) for 24 months. Parameters examined included: ( 1) twice daily observations, ( 2) weekly body weights and food consumption, ( 3) ophthalmic examinations ( all animals at pretest and 10 rats/ group at 6, 12 and 24 months), ( 4) standard hematology, clinical chemistry and urinalysis ( 10 rats/ group at 6, 12 and 24 months), and ( 5) gross necropsy, organ weights and histology ( 10 rats/ group at 6 and 12 months and all survivors at 24 months). There were no effects on mortality. At 1000 and 3000 ppm, clinical signs included emaciation, anemia and brown colored urine; ophthalmic examinations revealed narrowing of the fundus vasculature ( at 1000 ppm and both sexes at 3000 ppm). Significant decreases ( p< 0.05­ 0.001) in body weight gain were apparent in rats of both sexes receiving 1000 or 3000 ppm and significant decreases in food consumption were recorded for both sexes starting at week 3 ( males) and week 6 ( females). Consistent hematological findings indicative of anemia at 3000 ppm ( both sexes) were: significantly decreases erythrocyte counts, hematocrit, hemoglobin, mean corpuscular volume, mean corpuscular hemoglobin and mean corpuscular hemoglobin concentration. Anemia was also present in males at 1000 ppm and appeared to be less severe in females. Adverse effects on urinalysis parameters were confined to the two highest dose groups ( both sexes) and included: urine color, strongly positive bilirubin and urobilinogen. Significantly affected clinical chemistry parameters included: reduced glucose levels (
1000 ppm at 6 and 12 months;
3000 ppm at 6 months); increased total protein ( consistent effect only in the
at
100 ppm and generally at all Page 12 sampling intervals); increased total cholesterol ( at 1000 ppm and both sexes at 3000 ppm) and increased bilirubin (
1000 ppm at 6 and 12 months;
3000 ppm at 6 months). In addition, significant increases in GOT, GPT, AP and BUN generally correlated well with liver morphological changes at
1000 ppm ( ) . Similarly, increased absolute and relative liver and kidney weights at
1000 ppm ( both sexes) correlated well with liver and kidney histopathology effects. At termination, Oxadiazon also induced increased absolute and relative liver weights at 100 ppm (
) . Non­ neoplastic pathology included: hepatocyte changes consisting of progressive alterations from hypertrophy through fatty changes to necrosis were noted in males receiving 1000 and 3000 ppm and females receiving 3000 ppm. Other nonneoplastic changes noted in both sexes were: pigmented nephrosis and fat replacement in the pancreas at 1000 ppm and basophilic changes in the adrenal glands at 3000 ppm. The LOAEL is 100 ppm ( 5 mg/ kg/ day) based on increased absolute liver weights in males and females and increased total serum protein in females. The NOAEL is 10 ppm ( 0.5 mg/ kg/ day). Discussion of Tumor Data: Neoplastic findings were: increased incidences of benign and malignant liver tumors in males at 1000 and 3000 ppm after prolonged exposure to hepatotoxic doses. In addition, there was no decrease in latency for liver neoplasia. Adequacy of the Dose Levels Tested: Dosing was considered adequate in males and in females and the data support a presumption that the maximum tolerated dose ( MTD) lies between 100 and 1000 ppm. This chronic/ carcinogenicity study in the rat is Acceptable ( Guideline) and satisfies the guideline requirement for a combined chronic/ carcinogenicity study ( 83­ 5) in the rat ( MRID Nos. 00149003 [ main study]/ MRID 00157780 [ additional data]). MRID No.: 40993401 Executive Summary: In a chronic/ oncogenicity toxicity study ( MRID No. 40993401), Oxadiazon ( 95.9%) was administered to SPF Wistar rats ( 80/ sex/ dose) in the diet at dose levels of 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.106, 0.36, 3.5 or 39 mg/ kg/ day for males or 0, 0.131, 0.44, 4.2 or 44 mg/ kg/ day for females) for 104 weeks. Clinical signs were monitored daily. Body weights were determined weekly for the first 26 weeks and biweekly, thereafter; food consumption was determined weekly for 20 rats/ group. Groups of 8 rats/ sex/ group were sacrificed at weeks 26, 52 and 78 and 10 animals/ sex/ group at 104 weeks were subjected to hematology, biochemistry and urinalysis examinations. All 80 rats/ sex/ dose were reportedly examined for histopathology. Dose selection was based on a preliminary 4­ week range finding study with 10, 100, 1000 or 3000 ppm. At 1000 and 3000 ppm, signs of toxicity included: anemia ( males­­ both groups; females­­ 3000 ppm, only), effects on biochemical parameters associated with hepato­ renal disorders ( increased GOT, GPT, ALP, BUN, total cholesterol and/ or urobilinogen), and liver and kidney weight changes accompanied by a dark color. Page 13 There were no adverse effects on mortality, clinical signs or food consumption. Treatment related effects included: decreased body weight gain for high­ dose males generally throughout the study; statistically significant body weight losses (­ 8.9%) were reported for the 10­ and 1000 ppm females only at study termination. Hematological parameters significantly affected were: decreased hematocrit and hemoglobin ( high­ dose males at week 26) and decreased mean corpuscular volume and mean corpuscular hemoglobin ( high­ dose males at weeks 26, 78 and 104). There were no consistent hematological effects in the females. The generalized changes in the blood elements of male rats are indicative of anemia which was most evident at week 26. Significantly affected clinical chemistry parameters included: increased LDH, ALP, GOT, GPT, total and direct bilirubin and total cholesterol for high­ dose males at week 26; no toxicologically significant effects were seen in the females of any dose group. At 1000 ppm, males also showed increased urobilinogen at week 26. Increased liver weights were seen in high­ dose males and females throughout the study and statistically significant increases in kidneys ( both sexes) and testis ( males) were also consistently seen at 1000 ppm. Nonneoplastic pathology in the liver at 1000 ppm included:  centrilobular hepatocellular swelling ( and
) ;  acidophilic foci of cellular alteration ( ) ; brown pigmentation in the liver ( and
) ; and bile duct proliferation ( ) At 100 ppm,  centrilobular hepatocellular swelling was also seen in the males. Brown pigmentation in the proximal tubular cells and in cortical interstitial tissue ( and
) ; and chronic nephropathy (
) were also recorded for the kidneys of high­ dose rats. The LOAEL is 100 ppm ( 3.5 mg/ kg/ day) based on centrilobular swelling in the male rat livers; the NOAEL is 10 ppm ( 0.36 mg/ kg/ day). Discussion of Tumor Data: Neoplastic findings were: increased incidence of liver adenomas in males at 100 ( p< 0.05) and 1000 ppm ( p< 0.010); liver carcinomas were also increased at 1000 ppm in both sexes but not significantly. Adequacy of the Dose Levels Tested: Dosing was considered adequate in males based on signs of transient anemia,  serum enzyme activity,  bilirubin and liver weight,  body weight gain, and pathological changes in the liver ( centrilobular hepatocellular swelling and foci of cellular alteration). Females were considered to be tested at a dose below the maximum tolerated dose ( MTD). However, since the NOAEL and LOAEL were defined for males ( 0.36/ 3.5 mg/ kg/ day), the hypothetical values for females are expected to be higher. Hence, the NOAEL and LOAEL for males are considered to be protective for females. The pathology report for this chronic/ carcinogenicity study in the rat was considered incomplete; thus, the overall study was listed as Supplementary. At this time, no additional information is being requested because the results are consistent with an acceptable rat chronic/ carcinogenicity study ( MRID No. 0014003/ 00157780) that satisfies the guideline requirement. Similarly, the presence of liver neoplasms confirms the evidence of a carcinogenic effect seen in MRID No. 0014003/ 00157780. Using the more recent terminology, the study is now listed as Unacceptable/ guideline ( MRID No. 40993401). Page 14 3.2 Carcinogenicity Study in Mice Guideline #: 870.4200/ [ 83­ 2] MRID No.: 00115733 Executive Summary: In a mouse oncogenicity study ( MRID No. 00115733), Oxadiazon ( tech., 99.3% a. i., Lot/ Batch # BES 2253) was administered in the diet to CD­ 1 mice ( 70/ sex/ group) for up to 105 weeks at 0, 100, 300, 1000, or 2000 ppm ( equivalent to 0/ 0, 12/ 14, 37/ 44, 122/ 143, or 254/ 296 mg/ kg/ day [ M/ F], respectively). At 2000 ppm, significantly decreased survival ( and a dose­ related positive trend for decreased survival) were observed in males ( at termination, 43%, 24%, 36%, 27% and 4%, control to high dose) and in females ( at termination, 56%, 41%, 53%, 43% and 29%). During the first 26 weeks of treatment, 29/ 70 high­ dose males died or were sacrificed in extremis. It was stated that these animals were generally pale, inactive, weak, hypothermic and exhibited tremor and piloerection. Thoracic serosanguineous fluid was observed in these males at gross necropsy ( 15/ 29 treated vs 6/ 70 total controls affected and 1 of 2 controls that died by week 26). At histological examination, the following were also observed (# of animals): hypercellular spleens ( 18); diffuse, necrotic myocarditis ( 20); periacinar hepatocytic pallor ( 12); hepatic single cell necrosis ( 16); and pigmented Kupffer cells ( 8). An increase ( p< 0.05 or 0.01) in the total incidence of distended abdomen was observed at various intervals in all treated males ( 80­ 90% treated vs 60­ 61% controls). Pale eyes were observed in females ( 50­ 60% treated vs 31% controls). At 1000 and 2000 ppm, increased ( p< 0.05 or 0.01) incidence of pallor was observed ( 40­ 46% treated vs 21% controls) during the study. At 2000 ppm, body weights were reduced in males at week 104 (  12%, not analyzed statistically). Reductions ( p< 0.05 or 0.01) in mean body weight gain were observed in the males during weeks 1­ 13 (  13%) and for weeks 0­ 104 (  26%); during weeks 66­ 92, weight loss was greater at high dose than controls (­ 7 g vs. ­ 2 g, respectively). Slight anemia, as indicated by decreased ( p< 0.05, 0.01, or 0.001) hematocrit (  5­ 30%), hemoglobin (  6­ 28%), and erythrocyte count (  12­ 32%), was observed in the 1000 ppm males and 2000 ppm males and females. Neutrophil count was slightly increased at 2000 ppm in males (  83%) and females (  117%) at termination, possibly reflecting a mild inflammatory response. Increases ( p< 0.05, 0.01, or 0.001) with respect to concurrent controls were observed in absolute and relative ( to body weight) liver weights in all male treatment groups (  45%/ 52%, 46%/ 57%, 107%/ 120% and 86%/ 120%) and in the 1000 and 2000 ppm female groups (  48/ 53% and 103%/ 102%). At gross necropsy, increased incidence of hepatic pale areas/ foci and masses were observed in all male groups when excluding animals that died before week 27 ( pale areas/ foci 36%­ 59% treated vs 4% controls; masses 41%­ 47% treated vs 27% controls) and all female groups ( pale areas/ foci 11%­ 19% treated vs 7% controls; masses 10%­ 26% treated vs 3% controls). In addition, raised areas in the liver were observed in the 300, 1000, and 2000 ppm females ( 10­ 11% vs 1% control). Increases in large, eosinophilic hepatocytes were observed in all male and female groups without a clear doseresponse ( 7­ 23 treated affected vs 0­ 3 controls, N = 70, all groups). Slight to moderate hepatic amyloidosis was increased in all male treatment groups ( 9­ 22 treated affected vs. 0 Page 15 controls) and in high­ dose females ( 12/ 70 treated vs 3/ 70 controls). Increased incidence of pigmented Kupffer cells ( 7/ 41 treated vs 0/ 70 controls) were observed in males that did not die by week 26. Food consumption, food efficiency, and water consumption ( visually inspected, only) for both sexes at all doses were unaffected by treatment with Oxadiazon at any tested dose. The systemic toxicity LOAEL is 100 ppm for males and females ( equivalent to 12/ 14 mg/ kg/ day [ M/ F]) based on clinical signs, gross and microscopic liver lesions in both sexes, and increased liver weights in males. The systemic toxicity NOAEL is < 100 ppm. Discussion of Tumor Data: Under the conditions of this study, there was an increased incidence of hepatocellular neoplasms in males and females. Incidences of hepatocellular adenomas were increased ( p< 0.05, 0.01, or 0.001) in all groups of treated males ( 27.9%, 51.4%, 68.6%, 56.5% and 53.7%­ 68.6%, control to high dose) and females ( 4.4%, 18.8%, 25.7%, 32.9% and 41.2%) treatment groups. These were outside of historical control ranges of males ( 0­ 12%) in all groups, including controls, and of females ( 0­ 14%) for all treated groups. The incidences of adenocarcinomas were increased ( p< 0.05 or not significant) in all male treatment groups ( 7.4%, 20.0%, 24.3%, 24.6% and 24.4%, control to high dose) and in the 1000 and 2000 ppm female groups ( 12.9% and 10.3% vs 1.5%, controls). The incidences were outside of historical control ranges for males ( 0­ 8%) in all treatment groups and females ( 0­ 6%) at
1000 ppm. The incidences of combined adenomas and adenocarcinomas were increased ( p< 0.05, 0.01, or 0.001) in all male ( 29,4%, 57.1%, 74.3%, 63.8% and 68.3%) and female ( 5.9%, 18.8%, 27.1%, 38.6% and 47.1%) treatment groups ( no historical controls provided for combined neoplasms). Adequacy of the Dose Levels Tested: Dosing was considered adequate based on the finding of liver toxicity at all doses. The submitted study is classified as Acceptable/ guideline ( § 83­ 2b) and satisfies the guideline requirements for a carcinogenicity study in mice ( MRID No. 00115733). MRID No.: 00044322 Executive Summary: In an oral mouse oncogenicity study ( MRID 00044322), Oxadiazon ( 95.5% a. i., Lot/ Batch # MAG 405) was administered in the diet to CD­ 1 mice ( 60/ sex/ group) for up to 104 weeks at 0, 300, 1000 or 2000 ppm ( equivalent to 0/ 0, 48/ 62, 153/ 201, and 319/ 417 mg/ kg/ day [ M/ F], respectively. Actual daily dosage may have been slightly lower, based on the analytical diet concentrations). At study initiation, high­ dose animals received 3000 ppm diets. Due to high mortality, the compound was removed from the high­ dose diet for weeks 2 and 3, then dosing was re­ initiated at 2000 ppm. Animals that died during weeks 1­ 5 ( 10 males, 3 females) were replaced with parallel treated animals or control replacement animals that had not previously received the test article. No interim sacrifice was performed. Toxicity to the liver was observed at all doses. At 300 ppm, statistically significantly increased serum alkaline phosphatase (+ 60% above controls) and ALT or SGPT (+ 270%) in Page 16 females, along with a non­ significant increase in AST or SGOT (+ 76%, females) and ALT (+ 75%, males), and statistically significant increases in abs/ rel liver weights in both males (+ 26%/+ 34%) and females (+ 50%/+ 60%) were observed. These parameters usually showed dose­ dependent increases at
1000 ppm. Grossly visible liver masses ( combined males/ females 38% vs. 9%, controls) and liver microscopic lesions ( bile duct proliferation, pigmented macrophages, diffuse hepatocellular hyperplasia, nodular hyperplasia, nodular hypertrophy and centrilobular hypertrophy) were increased at
300 ppm in both sexes. Some of these lesions did not show a dose­ response, but were still considered treatment­ related. At 1000 ppm, significantly increased serum alkaline phosphatase (+ 620%), AST (+ 104%), ALT (+ 218%) and cholesterol (+ 82%) were observed in males, and possibly lenticular degeneration in the eyes of males ( 10% vs. 0, controls). At 2000 ppm, most of these parameters showed additional increases and significantly increased cholesterol in females (+ 81%), increased lenticular degeneration in the eyes of males ( 25% vs. 0%, controls) and liver focal necrosis in males ( 54% vs. 35%, controls) and females ( 41% vs. 25%, controls) were also observed. A 16% decrease in hematocrit in males was considered of equivocal biological significance. Survival ( after lowering of high dose to 2000 ppm), clinical signs, body weights, food consumption/ efficiency and urine occult blood in both sexes were unaffected at all dose levels. The systemic toxicity LOAEL is 300 ppm ( approximately 48/ 62 [ M/ F] mg/ kg/ day) based on increased liver effects in both sexes. The systemic toxicity NOAEL is < 300 ppm. Discussion of Tumor Data: Under the conditions of this study, there was evidence of an increased incidence of hepatocellular carcinoma in both sexes. The increase was significant ( p< 0.01) in both sexes at 1000 ( males ­ 24/ 60 or 40% vs 5/ 60 or 8.3%, controls; females ­ 12/ 61 or 19.7% vs 1/ 60 or 1.7%, controls) and 2000 ppm ( 27/ 69 or 39.1%, males and 13/ 63 or 20.6%, females). The incidence at 300 ppm in both males ( 7/ 60 or 11.7%) and females ( 4/ 60 or 6.7%) was not significant. Adequacy of the Dose Levels Tested: Dosing was considered adequate based on the finding of liver toxicity at all doses. The submitted study is classified as Unacceptable/ guideline ( § 83­ 2b). Although several study deficiencies were identified, the additional information is not being requested at this time because the results are consistent with an acceptable mouse carcinogenicity study ( MRID No. 00149003/ 00157780) that satisfies the guideline requirement. In the current study, the following were noted: ( 1) the summary tables of the gross pathology findings ( Tables 9 and 10) were illegible in the only study copy available for review and ( 2) it was unclear from the study report what system of classification of liver proliferative and neoplastic microscopic lesions were used in this study compared to current conventions of classification. Although hepatocellular carcinomas were increased in treated animals, no adenomas were reported, which are generally observed as part of the tumor progression ( MRID No. 00044322). MRID No.: 40993301 Page 17 Executive Summary: In a chronic/ oncogenicity toxicity study ( MRID No. 40993301), Oxadiazon ( 95.9%) was administered to 80 ICR­ JCL mice ( 80/ sex/ dose) in the diet at 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.315, 1.09, 10.6 or 113 mg/ kg/ day for males or 0, 0.278, 0.92, 9.3 or 99 mg/ kg/ day for females) for 98­ 99 weeks ( the study was scheduled to run for 104 weeks but due to deaths, it was terminated at 98­ 99 weeks). Clinical signs were monitored daily. Body weights were determined weekly for the first 26 weeks and biweekly, thereafter; food consumption was determined twice weekly for 8 cages ( 4 mice/ cage). Groups of 9­ 10 mice/ sex/ group were sacrificed at weeks 52 and 98/ 99 were subjected to hematology, biochemistry, urinalysis and pathology analysis. Dose selection was based on a preliminary 4­ week range finding study with 0, 10, 100, 1000 or 3000 ppm. Liver weights were increased in males at 100, 1000 and 3000 ppm and in females at 1000 and 3000 ppm. Signs of anemia were reported for both sexes at
1000 ppm. Elevated GOT and GPT ( indicative of hepatic toxicity) was also evident at 1000 and 3000 ppm ( ) and 3000 ppm (
) . There were no consistent adverse effects on mortality, clinical signs, body weight or food consumption. Hematological parameters significantly affected in male mice were: decreased hematocrit, hemoglobin and erythrocyte counts ( all exposure groups at week 52 but not at week 98); and decreased mean corpuscular volume and mean corpuscular hemoglobin ( highdose males at weeks 52 and 98). In females, significantly decreased hemoglobin, mean corpuscular volume and decreased mean corpuscular hemoglobin were observed at 1000 ppm after 52 weeks of treatment. The generalized changes in these blood elements are indicative of anemia which was most evident in the males at week 52. Significantly affected clinical chemistry parameters at 1000 ppm included: increased GLP, GOT, ALP and BUN ( and
) and at 100 ppm were: increased GLP and GOT( ) . High­ dose males also had brownish colored urine at week 52. Significantly increased liver weights ( absolute/ relative) were seen in high­ dose males at weeks 52 and 98 and in high­ dose females at week 98. Significant increases in absolute and relative adrenal ( week 98) and kidney (
week 98) weights were also seen at 1000 ppm. Non­ neoplastic pathology at 1000 ppm included:  centrilobular hepatocellular swelling (
) ;  diffuse hepatocellular swelling ( ) ; brown pigmentation in the liver and proximal tubules of the kidney ( and
) ; extramedullary hematopoiesis (
) diffuse hepatocellular necrosis ( ) and  auricular thrombus ( ) . At 100 ppm,  diffuse hepatocellular swelling and brown pigmentation in the liver were also seen in the males. The LOAEL is 100 ppm ( 10.6 mg/ kg/ day) based on anemia, hepatocellular swelling, necrosis and the formation of brown pigment in the liver and kidneys of male mice. This latter finding is consistent with the established mechanism of action of Oxadiazon in plants, ( i. e., inhibition of porphyrin biosynthesis). The NOAEL is 10 ppm ( 1.09/ 0.92 mg/ kg/ day for /
) . Discussion of Tumor Data: Neoplastic findings were: significant increases ( p< 0.05­< 0.001) in liver adenomas and carcinomas in males and females at 1000 ppm; liver adenomas and carcinomas were also significantly increased at 100 ppm in males. Page 18 Adequacy of the Dose Levels Tested: Dosing was considered adequate in males and females based on anemia and pathological changes in the liver at the highest dose tested. The pathology report for this chronic/ carcinogenicity study in the mouse was considered incomplete; thus, the overall study was listed as Supplementary. At this time, additional information is not being requested because the results are consistent with an acceptable mouse carcinogenicity study ( MRID No. 00115733) that satisfies the guideline requirement. Similarly, the presence of liver neoplasms confirms the evidence of a carcinogenic effect seen in other mouse long­ term studies ( MRID No. 00044322 and 00115733). Using the more recent terminology, the study is now listed as Unacceptable/ guideline ( MRID No. 40993301). 3.3 Classification of Carcinogenic Potential According to the Cancer Assessment Review Committee report, dated August 27, 1987 ( HED Document No. 007798), the original peer review ( September 9, 1986) placed Oxadiazon into Group B2 ( probable human carcinogen) but there was a minority opinion that the agent should be placed in Group C ( possible human carcinogen). Review of the weightof the­ evidence on Oxadiazon by the Scientific Advisory Panel ( dated November 20, 1987) reiterated this minority view. Consequently, the current Agency decision on the carcinogenic potential of Oxadiazon concurs with the Scientific Advisory Panel's ( SAP) classification of Oxadiazon as a group C carcinogen. The updated Q 1* has been set at 1.4 x 10­ 1( mg/ kg/ day)­ 1 in human equivalents. The rationale for the original classification as group B2 was based on the increased incidence of malignant or combined malignant and benign liver tumors: a) in multiple species ( CD ­ 1 mice and F344 rats of one or both sexes) and in multiple experiments ( liver tumors in two mouse studies and in one rat study). The decision to reclassify Oxadiazon as a Group C carcinogen was based on the rationale that liver tumors were produced in two of the three positive studies ( one mouse study and one rat study) at doses that exceeded the maximum tolerated dose ( MTD). Since that time, a new chronic/ oncogenicity toxicity study in rats ( MRID No. 40993401) and a new carcinogenicity study in mice ( MRID No. 40993301) have been submitted to the Agency. The HIARC recommended that the Q1* be revisited and that the CARC reconvene to evaluate these more recent studies. 4 MUTAGENICITY 4.1 Summaries Nine acceptable mutagenicity studies were available for review; summaries of these studies with MRID numbers are presented below: GENE MUTATION Page 19 a) Salmonella typhimurium/ Escherichia coli reverse gene mutation assay. The assay was negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 and E. coli WP2 hcr­ up to the highest dose tested ( 2500  g/ plate ­ S9; 1000  g/ plate + S9) of 99.18% Oxadiazon. The study is acceptable and satisfies the guideline requirements ( 870.5100/ 84­ 2) for a bacterial gene mutation assay ( MRID No. 00069893). b) S. typhimurium reverse gene mutation assay: The assay was negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 exposed to 97.49% Oxadiazon up to 5000  g/ plate+/­ S9; cytotoxicity was seen at
3330  g/ plate ­ S9. The study is acceptable and satisfies the guideline requirements ( 870.5100/ 84­ 2) for a bacterial reverse mutation assay ( MRID No. 41871701). c) L5178Y TK +/­ mouse lymphoma cell/ mammalian activation forward mutation assay: The assay was negative in cells treated with Oxadiazon ( 95.5% a. i.) up to reproducibly cytotoxic levels in the absence of S9 activation ( 1000  g/ mL) and severely cytotoxic doses (
200  g/ mL) with S9 activation. Oxadiazon was insoluble at
62.5  g/ mL. The study is acceptable and satisfies the guideline requirements ( 870.5300/ 84­ 2) for a mammalian cell gene mutation assay ( MRID No. 00115726). d) L5178Y TK +/­ mouse lymphoma cell/ mammalian activation forward mutation assay: The assay was negative in cells treated with recrystallized Oxadiazon ( 100% a. i.) up to cytotoxic levels ( 1000  g/ mL ­ S9; 250  g/ mL + S9). Oxadiazon was insoluble at concentrations
250  g/ mL. The study is acceptable and satisfies the guideline requirements ( 870.5300/ 84­ 2) for a mammalian cell gene mutation assay ( MRID 00115729). CHROMOSOME ABERRATIONS e) In vitro chromosome aberration assay in Chinese hamster ovary ( CHO) cells: The assay was negative in cells treated with Oxadiazon ( 95.5% a. i.) up to cytotoxic concentrations ( 75  g/ mL ­ S9; 41.6  g/ mL + S9) and the limit of solubility (
416  g/ mL). The study is acceptable and satisfies the guideline requirements ( 870.5373/ 84­ 2) for a mammalian cell chromosome aberration assay ( MRID 00115730). f) In vitro chromosome aberration assay in Chinese hamster ovary ( CHO) cells: The assay was negative in cells treated with recrystallized Oxadiazon ( 100% a. i.) up to cytotoxic concentrations ( 200  g/ mL ­ S9; 500  g/ mL + S9) and the limit of solubility ( 667  g/ mL ­ S9; 200  g/ mL + S9). The study is acceptable and satisfies the guideline requirements ( 870.5373/ 84­ 2) for a mammalian cell chromosome aberration assay ( MRID 00115728). OTHER MUTAGENIC MECHANISMS Unscheduled DNA synthesis( UDS) g) UDS in primary rat hepatocytes assay: The test was negative in hepatocytes exposed to Oxadiazon ( 95.5% a. i.) up to cytotoxic concentrations (
100 µ g/ mL) and the limit of Page 20 solubility (
50 µ g/ mL). The study is acceptable and satisfies the guideline requirements ( 870.5550/ 84­ 2) for a UDS assay ( MRID No. 00115727). h) UDS in primary rat hepatocytes assay: The test was negative in hepatocytes exposed to recrystallized Oxadiazon ( 100% a. i.) up to cytotoxic concentrations ( 100­ 500 µ g/ mL) and the limit of solubility (
25 µ g/ mL). The study is acceptable and satisfies the guideline requirements ( 870.5550/ 84­ 2) for a UDS assay ( MRID No. 00115723). In vitro cell transformation I) In vitro cell transformation assay in Syrian hamster kidney BHK21 C13/ HRC1 cells: The test was positive both with and without S9 activation, based on the induction of transformation frequencies ( TFs)
5 times the solvent control value at the LD 50 . Oxadiazon ( 90% a. i.) and recrystallized Oxadiazon ( 100 % a. i.) were tested up to cytotoxic concentrations with LD 50 values in the absence of S9­ mix of 118 µ g/ mL and 200 µ g/ mL, respectively. In the presence of S9­ mix, the LD 50 of Oxadiazon was 69 µ g/ mL; however, the LD 50 for recrystallized Oxadiazon was not determined as cell viability was 78% of the solvent control at the highest dose tested ( 400 µ g/ mL). The transformation frequencies ( the number of transformed colonies/ 106 surviving cells) at the LD 50 concentrations were 128 and 79 for cells treated with Oxadiazon in the absence and presence of S9­ mix, respectively, compared to the solvent control values of 4 and 5, respectively. Recrystallized Oxadiazon induced transformation frequencies of 55 at the LD 50 in the absence of S9­ mix and 60 at the highest dose tested in the presence of S9­ mix. A positive dose­ response trend was generally apparent for both concentrations. This study is classified as acceptable ( nonguideline) ( MRID No. 00115703). Page 21 4.2 Conclusions In addition to the above two S. typhimurium reverse gene mutation assays ( Ames test), seven Ames tests submitted by the sponsor were considered inadequate ( see HED Document No. 002168). Nevertheless, results from these assays indicated that an impurity ( identified as 24,865 RP) in Oxadiazon formulations was mutagenic in S. typhimurium strains TA98 and/ or TA100 in the presence of S9 activation. Lots/ batches of Oxadiazon with purity levels  90% that contained this impurity were also positive. As summarized above, the acceptable bacterial assays with
97.49% Oxadiazon were negative ( MRID Nos. 00069893 and 41871701). Similarly, neither 95.5% Oxadiazon nor recrystallized Oxadiazon ( 100%) were mutagenic or clastogenic in cultured mammalian cells and did not cause UDS in primary rat hepatocytes. There is, however, evidence that both formulations induced neoplastic transformation in Syrian hamster kidney cells both in the presence and in the absence of S9 activation. The finding of positive cell transformation supports the evidence from mouse bioassays ( MRID Nos. 00444322, 00115733 and 40993301) and the rat long­ term studies ( MRID Nos. 00149003/ 00157780 and 40993401) of liver tumor induction. Overall, the data indicate that Oxadiazon is not mutagenic but does cause neoplastic cell transformation in vitro. 5 FQPA CONSIDERATIONS 5.1 Adequacy of the Data Base: Acceptable prenatal toxicity studies in rats and rabbits with Oxadiazon have been submitted to the Agency. An acceptable reproductive toxicity study in rats with Oxadiazon was also submitted. Hence, there are no data gaps for the assessment of the effects of Oxadiazon following in utero exposure or the effects on young animals following early exposure. Neither acute nor subchronic neurotoxicity studies were submitted to the Agency. It is not, however, expected that Oxadiazon is a neurotoxicant since none of the acute, subchronic, chronic, developmental or reproductive toxicity studies showed evidence of an effect on the nervous system. 5.2 Neurotoxicity: No neurotoxicity studies were submitted to the Agency. 5.3 Developmental Toxicity a. Developmental Toxicity Study in the Rat ( ORAL) Guideline #: 870.3700; 83­ 3 MRID No.: 40470202 Page 22 Executive Summary: In a developmental toxicity study ( MRID 40470202), Oxadiazon technical ( 96.3%) was administered daily by gavage in 10 ml 1% aqueous methylcellulose vehicle/ kg body weight from Gestation Days 6 through 15 to groups of 20 pregnant Sprague­ Dawley rats per dose at 0, 3, 12 or 40 mg/ kg/ day. Pregnant females were examined daily for signs of toxicity and body weights were measured on Gestation Days 0, 3, 6, daily through Day 16 and on Days 18 and 20. Dams were sacrificed on Day 20 and uterine contents were examined. Very little maternal toxicity was observed at any dose. Small but statistically significant decreases in body weight (­ 2% less than controls) and body weight gain (­ 10%) in the highdose females at Days 16­ 20 were possibly due to resorptions of fetuses ( decreased maternal body weights also observed at
40 mg/ kg/ day in the range­ finding study). The maternal toxicity LOAEL is 40 mg/ kg/ day, based on slightly decreased body weight/ weight gain. The maternal toxicity NOAEL is 12 mg/ kg/ day. Treatment­ related fetal toxicity at 40 mg/ kg/ day included: slightly, not statistically significantly increased fetal resorptions ( 0.7/ dam vs. 0.4/ dam, controls) and post­ implantation loss ( 12.5% vs. 8.2%, controls) and significantly decreased body weight (­ 4.5% less than controls). Developmental effects at 40 mg/ kg/ day were confined to increased incidence of incomplete ossification, primarily in skull and vertebral bones. No effects were seen at lower doses. No treatment­ related malformations were observed at the doses tested. Fetal effects seen in this study are considered treatment­ related based on the steep dose­ response curve ( for fetal loss and decreased fetal weight) between 20­ 60 mg/ kg/ day in the preliminary rangefinding study. In the range­ finding study, which tested at 10, 20, 40, 60 or 80 mg/ kg/ day ( 6 dams/ dose group), no maternal or developmental toxicity was observed at 10 or 20 mg/ kg/ day. However, at 40 mg/ kg/ day, a mean fetal resorption rate of 40% ( 53­ 100% in 3/ 6 dams) was observed, increasing to 80­ 90% at 60 and 80 mg/ kg/ day. Weights of surviving fetuses were decreased. Decreased maternal weights were also observed at
40 mg/ kg/ day and were usually correlated with the increased litter resorption. Therefore, the effects seen at 40 mg/ kg/ day in the main study are considered a threshold response for Oxadiazon under the conditions of the main study. The developmental toxicity LOAEL ( threshold) is 40 mg/ kg/ day, based on increased fetal resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification. The developmental toxicity NOAEL ( threshold) is 12 mg/ kg/ day. This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a developmental toxicity study ( 83­ 3a) in the rat. b. Developmental Toxicity Study in the Rabbit ( ORAL) Guideline #: 870.3700; 83­ 3 MRID No.: 40470201 Executive Summary: In a developmental toxicity study ( MRID 40470201), Oxadiazon technical ( 95.6% ) was administered daily by gavage in 5 ml 1% aqueous methylcellulose vehicle/ kg body weight from gestation days 6 through 19 to groups of 15 to 19 pregnant New Page 23 Zealand White rabbits per dose at 0, 20, 60 or 180 mg/ kg/ day. Pregnant females were examined daily for signs of toxicity and body weights were measured on Gestation Days 0 and 6, on alternate days through day 20 and on days 24 and 28. Dams were sacrificed on Day 29 and uterine contents were examined. Treatment­ related maternal toxicity was observed at 60 mg/ kg/ day as transient weight loss (­ 0.01 kg vs. 0.10 kg gain, controls; p< 0.05) and slightly decreased food consumption during the first half of treatment (­ 15% less than controls, treatment days 6­ 12; not statistically significant). These effects were more pronounced at 180 mg/ kg/ day and showed statistically significant reductions in weight gain and marked reductions in food consumption during and after treatment. The maternal toxicity LOAEL is 60 mg/ kg/ day, based on transient weight loss and decreased food consumption during treatment. The maternal toxicity NOAEL is 20 mg/ kg/ day. Treatment­ related fetal toxicity at 180 mg/ kg/ day included: increased postimplantation loss and late resorptions ( 18.85% vs. 8.6%, controls; p< 0.05), decreased mean fetal weight (­ 10%) and increased incidence of bilateral hind­ limb flexure ( 4.2% of fetuses, 3 litters affected vs. 0%, controls). Marginal developmental effects at 180 mg/ kg/ day were: increased incidence of rib abnormalities, delayed/ incomplete ossification in several bones and asymmetrical pelvis. No effects were seen at lower doses and there were no treatment­ related malformations observed at any dose tested. The developmental toxicity LOAEL is 180 mg/ kg/ day, based on increased postimplantation loss, decreased mean fetal weight, increased bilateral hind­ limb flexure and possibly delayed/ incomplete ossification of several bones. The developmental toxicity NOAEL is 60 mg/ kg/ day. This study is classified Acceptable/ guideline; it satisfies the guideline requirement for a nonrodent developmental toxicity study ( 83­ 3b) in the rabbit. 5.4 Reproductive Toxicity Two Generation Reproduction Study in Rats ( dietary) Guideline #: 870.3800; 83­ 4a MRID Nos. 41230301( Dose­ range finding study)/ 41239801 ( Main study) Executive Summary: In a 2­ generation reproduction study ( MRID 41239801; range­ finding study MRID 41240301) Oxadiazon ( 96.6% a. i., batch # DA459) was administered in the diet continuously to CD rats ( 30 rats/ sex/ dose) at 0, 20, 60 or 200 ppm ( equivalent to an average daily intake [ M/ F] of 0, 1.50/ 1.84, 4.65/ 5.63 or 15.50/ 18.20 mg/ kg/ day, average of P and F 1 generation premating food consumption). Dose levels were selected based on the results of the 1­ generation range­ finding study, which tested at 0, 50, 100, 200, 400 or 800 ppm ( 6 animals/ sex/ dose, 4 weeks premating exposure). The P animals were exposed to the test substance beginning at approximately 6 weeks of age for 14 weeks prior to mating and continuing until sacrifice after weaning ( post­ partum day 25). F 1 pups selected ( 30/ sex/ dose) to produce the F 2 generation were exposed to the same dosage as their parents beginning at postnatal day ( PND) 25 for 14 weeks premating and continuously throughout the rest of the Page 24 study until weaning of the F 2 offspring ( postpartum day 25). Liver, kidneys, ovaries, uterus, prostate, epididymis, testes and seminal vesicles were weighed and examined for gross/ microscopic pathology. Mammary gland, pituitary and vagina were examined for pathological changes. The 1­ generation range­ finding study tested in 6 dams/ dose group at dietary concentrations of 0, 50, 100, 200, 400 or 800 ppm ( 0, 5/ 5, 9/ 9, 19/ 19, 36/ 38 or 67/ 75 mg/ kg/ day, respectively), administered beginning 15 days prior to initiation of mating until lactation day 4. No treatment­ related findings were reported at
200 ppm; effects at 400 and 800 ppm are discussed below. There was no evidence of treatment­ related changes in clinical signs, mortality, body weights or weight gains, food consumption, food efficiency, organ weights or microscopic or macroscopic pathology observed in P or F 1 adults in the main study. Slight liver alterations in F 1 adults at 200 ppm (+ 6% relative liver weight, females, periacinar hepatocellular hypertrophy, males) were considered an adaptive response. However, at 400 ppm in the range­ finding study, markedly decreased gestational weight gain (­ 34% below controls, primarily after GD 13) was observed ( due largely to increased fetal loss). At 800 ppm, decreased maternal weight gain of ­ 38% below controls, also primarily after GD 13, blood in the urine in the cage paper of males and blood in the nares/ face/ urogenital region of 1 dam were observed. The LOAEL ( main study) for parental toxicity is > 200 ppm ( 15.5 mg/ kg/ day; HDT in main study); however, a LOAEL of 400 ppm ( 38 mg/ kg/ day), based on decreased gestational weight gain, was observed in the range­ finding study. The parental toxicity NOAEL ( main study) is
200 ppm. No differences in reproductive parameters in P or F 1 parental animals, nor in F 1 or F 2 offspring viability, clinical signs, body weight or body weight gain, developmental landmarks, auditory or ophthalmological function or macroscopic pathology were observed in the main study. However, in the range­ finding study, pronounced reproductive/ offspring toxicity at 400 ppm in the 4 dams that littered ( 5 pregnant) included inactive/ pale mammary tissue, reduced litter size and increased gestation length (+ 1 day). Pre­/ perinatal mortality resulted in total litter losses for all dams by day 1 postpartum ( 17 offspring were examined: 20% late resorptions, 7.7% dead fetus, 73% without milk in stomach). At 800 ppm, 2 dams littered but all were late resorptions; 4 dams that failed to litter had blood in their cage on GD 23 ( implantation sites/ dam were comparable to controls). The reproductive/ offspring toxicity LOAEL ( main study) is > 200 ppm ( 15.5 mg/ kg/ day; HDT in main study); however, a LOAEL of 400 ppm ( 38 mg/ kg/ day), based on inactive mammary tissue and fetal/ neonatal death, was observed in the range­ finding study. The reproductive/ offspring toxicity NOAEL ( main study) is
200 ppm. This reproductive toxicity study in the rat is classified Acceptable/ guideline [ § 83­ 4( a)] and satisfies the guideline requirement for a multigenerational reproductive toxicity study in rats. Although no significant effects were observed at
200 ppm in the main or range­ finding studies, pronounced reproductive/ offspring toxicity, including complete litter loss, was observed at
400 ppm. The HIARC concluded that the neonatal loss seen at 400 ppm was attributable to maternal effects ( i. e., inactive mammary tissue resulting in possible starvation of the pups which was manifested as 73% of the examined offspring Page 25 without milk in their stomachs). The HIARC further concluded that the inactivity of mammary tissue may have been related to endocrine disruption. However, this finding was not considered to be likely because there was no supporting evidence of possible endocrine disruption observed in any other study in the Oxadiazon database. 5.5 Additional Information from Literature Sources ( if available) No additional information was obtained from the open literature for developmental, reproductive or neurotoxic effects of Oxadiazon. 5.2 Determination of Susceptibility There was qualitative evidence of increase susceptibility of fetuses in the rat developmental study. In this study, very little maternal toxicity ( a small but significant decrease in body weight, ­ 2% and a decrease in body weight gain, ­ 10%) was seen at the maternal and developmental LOAEL ( 40 mg/ kg/ day). By contrast, effects on offspring at this LOAEL were severe ( increased post­ implantation loss and late resorptions and decreased fetal weight). In the two generation study in rats, neonatal effects ( LOAEL of 38 mg/ kg/ day, based on neonatal losses) in the dose range­ finding phase of testing and the lack of milk in the pup stomach were considered to be attributable to maternal effects ( i. e., inactive mammary tissue) at 38 mg/ kg/ day. The findings of post­ implantation loss associated with the lack of milk could be due to endocrine disruption. There was, however, no evidence ( qualitative or quantitative) of increased susceptibility in the developmental rabbit study following in utero exposure or in the two­ generation reproduction study following pre­ or post­ natal exposure. 5.3 Recommendation for a Developmental Neurotoxicity Study The Committee concluded that a developmental neurotoxicity study was not recommended. This decision was based on results showing no evidence of neurotoxicity in any study in the database which included: chronic ( rats, mice and dogs), subchronic ( rat or rabbit), reproduction ( rat) or developmental ( rat or rabbit) toxicity studies. 6 HAZARD CHARACTERIZATION Oxadiazon is a selective pre­ emergent herbicide of the oxadiazole class which displays light­ dependent phytotoxicity through the accumulation of protoporphyrin IX in plants, yeast and mouse liver mitochondria. At present, there are no registered food or residential uses. The database for Oxadiazon is largely complete and provides sufficient information to characterize toxicity. The only data gap that has been identified at this time is the submission of a 28­ and/ or 90­ day inhalation study. In acute studies, Oxadiazon is only slightly toxic ( Toxicity Categories III or IV) with an oral LD 50 > 5000 mg/ kg, a dermal LD 50 > 2000 mg/ kg and an inhalation LC 50 > 1.94 mg/ L. Page 26 Oxadiazon is mildly irritating to ocular tissue and negligibly irritating to the skin ( both Toxicity Category III) and is not a dermal sensitizer. The major target organ of Oxadiazon is the liver. Effects were consistent among the species tested ( rat, dog, mouse) in both subchronic and chronic studies and typically included enlarged livers ( presumably due to the peroxisomal proliferating activity of Oxadiazon), along with increases in serum clinical chemistry parameters associated with hepatotoxicity such as alkaline phosphatase and serum aspartate or alanine aminotransferase. Although treatmentrelated microscopic lesions of the liver were not observed in dog subchronic or chronic oral studies, findings in rats and mice included pigmented Kupffer cells and bile canaliculi, periacinar pallor, increased acidophilic cells and hepatocellular necrosis. The hematopoietic system also appeared to be a target of Oxadiazon in all three species, based on mild anemia ( reductions in RBC, hematocrit and/ or hemoglobin). Increased pigmentation in the kidney was observed in rats, along with increased BUN and kidney weights. Although a dose­ dependent increase in thyroid weight was observed in the dog subchronic oral toxicity study, treatment­ related changes in thyroid weights or gross/ microscopic observations were not observed in other studies ( thyroid hormones were not evaluated). In a rat dermal absorption study, up to  9% of the applied dose was absorbed after 10 hours of exposure. Dermal toxicity studies ( 21­ day rabbit) support low dermal absorption: no toxicity was observed at the limit dose of 1000 mg/ kg/ day. Following long­ term dietary administration, Oxadiazon caused an increased incidence of hepatocellular adenoma and carcinoma in rats and mice. In mice, statistically significant increases of hepatocellular adenoma and combined adenoma/ adenocarcinoma were observed at all four dose levels tested (
100 ppm) in males and females. The incidence of hepatocellular adenocarcinoma was increased at all doses in males but only at the two highest doses ( 1000 and 2000 ppm; significant at 1000 ppm) in females. The highest dose tested in males ( 2000 ppm) exceeded the MTD based on excessive mortality. In SPF Wistar rats, the incidence of hepatocellular adenomas was increased in males; adenocarcinomas were increased but not significantly in both sexes at the highest dose tested ( 1000 ppm). A second study in F344 rats showed an increased incidence of hepatocellular adenoma and adenocarcinoma only in males at 1000 and 3000 ppm. A classification of Group C ( possible human carcinogen) and a Q 1* of 1.4 x 10­ 1 ( mg/ kg/ day)­ 1 were assigned by the HED Cancer Peer Review Committee in conjunction with the recommendations of the Scientific Advisory Panel. Since that time, a new chronic/ oncogenicity toxicity study in rats and a new carcinogenicity study in mice have been submitted to the Agency and are being evaluated for their impact on the cancer classification and the Q 1*. In a special mechanistic study in rats, Oxadiazon induced peroxisomal proliferation ( based on peroxisomal enzyme induction and electron microscopy) after a 14­ day dietary administration. Although some peroxisomal proliferator compounds are known to be liver carcinogens, there are insufficient data available to support this as a mechanism of carcinogenicity for Oxadiazon. Similarly, Oxadiazon did not show mutagenic potential in any in vitro assays with bacteria ( S. typhimurium and E. coli) or mammalian cells ( TK +/­ mouse lymphoma Page 27 cells), did not show clastogenic potential in the in vitro Chinese hamster ovary cell chromosomal aberration assays and did not induce unscheduled DNA synthesis in cultured primary rat hepatocytes. However, a dose­ related increase in transformation frequencies was observed in an in vitro Syrian hamster kidney BHK21 C13/ HRC1 cell transformation assay. Significant fetal toxicity ( fetal loss due to resorptions and post­ implantation loss, decreased fetal weight, skeletal variations) was observed in developmental toxicity studies in both rats and rabbits and in a rat two­ generation reproduction study. Neonatal survival was also sharply reduced in the reproduction study. The latter finding was due at least in part to effects on lactation, based on findings of inactive mammary glands in the dams at necropsy. These fetal/ neonatal effects occurred at the same dose levels at which maternal toxicity ( decreased weight gain/ weight loss) were observed. It is likely that neonatal loss may have resulted from starvation and would, therefore, be an effect of direct maternal toxicity. Inactivity of the mammary tissue as a possible effect of endocrine disruption was considered but was not found to be likely since there was no evidence from any other study in the database suggesting endocrine disruption. No fetal malformations were observed in the rat or rabbit developmental toxicity studies although, some skeletal variations ( delayed ossification, asymmetric pelvis) were reported. There was, however, no evidence ( qualitative or quantitative) of increased susceptibility in the developmental rabbit study following in utero exposure or in the two­ generation reproduction study following pre­ or post­ natal exposure. No neurotoxicity studies have been submitted for Oxadiazon. However, the available data do not indicate a need for neurotoxicological testing. No clinical signs of toxicity suggestive of neurobehavioral alterations nor evidence of neuropathological effects were observed in the available oral toxicity studies. There was no evidence for neurodevelopmental potential of Oxadiazon in the rat and rabbit developmental toxicity studies, nor in the rat two­ generation reproductive toxicity study. Based on pharmacokinetics/ metabolism studies in the rat, low doses ( 5 mg/ kg, single or multiple) of Oxadiazon were completely absorbed, metabolized and excreted in the urine and feces; virtually no free Oxadiazon was found in the urine. At this dose, the rates and routes of excretion of radioactivity were similar. At 500 mg/ kg, the rate of excretion was affected but the route was not. The excretion of radioactivity into the urine and the feces was sex dependent and the tissue residues were very low in all tissues except liver and fat. Over a 7­ day period, 85 to 93% of the test compound administered was excreted in the urine and feces. The radioactivity recovered in the urine, feces and tissues exceeded 94% of the dose and was sex­ related. Females excreted more radioactivity in the urine than males. The metabolism of Oxadiazon in rats was extensive, but the benzene and pyrozolidine rings were not modified. Eighteen ( 18) metabolites were identified in the urine and feces. Four ( 4) urinary and 5 fecal metabolites were present at levels greater than 1% of the dose. Among the 9 metabolites, U2, U7 and U10 from the urine correspond to F2, F7 and F9 of the feces. Female rats were efficient metabolizers and the urine was unique in that metabolites U4 and U5 were excreted in the urine only. Only conjugates of glucuronic acid were present in urine; there was no evidence of sulphate conjugates. The identified glucuronides were those of metabolites RP 29585 and RP25496. In addition to 5 fecal metabolites, intact Oxadiazon was present in feces Page 28 only and was dose­ related. At the high dose more than 53% of the administered radioactivity was intact Oxadiazon in the feces; at 5 mg/ kg, not more than 4.8% of the dose was intact Oxadiazon in the feces. This observation is consistent with extensive absorption followed by excretion in the feces by way of the bile. 7 DATA GAPS HIARC has requested the submission of a 28­ day inhalation study. 8 ACUTE TOXICITY Acute Toxicity of Oxadiazon Guideline No. Study Type MRIDs # Results Toxicity Category 870.1100/ [ 81­ 1] Acute Oral; Rat 97.5 % a. i. 41866501 LD 50 = > 5000 mg/ kg (
, combined) IV 870.1200/ 81­ 2 Acute Dermal; Rabbit 97.5 % a. i. 41866502 LD 50 = > 2000 mg/ kg (
, combined) III 870.1300/ 81­ 3 Acute Inhalation; Rat 93.7 % a. i. 41866503 LC 50 = > 1.94 mg/ L (
, combined) III 870.2400/ 81­ 4 Primary Eye Irritation; Rabbit 97.5 % a. i. 41866504 Mild irritant to ocular tissue III 870.2500/ 81­ 5 Primary Skin Irritation; Rabbit 97.5 % a. i. 41866505 Negligibly irritating to skin III 870.2600/ 81­ 6 Dermal Sensitization; Guinea pig 93.7% a. i. 41230401 Not a dermal sensitizer ( Buehler test) ­­ 81­ 8 Acute Neurotoxicity ND 9 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for various exposure scenarios are summarized below. Page 29 EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary NOAEL= N/ A UF = N/ A This risk assessment is not required because there are no food or feed uses for Oxadiazon Chronic Dietary NOAEL = N/ A UF = N/ A This risk assessment is not required because there are no food or feed uses for Oxadiazon Cancer Q 1* of 1.4 x 10­ 1 ( mg/ kg/ day)­ 1in human equivalentsa Group C " possible human carcinogen", based on liver tumors produced in two of the three positive studies ( one mouse study and one rat study) at doses that exceeded the maximum tolerated dose. Combined Chronic Toxicity/ Carcinogenicity Study in Rats MRID Nos. 00149003/ 00157780; Carcinogenicity Study in Mice MRID Nos. 00115733 Incidental Oral, Short­ and Intermediate­ Term NOAEL= 12 Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL). Developmental Toxicity ­ Rat MRID No. 40470202 Dermal, Shortand Intermediate­ Term NOAEL= 12 Increased fetal resorptions/ postimplantation loss, decreased fetal weight and increased incidence of incomplete ossification at 40 mg/ kg/ day ( LOAEL) b. Developmental Toxicity ­ Rat MRID No. 40470202 Page 30 EXPOSURE DOSE ( mg/ kg/ day) ENDPOINT STUDY Dermal, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL) b. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 Inhalation, Short­ Term NOAEL= 12 Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) c . Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Intermediate­ Term NOAEL= 12 Reduced body weight/ body weight gain at 40 mg/ kg/ day ( LOAEL) c . Developmental Toxicity ­ Rat MRID No. 40470202 Inhalation, Long­ Term NOAEL= 0.36 Increased centrilobular swelling in male livers at 3.5 mg/ kg/ day ( LOAEL) c. Combined Chronic Feeding/ Oncogenicity ­ Rat MRID Nos. 40993401, 00149003/ 00157780 a Q 1* may change awaiting the outcome of the CARC revisit. b For this risk assessment, the dermal absorption factor of 9% should be applied. c For this risk assessment, use a route­ to­ route extrapolation and a 100% absorption rate ( default value).

epa

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regulations

EPA-HQ-OPP-2002-0309-0011

Supporting & Related Material

HED DOC. NO. 014555 CANCER ASSESSMENT DOCUMENT EVALUATION OF THE CARCINOGENIC POTENTIAL OF OXADIAZON ( THIRD REVIEW) FINAL REPORT 1­ MAY­ 2001 CANCER ASSESSMENT REVIEW COMMITTEE HEALTH EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report ii DATA PRESENTATION: Nancy McCarroll, Toxicologist DOCUMENT PREPARATION: Sanjivani Diwan, Executive Secretary COMMITTEE MEMBERS IN ATTENDANCE: ( Signature indicates concurrence with the assessment unless otherwise stated). Karl Baetcke William Burnam Kerry Dearfield Vicki Dellarco Yiannakis Ioannou Nancy McCarroll Esther Rinde Joycelyn Stewart Clark Swentzel Linda Taylor NON­ COMMITTEE MEMBERS IN ATTENDANCE ( Signature indicates concurrence with the pathology report and statistical analysis of data, respectively) John M. Pletcher Pathology Consultant Lori Brunsman, Statistical Analysis Veronique LaCapra CRM ( SRRD) Seyed Tadayon Chemist ( Chem and Exposure) _______________________________________________________________________________ Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report iii CONTENTS Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. Background Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 III. Evaluation of Carcinogenicity Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 1. Combined Chronic Toxicity/ Carcinogenicity Study in Wistar Rats . . . . . . . . . . . . . . . 2 2. Combined Chronic Toxicity/ Carcinogenicity Studies in ICR­ JCL mice . . . . . . . . . . 8 IV. Other Toxicology Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 1. Mutagenicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 2. Structure Activity Relationships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3. Mode of Action Studies. . . . . . . . . . . . . . . . . . . .. . . . . . . . . . .. . . . . . . . . . . .. . . . . . .17 V. Committee's Assessment of the Weight­ of­ the Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . 18 VI. Classification of Carcinogenic Potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 VII. Quantification of Carcinogenic Potential. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 VIII. Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report iv EXECUTIVE SUMMARY On March 7, 2001, the Cancer Assessment Review Committee ( CARC) of the Health Effects Division ( HED) of the Office of Pesticide Programs met to reevaluate the carcinogenic potential of oxadiazon. In the original carcinogenicity assessment, oxadiazon was classified as a Group B2, probable human carcinogen, based on the increased incidence of malignant or combined benign and malignant liver tumors in multiple species ( CD ­ 1 mice and F344 rats of one or both sexes) and in multiple experiments ( two mouse studies and one rat study ( 1984; HED Document No. 004097). On September 3, 1986 during the 2nd meeting, the Toxicology Branch Peer Review Committee reaffirmed the earlier classification of oxadiazon as a Group B2 carcinogen but there was a minority opinion that the agent should be placed in Group C, possible human carcinogen ( 1987; HED Document No. 007798). Based on weight­ of­ the­ evidence for oxadiazon, the Scientific Advisory Panel reiterated the minority view ( 1987; HED Document No. 007798). Subsequently, the cancer classification for oxadiazon was revised to a Group C carcinogen and for the quantification of human cancer risk, a linear low dose extrapolation approach was recommended ( 1987; HED Document No. 007798). The decision to reclassify oxadiazon as a Group C carcinogen was based on the rationale that liver tumors were produced in two of the three positive studies ( one mouse study and one rat study) at doses that exceeded the maximum tolerated dose ( MTD). At the March 7, 2001 CARC meeting, information/ data previously not available to the Peer Review Committee were considered which included chronic toxicity/ carcinogenicity studies in Wistar rats and ICR­ JCL mice. In the rat study, oxadiazon was administered in the diet to groups of 80 male and 80 female Wistar rats at concentrations of 0, 3, 10, 100 or 1000 ppm ( 0, 0.106, 0.36, 3.5 or 39 mg/ kg/ day for males and 0, 0.131, 0.44, 4.2 or 44 mg/ kg/ day for females, respectively) for up to 104 weeks. In the mouse study, oxadiazon was administered to groups of 80 male and 80 female ICR­ JCL mice at dietary concentrations of 0, 3, 10, 100 or 1000 ppm ( 0, 0.315, 1.09, 10.6 or 113 mg/ kg/ day for males and 0, 0.278, 0.92, 9.3 or 99 mg/ kg/ day for females, respectively) for 98/ 99 weeks. The Registrant also submitted mechanistic studies to support the proposed mode of action for liver tumor induction observed in these studies. The CARC concluded that: ! There was clear evidence that oxadiazon was carcinogenic to male Wistar rats because: 1) There were statistically significant positive trends for liver adenomas, carcinomas and combined adenomas/ carcinomas. There was a statistically significant increase by pair­ wise comparison with the controls for liver adenomas and combined liver adenomas/ carcinomas at 100 and 1000 ppm and for liver carcinomas at 1000 ppm indicating a malignant component to the liver tumors; and 2) The incidences of liver adenomas at 100 ppm and 1000 ppm and carcinomas at 1000 ppm were outside the published range of spontaneous incidences in Wistar rats ( range: adenomas, 0%­ 2.5%; carcinomas, 0%­ 2.5%). The highest dose level tested in this study was considered to be Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report v adequate and not excessive in male rats because there were decreases in body weight gains and the clinical and histopathological liver changes observed were not severely adverse. The survival of the animals was not affected by the treatment. There was a statistically significant increasing trend for liver carcinomas in females but there was no significant increase in liver tumors in treated females by pair­ wise comparisons with controls. The Committee determined that, for female rats, the highest dose was adequate based on an increased incidence of chronic nephropathy. The CARC concluded that the increased incidence of liver tumors observed in the male rats was treatment­ related. ! There was clear evidence that oxadiazon was carcinogenic to male and female ICRJCL mice because: There were statistically significant positive trends for liver adenomas, carcinomas and combined adenomas/ carcinomas in both sexes. There were also statistically significant increases by pair­ wise comparison of the dosed groups with the controls for liver adenomas and carcinomas as well as for combined liver adenomas/ carcinomas at 100 and 1000 ppm for males and at 1000 ppm for females. There was a malignant component to the liver tumors in both sexes. The highest dose level tested was considered to be adequate and not excessive in both sexes based on increased liver weights and histopathological changes in the liver at 1000 ppm which were not severely adverse. The Committee concluded that there were treatment­ related increases in both benign and malignant liver tumors in male and female mice. The positive results of an in vitro cell transformation assay are in concordance with the findings of in vivo rodent bioassays. ! A battery of acceptable mutagenicity assays indicated that oxadiazon was not mutagenic. ! The mechanistic studies provide insufficient data to determine whether a threshold mechanism exists for the induction of liver tumors observed in rats and mice. Nevertheless, the formation of brown pigment in the liver and kidneys of rats and mice is consistent with the known inhibitory action of oxadiazon toward protoporphyrinogen oxidase, a critical enzyme in chlorophyll and heme biosynthesis. In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment ( July, 1999), the CARC classified oxadiazon into the category " Likely to be carcinogenic to humans" based on the following weight­ of­ the­ evidence considerations: 1. Treatment­ related benign and malignant liver tumors were observed in two species. There was clear evidence that oxadiazon induced a statistically significant increase in liver tumors in male Wistar rats and male and female ICR­ JCL mice. The findings of liver tumors are consistent with the results of earlier studies in male F­ 344 rats and male and female CD mice. The positive results from an in vitro cell transformation assay are in concordance with the results of in vivo rodent bioassays. 2. Oxadiazon was not mutagenic. However, it causes cell transformation in vitro; these results are in concordance with the carcinogenicity seen in in vivo rodent studies. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report vi The Committee recommended a low dose linear extrapolation approach for the quantification of human cancer risk based on the most potent liver tumors in rats and mice. This approach is supported by the inadequacy of data on the mode of action for oxadiazon­ induced liver tumors in rodents. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 1 I. INTRODUCTION According to the original carcinogenicity assessment for oxadiazon, the pesticide was ranked as a Group B2, probable human carcinogen ( 1984; HED Document No. 004097). The rationale for the classification, Group B2, was based on the increased incidence of malignant or combined malignant and benign liver tumors in multiple species ( CD ­ 1 mice and F344 rats of one or both sexes) and in multiple experiments ( two mouse studies and one rat study). The Toxicology Branch Peer Review of this agent was later held on September 3, 1986 and the Committee affirmed the earlier classification of oxadiazon as a Group B2 carcinogen but there was a minority opinion that the agent should be placed in Group C, possible human carcinogen ( 1987; HED Document No. 007798). Review of the weight­ of­ the­ evidence on oxadiazon by the Scientific Advisory Panel reiterated this minority view ( 1987; HED Document No. 007798). At that time, the Agency's decision on the carcinogenic potential of oxadiazon concurred with the Scientific Advisory Panel's ( SAP) classification of oxadiazon as a Group C carcinogen ( 1987; HED Document No. 007798). The decision to reclassify oxadiazon as a Group C carcinogen was based on the rationale that liver tumors were produced in two of the three positive studies ( one mouse study and one rat study) at doses that exceeded the maximum tolerated dose ( MTD). For the quantification of human cancer risk a linear low dose extrapolation approach was recommended ( Q1*= 1.4 x 10­ 1( mg/ kg/ day)­ 1 ). On March 7, 2001, the Cancer Assessment Review Committee ( CARC) met to reconsider the carcinogenicity classification of oxadiazon under the draft Agency Cancer Risk Assessment Guidelines ( 1999) for the human cancer risk assessment. At this meeting, information/ data previously not available or relevant to this review were presented by Nancy McCarroll of the Toxicology Branch. These include a chronic/ carcinogenicity toxicity study in Wistar rats ( MRID No. 40993401), a carcinogenicity study in ICR­ JCL mice ( MRID No. 40993301), genetic toxicology as well as mechanistic studies and data on structurally­ related compounds. Based on the available studies, the quantitative risk to humans was also evaluated. II. BACKGROUND INFORMATION Oxadiazon ( P. C. Code: 109001, CAS Number: 19666­ 30­ 9, 5­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 1,3,4­ oxadiazol­ 2­ one), also known as Ronstar, is a selective pre­ emergent and early post emergence herbicide that is effective primarily for the control of annual grasses and broadleaf weeds in turf. It has no food or feed uses. Aventis CropScience USA is supporting use of oxadiazon on golf courses, ornamentals, apartment/ condo lawns, athletic fields, parks, playgrounds and cemeteries. Oxadiazon destroys cell membranes and inhibits photosynthesis, probably by generating oxidizing radicals in the presence of light and is a powerful inhibitor of plant, yeast and mouse protoporphyrinogen oxidase, an enzyme critical in the biosynthesis of chlorophyll and heme ( Matringe et al., 1989). Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 2 . Figure 1. Chemical Structure of Oxadiazon III. EVALUATION OF CARCINOGENICITY AND OTHER EVIDENCE 4. Previous Chronic Toxicity/ Carcinogenicity Studies Earlier tumor data for Oxadiazon in F­ 344 rats and CD­ 1 mice were discussed previously ( HED Document NO. 007798, dated August 27, 1987) and are not reiterated here. 2. Combined Chronic Toxicity/ Carcinogenicity Study in Wistar Rats Reference Y. Shirasu ( 1987). Oxadiazon ­ 24 Month Chronic Toxicity and Carcinogenicity Study in Rats. Institute of Environmental Toxicology, Tokyo, Japan; Study No. Not listed; Report dated February 1987. ( Unpublished) MRID: 40993401 A. Experimental Design Oxadiazon ( 95.9%) was administered to SPF Wistar rats ( 80/ sex/ dose) in the diet at dose levels of 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.106, 0.36, 3.5 or 39 mg/ kg/ day for males or 0, 0.131, 0.44, 4.2 or 44 mg/ kg/ day for females) for 104 weeks. All 80 rats/ sex/ dose were reportedly examined for histopathology. B. Discussion of Tumor Data Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 3 The incidences of liver tumors in male and female rats are presented in Tables 1 and 2, respectively. For males, there were statistically significant ( p< 0.01) increasing trends for liver adenomas, carcinomas and combined adenomas/ carcinomas ( Table 1). There were also significant increases in the pair­ wise comparisons with the controls for liver adenomas at 100 ppm ( p< 0.05) and 1000 ppm ( p< 0.01), carcinomas at 1000 ppm ( p< 0.05) and combined adenomas/ carcinomas at 100 ppm ( p< 0.05) and 1000 ppm ( p< 0.01). For female rats, there was a statistically significant increasing trend ( p< 0.05) for liver carcinomas only and no significant increases in pair­ wise comparisons of the treated groups with the controls were noted for liver adenomas, carcinomas and combined adenomas/ carcinomas ( Table 2). Historical control data were not provided by the performing laboratory; however, the spontaneous incidences of liver tumors in Wistar rats reported by Welsh and Poteracki ( 1994) are as follows: males­­ adenomas: 1.02%, range 0­ 2.5%; carcinomas: 0.88%, range 0­ 2.5%; females­ adenomas: 2.34%, range 0­ 12%; carcinomas: 0.88%, range 0­ 10%. The incidences of adenomas at 100 and 1000 ppm ( 9% and 13% , respectively) and carcinomas ( 10%) at 1000 ppm in males exceeded the range of available spontaneous incidences. The incidences of liver carcinomas ( 4%) in females did not exceed the range of available spontaneous incidences. The Committee concluded that the increase in liver tumors in male rats was treatment related. C. Non­ neoplastic Lesions In 1991, the Agency requested the Registrant to provide new pathology summary tables and indicate the exact number of each tissue that was examined ( HED Document No. 008949) because the exact number of tissues/ organs examined could not be verified by the Reviewers. No correspondence regarding this request has been presented to HED. However, the recent review of data by the HED statistician indicated that none of the animals were excluded from the analyses. Therefore, the Committee concluded that the integrity of the study or the interpretation of the results is not compromised by this data deficiency. The histopatholgical examination revealed increases in non­ neoplastic changes in the liver at 1000 ppm. These included: centrilobular liver swelling ( and
) ; acidophilic foci of cellular alteration ( ) ; and brown pigmentation in the Stellate cells ( and
) ( Table 3). At 100 ppm, a significant ( p< 0.05) increase in the number of males with centrilobular liver swelling was seen. Brown pigmentation in the proximal tubular cells ( and
) and in cortical interstitial tissue ( ) as well as chronic nephropathy (
) were also noted in the kidneys of high­ dose rats. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 4 Table 1. Oxadiazon ­ SPF Wistar Rat Study Male Liver Tumor Rates+ and Exact Trend Test and Fisher's Exact Test Results ( p values)­ ( Brunsman, 2001) Dose ( ppm) 0 3 10 100 1000 Adenomas (%) p = 0/ 53 ( 0) 0.001** 1/ 55 ( 2) 0.509 1/ 54 ( 2) 0.505 5a/ 54 ( 9) 0.030* 7a / 52 ( 13) 0.006** Carcinomas (%) p= 0/ 53 ( 0) 0.000** 0/ 55 ( 0) 1.000 0/ 54 ( 0) 1.000 0/ 54 ( 0) 1.000 5b/ 52 ( 10) 0.027* Combined (%) p = 0/ 53 ( 0) 0.000** 1/ 55 ( 2) 0.509 1/ 54 ( 2) 0.505 5/ 54 ( 9) 0.030* 12/ 52 ( 23) 0.000** + Number of tumor bearing animals/ Number of animals examined, excluding those that died or were sacrificed before week 53. a First adenoma observed simultaneously at week 78 in interim sacrifice animals, doses 100 and 1000 ppm. b First carcinoma observed at week 78 in an interim sacrifice animal, dose 1000 ppm. Note: 26­ and 56­ week interim sacrifice animals are not included in this analysis. There were no liver tumors in any interim sacrifice animals at 26 or 52 weeks. Significance of trend denoted at control. Significance of pair­ wise comparison with control denoted at dose level. If *, then p < 0.05. If **, then p < 0.01. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 5 Table 2. Oxadiazon ­ SPF Wistar Rat Study: Female Liver Tumor Rates+ and Exact Trend Test and Fisher's Exact Test Results ( p values)­ ( Brunsman, 2001) Dose ( ppm) 0 3 10 100 1000 Adenomas (%) p = 1a/ 52 ( 2) 0.550 1/ 52 ( 2) 0.752 1/ 55 ( 2) 0.738 1/ 53 ( 2) 0.748 1/ 55 ( 2) 0.738 Carcinomas (%) p= 0/ 52 ( 0) 0.042* 0/ 52 ( 0) 1.000 0/ 55 ( 0) 1.000 0/ 53 ( 0) 1.000 2b/ 55 ( 4) 0.262 Combined (%) p = 1/ 52 ( 2) 0.098 1/ 52 ( 2) 0.752 1/ 55 ( 2) 0.738 1/ 53 ( 2) 0.748 3/ 55 ( 5) 0.330 + Number of tumor bearing animals/ Number of animals examined, excluding those that died or were sacrificed before week 53. a First adenoma observed at week 103, dose 0 ppm. b First carcinoma observed at week 104, dose 1000 ppm Note: 26 ­ and 52­ week interim sacrifice animals are not included in this analysis. There were no liver tumors in any in terim sacrifice animals at 26 and 56 weeks. Significance of trend denoted at control. Significance of pair­ wise comparison with control denoted at dose level. If *, then p < 0.05. If **, then p < 0.01. Table 3. Non­ neoplastic Lesions in the Liver of Wistar Rats Fed Dietary Administrations of Oxadiazon for 104 Weeks Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 6 Lesions of the Liver Malesa Group ( ppm) Femalesa Group ( ppm) 0 3 10 100 1000 0 3 10 100 1000 Centrilobular hepatocellular Swelling 1 2 1 8* 52* 3 2 1 9 33** Foci of Cellular Alteration ( acidophilic) 9 14 14 9 18* 12 10 8 14 9 Brown Pigmentation of Stellate Cells 0 0 0 1 35*** 4 1 4 1 12** Focal Hepatocellular Fatty Change 3 7 7 10* 8 9 10 3 8 5 a 80 animals/ sex were reportedly examined at each dose level. * Significantly different ( p< 0.05) than the vehicle control by Fisher's Exact Test. ** Significantly different ( p< 0.01) than the vehicle control by Fisher's Exact Test. *** Significantly different ( p< 0.001) than the vehicle control by Fisher's Exact Test. Selected non­ neoplastic changes in the kidney, which were considered to be treatment­ related, are shown in Table 4. At 1000 ppm, these included: brown pigmentation in the proximal tubular cells ( p< 0.001,
) , brown pigmentation in the cortical interstitial tissue ( p< 0.001, ) , and chronic nephropathy ( p< 0.01,
) . At lower doses, non­ neoplastic lesions were comparable to the vehicle control values. Table 4. Non­ neoplastic Lesions in the Kidneys of Wistar Rats Fed Dietary Administrations of Oxadiazon for 104 Weeks Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 7 Lesions of the Kidneys Malesa Group ( ppm) Femalesa Group ( ppm) 0 3 10 100 1000 0 3 10 100 1000 Brown Pigmentation in Proximal Tubular Cells 3 4 1 2 50*** 6 5 8 13 20*** Brown Pigmentation in Cortical Interstitial Tissue 2 0 0 1 49*** 0 0 1 1 2 Chronic Nephropathy 28 28 33 36 37 11 16 15 14 26** a 80 animals/ sex were reportedly examined at each dose level. * Significantly different ( p< 0.05) than the vehicle control by Fisher's Exact Test. ** Significantly different ( p< 0.01) than the vehicle control by Fisher's Exact Test. *** Significantly different ( p< 0.001) than the vehicle control by Fisher's Exact Test C. Adequacy of Dosing for Assessment of Carcinogenic Potential Statistical evaluation of mortality indicated no significant incremental changes with increasing doses of oxadiazon in the male and female rats ( Brunsman, 2001). The dosing at the highest dose ( 1000 ppm) was considered to be adequate and not excessive in male rats based on decreased body weight gain ( generally throughout the study), signs of transient anemia ( evident at week 26), increased serum enzyme activity ( LDH
63%; ALP 245%; SGOT 151%; SGPT 646%), increased bilirubin and increased liver and kidney weights with associated pathological changes at 1000 ppm which were not severely adverse ( Refer to Table 3 for details). For females at 1000 ppm, there was a decrease in the terminal body weight (­ 8.9%). However, the findings were confounded by apparently fairly large standard deviations. With the exception of decreased terminal body weight, there were no significant differences from controls in body weight measurements. Significant increases in liver and kidney weights were seen only at week 26 and 78 ( kidney only). While increases in liver weight and findings of liver pathology were reported for females at 1000 ppm, these effects were either less consistent or occurred less frequently than those observed in males at this level. Other findings ( anemia, increased serum enzymes and pathological change such as foci of cellular alteration) showing evidence of toxicity, which were generally confined to the high dose were not noted in females. However, there was a significant increase in the incidence of chronic nephropathy among high dose females. The Committee, therefore, concluded that the highest dose tested in female rats was adequate to assess the carcinogenic potential of oxadiazon. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 8 2. Combined Chronic Toxicity/ Carcinogenicity Study in ICR­ JCL Mice Reference Y. Shirasu ( 1987). Oxadiazon­ 23 Month Chronic Toxicity and Oncogenicity Study in Mice. Institute of Environmental Toxicology, Tokyo, Japan; Study No. Not listed; Report dated February 1987. ( Unpublished) MRID: 40993301 A. Experimental Design Oxadiazon ( 95.9%) was administered to 80 ICR­ JCL mice ( 80/ sex/ dose) in the diet at 0, 3, 10, 100 or 1000 ppm ( equivalent to 0, 0.315, 1.09, 10.6 or 113 mg/ kg/ day for males or 0, 0.278, 0.92, 9.3 or 99 mg/ kg/ day for females) for 98­ 99 weeks ( the study was scheduled to run for 104 weeks but due to deaths, it was terminated at 98­ 99 weeks). Groups of 9­ 10 mice/ sex/ group were sacrificed at weeks 52 were subjected to pathology analysis. B. Discussion of Tumor Data The incidences of liver tumors in male and female mice are presented in Table 5 and 6, respectively. For male mice, statistically significant increasing trends ( p< 0.01) were observed for liver adenomas, carcinomas and combined adenomas/ carcinomas ( Table 5). There were also significant increases by pair­ wise comparisons of the 100 and 1000 ppm dose groups with the controls for liver adenomas, combined adenomas/ carcinomas ( both at p < 0.01) and carcinomas ( p < 0.05 and p< 0.01, respectively). No significant increases were noted at lower doses ( 3 or 10 ppm). For female mice, statistically significant increasing trends ( p< 0.01) were noted for liver adenomas, carcinomas and combined adenomas/ carcinomas ( Table 6). There were statistically significant increases by pair­ wise comparison of the 1000 ppm dose group with the controls for adenomas ( p< 0.01), carcinomas ( p < 0.05) and combined adenomas/ carcinomas ( p < 0.01). Historical control data were not provided by the performing laboratory. Table 5. Oxadiazon ­ ICR­ JCL Mouse Study: Male Liver Tumor Rates+ and Exact Trend Test and Fisher's Exact Test Results ( p values)­ ( Brunsman, 2001) Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 9 Dose ( ppm) 0 3 10 100 1000 Adenomas (%) p = 2/ 69 ( 3) 0.000** 7/ 71 ( 10) 0.090 2/ 71 ( 3) 0.676 12/ 69 ( 17) 0.005** 16a/ 71 ( 23) 0.000** Carcinomas (%) p= 3/ 69 ( 4) 0.000** 1/ 71 ( 1) 0.299 4/ 71 ( 6) 0.516 11/ 69 ( 16) 0.023* 29b/ 71 ( 41) 0.000** Combined (%) p = 5/ 69 ( 7) 0.000** 8/ 71 ( 11) 0.300 6/ 71 ( 8) 0.520 23/ 69 ( 33) 0.000** 45/ 71 ( 63) 0.000** + Number of tumor bearing animals/ Number of animals examined, excluding those that died before week 46. a First adenoma observed at week 52 in an interim sacrifice animal, dose 1000 ppm. b First carcinoma observed at week 46, dose 1000 ppm. Note: Significance of trend denoted at control. Significance of pair­ wise comparison with control denoted at dose level. If *, then p < 0.05. If **, then p < 0.01. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 10 Table 6. Oxadiazon ­ ICR­ JCL Mouse Study: Female Liver Tumor Rates+ and Exact Trend Test and Fisher's Exact Test Results ( p values)­ ( Brunsman, 2001) Dose ( ppm) 0 3 10 100 1000 Adenomas (%) p = 0/ 52 ( 0) 0.000** 0/ 53 ( 0) 1.000 1a/ 46 ( 2) 0.469 1a/ 48 ( 2) 0.480 8a/ 51 ( 16) 0.003** Carcinomas (%) p= 1/ 52 ( 2) 0.000** 0/ 53 ( 0) 0.495 0/ 46 ( 0) 0.531 1/ 48 ( 2) 0.732 7b/ 51 ( 14) 0.028* Combined (%) p = 1/ 53 ( 2) 0.000** 0/ 53 ( 0) 0.495 1/ 46 ( 2) 0.721 2/ 48 ( 4) 0.470 15/ 51 ( 29) 0.000** + Number of tumor bearing animals/ Number of animals examined, excluding those that died or were sacrificed before week 53. a First adenoma observed at week 99 in final sacrifice animal simultaneously in doses of 10, 100 and 1000 ppm. b First carcinoma observed at week 83, dose 1000 ppm. Note: Interim sacrifice animals are not included in this analysis. There were no liver tumors in any interim sacrifice animals. Significance of trend denoted at control. Significance of pair­ wise comparison with control denoted at dose level. If *, then p < 0.05. If **, then p < 0.01. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 11 In addition to liver tumors in females, a significant ( p< 0.05) increase by pair­ wise comparison of the 1000 ppm dose group with the controls was noted for malignant lymphoma ( Table 7); however, no dose­ response was evident. The Committee concluded that these tumors were not treatment­ related because there was no dose­ response, the tumor response was variable and these tumors were not seen in the male mice. In addition, these tumors were also not reported in the previously performed mouse carcinogenicity and rat chronic/ carcinogenicity studies with oxadiazon. The historical control data were not available for comparison. Table 7. Oxadiazon ­ ICR­ JCL Mouse Study: Female Lymphoma Tumor Rates+ and Exact Trend Test and Fisher's Exact Test Results ( p values)­ ( Brunsman, 2001) Dose ( ppm) 0 3 10 100 1000 Malignant Lymphoma (%) p = 16/ 80 ( 20) 0.067 25/ 79 ( 32) 0.067 19/ 80 ( 24) 0.351 21a/ 80 ( 26) 0.227 27/ 80 ( 34) 0.037* + Number of tumor bearing animals/ Number of animals examined, excluding those that died before week 19. a First malignant lymphoma observed at week 19, dose 100 ppm. Significance of trend denoted at control. Significance of pair­ wise comparison with control denoted at dose level. If *, then p < 0.05. If **, then p < 0.01. C. Non­ neoplastic Lesions: In 1991, the Agency requested the Registrant to provide new pathology summary tables and indicate the exact number of each tissue that was examined ( HED Document No. 008949) because the exact number of tissues/ organs examined could not be verified by the Reviewers. No correspondence regarding this request has been presented to HED. However, the recent review of data by the HED statistician indicated that none of the animals were excluded from the analyses. Therefore, the Committee concluded that the integrity of the study or the interpretation of the results is not compromised by this data deficiency. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 12 The non­ neoplastic changes in the liver observed in male and female mice are listed in Table 8. At 1000 ppm, there was a significant increase in the incidence of centrilobular liver swelling ( p< 0.001
) , diffuse liver swelling ( p< 0.001 and
) , brown pigment disposition ( p< 0.001 and
) , and bile duct proliferation ( p< 0.001 ) . The incidence of diffuse liver swelling and brown pigment disposition was also significantly increased at 100 ppm ( p< 0.001) but only in the males. The formation of brown pigment in the liver and kidneys of male mice is consistent with the inhibition of porphyrin biosynthesis by oxadiazon. Other treatment­ related findings included a significant increase in the incidence of auricular hardening or thrombus in the heart of high­ dose males ( p< 0.05) and a significant ( p< 0.001) increase in brown pigment disposition in the proximal tubules of high­ dose male kidneys. Table 8. Non­ neoplastic Lesions in the Liver of ICR­ JCL Mice Fed Dietary Administrations of Oxadiazon for 98­ 98 Weeks Lesions of the Liver Malesa Group ( ppm) Femalesa Group ( ppm) 0 3 10 100 1000 0 3 10 100 1000 Centrilobular Hepatocellular Swelling 1 1 0 3 2 1 0 1 1 14*** Diffuse Hepatocellular Swelling 1 2 5 45*** 67*** 3 5 1 2 24*** Brown Pigmentation Disposition 4 3 5 47*** 59*** 0 1 0 3 35*** Extra medullary Hematopoiesis 1 2 6 1 0 13 10 7 6 4* Diffuse Hepatocellular Necrosis 1 2 4 16*** 7* 0 0 0 0 0 Bile Duct Proliferation 0 0 0 1 15*** 0 0 0 0 0 a 80 animals/ sex were reportedly examined at each dose level. * Significantly different ( p< 0.05) than the vehicle control by Fisher's Exact Test. ** Significantly different ( p< 0.01) than the vehicle control by Fisher's Exact Test. *** Significantly different ( p< 0.001) than the vehicle control by Fisher's Exact Test. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 13 D. Adequacy of Dosing for Assessment of Carcinogenic Potential Statistical evaluation of mortality indicated no significant incremental changes with increasing doses of oxadiazon in the male and female rats ( Brunsman, 2001). The CARC considered the dosing to be adequate and not excessive in males and females based on anemia and pathological changes in the liver at the highest dose tested ( HDT) which were not severely adverse ( Refer to Table 8 for details). The treatment related effects observed at 1000 ppm ( HDT) included transient anemia ( evident at week 52) in males and females, increased serum enzymes ( SGPT ( 275­ 300%) , SGOT ( 117%), ALP ( 325%) and BUN ( 44%) ( and
) and at 100 ppm: increased SGPT ( 147%) ( ) ), increased liver weights ( absolute and relative) in males at week 52 and 98 and in females at week 98 and increased absolute and relative adrenal ( ­­ week 98) and kidney (
­­ week 98) weights. IV. OTHER TOXICOLOGY DATA A. Mutagenicity and Cell Transformation Overall, the data indicate that oxadiazon is not mutagenic but does cause neoplastic cell transformation in vitro in Syrian hamster kidney BHK21 C13/ HRC1 cells. Nine acceptable mutagenicity studies were available for review. These studies satisfy the pre­ 1991 FIFRA guideline requirements . The summaries of these studies are presented below: GENE MUTATION a) Salmonella typhimurium/ Escherichia coli reverse gene mutation assay. The assay was negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 and E. coli WP2 hcr­ up to the highest dose tested ( 2500  g/ plate ­ S9; 1000  g/ plate + S9) of 99.18% oxadiazon ( MRID No. 00069893). b) S. typhimurium reverse gene mutation assay: The assay was negative in S. typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100 exposed to 97.49% oxadiazon up to 5000  g/ plate+/­ S9; cytotoxicity was seen at
3330  g/ plate ­ S9 ( MRID No. 41871701). c) L5178Y TK +/­ mouse lymphoma cell/ mammalian activation forward mutation assay: The assay was negative in cells treated with oxadiazon ( 95.5% a. i.) up to reproducibly cytotoxic levels in the absence of S9 activation ( 1000  g/ mL) and severely cytotoxic doses (
200  g/ mL) with S9 activation. Oxadiazon was insoluble at
62.5  g/ mL ( MRID No. 00115726). Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 14 d) L5178Y TK +/­ mouse lymphoma cell/ mammalian activation forward mutation assay: The assay was negative in cells treated with recrystallized oxadiazon ( 100% a. i.) up to cytotoxic levels ( 1000  g/ mL ­ S9; 250  g/ mL + S9; MRID 00115729). CHROMOSOME ABERRATIONS e) In vitro chromosome aberration assay in Chinese hamster ovary ( CHO) cells: The assay was negative in cells treated with oxadiazon ( 95.5% a. i.) up to cytotoxic concentrations ( 75  g/ mL ­ S9; 41.6  g/ mL + S9) and the limit of solubility (
416  g/ mL) ( MRID 00115730). f) In vitro chromosome aberration assay in Chinese hamster ovary ( CHO) cells: The assay was negative in cells treated with recrystallized oxadiazon ( 100% a. i.) up to cytotoxic concentrations ( 200  g/ mL ­ S9; 500  g/ mL + S9) and the limit of solubility ( 667  g/ mL ­ S9; 200  g/ mL + S9; MRID 00115728). OTHER MUTAGENIC MECHANISMS g) Unscheduled DNA Synthesis( UDS) in primary rat hepatocytes assay: The test was negative in hepatocytes exposed to oxadiazon ( 95.5% a. i.) to cytotoxic concentrations (
100 µ g/ mL) and the limit of solubility (
50 µ g/ mL) ( MRID No. 00115727). h) UDS in primary rat hepatocytes assay: The test was negative in hepatocytes exposed to recrystallized oxadiazon ( 100% a. i.) up to cytotoxic concentrations ( 100­ 500 µ g/ mL) and the limit of solubility (
25 µ g/ mL) ( MRID No. 00115723). CELL TRANSFORMATION i) In vitro cell transformation assay in Syrian hamster kidney BHK21 C13/ HRC1 cells: The test was positive both with and without S9 activation, based on the induction of transformation frequencies ( TFs)
5 times the solvent control value at the LD 50 . Oxadiazon ( 90% a. i.) and recrystallized oxadiazon ( 100 % a. i.) were tested up to cytotoxic concentrations with LD 50 values in the absence of S9­ mix of 118 µ g/ mL and 200 µ g/ mL, respectively. In the presence of S9­ mix, the LD 50 of oxadiazon was 69 µ g/ mL; however, the LD 50 for recrystallized oxadiazon was not determined as cell viability was 78% of the solvent control at the highest dose tested ( 400 µ g/ mL). The transformation frequencies ( the number of transformed colonies/ 106 surviving cells) at the LD 50 concentrations were 128 and 79 for cells treated with oxadiazon in the absence and presence of S9­ mix, compared to the solvent control values of 4 and 5, respectively. Recrystallized oxadiazon induced transformation frequencies of 55 at the LD 50 in the absence of S9­ mix and 60 at the highest dose tested in the presence of S9­ mix. A positive dose­ response trend was generally apparent for both concentrations. This study is classified as acceptable ( nonguideline) ( MRID No. 00115703). Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 15 2. Conclusions Acceptable bacterial assays with
97.49% oxadiazon were negative for gene mutations in Salmonella typhimurium and Escherichia coli ( MRID Nos. 00069893 and 41871701). Similarly, neither 95.5% oxadiazon nor recrystallized Oxadiazon ( 100%) were mutagenic or clastogenic in cultured mammalian cells ( MRID Nos. 00115726, 00115729, 00115728 and 00115730) and did not cause UDS in primary rat hepatocytes ( MRID Nos. 00115727 and 00115723). There is, however, evidence that both formulations induced neoplastic transformation in Syrian hamster kidney cells both in the presence and in the absence of S9 activation ( MRID No. 00115703). The finding of positive cell transformation supports the evidence from mouse bioassays ( MRID Nos. 00444322, 00115733 and 40993301) and the rat long­ term studies ( MRID Nos. 00149003/ 00157780 and 40993401) of liver tumor induction. B. Structural Activity Relationships The two structurally related compounds, azafenidin and sulfentrazone, are nonmutagenic and are not hepatocarcinogens in rats or mice. Oxadiazon belongs to the class of oxadiazoles. While oxadiazon is only somewhat similar in structure to other pesticides that have a chlorinated phenol ring and a heterocyclic ring ( Figure 2), it shares some biological properties with azafenidin and sulfentrazone ( i. e., inhibition of protoporphyrinogen oxidase and/ or adverse effects on the hematopoietic system and the liver of rodents). Sulfentrazone produced equivocal results in the mouse lymphoma forward mutation assay, was not mutagenic in Salmonella and was neither clastogenic nor aneugenic in vivo. There was also no evidence of a carcinogenic effect in 2­ year bioassays in rats and mice ( EPA, 1999). Azafenidin was not mutagenic in the available studies. The CARC agreed that the consensus classification for male rat thyroid tumors seen following administration of azafenidin should be in " Data are inadequate" category but no additional cancer studies were considered necessary nor would there be any quantification of human cancer risk.( CARC, 1999; HED Doc # 013794). Figure 2. Structural Activity Relationships: Oxadiazon and Related Structures Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 16 N N O O Cl Cl O CH 3 CH 3 CH 3 C H 3 CH 3 N N O Cl Cl O N CH N N O Cl Cl O N CH Oxadiazon Azafenidin Sulfentrazone Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 17 N N O Cl Cl NH N CH 3 S O O CH 3 F F C. Mode of Action Studies The Mechanism of Toxicity Assessment Review Committee ( MTARC) determined that the available information does not support the proposed non­ genotoxic mode of action for oxadiazon­ induced liver tumors in rodents ( McCarroll, 2001). The mechanistic studies including an unpublished study in Sprague Dawley rats ( MRID No. 42310001) and a published study by Richert et al., 1996 in Sprague Dawley rats, CD­ 1 mice and Beagle dogs were presented to the MTARC on February 8, 2001. The committee concluded that peroxisome proliferation may be a possible mode of action for oxadiazon­ induced liver tumors in rats and mice. However, there are deficiencies in the database which include lack of cell proliferation data in rat and mouse studies, lack of concordance between the dose response for peroxisomal enzymatic activity and liver tumor induction, and decrease rather than increase in catalase activity. Therefore, the available information is inadequate to determine the mode of action for oxadiazon­ induced liver tumors in rodents. V. COMMITTEE'S ASSESSMENT OF THE WEIGHT­ OF­ THE­ EVIDENCE 1. Carcinogenicity The CARC concluded that: Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 18 ! In the combined chronic toxicity/ carcinogenicity study in Wistar rats, there was clear evidence that oxadiazon was carcinogenic to male rats because: 1) There were statistically significant ( p< 0.01) positive trends for liver adenomas, carcinomas and combined adenomas/ adenocarcinomas. There was also a statistically significant ( p< 0.05 or p< 0.01) increase by pair­ wise comparisons of the 100 and 1000 ppm ( 3.5 and 39 mg/ kg/ day, respectively) dose groups with the controls for liver adenomas ( 9% and 13% , respectively, vs 0% in controls) and combined adenomas/ carcinomas ( 9% and 23% vs 0% in controls) as well as liver carcinomas ( 10% vs 0% in controls) at 1000 ppm; and 2) The incidences of liver adenomas and carcinomas were outside the range for the published spontaneous rates ( range both for liver adenomas and carcinomas : 0%­ 2.5%). For females, there was a statistically significant increasing trend for liver carcinomas but there were no significant pair­ wise comparisons of liver tumors in treated females. The highest dose level tested was considered to be adequate and not excessive for males based on decreased body weight gains as well as clinical and the clinical and histopatholgical liver changes observed which were not severely adverse. For female rats, the highest dose was considered to be adequate and not excessive based on an increased incidence of chronic nephropathy and liver changes. The survival of the animals was not affected by the treatment. The CARC concluded that the increases in both the benign and malignant liver tumors in the male rats were treatment­ related. ! In the combined chronic toxicity/ carcinogenicity study in ICR­ JCL mice, there was clear evidence that oxadiazon was carcinogenic to male and female mice because: 1) There were statistically significant ( p< 0.01) positive trends for liver adenomas, carcinomas and combined adenomas/ carcinomas in males and females. For males, there were also statistically significant ( p< 0.05 or p< 0.01) increases by pair­ wise comparisons of the 100 and 1000 ppm ( 10.6 and 113 mg/ kg/ day, respectively) dose groups with the controls for liver adenomas ( 17% and 23%, respectively, vs 3% in controls), carcinomas ( 33% and 63%, respectively, vs 4% in controls) and combined adenomas/ carcinomas ( 16% and 41% , respectively, vs 7% in controls). For females, there were also statistically significant ( p< 0.05 or < 0.01) increases by pair­ wise comparisons of the 1000 ppm dose group ( 99 mg/ kg/ day) with the controls for liver adenomas ( 16% vs 0% in controls), carcinomas ( 14% vs 2% in controls) and combined adenomas/ carcinomas ( 29% vs 2% in controls). The increase in the incidence of lymphomas in females was not considered to be treatment­ related because there was no doseresponse the tumor response was variable and this type of tumor was not seen in male mice or in earlier studies. The highest dose level tested for the male and female mice was considered to be adequate and not excessive based on the findings of anemia and histopatholgical Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 19 changes in the liver which were not severely adverse. There were no adverse effects on the body weight gain and survival of the animals. The Committee concluded that the increases in both benign and malignant liver tumors in male and female mice were treatment­ related. The positive results in an in vitro cell transformation assay are in concordance with the findings of liver tumor induction in the in vivo rodent studies. 2. Mutagenicity The CARC concluded that oxadiazon was negative for mutagenic potential in a battery of acceptable mutagenicity studies which satisfy the pre­ 1991 FIFRA guideline requirements. These studies included reverse gene mutation assays in bacteria, a mouse lymphoma forward gene mutation assay, chromosome aberration assays, and UDS assays. No new studies were requested by the CARC. 3. Structure­ Activity Relationships The structurally­ related compounds, azafenidin and sulfentrazone, are neither mutagenic nor liver carcinogens in rats or mice. 4. Mode of Action Studies The MTARC concluded that the available mechanistic data are insufficient to determine whether oxadiazon­ induced liver tumors in the rats and mice were associated with peroxisome proliferation. Nevertheless, the formation of brown pigment in the liver and kidneys of rats and mice is consistent with the inhibition of porphyrin biosynthesis by oxadiazon. It is caused by the disruption of the biosynthetic pathways producing heme that leads to accumulation of precursors throughout the body. VI. CLASSIFICATION OF CARCINOGENIC POTENTIAL In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment ( July, 1999), the CARC classified oxadiazon into the category " Likely to be carcinogenic to humans" based on the following weight­ of­ the­ evidence considerations: Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 20 1. Treatment­ related benign and malignant liver tumors were observed in two species. There was clear evidence that oxadiazon induced both benign and malignant liver tumors in male Wistar rats and male and female ICR­ JCL mice. Liver tumors were also noted in earlier studies with F­ 344 rats and CD­ 1 mice using higher doses of oxadiazon that exceeded the MTD. 2. Oxadiazon was not mutagenic. However, it causes cell transformation in vitro; these results are in concordance with the carcinogenicity seen in in vivo rodent studies. 3. The available mechanistic studies do not support a non­ genotoxic mode of action for oxadiazon ­ induced liver tumors in rodents. VII. QUANTIFICATION OF CARCINOGENIC POTENTIAL . For human cancer risk assessment, the CARC recommended using a linear low dose extrapolation approach based on the most potent liver tumors in the rats and mice. This approach is supported by the inadequacy of data on the mode of action for oxadiazon­ induced liver tumors in rodents. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 21 VII. BIBLIOGRAPHY MRID No. CITATION 40993401 Shirasu, Y. ( 1987). Oxadiazon ­ 24 Month Chronic Toxicity and Carcinogenicity Study in Rats. Institute of Environmental Toxicology, Tokyo, Japan; Study No. Not listed; Report dated February 1987. ( Unpublished). HED Doc.# 08949. 40993301 Shirasu, Y. ( 1987). Oxadiazon­ 23 Month Chronic Toxicity and Carcinogenicity Study in Mice. Institute of Environmental Toxicology, Tokyo, Japan; Study No. Not listed; Report dated February 1987. ( Unpublished). HED Doc.# 08949. ­­­­­­­­­ Brunsman, L. L. ( 2001). Oxadiazon Qualitative Risk Assessment ( Q 1 *) Based on SPF Wistar Rat and ICR_ JCL Mouse Dietary Studies. A memorandum from Lori L. Brunsman, Science Analyses Branch, Health Effects Division to Nancy McCarroll, Toxicology Branch, Health Effects Division, dated February 14, 2001. HED Doc # 014470. ­­­­­­­­­ CARC. ( 1999). Evaluation of the carcinogenic potential of Azafenidin/ Cancer Assessment Document. Cancer Assessment Review Committee , Health Effects Division, Office of Pesticide Programs. Final Report dated October 18, 1999. HED Doc # 013794. ­­­­­­­­­ EPA ( 1999). Office of Pesticide Programs List of Chemicals Evaluated for Carcinogenic Potential. Memorandum from William Burnam to Division Directors, Office of Pesticide Programs, Environmental Protection Agency. August 25, 1999. ­­­­­­­­­ Farber, T. M.. ( 1987). Classification of Oncogenic Potential of Oxadiazon. Memorandum from Theodore M. Farber, Health Evaluation Division to Edwin F. Tinsworth, Registration Division, Office of Pesticide Programs, U. S. EPA., dated August 27, 1987. HED Doc # 007798. ­­­­­­­­­ Litt, B. D. ( 1984). Carcinogenicity Risk Assessment for Oxadiazon. Memorandum from Bertram D. Litt, Toxicology Branch to Richard Mountfort Registration Division, Office of Pesticide Programs, U. S. EPA., dated November 21, 1984. HED Doc# 004097. ­­­­­­­­ Matringe, M., Camadro, J. M., Labbe, P., Scalla, R. ( 1989). Protoporphyrinogen oxidase inhibition by three peroxidizing herbicides: oxadiazon, LS 82­ 556 and M& B 39279. FEBS Letters 245, number 1, 2: 35­ 38. Oxadiazon ( 3 rd Review) Cancer Assessment Document Final Report 22 ­­­­­­­­­ McCarroll, N. ( 2001). Oxadiazon: Assessment of Mode of Action on Liver Carcinogenicity. A memorandum from Nancy McCarroll, Toxicology Branch to William Burnham, Immediate Office, Office of Pesticide Programs, U. S. EPA., dated February 28, 2001. ­­­­­­­­­ Quest, J. A. ( 1987). 2nd Peer Review of Oxadiazon. A memorandum from John A. Quest, Toxicology Branch to Richard Mountfort Registration Division, Office of Pesticide Programs, U. S. EPA., dated April 14, 1987. HED Doc # 07798 ­­­­­­­­ Richert, L., Price, S., Chesne, C., Maita, K. Carmichael, N. ( 1996). Comparison of the induction of hepatic peroxisome proliferation by the herbicide Oxadiazon in vivo in rats, mice, and dogs and in vitro in rat and human hepatocytes. Toxicol. Appl. Pharmacol 141: 35­ 43. ­­­­­­­­ Welsh, K. M. And Poteracki, J. ( 1994). Spontaneous neoplasms in control Wistar rats. Fundam Appl Toxicol 22: 65­ 72.

epa

2024-06-07T20:31:45.234402

regulations

EPA-HQ-OPP-2002-0309-0012

Supporting & Related Material

­ 1­ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: February 28, 2001 MEMORANDUM SUBJECT: Oxadiazon: Assessment of Mode of Action on Liver Carcinogenicity FROM: Nancy McCarroll Toxicology Branch Health Effects Division ( 7509C) THRU: Pauline Wagner, Co­ Chair Mechanism of Toxicity Assessment Review Committee ( MTARC) Health Effects Division ( 7509C) and Karl Baetcke, Co­ Chair Mechanism of Toxicity Assessment Review Committee ( MTARC) Health Effects Division ( 7509C) TO: William Burnham, Senior Scientist Advisor Chairman, Cancer Assessment Review Committee ( CARC) Immediate Office Health Effects Division ( 7509C) cc: Anna Lowit, Executive Secretary, MTARC Veronique LaCapra, Chemical Review Manager, SRRD Branch Files Oxadiazon ­ 2­ PC Code: 109001 DP Barcode: D266361 Action: The Mechanism of Toxicity Assessment Review Committee ( MTARC) met on February 8, 2001 to evaluate the mechanistic and other relevant data to determine whether the available findings support peroxisome proliferation as a possible mechanism of action for liver tumors induction by Oxadiazon. The mechanistic data included one 14­ day oral study in rats submitted by the Registrant ( MRID No. 42310001) and a journal article ( Richert et al., 1996). Conclusions: Based on the weight­ of­ the­ evidence, there are sufficient data to classify Oxadiazon as a non­ genotoxic hepatocarcinogen. The available data also provide suggestive evidence of peroxisome proliferation. There are, however, weaknesses in the database that preclude acceptance of peroxisome proliferation as the mode of action for Oxadiazon­ induced liver tumors; these include: ( 1) No cell proliferation data were reported for rats or mice; hence, mitogenesis could not be mechanistically linked to proliferation of peroxisomes. ( 2) There was no convincing concordance between the dose response for peroxisomal enzymatic activity and tumor formation. ( 3) The role of decreased catalase activity, which generally increases in the presence of a proxisome proliferator, was not explained by the investigators of the submitted study. The Committee concluded, therefore, that peroxisome proliferation may be a possible mode of action for Oxadiazon­ induced liver tumors in rats and mice. However, because of shortcomings in the database, the available information do not support this proposed non­ genotoxic mode of action for Oxadiazon at this time. ­ 3­ Committee Members in Attendance Members who were present and gave electronic concurrence to this report were: Karl Baetcke, Mike Ioannou, Anna Lowit, Alberto Protzel, and Pauline Wagner Data evaluation prepared by: Nancy McCarroll, Toxicology Branch Also in attendance were: Veronique LaCapra of SRRD and HaJung Sung of Rural Development Administration, Korea. ­ 4­ Proposed Mechanism of Action for Oxadiazon: Recommendations to the MTARC I. Background: The relevance of peroxisome proliferation ( PP) to hepatocarcinogenesis has been previously discussed ( see HED Memorandum: Lactofen: Assessment of Mode of Action on Liver Carcinogenicity from Robert F. Fricke to Christine Olinger, dated February 15, 2001). Within this document, criteria are presented that must be satisfied before a non­ genotoxic hepatocarcinogen can be classified as a PP. These criteria, which were established through the joint efforts of MTARC and CARC, are: 1. Changes in liver morphology indicating hepatomegaly as measured by increased relative liver weights and an increased number of peroxisomes as measured by morphometric analysis. 2. Evidence of cell proliferation as measured by increased relative liver weights and increased replicative DNA synthesis as measured by increased hepatocellular BrdU nuclear labeling in light microscopy. 3. Increased levels of enzymes involved in peroxisomal fatty acid metabolism, especially acyl or palmitoyl CoA oxidase. II. Physical and Chemical Properties of Oxadiazon Oxadiazon, 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 1,3,4­ oxadiazol­ 5­ one, is a selective pre­ emergent and early post emergence herbicide that is effective primarily for the control of annual grasses and broadleaf weeds in turf. The trade name for Oxadiazon in the U. S. is Ronstar. Oxadiazon has no food or feed uses. Most of the usage is allocated to golf courses. However, the Registrant is now supporting use of Oxadiazon on golf courses, apartment/ condo lawns, athletic fields, parks, playgrounds, and cemeteries. The mechanism of action is contact inhibition by affecting young shoots as they grow through the treated zone ( pre­ emergence) and complete coverage ( post­ emergence). Oxadiazon destroys cell membranes and inhibits photosynthesis, probably by generating oxidizing radicals in light and is a powerful inhibitor of plant, yeast and mouse protoporphyrinogen oxidase, an enzyme critical in the biosynthesis of chlorophyll and heme ( Matringe et al., 1989). Oxadiazon has the following structure: Empirical Formula: C 15 H 18 Cl 2 N 2 O 3 III. Classification of Carcinogenic Potential ­ 5­ According to the Cancer Assessment Review Committee ( CARC) report, dated August 27, 1987 ( HED Document No. 007798), the original peer review ( November 21, 1984, HED Document No. 004097) placed Oxadiazon into Group B2 ( probable human carcinogen) but there was a minority opinion that the agent should be placed in Group C ( possible human carcinogen). Review of the weight­ of­ theevidence on Oxadiazon by the Scientific Advisory Panel ( dated November 20, 1987) reiterated this minority view. Consequently, the current Agency decision on the carcinogenic potential of Oxadiazon concurs with the Scientific Advisory Panel's ( SAP) classification of Oxadiazon as a Group C carcinogen and the Q1* has been set at 1.4 x 10­ 1( mg/ kg/ day)­ 1 in human equivalents. The rationale for the original classification as group B2 was based on the increased incidence of malignant or combined malignant and benign liver tumors: a) in multiple species ( CD ­ 1 mice and F344 rats of one or both sexes) and in multiple experiments ( liver tumors in two mouse studies and in one rat study). The decision to reclassify Oxadiazon as a Group C carcinogen was based on the rationale that liver tumors were produced in two of the three positive studies ( one mouse study and one rat study) at doses that exceeded the maximum tolerated dose ( MTD). Since the time of the classification of the oncogenic potential of Oxadiazon as a Group C carcinogen, a new chronic/ oncogenicity study in rats ( MRID No. 40993401) and a new carcinogenicity study in mice ( MRID No. 40993301) have been submitted to the Agency. The Hazard Identification Assessment Review Committee ( HIARC) recommended that the Q1* be revisited and that the Cancer Assessment Review Committee ( CARC) reconvene to evaluate these more recent studies. The CARC is awaiting the outcome of the current MTARC deliberations before evaluating these more recent chronic studies. IV. Mutagenicity Oxadiazon is neither mutagenic nor clastogenic but does cause neoplastic cell transformation in vitro. Acceptable bacterial assays with 97.49% Oxadiazon were negative for gene mutations in Salmonella typhimurium and Escherichia coli ( MRID Nos. 00069893 and 41871701). Similarly, neither 95.5% Oxadiazon nor recrystallized Oxadiazon ( 100%) were mutagenic or clastogenic in cultured mammalian cells and did not cause unscheduled DNA synthesis ( UDS) in primary rat hepatocytes. There is, however, evidence that both formulations induced neoplastic transformation in Syrian hamster kidney cells both in the presence and in the absence of S9 activation. The finding of positive cell transformation supports the evidence from mouse bioassays ( MRID Nos. 00444322, 00115733 and 40993301) and the rat long­ term studies ( MRID Nos. 00149003/ 00157780 and 40993401) of liver tumor induction. V. Evaluation of the Toxicology Database for Peroxisome Proliferation as a Possible Mechanism of Action for Liver Tumors Induced by Oxadiazon Data submitted by the Registrant are from both guideline and one non­ guideline ( mechanistic) studies. In general, the database for Oxadiazon is complete and has been evaluated with respect to the potential of Oxadiazon to induce liver tumors via peroxisome proliferation. Results from submitted studies were selected to illustrate findings pertinent to peroxisome proliferation as the proposed mechanism of action of Oxadiazon and are summarized in Table 1. In addition, a published study conducted in rats, mice ­ 6­ and dogs ( Richert et al., 1996) has also been considered with pertinent results presented in Table 1. All data have been assessed relative to the peroxisome proliferation criteria presented earlier. A. Criterion 1: Increased Liver Weights and Increased Peroxisome Proliferation As shown in Table 1, increased absolute and relative liver weights were seen in both sexes of several rat strains ( Sprague­ Dawley, only examined, Fischer 344, CD, Wistar) in male and female mice ( CD­ 1 and ICR­ JCL) and Beagle dogs. The length of exposure ranged from 14 days to 2 years. Doses causing increased liver weights in rats ranged from 200 mg/ kg/ day ( 14 days), 51 mg/ kg/ day ( 6 months) to 6 mg/ kg/ day ( 24 months). In mice, the earliest time that liver weights were recorded in the Guideline studies was 52 weeks. At this interval, significant effects were seen at 113 mg/ kg/ day. By 104 weeks, liver weight increases were noted at doses 12 mg/ kg/ day. Similar results of significantly increased absolute and relative liver weights have been shown by Richert et al.( 1996) in Sprague­ Dawley rats ( 200 mg/ kg/ day, 14 days) and CD­ 1 mice ( 200 mg/ kg/ day, as early as 28 days post­­ treatment) but not in Beagle dogs after 28­ days of exposure. Regardless of the rodent species, hepatomegaly was generally more pronounced in males than in females. Hence, the data show convincing evidence pointing to hypertrophy as the cause of hepatomegaly in rats and mice. There is also evidence of hyperplasia in CD­ 1 mice but it was only seen in one of two studies conducted with this mouse strain and was not reported in strain ICRJCL In the 14­ day oral mechanism study ( MRID No. 42310001) with Sprague Dawley rats, electron micrographs showed an increase in peroxisomes at 500 mg/ kg/ day Oxadiazon. Livers from lower dose groups were not examined microscopically. However, electron microscopy of rat and mouse liver sections in the study of Richert et al. ( 1996), showed a qualitative and dosedependent increase in peroxisomes at 20 mg/ kg/ day ( minimal in 5 of 11 mice), 100 mg/ kg/ day ( moderate in 7 of 7 mice) and 200 mg/ kg/ day ( severe in 9 of 9 mice). Eight of 10 rats administered 500 mg/ kg/ day Oxadiazon also showed a " severe" increase in peroxisomes. B. Criterion 2: Evidence of Cell Proliferation As stated above, there is ample evidence of increased relative liver weights; however, no study has been submitted on the effects, if any, of Oxadiazon on replicative DNA synthesis. It is of note that Oxadiazon was tested in two in vitro assays ( MRID Nos. 00115723 and ­ 27) for UDS in primary rat hepatocytes. Both studies were negative for UDS, and cells undergoing DNA replication rather than DNA repair were reported to be evenly distributed among all groups. C. Criterion 3: Evidence of Increased Enzymatic Activity Increased levels of enzymes associated with liver toxicity ( ALP, SGOT, SGPT and/ or LDH) were recorded in subchronic dietary studies lasting 90­ days in rats as well as chronic studies lasting 1­ 2 years in rats, mice or dogs and can be seen in many of the studies listed in Table 1. In the 14­ day oral mechanism study ( MRID No. 42310001) with Sprague Dawley rats, dose­ related increases in palmitoyl CoA oxidation ( PAO), palmitoyl carnitine transferase and acetyl carnitine ­ 7­ transferase ( ACT) were reported at 20, 200 and 500 mg/ kg/ day; effects at 200 mg/ kg/ day were significant. Catalase activity was, however, significantly reduced at 200 and 500 mg/ kg/ day. This decrease in catalase activity, which is generally increased in the presence of peroxisome proliferation, was not explained by the investigators. In agreement with the peroxisomal enzyme activity results from the submitted 14­ day study, Richert et al. ( 1996) found a significant ( p< 0.05) and dose­ related increase in rat ( PAO) and ACT at 200 and 500 mg/ kg/ day. In mice, the same investigators noted that increases in PAO were achieved at 100 ( 174% of control) and 200 mg/ kg ( p< 0.05). ACT was also significantly increased at these levels. No biochemical assays in dogs were performed. In vitro studies conducted as part of these investigations showed concentration dependent increases in both PAO and ACT at 2.5­ 10 x 10­ 5 M Oxadiazon in primary rat hepatocytes; no effect were seen in cultured human hepatocytes at comparable doses. While increases in the activity of the two enzyme markers for peroxisome proliferation followed exposure to Oxadiazon, the concordance between the dose response for peroxisome enzymes and liver tumor induction is not strong. As shown in Table 2, a dose of 113 mg/ kg/ day induced significant ( p< 0.01) increases in adenomas (+ 23%) carcinomas (+ 41%) and adenomas/ carcinomas combined (+ 63%) in male mouse livers while a comparable dose ( 100 mg/ kg/ day) caused only a moderate increase in the number of peroxisomes and a less than 2­ fold increase in PAO. At 10.6 mg/ kg/ day in the oncogenicity study, adenomas (+ 17%) carcinomas (+ 16%) and adenomas/ carcinomas combined (+ 33%) were also significantly increased. However, only a slight increase in the number of peroxisomes and no increased in PAO were seen. Similar evidence of a weak response in peroxisome enzymes was note in male rats dosed with either 200 or 500 mg/ kg/ day Oxadiazon in the submitted mechanistic study or the published results of Richert et al., ( 1996). Increases in PAO only ranged from 1.4­ to 2.1­ fold over control while liver tumor induction was achieved at 3.5 mg/ kg/ day. ACT activity, which is distributed not only in the peroxisomes but also in endoplasmic reticulum and mitochondria, only reached a 6­ fold increase in male rats at 500 mg/ kg/ day. Although temporal associations were considered, the Committee acknowledged , based on its experience with peroxisome proliferators that increased peroxisome enzyme activity generally occurs ( regardless of the time interval) at doses near the tumor doses. It concluded, therefore, that the findings with Oxadiazon indicate that tumorigenic doses were substantially lower than levels inducing peroxisome enzymes. VI. Other Modes of Action As stated previously, Oxadiazon is not mutagenic, and with the exception of peroxisome proliferation, no other mode of action has been hypothesized for Oxadiazon. However, a possible alternative mode of action could be oxidative damage to DNA through the production of hydrogen peroxide by increased fatty acid oxidation. This is because of the decreased catalase activity noted in the 14­ day submitted study. Theoretically, the reduction in catalase activity could lower the degradation rate of H 2 O 2 thus initiating increased levels of H 2 O 2. Cattley et al. ( 1998) have hypothesized that since catalase levels " are never increased more than twofold an imbalance between generation and degradation of H 2 O 2 within the peroxisome" would exist. The excess H 2 O 2, that would result from a loss of catalase ­ 8­ ( as demonstrated in the Oxadiazon study), could conceivably escape from the peroxisome, react with transition metals and form hydroxyl radicals. Cattley et al. note that if these radicals form in the proximity of macromolecules, oxidative damage may occur. VII. Structural Activity Relationships ( SAR) Oxadiazon is not known to be structurally related to other known herbicides that are also peroxisome proliferators ( Richert et al., 1996); however, a wide variety of chemical classes have been shown to have the potential to induce peroxisome proliferation. VIII. Conclusions Based on the weight­ of­ the­ evidence, there are sufficient data to classify Oxadiazon as a nongenotoxic hepatocarcinogen. The available data also provide suggestive evidence of peroxisome proliferation. There are, however, weaknesses in the database that preclude acceptance of peroxisome proliferation as the mode of action for Oxadiazon­ induced liver tumors; these include: ( 1) No cell proliferation data were reported for rats or mice; hence, mitogenesis could not be mechanistically linked to proliferation of peroxisomes. ( 2) There was no convincing concordance between the dose response for peroxisomal enzymatic activity and tumor formation. ( 3) The role of decreased catalase activity, which generally increases in the presence of a proxisome proliferator, was not explained by the investigators of the submitted study. The Committee concluded, therefore, that peroxisome proliferation may be a possible mode of action for Oxadiazon­ induced liver tumors in rats and mice. However, because of shortcomings in the data base, the available information do not support this proposed non­ genotoxic mode of action for Oxadiazon at this time. REFERENCE Richert, L., Price, S., Chesne, C., Maita, K. Carmichael, N. ( 1996). Comparison of the induction of hepatic peroxisome proliferation by the herbicide oxadiazon in vivo in rats, mice, and dogs and in vitro in rat and human hepatocytes. Toxicol. Appl. Pharmacol 141: 35­ 43. Cattley, R. C., DeLuca, J., Elcombe, C., Fenner­ Crisp, P., Lake, B. G., Marsman, D. S., Pastoor, T. A., Popp, J. A., Robinson, D. E., Schwetz, B., Tugwood, J., Wahli, W. ( 1998). Do peroxisome proliferating compounds pose a hepatocarcinogenic hazard to humans? Reg Toxicol and Pharm 27: 47­ 60. Matringe, M., Camadro, J. M., Labbe, P., Scalla, R. ( 1989). Protoporphyrinogen oxidase inhibition by three peroxidizing herbicides: oxadiazon, LS 82­ 556 and M& B 39279. FEBS Letters 245, number 1, 2: 35­ 38. ­ 9­ Table 1 : Summary of Liver Effects with Oxadiazon Study ( MRID) Liver Weight Liver Enzymes Liver Histopathology ( Nonneoplastic) Liver histopathology ( Tumors) 14­ Day Oral Peroxisome Proliferation ­ Rat ( Sprague­ Dawley) ( 42310001): 0, 20, 200, 500 mg/ kg/ day Abs & rel wt ( p< 0.05) 200 & 500 mg/ kg ( p< 0.05) and dose­ related at 200 & 500 mg/ kg
catalase, PAO, palmitoyl carnitine transferase, ACT,
G 6 PO4ase at 500 mg/ kg At 500 mg/ kg: peroxisome proliferation; lipids; sinusoidal dilation & rough endoplasmic reticulum damage NA Oral Peroxisome Proliferation in Rat ( Sprague­ Dawley): 0, 20, 200, 500 mg/ kg/ day­­ 14 days ( 10/ group) Mice ( CD­ 1): 0, 100, 200 mg/ kg/ day­­ 28 days ( 12/ group) Dogs ( Beagles): 0, 500 mg/ kg­­ 28 days ( 3/ group) ( Richert et al., 1996) Abs & rel wt ( p< 0.05)  200 mg/ kg/ day­­ rats  100 mg/ kg/ day­­ mice NS 500 mg/ kg/ day­­ dogs Dose­ related PAO & ACT; ( p< 0.05) at 200 & 500 mg/ kg/ day­­ rats Dose­ related PAO & ACT; ( p< 0.05) at 200 ( PAO) & 200 & 500 mg/ kg/ day( ACT) ­­ mice At 500 mg/ kg ( only dose tested): peroxisome proliferation ( severe in 8/ 10 ­ rats Dose­ related peroxisome proliferation ( minimal at 20 5/ 11; moderate at 100 7/ 7; severe at 200 mg/ kg/ day 9/ 9 ­ mice) No effects­­ dogs NA Abbreviations: ALP = Alkaline phosphatase LDH = Lactate dehydrogenase SGOT = Serum glutamic­ oxaloacetic transaminase PAO = Palmitoyl CoA oxidase SGPT = Serum glutamic­ pyruvic transaminase ACT = Acetyl carnitine transferase ­ 10­ Study ( MRID) Liver Weight Liver Enzymes Liver Histopathology ( Nonneoplastic) Liver Histopathology ( Tumors) 90­ Day Dietary
Rat ( CD) ( 00111804): 0, 25, 100, 1000 mg/ kg/ day Abs & rel wt ( p< 0.05) 100 & 1000 mg/ kg (
) wks 4 & 13: ALP ( 100& 1000 mg/ kg;
1000 mg/ kg), wk 13: SGOT ( 100& 1000 mg/ kg;
1000 mg/ kg), wks 4 & 13: SGPT( 100& 1000 mg/ kg;
1000 mg/ kg) At 1000 mg/ kg (
) & 100 mg/ kg ( ) : brown pig. Kupffer cells & bile canaliculi; marked variability in cell size and staining properties of hepatocytes & necrotic hepatocytes ( Above findings generally seen in  90% &  60%
) NA Chronic/ Onco Rat ( Fischer 344) ( 00149003/ 00157780): 0, 10, 100, 1000, 3000 ppm (  0, 0.5, 4.8, 50.9, 163.1 mg/ kg/ day ; 0, 0.6, 5.9, 60.9, 192.7 mg/ kg/ day
) Abs & rel wt ( p  0.05­ 0.001) 6 mo: 1000 ( ) & 3000 ppm (
) ; 12 mo: 1000 & 3000 ppm (
) ; 24 mo: 100, 1000 & 3000 ppm (
) 6 mo: At  1000 ppm ( ) ALP, SGPT­­ ( at 3000 ppm ) SGOT ( at 3000 ppm
) SGOT, SGPT, LDH, ALP; 12 mo: ( at  1000 ppm
) ALP, SGPT ; 24 mo: ( at 3000 ppm ) ALP, LDH Progressive alterations from hypertrophy through fatty changes to necrosis (  1000 ppm & 3000 ppm ) ( p< 0.05) pairwise and trend adenomas & carcinomas combined (  1000 ppm ) . No decrease in latency. Benign & malignant tumors after prolonged exposure to hepatotoxic doses ­ 11­ Study ( MRID) Liver Weight Liver Enzymes Liver Histopathology ( Nonneoplastic) Liver histopathology ( Tumors) Chronic/ Onco Rat ( Wistar) ( 40993401): 0, 0, 3, 10, 100, 1000 ppm (  0, 0.1, 0.4, 3.5, 39 mg/ kg/ day ; 0, 0.1, 0.4, 4.2, 44 mg/ kg/ day
) Abs & rel wt ( p  0.05­ 0.001) 26 wk: 1000 ppm (
) ; 52 wk: 1000 ppm ( ) ; 78 wk: 1000 ppm (
) ; 104 wk: 1000 ppm ( ) wks 26: LDH ( 1000 mg/ kg & wk 52); ALP ( 1000 mg/ kg); SGOT/ SGPT ( 1000 mg/ kg). Wks 52, 78 & 104: No effects. At 1000 ppm ( p  0.01­ 0.001): centrilobular hepato. swell.(
) ; brown pigmentation in liver) (
) ; foci of cell alteration ( ) ; bile duct proliferation) ( ) . At 100 ppm ( p< 0.05) , centrilobular hepato. swell.( ) ( ) S trend ( p< 0.01) & S pairwise 100 & 1000 ppm ( p< 0.05­ 0.01) liver adenomas and/ or carcinomas combined. At 1000 ppm, S pairwise ( p< 0.05) carcinomas . Onco Mice ( CD­ 1) ( 00044322): 0, 300, 1000, 2000 ppm (
0, 48, 153, 319 mg/ kg/ day ; 0, 62, 201, 417 mg/ kg/ day
) Abs & rel wt ( p  0.05­ 0.01) at 104 wk:  300 ppm (
) wk 104: ( p  0.05­ 0.01) ALP (  300 ppm
,  1000 ppm ); SGOT (  1000 ppm
) ; SGPT (  300 ppm
,  1000 ppm ) centrilobular hypertrophy (  300 ppm
) ; diffuse hepatocellular hyperplasia & hypertrophy (  300 ppm
) ; nodular hyperplasia & hypertrophy (  300 ppm
) ; focal necrosis ( 2000 ppm
) ­­ no stats p< 0.01 hepatocarcinomas (  1000 ppm
) . No decrease in latency. ­ 12­ Study ( MRID) Liver Weight Liver Enzymes Liver Histopathology ( Nonneoplastic) Liver histopathology ( Tumors) Onco Mice ( CD­ 1) ( 00115733): 0, 100, 300, 1000, 2000 ppm (
0, 12, 37, 122, 254 mg/ kg/ day ; 0, 14, 44, 143, 296 mg/ kg/ day
) Abs & rel wt ( p  0.05­ 0.001) at 105 wk:  100 ppm ( ) ,  1000 ppm (
) Not Done No detail; terminal sac: lesions listed as masses ( all dose groups, both sexes), pale areas/ foci ( all dose groups, both sexes), raised areas ( all dose groups, females only) unscheduled deaths: pigmented Kupffer cells, hepatic single cell necrosis ( high­ dose males) p< 0.05­ 0.01 liver adenomas (  100 ppm
) ; p< 0.05 carcinomas (  100 ppm 1000 ppm
) ; p< 0.05­ 0.01 combined liver adenomas & carcinomas (  100 ppm
) . p< 0.05 trend for carcinomas ( ) , adenomas (
) & combined (
) Onco Mice ( ICR­ JCL) ( 40993301): 0, 3, 10, 100, 1000 ppm (
0, 0.3, 1, 11, 113 mg/ kg/ day ; 0, 0.3, 1, 9, 99 mg/ kg/ day
) Abs & rel wt ( p  0.05­ 0.001) at 52 & 98 wk: 1000 ppm ( ) , 98 wk: 1000 ppm (
) wks 52: ALP ( 1000 mg/ kg & wk 98
1000 ppm); SGOT (  100 ppm). SGPT (  100 ppm wk 52 & at wk 98;
1000 mg/ kg at wk 52) At 1000 ppm ( p< 0.001): centrilobular hepato. swell.(
) ; diffuse hepatocellular swell.(
) ; brown pigmentation (
) diffuse hepatocellular necrosis ( only) at 1000 ppm ( p< 0.05) but ( p< 0.001) at 100 ppm. Also in at 100 ppm: ( p< 0.001) diffuse hepatocellular swell and brown pigmentation ( only) p< 0.01 liver adenomas (  100 ppm , 1000 ppm ) ; p< 0.01 liver carcinomas (  100 ppm , 1000 ppm ) p< 0.01 liver adenomas/ carcinomas combined (  100 ppm , 1000 ppm ) .
: p< 0.05­ 0.01 trend for liver adenomas, carcinomas, and adenomas/ carcinomas combined. ­ 13­ Study ( MRID) Liver Weight Liver Enzymes Liver Histopathology ( Nonneoplastic) Liver histopathology ( Tumors) 1­ Year Chronic Dog ( Beagles) ( 41326401) 0, 5, 20, 60, 200 mg/ kg/ day Abs & rel wt ( p  0.05­ 0.01) at necropsy: : rel  60 mg/ kg/ day­­ abs at  60 mg/ kg/ day also but NS;
: abs  20 mg/ kg/ day­­ rel also but S only at 60 mg/ kg/ day wks 24 & 50: SGOT ( 60 mg/ kg ( p< 0.05) periacinar apoptosis centriacinar hepatocytic vacuolation None 2­ Generation Reproduction Rat ( CD) ( 41239801) 0, 20, 60, 200 ppm (
0, 1.5, 4.65, 15.5 mg/ kg/ day ; 0, 1.8, 5.6, 18.2 mg/ kg/ day
) P adults: No effect F1 adults: Sli rel wt 200 ppm
F1 and F2 offspring: Not measured Not measured P adults: No effects F1 adults: periacinar hepatocellular hypertrophy 200 ppm F1 or F2 offspring: No effects None Abbreviations: ALP = Alkaline phosphatase LDH = Lactate dehydrogenase SGOT = Serum glutamic­ oxaloacetic transaminase PAO = Palmitoyl CoA oxidase SGPT = Serum glutamic­ pyruvic transaminase ACT = Acetyl carnitine transferase a Data were extracted from Richert et al. ( 1996). b Data were extracted from Richert et al. ( 1996). c Data were from Mouse 23­ month chronic toxicity and oncogenicity study ( MRID No. 40993301). ­ 14­ Table 2. Summary of Peroxisomal Effects and Liver Tumor Induction in Male Mice Administered Oxadiazon Dose ( mg/ kg/ day) No. of Peroxisomesa Peroxisomal Enzyme Activitiesb Neoplasmsc Palmitoyl CoA oxidase (% over control) Acetyl carnitine transferase (% over control) Adenomas Carcinomas Adenomas/ Carcinomas Combined 0 0 ­­ ­­ 2/ 69 3% 3/ 69 4% 5/ 69 7% 0.3 ­­ ­­ ­­ 7/ 71 10% 1/ 71 1% 8/ 71 11% 1.1 ­­ ­­ ­­ 2/ 71 3% 4/ 71 6% 6/ 71 8% 10.6 ­­ ­­ ­­ 12/ 69** 17% 11/ 69* 16% 23/ 69** 33% 20 Slight ( 6/ 11) 106 113 ­­ ­­ ­­ 100 Moderate ( 7/ 7) 174 389* ­­ ­­ ­­ 113 ­­ ­­ ­­ 16/ 71** 23% 29/ 71** 41% 45/ 71** 63% 200 Severe ( 9/ 9) 259* 459.5* * Significantly different than control ( p< 0.05) ** Significantly different than control ( p< 0.01)

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1 See memo ­ Deriving Q 1 * s Using the Unified Interspecies Scaling Factor, P. A. Fenner­ Crisp, Director, HED, 7/ 1/ 94. HED DOC. NO. 014450 MEMORANDUM January 23, 2001 SUBJECT: REVISED Oxadiazon Quantitative Risk Assessment ( Q 1 *) Based On ICR­ JCL Mouse and SPF Wistar Rat Dietary Studies With 3/ 4' s Interspecies Scaling Factor P. C. Code 109001 TO: Nancy McCarroll, Geneticist Toxicology Branch Health Effects Division ( 7509C) FROM: Lori L. Brunsman, Statistician Science Information Management Branch Health Effects Division ( 7509C) THROUGH: Jess Rowland, Branch Chief Science Information Management Branch Health Effects Division ( 7509C) Conclusion The most potent unit risk, Q 1 *( mg/ kg/ day)­ 1, of those calculated for Oxadiazon is that for male mouse liver adenoma and/ or carcinoma combined tumor rates at 5.52 x 10­ 2 in human equivalents. The dose levels used from the 98­ week dietary study were 0, 3, 10, 100, and 1000 ppm of Oxadiazon. The corresponding tumor rates were 3/ 51, 1/ 55, 4/ 57, 11/ 58, and 29/ 55, respectively. Background On September 3, 1986, the Toxicology Branch Peer Review Committee classified Oxadiazon as a Group B2 ­ probable human carcinogen, and recommended that, for the purpose of risk characterization, a low dose extrapolation model be applied to the experimental animal tumor data for quantification of human risk ( Q 1 *). A Q1* based upon male liver ( carcinoma and/ or adenoma) tumor rates was generated using mg/ kg b. w.^ 2/ 3' s/ day cross species scaling factor ( Oxadiazon hand­ written memo, B. Fisher, 3/ 16/ 87). This revised memo has been generated in response to new, more appropriate chronic/ oncogenicity studies submitted to the Agency and to reflect the Agency policy change from use of the 2/ 3' s to the 3/ 4' s scaling factor in 1994 1. Quantifications of risk have subsequently 2 been estimated for these new studies. The most potent unit risk will be used for the purpose of lifetime cancer risk assessment by the Agency. In this case, the most potent unit risk, Q 1 *, is that for male mouse liver adenoma and/ or carcinoma combined tumor rates at 5.52 x 10­ 2 in human equivalents. All unit risks have been converted from animals to humans by use of the 3/ 4' s scaling factor ( Tox_ Risk program, Version 3.5, K. Crump, 1994) 1. For the conversion to human equivalents, weights of 0.03 kg for the mouse, 0.35 kg for the rat, 70 kg for humans, the use of 98 weeks for the mouse life­ span default and 104 weeks for the rat lifespan default were used. It is to be noted that the Q 1 * ( mg/ kg/ day)­ 1 is an estimate of the upper bound on risk and that, as stated in the EPA Risk Assessment Guidelines, the true value of the risk is unknown, and may be as low as zero. Dose­ Response Analysis There were no significant incremental changes in mortality with increasing doses of Oxadiazon in male or female mice or rats reported in the studies. The unit risks, Q 1 *` s, were obtained by the application of the Multi­ Stage model ( Tox_ Risk program, Version 3.5, K. Crump, 1994). Male mice had a significant increasing trend at p < 0.01, and significant differences in the pair­ wise comparisons of the 100 ( p < 0.05) and 1000 ( p < 0.01) ppm dose groups with the controls, for liver adenomas and/ or carcinomas combined. Female mice had a significant increasing trend at p < 0.01, and a significant difference in the pair­ wise comparison of the 1000 ppm dose group with the controls at p < 0.05, for liver adenomas and/ or carcinomas combined. There was also a significant difference in the pair­ wise comparison of the 1000 ppm dose group with the controls for malignant lymphomas at p < 0.05. Male rats had a significant increasing trend at p < 0.01, and significant differences in the pair­ wise comparisons of the 100 ( p < 0.05) and 1000 ( p < 0.01) ppm dose groups with the controls, for liver adenomas and/ or carcinomas combined. There were no significant trends or pair­ wise comparisons for the liver tumors of female rats. Additional Q 1 * Calculations The unit risk, Q 1 *( mg/ kg/ day)­ 1, of Oxadiazon based upon female mouse malignant lymphoma tumor rates is 2.89 x 10­ 2 in human equivalents. The dose levels used from the 98­ week dietary study were 0, 3, 10, 100, and 1000 ppm of Oxadiazon. The corresponding tumor rates were 16/ 52, 25/ 53, 19/ 46, 21/ 48, and 27/ 51, respectively. 3 The unit risk, Q 1 *( mg/ kg/ day)­ 1, of Oxadiazon based upon female mouse liver adenoma and/ or carcinoma combined tumor rates is 1.31 x 10­ 2 in human equivalents. The dose levels used from the 98­ week dietary study were 0, 3, 10, 100, and 1000 ppm of Oxadiazon. The corresponding tumor rates were 1/ 52, 0/ 53, 0/ 46, 1/ 48, and 7/ 51, respectively. The unit risk, Q 1 *( mg/ kg/ day)­ 1, of Oxadiazon based upon male rat liver adenoma and/ or carcinoma combined tumor rates is 3.34 x 10­ 2 in human equivalents. The dose levels used from the 104­ week dietary study were 0, 3, 10, 100, and 1000 ppm of Oxadiazon. The corresponding tumor rates were 0/ 53, 1/ 55, 1/ 54, 5/ 54, and 12/ 52, respectively. The unit risk, Q 1 *( mg/ kg/ day)­ 1, of Oxadiazon based upon female rat liver adenoma and/ or carcinoma combined tumor rates is 8.16 x 10­ 3 in human equivalents. The dose levels used from the 104­ week dietary study were 0, 3, 10, 100, and 1000 ppm of Oxadiazon. The corresponding tumor rates were 1/ 52, 1/ 52, 1/ 55, 1/ 53, and 3/ 55, respectively. 4 SignOff Date: 1/ 23/ 01 DP Barcode: D000000 HED DOC Number: 014450 Toxicology Branch: SAB

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: February 13, 2001 SUBJECT: Oxadiazon. ( List B, Case No. 2485) The Outcome of the HED Metabolism Assessment Review Committee Meeting Held on 01/ 30/ 01. DP Barcode 272425. Chemical 109001. FROM: Sheila Piper, Chemist Chemistry and Exposure Branch Health Effects Division ( 7509C) THROUGH: Francis B. Suhre, Branch Senior Scientist Chemistry and Exposure Branch Health Effects Division ( 7509C) and Christine Olinger, Chair of HED MARC Reregistration Branch I Health Effects Division ( 7509C) TO: Yan W. Donovan, Chemist, RAB1/ HED ( 7509C) MARC Executive Secretary Material Reviewed The Metabolism Assessment Review Committee ( MARC) met on January 30, 2001 to consider the degradation of oxadiazon ( 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one) in water. Specifically, MARC was asked to determine which degradates should be included in the risk assessment. EFED supplied information that was presented to MARC ( S. Piper, N. McCarroll and J. Melendez, D271728, 1/ 10/ 01) describing degradates found or having the potential to be found in soil and water. MARC Conclusions The Committee concluded that the parent compound, oxadiazon is the only residue to be included in a drinking water risk Page ­ 2­ assessment. Although, MARC expressed concern about the toxicity of other metabolites of oxadiazon, the Committee do not recommend including them in a drinking water risk assessment because they are not likely to be present in drinking water. Supporting Reasons The Committee considered the following information to arrive at the conclusion shown above: ­ The major degradate observed in the laboratory studies is the hydrolysate 1­ trimethylacetyl­ 2­( 2,4­ dichloro­ 5­ isopropoxyphenyl) hydrazine ( RP26123). This degradate reached a maximum of
45% of the applied on day 31 at pH 9 only. RP26123 was < 4% in all the other laboratory studies at all samplings, including the aerobic soil metabolism, the photolysis on soil, and a supplemental anaerobic soil metabolism study. The available data indicates that metabolite RP26123 should be a minor component in the environment under most conditions. In addition, the Committee concluded that this metabolite is not likely to be significantly more toxic than the parent. ­ The only significant route of degradation for the chemical oxadiazon is aqueous photolysis. Several ( about 20) minor degradates were produced in the laboratory study; only one was slightly above the 10% level ( RP37084, nomenclature not provided by the registrant). The maximum level of RP37084 was only 11.5% at the last test interval, when only 27.6% of the applied radioactivity remained undegraded. Since by the time the degradate reached 11.5% the levels of oxadiazon had decreased substantially ( to 27.6% of the applied), it appears that the levels of the degradate would not increase much further. Moreover RP37084 was not an important metabolite in the soil photolysis study or in any other laboratory study. The available data indicates that metabolite RP37084 should be a minor component in the environment under most conditions. In addition, the Committee concluded that this metabolite is not likely to be significantly more toxic than the parent. Individuals in Attendance 1. MARC Members Alberto Protzel, Christine Olinger, Rick Loranger, Leung Cheng, Page ­ 3­ John Doherty, Abdallah Khasawinah, and Sheila Piper. 2. Scientists ( non­ MARC members) Nancy McCarroll( TOX1), Mike Ioannou( TOX1), Veronique LaCapra( SRRD), and Jose Melendez( EFED). cc: SF, RF, List B File, S. Piper, N. McCarroll ( TOX1), Jose Melendez( EFED) RDI: C. Olinger: 2/ 06/ 01; F. B. Suhre: 2/ 09/ 01 7509C: CEB1: CM­ 2: Room 810F: 308­ 2717: Oxadiazon Page ­ 4­

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3­ 2­ 01 MEMORANDUM SUBJECT: Oxadiazon. List B Reregistration Case 2485. PC Code 109001. Product Chemistry Chapter for the Reregistration Eligibility Decision [ RED] Document. DP Barcode D273104. FROM: K. Dockter, Chemist Reregistration Branch 2 Health Effects Division [ 7509C] THRU: Alan Nielsen, Branch Senior Scientist Reregistration Branch 2 Health Effects Division [ 7509C] TO: Nancy McCarroll, Risk Assessor Toxicology Branch Health Effects Division [ 7509C] Oxadiazon [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ iospropoxyphenyl) 2­ 1,3,4­ oxadiazolin­ 5­ one] is a preemergence, early postemergence herbicide registered to control annual grasses and broadleaf weeds. Empirical formula: C 15 H 18 Cl 2 N 2 O 3 Molecular weight: 345.2 CAS Registry No.: 19666­ 30­ 9 PC Code: 109001 Chemical structure by J. Punzi 2 A search of REFS conducted 2/ 14/ 01 identified a single oxadiazon MP registered under PC Code 109001, the Aventis Cropscience USA LP 94 % technical [ T]; EPA Reg. No. 264­ 450. There are 47 active end use products. Only the Aventis 94% T is subject to a RED. The product chemistry data base is complete. However, the current Confidential Statement of Formula [ CSF], dated 4/ 7/ 78, is inadequate. Nominal concentration and upper limit must be stated for all components. Additionally, the lower limit must be stated for the a. i. The CSF must be executed by the current registrant. The Series 830 physical and chemical properties are given in the table below. GLN MRID Data 6302 Color jacket white 6303 Physical state " crystalline pwd. 6304 Odor " odorless 7200 MP " 90 C 7300 Bulk density 41565701 1.3 g/ mL 7840 Water solubility jacket 0.0007 g/ L @ 20 C 7950 vp 41230301 7.76x10­ 7 mm Hg [ gas satn.] 7550 P ow 41230302 log P = 4.91 6313 Stability to normal and elevated temperatures, metals, and metal ions 41877601 stable for 30 days @ 55 C; stable in presence of aluminum, iron, & tin pwds. But > 5% loss in presence of ferric chloride. Bibliography 41565701 Chabassol, Y.; Hunt, G. [ 1990] Oxadiazon­ Specific Gravity and Density at 20 C: Study No. 89­ 15. Unpublished study prepared by Rhone­ Poulenc Ag Co. 16 p. 41230301 Hoffman, M. [ 1989] Vapor Pressure Determination of Oxadiazon: Project No. HLA 6001­ 372. Unpublished study prepared by Hazelton Labs. America, Inc. 71 p. 41230302 Seymour, R.; Hall, L. [ 1988] Octanol/ Water Partition Coefficient Determination for Oxadiazon; Report No. 40434. Unpublished study prepared by Rhone­ Poulenc Ag Co. 12 p. 3 41877601 Sanders, J. [ 1991] Oxadiazon, Technical ­ Determination of Stability; Lab. ID 4053­ 91­ 0061­ AS. Unpublished study prepared by Ricerca, Inc. 102 p. cc: List B file, SF, RF, Dockter, N. McCarroll, S. Piper, S. Tadayan. RD\ I TB/ CEB/ RRB2 Oxadiazon RED Team. 7509C: RRB2: Rm712N: 57886: KD/ kd Oxadiazon RED [ 9856_ 1] = D273104. RED. wpd.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES DATE: March 27, 2001 SUBJECT: Oxadiazon. List B Reregistration Case 2485. PC Code 109001. Product Chemistry and Residue Chemistry Chapter for the Reregistration Eligibility Decision [ RED] Document. DP Barcode D273740. FROM: Sheila Piper, Chemist Chemistry Exposure Branch Health Effects Division [ 7509C] THRU: Francis B. Suhre, Branch Senior Scientist Chemistry Exposure Branch Health Effects Division [ 7509C] TO: Nancy McCarroll, Risk Assessor Toxicology Branch Health Effects Division [ 7509C] The Product Chemistry and Residue Chemistry databases for oxadiazon are complete. The registrant, Aventis Environmental Science USA is no longer supporting oxadiazon in or on food, feed, or residential uses ( Revocation Letter for Oxadiazon Tolerances, 1/ 24/ 01). Currently, the registrant is only supporting the use of oxadiazon on golf courses and ornamentals. The request for revocation of oxadiazon on food, feed or residential uses has been granted and tolerances will be revoked. Attachments 1 and 2: Oxadiazon Product and Residue Chemistry RED Chapter cc: SF, RF, List B File, S. Piper RDI: F. B. Suhre: 3/ 23/ 01 7509C: CEB1: CM­ 2: Room 810F: 308­ 2717: Oxadiazon REREGISTRATION ELIGIBILITY DECISION PRODUCT CHEMISTRY CONSIDERATIONS PC Code 109001; Case 2485 ( DP Barcode D273104) Oxadiazon [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ iospropoxyphenyl)­ 2­ 1,3,4­ oxadiazolin­ 5­ one] is a preemergence, early postemergence herbicide registered to control annual grasses and broadleaf weeds. Empirical formula: C 15 H 18 Cl 2 N 2 O 3 Molecular weight: 345.2 CAS Registry No.: 19666­ 30­ 9 PC Code: 109001 Oxadiazon A search of REFS conducted 2/ 14/ 01 identified a single oxadiazon MP registered under PC Code 109001, the Aventis Environmental Science USA LP 94 % technical [ T]; EPA Reg. No. 264­ 450. There are 47 active end use products. Only the Aventis 94% T is subject to a RED. The product chemistry data base is complete. However, the current Confidential Statement of Formula [ CSF], dated 4/ 7/ 78, is inadequate. Nominal concentration and upper limit must be stated for all components. Additionally, the lower limit must be stated for the a. i. The CSF must be executed by the current registrant. The Series 830 physical and chemical properties are given in the table below: GLN MRID Data 6302 Color jacket white 6303 Physical state " crystalline powder 6304 Odor " odorless 7200 MP " 90 C 7300 Bulk density 41565701 1.3 g/ mL 7840 Water solubility jacket 0.0007 g/ L @ 20 C 7950 vp 41230301 7.76x10­ 7 mm Hg [ gas satn.] 7550 P ow 41230302 log P = 4.91 6313 Stability to normal and elevated temperatures, metals, and metal ions 41877601 stable for 30 days @ 55 C; stable in presence of aluminum, iron, & tin pwds. But > 5% loss in presence of ferric chloride. Bibliography 41565701 Chabassol, Y.; Hunt, G. [ 1990] Oxadiazon­ Specific Gravity and Density at 20 C: Study No. 89­ 15. Unpublished study prepared by Rhone­ Poulenc Ag Co. 16 p. 41230301 Hoffman, M. [ 1989] Vapor Pressure Determination of Oxadiazon: Project No. HLA 6001­ 372. Unpublished study prepared by Hazelton Labs. America, Inc. 71 p. 41230302 Seymour, R.; Hall, L. [ 1988] Octanol/ Water Partition Coefficient Determination for Oxadiazon; Report No. 40434. Unpublished study prepared by Rhone­ Poulenc Ag Co. 12 p. 41877601 Sanders, J. [ 1991] Oxadiazon, Technical ­ Determination of Stability; Lab. ID 4053­ 91­ 0061­ AS. Unpublished study prepared by Ricerca, Inc. 102 p. OXADIAZON REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 109001; Case 2485 ( DP Barcode D273740) TABLE OF CONTENTS page INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 REGULATORY BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 SUMMARY OF SCIENCE FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 GLN 860.1200: Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 GLN 860.1300: Nature of the Residue ­ Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 GLN 860.1300: Nature of the Residue ­ Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 GLN 860.1340: Residue Analytical Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 GLN 860.1360: Multiresidue Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 GLN 860.1380: Storage Stability Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 GLN 860.1500: Crop Field Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 GLN 860.1520: Processed Food/ Feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 GLN 860.1480: Meat, Milk, Poultry, Eggs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 GLN 860.1400: Water, Fish, and Irrigated Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 GLN 860.1460: Food Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 GLNs 860.1850 and 860.1900: Confined/ Field Accumulation in Rotational Crops . . . 5 TOLERANCE REASSESSMENT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Tolerances Listed Under 40 CFR § 180.346 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 CODEX HARMONIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 DIETARY EXPOSURE ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 AGENCY MEMORANDA CITED IN THIS DOCUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 7 INTRODUCTION 2 Oxadiazon, ( 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ isopropoxyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one) is a selective pre­ emergent and early post emergence herbicide that is effective primarily for the control of annual grasses and broadleaf weeds in turf. Oxadiazon is manufactured by Aventis CropScience USA, under the trade name Ronstar ® and formulations are available as emulsifiable concentrates, granules, flowable and wetable powders. The registrant are no longer supporting oxadiazon in or on food, feed or residential uses. Currently, the registrant is only supporting the use of oxadiazon on golf courses and ornamentals ( Revocation Letter for Oxadiazon Tolerances, 1/ 24/ 01). REGULATORY BACKGROUND Oxadiazon is a list B reregistration chemical and was subject of a Phase III Review dated 1/ 3/ 90 ( C. Olinger). This document summarized regulatory conclusions on the available residue chemistry data and specified that additional data were not required for reregistration purposes. The information contained in this document outlines the current Residue Chemistry Science Assessments with respect to the reregistration of oxadiazon. Tolerances have been established for combined residues of oxadiazon and its metabolites [ 2­ tertbutyl 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one and 2­ carboxyiso­ propyl­ 4­( 4­ dichloro) 5­ isopropo­ xyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one] in or on: rice straw ( 0.2 ppm); milk fat ( 0.1 ppm; reflecting negligible residues in milk); Brazil nuts, bush nuts, butternuts, cashews, chestnuts, crabapples, filbert, hazelnuts, hickory nuts, macadamia nuts, pears, pecans, pistachio nuts, quinces, rice grain, stone fruit and walnuts ( 0.05 ppm); and in the meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep ( 0.01 ppm) [ 40 CFR § 180.346]. The HED Metabolism Assessment Review Committee ( S. Piper, D272425, 2/ 13/ 01) has concluded that the parent compound, oxadiazon is the only residue to be included in a drinking water risk assessment. The chemical structure of oxadiazon is shown below: SUMMARY OF SCIENCE FINDINGS GLN 860.1200: Directions for Use A REFS search, conducted on 2/ 14/ 01, identified a single oxadiazon MP registered under PC Code 109001, the Aventis 3 Environmental Science USA LP 94% technical [ T]; EPA Reg. No. 264­ 450. There are 47 active end use products, registered pesticide products under FIFRA with labeling claiming oxadiazon as the active ingredient. The use sites claimed on the labels of these products are non­ residential lawns ( turf) and ornamental plants. Three of the products are registered under 24( c) and the other 44 products are registered under Section 3 of FIFRA. Only the Aventis 94% is subject to a reregistration eligibility decision. For the purpose of generating this Residue Chemistry Science Chapter, the Aventis will not support aerial application ( will put restriction on the Ronstar ® labels) or greenhouse useage ( already restricted on the Ronstar ® labels). Aventis will add these label restrictions to the products ( Ronstar ® 50% intermediate and Ronstar ® Technical) used by other registrants to formulate their own products. Details of the rates and application intervals are presented below: $ Maximum of 4 lbs ai/ A per application per six month period. $ If the 4 lbs is split, applications within the six month period must be 6 to 8 weeks apart. $ Maximum of 8 lbs ai/ A per year or 4 lbs every six months. GLN 860.1300: Nature of the Residue ­ Plants The qualitative nature of the residue in plants is not adequately understood. The registrant submitted an inadequate rice metabolism study. Furthermore, no data were available concerning the metabolism of oxadiazon in/ on crops representing orchard crops. The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. GLN 860.1300: Nature of the Residue ­ Animals The qualitative nature of the residue in animals is not adequately understood. The registrant submitted an inadequate ruminant metabolism study. Furthermore, no data on poultry were submitted. The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. GLN 860.1340: Residue Analytical Methods Adequate methodology is available for the enforcement of tolerances for residues of oxadiazon in or on plant and animal commodities. A GLC/ electron capture ( EC) method is included in Pesticide Analytical Manual ( PAM) Vol. II as Method 1 for analysis of oxadiazon residues in rice, soybeans, peanuts, onions, and potatoes ( Pesticide Reg. Sec, 180.346). A modified version of 4 Method III has also been used for analysis of residues in turf, nuts, and orchard fruit. Method III includes similar procedures for analysis of oxadiazon residues in milk and dairy cattle tissue. GLN 860.1360: Multiresidue Methods The Pestrak data base dated 12/ 13/ 89 indicates that oxadiazon recovery is complete (> 80%) using Multiresidue Protocol D and either partial ( 50­ 80%; fatty foods) or complete ( non­ fatty foods) using Protocol E, and that the two metabolites of concern were included in the tolerance expression. The requirements to conduct multiresidue method trials with oxadiazon and its metabolites are waived. GLN 860.1380: Storage Stability Data The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. Therefore, reregistration requirements for storage stability data are waived for plant and animal commodities. GLN 860.1500: Crop Field Trials The reregistration requirements for magnitude of the residue in/ on the following raw agricultural commodities ( RACs) have been waived: rice ( grain and straw), Brazil nuts, bush nuts, butternuts, cashews, chestnuts, crabapples, filberts, hazelnuts, hickory nuts, macadamia nuts, pears, pecans, pistachio nuts, quinces, stone fruits and walnuts. The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. GLN 860.1520: Processed Food/ Feed The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. Therefore, reregistration requirements for magnitude of the residue in the processed commodities of plum ( dried prune) has been waived. GLN 860.1480: Meat, Milk, Poultry, Eggs The reregistration requirements for magnitude of the residue in meat, milk, poultry, and eggs are waived. The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. GLN 860.1400: Water, Fish, and Irrigated Crops 5 Oxadiazon is presently not registered for direct use on water and aquatic food and feed crops; therefore, no residue chemistry data are required under this guideline topic. GLN 860.1460: Food Handling Oxadiazon is presently not registered for use in food­ handling establishments; therefore, no residue chemistry data are required under this guideline topic. GLNs 860.1850 and 860.1900: Confined/ Field Accumulation in Rotational Crops The registrant has requested revocation of oxadiazon on food/ feed uses and tolerances will be revoked. Therefore, reregistration requirements for accumulation in rotational crops are waived. Tolerance Reassessment Summary Tolerances for residues of oxadiazon in/ on plant and animal RACs are currently expressed in terms of oxadiazon and its metabolites [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one and 2­ carboxyiso­ propyl­ 4­( 4­ dichloro) 5­ isopropo­ xyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one] [ 40 CFR § 180.346]. The HED Metabolism Assessment Review Committee ( S. Piper, D272425, 2/ 13/ 01) has concluded that the parent compound, oxadiazon is the only residue to be included in a drinking water risk assessment. The tolerance definition listed under 40 CFR § 180.346 should be changed to the following: Tolerances have been revoked for oxadiazon and its metabolites [ 2­ tert­ butyl­ 4­( 2,4­ dichloro­ 5­ hydroxyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one and 2­ carboxyiso­ propyl­ 4­( 4­ dichloro) 5­ isopropo­ xyphenyl)­ 21,3,4­ oxadiazolin­ 5­ one] in or on the following raw agricultural commodities presented in Table A: Table A. Tolerance Reassessment Summary for Oxadiazon. Commodity Current Tolerance ( ppm) Tolerance a Reassessment ( ppm) Comme Tolerances listed under 40 CFR § 180.346: Brazil nuts, bush nuts, butternuts, cashews, chestnuts, filbert, hazelnuts, hickory nuts, macadamia nuts, pecans, pistachio nuts, and walnuts. 0.05 Revoke The registran Cattle, meat, fat, mbyp 0.01 Revoke The registran Crabapples 0.05 Revoke The registran Commodity Current Tolerance ( ppm) Tolerance a Reassessment ( ppm) Comment/ Correct Commodity Definition 6 Goats, meat, fat, mbyp 0.01 Revoke The registrant will not support this use. Hogs, meat, fat, mbyp 0.01 Revoke The registrant will not support this use. Horses, meat, fat, mbyp 0.01 Revoke The registrant will not support this use. Milk, fat 0.1 Revoke The registrant will not support this use. Pears 2.0 Revoke The registrant will not support this use. Quinces 0.05 Revoke The registrant will not support this use. Rice, grain 0.05 Revoke The registrant will not support this use. Rice, straw 0.2 Revoke The registrant will not support this use. Sheep, meat, fat, mbyp 0.01 Revoke The registrant will not support this use. Stone fruits 0.05 Revoke The registrant will not support this use. a The registrant, Aventis submitted a revocation letter ( 1/ 24/ 01) for oxadiazon in which they are not supporting any tolerances for oxadiazon in or on food. DIETARY EXPOSURE ASSESSMENT SUMMARY A dietary risk assessment for the uses of oxadiazon is not needed at this time because there are no food/ feed uses for oxadiazon. CODEX HARMONIZATION 7 There are no CODEX, Canadian, or Mexican tolerances for oxadiazon residues on the 16 commodities listed in 40 CFR § 180.346. AGENCY MEMORANDA CITED IN THIS DOCUMENT HED No: None DP Barcode: D271728 Subject: Oxadiazon. Issues to be Presented to the HED Metabolism Assessment Review Committee ( MARC). From: S. Piper, HED To: HED Metabolism Committee Dated: 1/ 10/ 01 MRID( s): None HED No: None DP Barcode: D272425 Subject: Oxadiazon. The Outcome of the HED Metabolism Assessment Review Committee Meeting Held on 1/ 30/ 01. From: S. Piper, HED To: HED Metabolism Committee Dated: 2/ 13/ 01 MRID( s): None 8

epa

2024-06-07T20:31:45.256345

regulations

EPA-HQ-OPP-2002-0310-0001

Notice

Pesticide Products; Registration Approval

70945 Federal Register / Vol. 67, No. 229 / Wednesday, November 27, 2002 / Notices Washington, DC, 20460 0001, Attention: Docket ID Number OPP 2002 0317. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0317. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the registration activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Registration Application EPA received an application as follows to register a pesticide product containing an active ingredient not included in any previously registered products pursuant to the provision of section 3( c)( 4) of FIFRA. Notice of receipt of this application does not imply a decision by the Agency on the application. Product Containing an Active Ingredient not Included in any Previously Registered Products File symbol: 56228 GU. Applicant: United States Department of Agriculture, Animal Plant and Health Inspection Service, 4700 River Road, Unit 152, Riverdale, MD 20737. Product name: Acetaminophen For Brown Treesnake Control. Product type: Pesticide. Active ingredient: Contains 72.7% of the new active ingredient acetaminophen. Proposed classification/ Use: For control and reduction of brown treesnake abundance on Guam and the Northern Mariana Islands and to protect against brown treesnakes being exported to Hawaii or the Continental United States as hitchhikers in cargo. List of Subjects Environmental protection, Pesticides and pest. Dated: November 18, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 30122 Filed 11 26 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0310; FRL 7280 5] Pesticide Product; Registration Approval AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces Agency approval of an application to register the pesticide product Bromuconazole Technical containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9354; and e­ mail address: waller. mary@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0310. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., VerDate 0ct< 31> 2002 16: 54 Nov 26, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 27NON1. SGM 27NON1 70946 Federal Register / Vol. 67, No. 229 / Wednesday, November 27, 2002 / Notices Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. In accordance with section 3( c)( 2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office ( A 101), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. The request should: Identify the product name and registration number andspecify the data or information desired. A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service ( NTIS), 5285 Port Royal Rd., Springfield, VA 22161. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Did EPA Approve the Application? The Agency approved the application after considering all required data on risks associated with the proposed use of bromuconazole, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of bromuconazole when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment. III. Approved Application EPA issued a notice, published in the Federal Register of May 10, 1994 ( 59 FR 24151) ( FRL 4770 4), which announced that Rhone­ Poulenc Ag Company had submitted an application to register the pesticide product Bromuconazole Technical ( EPA File Symbol 264 LUT), containing bromuconazole at 97.0%, an active ingredient not included in any previously registered product. The application was approved on September 30, 2002, as Bromuconazole Technical, a manufacturing use product for manufacturing, formulating and repackaging use ( EPA Registration Number 264 547). List of Subjects Environmental protection, Pesticides and pests. Dated: November 16, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 30124 Filed 11 26 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0313; FRL 7280 9] Pesticide Emergency Exemptions; Agency Decisions and State and Federal Agency Crisis Declarations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: EPA has granted or denied emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) for use of pesticides as listed in this notice. The exemptions or denials were granted during the period July 1, 2002 until September 30, 2002 to control unforseen pest outbreaks. FOR FURTHER INFORMATION CONTACT: See each emergency exemption or denial for the name of a contact person. The following information applies to all contact persons: Team Leader, Emergency Response Team, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9366. SUPPLEMENTARY INFORMATION: EPA has granted or denied emergency exemptions to the following State and Federal agencies. The emergency exemptions may take the following form: Crisis, public health, quarantine, or specific. EPA has also listed denied emergency exemption requests in this notice. I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are a federal or state government agency involved in administration of environmental quality programs ( i. e., Departments of Agriculture, Environment, etc). Potentially affected entities may include, but are not limited to: Federal or State Government Entity, ( NAICS 9241), i. e., Departments of Agriculture, Environment, etc. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0313. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA VerDate 0ct< 31> 2002 16: 54 Nov 26, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 27NON1. SGM 27NON1

epa

2024-06-07T20:31:45.261312

regulations

EPA-HQ-OPP-2002-0311-0001

Notice

Endangered Species Protection Program Field Implementation. Notice of Proposed Field Implementation Approach and Request for Comment (For Documents 2-4 Below, There are no Documents Associated With Those Entries).

71549 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices Disinfection Byproducts Rule ( DBPR) to provide greater protection against risks associated with microbial pathogens and disinfection byproducts in drinking water. The Committee provided consensus recommendations for the LT2ESWTR and Stage 2 DBPR in September 2000, as stated in an Agreement in Principle ( 65 FR 83015, December 29, 2000). In this meeting, EPA will inform the Committee regarding the status of development of the LT2ESWTR and Stage 2 DBPR. Dated: November 25, 2002. Cynthia C. Dougherty, Director, Office of Ground Water and Drinking Water. [ FR Doc. 02 30461 Filed 11 29 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ FRL 7414 9] Meeting of the National Drinking Water Advisory Council AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of public meeting. SUMMARY: In accordance with section 10( a)( 2) of Public Law 92 423, `` The Federal Advisory Committee Act,'' notice is hereby given of the forthcoming conference call meeting of the National Drinking Water Advisory Council ( Council), established under the Safe Drinking Water Act, as amended ( 42 U. S. C. 300f et seq.). The Council will discuss underground injection control with respect to the practice of hydraulic fracturing for coal­ bed methane production. DATES: The meeting will be held on December 12, 2002, from 10 a. m. to 1 p. m., Eastern Standard Time. ADDRESSES: Council members will teleconference into Room 2123 of the EPA East building, which is physically located at 1201 Constitution Avenue, NW, Washington, DC. A limited number of additional phone lines may be available for members of the public who are outside of the Washington DC metropolitan commuting area and are unable to attend in person. Any additional teleconferencing lines that are available will be reserved on a firstcome first­ serve basis by the Designated Federal Officer. FOR FURTHER INFORMATION CONTACT: Members of the public who would like to attend the meeting, present an oral statement, submit a written statement in advance, or make arrangements to teleconference into the meeting should contact Brenda Johnson, Designated Federal Officer, National Drinking Water Advisory Council, by December 6, 2002. Ms. Johnson can be reached at ( 202) 564 3791; by e­ mail at johnson. brendap@ epa. gov, or by regular mail at U. S. Environmental Protection Agency, Office of Ground Water and Drinking Water ( M/ C 4601M), 1200 Pennsylvania Avenue, NW, Washington, DC 20460. SUPPLEMENTARY INFORMATION: The Council encourages the public's input and will allocate a portion of the meeting for this purpose. To ensure adequate time for public involvement, oral statements will be limited to five minutes, and it is preferred that only one person present the statement on behalf of a group or organization. Any person who wishes to file a written statement can do so before or after a Council meeting. Written statements received prior to the meeting will be distributed to all members of the Council before any final discussion or vote is completed. Any statements received after the meeting will become part of the permanent meeting file and will be forwarded to the Council members for their information. Dated: November 25, 2002. Cynthia C. Dougherty, Director, Office of Ground Water and Drinking Water. [ FR Doc. 02 30462 Filed 11 29 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0311; FRL 7283 7] Endangered Species Protection Program Field Implementation AGENCY: Environmental Protection Agency ( EPA or Agency). ACTION: Notice of proposed field implementation approach and request for comment. SUMMARY: EPA's Office of Pesticide Programs is describing, and requesting comment on, implementation of its Endangered Species Protection Program ( ESPP, or the Program). The goal of the ESPP is to carry out responsibilities under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) in compliance with the Endangered Species Act ( ESA), while at the same time not placing unnecessary burden on agriculture and other pesticide users. This Notice describes how EPA proposes to implement its responsibilities under section 7( a)( 2) of ESA by completing and upgrading County Bulletins, amending pesticide labels to reference County Bulletins, and enhancing monitoring programs. Regulations found at 50 CFR part 402 acknowledge that there may be Federal programs for which revisions to standard regulatory processes could result in more effective and efficient coordination among Federal agencies and thus, more effective and efficient protection of listed species. As such, those regulations ( 50 CFR part 402) allow Federal agencies to establish alternate procedures, applicable to specific Federal programs, for satisfying the provisions of ESA section 7( a)( 2). Those alternate procedures are known as counterpart regulations. Through a separate Advance Notice of Proposed Rulemaking ( ANPR) to be issued on or about the same date as this Notice, EPA, the Department of the Interior ( DOI), and the Department of Commerce ( DOC) are seeking public input on ways that such counterpart regulations could improve the ESA consultation process with respect to pesticide registrations. Similarly, implementing regulations under FIFRA may be revised to ensure a more effective program. The docket for this Notice ( docket identification number OPP 2002 0311) includes a summary of the current technical review and consultation approaches employed by the Agency, and the standard evaluation procedure used for ecological risk assessments. That information has been subject to public comment in the past, has been used during EPA's Interim Endangered Species Protection Program, and will continue to be used until the Agency, DOI and DOC take comment on these aspects of the Program through the ANPR and modify them as appropriate. DATES: Comments, identified by docket ID number OPP 2002 0311, must be received on or before March 3, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of this Notice. FOR FURTHER INFORMATION CONTACT: Mary Powell, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 7384; fax number: ( 703) 308 3259; e­ mail address: powell. mary@ epa. gov. SUPPLEMENTARY INFORMATION: This Notice is organized into four units. Unit I. provides general information about applicability of this Notice, availability of additional information, and how to VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71550 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices comment on the Notice. Unit II. provides background information, including the Agency's legal authority for taking this action, the Interim ESPP, and EPA's efforts to develop this proposed field implementation approach. Unit III. describes the proposed field implementation of the ESPP, and Unit IV. provides the references cited throughout this Notice. While the Agency seeks comments on any aspect of this Notice, it also is hoping to obtain input on certain specific aspects. Within the various units of this Notice, EPA has indicated specific issues on which the Agency is particularly interested in obtaining comment. These issues are noted within the appropriate units under a subheading of `` Specific Input Requested.'' Further, the Agency seeks comment on whether any aspect of this field implementation proposal is more appropriately addressed through the counterpart regulations that are the subject of a separate ANPR, to be published by the Agency, DOI, and DOC on or about the same date as this Notice. I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to farmers; pesticide registrants; pesticide users; agricultural trade associations; public interest groups; groups involved in or interested in endangered species protection; and local, State, Tribal, U. S. Territory, and Federal government agencies. Because other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0311. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number ( in this case, number OPP 2002 0311) in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71551 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0311. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0311. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0311. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0311. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find these suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at your estimate. 5. Provide specific examples to illustrate your concerns. 6. Offer alternatives. 7. Make sure to submit your comments by the comment period deadline identified. 8. To ensure proper receipt by EPA, identify the appropriate docket ID number ( in this case, docket ID number OPP 2002 0311) in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments. II. Background Information on the Endangered Species Protection Program A. Authority and Responsibility under FIFRA and ESA Since 1970, EPA has had responsibility for regulating the sale, distribution and use of pesticides under the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA). EPA has granted registrations, or licenses, to thousands of pesticides containing hundreds of active ingredients and has continuing oversight over such actions. These registrations encompass thousands of different use sites and practices across the United States. FIFRA as amended ( 7 U. S. C. 135 et seq.) governs the regulation of pesticides in the United States. Under FIFRA, a pesticide product may be sold or distributed in the United States only if it is registered or exempted from registration by EPA. Before a product can be registered unconditionally, it must be shown, among other things, that the pesticide, when used in accordance with widespread and commonly recognized practice, will not generally cause `` unreasonable adverse effects on the environment'' ( section 3( c)( 5)). FIFRA defines this standard to include `` any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of'' the pesticide ( FIFRA section ( 2)( bb)( 1)). This is known as the FIFRA risk/ benefit standard. Amendments to FIFRA in 1988 required that in addition to the original registration decision, all pesticides first registered before November 1984 be reviewed against more up­ to­ date data requirements and standards, and decisions made about whether these pesticides should be `` reregistered'' ( FIFRA section 4( a)). FIFRA was amended again in 1996 with enactment of the Food Quality Protection Act. FQPA put into place a new standard for assessing human dietary risk ( FIFRA section 2( bb)( 2)), but it did not alter the risk benefit­ standard of section 2( bb)( 1) for assessing ecological risk. It also required that EPA periodically review pesticide registrations ( establishing a goal of such review every 15 years) to determine whether such registrations meets the requirements of the Act ( FIFRA section 3( g)( 1)( A)). Congress enacted the ESA ( 16 U. S. C. 1531 et seq.) to protect and promote the recovery of animal and plant species that are threatened or in danger of becoming extinct and to ensure that the critical habitat upon which they depend is not destroyed or adversely modified. The ESA institutes certain prohibitions against `` taking'' threatened or endangered ( listed) species. Section 7( a)( 1) of the ESA, 16 U. S. C. 1536( a)( 1), requires Federal agencies use their authorities in furtherance of the purposes of the Act, by carrying out programs for the conservation of listed species. Public Law 100 478, October 7, 1988, amended the ESA and states that EPA should fulfill its obligation to conserve listed species, while at the same time considering the needs of agriculture and other pesticide users. Section 7( a)( 2) of the ESA, 16 U. S. C. 1536, and the implementing regulations at 50 CFR part 402, further require Federal agencies to ensure that their VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71552 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices actions are not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of critical habitat. This duty extends to licensing activities such as the registration of pesticides by EPA. In meeting the section 7( a)( 2) requirement, EPA must consult with the Services regarding the effects of Agency actions on listed species. In fulfilling this requirement, Federal agencies must use the best scientific and commercial data available. The Secretary of the Interior has delegated the interagency consultation responsibilities to the U. S. Fish and Wildlife Service; the Secretary of Commerce has delegated the interagency consultation responsibilities to the National Oceanic and Atmospheric Administration. EPA and the Services are currently engaged in a number of separate, but related activities relative to EPA's responsibilities under the ESA. First, under ESA section 7( a)( 1), EPA and the Services are engaged in an ongoing Proactive Conservation Review. This review of EPA's ESPP, is intended to clarify for the Federal agencies, EPA's approach to risk assessment, criteria that indicate a listed species may be at risk, and the requirements imposed on EPA by the ESA regulations governing consultation. The review will also identify areas or issues relative to risk assessment, criteria and consultations that may require modification to ensure an effective and efficient process of consultation among EPA and the Services. While this review is conducted under ESA section 7( a)( 1), the outcomes of the review will likely be used to help focus discussions on technical and science policy issues that need to be addressed in order to effectively carry out responsibilities under ESA section 7( a)( 2). As noted in the SUMMARY section of this Notice, EPA and the Services are also publishing an ANPR, at or about the same time as publication of this Notice. The purpose of the ANPR is to gain public input relative to the consultation, technical, and science policy issues that need to be addressed in order to effectively carry out responsibilities under ESA section 7( a)( 2). As part of the ESPP, this Federal Register Notice proposes a field implementation plan for putting in place any protection measures necessary to ensure EPA's compliance with ESA section 7( a)( 2). This plan, once final, will be used to put in place protection measures identified through consultations with the Services. EPA may also use this implementation approach as appropriate, to put measures in place necessary to protect listed species, even in the absence of a Biological Opinion from the Services. B. EPA's Role 1. ESA section 7( a)( 1) obligations. As noted in Unit II. A. above, EPA has responsibilities under both section 7( a)( 1) and 7( a)( 2) of the ESA. Under section 7( a)( 1), EPA uses its authorities to conserve listed species, in consultation with the Services. The Proactive Conservation Review discussed in Unit II. F. 2. is being carried out under section 7( a)( 1) of ESA. In addition, EPA has carried out a number of other activities intended to conserve listed species including: Hosting a Wb site that contains listed species fact sheets and a county­ scale data base of listed species occurrences; maintaining a toll­ free telephone number for public inquiries relative to pesticide use and listed species protection; and producing and disseminating educational materials for students. Additionally, EPA has worked with State agencies responsible for pesticide programs, to ensure that pesticide applicators certified by the States, receive information during their certification training, relative to endangered species protection needs. 2. ESA section 7( a)( 2) obligations. Under section 7( a)( 2) of ESA, EPA must ensure that its actions are `` not likely to jeopardize the continued existence of any'' listed species or `` result in the destruction or adverse modification of'' their designated critical habitat. In carrying out its responsibilities, EPA's challenge is how to implement FIFRA, a risk/ benefit statute, in a way that ensures compliance with the requirements of the ESA mandate to protect listed species and to do so at use sites that are geographically, ecologically, agronomically, and economically diverse and changeable. EPA seeks to carry out these protections for thousands of pesticide products in ways that users can be expected to implement reliably and routinely without unnecessary burden. The Agency is responsible for reviewing information and data to determine whether a pesticide product may be registered for a particular use. As part of that determination, the Agency assesses whether listed species or their designated critical habitat may be affected by the use of the product. If EPA determines that the action may affect a listed species, the interagency coordination regulations require the Agency to enter into a process with the Services called `` consultation'' ( 50 CFR 402.14). The consultation process is designed to ensure that the Agency action is not likely to jeopardize the continued existence of a listed species or result in destruction or adverse modification of its designated critical habitat ( ESA section 7( a)( 2)). Following consultation, the Agency is responsible for implementing protections, if necessary, through its available authority. More information on `` may affect determinations'' and consultations may be found in Unit II. D. EPA must also `` confer'' with the Services if its actions may jeopardize the continued existence of species proposed for listing or result in destruction or adverse modification of habitat proposed for designation as critical habitat. Consultation is not necessary if EPA determines that a particular action will have `` no effect'' on listed species or designated critical habitat. ( See Unit II. D. 1. c. for a discusssion of `` no effect determinations.'' C. The Roles of FWS and NOAA Fisheries DOI's U. S. Fish and Wildlife Service ( FWS) administers the ESA for most species. DOC's National Marine Fisheries Service ( NOAA Fisheries) administers the ESA for certain listed marine and anadromous species. Both FWS and NOAA Fisheries ( jointly, the Services) enter into formal or informal consultation or conference with EPA concerning effects to listed species and species proposed for listing as well as effects on critical habitat. The consultation process is described in Unit II. D. 3. below. The Services may determine whether an EPA action is likely to cause jeopardy to the continued existence of a species and if so, the Services may propose reasonable and prudent alternatives to the action to avoid jeopardy. The Services may also issue incidental take statements that authorize takings of listed species incidental to certain Federal actions. D. Effects Determinations and Consultations In the past, EPA has conducted a number of consultations with the Services. The Agency's experience with those has demonstrated that the agencies need to reexamine their programs to improve both the efficiency and effectiveness of consultation. EPA and the Services are currently participating in a joint Proactive Conservation Review ( see Unit II. F. 2.) to explore potential modifications for better integrating the FIFRA and ESA processes. The Agency, DOI and DOC are seeking public input on the consultation process and EPA's endangered species assessment VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71553 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices processes through a separate ANPR, to be published on or about the same date as this Notice, and intend to address these provisions through counterpart regulations. Similarly, subsequent to the ANPR, certain FIFRA regulatory processes may be reviewed for possible revisions that could make the program more efficient or effective. While the Agency is not seeking comment on these aspects of its protection efforts through this Notice, it is including a summary of its current process for making effects determinations and consulting with the Services in Unit II. D. 2. below, for purposes of providing context to the reader. 1. Effects determinations. To the degree possible, endangered species issues are and will be addressed within the Agency's existing processes of registration and reregistration. Concurrently, the Agency will review those pesticides that have been through reregistration and that may affect listed species, or did not undergo ESA review during reregistration. EPA has no standard data requirements for endangered species effects determinations, beyond those normally required during registration and reregistration. However, in making such effects determinations in the past, the Agency has requested data for specific listed species concerns, and may continue to do so in the future. As the Proactive Conservation Review and ANPR move forward ( see Unit II. F. 2.), and as EPA begins to meld the process for making these determinations into existing registration and reregistration activities, the Agency may revisit the necessity for identifying data requirements specific to listed species. The potential of a pesticide to directly affect any particular species is based on two factors: The toxicity of the chemical to the species, and exposure. The latter includes the estimated environmental concentrations ( EECs) that would result from labeled use of a pesticide and the potential for actual exposure of the species of concern to those EECs. Direct effects may be in either of two broad categories: Acute effects or chronic effects, including both lethal and sublethal effects. Species may also be affected indirectly through modification of their habitat or through effects on their food supply. EPA relies on a wide range of environmental data to assess the potential effects of pesticides on listed species. These data include toxicological studies, laboratory and field studies of the fate and transport of pesticides, mathematical fate and transport models, and field studies monitoring pesticide concentrations and adverse effects to non­ target organisms. a. Acute lethal and sublethal effects. Acute data are derived from toxicity tests with lethality as the primary endpoint. The standard acute tests submitted for pesticide registration also include analysis of observable sublethal effects. For example, a typical acute test for a fish will include concentrations that cause no mortality and often no observable sublethal effects, as well as concentrations that would cause 100% mortality. Sublethal effects may or may not be observed at concentrations below that which cause 100% mortality. Where sublethal effects are observed, the Agency includes such information in its assessment of whether a pesticide may affect a listed species. The effects at test concentrations can be used to statistically predict the effects likely to occur at various pesticide concentrations; a well­ done test can even be extrapolated to concentrations below those tested ( or above the test concentrations, if the highest concentration did not produce 100% mortality). b. Chronic lethal and sublethal effects. Potential chronic effects of a pesticide can be evaluated based on several types of tests and conducted on one of several possible species, depending on the listed species of interest. For example, chronic tests for a listed bird could be conducted on the mallard or bobwhite quail, whereas such tests for a listed estuarine species would be conducted on mysid shrimp. Chronic tests primarily evaluate the potential for reproductive effects and effects on the offspring. Other observed sublethal effects are also required to be reported. An abbreviated chronic test is usually the first chronic test conducted and will indicate the likelihood of reproductive or chronic effects at relevant concentrations. If such effects are found, then a full life­ cycle test will generally be required. If the nature of the chemical is such that reproductive effects are expected, the abbreviated test may be skipped in favor of the full lifecycle test. These chronic tests are designed to determine a `` no observable effect level'' ( NOEL) and a `` lowest observable effect level'' ( LOEL). c. Assessment. EPA typically evaluates the potential of a pesticide to affect listed species by conducting a screening level assessment and, if necessary, a species­ specific assessment. During the screening level assessment process, the Agency generally does not determine whether in fact any specific threatened or endangered species may be affected by the pesticide, but merely whether a concern would exist if a threatened or endangered species were exposed to the EECs, given the toxicity of the specific pesticide to the species. The screening steps start out very conservative and become more refined with each step. EPA determines that there is `` no effect'' on listed species if, at any step in the screening level assessment, no Levels of Concern ( LOCs) are exceeded. After EPA performs all the available steps in the screening level assessment, a pesticide may still exceed the Agency's LOCs for listed species ( see Unit II. D. 1. d.). The Agency will then conduct a speciesspecific assessment to make effects determinations for individual listed species and their designated critical habitat. Units II. D. 1. d. through II. D. 1. g. provide an example of this process for aquatic species. Similar steps are undertaken for terrestrial species. d. Screening level assessment. EPA begins its screening level assessments by conducting a basic ecological risk assessment that uses available data and generally conservative assumptions to establish the EEC. EPA then uses increasingly specific methods and data and more refined exposure models to refine the EEC of the pesticide. Where available, EPA may also use field monitoring data for a variety of purposes. At each screening step, the more refined EEC is compared to the toxicity of the pesticide active ingredient to determine whether the pesticide exceeds LOCs established for listed aquatic and terrestrial species. EPA's Standard Evaluation Procedure for Ecological Risk Assessment ( June, 1986. EPA­ 540/ 9­ 85­ 001) provides that LOCs are exceeded for acute effects on listed species when the EEC of a pesticide is greater than 1/ 20th the LC50 for appropriate aquatic species or 1/ 10th the LC50 or LD50 for appropriate terrestrial species. Thus, under current practices, the LOCs for listed species incorporate an extra level of protection that is not used in the LOCs for other non­ target species. ( LC50 is the statistically derived estimate of concentration expected to cause 50% lethality. LD50 is the statistically derived estimate of oral dose expected to result in 50% lethality.) LOCs are exceeded for chronic and/ or reproductive effects when the EEC exceeds the NOEL in appropriate studies. In the first step of EPA's screening level assessment, the Agency uses a quantitative comparison between the default EEC and the toxicity of the chemical. A default EEC is based on application rates from pesticide labels and on extremely conservative assumptions of movement of the pesticide to water rather than on actual VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71554 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices chemical fate and transport data. Toxicity values for the pesticide are taken from data submitted by pesticide registrants to support their registration request. The application rate is determined from pesticide labels. EPA then compares the toxicity values with the default EEC to determine whether the pesticide exceeds EPA's endangered species LOCs. If no LOCs are exceeded, the pesticide has `` no effect'' on listed species and the analysis ends. However, if an LOC is exceeded, EPA may proceed to the next screening step to refine its assessment. In this next step, the Agency refines its ecological risk assessment by running the GENEEC ( generic EEC) model with a variety of inputs on application methods and rates, and chemical fate and transport data to calculate the EEC. Running this model provides a more refined EEC for comparison with the toxicity data. Again, if an endangered species' LOC is exceeded at this step, EPA may proceed to the next step to further refine its assessment. If the model described below is not available for the particular use scenario being evaluated, EPA would typically move to a speciesspecific assessment as described in Unit II. D. 1. e. below. In the next step, the Agency uses a much more sophisticated model the Pesticide Root Zone Model­ Exposure Analysis Modeling System ( PRZM/ EXAMS) to calculate more refined EECs. This model includes more chemical fate and transport data, and it involves selecting a use site ( e. g., wheat or apples) scenario and modifying the scenario to reflect the nature of the pesticide use. These scenarios are based upon actual field data on crop location, extent to which the crop is grown, soil characteristics, climate, etc. Use site scenarios exist only for major and a few minor crops, and would need to be developed to run this model for other crops. If an endangered species LOC is exceeded at this step, a species­ specific assessment is conducted. e. Species­ specific assessment. To conduct a species­ specific assessment, EPA takes the basic quantitative information from its screening level assessment developed for all non­ target organisms and puts that information in context for individual listed species and their locations. Important ecological parameters such as stream flow rates and soil types, pesticide use information, the geographic relationship between specific pesticide uses and species locations, and biological requirements and behavioral aspects of the particular species are typically considered. Where reliable, published data are not available, information for such parameters is typically obtained through contacts with knowledgeable experts, including extension agents, crop advisors, resource specialists, and watershed experts. These steps enable the Agency to refine its generic assessment into one specific to individual listed species and their designated critical habitat. If LOCs are exceeded after this analysis, the Agency may work with the registrant to determine whether sufficient protection measures can be incorporated into the registration or reregistration to achieve a no­ effect determination. Only if those efforts are unsuccessful will EPA declare a `` may affect determination.'' f. Use of field monitoring in assessing risks. Field monitoring data can supplement modeling and provide a more direct means to assess whether species may be exposed to the pesticide at a level sufficient to cause an effect, if the monitoring program was designed or is appropriate for this purpose. For example, using monitoring data where water samples are obtained one time per quarter year does not necessarily provide information from which exposure levels can be determined, although data can alert EPA to locations where pesticide exposure may be occurring to trigger further assessment or analysis. However, even in cases where appropriately designed monitoring was conducted, EPA would still typically conduct exposure modeling when field monitoring data do not exist for all species locations, and EPA would still typically conduct a species­ specific assessment, as described in Unit II. D. 1. e. above, to determine whether a particular species may be exposed to the monitored levels of the pesticide. In summary, EPA typically evaluates the potential of a pesticide to affect listed species by conducting increasingly refined screening level assessments, and, if necessary, a final species­ specific assessment. 2. Consultation procedures. Service regulations provide for two types of consultations once a `` may affect determination'' has been made. a. Informal consultation. Informal consultation is an option available to an action agency ( in this case EPA) to assist the action agency in determining whether formal consultation is required. During this process, the Services can suggest modifications to an EPA action to avoid the likelihood of adverse effects to a listed species or its designated critical habitat. The informal consultation process is completed with a written concurrence by the Services with EPA's determination that its action is `` not likely to adversely affect'' listed species or designated critical habitat. If the Services do not concur with EPA's finding of `` not likely to adversely affect,'' then formal consultation must be initiated. b. Formal consultation. Formal consultation is required if the Agency determines that a pesticide may affect or is likely to adversely affect a listed species or critical habitat. In this case, EPA makes a written request for formal consultation with the Services on a particular Agency action ( i. e., a pesticide registered for a specific use). Basically, a consultation package consists of EPA's assessment of the potential for a listed species or designated critical habitat to be adversely affected by the registration of a particular pesticide. More specifically, the package includes a description of the action under consideration, areas that may be affected, listed species or critical habitats at issue, a description of the manner in which the action may affect any listed species or critical habitat, and an analysis of cumulative effects and any relevant reports. The consultation package must use the best scientific and commercial data available. In response, the Services develop and provide to EPA a Biological Opinion, which provides the Services' opinion on whether the use of the pesticide in question is `` likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat'' ( 50 CFR 402.14( g)). If a Biological Opinion concludes that an action is likely to jeopardize a listed species or adversely modify its designated critical habitat, then the Biological Opinion will include `` reasonable and prudent alternatives,'' if any, that EPA may undertake to avoid the likelihood of jeopardy to the species or destruction or adverse modification of critical habitat. Reasonable and prudent alternatives ( 50 CFR 402.02) are actions that: ( 1) The consulting agency is capable of implementing under its authority and jurisdiction. ( 2) Allow the agency action to be implemented in a manner consistent with its intended purpose. ( 3) Are economically and technologically feasible. ( 4) Are not likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat. Biological Opinions will frequently include information for use in implementing protections. For those few species that the Services determine are VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71555 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices subject to collection threats, the Services generally will encourage development of alternative protections, such as landowner agreements ( see Unit II. E. 3. b. for more information on landowner agreements). Biological Opinions may also include an `` incidental take statement.'' For listed species, to `` take'' means `` to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct'' ( ESA section 3). Incidental take refers to takings that result from, but are not the purpose of, carrying out an otherwise lawful activity ( 50 CFR 402.02). Incidental take statements specify, among other things, the amount or extent of any anticipated incidental taking ( e. g., the number of individuals) and the `` reasonable and prudent measures'' needed to minimize the impact of such a taking. The Biological Opinion may contain reasonable and prudent measures to reduce the impact of incidental take, even if no jeopardy to the listed species is found. If the amount or extent of taking specified in the incidental take statement is exceeded, EPA must reinitiate formal consultation ( 50 CFR 402.16( a)). The incidental take statement also conveys to the action agency, any applicant to the agency, and any users of the product an exemption from the take prohibitions of the ESA, provided that the action is implemented in a manner consistent with the reasonable and prudent measures included with the incidental take statement ( ESA section 7( o)( 2)). Reinitiation of consultation must occur if new information reveals effects of the action that may affect listed species or critical habitat in a manner or extent not previously considered; if the identified action is subsequently modified in a manner that causes an effect to the listed species or critical habitat that was not considered in the Biological Opinion; or if a new species is listed or critical habitat designated that may be affected by the identified action ( 50 CFR 402.16). E. Initial Efforts at Program Implementation EPA's past efforts to carry out its responsibilities under FIFRA and ESA fall into three areas: Assessment and consultation; implementation of protections; and an interim Program that relies on education, cooperation and public outreach. 1. Assessment and consultation. EPA has been consulting with FWS on endangered species issues since 1977, and has used a variety of approaches to these consultations. The various approaches yielded variable results in terms of efficiency, effectiveness at addressing potential risk to a given species, and equity among pesticide registrants and equity among pesticide users. a. `` Case­ by­ case'' consultations. In more than 80 instances, the Agency has assessed the potential effects of a pesticide on all listed species, across all proposed uses of a single pesticide. The benefit to this approach to consultation ( one pesticide, all proposed uses) is that it is comprehensive as to the agency action and manageable since it involves a single pesticide. The major drawbacks to this approach resulted from use limitations being proposed for a specific pesticide while competing pesticides that may also pose risks to species had not yet been reviewed. b. `` Cluster'' consultations. In order to mitigate the potential inequity to competing registrants from the case­ bycase approach, the Agency engaged the FWS in several `` cluster'' consultations. These consultations were based on an assessment of all pesticides registered for use on certain crops. For example, in the `` cotton cluster'' EPA assessed and consulted as appropriate on any pesticide registered for use on cotton. By approaching assessment and consultation in this manner, the Agency alleviated the potential inequity of caseby case consultations since competitive products for the same use were assessed at the same time. However, this approach carried with it certain other problems. The consultations resulting from this approach were much larger and more complex. At the request of the FWS, EPA reinitiated consultation on portions of these `` clusters'' to address newly listed species and obtain `` incidental take'' statements. The resulting reinitiation encompassed certain uses of 112 pesticides that had the potential to affect one or more of 165 different listed species. For both the original consultations and the reinitiation, the statutory time frame provided for the Services to complete a Biological Opinion proved difficult to meet. This approach, while eliminating the inequity among pesticide registrants, created a potential inequity among pesticide users. In these cluster consultations, a pesticide was assessed for one crop, but not for other crops for which it was registered. If the assessed crop was grown adjacent to the unassessed crop, growers of the one crop could face use limitations while growers of the other did not. c. `` Species­ based'' consultations. A third approach to assessment and consultation was intended to ensure that a species was completely addressed at once. This `` species­ based'' approach was used to request formal consultation for 31 pesticides. Under this approach, the Agency and the Services identified the species most vulnerable to effects from exposure to pesticides; identified all the pesticides to which that species might be exposed; and identified all other species that might be exposed to those uses of these pesticides. The Agency's consultation would encompass any combination of these factors that produced a `` may affect determination.'' Because of the diversity of uses of these pesticides and the large number of species potentially affected, it was necessary to divide the consultation into two parts. FWS has completed part I. EPA asked FWS to suspend work on part II while EPA and the Services undertake the ESA Section 7( a)( 1) Proactive Conservation Review to facilitate the overall consultation process ( see Unit II. F. 2. for more information on the Proactive Conservation Review). The benefits of this approach appear to be that a particular species would be protected from all pesticide exposures with a potential to harm the species, at one time. However, because of the complexity of these assessments, the time necessary to identify protections is protracted significantly. 2. Implementation of protections. In the past, EPA has proposed several approaches for implementing an endangered species protection program ( 53 FR 7716, March 9, 1988; 54 FR 27984, July 3, 1989). Under these previous proposals, product labels would have been amended, where necessary, to instruct users to follow specific use limitations. These limitations would have been described in County Bulletins developed by EPA to protect listed species in their area. Bulletins would contain general information about the ESPP, a map of the county depicting areas in which limitations applied, and a table indicating the particular use limitations for specific pesticides in specific areas of the county. States and Tribes would have had the option to initiate and propose to EPA alternative plans for protecting listed species in their area. If EPA deemed these plans to be feasible, and the Services deemed them protective of the species, EPA would adopt the provisions of the plan as the Federal requirements for that State or Tribe. Other elements of implementation would have included public participation, to include the opportunity for comment on the maps and County Bulletins and State­ initiated plans ( Unit III. F.). VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71556 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices Moving forward with a final program implementation scheme did not seem feasible at those earlier points in the history of the program's development. There remained significant issues with potential resulting inequities and resource implications created by the variety of priority setting schemes for assessment and consultation. There also was concern that County Bulletins, enforceable under FIFRA misuse provisions, did not provide sufficient flexibility for pesticide applicators to exercise judgement based on local conditions, to protect listed species in ways that posed the least burden. Consequently, EPA decided, for the interim, to maintain its case­ by­ case approach to assessment and consultation and to conduct a voluntary ESPP to protect listed species and their habitats. As part of this interim program, EPA has undertaken a number of activities designed to address efficiency, effectiveness and equity issues and to develop an improved ESPP implementation plan. 3. Interim program. The interim ESPP relies on education, cooperation and public outreach to achieve its goals. The interim ESPP involves the voluntary participation of States and pesticide users, typically through the use of Interim Pamphlets as described below. Some States also have participated in the program by developing and piloting State­ initiated plans to protect listed species within that State. Key components of the interim ESPP include: a. Distributing Interim Pamphlets. These Pamphlets, which are precursors to the County Bulletins, were developed for voluntary use during the Interim ESPP to encourage the protection of listed species. Based largely on Biological Opinions, the Pamphlets include the name of the species of concern, a table of the pesticides that may harm that species, a description of the use limitations necessary to protect the species, and a county­ level map showing the geographic areas associated with these use limitations. The type of map and level of detail depends in part on the sensitivity of the listed species to other factors, such as collection. ( See Unit III. B. for distribution procedures and more information on County Bulletins.) b. Developing State­ and Tribespecific approaches. Several States have developed alternative approaches to protecting certain listed species during the Interim Program. For example, Minnesota and Wisconsin have succeeded in protecting listed plants by developing landowner agreements with private individuals. These agreements identify protective measures specific to the geographic area involved in the agreement and are made with FWS and the appropriate State agencies. California has put a program in place whereby use of particular pesticides requires a State permit, the provisions of which take into account the proximity of use to a listed species. Still others have proceeded under the general direction of the Agency's Interim Program but have developed alternatives to county mapping that better communicate protection measures to their citizens. F. Development of this Implementation Proposal In developing this implementation proposal, EPA considered information and comments from a number of sources. Those sources included public comments submitted in response to past proposals and other information described below. 1. EPA initiatives. EPA has been working on the technical aspects of the ESPP. These efforts include collecting additional data on species biology and habitat locations, agricultural crop and other pesticide use locations, and pesticide toxicity and exposure. In certain cases, additional research was conducted that specifically provided data needed to address risks to listed species. Examples include studies on herbicide effects on cacti, and effects of insecticide use on terrestrial snails. As required by Public Law 100 478, October 7, 1988, EPA completed and submitted a report to Congress titled `` Report to Congress on the Endangered Species Protection Program as it Relates to Pesticide Regulatory Activities.'' The report describes the joint efforts by EPA, USDA, and FWS to determine the effects of pesticide use on listed species. It also summarizes EPA's efforts to communicate use limitations to pesticide users, to determine alternatives to outright prohibitions, to develop and distribute accurate maps of use limitation areas related to listed species, and to improve communications among EPA, USDA, and FWS. 2. Proactive Conservation Review. In a joint effort with the Services, the Agency has undertaken a Proactive Conservation Review, authorized under ESA section 7( a)( 1). EPA and the Services are analyzing the processes EPA uses to determine whether a pesticide may affect a listed species and to assess generic mitigation measures. The Services and EPA have agreed to explore issues relative to five specific areas: ( 1) EPA's test methodologies, ( 2) environmental exposure assessment processes, ( 3) risk assessments, ( 4) conservation measures, and ( 5) followup to EPA action to ensure continuing protection and conservation of listed species. One product of the Proactive Conservation Review will be a handbook setting forth the processes and procedures that will be followed by EPA, NOAA Fisheries and FWS relative to species conservation, pesticide consultations, and protection measures for listed species deemed to be potentially affected by pesticide exposure. 3. EPA Regional programs. EPA Regional offices continue to act as liaisons with State lead agencies ( SLAs) for pesticide regulatory activities, Tribes and U. S. territories; train State representatives in the ESPP; distribute program materials; contribute to the development of educational and outreach materials; and work closely with States in developing State­ initiated plans. 4. State efforts. To ensure that the county maps delineating the pesticide use limitation areas are precise and reflect the result of assessments that were based on currently occupied habitat, EPA has continued to work with the States, FWS, and USDA in developing, reviewing and revising the maps. Opportunity also has been provided for their comment on the specific pesticide use limitations for individual species. State involvement varies, but review usually includes participation by the SLA responsible for pesticide programs at the State level ( usually the State Department of Agriculture), State heritage and conservation agencies, the pesticide coordinator for pesticide applicator certification and training, and others. EPA has encouraged the States to include a balanced role for representatives of non­ government environmental groups and the pesticide user community as well. States continue to play an active role in other aspects of the ESPP. Their efforts include developing Stateinitiated plans, incorporating endangered species modules into pesticide applicator certification and training programs, refining species location information, and providing input on the future directions of the ESPP and ways to achieve program goals more effectively. 5. National partners' workshops. As EPA began to revitalize the ESPP, three national workshops were held ( in 1997, 1999 and 2001). The purpose of these workshops was to seek input on future directions of the ESPP and on ways to achieve goals more effectively. These workshops resulted in the formulation VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71557 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices of the framework for this final program proposal. At the heart of each of these workshops was the discussion of a range of practical, nuts­ and­ bolts solutions for furthering endangered species protection consistent with the ESA. A few dominant themes were apparent throughout: To better protect threatened and endangered species, everyone involved needs to communicate better; to share information, data and resources; and to identify and focus on priorities to make better use of limited resources. While the use of technology to foster endangered species protection is crucial, consideration must also be given to non­ technological alternatives and innovative practices ( see Unit III. E. 3. b. for some examples). III. The Endangered Species Protection Program ­ Field Implementation Proposal EPA's implementation proposal is based on two goals. The first is to provide appropriate protection to listed species and their habitats from potential harm due to pesticide use. The second is to avoid placing unnecessary burden on pesticide users and agriculture. The following sections describe the elements of EPA's proposed approach to implementing endangered species protections under existing ESA regulations. These elements include: Scope, approach to reviewing pesticides, completing and upgrading County Bulletins, amending pesticide labels to reference County Bulletins, enhancing monitoring programs, compliance and enforcement, and public participation. Finally, this section describes the role of States and Tribes in the Program, implementation timing, and program maintenance. A. Scope of the ESPP All pesticide products for which EPA makes a `` may affect'' determination may be subject to the ESPP. 1. Indoor products determination. EPA has determined that pesticide products bearing label directions only for use indoors, and where the applied pesticide remains indoors, will not result in exposure to listed species. Therefore, these products will have `` no effect'' on listed species and generally would not be subject to the ESPP. Indoor use includes application within transport vehicles and within any structure with enclosed walls and a roof, such as buildings, greenhouses, outbuildings, etc. This `` no effect'' determination would not apply to a pesticide that is applied indoors, but could expose outdoor environments ( such as pesticides applied in cooling towers or used as cattle dips). Whether these products result in a `` may affect'' determination will be assessed on a case­ by­ case basis. If a `` may affect'' determination is made for these products, they would be subject to the ESPP. 2. Public health emergencies. Under section 18 of FIFRA ( 40 CFR part 166), a State or Federal public health agency may request that EPA grant an emergency exemption from pesticide registration requirements for a public health emergency if the State or Federal agency can demonstrate that: a. An emergency, non­ routine condition exists that requires the use of a pesticide. b. Effective registered pesticides or alternative practices are not available or economically or environmentally feasible. c. The situation will present significant risks to human health. Public health emergencies, verified by State or Federal public health authorities, include situations in which: ( 1) A pest outbreak poses a significant risk to human health or in which the elements for disease outbreak ( i. e., virus activity, large population of disease vectors either present or pending, or others) are demonstrated to be in place and prompt action is required to avert an actual disease outbreak, and ( 2) An actual disease outbreak is in progress and immediate action is essential to arrest the outbreak. In the latter case, a crisis exemption under section 18 may be appropriate, which allows a Federal or State agency to authorize the emergency use of a pesticide if its use is critical and enough time is not available for EPA to receive and complete a review of the specific request for a public health exemption. Consultations on emergency actions are conducted in accordance with Service regulations found at 50 CFR 402.05. Generally, in accordance with the ESA, EPA does not authorize use of a pesticide under section 18 if that pesticide will jeopardize a listed species or adversely modify critical habitat. However, if no practical alternative control measures are available, during a public health emergency, a public health exemption under section 18 may be sought for the use of a pesticide that was found to jeopardize listed species or adversely modify its critical habitat. Specific Input Requested ­ Public Health Emergencies Is the above section 18 approach the appropriate mechanism to address potential intersections of public health and listed species protections? Should actions relative to public health emergencies require consultation with the Services, and if so, should it be an emergency consultation? What specific alternatives might be appropriate? How do these alternatives allow the appropriate weighing and balancing of public health and listed species protection? 3. Review of pesticides. To the degree possible, endangered species issues will be addressed within the Agency's existing review processes of registration and reregistration so that when a registration or reregistration decision is made, it fully addresses issues relative to listed species protection. Concurrently, the Agency will begin a process to review those pesticides that have been through reregistration review and were found potentially to affect listed species or their critical habitat, or where the potential for effects on listed species or their critical habitat was not considered. This does not limit EPA's ability to make changes in its technical approach nor in its data requirements. EPA and the Services are seeking input relative to the technical and consultation aspects of the program through an ANPR. EPA attempted several different approaches to prioritizing reviews in the past ( see Unit II. E. a. through II. E. c.), each resulting in a different set of issues and each more or less effective in differing ways. EPA's proposed approach of addressing potential effect to listed species on a chemical­ bychemical basis, is not without issues. With any approach, EPA believes the best way to address the issues is to develop a technical and consultation process that allows the Federal Government to make appropriate decisions in a timely manner. By focusing our internal processes to address listed species concerns during registration and reregistration where possible, and by identifying and implementing improvements in the technical aspects of review and in the consultation processes, EPA believes many of the issues resulting from a chemical­ by­ chemical approach to review will be resolved. 4. Effect determinations and consultations. EPA's technical review policies ( Unit II. D.) and the Services' technical information and analysis requirements under the ESA section 7 consultation regulations currently form the analytical and procedural bases of EPA's Interim Endangered Species Protection Program. As noted in Unit II. F. 2., EPA is engaged in a Proactive Conservation Review with the Services under ESA section 7( a)( 1) to analyze, among other things, the processes EPA uses to determine whether a pesticide may affect a listed species. Further, EPA VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71558 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices and the Services will be taking comment through an ANPR on options for counterpart regulations that could amend the existing ESA and FIFRA regulatory regimes in a manner that improves consultations on pesticide actions. Until these efforts are finalized, EPA's current procedures and the Services' existing regulations at 50 CFR part 402 will continue to form the analytical and procedural bases of the ESPP. B. Completing and Upgrading County Bulletins The Interim Pamphlets ( Unit II. E. 3.) have been the centerpiece of the ESPP. As a top priority, EPA will update existing Pamphlets to reflect all current Biological Opinions, including the identified species of concern, a table of pesticides that may harm those species, and current use limitations to protect listed species. EPA will then convert these Pamphlets to County Bulletins. The Agency will continue to provide access to the Bulletins through its home page on the Internet ( www. epa. gov/ espp) and improve the distribution network. The Bulletins will be developed by EPA in cooperation with the Services, USDA, States and Tribes. EPA will generally determine appropriate use limitations and recommendations in the Bulletins by reviewing results of ESA section 7 consultations and any other relevant information that addresses the needs of the listed species. The Bulletins will only be maintained and issued for counties for which protection measures have been deemed necessary. Bulletins will: 1. Identify the species of concern. 2. Name the pesticides that may harm the listed species. 3. Provide a description of the protection measures necessary to protect the species. Where species or habitat descriptions are helpful or necessary to identify use limitations, EPA will also include this information. 4. Contain a county map showing the geographic area associated with the protection measures, depending on the sensitivity of the species to other factors such as collection. Typically, maps will show a shaded area indicating the area where pesticide use should be modified to protect that species. Within shaded areas on the maps, the specific protection measures will be identified for the pesticide and the species being protected. To ensure precision, EPA has been working with other Federal agencies and the States in revising the maps and the tables of pesticide use. EPA will develop draft maps and tables of pesticide use limitations and send them to the States, Services, and USDA for review as EPA updates the information for the County Bulletins, or as completion of consultations results in EPA's decision to include additional pesticides or species, or delete currently included pesticides or species. Based on comments from Federal agencies, States and Tribes during the review process, EPA will work with the commenters to resolve any problems and to make any necessary revisions to the Bulletins. EPA also is working on making the maps easier to use. For example, EPA has been exploring various mapping formats in attempting to convey information to pesticide users most effectively. In some cases, townshiprange section designation may be the best way to delineate the habitat of a species, while in other situations, local landmarks such as roads or streams may work more effectively. The Bulletins also will contain a printing date to indicate the date the Bulletin was issued. As new information becomes available and a Bulletin is revised, EPA will issue a new, revised Bulletin with a new printing date. This Bulletin will supersede the Bulletin previously issued, as identified by the new printing date. EPA will review the County Bulletins as necessary, but generally will not update them more than once annually. Specific Input Requested ­ County Bulletins County Bulletins will be the main basis for conveying information to pesticide users. The Agency is particularly interested in comment on various aspects of these documents as detailed below. ( To facilitate comment, an Interim Pamphlet may be printed from the Web site at www. epa. gov/ espp/ usa­ map. htm.) Are there ways to make the instructions for use easier to understand? Is the mapped information depicted in a way that is understandable? For example, is the use of township­ range­ section designations appropriate? Is the use of natural and man­ made landmarks appropriate? Is it clear what pesticides are subject to what use modifications to protect listed species? Are there ways to make the protection measures easier to understand? Are the narrative descriptions of habitat or of species as a map supplement helpful? How can the Agency make protection areas as specific as possible without infringing on the privacy of individual landowners, who may be the sole custodians of a species on their property, while still protecting the species and not subjecting the species to potential harm by revealing its specific location? How can EPA ensure that growers know they have the most recent Bulletins? Is annual updating of the Bulletins the right frequency? If not, how often should EPA update them? How can EPA work with States to improve the development of Bulletins? C. Bulletin Distribution Procedures EPA has been developing its distribution plan for Bulletins and other ESPP information. A key factor in developing this plan is to make sources of Bulletins and other information convenient to pesticide users. In addition, different mechanisms may be appropriate for different States and Tribes. As a result, distribution mechanisms could include several or all of the following methods, depending on the State or Tribe: 1. Mechanisms identified by SLAs. 2. Direct mailing to pesticide applicators within an affected county. 3. Pesticide dealers and distributors. Ideally, Bulletins will be available when and where pesticide applicators buy or obtain their pesticides. 4. Cooperative Extension Service, Natural Resources Conservation Service, Agricultural Stabilization and Conservation offices, and USDA county offices in the vicinity of affected counties. 5. The Services' regional and field offices, where appropriate. 6. EPA Headquarters, Regional offices, EPA's toll­ free number and Web site. EPA plans to evaluate these mechanisms continually and to modify any part of the distribution process as the need arises and as more is learned about the effectiveness of the various mechanisms. Specific Input Requested ­ Bulletin Distribution Are the mechanisms identified for Bulletin distribution appropriate? What other mechanisms would be of value? D. Amending Pesticide Labels to Reference County Bulletins EPA proposes to request label amendments of pesticide products for which protection measures have been identified. This amendment would generally include a statement directing the user to follow the information in the County Bulletin. The label also would include a statement regarding the VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71559 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices potential for effects to listed species. Finally, the label would include information on how the user can obtain the County Bulletin. The County Bulletins, in turn, would contain specific information on species and areas where protection measures were necessary. Such a system would help ensure that pesticide users are aware, before applying pesticides, of both the potential harm to listed species and how they can obtain information necessary to protect listed species. The Agency has several approaches to requesting label amendments for currently registered pesticides. In Reregistration Eligibility Decisions ( REDs), the Agency can make clear its regulatory position on listed species protection and indicate the labeling that would be necessary for products to be considered eligible for reregistration. The Agency also could issue a Pesticide Registration ( PR) Notice requesting amendments of pesticide labels for which limitations have been identified to protect listed species or critical habitat. The Agency also could determine that in the absence of the amended label language, the pesticide would no longer meet the risk/ benefit standard of FIFRA and would, therefore, be subject to cancellation. The Agency intends to use the first approach when completion of a listed species and critical habitat assessment and the identification of use limitations coincides with completion of a RED. However, this approach will not work in those instances where these two activities are not coincidental ( i. e., the RED is completed ahead of the listed species determinations or vice versa). To facilitate label changes in these situations, the Agency would first review the existing Interim Pamphlets to determine that the information is current. The Agency then intends to prepare a PR Notice that will generally request registrants of products in those Pamphlets to make label changes relative to listed species. Specific suggested label language would be articulated in the PR Notice. After passage of the time frames that would be articulated in that Notice, products for which revised label statements are requested, and which do not bear that statement, may be considered misbranded under FIFRA section 12( a)( 1)( E) and may be subject to a Notice of Intent to Cancel. If necessary, subsequent PR Notices would generally be issued annually to request label changes for additional products. These Notices will also indicate any products that have been removed from the Program. Because the label statements would not be county­ specific or use­ site specific, registrants would not need to change their product label once the appropriate changes have been made, if protection measures are extended to new locations or new species need protection. Label changes would be necessary only if the protective measures specified in the Bulletin are rescinded for all uses of the product. As noted in Unit III. H., the Agency intends to take public input on several phases of listed species assessment before implementing new measures. The Agency proposes the following generic label statement be adopted for instructing pesticide users about listed species protection: This product may have effects on federally listed threatened and endangered species or critical habitat in some counties. When using this product, you must follow the measures contained in the County Bulletin for the county in which you are applying the pesticide. To determine whether your County has a Bulletin consult http:// www. epa. gov/ espp/ usa­ map. htm. Bulletins also may be available from local pesticide dealers, extension offices, or State pesticide agencies. Specific Input Requested ­ Labels The Agency specifically requests comment on how best to accomplish label changes to protect listed species, where EPA, FWS or NOAA Fisheries has identified use limitations to ensure protection. The Agency also seeks suggestions for specific label language to relay the information articulated in this section. E. Enforcement For pesticide products determined to affect listed species or critical habitat, the Agency is proposing that the product labels carry a statement directing users to follow the appropriate County Bulletin in effect at the time of product application. Another option is that all Bulletins published by an annual date certain will be in effect for 12 months. In either case, pesticide users who fail to follow provisions applicable to their pesticide application, whether that failure results in harm to a listed species or not, would be subject to enforcement under the misuse provisions of FIFRA ( section 12( a)( 2)( G)). Specific Input Requested ­ Enforcement In connection with these approaches, EPA seeks public comment on whether: Either or both of these approaches provide effective means to implement species protection. There are alternative means to ensure appropriate protection of species that may be adversely affected from the use of a pesticide. F. Enhancing Monitoring Programs Evaluating the extent to which the ESPP is protecting and contributing to the conservation of listed species can be accomplished in several ways. Potential options include monitoring to determine the degree to which pesticide users in affected areas are or are not applying pesticides in accordance with the County Bulletins, best management practices associated with landowner agreements, and State­ specific approaches. To determine the feasibility of this type of monitoring, EPA proposes several pilot studies. At least two States would conduct a pilot study with the Agency regarding adherence to information in the Bulletins. States selected for this pilot would be from among those that are currently working on more efficient ways to distribute County Bulletins. EPA also proposes that another State, from among those currently employing landowner agreements in their endangered species protection efforts, pilot a review of the effectiveness of landowner agreements. Finally, the Agency proposes that two additional States assist in piloting a review of the effectiveness of Statespecific approaches ( Unit II. E. 3. b.). Again, the States selected for this pilot would be from among those that have implemented protection programs that vary from EPA's proposal in some significant respect. Also, it is important that data being collected through acceptable sources be used to the fullest extent possible to maximize efficiencies and minimize costs. EPA proposes to use more effectively the information being obtained by the U. S. Geological Survey to detect pesticides in surface and ground water, information provided to EPA's Office of Water under the Clean Water Act, and State­ level ground or surface water monitoring resulting from State pesticide program efforts. EPA will also use the technical data identified during section 7 consultations with the Services. EPA proposes to analyze this information to determine if residues of pesticides are occurring at levels of concern in aquatic environments. Further, EPA proposes to augment these data with targeted terrestrial residue monitoring, possibly to include postregistration monitoring by registrants or others. Locations would be determined with input from the Services and the appropriate State or Tribe, based on proximity of pesticide use sites with species locations. If such pilots result in broader monitoring, this would be conducted as part of the States' or Tribes' ongoing enforcement efforts. VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71560 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices Finally, EPA would continue and improve upon its cooperation with the Services, States, Tribes, and others to review reported incidents in which pesticides have had an impact on listed species and critical habitat. EPA has been working with FWS field offices throughout the country, as well as other Federal and State agencies, to ensure that EPA has the best possible information on incidents. EPA's Environmental Fate and Effects Division maintains an Ecological Incidents Information System. EPA also gathers incident information from registrant reports submitted under FIFRA section 6( a)( 2), or those in which pesticide registrants report to the Agency on observed adverse effects. Specific Input Requested ­ Enhanced Monitoring In particular, the Agency is interested in obtaining public input on the following issues: The appropriate role of pesticide registrants and manufacturers in performing environmental monitoring. The role incident data could play in protecting listed species and critical habitat. Whether there are other ongoing monitoring programs EPA should consider reviewing routinely for information. The role the Services should play in monitoring programs. Other methods of monitoring that might be appropriate for the agencies to implement. How to improve the quality of information on the effects of pesticides on listed species and critical habitat. G. Role of the States and Tribes Because local and State and Tribal circumstances may influence the effectiveness of different approaches to listed species protection, States and Tribes will continue to be integral to the success of the ESPP. Specific roles include review of county maps; review of use limitations to protect species; determining the effectiveness of the program; and, at their discretion, development of alternative approaches for protecting listed species. 1. Review of county maps. States and Tribes will be requested to provide input to the Agency on county maps to accomplish several things. First, accuracy of the maps is key to success of relaying information to pesticide users. Therefore, States and Tribes will be requested to provide feedback on draft maps relative to whether they accurately depict landmarks, rivers, roads, etc. Further, State and Tribal input on how best to characterize use limitation areas on the County maps will be sought. For example, some States believe that their pesticide users would be best served by designating limitation areas based on townshiprange section mapping, while other States believe their pesticide users would prefer designations based on natural and man­ made landmarks such as rivers, roads and railways. 2. Review of use limitations to protect species. States and Tribes also will be requested to provide input to the Agency on any potential use limitations for species protection. The purpose of this review would be for the Agency to ascertain, based on local conditions, whether specific use limitations could be implemented. States and Tribes will also be sources of input on the technological and economic feasibility of implementing any proposed use limitations. 3. Help determine the effectiveness of the program. Because States and Tribes are in closer contact with pesticide users than is the Agency, they will be requested to assist the Agency in determining whether the ESPP as implemented is effective in protecting listed species. They also will be requested to assist in determining whether the limitations outlined in County Bulletins are being followed or modified based on local conditions, and whether any generic changes in the County Bulletins would improve the success of this program. 4. Develop alternative approaches to protect listed species. States and Tribes may develop and propose alternative plans for protecting listed species in their areas. Such a plan would recommend measures and approaches that EPA could use to protect listed species in that area. If these plans are submitted to EPA for review and approval, EPA will coordinate with the Services and consult, as appropriate, to determine that the provisions of the plan will provide adequate protections for listed species within that State or Tribal land. If EPA approves the plan following any necessary consultation with the Services, EPA would then adopt it and could require, through Bulletins, that users comply with the requirements of the plan. Alternative plans can be developed for all or a portion of the species affected in that State or Tribal land. An alternative plan may be submitted to EPA at any time. However, once the federally initiated actions are implemented within an area, those requirements will be effective in that area until the alternative plan is approved for implementation. H. Public Participation EPA has encouraged the involvement of Federal agencies, States, Tribes and members of the public throughout the development of the ESPP and will continue to provide opportunities for public participation once the program is final. EPA intends the final ESPP to be as flexible as possible and to modify it as necessary to achieve the goals of protecting listed species and minimizing the impact on pesticide users. Eventually, the ongoing program will meld its components of public participation with existing practices in the registration and reregistration processes. EPA will always welcome comments from the public on the various aspects of the program. EPA intends periodically to reevaluate the Program, review public comments, and modify the ESPP to continually improve protection of listed species while serving the public interest. Additionally, there are several major phases of a listed species assessment that have opportunity for public input: ( 1) Prior to a `` may affect determination'' by EPA, ( 2) subsequent to such determination but during development of information with which to consult with the Services, and ( 3) prior to issuance of a Biological Opinion to EPA by the Services. EPA proposes to engage the public in each of these phases as noted below. When any of these phases corresponds with a public participation phase under EPA's ongoing review processes ( i. e, reregistration review), that ongoing public process will be used. 1. Prior to a `` may affect determination.'' The Agency proposes to notify affected pesticide registrants and provide them an opportunity to update information or provide additional information relative to the determination. Subsequently, the Agency will make public in draft, any determination that a pesticide `` may affect'' a listed species. The public will have a 30 day opportunity to provide input to that determination. 2. Subsequent to a `` may affect determination.'' The Agency will accept information provided for use during consultation with the Services. Information provided subsequent to a `` may affect determination'' being made will not be considered by the Agency alone but will be shared with the Services for joint consideration during consultation. 3. Public comment on draft Biological Opinion. The Agency intends to request that the Services provide draft Biological Opinions to the Agency upon VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1 71561 Federal Register / Vol. 67, No. 231 / Monday, December 2, 2002 / Notices their development. The Agency will provide opportunity for public input to any reasonable and prudent measures or alternatives recommended by the Services in these draft Biological Opinions. The purpose of this review would be to determine whether the alternatives or measures can be reasonably implemented and whether there are alternative measures that may provide similar protection but result in less impact. The Agency will consider this input in developing its response to the draft Biological Opinions. Specific Input Requested ­ Public Participation The Agency seeks specific suggestions on how the public could most effectively be informed of the Agency's determinations and consultations. The Agency also seeks other suggestions for enhancing public involvement in the ESPP. I. Implementation Timing Once public comment on this Notice has been considered and a final Notice issued, the Agency intends to begin field implementation of the ESPP. At the same time, EPA recognizes that technical and consultation process issues may change based on input in response to the ANPR the Agency will issue with DOI and DOC on or about the same date as this Notice, or changes to FIFRA implementation regulations. However, the Agency believes the responsible approach is to implement in a timely manner, those aspects of listed species protection that the Agency can, while building modifications and efficiencies into the longer term effort of a sustained approach to protecting listed species. Within 6 months of reviewing existing Interim Pamphlets for accuracy, the Agency intends to modify them as appropriate and issue them as County Bulletins. While the Bulletins will be widely available, they will be effective upon reference to them on pesticide labels. The Agency also will develop for public comment a PR Notice that will identify time frames in which the Agency anticipates that registrants could modify labels for these products. Upon issuance of a final Notice of Program Field Implementation, the Agency will begin the process of reviewing, for endangered species implications, those pesticides for which REDs have already been issued but for which specific endangered species assessments were not completed during the RED process. As pesticides are reviewed and determinations made for listed species, the Agency will begin creating Bulletins or preparing to include these pesticides in existing Bulletins, as appropriate. EPA will review the County Bulletins as necessary, but generally update them not more than once annually. Specific Input Requested ­ Implementation Timing How can EPA time the release of County Bulletins to minimize the potential disruption to pesticide users during a growing season? J. Program Maintenance To the degree possible, endangered species issues are and will be addressed within the Agency's existing processes of registration and reregistration. Concurrently, the Agency will review those pesticides that have been through reregistration and were found potentially to affect listed species, or did not undergo ESA review during reregistration. Once all registered pesticides have been re­ evaluated, EPA's future obligations to consult under ESA will be fulfilled through an ongoing process of evaluation and referral. If new, valid information becomes available on existing pesticide registrations, or if new species affected by specific pesticides are listed under the ESA, EPA will re­ evaluate its determinations and reinitiate consultation when appropriate. EPA anticipates that reinitiation on the basis of new information will occur on an annual or biannual basis, as necessary. EPA will periodically reinitiate consultation, as appropriate, on pesticides already included in the Program to obtain Biological Opinions for newly listed species. It is not the Agency's intent, however, to change product labels and County Bulletins constantly; rather, EPA intends to maintain the ability to act on listed species and critical habitat issues if a new body of data becomes available. IV. References All references are available for public review in the public docket. The references used in this document are: 1. U. S. Environmental Protection Agency. 2002. Process for Assessing Potential Risks to Endangered and Threatened Species and Consultation with the National Marine Fisheries Service and the U. S. Fish and Wildlife Service. 2. U. S. Environmental Protection Agency. 1986. Hazard Evaluation Division Standard Evaluation Procedure, Ecological Risk Assessment. 3. U. S. Environmental Protection Agency. 1991. Report to Congress on the Endangered Species Protection Program as it Relates to Pesticide Regulatory Activities. List of Subjects Environmental protection, Pesticides, Endangered species. Dated: November 25, 2002. James Jones, Acting Director, Office of Pesticide Programs. [ FR Doc. 02 30463 Filed 11 29 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ FRL 7415 4] CERCLA Administrative Consent Order Containing Proposed Past Costs Settlement Related to the Butternuts Landfill Superfund Site, Town of Butternuts, Otsego County, NY AGENCY: Environmental Protection Agency. ACTION: Notice; request for public comment. SUMMARY: In accordance with Section 122( i) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, amended (`` CERCLA''), 42 U. S. C. 9622( i), notice is hereby given by the U. S. Environmental Protection Agency (`` EPA''), Region II, of an administrative consent order (`` Order'') pursuant to sections 104, 106, 107, and 122 of CERCLA 42 U. S. C. 9604, 9606, 9607, and 9622, addressing, inter alia, proposed recovery of past response costs paid by EPA with regard to the Butternuts Landfill Superfund Site (`` Site'') located in the Town of Butternuts, Otsego County, New York. The Order requires the settling party, Hugo Neu Schnitizer East (`` Respondent''), to perform a removal action at the Site and also pay $ 40,000 in reimbursement of EPA's past response costs at the Site. The settlement includes a covenant not to sue the Respondent pursuant to sections 106 and 107( a) of CERCLA, 42 U. S. C. 9606, 9607( a), for performance of the removal action and for recovery of EPA's past costs and oversight costs. For thirty ( 30) days following the date of publication of this notice, EPA will receive written comments relating only to the portion of the Order which settles EPA's claim for recovery of its past response costs. EPA will consider all such comments received and may modify or withdraw its consent to the past costs settlement if comments received disclose facts or considerations that indicate that the proposed past costs settlement is inappropriate, improper or inadequate. EPA's response VerDate 0ct< 31> 2002 17: 27 Nov 29, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02DEN1. SGM 02DEN1

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regulations

EPA-HQ-OPP-2002-0311-0005

Supporting & Related Material

Page 1 of 7 PROCESS FOR ASSESSING POTENTIAL RISKS TO ENDANGERED AND THREATENED SPECIES AND CONSULTATION WITH THE NATIONAL MARINE FISHERIES SERVICE AND THE U. S. FISH AND WILDLIFE SERVICE U. S. Environmental Protection Agency 2002 A. Consultation Procedures Regulations governing ESA s section 7 consultation procedures pursuant to section 7 of ESA are codified in 50 CFR Part 402. A discussion of these regulations in reference to EPA s registration and reregistration activities follows. 1. A " conference" is designed to identify potential problems between an agency action, such as pesticide registration, and a species proposed to be listed ( i. e., before it is listed) under ESA. There is also a more formal conference procedure ( 50 CFR 402.10 ( d) and ( e)), which follows the same basic procedures as a formal consultation, except that again the species is not yet listed. The EPA hopes to make use of formal conferences in the future, where appropriate, to provide more timely protection to listed species. 2. An " early consultation" attempts to identify potential conflicts between listed species and their critical habitats, and proposed actions prior to applying for the Federal pesticide registration. This type of consultation is conducted between the Federal agency, EPA, and FWS, but involves the registrant or applicant throughout the process. Pesticide registration has not used early consultation because the amount and quality of data needed from the registrant would be equivalent to that needed for registration, and the process would provide no benefit. Aspects of this consultation procedure ( i. e., early involvement of the applicant) can be useful in expediting public health emergency exemption consultations. 3. A " biological assessment" evaluates the potential effects of Federal action( s) on listed species. species that are proposed to be listed, and their critical habitats. The goal is to determine which species or habitats are likely to be adversely affected and to determine if consultation is necessary. Biological assessments are only required for major construction activities. An agency may request from FWS a list of species that may be in the area of concern. This process is only required within the biological assessment process but can be requested for any action. The FWS is to provide such a list to the agency within 30 days. 4. An " informal consultation" is an optional process between a Federal agency and FWS and is designed to assist the Federal agency in determining if formal consultation and/ or a conference are required. 5. A " formal consultation" is the process in which a Federal agency first determines if an agency action such as pesticide registration " may affect" a listed species or its critical habitat. If Page 2 of 7 " no effect" is determined, the process concludes. If there is a " may affect" determination, then the agency initiates formal consultation with FWS which describes ( ii the action, ( ii) the specific area( s) affected, ( iii) any species or critical habitats that may be affected. ( iv) how the action will impact the species or habitats. ( v) any cumulative effects, and ( vi) any other relevant information. The FWS then concludes the formal consultation within 90 days, unless extended by mutual agreement. Within 45 days after the conclusion of the formal consultation, FWS issues a written finding called a Biological Opinion to the Federal agency. During this 45­ day time period, the Federal agency may request a draft of the Opinion primarily to analyze the reasonable and prudent alternatives. This cannot extend the 45­ day period by more than 10 days unless an extension is mutually agreed upon. The Biological Opinion should include a summary of the information on which the consultation is based, and a discussion of the effects of the action on the listed species or critical habitats, including a FWS determination on whether the action is likely to jeopardize the continued existence of a species or result in the destruction or adverse modification of critical habitat. Incidental take of species for which there is a " may affect" but is not likely to be jeopardized, will be identified. If possible, FWS will identify reasonable and prudent alternatives to the action, such as modification of the use of the pesticide, that the agency or registrant can take to avoid jeopardy. In addition, the Biological Opinion will identify ( i) the amount or extent, if any, of acceptable incidental take of the species, ( ii) reasonable and prudent measures to the action that will minimize the impact. ( iii) terms and conditions to implement the reasonable and prudent measures, and ( iv) procedures to handle or dispose of species taken. The FWS can also provide conservation recommendations that the agency may or may not consider. Issuance of the Biological Opinion terminates the formal consultation process. If the Federal agency cannot comply with a Biological Opinion, it may apply for an exemption under section 7 of ESA. 6. A " reinitiation of consultation" is required if ( i) incidental take is exceeded, ( ii) new information is obtained which may affect the assessment( s) of species or critical habitats in a manner not previously considered, ( iii) the action is subsequently modified and causes an effect to the species or habitat not previously considered, and ( iv) new species or critical habitats have been designated that may be affected by the action. B. The EPA s " May Affect" Determinations Ecological risk from pesticide use is a function of toxicity and environmental exposure ( Ref. 1). This Unit summarizes risk assessment procedures used by EPA and indicates how these standard procedures are adapted for determining whether a pesticide " may affect" listed species. The EPA evaluates data and risks in a tiered fashion. The first risk evaluation is based upon laboratory toxicity and environmental fate data, If the initial evaluation indicates a significant Page 3 of 7 concern, then EPA requests registrants to supply additional laboratory and/ or field data in order to refine the risk assessment. 1. Toxicity evaluations. Data used in assessing toxicity include acute and chronic test data. For acute toxicity, EPA evaluates LC5O and LD5O tests, which are submitted in response to EPA data requirements ( 40 CFR Part 158). The LC5O is the statistically derived estimate of the concentration ( median lethal concentration) that would cause mortality to 50 percent of the test population. in contrast, the LD5O is the statistically derived estimate of the single dose ( median lethal dose) that would cause mortality to 50 percent of the test population. Both tests are conducted with surrogate species that are used to evaluate the potential risk to other species. To assess acute toxicity of pesticides to birds, EPA guidelines require one LD5O study for an upland game bird ( preferably bobwhite quail) or waterfowl ( preferably mallard duck) and one LC5O study for each species. To assess toxicity to aquatic species ( fish and invertebrates), EPA requires LC5O studies on a warm water species ( preferably bluegill sunfish), a cold water species ( preferably rainbow trout), and an invertebrate ( preferably Daphnia magna). Toxicity to nontarget mammals is initially assessed by considering LD5O data for laboratory rats, which EPA requires to evaluate pesticide hazards to humans. Typically, EPA requires data on honeybees to address the risks to beneficial insects. In situations where additional, scientifically valid, toxicity data related to acute effects in wildlife and aquatic organisms are available EFED will consider them in establishing the toxicity endpoint for risk assessment. It is EFED's policy to conduct risk assessments using the acute lethal endpoint from the most sensitive species tested. The acute toxicity data described above are basic requirements that are generally available for all pesticides with outdoor uses. For some kinds of pesticide uses, or where these basic data warrant additional data, EPA may require higher tier testing. Higher tier acute data may include toxicity to estuarine fish, invertebrates, and oyster embryo larvae; and oyster shell deposition studies. Chronic toxicity data are all higher tier and may include data or avian reproductive effects, fish early­ life stage toxicity, chronic toxicity to mammals and to freshwater fishes, estuarine fishes, and invertebrates. The chronic toxicity endpoints commonly considered by EFED include frank effects on reproduction such as numbers of offspring produced and their survival as well a growth effects. Rarely are data from field studies, aquatic pond studies, or secondary toxicity studies available, although such data recently have been required for some pesticides. The EPA validates all data using its Standard Evaluation Procedures ( Refs 2 through 24). For assessment of potential effects to plants, EFED may request toxicity data regarding seedling emergence and vegetative vigor in a variety of terrestrial plants as well as plant growth studies for aquatic plants. Effects endpoints for terrestrial plants are established for the most sensitive tested dicot and monocot plants and are set at the no observed adverse effect concentration ( NOAEC) or EC05 values if NOAEC values are unavailable. 2. Environmental exposure. Data used for the exposure assessment of a pesticide include ( 1) its physical/ chemical properties; ( 2) environmental fate data, including data on persistence; ( 3) Page 4 of 7 label information such as application sites, rates, methods, and timing; ( 4) bioconcentration; and ( 5) factors related to the species themselves, such as their biology, ecology, and distribution. Occasionally, field residue data applicable to non­ target species are available. The exposure assessment has two components. The first component is the determination of the EECs that may result from use of the pesticide according to label directions. The second is a determination of whether non­ target species are expected to be exposed to the EEC. The EPA uses various models to determine EECs to evaluate the risk to aquatic species. Whenever possible. actual field study or residue data also are reviewed. The models used include ( a) a water model, ( b) a simple drift model, ( c) a simple runoff model, and ( d) a computer runoff and exposure simulation model. Computer based models include the Pesticide Root Zone Model coupled with the Exposure Analysis Modeling System ( EXAMS). To determine EECs for listed terrestrial species, EPA estimates residues on food items consumed by the species. Estimated residues, primarily on plants and insects, are based mainly on the work of Hoerga and Kenaga ( 1972) and Fletcher et al. ( 1994). These works are a compendium of measured pesticide residue values for several types of vegetable material, such as long and short range grasses; leaves and leafy crops; forage crops; pods containing seeds; and fruit ( cherries, peaches, grapes, citrus). Residues are given on the basis of a pesticide application rate of lb/ A and then adjusted for the label rate. The estimates represent upper bound expected residues for day zero ( immediately after application). When possible, actual validated residue data also are considered. In estimating the environmental concentrations, EPA also considers the formulation of the product, such as liquid, granular, or fumigant formulations. The available validated pesticide and environmental fate data are used in the computer based models to provide more accurate assessments from multiple applications, as identified on the label. Specific scenarios have been developed for runoff from specific crop sites, as well as environmental concentrations in a pond or headwater stream environment. Data, such as water chemistry data, are often insufficient to accurately run the more sophisticated computer based models. The EPA is attempting to develop additional scenarios to address additional use sites, different application methods ( aerial, ground, etc.), cropping practices ( no­ till, strip crop, rotation, etc.), application techniques ( band, infurrow side­ dressing, etc.), and integrated pest management practices so that alternatives can be identified that will protect listed species. 3. Risk assessment. In assessing the risk to non­ target species in general, EPA compares the toxicity information with the EEC and then determines the likelihood that non­ target organisms will actually be exposed. Comparisons of LC5O or LD50 values with EECs indicate whether additional data may be required or that a particular pesticide may warrant restricted use classification if actual exposure may occur. When evaluating impacts to federally listed species, EPA does not rely solely on the LC5O or LD5O end points since some listed species may not be able to withstand even the loss of a few individuals in the population. much less 50 percent. Page 5 of 7 Therefore, more stringent criteria have been developed to provide greater protection for populations of listed species, whose numbers in many instances are dangerously low. Thus, criteria were developed to determine the environmental concentrations at which a pesticide A " may affect" a listed species. These criteria were developed for mammals, birds, and aquatic organisms as follows: mammals B EEC equal to or greater than 1/ 5th the lowest mammalian acute oral LD1O or LC1O, or 1/ 10th the lowest LD5O or LC5O; birds B EEC equal to or greater than 1/ 5th the lowest avian acute oral LD1O or subacute dietary LC1O or 1/ 10th the lowest LD5O or LC5O; and aquatic organisms B EEC equal to or greater than 1/ 10th the lowest aquatic LC1O, or 1/ 20th the lowest aquatic LC5O. Terrestrial plant criteria are set at an EEC equivalent to the EC05 or the NOAEC, depending upon toxicity data availability. When the above criteria are exceeded for any relevant taxa, the magnitude of the potential impact is determined by calculating a hazard ratio, which is the ratio of the EEC ( based on a specific application rate) over the toxicity criteria. Any hazard ratio of one or greater confirms that a " may affect" situation exists, since the predicted residues in the environment are equal to or exceed the amount of the pesticide that could be hazardous to the species. Higher hazard ratios indicate a greater magnitude of concern. For most currently registered pesticides, ecological impacts from acute toxicity are more likely than those from chronic toxicity. However, EPA also considers information related to subchronic and chronic risks, reproductive effects, and bioaccumulation factors. The laboratory test data ( e. g., chronic feeding, life cycle, oncogenicity, or reproductive studies) on no­ effect levels or no­ observable­ effect levels ( NOEL) and/ or effect levels are compared with estimated or actual field residues. When these residues are in excess of the NOEL for appropriate surrogates of listed species, EPA considers there is a potential that the pesticide may affect a species and therefore, conducts more in depth assessments. Secondary hazards are associated with acute and chronic toxicity relating to bioaccumulation of a pesticide in the food chain and body residues of target or non­ target organisms consumed by organisms higher in the food chain. Again, estimated or actual residues In food items are correlated with diet of the non­ target organisms and compared with the acute and chronic toxicity values. In evaluating the risk from pesticide use, EPA also considers other information. For example, toxicity to non­ target insects, such as honey bees, is important because pollination can be critical to certain listed plants. Any reports of pesticide incidents involving non­ target species, even if they are not listed species, also are considered. Page 6 of 7 Finally, effects on listed species habitats and food supply are also considered. For example, the Everglade snail kite feeds specifically on the apple snail. Therefore, any disruption of the apple snail's habitat from pesticides or pesticide toxicity to the apple snail itself may adversely affect the Everglade snail kite. Also, herbicide disruptions of animal and plant community balance also could adversely impact the habitat or micro­ habitat of listed species. For example, herbicides are unlikely to be directly toxic to the valley elderberry longhorn beetle, but they may destroy the elderberry trees in which the beetle lives. On occasion, pesticide use may be beneficial to some species habitats by reversing adverse plant competition trends that have been exacerbated by other human activities, such as exotic introductions and wildfire control. When all the data are evaluated, if a " may affect determination" is made, EPA assembles all of the relevant information and/ or references, along with any reasonable and prudent alternatives that are known, and sends it to FWS requesting consultation, per the Services regulations. The species and pesticides included in this request are only those where a " may affect determination" was made. Following receipt of the request for consultation, FWS prepares the Biological Opinion and determines if the use is likely to pose jeopardy to the continued existence of a species, if the use will result in the destruction or adverse modification of critical habitat of a species or if incidental take is anticipated and provisions are necessary to minimize these impacts. A " may affect determination" by EPA may not result in a jeopardy determination by FWS or result in any anticipated incidental take. C. Threshold Application Rate Estimates Some pesticides ( e. g., certain ones that have been subject to Special Review) have been evaluated enough that the application rates that would result in a " may affect" determination are already known. For other pesticides, EPA will first screen them to determine if the highest application rate would result in a " may affect" determination. Pesticides that do not exceed the " may affect" criteria are dropped from further analysis. For pesticides that do exceed the criteria at the highest application rate, EPA then will determine the EEC that would result from an application rate of 1 pound active ingredient per acre ( lb ai/ A) for various combinations of application methods and formulation types ( and environments, where appropriate) of a pesticide. Typically, EPA then will compare the resulting EEC s to toxicity to obtain a hazard ratio. A hazard ratio of " 1" or greater indicates that the EEC has met or exceeded our " may affect" criteria. If using 1 lb ai/ A application rate results In a hazard ratio of less than one ( indicating the " may affect" criteria has not been met at that rate), the ratio allows EPA to calculate the highest application rate that would still not result in a " may affect" determination, which may be compared with product label rates. This is accomplished by multiplying the 1 lb ai/ A application rate by the reciprocal of the hazard ratio. For example, if the hazard ratio is 1/ 5 based on a 1 lb ai/ A application rate, the Page 7 of 7 application rate which would result in a " may affect" determination would be 1 lb ai/ A x 5/ 1 or 5 lb ai/ A. The same procedure applies even if the hazard ratio is greater than 1. However, the application rate derived in the latter case might not be a rate specified on the label, in which case all label use rates would result in a " may affect" to listed species. U. S. Environmental Protection Agency. 1986. Hazard Evaluation Division Standard Evaluation Procedure, Ecological Risk Assessment Fletcher, J. S., J. E. Nellesson and T. G. Pfleeger. 1994. Literature Review and Evaluation of the EPA Food­ Chain ( Kenaga) Nomogram, an Instrument for Estimating Pesticide Residues on Plants. Environ. Tox. and Chem. 13( 9): 1383­ 1391. Hoerger, F. and E. E. Kenaga. 1972. Pesticide Residues on Plants: Correlation of Representative Data as a Basis for Estimation of Their Magnitude in the Environment. IN: F. Coulston and F. Corte, eds., Environmental Quality and Safety: Chemistry, Toxicology, and Technology. Vol I. Georg Thieme Publishers, Stuttgart, West Germany, pp. 9­ 28.

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2024-06-07T20:31:45.287066

regulations

EPA-HQ-OPP-2002-0312-0001

Notice

Diazinon; End-Use Products Cancellation Order

72943 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Notices also required. Any owner or operator subject to the rule shall maintain a file of these measurements, and retain the file for at least two years following the date of such measurements, maintenance reports, and records. Burden Statement: The EPA would like to solicit comments to: ( i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; ( ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses. In the previously approved ICR, the estimated number of respondents for this information collection was 390 with 390 responses per year. The annual industry reporting and recordkeeping burden for this collection of information was 15,463 hours. On the average, each respondent reported once per year and approximately 40 hours were spent preparing each response. The total annual reporting and recordkeeping cost burden for this collection of information was $ 15,000. This included an annual cost of $ 1,000 associated with capital/ startup costs and $ 14,000 associated with the annual operation and maintenance costs. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. Dated: November 27, 2002. Michael M. Stahl, Director, Office of Compliance. [ FR Doc. 02 31016 Filed 12 6 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0312; FRL 7280 7] Diazinon; End­ Use Products Cancellation Order AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces EPA's cancellation order for the product and use cancellations as requested by companies ( hereafter collectively referred to as the `` EUP Registrants'') that hold the registrations of pesticide End­ Use Products ( EUPs) containing the active ingredient diazinon and accepted by EPA, pursuant to section 6( f) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). This order follows up an September 11, 2002, notice of receipt from the EUP Registrants, of requests for cancellations and or amendments of their diazinon product registrations to terminate all indoor uses, certain agricultural uses and certain outdoor non­ agricultural uses. In the September 11, 2002 notice, EPA indicated that it would issue an order granting the voluntary product and use registration cancellations unless the Agency received any substantive comment within the comment period that would merit its further review of these requests. The Agency did not receive any comments specific to these cancellations. Accordingly, EPA hereby issues in this notice a cancellation order granting the requested cancellations. Any distribution, sale, or use of the products subject to this cancellation order is only permitted in accordance with the terms of the existing stocks provisions of this cancellation order. DATES: The cancellations are effective December 9, 2002. FOR FURTHER INFORMATION CONTACT: Laura Parsons, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, telephone number: ( 703) 305 5776; fax number: ( 703) 308 7042; email address: parsons. laura@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. You may be potentially affected by this action if you manufacture, sell, distribute, or use diazinon products. The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule, for purposes of 5 U. S. C. 804( 3). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0312. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may VerDate 0ct< 31> 2002 15: 07 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09DEN1. SGM 09DEN1 72944 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Notices be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Receipt of Requests to Cancel and Amend Registrations to Delete Uses. A. Background Certain registrants requested in letters dated December 2001, and January, February, March, April, May, June, and July 2002 that their diazinon registrations be amended to delete all indoor uses, certain agricultural uses, and any other uses that the registrants do not wish to maintain. The requests also included deletions of outdoor nonagricultural uses from the labeling of certain end­ use products so that such products would be labeled for agricultural uses only. Similarly, other diazinon end­ use registrants requested voluntary cancellation of their diazinon EUP registrations with indoor use and/ or certain outdoor non­ agricultural uses, and any other uses that the registrants do not wish to maintain. EPA announced its receipt of these abovementioned cancellation requests in a Federal Register notice dated September 11, 2002 ( 67 FR 57589), ( FRL 7197 8). These requested cancellations and amendments are consistent with the requests in December 2000 by the manufacturers of diazinon technical products, and EPA's approval of such requests, to terminate all indoor uses and certain agricultural uses from their diazinon product registrations because of EPA's concern with the potential exposure risk, especially to children, associated with diazinon containing products. The indoor uses and agricultural uses subject to cancellation are identified in List 1 below: List 1 Uses Requested for Termination 1. Indoor uses: Pet collars, or inside any structure or vehicle, vessel, or aircraft or any enclosed area, and/ or on any contents therein ( except mushroom houses), including food/ feed handling establishments, greenhouses, schools, residences, commercial buildings, museums, sports facilities, stores, warehouses and hospitals. 2. Agricultural uses: Alfalfa, bananas, Bermuda grass, dried beans, dried peas, celery, red chicory ( radicchio), citrus, clover, coffee, cotton, cowpeas, cucumbers, dandelions, forestry ( ground squirrel/ rodent burrow dust stations for public health use), kiwi, lespedeza, parsley, parsnips, pastures, peppers, potatoes ( Irish and sweet), sheep, sorghum, squash ( winter and summer), rangeland, Swiss chard, tobacco, and turnips ( roots and tops). In today's Cancellation Order, EPA is approving the registrants' requested cancellations and amendments of the their diazinon end­ use products registrations to terminate all uses identified in List 1. B. Requests for Voluntary Cancellation of End­ Use Products The end­ use product registrations for which cancellation was requested are identified in the following Table 1. TABLE 1. END­ USE PRODUCT REGISTRATION CANCELLATION REQUESTS Company EPA Registration # Product Farnam Companies, Inc. 270 282 Diazinon 2EC Prentiss Inc. 655 457 655 462 655 519 Prentox Diazinon 4E Insecticide Prentox Diazinon 4S Insecticide Prentox Liquid Household Spray # 1 Universal Cooperatives, Inc. 1386 573 1386 651 Diazinon Emulsifiable Lawn and Garden Insecticide Security Brand 2% Diazinon Granules Lawn Insect Control Virbac AH, Inc. 2382 168 2382 171 2382 172 Diazinon­ Pyriproxyfen Collar for Dogs and Puppies # 1 Diazinon­ Pyriproxyfen Collar for Dogs and Puppies # 3 Diazinon­ Pyriproxyfen Collar for Dogs and Puppies # 2 ABC Compounding, Inc. 3862 71 Drop Dead Insect Spray Cerexagri, Inc. 4581 335 Knox Out 2 FM Amvac Chemical Corp. 5481 224 5481 241 Diazinon 4E Alco Housing Authority Roach Concentrate US Marketing Distributors 6409 14 Professional Do it Yourself Exterminator's Kit Formula 400 Voluntary Purchasing Group, Inc. 7401 67 Ferti­ Lome Rose Spray Containing Diazinon & Daconil. Earth Care/ Division of United Industries Corp. 8660 101 8660 115 8660 106 Vertagreen 5% Diazinon Insecticide Vertagreen Diazion Pre­ Weed Vertagreen Diazinon Pre­ Weed Plus The Andersons Lawn Fertilizer Division 9198 189 Proturf Insecticide One Waterbury Companies, Inc. 9444 89 CB Aqueous Residual Insecticide Athea Laboratories, Inc. 10088 71 Roach and Ant Killer Verpas Products, Inc. 13926 6 Diaciclon F­ 5 Wagnol Inc. 33912 1 Wagnol 40 Pest Control Spray Concentrate Contains Diazinon T­ Tex Corp. 39039 5 Dryzon WP Livestock Premise & Sheep Insecticide VerDate 0ct< 31> 2002 15: 07 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09DEN1. SGM 09DEN1 72945 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Notices TABLE 1. END­ USE PRODUCT REGISTRATION CANCELLATION REQUESTS Continued Company EPA Registration # Product Chem­ Tech Ltd. 47000 63 Pressurized Household Insect Spray Concentrate Contains Diazinon and DDVP Marman USA , Inc. 48273 25 Marman Diazinon AG 60 EC Control Solutions Inc 53883 58 Martin's Diazinon 4E Indoor­ Outdoor Insecticide Arkopharma, Inc. 69607 1 Double Duty Flea & Tick Collar For Dogs EPA did not receive any substantive comments that would merit further review expressing a need of diazinon products for indoor use. Accordingly, the Agency is issuing an order in this notice canceling the registrations identified in Table 1, as requested by the EUP registrants. C. Requests for Voluntary Amendments of End­ Use Product Registrations to Terminate Certain Uses Pursuant to section 6( f)( 1)( A) of FIFRA, many EUP Registrants submitted requests to amend a number of their diazinon end­ use product registrations to terminate the uses identified in List 1 of this notice or any other uses as specified for each product in the September 13, 2001, Diazinon 6( f) Notice and reiterated in Table 2 below. EPA did not receive any comments expressing a need for any of the canceled uses. The registrations for which amendments to terminate specific uses were requested are identified in the following Table 2: TABLE 2. END­ USE PRODUCT REGISTRATION AMENDMENT REQUESTS Company EPA Registration # Product Name: Use Deletions Dragon Chemical Corp. 16 119 16 157 16 166 Dragon 5% Diazinon Granules Celery. Diazinon 25% Diazinon Spray: Almonds Dragon Diazinon Water­ Based Concentrate: Almonds Southern Agricultural Insecticides Inc. 829 264 SA­ 50 Brand 5% Diazinon Granules Celery TABLE 2. END­ USE PRODUCT REGISTRATION AMENDMENT REQUESTS Continued Company EPA Registration # Product Name: Use Deletions Universal Cooperative Inc. 1386 599 1386 648 Diazinon 4 EC ( AG): Beans, Cucumbers Parsley, Parsnips, Peas, Peppers, Potatoes ( Irish), Squash ( Summer and Winter), Sweet Potatoes, Swiss Chard, Turnips Lawn Pest Control, Nuisance Pests in Outside Areas, Grassland Insects, and Indoor Ornamentals 5% Diazinon Insect Killer Granules: Celery Knox Fertilizer Co. Inc. 8378 32 Shaw's 5% Diazinon Insect Granules: Celery III. Cancellation Order Pursuant to section 6( f) of FIFRA, EPA hereby approves the requested cancellations of diazinon product and use registrations identified in Tables 1 and 2 of this notice. Accordingly, the Agency orders that the diazinon end­ use product registrations identified in Table 1 are hereby canceled. The Agency also orders that all of the uses identified in List 1 and all other uses ( including specific outdoor non­ agricultural uses) identified for deletion in Table 2 are hereby canceled from the end­ use product registrations identified in Table 2. Any distribution, sale, or use of existing stocks of the products identified in Tables 1 and 2 in a manner inconsistent with the terms of this order or the Existing Stock Provisions in Unit IV of this notice will be considered a violation of section 12( a)( 2)( K) of FIFRA and/ or section 12( a)( 1)( A) of FIFRA. IV. Existing Stocks Provisions For purposes of this Order, the term `` existing stocks'' is defined, pursuant to EPA's existing stocks policy ( 56 FR 29362, June 26, 1991), as those stocks of a registered pesticide product which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the amendment or cancellation. The existing stocks provisions of this Cancellation Order are as follows: 1. Distribution or Sale of Products Bearing Instructions for Use on Agricultural Crops. The distribution or sale of existing stocks by the registrant of any product listed in Table 1 or 2 that bears instructions for use on the agricultural crops identified in List 1 will not be lawful under FIFRA 1 year after the effective date of the cancellation order, except for the purposes of shipping such stocks for export consistent with section 17 of FIFRA or for proper disposal. Persons other than the registrant may continue to sell or distribute the existing stocks of any product listed in Table 2 that bears instructions for any of the agricultural uses identified in List 1 after the effective date of the cancellation order. 2. Distribution or Sale of Products Bearing Instructions for Use on Outdoor Non­ Agricultural Sites. The distribution or sale of existing stocks by the registrant of any product listed in Table 1 or 2 that bears instructions for use on outdoor non­ agricultural sites will not be lawful under FIFRA 1 year after the effective date of the cancellation order, except for the purposes of shipping such stocks for export consistent with section 17 of FIFRA or for proper disposal. Persons other than the registrant may continue to sell or distribute the existing stocks of any product listed in Table 1 or 2 that bears instructions for use on outdoor non­ agricultural sites after the effective date of the cancellation order. 3. Distribution or Sale of Products Bearing Instructions for Use on Indoor Sites. The distribution or sale of existing stocks by the registrant of any product VerDate 0ct< 31> 2002 15: 07 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09DEN1. SGM 09DEN1 72946 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Notices listed in Table 1 or 2 that bears instructions for use at or on any indoor sites ( except mushroom houses), shall not be lawful under FIFRA as of the effective date of the cancellation order, except for the purposes of shipping such stocks for export consistent with section 17 of FIFRA or for proper disposal. 4. Retail and Other Distribution or Sale of Existing Stock of Products For Indoor Use. The distribution or sale of existing stocks by any person other than the registrants of products listed in Table 1 or 2 bearing instructions for any indoor uses except mushroom houses will not be lawful under FIFRA after December 31, 2002, except for the purposes of shipping such stocks for export consistent with section 17 of FIFRA or for proper disposal. 5. Use of existing stocks. EPA intends to permit the use of existing stocks of products listed in Table 1 or 2 until such stocks are exhausted, provided such use is in accordance with the existing labeling of that product. List of Subjects Environmental protection, Pesticides and pests. Dated: November 22, 2002. Lois Rossi, Director, Special Review and Reregistration Division, Office of Pesticide Programs. [ FR Doc. 02 31013 Filed 12 6 02; 8: 45am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ FRL 7413 3] Napa State Hospital Administrative Consent Agreement and Final Order; Notice of Proposed Administrative Consent Agreement and Final Order Pursuant to Section 311( b)( 6) of the Clean Water Act AGENCY: Environmental Protection Agency, Region IX. ACTION: Notice, request for public comments. SUMMARY: In accordance with section 311( b)( 6)( C) of the Clean Water Act, (`` CWA''), 33 U. S. C. 1321( b)( 6)( C), notice is hereby given of a proposed Consent Agreement and Final Order (`` CA/ FO,'' Region 9 Docket No. OPA 9 2003 0001), which resolves penalties for alleged violations of sections 311( b)( 3) and 311( j) of the CWA. The respondent to the CA/ FO is the Napa State Hospital, an agency of the State of California. Through the proposed CA/ FO, the Napa State Hospital will pay $ 40,000 to the Oil Spill Liability Trust Fund as a penalty for alleged violations involving the discharge of oil into waters of the United States, and the failure to prepare and maintain a spill prevention, control and countermeasure plan. The penalty included in this CA/ FO was calculated in accordance with the Agency's guidance document, Civil Penalty Policy for section 311( b)( 3) and section 311( j) of the Clean Water Act, dated August 1998. For 30 days following the date of publication of this notice, the Agency will receive written comments relating to the proposed CA/ FO. Any person who comments on the proposed CA/ FO shall be given notice of any hearing held and a reasonable opportunity to be heard and to present evidence. If no hearing is held regarding comments received, any person commenting on this proposed CA/ FO may, within 30 days after the issuance of the final order, petition the Agency to set aside the CA/ FO, as provided by section 311( b)( 6)( C)( iii) of the CWA, 33 U. S. C. 1321( b)( 6)( C)( iii). DATES: Comments must be submitted on or before January 8, 2003. ADDRESSES: The proposed CA/ FO may be obtained from J. Andrew Helmlinger, telephone ( 415) 972 3904. Comments regarding the proposed CA/ FO should be addressed to Danielle Carr ( ORC 3) at 75 Hawthorne Street, San Francisco, California 94105, and should reference the Napa State Hospital and Region IX docket OPA 9 2003 0001. FOR FURTHER INFORMATION CONTACT: J. Andrew Helmlinger, Office of Regional Counsel, ( 415) 972 3904, U. S. Environmental Protection Agency, Region 9, 75 Hawthorne Street, San Francisco, CA 94105. Dated: November 14, 2002. Debbie Jordan, Acting Director, Superfund Division. [ FR Doc. 02 30121 Filed 12 6 02; 8: 45 am] BILLING CODE 6560 50 P FEDERAL COMMUNICATIONS COMMISSION [ Report No. AUC 02 49 A ( Auction No. 49); DA 02 3287] Auction No. 49 Auction of Lower 700 MHz Band Licenses Scheduled for April 16, 2003; Comment Sought on Reserve Prices or Minimum Opening Bids and Other Auction Procedures AGENCY: Federal Communications Commission. ACTION: Notice. SUMMARY: This document announces the auction of 251 licenses in the Lower 700 MHz band C block ( 710 716/ 740 746 MHz) scheduled to commence on April 16, 2003. This document also seeks comment on reserve prices or minimum opening bids and other auction procedures. DATES: Comments are due on or before December 16, 2002, and reply comments are due on or before December 23, 2002. ADDRESSES: Comments and reply comments must be sent by electronic mail to the following address: auction49@ fcc. gov. FOR FURTHER INFORMATION CONTACT: Legal questions: Howard Davenport ( 202) 418 0660; General auction questions: Lyle Ishida ( 202) 418 0660 or Linda Sanderson ( 717) 338 2888. For service rule questions: Amal Abdallah, Policy and Rules Branch, or Joanne Epps and Melvin Spann, Licensing and Technical Analysis Branch, at ( 202) 418 0620. SUPPLEMENTARY INFORMATION: This is a summary of the Auction No. 49 Comment Public Notice released December 2, 2002. The complete text of the Auction No. 49 Comment Public Notice, including attachments, is available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY A257, Washington, DC 20554. Auction No. 49 Comment Public Notice may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., Room CY B402, Washington, DC 20554, telephone 202 863 2893, facsimile 202 863 2898, or via e­ mail qualexint@ aol. com. 1. By the Auction No. 49 Comment Public Notice, the Wireless Telecommunications Bureau (`` Bureau'') announces the auction of 251 licenses in the Lower 700 MHz band C block ( 710 716/ 740 746 MHz) scheduled to commence on April 16, 2003 ( Auction No. 49). This auction will include the C block licenses that remained unsold in Auction No. 44, which closed on September 18, 2002. A complete list of licenses available for Auction No. 49 is included as Attachment A of the Auction No. 49 Comment Public Notice. The C block is a 12­ megahertz spectrum block, consisting of a pair of 6­ megahertz segments, which is licensed over 734 Metropolitan Statistical Areas (`` MSAs'') and Rural Service Areas (`` RSAs''). 2. The following table contains the block/ frequency cross­ reference for the 710 716/ 740 746 MHz bands: VerDate 0ct< 31> 2002 15: 07 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 09DEN1. SGM 09DEN1

epa

2024-06-07T20:31:45.294444

regulations

EPA-HQ-OPP-2002-0314-0001

Rule

Pyriproxyfen; Pesticide Tolerance for Emergency Exemption

71105 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations agricultural services; management of health care facilities; mailing, reproduction, and commercial art; and temporary help supply services. * * * * * [ FR Doc. 02 30136 Filed 11 27 02; 8: 45 am] BILLING CODE 3510 06 P LIBRARY OF CONGRESS Copyright Office 37 CFR Part 253 [ Docket No. 2002 4 CARP NCBRA] Cost of Living Adjustment for Performance of Musical Compositions by Colleges and Universities AGENCY: Copyright Office, Library of Congress. ACTION: Final rule. SUMMARY: The Copyright Office of the Library of Congress announces a cost of living adjustment of 2.0% in the royalty rates paid by colleges, universities, or other nonprofit educational institutions that are not affiliated with National Public Radio for the use of copyrighted published nondramatic musical compositions in the BMI and ASCAP repertories. The cost of living adjustment is based on the change in the Consumer Price Index from October, 2001, to October, 2002. EFFECTIVE DATE: January 1, 2003. FOR FURTHER INFORMATION CONTACT: Tanya M. Sandros, Senior Attorney, Copyright Arbitration Royalty Panel, P. O. Box 70977, Southwest Station, Washington, D. C. 20024. Telephone: ( 202) 707 8380. Telefax: ( 202) 252 3423. SUPPLEMENTARY INFORMATION: Section 118 of the Copyright Act, 17 U. S. C., creates a compulsory license for the use of published nondramatic musical works and published pictorial, graphic, and sculptural works in connection with noncommercial broadcasting. Terms and rates for this compulsory license, applicable to parties who are not subject to privately negotiated licenses, are published in 37 CFR part 253 and are subject to adjustment at five­ year intervals. 17 U. S. C. 118( c). The most recent proceeding to adjust the terms and rates for the section 118 license began in April of this year. 67 FR 15414 ( April 1, 2002). On October 30, 2002, the Copyright Office announced proposed regulations governing the terms and rates of copyright royalty payments with respect to certain uses by public broadcasting entities of published nondramatic musical works, and published pictorial, graphic, and sculptural works, including a provision to adjust § 253.10 which provides for an annual cost of living adjustment of the rates for the public performance of musical compositions in the ASCAP and BMI repertories by public broadcasting entities licensed to colleges and universities set forth in § 253.5 for the new license period, 2003 2007. 67 FR 66090 ( October 30, 2002). Under the proposed rules, the § 253.5 rate for the public performance of musical compositions in the SESAC repertory will be $ 80 for 2003, subject to an annual cost of living adjustment in each subsequent year thereafter during the licensing period. Section 253.10( b) requires that the Librarian publish a revised schedule of rates for the public performance of musical compositions in the ASCAP, BMI, and SESAC repertories by public broadcasting entities licensed to colleges and universities, reflecting the change in the Consumer Price Index. Accordingly, the Copyright Office of the Library of Congress is hereby announcing the change in the Consumer Price Index and performing the proposed annual cost of living adjustment to the rates set out in § 253.5( c) for the public performance of musical compositions in the BMI and ASCAP repertories in accordance with the October 30 proposed regulations. The change in the cost of living as determined by the Consumer Price Index ( all consumers, all items) during the period from the most recent Index published before December 1, 2001, to the most recent Index published before December 1, 2002, is 2% ( 2001' s figure was 177.7; the figure for 2001 is 181.3, based on 1982 1984= 100 as a reference base). Rounding off to the nearest dollar, the royalty rate for the use of musical compositions in the repertory of ASCAP is $ 249 and the use of the musical compositions in the repertory of BMI is the same, $ 249. If no comments are received regarding the proposed amendments to § § 253.5 and 253.10 announced in the October 30 Federal Register notice and the final rules are published before January 1, 2003, the cost of living adjustments announced in this notice shall become effective on January 1, 2003. List of Subjects in 37 CFR Part 253 Copyright, Radio, Television. Final Regulation For the reasons set forth in the preamble, part 253 of title 37 of the Code of Federal Regulations is amended as follows: PART 253 USE OF CERTAIN COPYRIGHTED WORKS IN CONNECTION WITH NONCOMMERCIAL EDUCATIONAL BROADCASTING 1. The authority citation for part 253 continues to read as follows: Authority: 17 U. S. C. 118, 801( b)( 1) and 803. 2. Section 253.5 is amended by revising paragraphs ( c)( 1) through ( c)( 2) as follows: § 253.5 Performance of musical compositions by public broadcasting entities licensed to colleges and universities. * * * * * ( c) * * ( 1) For all such compositions in the repertory of ASCAP, $ 249 annually. ( 2) For all such compositions in the repertory of BMI, $ 249 annually. * * * * * Dated: November 21, 2002. Marybeth Peters, Register of Copyrights. [ FR Doc. 02 30145 Filed 11 27 02; 8: 45 am] BILLING CODE 1410 33 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0314; FRL 7281 2] Pyriproxyfen; Pesticide Tolerance for Emergency Exemption AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes a time­ limited tolerance for residues of pyriproxyfen in or on strawberry. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of the pesticide on strawberry. This regulation establishes a maximum permissible level for residues of pyriproxyfen in or on this food commodity. The tolerance will expire and is revoked on December 31, 2004. DATES: This regulation is effective November 29, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0314, must be received on or before January 28, 2003. ADDRESSES: Written objections and hearing requests may be submitted VerDate 0ct< 31> 2002 12: 36 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1 71106 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VII. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9356; e­ mail address: conrath. andrea@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop producers ( NAICS 111) Animal producers ( NAICS 112) Food manufacturing ( NAICS 311) Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0314. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings EPA, on its own initiative, in accordance with sections 408( e) and 408 ( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a, is establishing a tolerance for residues of the insecticide pyriproxyfen, 2­[ 1­ methyl­ 2­( 4­ phenoxyphenoxy) ethoxypyridine], in or on strawberry at 0.30 part per million ( ppm). This tolerance will expire and is revoked on December 31, 2004. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations. Section 408( l)( 6) of FFDCA requires EPA to establish a time­ limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18­ related tolerances to set binding precedents for the application of section 408 of FFDCA and the new safety standard to other tolerances and exemptions. Section 408( e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i. e., without having received any petition from an outside party. Section 408( b)( 2)( A)( i) of FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that `` emergency conditions exist which require such exemption.'' This provision was not amended by the Food Quality Protection Act ( FQPA) of 1996. EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Pyriproxyfen on Strawberry and FFDCA Tolerances The California Department of Pesticide Regulation has indicated that populations of the silverleaf whitefly in the State are at levels which could result in significant damage to the State's strawberry crop. This pest is relatively newly­ introduced into the U. S., and the registered alternatives have not provided adequate control thus far. Without adequate control, this pest was expected to result in significant crop damage and yield losses for strawberry growers, leading to significant economic losses. EPA has authorized under FIFRA section 18 the use of pyriproxyfen on strawberry for control of the silverleaf whitefly in California. After having reviewed the submission, EPA concurs that emergency conditions exist for this State. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of pyriproxyfen in or on strawberry. In doing so, EPA considered the safety standard in section 408( b)( 2) of FFDCA, and EPA decided that the necessary tolerance under section 408( l)( 6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in VerDate 0ct< 31> 2002 12: 36 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1 71107 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations order to address an urgent non­ routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408( l)( 6) of FFDCA. Although this tolerance will expire and is revoked on December 31, 2004, under section 408( l)( 5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on strawberry after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether pyriproxyfen meets EPA's registration requirements for use on strawberry or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of pyriproxyfen by a State for special local needs under FIFRA section 24( c). Nor does this tolerance serve as the basis for any State other than California to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for pyriproxyfen, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Aggregate Risk Assessment and Determination of Safety EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 ( 62 FR 62961) ( FRL 5754 7). Consistent with section 408( b)( 2)( D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of pyriproxyfen and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of FFDCA, for a time­ limited tolerance for residues of pyriproxyfen in or on strawberry at 0.30 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows. A. Toxicological Endpoints EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pyriproxyfen, a summary of the toxicological dose and endpoints for pyriproxyfen for use in this human risk assessment, and the most recent estimated aggregate risks resulting from registered uses are discussed in the Federal Register for August 28, 2002 ( 67 FR 55150) ( FRL 7195 7) Final Rule establishing tolerances for residues of pyriproxyfen in/ on acerola, bushberry subgroup, feijoa, guava, jaboticaba, juneberry, lingonberry, longan, lychee, passionfruit, pulasan, rambutan, salal, Spanish lime, starfruit, stone fruit group, and wax jambu. Refer to the August 28, 2002 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment, including this use on strawberry. B. Exposure Assessment EPA assessed risk scenarios for pyriproxyfen under chronic and intermediate and short­ term ( residential) scenarios. Because there were no acute endpoints identified, an acute risk assessment was not conducted. Nor was a cancer aggregate risk assessment conducted, because pyriproxyfen is classified as `` not likely'' to be a human carcinogen. The Dietary Exposure Evaluation Model ( DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the Department of Agricultural ( USDA) 1989 1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Published and proposed tolerance level residues and 100% crop treated were assumed for all commodities, and the default processing factors were applied. Using these exposure assumptions, EPA concluded that pyriproxyfen chronic exposures from food consumption are below levels of concern (< 100% of the chronic Population Adjusted Dose ( cPAD)) for the general U. S. population and all population subgroups. The cPAD utilized for the most highly exposed subgroup ( children 1 6 years old) is 2.7%. Chronic risk from dietary exposure for infants (< 1 year old) and children ( 7 12 years old) utilizes 2.0% and 1.6% of the cPAD, respectively. Chronic dietary risk for the general U. S. population is 1.0% of the cPAD, and the estimated chronic risk for all other population subgroups is below this level. In addition, despite the potential for chronic dietary exposure to pyriproxyfen in drinking water, after calculating drinking water levels of concern ( DWLOCs) and comparing them to conservative model EECs of pyriproxyfen in surface and ground waters, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following table: TABLE 1. AGGREGATE RISK ASSESSMENT FOR CHRONIC EXPOSURE TO PYRIPROXYFEN Population Subgroup cPAD ( mg/ kg) % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb) General U. S. population 0.35 1.0 0.4 0.006 12,000 Children ( 1 6 years old) 0.35 2.7 0.4 0.006 3,100 Children ( 7 12 years old) 0.35 1.6 0.4 0.006 3,200 VerDate 0ct< 31> 2002 12: 36 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1 71108 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations TABLE 1. AGGREGATE RISK ASSESSMENT FOR CHRONIC EXPOSURE TO PYRIPROXYFEN Continued Population Subgroup cPAD ( mg/ kg) % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb) Infants (< 1 year old) 0.35 2.0 0.4 0.006 3,200 Short­ term and intermediate­ term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). The term `` residential exposure'' is used in this document to refer to nonoccupational non­ dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, flea and tick control on pets). Pyriproxyfen is currently registered for various residential non­ dietary sites, and is used for flea and tick control ( home environment and pet treatments) as well as products for ant and roach control. Pet owners could potentially be exposed to pyriproxyfen during applications to pets; however, since no short­ term dermal or inhalation endpoints were identified, only a postapplication residential assessment was conducted. Both adults and toddlers could potentially be exposed to pyriproxyfen residues on treated carpets, floors, upholstery, and pets, but it is anticipated that toddlers will have higher exposures than adults due to behavior patterns. Therefore, the residential risk assessment addressed post­ application exposures of toddlers, which is considered to be a worst­ case scenario. Short­ term, intermediate­ term, and long­ term toddler hand­ to­ mouth exposures ( consisting of petting treated animals and touching treated carpets/ flooring) were assessed; long­ term dermal exposures were also assessed for products with anticipated efficacy of more than 6 months ( carpet powders and pet collars). Toddler exposures to combined treatment scenarios, where a pet owner treats the home environment and the pet in the same period were also assessed. The Agency has determined that it is appropriate to aggregate chronic food and water and short­ term and intermediate­ term exposures for pyriproxyfen. Using the exposure assumptions described above for shortterm and intermediate­ term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs as shown in the following table: TABLE 2. AGGREGATE RISK ASSESSMENT FOR SHORT­ TERM AND INTERMEDIATE­ TERM EXPOSURE TO PYRIPROXYFEN Population Subgroup Target MOE Short­ Term Aggregate MOE ( Food + Residential) Intermediate­ Term Aggregate MOE ( Food + Residential Surface, Ground Water EECs ( ppb) Short­ Term DWLOCs ( ppb) Intermidate­ Term DWLOCs ( ppb) U. S. population 100 29,000 10,000 0.4, 0.006 35,000 12,000 Infants (< 1 year old) 100 1,800 650 0.4, 0.006 9,400 3,000 Children ( 1 6 years) 100 1,700 620 0.4, 0.006 9,400 2,900 Children ( 7 12 years) 100 1,900 670 0.4, 0.006 9,500 3,000 These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. For surface and ground water, the EECs for pyriproxyfen are significantly less than the DWLOCs as a contribution to intermediate­ term and short­ term aggregate exposure. Therefore, EPA concludes with reasonable certainty that residues of pyriproxyfen in drinking water do not contribute significantly to the intermediate­ term or short­ term aggregate human health risk at the present time. Pyriproxyfen is classified as not likely to be a human carcinogen, so the Agency did not conduct a cancer aggregate risk assessment. Based upon these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to pyriproxyfen residues. V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology ( gas liquid chromatography with nitrogen­ phosphorus ( GLC/ NP) detector) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755 5350; telephone number: ( 410) 305 2905; e­ mail address: residuemethods@ epa. gov. B. International Residue Limits There are no Codex, Canadian, or Mexican maximum residue limits for residues of pyriproxyfen in/ on strawberry, so international harmonization is not an issue. C. Conditions A maximum of two applications may be made, at a maximum rate of 30 grams active ingredient ( a. i.), using ground application equipment only. No more than 60 grams a. i. may be applied per acre per season. VI. Conclusion Therefore, the tolerance is established for residues of pyriproxyfen, 2­[ 1­ methyl­ 2­( 4­ phenoxyphenoxy) ethoxypyridine], in or on strawberry at 0.30 ppm. VII. Objections and Hearing Requests Under section 408( g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. VerDate 0ct< 31> 2002 12: 36 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1 71109 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0314 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before January 28, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by the docket ID number OPP 2002 0314, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e­ mail to: opp­ docket@ epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). VIII. Regulatory Assessment Requirements This final rule establishes a timelimited tolerance under section 408 of the FFDCA. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect VerDate 0ct< 31> 2002 12: 36 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1 71110 Federal Register / Vol. 67, No. 230 / Friday, November 29, 2002 / Rules and Regulations on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. IX. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 8, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.510 is amended by alphabetically adding `` strawberry'' to the table in paragraph ( b) to read as follows: § 180.510 Pyriproxyfen; tolerances for residues. * * * * * ( b) * * * Commodity Parts per million Expiration/ revocation date * * * * * Strawberry ................................................ 0.30 12/ 31/ 04 * * * * * [ FR Doc. 02 30260 Filed 11 27 02; 8: 45 am] BILLING CODE 6560 50 S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1, 2, 27, 87, 90 and 95 [ WT Docket No. 02 08; FCC 02 152] License Services in the 216 220 MHz, 1390 1395 MHz, 1427 1429 MHz, 1429 1432 MHz, 1432 1435 MHz, 1670 1675 MHz, and 2385 2390 MHz Government Transfer Bands AGENCY: Federal Communications Commission. ACTION: Final rule; correction. SUMMARY: The Federal Communications Commission published a document in the Federal Register on June 20, 2002, ( 67 FR 41847), revising the Quiet Zone procedures for operation near GOES stations. The publication incorrectly indicated that the GOES procedures were contained in § 1.924( f) and, therefore, inadvertently removed the Quiet Zone procedures for operation in the 420 450 MHz band. This document corrects the Quiet Zone procedures by re­ inserting the procedures for operation in 420 450 MHz band into § 1.924( f) and lists the updated procedures for operation near GOES stations into § 1.924( g). DATES: Effective November 29, 2002. FOR FURTHER INFORMATION CONTACT: Keith Fickner regarding legal matters, and/ or Brian Marenco or Tim Maguire regarding engineering matters via phone at ( 202) 418 0680, via TTY ( 202) 418 7233, or via e­ mail at kfickner@ fcc. gov, bmarenco@ fcc. gov or tmaguire@ fcc. gov, respectively, Wireless Telecommunications Bureau, Federal Communications Commission, Washington, DC 20554. SUPPLEMENTARY INFORMATION: In the FR Doc. 02 15373 published in the Federal Register on June 20, 2002, ( 67 FR 41847) the Commission updated the Quiet Zone procedures for operation near GOES stations. The document incorrectly indicated that the GOES procedures were contained in § 1.924( f). The GOES procedures are supposed to be listed in § 1.924( g). The Quiet Zone procedures listed in § 1.924( f) are intended for operation in the 420 450 MHz band. Therefore, the Federal Register publication inadvertently deleted the Quiet Zone procedures for operation in the 420 450 MHz band. The Quiet Zone procedures for operations near GOES stations are intended to apply only to operation in the 1670 1675 MHz band. Therefore, the Quiet Zone procedures for operation in the 420 450 MHz band should be re­ inserted into § 1.924( f) and VerDate 0ct< 31> 2002 16: 53 Nov 27, 2002 Jkt 200001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 29NOR1. SGM 29NOR1

epa

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regulations

EPA-HQ-OPP-2002-0316-0001

Notice

Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations

72673 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices Famoxadone at 97.8%. Proposed classification/ Use: None. For the manufacture of fungicides only. 2. File Symbol: 352 ANU. Applicant: E. I. du Pont de Nemours and Company. Product Name: DPX­ KP481 50DF Fungicide. Fungicide. Active ingredients: Famoxadone at 25% and Cymoxanil at 25%. Proposed classification/ Use: None. For control of downy mildew in cucurbits and lettuce and for the control of early blight and late blight in potatoes and fruiting vegetables. 3. File Symbol: 3125 LLN. Applicant: Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. Product Name: KWG 4168 300 CS. Fungicide. Active ingredient: Spiroxamine at 30.9%. Proposed classification/ Use: None. For control of powdery mildew on grapes. 4. File Symbol: 3125 LLR. Applicant: Bayer CropScience. Product Name: Spiroxamine Technical. Fungicide. Active ingredient: Spiroxamine at 96.6%. Proposed classification/ Use: None. For use in the manufacture of fungicides. 5. File Symbol: 7969 ROA. Applicant: BASF Corporation, P. O. Box 13528, Research Triangle Park, NC 27709 3528. Product Name: BAS510 02F Turf Fungicide. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 70.0%. Proposed classification/ Use: None. For disease control on golf course turfgrass. 6. File Symbol: 7969 ROI. Applicant: BASF Corporation. Product Name: BAS510 F Manufacturing Use Product. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 99.0%. Proposed classification/ Use: None. For use in fungicide formulations. 7. File Symbol: 7969 ROO. Applicant: BASF Corporation. Product Name: BAS516 02 F Crop Fungicide. Fungicide. Active ingredients: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 25.2% and pyraclostrobin at 12.8%. Proposed classification/ Use: None. For use on berries, bulb vegetables, grapes, carrots, pistachio, tree nuts, stone fruits, and strawberries. 8. File Symbol: 7969 ROT. Applicant: BASF Corporation. Product Name: BAS510 02 F Crop Fungicide. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 70.0%. Proposed classification/ Use: None. For use on berries, dry and succulent beans, bulb vegetables, canola, carrots, fruiting vegetables, grapes, lettuce, peanuts, pistachio, potatoes, tree nuts, stone fruits, and strawberries. 9. File Symbol: 11656 OI. Applicant: Western Farm Services, Inc., P. O. Box 1168, Fresno, CA 93715. Product Name: Bud Break Plant Growth Regulator. Plant Growth Regulator. Active ingredients: Ammonium nitrate at 36.0% and Calcium nitrate at 31.0%. Proposed classification/ Use: None. For agricultural use only. 10. File Symbol: 62719 GTG. Applicant: Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 1054. Product Name: Quinoxyfen Technical. Fungicide. Active ingredient: Quinoxyfen at 97.7%. Proposed classification/ Use: None. For manufacturing use only. 11. File Symbol: 62719 GTL. Applicant: Product Name: Quintec. Fungicide. Active ingredient: Quinoxyfen at 22.58%. Proposed classification/ Use: None. A protectant fungicide for the control of powdery mildew on grapes and hops. 12. File Symbol: 62719 GTU. Applicant: Dow AgroSciences LLC. Product Name: Quinoxyfen Manufacturing Use Concentrate. Fungicide. Active ingredient: Quinoxyfen at 53.5%. Proposed classification/ Use: None. For manufacturing use only. List of Subjects Environmental protection, Pesticides and pest. Dated: November 26, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 30945 Filed 12 5 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0316; FRL 7281 5] Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request for amendments by registrants to delete uses in certain pesticide registrations. Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to delete one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any request on the Federal Register. DATES: The deletions are effective on June 4, 2003, or on January 6, 2003 for product registration 019713 00263, unless the Agency receives a withdrawal request on or before dates given above. The 30 day comment period applies to product registration 019713 00263 only. Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant on or before dates given above. ADDRESSES: Withdrawal requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0316 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Hollins, Office of Pesticide Programs ( 7502C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5761; e­ mail address: hollins. james@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0316. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the VerDate 0ct< 31> 2002 17: 30 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72674 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. What Action is the Agency Taking? This notice announces receipt by the Agency of applications from registrants to delete uses in certain pesticide registrations. These registrations are listed in Table 1 by registration number, product name/ active ingredient, and specific uses deleted: TABLE 1. REGISTRATIONS WITH REQUESTS FOR AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS EPA Registration No. Product Name Active Ingredient Delete From Label 000264 00325 SEVIN Brand 97.5% Manfacturing Concentrate Insecticide Carbaryl Poultry 001327 00041 Fulex Nicotine Fumigator Nicotine Greenhouse food crops 001812 00355 Trilin Trifluralin Eggplant, onion 004581 00402 TOPSIN M 70W Turf and Ornamentals Thiophanate­ methyl Sod farms 004581 00405 TOPSIN M 4.5F Turf and Ornamentals Thiophanate­ methyl Sod farms 019713 00263 Drexel Diazinon 5G Diazinon Celery 019713 00539 Drexel Metolachlor Technical Metolachlor Turf use 060063 00017 Sipcam Metolachlor Technical Metolachlor Turf use Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant before dates indicated in DATES section of this notice to discuss withdrawal of the application for amendment. This 30 or 180 day period will also permit interested members of the public to intercede with registrants prior to the Agency's approval of the deletion. Table 2 includes the names and addresses of record for all registrants of the products in Table 1, in sequence by EPA company number. TABLE 2. REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS EPA Company No. Company Name and Address 000264 Bayer Cropscience LP, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709 001327 Fuller System, Inc., Box 3053, Woburn, MA 01888 001812 Griffin L. L. C., Box 1847, Valdosta, GA 31603 TABLE 2. REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS Continued EPA Company No. Company Name and Address 004581 Cerexagri, Inc., 630 Freedom Business Center, Suite 402, King Of Prussia, PA 19046 019713 Drexel Chemical Co, 1700 Channel Ave., Box 13327, Memphis, TN 38113 060063 Sipcam Agro USA, Inc., 300 Colonial Parkway, Suite 230, Roswell, GA 30076 III. What is the Agency Authority for Taking this Action? Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to delete one or more uses. The Act further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the Federal Register. Thereafter, the Administrator may approve such a request. IV. Procedures for Withdrawal of Request Registrants who choose to withdraw a request for use deletion must submit such withdrawal in writing to James A. Hollins, at the address under FOR FURTHER INFORMATION CONTACT, postmarked on or before dates indicated in DATES section of this notice. V. Provisions for Disposition of Existing Stocks The Agency has authorized the registrants to sell or distribute product under the previously approved labeling for a period of 18 months after approval of the revision, unless other restrictions have been imposed, as in special review actions. List of Subjects Environmental protection, Pesticides and pests. Dated: November 21, 2002. Linda Vlier Moos, Acting Director, Information Resources and Services Division. [ FR Doc. 02 30944 Filed 12 5 02; 8: 45 am] BILLING CODE 6560 50 S VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1

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regulations

EPA-HQ-OPP-2002-0317-0001

Notice

Pesticide Products; Registration Applications

70943 Federal Register / Vol. 67, No. 229 / Wednesday, November 27, 2002 / Notices www. ferc. gov using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at 1 866 208 3676, or for TTY, ( 202) 502 8659. A copy is also available for inspection and reproduction at the address in item h above. n. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of rules of practice and procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application. Any filings must bear in all capital letters the title `` COMMENTS,'' `` PROTEST,'' or `` MOTION TO INTERVENE,'' as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application. Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives. Linwood A. Watson, Jr., Deputy Secretary. [ FR Doc. 02 30207 Filed 11 26 02; 8: 45 am] BILLING CODE 6717 01 P ENVIRONMENTAL PROTECTION AGENCY [ FRL 7414 3] Interagency Project To Clean Up Open Dumps on Tribal Lands: Request for Proposals AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice of availability. SUMMARY: The Tribal Solid Waste Interagency Workgroup ( Workgroup) is soliciting proposals for its fifth year of the Tribal Open Dump Cleanup Project ( Cleanup Project). Since FY99, the Workgroup has funded approximately $ 8.8 million in projects. In FY02, the Interagency Workgroup made approximately $ 2.2 million available to fully or partially fund 27 selected projects, for an average of approximately $ 80,000 a proposal. A similar amount of funding is being projected for FY03. Each of these projects will result in the closure or upgrade of one or more open dumps located on tribal lands. The Cleanup Project is part of a federal effort to help tribes comprehensively address their solid waste needs. The purpose of the Cleanup Project is to assist with closing or upgrading tribal high­ threat waste disposal sites and providing alternative disposal and integrated solid waste management. The Workgroup was established in April 1998 to coordinate federal assistance to tribes in bringing their waste disposal sites into compliance with the municipal solid waste landfill criteria ( 40 CFR part 258). Current Workgroup members include representatives from the U. S. Environmental Protection Agency ( EPA); the Bureau of Indian Affairs ( BIA); the Indian Health Service ( IHS); the Bureau of Land Management; the departments of Agriculture, Defense, and Housing and Urban Development. Criteria: Eligible recipients of assistance under The Cleanup Project include federally recognized tribes and intertribal consortiums. A full explanation of the submittal process, the qualifying requirements, and the criteria that will be used to evaluate proposals for this project may be found in the Request for Proposals package. DATES: For consideration, proposals must be received by close of business on January 31, 2003. Proposals postmarked on or before but not received by the closing date will not be considered. Please do not rely solely on overnight mail to meet the deadlines. FOR FURTHER INFORMATION CONTACT: Copies of the Request for Proposals package may be downloaded from the Internet at < www. epa. gov/ tribalmsw> by clicking on `` Recent Additions.'' Copies may also be obtained by contacting EPA, IHS or BIA regional or area offices or one of the following Workgroup representatives: EPA Charles Bearfighter Reddoor 703 308 8245, Christopher Dege, 703 308 2392, or Tonya Hawkins, 703 308 8278. IHS Steve Aoyama, 301 443 1046. BIA Debbie McBride, 202 208 3606. Dated: November 4, 2002. Robert Springer, Director, Office of Solid Waste. [ FR Doc. 02 30116 Filed 11 26 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0317; FRL 7281 4] Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces receipt of an application to register a pesticide product containing a new active ingredient not included in any previously registered products pursuant to the provisions of section 3( c)( 4) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. DATES: Written comments, identified by the docket ID number OPP 2002 0317, must be received on or before December 27, 2002. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Geri McCann, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 605 0716; e­ mail address; mccann. geri@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are a pesticide manufacturer. Potentially affected entities may include, but are not limited to: Pesticide Manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether VerDate 0ct< 31> 2002 16: 54 Nov 26, 2002 Jkt 200001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 27NON1. SGM 27NON1 70944 Federal Register / Vol. 67, No. 229 / Wednesday, November 27, 2002 / Notices you or your business may be affected by this action, you should carefully examine the applicability provisions in Section II of this notice. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0317. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legalholidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public comments, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0317. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0317. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., VerDate 0ct< 31> 2002 16: 54 Nov 26, 2002 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 27NON1. SGM 27NON1 70945 Federal Register / Vol. 67, No. 229 / Wednesday, November 27, 2002 / Notices Washington, DC, 20460 0001, Attention: Docket ID Number OPP 2002 0317. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0317. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the registration activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Registration Application EPA received an application as follows to register a pesticide product containing an active ingredient not included in any previously registered products pursuant to the provision of section 3( c)( 4) of FIFRA. Notice of receipt of this application does not imply a decision by the Agency on the application. Product Containing an Active Ingredient not Included in any Previously Registered Products File symbol: 56228 GU. Applicant: United States Department of Agriculture, Animal Plant and Health Inspection Service, 4700 River Road, Unit 152, Riverdale, MD 20737. Product name: Acetaminophen For Brown Treesnake Control. Product type: Pesticide. Active ingredient: Contains 72.7% of the new active ingredient acetaminophen. Proposed classification/ Use: For control and reduction of brown treesnake abundance on Guam and the Northern Mariana Islands and to protect against brown treesnakes being exported to Hawaii or the Continental United States as hitchhikers in cargo. List of Subjects Environmental protection, Pesticides and pest. Dated: November 18, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 30122 Filed 11 26 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0310; FRL 7280 5] Pesticide Product; Registration Approval AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces Agency approval of an application to register the pesticide product Bromuconazole Technical containing an active ingredient not included in any previously registered product pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9354; and e­ mail address: waller. mary@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0310. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., VerDate 0ct< 31> 2002 16: 54 Nov 26, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 27NON1. SGM 27NON1

epa

2024-06-07T20:31:45.313212

regulations

EPA-HQ-OPP-2002-0319-0001

Proposed Rule

Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

72675 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0319; FRL 7281 9] Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0319, must be received on or before January 6, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 8380; e­ mail address: gandhi. bipin@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, pesticide manufacturer, or antimicrobial pesticide manufacturer. Potentially affected entities may include, but are not limited to: Industry ( NAICS 111), e. g., Crop Production. Industry ( NAICS 112), e. g., Animal Production. Industry ( NAICS 311), e. g., Food manufacturing. Industry ( NAICS 32532), e. g., Pesticide Manufacturing. Industry ( NAICS 32561), e. g., Antimicrobial Pesticide. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0319. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e­ VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72676 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0319. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0319. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0319. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0319. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 20, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. 3E6523 EPA has received a pesticide petition ( PP 3E6523) from Akzo Nobel Industrial Specialties, Inc., 15200 Almeda Road, Houston, TX 77053 proposing, pursuant to section 408( d) of the FFDCA, 21 U. S. C. 346a( d), to amend 40 CFR 180.960 to establish an exemption from the requirement of a tolerance for a­ Hydro­ ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates, poly( oxyethylene) content is 4 12 moles. EPA has determined that the petition contains data or information VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72677 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry Analytical method. Akzo Nobel is petitioning that a­ hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates be exempt from the requirement of a tolerance based upon the definition of a low risk polymer under 40 CFR 723.250( e). Therefore, an analytical method to determine residues of ahydro ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates in raw agricultural commodities ( RACs) is not required. B. Toxicological Profile As part of the EPA policy statement on inert ingredients, the Agency set forth a list of studies which would generally be used to evaluate the risks posed by the presence of an inert ingredient in a pesticide formulation. However, where it can be determined without the data that the inert ingredient will present minimal or no risk, the Agency generally does not require some or all of the required studies to rule on the proposed tolerance or exemption from the requirement of a tolerance for an inert ingredient. Akzo Nobel Industrial Specialties, Inc. believes that the data and the information described below are adequate to ascertain the toxicology and characterize the risk associated with the use of a­ hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates, poly( oxyethylene) content is 4 12 moles which represent C8 alkyl ether citrate ( CAS Registration Number: 330977 00 9), C10­ C16 alkyl ether citrates ( CAS Registration Number: 330985 58 5) and C16­ C18­ alkyl ether citrates ( CAS Registration Number: 330985 61 0) as inert ingredients in pesticide formulations. In the case of certain chemical substances that are defined as `` polymers'' the EPA has established a set of criteria which identify categories of polymers that present low risk. These criteria ( codified in 40 CFR 723.250) identify polymers that are relatively unreactive and stable compared to other chemical substances as well as polymers that are not readily absorbed. These properties generally limit a polymer's ability to cause adverse effects. In addition, these criteria exclude polymers about which little is known. The EPA believes that polymers meeting the criteria noted below will present minimal or no risk. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates, poly( oxyethylene) content is 4 12 moles which represent C8 alkyl ether citrate ( CAS Registration Number: 330977 00 9), C10­ C16 alkyl ether citrates ( CAS Registration Number: 330985 58 5) and C16­ C18­ alkyl ether citrates ( CAS Registration Number: 330985 61 0) conform to the definition of a polymer given in 40 CFR 723.250( b) and meet the following criteria that are used to identify low risk polymers. 1. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates are not cationic polymers, nor are they reasonably anticipated to become cationic polymers in a natural aquatic environment. 2. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates contain as an integral part of their composition the atomic elements carbon, oxygen, and hydrogen. 3. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates do not contain as an integral part of their composition any elements other those listed in 40 CFR 723.250( d)( 2)( ii). 4. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates are not designed, nor are they reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates are not manufactured or imported from monomers and/ or other reactants that are not already included on the Toxic Substances Control Act ( TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates are not water absorbing polymers. 7. a­ Hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates do not contain any group as reactive functional groups. 8. The minimum number­ average molecular weights of polymers represented by a­ hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates are listed as shown below: C8 alkyl ether citrate ( CAS Registration Number: 330977 00 9) 1,300 daltons C10­ C16 alkyl ether citrates ( CAS Registration Number: 330985 58 5) 1,100 daltons C16­ C18­ alkyl ether citrates ( CAS Registration Number: 330985 61 0) 1,300 daltons Substances with molecular weights greater than 400 generally are not absorbed through the intact skin, and substances with molecular weights greater than 1,000 generally are not absorbed through the intact gastrointestinal ( GI) tract. Chemicals not absorbed through the skin or GI tract generally are incapable of eliciting a toxic response. 9. The polymers represented by ahydro ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates have numberaverage molecular weights greater than 1,100 and contain less than 10% oligomeric material below molecular weight of 500 and less than 25% oligomeric material below 1,000 molecular weight. In addition, the monomers/ reactants that are used for the production of polymers represented by a­ hydro­ ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates have prior clearances by the Food and Drug Administration ( FDA) under 21 CFR for food contact applications, and by the Environmental Protection Agency under 40 CFR for use in pesticide formulations applied to raw agricultural commodities ( RAC). 1. Citric acid ( CAS Registration Number: 77 92 9) was affirmed by FDA as generally recognized as safe ( GRAS) under 21 CFR 184.1033 for use in food for human consumption. 2. Citric acid ( CAS Registration Number: 77 92 9) is cleared under 40 CFR 180.1001( c) and ( e) as an inert ingredient in pesticide formulations applied to RAC. It is included in Inerts ­ List 4A. 3. Fatty alcohols are widely present in oils, fats and waxes which are used in human food. Some waxes ( bees wax, candelilla wax and carnauba wax) are GRAS substances ( 21 CFR Part 184). Bees wax and carnauba wax are in Inerts ­ List 4B. 4. C8­ C18 Alcohols are List 3 inerts. Ethoxylated C10­ C16 alcohols ( CAS Registration Number: 68002 97 1) and ethoxylated C16­ C18 alcohols ( CAS Registration Number: 68439 49 6) are included in Inerts ­ List 3. Ethoxylated C9­ C16 alcohols ( CAS Registration Number: 97043 91 9) are in Inerts ­ List 4B. C. Aggregate Exposure Although exposure to three polymers represented by a­ hydro­ ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates may occur through dietary sources, the chemical characteristics of these polymers lead to the conclusion that there is a reasonable certainty of no harm from aggregate exposure to these polymers. VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72678 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide products applied to food crops. EPA has also established exemptions from tolerance for polymeric materials used as pesticide inert ingredients that it considers to be intrinsically safe based on the fact that they are listed on the TSCA Inventory or meet the requirements of the amended TSCA polymer exemption and are thereby not subject to the requirements of the premanufacturing notification. Any exposure resulting from the approval of three polymers represented by a­ hydro­ ­ hydroxypoly oxyethylene) C8­ C18­ alkyl ether citrates in pesticide formulations for use on growing crops or to RAC after harvest is not warranted. D. Cumulative Effects At this time there is no information to indicate that any toxic effects produced by three polymers represented by ahydro ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates having a number average molecular weight of at least 1,100 would be cumulative with those of any other chemical substance( s). Given the categorization of these polymers as a `` low risk polymer'' ( 40 CFR 723.250) and their proposed use as inert ingredients in pesticide formulations, there is no reasonable expectation of increased risk due to cumulative exposure. E. Safety Determination 1. U. S. population. As a matter of policy, EPA has in the past established exemptions from tolerance for polymeric substances used as pesticide inert ingredients that it considers to be intrinsically safe based on the fact that they are listed on the TSCA Inventory or meet the requirements of the amended TSCA polymer exemption and are thereby not subject to the requirements of premanufacture notice ( PMN). The Agency has maintained that polymers meeting the polymer exemption criteria will present minimal risk to human health when used as inert ingredients in pesticide formulations. 2. Infants and children. FFDCA section 408 provides that EPA shall supply an additional tenfold margin of safety for infants and children in the case of threshold effects where prenatal and/ or postnatal toxicity are found or there is incompleteness of the database, unless EPA concludes that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through the use of margin of exposure ( MOE) analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. Due to the low expected toxicity of these three polymers represented by ahydro ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates, a safety factor analysis is not required for assessing the risk. For the same reasons the additional safety factor is unnecessary. F. International Tolerances Akzo Nobel Industrial Specialties, Inc. is not aware of any country requiring a tolerance for the three polymers represented by a­ hydro­ ­ hydroxy­ poly( oxyethylene) C8­ C18­ alkyl ether citrates having a number average molecular weights of at least 1,100. Nor have there been any CODEX Maximum Residue Levels ( MRLs) established for any food crops at this time. [ FR Doc. 02 30946 Filed 12 5 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0211; FRL 7283 3] Imazethapyr; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0211, must be received on or before January 6, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5697; e­ mail address: tompkins. jim@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Crop production ( NAICS 111) Animal production ( NAICS 112) Food manufacturing ( NAICS 311 Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0211. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to VerDate 0ct< 31> 2002 17: 07 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1

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Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 0161.09/OMB No. 2070-0027; Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides

72164 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices action it takes, i. e., issues, amends, or revokes, a State registration. The Agency has 90 days to disapprove the registration. In such cases, the State is responsible for notifying the affected registrant. Burden Statement: According to the Paperwork Reduction Act ( PRA), `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that is subject to approval under the PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections appear on the collection instruments or instructions, in the Federal Register notices for related rulemakings and ICR notices, and, if the collection is contained in a regulation, in a table of OMB approval numbers in 40 CFR part 9. The following is a summary of the burden estimates taken from the ICR: Respondents/ affected entities: State and territorial governments ( the 50 states plus Washington, DC, Puerto Rico, the U. S. Virgin Islands, Guam and the islands of the Pacific Territory, and American Samoa). Estimated total number of potential respondents: 60. Frequency of response: As needed. Estimated total/ average number of responses for each respondent: 5 6. Estimated total annual burden hours: 18,200. Estimated total annual burden costs: $ 1,585,150. Changes in the ICR Since the Last Approval: The Agency revised its burden estimates for both States and applicants based on information received during the public comment period and in consultation with respondents. The average applicant response burden decreased by 29 hours while the average State response burden increased by 11.5 hours, resulting in a net decrease in burden for the activities associated with this ICR. EPA estimates that the overall respondent burden has decreased from 24,604 hours to 18,200 hours, a decrease in burden of 6,404 hours. These changes are described in detail in the ICR. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above. Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 30758 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0320; FRL 7417 6] Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 0161.09/ OMB No. 2070 0027; Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides; OMB No. 2070 0027; EPA No. 0161.09. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs. DATES: Additional comments may be submitted on or before January 3, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 6475; fax number: ( 703) 305 5884; e­ mail address: vogel. nancy@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. The Federal Register document, required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on December 12, 2001 ( 66 FR 64246). EPA received no comments on this ICR during the 60­ day comment period. EPA has established a public docket for this ICR under Docket ID No. OPP 2002 0320 ( formerly Docket Control No. OPP 00751), which is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to oppdocket epa. gov, or by mail to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0320; and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72165 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http;// www. epa. gov./ edocket. ICR Title: Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides ( OMB NO. 2070 0027; EPA No. 0161.09) ICR Status: This is a request for extension of an existing approved collection that is currently scheduled to expire on November 30, 2002. EPA is asking OMB to approve this ICR for three years. Under 5 CFR 1320.12( b)( 2), the Agency may continue to conduct or sponsor the collection of information while the submission is pending at OMB. Abstract: This information collection program is designed to enable the Environmental Protection Agency ( EPA) to provide notice to foreign purchasers of unregistered pesticides exported from the United States that the pesticide product cannot be sold in the United States. Section 17( a)( 2) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) requires an exporter of any pesticide not registered under FIFRA section 3 or sold under FIFRA section 6( a)( 1) to obtain a signed statement from the foreign purchaser acknowledging that the purchaser is aware that the pesticide is not registered for use in, and cannot be sold in, the United States. A copy of this statement must be transmitted to an appropriate official of the government in the importing country. The purpose of the purchaser acknowledgment statement requirement is to notify the government of the importing country that a pesticide judged hazardous to human health or the environment, or for which no such hazard assessment has been made, will be imported into that country. This information is submitted in the form of annual or per­ shipment statements to the EPA, which maintains original records and transmits copies thereof to appropriate government officials of the countries which are importing the pesticide. Burden Statement: The annual `` respondent'' burden for this ICR is estimated to be 24,753 hours. According to the Paperwork Reduction Act ( PRA), `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that is subject to approval under the PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections appear on the collection instruments or instructions, in the Federal Register notices for related rulemakings and ICR notices, and, if the collection is contained in a regulation, in a table of OMB approval numbers in 40 CFR part 9. The following is a summary of the burden estimates taken from the ICR: Respondents/ affected entities: Individuals or entities engaged in activities related to the registration of a pesticide product. Estimated total number of potential respondents: 2,500. Frequency of response: Annual or pershipment Estimated total/ average number of responses for each respondent: 1. Estimated total annual burden hours: 24,753. Estimated total annual burden costs: $ 1,902,400. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above. Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 30759 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ FRL 7417 5] Agency Information Collection Activities: Submission for OMB Review; Comment Request; NSPS for Beverage Can Surface Coating AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Title: NSPS for Beverage Can Surface Coating 40 CFR part 60, subpart WW, OMB Control Number 2060 0001, expiration date January 31, 2003. The ICR describes the nature of the information collection and its expected burden and cost; where appropriate, it includes the actual data collection instrument. DATES: Comments must be submitted on or before January 3, 2003. ADDRESSES: Send comments, referencing EPA ICR Number 0663.08 and OMB Control Number 2060 0001, to the following addresses: Susan Auby, United States Environmental Protection Agency, Collection Strategies Division ( Mail Code 2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460 0001; and to the Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: For a copy of the ICR, contact Susan Auby at ( 202) 566 1672 or by e­ mail to auby. susan@ epa. gov or download from the Internet at: http:// www. epa. gov/ icr, and refer to EPA ICR Number 0663.08. For technical questions about the ICR, contact Steven Hoover at ( 202) 564 7007, or by e­ mail to: hoover. steven@ epa. gov. SUPPLEMENTARY INFORMATION: Title: NSPS for Beverage Can Surface Coating 40 CFR part 60, subpart WW, OMB Control Number 2060 0001, EPA ICR Number 0663.08, expiration date January 31, 2003. This is a request for extension of a currently approved collection. Abstract: The New Source Performance Standards ( NSPS) for Surface Coating of Beverage Cans were proposed on November 26, 1980, and promulgated on August 25, 1983. These standards apply to each beverage can surface coating operation in which organic coatings are applied ( exterior base coat operations, over varnish coating operations, and inside spray coating operations) that commenced construction, modification or reconstruction after November 26, 1980. Approximately 46 sources are currently subject to the standard, and it is estimated that 2 sources per year will VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1

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Supporting & Related Material

November 14, 2002 Page 1 of 17 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR) 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection TITLE: Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides OMB No. 2070­ 0027 EPA No. 0161.09 1( b) Short Characterization/ Abstract This information collection program is designed to enable the Environmental Protection Agency ( EPA) to provide notice to foreign purchasers of unregistered pesticides exported from the United States that the pesticide product cannot be sold in the United States. Section 17( a)( 2) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) requires an exporter of any pesticide not registered under FIFRA section 3 or sold under FIFRA section 6( a)( 1) to obtain a signed statement from the foreign purchaser acknowledging that the purchaser is aware that the pesticide is not registered for use in, and cannot be sold in, the United States. A copy of this statement must be transmitted to an appropriate official of the government in the importing country. The purpose of the purchaser acknowledgment statement requirement is to notify the government of the importing country that a pesticide judged hazardous to human health or the environment, or for which no such hazard assessment has been made, will be imported into that country. This information is submitted in the form of annual or per­ shipment statements to the EPA, which maintains original records and transmits copies thereof to appropriate government officials of the countries which are importing the pesticide. The burden for this information collection has been constant since the implementation of the 1993 pesticide export policy governing the export of pesticides, devices, and active ingredients used in producing pesticides. EPA is including in this renewal of the information collection request an estimate of the burden imposed by export labeling requirements, which meet the definition of third­ party labeling. 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection This information is required to be submitted to EPA pursuant to section 17( a)( 2) of FIFRA. Regulations pertaining to exporting pesticides are contained in Title 40 of the Code of Federal Regulations, Part 168, Subpart D. November 14, 2002 Page 2 of 17 2( b) Practical Utility/ Users of the Data Section 17( a)( 2) of FIFRA requires all exporters of unregistered pesticides to obtain signed statements from their customers acknowledging that they are aware that their purchased products are not registered in the United States. Hence, one use of this collection activity is in assuring that foreign purchasers of pesticides produced in the U. S. are aware of the products' U. S. registration status. When such statements are submitted to EPA, the Agency is provided with a record of foreign destinations of domestically produced unregistered products. This is important to enable the Agency to assure that such products, which are produced in the U. S. but cannot be legally sold for use in the U. S., have been legally distributed. In addition, such statements are required by statute to be directed onward to the appropriate government officials in importing countries. These officials may use such documents to verify the U. S. registration status of products which are arriving or have arrived in their country. Officials of foreign governments can also use this information to verify how many shipments of a particular pesticide are being sent to their country. This information is extremely useful in countries which do not have the resources to maintain extensive import records or control systems. 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication The submission of purchaser acknowledgment statements is a statutory provision which must be met before unregistered pesticides may be exported. This information is in turn required by statute to be sent to the governments of importing countries. With the current system, EPA recognizes that repeated submissions of purchaser acknowledgment statements involving the same country, purchase, and chemical would be duplicative, except in regards to identifying the number of shipments to which they apply. For this reason, EPA only requires this statement to be submitted once per year and that the exporter provides summary information indicating the number of shipments which apply to each submitted statement. This eliminates the redundancy that would be associated with the submission of identical acknowledgment statements, while still providing EPA and foreign governments with full information regarding the number of shipments in the calendar year. November 14, 2002 Page 3 of 17 3( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA published a Federal Register Notice that provided a 60­ day public notice and comment period that ended on February 11, 2002 ( see Attachment ). No comments were received in response to that notice. 3( c) Consultations EPA consulted with several stakeholders in developing the burden estimates for this ICR renewal, including: Jose Lopez, Marketing Arm International Inc. 941­ 743­ 5533 David Edison, Environmental Safety Products 541­ 332­ 8202 Richard Costlow, Rohm & Haas Co. 215­ 641­ 7331 All stakeholders contacted believed that the estimates in the ICR were reasonable and in line with actual costs. David Edison of Environmental Safety Products noted that while complying with FIFRA 17( a) generally takes little time, follow­ up, involving resubmitting the forms and answering questions from foreign purchasers, can be time­ consuming. Richard Costlow of Rohm & Haas added that complying with the multilingual labeling requirements can be more time­ consuming and costly when the foreign purchaser is in an Asian or Arabic speaking country. 3( d) Effects of Less Frequent Collection By offering the compliance option of annual reporting, EPA is offering a less frequent information collection to reduce the burden of per­ shipment reporting. Further reduction, i. e., to a one­ time submission for the life of the product or otherwise to a frequency of less than once a year would damage the correlation of statements with the actual regulatory status of pesticide products, which may change from year to year. Unless statements are renewed on an annual basis, it becomes difficult for the purchaser to know whether the regulatory status of the product has changed from the previous year, or for foreign governments to determine whether or not the regulatory status reflected in the most current statement reflects the actual regulatory status of the product. The annual summaries provide EPA with the ability to monitor compliance with the requirements of section 17( a). Currently, such records need be kept for only two years. Since the summaries are submitted at the end of an applicable year, less frequent submissions would occasionally result in the necessary records not being available to validate submissions. November 14, 2002 Page 4 of 17 3( e) General Guidelines The following areas are not applicable to this information request: reports of quarterly or greater frequency. records required to be maintained for more than three years. statistical surveys. written responses to this information collection required less than 30 days after receipt. required specific format ( NB: the new system may include a specific format). submission of more than an original and two copies of the information collected. remuneration to be received by the respondents for the information submission. OMB's regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses, and an explanation of the decision ( 5 CFR 1320.5( a)( iii)( E)). No automated techniques for information submission are available which are suitable to this information collection. But during the implementation of the new requirements under the Rotterdam Convention on the Prior Informed Consent ( PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade ( see discussion in section 6( d), below), electronic submission and transmission will be examined. The submissions must be made in a form which can be sent to and subsequently read and understood by appropriate officials of foreign governments. 3( f) Confidentiality Although the EPA urges submitters to minimize the amount of claimed Confidential Business Information ( CBI), all data and/ or information brought to the Agency in conjunction with this rule that may be claimed as trade secret, commercial or financial information will be protected from disclosure by EPA under FIFRA section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. Confidential business information may be required to be submitted in the case where a business wishes to export an unregistered research pesticide product. EPA recognizes that the chemical identity of the product may require protection as confidential business information, but believes that it is essential that the Agency nevertheless be able to accurately identify the nature of the product, both for domestic compliance monitoring and to meet possible future requirements under the PIC agreement. The name of the foreign purchaser is generally afforded CBI treatment in the U. S., but, according to statute, must be reported to the government of the importing country. EPA is aware that foreign governments consider the name of the purchaser in their country to be the most useful information transmitted with the export notice. Aside from the name and address of the foreign purchaser, no information required to be November 14, 2002 Page 5 of 17 submitted in purchaser acknowledgment statements is considered to be confidential. EPA has specifically stated that certain information which could be considered confidential is not included in the statements. Specifically, the identity of a product under research and development may be identified by use of identification codes which protect proprietary information. ( However, most research and development shipments are exempt from the requirement.) EPA also is not requiring that the acknowledgment statements, the estimates, or the annual summaries indicate the amount of product shipped or to be shipped, since this information may be confidential. The actual fact that shipments occur is not considered to be confidential since the statute clearly requires that such submission be made to EPA, and that such statements be transmitted to foreign governments, where it is not possible for EPA to protect confidentiality. 3( g) Sensitive Questions No information of a sensitive nature is required to be submitted. 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents ­ NAICS Codes Respondents affected by the collection activities under this ICR are individuals or entities who either manufacture and export or who reformulate or repackage and export unregistered pesticides. The North American Industrial Classification System ( NAICS) code assigned to the parties responding to this information is as follows: Category NAICS code Examples of potentially affected entities Pesticide and other agricultural chemical manufacturing 325320 Individuals or entities engaged in activities related to the registration of a pesticide product. 4( b) Information Requested There are no forms for this activity. In preparing the statement, the exporter is free to format the document in any manner as long as it includes all of the required information. The exporter must obtain the signed statement from the foreign purchaser before the pesticide can be shipped. i. Data items, including record keeping requirements: Foreign Purchaser Acknowledgment Statement ( FPAS) ­ The respondent must ascertain the November 14, 2002 Page 6 of 17 registration status of the product that is being produced for export. After determining that an exported product is not registered in the Untied States, the exporter must obtain a statement of the type described in item 3( b)( i) from the foreign purchaser of the pesticide product. This will normally require that the exporter provide the purchaser with a prepared statement for signature or with instructions that are adequate to ensure that the purchaser can prepare the statement. If the exporter anticipates making more than one shipment of the product to the purchaser in a given year, the exporter may elect to notify EPA only at the time of the first shipment and to choose to comply with the annual reporting option, which requires the submission of an annual summary of shipments of pesticides shipped to each purchaser. The exporter is required to send a copy of the purchaser acknowledgment statement to EPA within 7 days of having shipped the pesticide, along with a signed statement that the shipment did not occur prior to receipt of the purchaser acknowledgment statement. In addition, if the exporter chooses the annual reporting option, he or she must include a statement that the FPAS is for the first shipment of a pesticide to a particular purchaser in a specific country, and that the exporter will report this information annually. Where an exporter chooses to comply with the annual summary reporting option, a summary must be sent after the end or the calendar year which lists all shipments of a particular pesticide shipped to a particular foreign purchaser. It is not required for the statement to be shipped in time for EPA to notify the importing country prior to arrival of the pesticide. Submission of a purchaser acknowledgment statement does not require the maintenance of any records unique to this section. All records needed to ensure and verify compliance with this requirement are required under section 8 of FIFRA. The FPAS must contain the following information: Name and address of exporter. Name and address of foreign purchaser. Name of product and active ingredient. Statement that foreign purchaser is aware that the product is not registered for use in the United States and cannot be sold for use in the United States. If known, country of final destination of the exported shipment if different from country of import. Signature of foreign purchaser. Date that purchaser acknowledgment statement is signed by foreign purchaser. Certification that shipment did not occur prior to receipt of Purchaser Acknowledgment Statement Exporter's signature. Third Party Notification Requirements; Export Labeling ­ The following information must be November 14, 2002 Page 7 of 17 included on the labels or labeling of exported pesticides: EPA pesticide producing establishment number. Warning or caution statements. The statement " Not Registered for Use in the United States of America." The labels of all pesticides, devices, and active ingredients which are not registered for use in the United States under FIFRA section 3 must include this statement. The ingredient statement. Identity of parties. Weight or measure. Additional warning for highly toxic pesticides. Use classification statement. Multilingual labeling requirement ­ The following labeling information must be multilingual: Warning and caution statements. Where applicable, the statement " Not registered for use in the United States of America." Ingredient statement If the pesticide, device or active ingredient is highly toxic to humans, the skull and crossbones, the word " Poison," and a statement of practical treatment must appear on the label. The word " Poison" and the statement of practical treatment shall be in English and in an acceptable language of the country of import, and in an acceptable language in the country of final destination, if known or reasonably ascertainable. ( ii) Respondent Activities A) Submission of Foreign Purchaser Acknowledgment Statement B) Exemption of research and development pesticides. Records supporting research and development status must include records of communication received by exporter regarding research intent of shipment and information indicating knowledge that quantity shipped is consistent with research intent. Persons claiming an exemption from the FPAS requirement for the export of research and development products must maintain records which support the R& D claim for each shipment so claimed. In its policy, EPA has limited research claims only to shipments where it is unlikely that the quantity shipped could have a significant commercial use. Thus the records must be sufficient to support the claim that the quantity shipped is only sufficient for use within the limits of the policy. This can be done either in the form of communications received from the purchaser before or on the date of export or in the form of instructions sent to the purchaser before or on the date of export. November 14, 2002 Page 8 of 17 Alternatively, the exporter may retain records which indicate that the quantity shipped is compatible with the claim that the amount sent is not enough to be used in applications exceeding those provided as exempt under the policy. Such information could include results of test, citations of literature, or other information which supports the claim. At the time of shipment, the exporter must produce a record of the identity, amount, and date that the pesticide was shipped, the destination and purchaser, and the intended research use. Most of this information is provided in copies of or original invoice/ shipping records normally maintained for such products. Note that records of shipment of pesticides are already required to be maintained under FIFRA section 8. Other documentation supporting research use is generally available as typical business practice and should not impose additional burden to maintain with shipping records. Records of shipment and confirmation of research intent must be maintained and made available for inspection and copying by EPA for two years following the exportation of the pesticide. C) Export labeling Every exported pesticide, device, and active ingredient used in producing a pesticide must bear a label or labeling which meets the requirements of FIFRA section 17( a)( 1). This requirement applies to all such pesticides, devices, or active ingredients, regardless of whether the export is for commercial or research and development use. The specific requirements for the labeling of exported pesticides are described in section 4( b) of this paper. The required label statements may be met through either immediate container labels, or accompanying supplemental labeling, or through a combination of the two. EPA included supplemental labeling as an option to ease the compliance burden of this requirement. Rather than prepare individual product labels with the necessary information, the exporter can attach a paper to the shipping container, e. g., attaching a paper to the shrink wrap around multiple containers on a shipping pallet. Exporters are also required to keep records of the product labeling used, including the EPA registered labeling, any foreign labeling on or attached to the product when shipped, and as applicable, any supplemental labeling used. The records shall be maintained in a manner that shows exactly which labels and labeling accompanied each shipment of a pesticide product to a foreign country. 5. THE INFORMATION COLLECTED ­­ AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities EPA is required to perform the following activities: November 14, 2002 Page 9 of 17 Respond to questions submitted by respondents Receive submissions of acknowledgment statements, certification statements, notifications of shipments and summaries of shipments Review submissions for completeness Transmit submissions of acknowledgment statements, notifications and summaries of shipments to appropriate government officials of importing countries Maintain a file of all submissions Respond to requests for the information 5( b) Collection Methodology and Management EPA maintains a file of all submitted acknowledgment statements. This file includes the following for each submitted statement: ( 1) a copy of the purchaser acknowledgment statement and certification that shipment did not occur before receipt of statement by exporter; ( 2) a copy of the delivery receipt and the date that the statement was signed and delivered to EPA; ( 3) the date that the statement was forwarded to the appropriate government official and agency of the importing country; and ( 4) a copy of the estimate summary of the number of shipments to be made in association with that statement. EPA reviews its files annually for completeness, following the submission of annual summaries of shipments, by referencing establishment reporting records for apparent discrepancies. EPA targets inspections based on such apparent discrepancies to determine whether a violation under FIFRA has occurred. 5( c) Small Entity Flexibility Under this reporting requirement, small entities must follow the same collection procedures as large companies. However, EPA provides flexibility in the formatting of submissions which will reduce the proportionately higher burden which would be placed on occasional submitters by strict requirements. In addition, the Agency allows respondents to determine the method of obtaining the purchaser acknowledgment statement. Finally, respondents are allowed flexibility in choosing between annual estimates and summaries or pershipment statements. 5( d) Collection Schedule Not applicable. The activity is conducted only as purchaser acknowledgment statements are received. There is no set schedule for the collection of this information. 6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden November 14, 2002 Page 10 of 17 The overall respondent burden hours associated with this collection total 24,753 hours per year. The average number of respondents per calendar year over the past three years has remained constant at 2,500. No changes have been made to requirements for foreign purchaser acknowledgments. The requirements to be fulfilled under this ICR consist of two parts: submission of the Foreign Purchaser Acknowledgment Statements ( FPAS); and the third party notification export labeling requirement. The third party labeling requirement is further subdivided into labeling requirements for unregistered exported pesticide products and multilingual labeling for registered exported pesticide products. Estimating the Respondent Burden of the FPAS Requirement This ICR renewal includes a respondent burden estimate of 2,650 hours for the FPAS requirement. This figure is based on the approximately 2,500 notices received annually pursuant to the export policy. Table 1 presents the expected labor mix required and a breakdown of the FPAS collection activities per respondent. Annual Respondent Burden/ Cost: Submission of Foreign Purchaser Acknowledgment Statement Collection Activity Burden Hours Total Mgmt $ 123/ hr Tech $ 83/ hr Cler $ 38/ hr Hours Cost ($) Read Regulations 0.08 0.08 9.84 Plan Activities 0.08 0.08 6.64 Gather Information 0.08 0.08 6.64 Process, compile and reveal information 0.16 0.16 13.28 Complete paperwork 0.25 0.25 0.50 30.25 Record, disclose & display information 0.08 0.08 3.04 November 14, 2002 Page 11 of 17 Store, maintain and file information 0.08 0.08 3.04 TOTAL 0.08 0.57 0.41 1.06 72.73 ANNUAL BURDEN: 1.06 hrs ( 64 minutes) X 2,500 respondents = 2,650 hours per year ANNUAL COSTS: $ 72.73 X 2,500 respondents = $ 181,825 per year The clarifications regarding record keeping to ensure compliance will not result in additional burden since all such records are either already required to be kept under FIFRA Section 8 or are maintained in the normal course of business. Exporters who feel that pershipment submissions represent undue burden may choose to report annually. The per­ shipment notification and annual summary requirements of this option are based on records of production and shipment records already required by regulations under FIFRA Section 8, so such information will be readily available to exporters, who may submit it without reformatting or special preparation. These annual submissions may be included as part of the annual submission of acknowledgment statements and thus would result in minimal burden. Estimating the Respondent Burden of the Third Party Notification Export Labeling Requirement It is estimated that one­ quarter of the pesticides exported from the U. S. are not registered for use in the United States. Approximately 900 unregistered pesticide products are exported annually. To estimate the total number of registered pesticides exported from the U. S. annually, EPA multiplied by four the number of unregistered pesticide products. Multiplying this by four gives an estimated total of 3,600 pesticide products( registered and unregistered) exported annually. As discussed above in section 4( b), certain information must be included on the labels or labeling of exported pesticides. The labeling requirements may be met by supplemental labeling attached to either the product container or the shipping container. November 14, 2002 Page 12 of 17 Annual Respondent Burden/ Cost: Labeling Requirement for Unregistered Exported Pesticide Products Collection Activity Burden Hours Total Mgmt $ 123 Tech $ 83 Cler $ 38 Hours Costs ($) Read Regulations 0.5 0.5 61.5 Design Labels 2.0 2 166.0 Translate Labels 5.0 5 415.0 Complete Paperwork and Store Information 0.5 0.5 19.0 TOTAL 0.5 7.0 0.5 8.0 661.5 ANNUAL BURDEN: 8 hours x 900 unregistered products = 7,200 hours ANNUAL COSTS: $ 661.5 x 900 unregistered products = $ 595,350. Certain information must be provided in the languages of the country or countries of final destination. EPA estimates that it will take respondents approximately 5.5 hours to meet the multilingual labeling requirement for each product. EPA estimates that to prepare one label in one language would take approximately one hour. In reviewing the major destinations of export shipments, EPA estimates that most labels would be in one or more of the following languages: French, Spanish, German, Taiwanese, and Portuguese. November 14, 2002 Page 13 of 17 Multilingual Labeling for Registered Exported Pesticide Products Collection Activity Burden Hours Total Mgmt $ 123 Tech $ 83 Cler $ 38 Hours Costs ($) Translate Label 5 5 415 Complete Paperwork and Store Information 0.5 0.5 19 TOTAL 0 5 0.5 5.5 434 ANNUAL BURDEN: 5.5 hours x 2700 exported registered products = 14,850 hours ANNUAL COSTS: $ 434 x 2700 exported registered products = $ 1,171,800 6( b) Estimating Respondent Cost The total annual respondent cost for this ICR is estimated to be $ 1,948,975, broken down as follows: Foreign purchaser acknowledgment statement $ 181,825 Labeling/ unregistered pesticides $ 595,350 Labeling/ registered pesticides $ 1,171,800 TOTAL $ 1,948,975 EPA estimated the respondent burden cost based on the estimated hourly loaded labor rate ( including salary and overhead expenses) of $ 123 for management, $ 83 for technical personnel, and $ 38 for clerical staff. These labor rates are based on information taken from the Bureau of Labor Statistics, and match the labor rates used in other pesticide program related ICRs that were recently submitted to OMB. 6( c) Estimating Agency Burden and Cost Agency costs for this information collection activity are minimal, and include only the November 14, 2002 Page 14 of 17 record keeping associated with the receipt of the acknowledgment statements and costs associated with the transmittal of acknowledgment statements to the appropriate government official in the importing country. EPA estimates such costs at a GS­ 13 gross salary level ( including benefits) for .583 hours ( 35 minutes) per statement. This estimate presumes that all relevant tasks are performed at a GS­ 13 level, which may overestimate the Agency cost of this activity. The total annual burden therefore is 2500 FPASs time 35 minutes per FPAS equals 1457.5 hours. The annual cost is 1800 times $ 35.15 per statement, or $ 63,270. The distribution of this burden for specific tasks is described in the table describing the Agency tally in section 6( d) ( ii) ( Table 4), below. 6( d) Bottom Line Burden Hours and Cost Tables ( i) Respondent Burden FPAS 2,703 HOURS LABELING 7,200 HOURS MULTILINGUAL LABELING 14,850 HOURS TOTAL ANNUAL RESPONDENT BURDEN 24,753 HOURS ( ii) Agency Burden Annual Agency Burden/ Cost Estimates: Foreign Purchaser Acknowledgment Statement Requirement ( Table 4) Collection Activity Hours Annual Cost ($) Receive, review acknowledgment statements for completeness, and enter in log book 0.08 5.08 Data entry of information in acknowledgment statements 0.25 15.25 Make necessary copies and transmit submission to appropriate government officials of importing countries 0.16 9.76 Maintain a file of all submissions 0.08 5.06 TOTAL 0.57 35.15 November 14, 2002 Page 15 of 17 ANNUAL BURDEN: 2,500 statements x 0.576 hours = 1,440 hours ANNUAL COSTS: 2,500 statements x $ 35.15 = $ 63,270 6( d) Bottom Line Burden Hours and Cost Table TOTAL Hours Costs Respondent Burden Estimate 24753 $ 1,948,975 Agency Burden Estimate 1440 $ 87,875 Variations in the Annual Bottom Line Significant variations in the annual respondent burden or cost are possible during, or just after the end of, the three­ year term of this information collection activity. The matter is now before Congress, which is considering legislation to amend FIFRA to include authorities necessary to fully implement the PIC agreement. Effective implementation of PIC will require ratification and implementing legislation, and specific plans for affecting changes in the relevant U. S. laws and regulations are under development. The PIC Agreement includes a provision on export notification, which differs from the export notification provisions of FIFRA section 17 and 40 CFR 168, Subpart D.. Currently, the Administration's bill, which was introduced in May 2002, does not include amendments to existing section 17 export notification requirements, but does include the requirement for the PIC export notification. The PIC notification system differs in applicability, in timing, and in the information transmitted from the current provisions of section 17( a)( 2) and 40 CFR 168, Subpart D. The scope of the PIC export notification is limited to those pesticides banned or severely restricted by an exporting country, pursuant to the definitions in the Agreement. The timing of the notice is to occur prior to the actual shipment, for the first time in a calendar year. The PIC notification does not include a provision for a foreign purchaser to sign an acknowledgment statement, and data elements in the PIC notice differ slightly. The export notification requirement ceases altogether once the pesticide is included in the PIC procedure ( and certain other conditions have been met). 6( f) Burden Statement Annual respondent burden for this collection of information is estimated to average 1.08 hours ( 65 minutes) per response, including the time for reviewing instructions, gathering and maintaining the data needed, and completing and reviewing the collection of information. The agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. November 14, 2002 Page 16 of 17 Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing burden, to: Director, Collection Strategies Division, Mail Code 2822, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460; and to Paperwork Reduction Act Project ( OMB No. 2070­ 0027), Office of Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked " Attention Desk Officer for EPA." November 14, 2002 Page 17 of 17 Attachments to the Supporting Statement Attachment A FIFRA section 17 ­ Imports and Exports ­ available electronically at http:// www. epa. gov/ pesticides/ fifra. htm# sec17 Attachment B 40 Code of Federal Regulations, Part 168, Subpart D ­ Section 168.75 Procedures for exporting unregistered pesticides ­­ purchaser acknowledgment statements ­ available electronically at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr168_ 00. html Attachment C 66 FR 64246 ­ Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides; Renewal of Pesticide Information Collection Activities and Request for Comments ( published December 12, 2001) ­ available electronically at http:// www. epa. gov/ fedrgstr/ EPA­ PEST/ 2001/ December/ Day­ 12/ p30596. htm

epa

2024-06-07T20:31:45.325153

regulations

EPA-HQ-OPP-2002-0321-0001

Notice

Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 0595.08/OMB Control No. 2070-0055; Notice of Pesticide Registration by States To Meet a Special Local Need Under FIFRA Section 24(c)

72163 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices Linwood A. Watson, Jr., Deputy Secretary. [ FR Doc. 02 30717 Filed 12 3 02; 8: 45 am] BILLING CODE 6717 01 P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Project No. 12087 001] White River Falls Energy Associates, Inc.; Notice of Surrender of Preliminary Permit November 27, 2002. Take notice that White River Falls Energy Associates, Inc., permittee for the proposed White River Falls Project, has requested that its preliminary permit be terminated. The permit was issued on February 6, 2002, and would have expired on January 31, 2005. The project would have been located on the White River in Wasco County, Oregon. The permittee filed the request on September 9, 2002, and the preliminary permit for Project No. 12087 shall remain in effect through the thirtieth day after issuance of this notice unless that day is a Saturday, Sunday, or holiday as described in 18 CFR 385.2007, in which case the permit shall remain in effect through the first business day following that day. New applications involving this project site, to the extent provided for under 18 CFR part 4, may be filed on the next business day. Linwood A. Watson, Jr., Deputy Secretary. [ FR Doc. 02 30711 Filed 12 3 02; 8: 45 am] BILLING CODE 6717 01 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0321; FRL 7417 7] Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 0595.08/ OMB Control No. 2070 0055; Notice of Pesticide Registration by States To Meet a Special Local Need Under FIFRA Section 24( c) AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Notice of Pesticide Registration by States to Meet a Special Local Need Under FIFRA Section 24( c); EPA ICR No. 0595.08; OMB Control No. 2070 0055. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs. DATES: Additional comments may be submitted on or before January 3, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 6475; fax number: ( 703) 305 5884; e­ mail address: vogel. nancy@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. The Federal Register document, required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on December 12, 2001 ( 66 FR 64249). EPA received one comment on this ICR during the 60­ day comment period, and that comment is addressed in the ICR. EPA has established a public docket for this ICR under Docket ID No. OPP 2002 0321 ( formerly Docket Control No. OPP 00753), which is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to oppdocket epa. gov, or by mail to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0321; and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. ICR Title: Notice of Pesticide Registration by States to Meet a Special Local Need ( SLN) Under FIFRA Section 24( c) ( EPA ICR 0595.08, OMB Control No. 2070 0055). ICR Status: This is a request for extension of an existing approved collection that is currently scheduled to expire on November 30, 2002. EPA is asking OMB to approve this ICR for three years. Under 5 CFR 1320.12( b)( 2), the Agency may continue to conduct or sponsor the collection of information while the submission is pending at OMB. Abstract: This data collection program is designed to provide the Environmental Protection Agency ( EPA, the Agency) with the necessary data to review approval of State­ issued pesticide registrations. The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), section 24( c) authorizes the States to register additional uses of federally registered pesticides for distribution and use within the State to meet a special local need ( SLN). A Stateissued registration under FIFRA section 24( c) is deemed a Federal registration for the purposes of the pesticide's use within the State's boundaries. A State must notify EPA, in writing, of any VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1 72164 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Notices action it takes, i. e., issues, amends, or revokes, a State registration. The Agency has 90 days to disapprove the registration. In such cases, the State is responsible for notifying the affected registrant. Burden Statement: According to the Paperwork Reduction Act ( PRA), `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that is subject to approval under the PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections appear on the collection instruments or instructions, in the Federal Register notices for related rulemakings and ICR notices, and, if the collection is contained in a regulation, in a table of OMB approval numbers in 40 CFR part 9. The following is a summary of the burden estimates taken from the ICR: Respondents/ affected entities: State and territorial governments ( the 50 states plus Washington, DC, Puerto Rico, the U. S. Virgin Islands, Guam and the islands of the Pacific Territory, and American Samoa). Estimated total number of potential respondents: 60. Frequency of response: As needed. Estimated total/ average number of responses for each respondent: 5 6. Estimated total annual burden hours: 18,200. Estimated total annual burden costs: $ 1,585,150. Changes in the ICR Since the Last Approval: The Agency revised its burden estimates for both States and applicants based on information received during the public comment period and in consultation with respondents. The average applicant response burden decreased by 29 hours while the average State response burden increased by 11.5 hours, resulting in a net decrease in burden for the activities associated with this ICR. EPA estimates that the overall respondent burden has decreased from 24,604 hours to 18,200 hours, a decrease in burden of 6,404 hours. These changes are described in detail in the ICR. According to the procedures prescribed in 5 CFR 1320.12, EPA has submitted this ICR to OMB for review and approval. Any comments related to the renewal of this ICR should be submitted within 30 days of this notice, as described above. Dated: November 22, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 30758 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0320; FRL 7417 6] Agency Information Collection Activities; Submission to OMB; Comment Request; EPA ICR No. 0161.09/ OMB No. 2070 0027; Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Foreign Purchaser Acknowledgment Statement of Unregistered Pesticides; OMB No. 2070 0027; EPA No. 0161.09. The ICR, which is abstracted below, describes the nature of the information collection activity and its expected burden and costs. DATES: Additional comments may be submitted on or before January 3, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 6475; fax number: ( 703) 305 5884; e­ mail address: vogel. nancy@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. The Federal Register document, required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on December 12, 2001 ( 66 FR 64246). EPA received no comments on this ICR during the 60­ day comment period. EPA has established a public docket for this ICR under Docket ID No. OPP 2002 0320 ( formerly Docket Control No. OPP 00751), which is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to oppdocket epa. gov, or by mail to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0320; and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise VerDate 0ct< 31> 2002 19: 04 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 04DEN1. SGM 04DEN1

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EPA-HQ-OPP-2002-0321-0002

Supporting & Related Material

November 20, 2002 Page 1 of 26 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR) 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection Notice of Pesticide Registration by States to Meet a Special Local Need ( SLN) under FIFRA Section 24( c) OMB NO. 2070­ 0055; EPA NO. 0595.08 1( b) Short Characterization/ Abstract This data collection program is designed to provide the Environmental Protection Agency ( EPA, the Agency) with the necessary data to review approval of State­ issued pesticide registrations. The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), Section 24( c) authorizes the States to register additional uses of federally registered pesticides for distribution and use within the State to meet a special local need ( SLN). A State­ issued registration under FIFRA section 24( c) is deemed a federal registration for the purposes of the pesticide's use within the State's boundaries. A State must notify EPA, in writing, of any action it takes, i. e., when it issues, amends, or revokes a State registration. The Agency has 90 days to disapprove the registration. In such cases, the State is responsible for notifying the affected registrant. 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection The EPA requires this information to ensure that the States do not issue any registrations that might conflict with other requirements in FIFRA, or with section 408 of the Federal Food Drug, and Cosmetic Act ( FFDCA) which require that a tolerance exist for any pesticide used on a food or feed commodity. FIFRA section 24 ( c)( 3) mandates that if the Administrator determines that a registration issued by a State is inconsistent with the FFDCA or if the use of a pesticide registered by the State constitutes an imminent hazard, the Administrator may disapprove the registration. 2( b) Practical Utility/ Users of the Data The potential respondents to this information collection activity are the States, which are defined in FIFRA section 2 ( aa) to include Washington, D. C., Puerto Rico, the U. S. Virgin Islands, Guam and the islands of the Pacific Territory, and American Samoa. The information " users" are the Agency decision makers within the Office of Pesticide Programs ( OPP) and is used November 20, 2002 Page 2 of 26 to ensure conformity with FIFRA and FFDCA. The States are required to collect from the manufacturer or grower groups adequate information to support the section 24( c) application for registration or amendment. Both the State and the manufacturer or grower group are required to keep records. 3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication Not applicable. This is the only information collection activity of its kind and information collected in this data collection program is collected only once per receipt of an application for a FIFRA section 24( c) registration. Consequently, the possibility for duplication does not exist. 3( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA published a Federal Register ( FR) Notice that provided a 60­ day public notice and comment period that ended on February 11, 2002 ( see Attachment C). The Agency received one comment ( Attachment D) in response to this notice from Mr. Erik Johansen of the Washington State Department of Agriculture ( WSDA). Mr. Johansen noted that the estimated total/ average number of responses from each respondent, which was listed in the FR Notice as 1­ 3, appeared to be low. Mr. Johansen estimated that the WSDA issues approximately 37 SLN registrations per year and corresponds with EPA a total of approximately 75­ 100 times per year regarding SLN registrations. This correspondence includes label revisions, cancellations of SLN registrations, and other actions. EPA carefully considered Mr. Johansen's comments and agrees with his assertion that its estimate of the total/ average number of responses from each respondent which was listed in the first FRN as 1­ 3 was low. This renewal ICR includes a more realistic estimate of 5­ 6 responses per State ( the Agency expects to receive an average of 350 applications annually for the three years covered by this renewal ICR, divided by 60 respondents). In addition, Mr. Johansen commented that the estimated number of responses from each respondent pertaining to activities such as those described in his comment should be included in the activity description and accounted for as paperwork burdens. The burden estimates in this ICR for State governments already include the preceding activities as part of the paperwork burden, but the Agency has updated the activity descriptions in this ICR to more accurately reflect Mr. Johansen's concerns. 3( c) Consultations In addition to informal consultation between States and the EPA during the submission and review of SLN registration applications, which occurs on an ongoing basis, EPA staff contacted the following representatives of State regulatory agencies and asked them for their November 20, 2002 Page 3 of 26 assessment of the burden estimates in the ICR: John Inouye California Department of Pesticide Regulation Sacramento, CA Phone: ( 926) 324­ 3538 John R. Lake Pennsylvania Department of Agriculture Harrisburg, PA 17110 Phone: ( 717) 772­ 5211 Mr. Jim Gray North Dakota Department of Agriculture Bismarck, ND 58505 Phone: ( 701) 382­ 1505 Mr. Inouye replied that conditions pertaining to SLN registrations vary so widely in his State that providing an estimate was not possible. Mr. Lake responded that he estimated that processing of an SLN registration by his State, depending on concerns applicable to the pesticide and use requested, could range from as many as 24 hours to as few as 3. Mr. Gray's response also indicated that processing time could vary widely depending on various concerns, but that processing time averaged approximately 15 hours per submission. The Agency agrees with these assessments, and based on the responses received, calculates that the States spend an average of 13 hours processing an SLN submission. EPA staff also contacted, by electronic mail, representatives of companies involved as applicants for State registrations to obtain their assessment of the burden associated with this information collection activity. The Agency received feedback from the following pesticide registrants and included their responses as Attachment E to this supporting statement: Rebecca Johnston BASF Corp. Mt. Olive, NJ Jack Cain Dupont Wilmington, DE F. Andy Hedgecock Monsanto Co. St. Louis, MO November 20, 2002 Page 4 of 26 Greg Watson Syngenta Greensboro, NC The Agency used the registrant feedback to revise the estimated burden for submitting applications for special local need registrations to States and has provided a detailed discussion in section 6 of this supporting statement. 3( d) Effects of Less Frequent Collection Not applicable. This activity is conducted only once per receipt of an application for a FIFRA section 24( c) registration. Consequently, there is no way that the EPA can reduce the frequency of the collection. 3( e) General Guidelines The recordkeeping activities briefly described in this ICR exceed OMB's guideline that agencies not require that records be retained for more than 3 years ( 5 CFR 1320.5( d)( 2)( iv)). As authorized under FIFRA section 8, EPA regulations require that registrants retain records containing research data relating to registered pesticides ( including all data submitted to EPA in support of a registration ­ see 40 CFR 169.2( k)) for as long as the registration is valid and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR ( see OMB Control No. 2070­ 0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA)). In addition, this ICR does not include any estimated burden or costs related to the third party activities associated with pesticide product labeling. In 1995, OMB determined, in the context of OMB Control No. 2070­ 0060, Application for New and Amended Pesticide Registration, that the Agency does not need to estimate burden or costs for the third party disclosure requirement involving the registrant's disclosure of product specific information to potential users and the general public through the pesticide labeling. This activity is not considered to be a collection of information subject to approval under the PRA because the information that must be included as the product labeling has been approved and provided by EPA. ( 5 CFR 1320.3( c)( 2)). Finally, OMB's regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses, and an explanation of the decision ( 5 CFR 1320.5( a)( iii)( E)). At the present time, applications for 24( c) registration are submitted on written forms via the mail. OPP is not yet prepared to accept the electronic submission of any forms listed in this ICR. Forms­ based submissions likely would be transmitted via the World Wide Web and neither OPP nor the Agency's Office of Environmental Information have developed the information technology November 20, 2002 Page 5 of 26 approaches that would adequately protect FIFRA Confidential Business Information submitted in this way. 3( f). Confidentiality The Agency estimates that fewer than 0.1% of the 24( c) registrations it receives are for new products and would thus require submission of a Confidential Statement of Formula, which contains Confidential Business Information ( CBI). However, as many as 5% to 10% of 24( c) registrations may include residue data, which also contains CBI, in support of an unregistered use. In addition, any data and/ or information brought to the Agency in conjunction the submission of 24( c) registrations may be claimed as trade secret, commercial or financial information and must be protected from disclosure by EPA under FIFRA section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. All CBI data submitted to the EPA under FIFRA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual. 3( g) Sensitive Questions Not applicable. No information of a sensitive or private nature is requested in conjunction with this collection activity. In addition, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A­ 108. 4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Code Section 2( aa) of FIFRA defines " State" to include any of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Trust Territory of the Pacific Islands, and American Samoa. The North American Industrial Classification System ( NAICS) code for the State government agencies participating in this data collection is 92411. 4( b) Information Requested ( i) Information Requested by States to support SLN registrations. ( A) Application for a 24( c) registration. Applicants for State registrations under FIFRA section 24( c) to meet a special local need ( typically pesticides manufacturers and grower groups) must submit the following information directly the State using EPA Form 8570­ 25, Application for/ Notification of State Registration of November 20, 2002 Page 6 of 26 a Pesticide to Meet a Special Local Need ( Attachment F) and EPA Form 8570­ 4, Confidential Statement of Formula, ( Attachment G) when applicable: ( 1) Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use. ( 2) The name of the pesticide product, and, if the application is for an amendment to a federally registered product the EPA registration number of that product, ( 3) A copy of the proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of: ( a) For a new product, a copy of the complete proposed labeling; or, ( b) For an additional use of a federally registered product, a copy of proposed supplemental labeling and a copy of the labeling for the federally registered product. ( c) If a State classifies for restricted use a product or use, which is not required to be so classified under FIFRA, supplemental labeling for the product or use containing additional appropriate precautions, and a statement that the product or use is for restricted use within the State may be required. ( 4) The complete formula of the product, if the application is for a new product registration. ( 5) Any other information that is required to be reviewed prior to registration. ( B) Information following the issuance of a 24( c) registration. A copy of the final printed labeling as soon as practical after a registration is issued. New product labeling must all contain: ( 1) A statement identifying the State where registration is to be valid. ( 2) The special local need registration number assigned by the State. ( 3) For an additional use of a federally registered product, the State must require that at the time of sale, labeling from the federally registered product be accompanied by supplemental labeling. ( C) Information Requested by EPA to verify an SLN registration. Within ten working days from the date a State issues, amends or revokes a registration, the State is required to notify the EPA, in writing, of the action. ( 1) Using EPA Form 8570­ 25 where applicable, notification of State registrations, or amendments thereto, shall include: November 20, 2002 Page 7 of 26 ( a) Effective date of the registration or amendment, ( b) Confidential statement of the formula of any new product, and ( c) A copy of the draft labeling reviewed and approved by the State, provided that labeling previously approved by the Administrator as part of a federal registration need not be submitted. ( 2) Notification of State registrations or amendments shall be supplemented by the State sending to the EPA a copy of the final printed labeling approved by the State within 60 days after the effective date of the registration or amendment. ( 3) Notification of revocation of a registration by a State shall indicate the effective date of revocation, and shall state the reasons for revocation. ( 4) The Agency may request, when appropriate, that a State submit any data used by the State to determine that unreasonable adverse effects will not be caused. ( ii) Respondent Activities The following are the activities in which an applicant must engage in order to obtain a State registration under FIFRA section 24( c). Gather data Proposed label, product formulation ( if applicable), name of applicant, name of product, federal registration number ( if applicable), and any other information required by the State. Submit materials to the State Compile necessary data and materials. Complete application for State registration ( EPA Form 8570­ 25) and submit to State Store, file, and maintain the information Applicant must maintain records of information submitted to the State for as long as the State registration is active. November 20, 2002 Page 8 of 26 A State must engage in the following activities in order to comply under this data collection program: Compile information Organize data submitted by registrant ( or grower group) to develop the SLN justification. Registrant must maintain records of information submitted to the State. Review information Evaluate the data: 1. Determine whether there is a special local need for the registration; 2. Determine that use of the product for which registration is sought will not cause unreasonable adverse effects on humans or the environment; 3. For use of a product with public health claims, determine that the product warrants the claims made, i. e., efficacy determination; 4. Review the proposed labeling submitted with the application to determine State and federal compliance; 5. Issue or amend State registration. Notify Federal Government Complete and submit EPA Form 8570­ 25 and all accompanying data and materials. Respond to any Agency questions or concerns. Store, file, and maintain the data Maintain copies of the information and data submitted to EPA. Respond to Registrant ( if necessary) Notify registrant if Federal Government disapproves the State's registration. November 20, 2002 Page 9 of 26 5. THE INFORMATION COLLECTED ­ AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities EPA must conduct the following activities under this data collection activity: Read and record State­ submitted information EPA Form 8570­ 25 and the application is screened, jacket created, and information is recorded in electronically for tracking purposes. Review data submissions Review materials for adherence to federal requirements of label integrity, lack of imminent risk, and the existence of appropriate tolerances. Publish summary of 24( c) s Publish, on a regular basis, in the Federal Register, a summary of all State registrations received and those disapproved. Notify State ( if necessary) Notify the State if the registration is disapproved. Store/ file/ maintain the data Maintains an electronic reference file on all FIFRA section 24( c) applications received and approved. 5( b) Collection Methodology and Management The section 24( c) application form and any supporting materials are received and datemarked to start the 90­ day clock. They are screened for completeness, a master file jacket is created for the incoming application, and the case is assigned a unique identifier. Identifying information then is extracted for the required FR Notice of receipt, for the Pesticide Product Information System ( PPIS) inventory of all 24( c) actions, and for tracking records. The file then is reviewed for substantive acceptability, and any scientific data is routed for review by appropriate specialists. When all reviews are completed a decision is made to accept or disapprove the application. If the decision is to disapprove the application, the State is notified, and a notice of disapproval is published in the FR. The disapproval is recorded in the PPIS data base. If the decision is to accept the application, this is recorded in the master file, and no further action is required. November 20, 2002 Page 10 of 26 5( c) Small Entity Flexibility Not applicable. As identified in section 4( a) of this supporting statement, Section 24 of FIFRA applies directly only to the government agencies of the 50 states, Washington D. C., and the territorial governments of the United States; it does not apply to other entities. States are not small entities as defined under the Regulatory Flexibility Act and the Unfunded Mandates Reform Act. Small entity flexibility does not exist under this information collection activity because the respondent community does not consist of any small entities. While pesticide manufacturers and grower groups may be affected by EPA­ State activities under this ICR, any activities they undertake are in response to FIFRA Section 24, which expressly delegates certain pesticide registration authority to States. These entities must comply with State procedures to obtain a special local need registration under FIFRA section 24( c). Consequently, the Agency cannot offer them any flexibility without intruding on State processes. 5( d) Collection Schedule Not applicable. This activity is conducted only once per receipt of an application for a FIFRA section 24( c) registration. Consequently, there is no set schedule for collection of this information. 6. ESTIMATING BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden ( i) Applicant Burden As discussed in further detail under section 6( e) of this supporting statement, the Agency estimates the average burden for applicants for State registrations under FIFRA section 24( c) to equal approximately 39 hours per response. This includes 14 hours of management labor, 19 hours of technical labor and 6 hours of clerical labor per response. The Agency expects that nearly 350 applications will be submitted annually during the next 3 years and therefore estimates that the annual applicant burden will equal 13,650 hours. ( ii) State Agency Burden As discussed in further detail in sections 3( c) and 6( e) of this supporting statement, EPA estimates the State Agency burden to average 13 hours per response. This includes an estimated 12.3 hours of technical labor and 0.7 hours of clerical labor per State agency response. The Agency anticipates that nearly 350 SLN applications will be submitted each year for an estimated annual burden of 4,550 hours. From that, EPA estimates that each State will receive, on average, 5 or 6 SLN applications per year. November 20, 2002 Page 11 of 26 ( iii) Overall Burden The overall respondent burden associated with this collection is estimated to be 18,200 hours per year. Respondents include both the State governments and the companies filing for State registrations. No changes have been made in the requirements for Section 24( c) applications, and no changes have been made to the provisions of this information collection activity. 6( b) Estimating Respondent Cost EPA has increased its estimated labor rates for applicants and State government personnel factoring in an inflation cost index of 1.056 based on the Gross Domestic Product. These labor rates are fully loaded and included benefits and overhead costs. For applicants, EPA estimates labor costs of $ 130, $ 88 and $ 40 per hour for management, technical and clerical burden, respectively. For State agency personnel, EPA estimates labor costs of $ 84, $ 63, and $ 32 per hour for management, technical and clerical burden, respectively. Using the Agency's burden estimates and the fully loaded labor rates, the Agency estimates the applicant costs to be approximately $ 3,732 per response and State agency costs to be approximately $ 797 per response for a total of $ 4,529 per response. The overall annual cost associated with this information collection, based on an estimate 350 responses per year, is estimated to be $ 1,585,150. November 20, 2002 Page 12 of 26 RESPONDENT BURDEN/ COST ESTIMATES PER 24( c) REGISTRATION REGISTRANT HOURS, RATES TOTAL Collection Activities Mgmt. $ 130/ hr Tech. $ 88/ hr. Cler. $ 40/ hr. Hours Costs ($) Gather data 5.00 12.50 0.00 17.50 1,750 Submit materials to State 9.00 5.50 1.00 15.50 1,694 Store/ file/ maintain the data 0.00 1.00 5.00 6.00 288 TOTAL 14.00 19.00 6.00 39.00 $ 3,732 STATE GOVERNMENT HOURS, RATES TOTAL Collection Activities Mgmt. $ 84/ hr Tech. $ 63/ hr. Cler. $ 32/ hr. Hours Costs Compile information 0.0 1.0 0.0 1.0 63.00 Review submission information 0.0 5.5 0.0 5.5 346.50 Complete and transmit paperwork to EPA ( including label revisions, SLN registration cancellations, and other follow­ up actions) 0.0 5.4 0.4 5.8 353.00 Store/ file/ maintain the data 0.0 0.0 0.1 0.1 3.20 Respond to Registrant ( if necessary) 0.0 0.4 0.2 0.6 31.60 TOTAL 0.0 12.3 0.7 13 $ 797.30 ANNUAL BURDEN: 52 Total Hours x 350 Applications = 18,200 hours ANNUAL COSTS: $ 4,529 x 350 Applications = $ 1,585,150 November 20, 2002 Page 13 of 26 6( c) Estimating Agency Burden and Cost The Agency technical employee burden associated with the 24( c) registration program has been estimated from the Time Accounting Information System ( TAIS) and OPP's regulatory action resource tracking systems, although neither management nor clerical burden is captured by these systems. The estimate for management burden is based on the assumption that only a small portion of 24( c) registrations require management decisions, usually only those the technical staff recommends for denial. The hours associated with reviewing the data submissions and publishing summaries have been revised to reflect that it is actually the data review portion of the collection activity that takes the most time. The estimate for notifying the State is small because of the small number of application denials. The Agency cost associated with this program is estimated to be $ 352,124 per year. The labor rates are based on Office of Personnel Management salary tables for federal employees for the years 1999 through 2001 and include benefits and overhead costs, as well as locality pay for the Washington, DC­ Baltimore area. The total Agency costs also include FR and electronic mailing costs. ANNUAL AGENCY BURDEN/ COST ESTIMATES PER 24( c) SUBMISSION COLLECTION ACTIVITIES HOURS, RATES TOTAL Mgmt. $ 96/ hr. Tech. $ 70/ hr Cler. $ 33/ hr. Hours Costs Read and record Statesubmitted information 0.0 0.1 0.1 0.2 10.30 Review data submissions 0.6 11.0 0.0 11.6 827.60 Publish summary of 24( c) s 0.1 0.5 0.1 0.7 47.90 Store/ file/ maintain the data 0.0 0.0 0.1 0.1 3.30 Notify the State ( if necessary) 0.1 0.2 0.1 0.4 26.90 TOTAL 0.8 11.8 0.4 13.0 $ 916 ANNUAL BURDEN: 13 Total Hours x 350 Applications = 4,550 Hours ANNUAL COSTS: $ 916 x 350 Applications $ 320,600 ANNUAL MAILING COSTS: $ 31,524 ( Federal Register mailing costs of $ 20,232 + electronic mail costs of $ 11,292) TOTAL ANNUAL AGENCY COSTS: $ 352,124 November 20, 2002 Page 14 of 26 6( d). Bottom Line Hours And Costs MASTER TABLE TOTAL Hours Costs Respondents ( applicants & states) 18,200 $ 1,585,150 Agency 4,550 $ 352,124 6( e) Reasons For Changes in Burden When this information collection activity was renewed in 1996 and 1999, the Agency included burden estimates for applicant activities to conform to the amended Paperwork Reduction Act requirements. Based on their expertise, the Agency's staff experts estimated at the time that the applicant paperwork burden was approximately 68 hours per application. The Agency did not receive any information during the public comment period for this renewal that indicated a revision to this estimate was needed. Information received by the Agency during consultations with applicants indicated that previous estimates of average " per­ application" burden were too high. The Agency has revised the estimated applicant burden downward to approximately 39 hours per response to reflect the information supplied by applicants. While EPA revised its assessment of applicant burden downward based on consultations with respondents, the Agency revised its assessment of State agency burden upward in response to respondent feedback. EPA had historically estimated the to burden State agencies as 2.5 hours per response. We learned during our consultation with our State partners that 13 hours per response is a more accurate assessment of burden. Our estimates have been revised to reflect the discussions with respondents. The effect of these revisions to our burden estimates has led to a net reduction of annual respondent burden associated with this collection by 6,404 hours. When OMB last approved this information collection activity in 1999, the Agency estimated the annual burden to equal 24,604 hours annually. This renewal ICR reflects a 29 hour burden decrease per response for applicants, while showing a 11.5 hour burden increase per response for States. This 6,404 hour burden decrease represents an adjustment to EPA's burden­ hour estimate in the current ICR. 6( f) Burden Statement The annual respondent burden for this ICR is estimated to average 52 hours per response ( 39 hours per applicant and 13 hours per State), including time for compiling the information/ data submitted by the registrant, reviewing the information for special local needs November 20, 2002 Page 15 of 26 determination, completing paperwork to notify the federal government, storing/ filing/ maintaining the data, and responding back to the registrant if the registration is disapproved by EPA. The burden estimate includes hours spent by the registrant in preparing the application for submission to EPA. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to: Director, Collection Strategies Division, Mail Code 2822, U. S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460; and to Paperwork Reduction Act Project ( OMB No. 2070­ 0055), Office of Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked " Attention Desk Officer for EPA." November 20, 2002 Page 16 of 26 ATTACHMENTS TO THE SUPPORTING STATEMENT ATTACHMENT A: FIFRA Section 24( c) ( 7 U. S. C. 136v) ­ available electronically at http:// www. epa. gov/ pesticides/ fifra. htm# sec24 ATTACHMENT B: FFDCA Section 408 ( 21 U. S. C. 346a) ­ available electronically at http:// uscode. house. gov/ usc. htm ATTACHMENT C: 66 FR 64249 ­ FIFRA Section 24( c) Special Local Need Registrations; Renewal of Pesticide Information Collection Activities and Request for Comments ( published December 12, 2001) ­ available electronically at http:// www. epa. gov/ fedrgstr/ EPA­ PEST/ 2001/ December/ Day­ 12/ p30597. htm ATTACHMENT D: Public Comment Regarding 66 FR 64249 ­ Comments of Mr. Erik Johansen, Washington State Department of Agriculture ­ An electronic copy of this attachment follows in the electronic file for this ICR. ATTACHMENT E: Applicant Estimates of Burden ­ Applicant feedback received during Agency consultation activities ­ An electronic copy of this attachment follows in the electronic file for this ICR. ATTACHMENT F: Application for/ Notification of State Registration of a Pesticide to Meet a Special Local Need ( EPA Form 8570­ 25) ­ available electronically at http:// www. epa. gov/ opprd001/ forms/ 8570­ 25. pdf ATTACHMENT G: Confidential Statement of Formula ( EPA Form 8570­ 4) ­ available electronically at http:// www. epa. gov/ opprd001/ forms/ 8570­ 4. pdf ATTACHMENT H: Display Related to OMB Control # 2070­ 0055 ­ Listings of Related Regulations in 40 CFR 9.1 ­ An electronic copy of this attachment follows in the electronic file for this ICR. ATTACHMENT I: 40 CFR 162, Subpart D ­ STATE REGISTRATION OF PESTICIDE PRODUCTS: Regulations Pertaining to State Registration of Pesticides To Meet Special Local Needs ­ available electronically at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr162_ 00. html OMB CONTROL NO. 2070­ 0055 ATTACHMENT D Public Comment Regarding 66 FR 64249 Comments of Mr. Erik Johansen, Washington State Department of Agriculture Comments for EPA Public Docket re: Docket control number OPP­ 00753, ICR for FIFRA Section 24( c) Special Local Need Registrations Washington State Department of Agriculture ( WSDA) issues approx. 37 SLN registrations per year ( 1999, 2000, 2001). WSDA revises several dozen SLN labels per year, and cancels several dozen SLN registrations per year. WSDA also responds to several requests per year from EPA regarding SLN registrations ( recommendations for label revision, requests for additional information, other actions). Therefore, a reasonable estimate is that WSDA corresponds with EPA approx. 75­ 100 times per year regarding SLN registrations. The Federal Register, December 12, 2001 ( Volume 66, Number 239, Page 64249­ 64251) indicates in Section V ( Burden and Cost Estimates) that the estimated total/ average number of responses from each respondent ( including states) is 1­ 3. This estimate appears to be inaccurate. Feel free to contact me if there are any questions regarding these comments. Erik W. Johansen Pesticide Registration Specialist / Pollinator Protection & Spray Adjuvants Phone ( 360) 902­ 2078 Fax ( 360) 902­ 2093 email ejohansen@ agr. wa. gov OMB CONTROL NO. 2070­ 0055 ATTACHMENT E Applicant Estimates of Burden Applicant feedback received during Agency consultation activities Page 19 of 26 Generic EPA Request for Registrant Feedback on Burden for FIFRA 24( c) Activities Sent via e­ mail by Jim Tompkins, US EPA/ Office of Pesticide Programs, on 11/ 07/ 2002 The Agency is working on the renewal of the Information Collection Request ( ICR) for 24( c) s under which the Agency is given authority to collect the information submitted with a 24( c) registration. As part of the 24( c) ICR, the Agency must provide an estimate of the burden on registrants to complete a 24( c) registrations. To assist EPA in providing a reasonable estimate of the burden to registrants to complete a 24( c) registration, I am requesting that you provide your best estimate of the hours in each category to complete an average 24( c) realizing some 24( c) s take more time and other 24( c) s take less time. We will then average the responses from a number of registrants to provide OMB with a reasonable burden estimates. Nobody is sure of where the burden estimates in the current ICR came from so it is time for a little reality check. Registration Manager Technical Support Clerical Support Gather Data Prepare 24( c) for Submission to State Clerical typing filing etc. Please forward this message to the appropriate person. If possible, I need a response by November 14. Thank You Jim T Page 20 of 26 ­­­­­ Forwarded by Jim Tompkins/ DC/ USEPA/ US on 11/ 20/ 02 01: 34 PM ­­­­­ Jack Cain < Jack. Cain@ USA. dupont. com> 11/ 13/ 02 07: 36 AM To: Jim Tompkins/ DC/ USEPA/ US@ EPA cc: Subject: Re: 24( c) Burden Estimate Jim, Based on input from other 2 other Reg. Managers in our group, our State Registration coordinator and two of our Field Dev. folks ( tech support) we came up with the following # s ( note they are averages from all the inputs I received). Registration Manager Technical Support Clerical Support Gather Data 4 hrs 12 hrs Prepare 24( c) for Submission 8 hrs 6 hrs 2 hrs to State Clerical typing 1.5 hrs 2 hrs filing etc. Hope this helps, Jack Page 21 of 26 ­­­­­ Forwarded by Jim Tompkins/ DC/ USEPA/ US on 11/ 20/ 02 01: 35 PM ­­­­­ Rebecca L Johnston < johnstrl@ basf­ corp. com> 11/ 12/ 02 10: 51 AM To: Jim Tompkins/ DC/ USEPA/ US@ EPA cc: Subject: Re: 24( c) Burden Estimate Jim, I did not receive a confirmed delivery so I am sending again. Rebecca ­­­­­ Forwarded by Rebecca L Johnston/ APN/ PRINCETON/ BASF­ CORP/ BASF on 11/ 12/ 2002 10: 51 AM ­­­­­ Rebecca L Johnston 11/ 08/ 2002 03: 04 PM To: Tompkins. Jim cc: Joseph S O'Grodnick, Laura A Sears Subject: Re: 24( c) Burden Estimate( Document link: Rebecca L Johnston) Jim, Attached is BASF's estimate of the effort required to prepare a 24( c) application. Any questions, please do not hesitate to ask. ( See attached file: Information Collection Request for 24. doc) Regards, Rebecca Page 22 of 26 BASF Corporation BASF Information Collection Request for 24( c) Registrations Registration Mgr Technical Support Clerical Support Overall Coordination 8 hours Support/ Gather Data ° Label ° Justification ° Data Summaries 16 hours 8 hours 8 hours Prepare Submission ° Label ° Justification ° Data Summaries 16 hours 8 hours 8 hours Clerical Activities ° Applications ° Cover Memos ° Duplication ° Filing 16 hours Total = approx. 11 days ( 88 hrs) 1 day = typical 8 hour workday Estimated effort assumes the maximum requirements and a first time 24( c) application. R. Johnston 11/ 8/ 02 November 20, 2002 Page 23 of 26 26 Davis Drive, PO Box 13528, Research Triangle Park, NC 27709­ 3528 Telephone ( 919) 547­ 2000 Page 24 of 26 ­­­­­ Forwarded by Jim Tompkins/ DC/ USEPA/ US on 11/ 20/ 02 01: 37 PM ­­­­­ " HEDGECOCK, F ANDY [ AG/ 1000]" < f. andy. hedgecock@ monsanto. com> 11/ 08/ 02 12: 58 PM To: Jim Tompkins/ DC/ USEPA/ US@ EPA cc: Subject: FW: 24( c) Burden Estimate Jim, Russ asked if I could provide a response on this for Monsanto. I've made an estimate of the average time spent submitting to one state based on the matrix you had below across the three functional types and three process pieces. Registration Manager Technical Support Clerical Support Gather Data ­ 12 hours ­ Prepare 24( c) for Submission 4 hours ­ ­ to State Clerical typing ­ ­ 1 hour filing etc. Let me know if you need other information. Regards, F. Andy Hedgecock Director, State Regulatory Affairs Monsanto Worldwide Regulatory Affairs phone: 314/ 694­ 5486 cel: 314/ 378­ 5632 fax: 314/ 694­ 4028 email: f. andy. hedgecock@ monsanto. com < mailto: f. andy. hedgecock@ monsanto. com> Page 25 of 26 ­­­­­ Forwarded by Jim Tompkins/ DC/ USEPA/ US on 11/ 20/ 02 01: 43 PM ­­­­­ greg. watson@ syngenta. com 11/ 08/ 02 03: 59 PM To: Jim Tompkins/ DC/ USEPA/ US@ EPA cc: Subject: RE: 24( c) Burden Estimate Dear Jim, As promised, here is the feedback from us regarding the ICR: Registration Manager Technical Support* Clerical Support Gather Data 1 hour 10 hours ­ Prepare SLN for Submission 8 hours ­ 1 hour to State Clerical ­ typing, 1 hour ­ 1 hour filing etc. * includes compiling and summarizing internal and external data, calling COI's, etc. It does not include conducting efficacy or residue field trials required to obtain a 24c registration. Please let me know if this was what you were after or if additional information is needed. Have a good weekend, Greg November 20, 2002 Page 26 of 26 OMB CONTROL NO. 2070­ 0055 ATTACHMENT H Display Related to OMB Control # 2070­ 0027 ­ Listings of Related Regulations in 40 CFR 9.1 As of May 10, 1993, the OMB approval numbers for EPA regulations in Chapter I of Title 40 of the Code of Federal Regulations ( CFR) appear in a listing in 40 CFR 9.1 ( 58 FR 27472). This listing fulfills the display requirements in section 3507( f) of the Paperwork Reduction Act ( PRA) for EPA regulations. The listing at 40 CFR 9.1 displays this OMB Control number for the following regulations: Program Title 40 CFR citation Good Laboratory Practice Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 State Registration of Pesticide Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162.153

epa

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regulations

EPA-HQ-OPP-2002-0323-0001

Notice

Experimental Use Permit; Receipt of Application

[ Federal Register: December 11, 2002 ( Volume 67, Number 238)] [ Notices] [ Page 76177­ 76179] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr11de02­ 36] ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ENVIRONMENTAL PROTECTION AGENCY [ OPP­ 2002­ 0323; FRL­ 7283­ 1] Experimental Use Permit; Receipt of Application AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ SUMMARY: This notice announces receipt of an application 68467­ EUP­ A from Dow AgroSciences requesting an experimental use permit ( EUP) for the plant incorporated­ protectant Bacillus thuringiensis Cry1F and Cry1Ac. The Agency has determined that the application may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11( a), the Agency is soliciting comments on this application. DATES: Comments, identified by docket ID number OPP­ 2002­ 0323, must be received on or before January 10, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Leonard Cole, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460­ 0001; telephone number: ( 703) 305­ 5412; e­ mail address: cole. leonard@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are interested in agricultural biotechnology or may be required to conduct testing of chemical substances under the Federal, Food, Drug, and Cosmetic Act ( FFDCA) or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP­ 2002­ 0323. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305­ 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are [[ Page 76178]] mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e­ mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket , and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP­ 2002­ 0323 The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP­ 2002­ 0323. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC, 20460­ 0001, Attention: Docket ID Number OPP­ 2002­ 0323. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP­ 2002­ 0323. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Background Dow AgroSciences has submitted an application for an EUP for the plant incorporated­ protectant Bacillus thuringiensis Cry1F and Cry1Ac in cotton. The requested number of acres for this plant incorporatedprotectant is 2,826. The EUP is for the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Louisiana, Mississippi, Missouri, New Mexico, North Carolina, Puerto Rico, South Carolina, Tennessee, and Texas. Test plants will consist of cotton. III. What Action is the Agency Taking? Following the review of the Dow AgroSciences application and any comments and data received in response to this notice, EPA will decide whether to issue or deny the EUP request for this EUP program, and if issued, the conditions under which it is to be conducted. Any issuance of an EUP will be announced in the Federal Register. [[ Page 76179]] IV. What is the Agency's Authority for Taking this Action? EPA takes this action under 40 CFR part 172. List of Subjects Environmental protection, Experimental use permits. Dated: November 22, 2002. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. [ FR Doc. 02­ 31165 Filed 12­ 10­ 02; 8: 45 am] BILLING CODE 6560­ 50­ S

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regulations

EPA-HQ-OPP-2002-0325-0002

Supporting & Related Material

United States Environmental Protection Agency Prevention, Pesticides and Toxic Substances ( 7101) EPA 712 C 02 189 December 2002 Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity Testing Background i INTRODUCTION This guideline is one of a series of test guidelines that have been developed by the Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations. The Office of Prevention, Pesticides and Toxic Substances ( OPPTS) has developed this guideline through a process of harmonization that blended the testing guidance and requirements that existed in the Office of Pollution Prevention and Toxics ( OPPT) and appeared in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations ( CFR), the Office of Pesticide Programs ( OPP) which appeared in publications of the National Technical Information Service ( NTIS) and the guidelines published by the Organization for Economic Cooperation and Development ( OECD). The purpose of harmonizing these guidelines into a single set of OPPTS guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements of the U. S. Environmental Protection Agency under the Toxic Substances Control Act ( 15 U. S. C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act ( 7 U. S. C. 136, et seq.). Final Guideline Release: This guideline is available from the U. S. Government Printing Office, Washington, DC 20402 on disks or paper copies: call ( 202) 512 0132. This guideline is also available electronically in PDF ( portable document format) from EPA's Internet Web site at http:/ / www. epa. gov/ opptsfrs/ home/ guidelin. htm. 1 OPPTS 870.1000 Acute toxicity testing background. ( a) Scope ( 1) Applicability. This guideline is intended to meet testing requirements of both the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) ( 7 U. S. C. 136, et seq.) and the Toxic Substances Control Act ( TSCA) ( 15 U. S. C. 2601). ( 2) Background. The source material for this revised harmonized test guideline is OPPTS 870.1000 Acute Toxicity Testing Background, dated August 1998. ( b) Purpose. The Agency considers the evaluation of toxicity following short term exposure to a chemical to be an integral step in the assessment of its toxic potential under the regulatory framework of its pesticide and toxic substances programs. In the assessment and evaluation of the toxic characteristics of a substance, acute toxicity is generally performed by the probable route of exposure in order to provide information on health hazards likely to arise from short­ term exposure by that route. For pesticides, the short­ term toxicity testing battery consists of acute toxicity tests by the oral, dermal, and inhalation routes; skin and eye irritation testing; and testing for dermal sensitization. Data from an acute study may serve as a basis for hazard categorization, labeling, or child­ resistant packaging and may also serve to designate pesticides which may be applied only by certified applicators. It may also be an initial step in establishing a dosage regimen in subchronic and other studies and may provide information on absorption and the mode of toxic action of a substance. An evaluation of acute toxicity data should include the relationship, if any, between the exposure of animals to the test substance and the incidence and severity of all abnormalities, including behavioral and clinical abnormalities the reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxic effects. ( c) History ( 1) Acute toxicity test guidelines. Test guidelines for acute toxicity were first published by the Agency in October 1982 as part of Subdivision F of the Pesticide Assessment Guidelines for the Office of Pesticide Programs ( OPP) ( see paragraph ( g)( 1) of this guideline) and in 40 CFR part 797 in September 1985 for the Office of Pollution Prevention and Toxics ( OPPT). ( 2) Rejection rate analysis. In 1993, as part of its Pesticide Rejection Rate Analysis, Agency and industry scientists met to perform a guidelineby guideline review of toxicology studies including acute toxicity studies. The purpose of this guideline­ by­ guideline review was to identify those factors that most frequently cause toxicology studies required for pesticide reregistration to be rejected. The results were published as the Pesticide Reregistration Rejection Rate Analysis: Toxicology ( see paragraph ( g)( 2) of this guideline). In 1995, representatives from the Agency met with the American Crop Protection Association ( ACPA), the Chemical Producers and Distributors Association ( CPDA), the Chemical Manufacturers Asso­ 2 ciation ( CMA), Health Canada, and the California Department of Pesticide Regulation ( CDPR) to discuss acceptable methods for the conduct of acute toxicity studies. The discussions of this meeting were incorporated into a preliminary Registration Division document titled Conduct of Acute Toxicity Studies ( see paragraph ( g)( 3) of this guideline). These documents supplement the acute toxicology guidelines in Subdivision F. ( 3) Guideline harmonization. The Series 870 Health Effects test guidelines have been harmonized between OPP and OPPT and, where possible with the Organization for Economic Cooperation and Development ( OECD) test guidelines. Scientific considerations from both of the analyses described in paragraph ( c)( 2) of this guideline have been incorporated into the revised test guidelines. ( d) Approaches to the determination of acute toxicity. ( 1) At present, the evaluation of chemicals for acute toxicity is necessary for the protection of public health and the environment. The Agency supports measures dedicated to reducing the use of animals in toxicity testing. When animal testing is required for this purpose, testing should be done in ways that minimize numbers of animals used and that take full account of their welfare. To this end, when conducting a test, the Agency stresses the simultaneous monitoring of several endpoints of toxicity in animals in a single acute study including sublethal effects as well as lethality. Dosed animals are observed for abnormal behavioral manifestations such as increased salivation or muscular incoordination, in addition to the recovery from these effects during the observation period. Both dead and surviving animals are necropsied to evaluate gross anatomical evidence of organ toxicity. In selected cases, additional testing may be justified to better characterize the kinds of abnormalities that have been found in the organs of the necropsied animals. These sound, scientific practices represent some of the means which maximize the utility of the data obtained from a limited number of test animals to achieve a balance between protecting humans and the environment, and the welfare and utilization of laboratory animals. ( 2) EPA recommends the following means to reduce the number of animals used to evaluate acute effects of chemical exposure while preserving its ability to make reasonable judgements about safety: ( i) Use of data from structurally related substances or mixtures. In order to minimize the need for animal testing for acute effects, the Agency encourages the review of existing acute toxicity information on chemical substances that are structurally related to the agent under investigation. In certain cases, it may be possible to obtain enough information to make preliminary hazard evaluations that may reduce the need for further animal testing for acute effects. Similarly, mixtures or formulated products that are substantially similar to well­ characterized mixtures or products may not need additional testing if there are sufficient bridging data available 3 for meaningful extrapolation. In those cases, classification would be extrapolated from the mixture already tested. ( ii) EPA recommends the Up­ and­ Down Procedure ( UDP), as detailed in this guideline and adopted by OECD as test Guideline 425 ( see paragraph ( g)( 4) of this guideline), to access acute oral toxicity. This method provides a point estimate of lethality and confidence interval. A dedicated program ( AOT425StatPgm) has been developed by EPA to assist laboratories in the conduct of this protocol. The Agency strongly recommends the use of this software package which is available on EPA's Internet Web site at http:// www. epa. gov/ oppfead1/ harmonization. Acute oral toxicity testing may also be performed using the Fixed Dose Method of OECD Guideline 420 ( see paragraph ( g)( 5) of this guideline) or the Acute Toxic Class Method of OECD Guideline 423 ( see paragraph ( g)( 6) of this guideline These methods assess lethality within a dose range. ( iii) Weight of evidence approaches to dermal and ocular irritation. Several factors should be considered in determining the corrosion and irritation potential of chemicals before testing is undertaken. Existing human experience and data and animal observations and data should be the first line of analysis, as it gives information directly referable to effects on the skin. In some cases, enough information may be available from structurally related compounds to make classification decisions. Likewise, pH extremes ( pH < 2 or > 11.5) may indicate dermal effects, especially when buffering capacity is known, although the correlation is not perfect. Generally such agents are expected to produce significant effects on the skin. It also stands to reason that if a chemical is extremely toxic by the dermal route, a dermal irritation/ corrosion study may not be needed. Likewise, if there is a lack of any dermal reaction at the limit dose ( 2,000 mg/ kg) in an acute toxicity study ( for which observations of dermal reactions were made), a dermal irritation/ corrosion study again may not be needed for labeling purposes. It should be noted, however, that often acute dermal toxicity and dermal irritation/ corrosion testing are performed in different species that may differ in sensitivity. In vitro alternatives that have been validated and accepted may also be used to help make classification decisions ( iv) All of the available information on a chemical should be used in determining the need for in vivo dermal irritation testing. Although information might be gained from the evaluation of single parameters within a tier ( e. g., caustic alkalies and acids with extreme pH ( pH < 2 or > 11.5) should be considered as dermal corrosives), there is merit in considering the totality of existing information and making an overall weight of evidence determination. This is especially true when there is information available on some but not all parameters. ( v) Use of limit testing. For chemicals judged to be relatively nontoxic a single group of animals is given a large dose of the agent. If 4 no lethality is demonstrated, no further testing is pursued. The substance is classified in hazard categories according to the limit dose used. ( See the following paragraph for a discussion of toxicity categories under FIFRA). ( e) Regulatory applications under FIFRA. ( 1) Precautionary labeling provides the pesticide user with a general idea of the potential toxicity, irritation and sensitization hazard associated with the use of a pesticide ( see EPA Label Review Manual ( paragraph ( g)( 7) of this guideline) and 40 CFR Part 156 Labeling Requirements for Pesticides and Devices). Precautionary labeling also identifies the precautions necessary to avoid exposure as well as any personal protective equipment which should be used when handling a pesticide and statements of practical treatment in case of accidental exposure. A globally harmonized system for classification and labeling has been approved through the United Nations. Implementation will be phased in by United Nations countries, with schedules to be announced. This section describes the current system in place for pesticides in the United States and will be revised and updated when the globally harmonized system is fully implemented. ( 2) Precautionary labeling which includes the signal word, personal protective equipment, hazard symbol, and statements of practical treatment is normally determined by six acute toxicity studies and product composition The acute oral, acute dermal and acute inhalation studies are used to determine the LD50 of a product via the designated route of exposure. The primary eye irritation and primary skin irritation studies measure the severity of irritation or corrosivity caused by a product. The dermal sensitization study determines whether a product is capable of causing an allergic reaction. With the exception of the dermal sensitization study, each acute toxicity study is assigned a toxicity category as defined in the table below. All products falling into toxicity categories I IV must bear a signal word and in some cases warning symbols. ( 3) Personal Protective Equipment. Personal protective equipment which includes use of protective clothing, chemical resistant gloves, protective eye gear, and respiratory protective devices, is determined by the results of six acute toxicity studies according to toxicity category ( see table). The degree of protection required is graded according to the degree of acute toxicity and the hazard classification category of the chemical or product. These requirements are set forth in 40 CFR 170.240 in the Worker Protection Standard. ( 4) Restricted entry intervals. Agricultural products must display a restricted entry interval. A restricted entry interval is the time immediately following a pesticide application during which entry into the treated area is restricted. Restricted entry intervals are based on the most severe acute toxicity category assigned to the acute dermal, eye irritation and skin irritation data for all of the active ingredients in a pesticide product. The dura­ 5 tion of restricted entry intervals is based on the severity of toxicity, with products classified in category I requiring intervals of 48 hours or more and products classified in category III or IV requiring intervals of 12 hours. ( 5) Child­ resistant packaging. FIFRA establishes standards with respect to pesticide packaging of products intended for use in residential settings in order to protect children or adults from serious illness or injury resulting from accidental ingestion or contact with pesticides. Criteria in 40 CFR part 157 for which pesticides must be distributed or sold in childresistant packaging are based on classification according to the toxicity categories set forth in the table. ( 6) Restricted use pesticide. The Agency determines whether a pesticide must be applied under the direct supervision of a certified applicator. Such clarification for restricted use is based upon consideration of toxicity data, including acute toxicity, exposure, and intended use. ( 7) Biochemical pest control agents are tested in a special tiered progression The technical grade biochemical pest control agent is always characterized by acute toxicity tests. However, because of their nontoxic mode of action against the target pest, further testing of the biochemical pest control agent is normally not required. Microbial pest control agents are tested using the OPPTS Harmonized Test Guidelines Series 885, Microbial Pesticide Test Guidelines, for pathogenicity/ infectivity. In addition, all formulations of microbial pest control agents are tested for precautionary labeling using acute toxicity tests in the OPPTS Harmonized Test Guidelines Series 870, Health Effects Test Guidelines. 6 Toxicity Categories Study Category I Category II Category III Category IV Acute Oral Up to and including 50 mg/ kg > 50 through 500 mg/ kg > 500 through 5000 mg/ kg > 5000 mg/ kg Acute Dermal Up to and including 200 mg/ kg > 200 through 2000 mg/ kg > 2000 through 5000 mg/ kg > 5000 mg/ kg Acute Inhalation Up to and including 0.05 mg/ liter > 0.05 through 0.5 mg/ liter > 0.5 through 2 mg/ liter > 2 mg/ liter Eye Irritation Corrosive ( irreversible destruction of ocular tissue) or corneal involvement or irritation persisting for more than 21 days Corneal involvement or irritation clearing in 8­ 21 days Corneal involvement or irritation clearing in 7 days or less Minimal effects clearing in less than 24 hours Skin irritation Corrosive ( tissue destruction into the dermis and/ or scarring) Severe irritation at 72 hours ( severe erythema or edema) Moderate irritation at 72 hours ( moderate erythema) Mild or slight irritation ( no irritation or slight erythema) Study Study results Study results Dermal Sensitization Product is a sensitizer or is positive for sensitization Product is not a sensitizer or is negative for sensitization ( f) Regulatory applications under TSCA. ( i) Acute oral toxicity data are used to provide a basic understanding of acute effects and to serve as a starting point for human hazard and risk assessments focused on occupational and general population exposures. ( ii) Acute oral toxicity testing is included in testing menus to obtain basic or `` screening level'' information on certain chemicals. These include higher volume/ higher exposure new chemicals where TSCA section 5( e) `` exposure­ based'' testing authorities are used to obtain a basic level of hazard and environmental fate information; and High Production Volume existing chemicals ( i. e., those produced and/ or imported at or above 1 million lbs/ yr) information data set. ( g) References. The following references should be consulted for additional background information on this test guideline. ( 1) U. S. Environmental Protection Agency. Pesticide Assessment Guidelines, Subdivision F: Health Effects. EPA report 540/ 09 82 025, October 1982. ( 2) U. S. Environmental Protection Agency. Pesticide Reregistration Rejection Rate Analysis: Toxicology. EPA report 738 R 93 004. July 1993. ( 3) U. S. Environmental Protection Agency. Conduct of Acute Toxicity Studies. EPA report 737 R 97 002. September 1997. ( 4) Organization for Economic Cooperation and Development, OECD Guidelines for Testing of Chemicals. Guideline 425: Acute Oral Toxicity Up­ and­ Down Method. Approved: December 2001. 7 ( 5) Organization for Economic Cooperation and Development, OECD Guidelines for Testing of Chemicals. Guideline 420: Acute Oral Toxicity­ Fixed Done Method. Adopted: December 2001. ( 6) Organization for Economic Cooperation and Development, OECD Guidelines for Testing of Chemicals. Guideline 423: Acute Oral Toxicity­ Acute Toxic Class Method. Adopted: December 2001. ( 7) U. S. Environmental Protection Agency. Label Review Manual 2nd Edition. EPA report 737 B 96 001. December 1996.

epa

2024-06-07T20:31:45.351849

regulations

EPA-HQ-OPP-2002-0325-0003

Supporting & Related Material

United States Environmental Protection Agency Prevention, Pesticides and Toxic Substances ( 7101) EPA 712 C 02 190 December 2002 Health Effects Test Guidelines OPPTS 870.1100 Acute Oral Toxicity i INTRODUCTION This guideline is one of a series of test guidelines that have been developed by the Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations. The Office of Prevention, Pesticides and Toxic Substances ( OPPTS) has developed this guideline through a process of harmonization that blended the testing guidance and requirements that existed in the Office of Pollution Prevention and Toxics ( OPPT) and appeared in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations ( CFR), the Office of Pesticide Programs ( OPP) which appeared in publications of the National Technical Information Service ( NTIS) and the guidelines published by the Organization for Economic Cooperation and Development ( OECD). The purpose of harmonizing these guidelines into a single set of OPPTS guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements of the U. S. Environmental Protection Agency under the Toxic Substances Control Act ( 15 U. S. C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act ( 7 U. S. C. 136, et seq.). Final Guideline Release: This guideline is available from the U. S. Government Printing Office, Washington, DC 20402 on disks or paper copies: call ( 202) 512 0132. This guideline is also available electronically in PDF ( portable document format) from EPA's Internet Web site at http:/ / www. epa. gov/ opptsfrs/ home/ guidelin. htm. Also, the Agency has developed and strongly recommends users to solely use, the software program for performing the Up­ and­ Down Procedure and calculating the LD50 and confidence interval. The software program ( AOT425StatPgm) is available on EPA's Internet Web site at http:// www. epa. gov/ oppfead1/ harmonized. 1 OPPTS 870.1100 Acute oral toxicity. ( a) Scope Applicability. This guideline is intended to meet testing requirements of both the Federal Insecticide, Fungicide, and Rodenticida Act ( FIFRA) ( 7 U. S. C. 136, et seq.) and the Toxic Substances Control Act ( TSCA) ( 15 U. S. C. 2601). ( 2) Background. The source material for this revised harmonized test guideline is OPPTS 870.1100 Acute Oral Toxicity, dated August 1998 and OECD test Guideline 425 Acute Oral Toxicity Up­ and­ Down Procedure. ( b) Purpose. In the assessment and evaluation of the toxic characteristics of a substance, determination of acute oral toxicity is usually an initial step. It provides information on health and environmental hazards likely to arise from short­ term exposure by the oral route. Data from an acute study may serve as a basis for classification and labeling. It is traditionally a step in establishing a dosage regimen in subchronic and other studies and may provide initial information on the mode of toxic action of a substance. An evaluation of acute toxicity data should include the relationship, if any, between the exposure of animals to the test substance and the incidence and severity of all abnormalities, including behavioral and clinical abnormalities, the reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxic effects. ( c) Definitions. The definitions in Section 3 of the Toxic Substances Control Act ( TSCA) and the definitions in 40 CFR Part 792 Good Laboratory Practice Standards apply to this test guideline. The following definitions also apply to this test guideline. Acute oral toxicity is the adverse effects occurring within a short time of oral administration of a single dose of a substance or multiple doses given within 24 hours. Confidence interval ( CI) is an interval estimate, a range of values, intended to include the true LD50 with a specified degree of confidence. Delayed death means that an animal does not die or appear moribund within 48 hours, but dies later during the 14­ day observation period. Dose is the amount of test substance administered. Dose is expressed as weight ( g, mg ( grams, milligrams)) or as weight of test substance per unit weight of test animal ( e. g., mg/ kg ( milligrams/ kilograms)). Dose progression factor, sometimes termed a dose spacing factor, refers to the multiple by which a dose is increased ( i. e., the dose progression) when an animal survives or the divisor by which it is decreased when an animal dies. The dose progression factor is recommended to be the antilog of 1/( the estimated slope of the dose­ response curve). The default 2 dose progression factor is recommended to be 3.2 = antilog 0.5 = antilog ( 1/ 2). LD50 ( median lethal dose), oral, is a statistically derived single dose of a substance that can be expected to cause death in 50 per cent of animals when administered by the oral route. The LD50 value is expressed in terms of weight of test substance per unit weight of test animal ( mg/ kg). Limit dose refers to a dose at an upper limitation on testing ( 2000 5000 mg/ kg). Moribund status of an animal refers to being in a state of dying or inability to survive, even if treated. Nominal sample size refers to the total number of tested animals, reduced by one less than the number of like responses at the beginning of the series, or by the number of tested animals up to but not including the pair that creates the first reversal. For example, for a series where X and O indicate opposite animal outcomes ( for instance, X could be dies within 48 hours and O survives) in a pattern as follows: OOOXXOXO, we have the total number of tested animals ( or sample size in the conventional sense) as 8 and the nominal sample size as 6. This particular example shows 4 animals following a reversal. It is important to note whether a count in a particular part of the guideline refers to the nominal sample size or to the total number tested. For example, the maximum actual number tested is 15. When testing is stopped based on that basis, the nominal sample size will be less than or equal to 15. Members of the nominal sample start with the ( r­ 1) st animal ( the animal before the second in the reversal pair) ( see reversal below). Probit is an abbreviation for the term `` probability integral transformation'' and a probit dose­ response model permits a standard normal distribution of expected responses ( i. e., one centered to its mean and scaled to its standard deviation, sigma ) to doses ( typically in a logarithmic scale) to be analyzed as if it were a straight line with slope the reciprocal of sigma. A standard normal lethality distribution is symmetric; hence, its mean is also its true LD50 or median response. Reversal is a situation where nonresponse is observed at some dose, and a response is observed at the next dose tested, or vice versa ( i. e., response followed by nonresponse). Thus, a reversal is created by a pair of responses. The first such pair occurs at animals numbered r­ 1 and r. Sigma is the standard deviation of a log normal curve describing the range of tolerances of test subjects to the chemical ( where a subject is expected capable of responding if the chemical dose exceeds the subject's tolerance). The estimated sigma provides an estimate of the variation 3 among test animals in response to a full range of doses. See slope and probit. Slope ( of the dose­ response curve) is a value related to the angle at which the dose response curve rises from the dose axis. In the case of probit analysis, when responses are analyzed on a probit scale against dose on a log scale this curve will be a straight line and the slope is the reciprocal of sigma, the standard deviation of the underlying test subject tolerances which are assumed to be normally distributed. See probit and sigma. Stopping rule is used in this guideline synonymously with ( 1) a specific stopping criterion and ( 2) the collection of all criteria determining when a testing sequence terminates. In particular, for the main test, stopping rule is used in paragraph ( e)( 2)( ii) of this guideline as a shorthand for the criterion that relies on comparison of ratios to a critical value. ( d) Approaches to the determination of acute toxicity. EPA recommends the Up­ and­ Down Procedure ( UDP) as detailed in this guideline and adopted by the Organization for Economic Cooperation and Development ( OECD) as test Guideline 425 ( see paragraph ( n)( 1) of this guideline to assess acute oral toxicity. This method provides a point estimate of lethality and confidence interval around the LD50. Acute oral toxicity testing may also be performed using the Fixed Dose Method of OECD Guideline 420 ( see paragraph ( n)( 2) of this guideline) or the Acute Toxic Class Method of OECD Guideline 423 ( see paragraph ( n)( 3) of this guideline These methods assess lethality within a dose range. ( e) Introduction to the UDP ( 1) Background. ( i) The concept of the up­ and­ down testing approach was first described by Dixon and Mood ( see paragraphs ( n)( 4) through ( n)( 7) of this guideline). In 1985, Bruce proposed to use an UDP for the determination of acute toxicity of chemicals ( see paragraph ( n)( 8) of this guideline). There exist several variations of the up­ and­ down experimental design for estimating an LD50. This guideline is derived from the UDP of Bruce as adopted by the American Society for Testing and Materials ( ASTM) in 1987 ( see paragraph ( n)( 9) of this guideline) and revised in 1990. A study comparing the results obtained with the UDP, the conventional LD50 test and the Fixed Dose Procedure ( FDP, OECD Guideline 420) was published in 1995 ( see paragraph ( n)( 10) of this guideline). ( ii) The UDP described in this guideline is of value in minimizing the number of animals required to estimate the acute oral toxicity of a chemical. In addition to the estimation of LD50 and CI, the test procedure allows the observation of signs of toxicity. The UDP does not provide information about the slope of the dose­ response curve. ( iii) The guideline significantly reduces the number of animals used in comparison to the traditional LD50 test, which often required at least 30 animals in a test: ( A) The stopping rule limits the number of animals 4 in a test; ( B) sequential dosing introduces further efficiencies in animal use; ( C) initial dosing is now set to be below the LD50 increasing the percentage of animals in which dosing levels will be sublethal and thereby providing some reduction in pain and distress; and ( D) the use of a single sex ( usually females) reduces the number of animals needed and minimizes the variability in the test population. In addition, the OECD Guidance Document on Humane Endpoints ( see paragraph ( n)( 11) of this guideline) should be followed in order to reduce the overall suffering of test animals used in this type of toxicity test. ( 2) Initial considerations ( i) Choice of starting dose and dose progression factor. All available information on the test substance should be considered by the testing laboratory prior to conducting the study in order to determine if a preliminary estimate of the LD50 and the slope of the dose­ response curve can be made. Because the method has a bias toward the starting dose, it is essential that initial dosing occur below the LD50. In addition, the UDP performs best when the spacing between doses or dose progression factor is based on an accurate estimate of the slope of the dose­ response curve. ( See paragraphs ( i)( 3)( ii) and ( m)( 1) of this guideline for discussion of dose sequences and starting values.) Initial information may include the identity and chemical structure of the substance; its physical chemical properties; the results of any other in vitro or in vivo toxicity tests on the substance or mixtures; toxicological data on structurally related substances or similar mixtures; and the anticipated use( s) of the substance. For example, data from an in vitro cytotoxicity assay can also be useful as one of the tools in setting a starting dose for the in vivo assessment of acute oral toxicity ( see paragraphs ( n)( 10) through ( n)( 12) of this guideline). ( A Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity is available ( see paragraph ( n)( 11) of this guideline), and preliminary information suggests that the use of this approach may further reduce the number of animals used for in vivo testing ( see paragraph ( n)( 11) of this guideline). Preliminary estimates of the LD50 and the dose­ response slope will help in selecting a dose progression factor and a starting dose for testing. ( ii) Default starting dose and dose progression factor. If no information is available to make a preliminary estimate of the LD50 and the slope of the dose­ response curve, results of computer simulations have suggested that starting near 175 mg/ kg and using half­ log units ( corresponding to a dose progression of 3.2) between doses will produce the best results. This starting dose should be modified if the substance is likely to be highly toxic. The half­ log spacing provides for a more efficient use of animals, and increases accuracy in the prediction of the LD50 value. However, for chemicals with large variability ( i. e., shallow dose­ response slopes), bias can still be introduced in the lethality estimates and the LD50 estimate will have a large statistical error, similar to other acute toxicity methods. To correct for this, the main test includes a stopping rule keyed 5 to properties of the estimate rather than a fixed number of test observations ( See paragraph ( i)( 3)( iii) of this guideline.) ( iii) Delayed toxicity. The method is easiest to apply to materials that produce death within one or two days. The method would not be practical to use when considerably delayed death ( five days or more) can be expected. ( iv) Computation. Computers are used to facilitate animal­ by­ animal calculations that establish testing sequences and provide final estimates. The users of this protocol are strongly urged to solely use the Agencydeveloped software package ( AOT425StatPgm) for performing the test and the calculation of the LD 50. The software is available on EPA's Internet Web site at http:// www. epa. gov/ oppfead1/ harmonized. ( v) Humane practices. Moribund animals or animals obviously in pain or showing signs of severe and enduring distress shall be humanely killed, and are considered in the interpretation of the test results in the same way as animals that died on test. Criteria for making the decision to kill moribund or severely suffering animals, and guidance on the recognition of predictable or impending death are the subject of an OECD guidance document ( see paragraph ( n)( 11) of this guideline). ( vi) Limit test. A limit test can be used efficiently to identify chemicals that are likely to have low acute toxicity. ( f) Principle of the limit test. The limit test is a sequential test that uses a maximum of 5 animals ( see paragraphs ( i)( 2)( i) through ( i)( 2)( iv) of this guideline). A test dose of 5000 mg/ kg is used. The selection of a sequential test plan increases the statistical power and also has been made to intentionally bias the procedure towards rejection of the limit test for compounds with LD50s near the limit dose; i. e., to err on the side of safety. As with any limit test protocol, the probability of correctly classifying a compound will decrease as the actual LD50 more nearly resembles the limit dose. ( g) Principle of the Main Test. ( 1) The main test consists of a single ordered dose progression in which animals are dosed, one at a time, at 48­ hour intervals. The first animal receives a dose a step below the level of the best estimate of the LD50. If the animal survives, the dose for the next animal is increased to a factor of one half log times the original dose; if it dies, the dose for the next animal is decreased by a similar dose progression. ( Note: 3.2 is the default factor corresponding to a dose progression of one half log unit in the Agency developed software program ( AOT425StatPgm). However, this value may be changed. Paragraphs ( i)( 3)( ii) and ( m)( 12) of this guideline provide further guidance for choice of dose spacing factor.) Each animal should be observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision is based on the 48­ hour survival pattern 6 of all the animals up to that time. ( See paragraphs ( i)( 3)( i) and ( i)( 3)( v) of this guideline on choice of survival interval.) A combination of stopping criteria is used to keep the number of animals low while adjusting the dosing pattern to reduce the effect of a poor starting value or low slope ( see paragraph ( i)( 3)( iv) of this guideline). Dosing is stopped when one of these criteria is satisfied ( see paragraphs ( i)( 3)( iii) and ( k)( 2) of this guideline), at which time an estimate of the LD50 and a CI are calculated for the test based on the status of all the animals at termination. For most applications, testing will be completed with only 4 animals after initial reversal in animal outcome. The LD50 is calculated using the method of maximum likelihood ( see paragraphs ( k)( 2) and ( k)( 2)( iii) of this guideline ( 2) The results of the main test procedure serve as the starting point for a computational procedure to provide a CI estimate where feasible. A description of the basis for this CI is outlined in paragraph ( k)( 3) of this guideline. ( h) Preparation for testing ( 1) Selection of animals species. The preferred rodent species is the rat although other rodent species may be used. ( 2) Single sex selection. The test is conducted using a single sex in order to reduce variability and as a means of minimizing the number of animals used. Either sex may be used, however, if there is information available indicating differences in sensitivity, the most sensitive sex ( usually females) should be tested ( see paragraph ( n)( 11) of this guideline). ( i) Literature surveys of conventional LD50 tests show that usually there is little difference in sensitivity between the sexes but, in those cases where differences were observed, females were often slightly more sensitive ( see paragraph ( n)( 10) of this guideline). For chemicals that are direct acting in their toxic mechanism, female rats may have a lower detoxification capacity than males, as measured by specific activity of phase I and II enzymes. However, all available information should be evaluated, for example on chemical analogues and the results of testing for other toxicological endpoints on the chemical itself, as this may indicate that males may be more sensitive than females. Knowledge that metabolic activation is required for a chemical's toxicity can also indicate that males may be the more sensitive sex. ( ii) Occasionally, the results of subsequent testing, for example a subchronic test, may raise concerns that the more sensitive sex had not been used. In such cases, and only when considerable differences between the sexes are suspected, it may be necessary to conduct another full acute oral toxicity study in the second sex. This is preferable to conducting confirmatory testing in a small group of animals of the second sex as a late satellite to the original test because there is a strong possibility that this 7 would produce results that are difficult to interpret. The impact of conducting a second full test on the overall number of animals used in acute toxicity testing should be small because re­ testing is anticipated to be infrequent and the results of the test in one sex, together with data from any subsequent studies, will greatly assist in the selection of starting doses closer to the LD50 in the second test. ( 3) Age and weight ranges. Healthy young adult animals of commonly used laboratory strains should be employed. Females should be nulliparous and non­ pregnant. At the commencement of its dosing, each animal should be between 8 weeks and 12 weeks old. In order to minimize the contribution of developmental variability to study outcome, 10 weeks, with a range of ± 1 week is recommended if practical. The weight of each animal should fall in an interval ± 20% of the mean initial weight of all previously dosed animals. ( 4) Housing and feeding conditions. The temperature in the experimental animal room should be 22 ° C ( ± 3 ° C). The relative humidity should be at least 30% and preferably not exceed 70% other than during room cleaning. Lighting should be artificial, the sequence being 12 hours light and 12 hours dark. The animals are housed individually. For feeding, conventional rodent laboratory diets may be used with an unlimited supply of drinking water. ( 5) Preparation of animals. The animals are randomly selected, marked to permit individual identification, and kept in their cages for at least 5 days prior to dosing to allow for acclimatization to the laboratory conditions. As with other sequential test designs, care must be taken to ensure that animals are available in the appropriate size and age range for the entire study. ( 6) Preparation of doses. ( i) When necessary, the test substance is dissolved or suspended in a suitable vehicle. The use of an aqueous solution suspension/ emulsion is recommended wherever possible, followed in order of preference by a solution/ suspension/ emulsion in oil ( e. g. corn oil) and then possibly solution in other vehicles. For vehicles other than water the toxicological characteristics of the vehicle should be known. Dosing preparations must be prepared shortly prior to administration unless the stability of the preparation over the period during which it will be used is known. Where preparation shortly before administration is not practicable and the stability of the preparation is not known, this will need to be demonstrated analytically. ( ii) Constant concentration should be used in dosing unless there is clear scientific or regulatory justification for not doing so. The maximum dose volume for administration must not be exceeded. The maximum volume of liquid that can be administered at one time depends on the size of the test animal. In rodents, the volume should not normally exceed 8 1 ml/ 100g of body weight; however, in the case of aqueous solutions, 2 ml/ 100g body weight can be considered. ( 7) Administration of doses. ( i) The test substance is administered in a single dose by gavage using a stomach tube or a suitable intubation cannula. In the unusual circumstance that a single dose is not possible, the dose may be given in smaller fractions over a period not exceeding 24 hours. ( ii) Animals should be fasted prior to dosing ( e. g., with the rat, food but not water should be withheld overnight; with the mouse, food but not water should be withheld for 3 4 hours). Following the period of fasting, the animals should be weighed and the test substance administered. The fasted body weight of each animal is determined and the dose is calculated according to the body weight. After the substance has been administered, food may be withheld for a further 3 4 hours in rats or 1 2 hours in mice. Where a dose is administered in fractions over a period of time, it may be necessary to provide the animals with food and water depending on the length of the period. ( i) The up­ and­ down testing procedure ( 1) Choice of limit test and main test. The limit test is primarily used in situations where the experimenter has information indicating that the test material is likely to be nontoxic, i. e., having toxicity below regulatory limit doses. Information about the toxicity of the test material can be gained from knowledge about similar tested compounds or similar tested mixtures or products, taking into consideration the identity and percentage of components known to be of toxicological significance. In those situations where there is little or no information about its toxicity, or in which the test material is expected to be toxic, the main test should be performed. ( 2) Implementation of the limit test. ( i) The Agency has developed dedicated software for performing the test and calculation of test results ( see paragraph ( e) ( 2)( iv) of this guideline). ( ii) Dose one animal at 5000 mg/ kg. If the animal dies, conduct the main test starting at 175 mg/ kg to determine the LD50. If the animal survives dose two additional animals. If both animals survive, the LD50 is greater than the limit dose and the test is terminated ( i. e. carried to full 14­ day observation without dosing of further animals). If one or both animals die, then dose an additional two animals, one at a time. If an animal unexpectedly dies late in the study, and there are other survivors, it is appropriate to stop dosing and observe all animals to see if other animals will also die during a similar observation period ( see paragraph ( g)( 1) of this guideline for initial observation period). Late deaths should be counted the same as other deaths. The results are evaluated as follows ( O= survival and X= death). 9 ( iii) The LD50 is less than the test dose ( 5000 mg/ kg) when three or more animals die. If a third animal dies, conduct the main test. O XO XX O OX XX O XX OX O XX X ( iv) The LD50 is greater than the test dose ( 5000 mg/ kg) when three or more animals survive. O OO O XO XO O XO O O OX XO O OX O O XX OO ( v) If a limit test is performed at 2000 mg/ kg, animals should be dosed sequentially and testing should be performed on all five animals. ( 3) Implementation of the main test. ( i) The Agency has developed dedicated software for performing the test and calculation of test results ( see paragraph ( e) ( 2)( iv) of this guideline). ( ii) Performing the UDP. Single animals are dosed in sequence usually at 48­ hour intervals. However, the time interval between dosing is determined by the onset, duration, and severity of toxic signs. Treatment of an animal at the next dose should be delayed until one is confident of survival of the previously dosed animal. The time interval may be adjusted as appropriate, e. g., in case of inconclusive response. The test is simpler to implement when a single time interval is used for making sequential dosing decisions. Nevertheless, it is not necessary to recalculate dosing or likelihood­ ratios if the time interval changes midtest. For selecting the starting dose, all available information, including information on structurally related substances and results of any other toxicity tests on the test material, should be used to approximate the LD50 as well as the slope of the dose­ response curve. ( iii) Choice of starting dose and dose progression. The first animal is dosed a step below the toxicologist's best estimate of the LD50. If the animal survives, the second animal receives a higher dose. If the first animal dies or appears moribund, the second animal receives a lower dose. The same dosing decision pattern is followed for each subsequent animal. 10 The dose progression factor should be chosen to be the antilog of 1/( the estimated slope of the dose­ response curve) ( a progression of 3.2 corresponds to a slope of 2) and should remain constant throughout testing. Thus, when there is no information on the slope of the substance to be tested, a default dose progression factor of 3.2 is used. Using the default progression factor, doses would be selected from the sequence 1.75, 5.5, 17.5, 55, 175, 550, 1750, 5000. If no estimate of the substance's lethality is available, dosing should be initiated at 175 mg/ kg. In most cases, this dose is sublethal and therefore serves to reduce the level of pain and suffering If animal tolerances to the chemical are expected to be highly variable ( i. e., slopes are expected to be less than 2.0), consideration should be given to increasing the dose progression factor beyond the default 0.5 on a log dose scale ( i. e., 3.2 progression factor) prior to starting the test. Similarly, for test substances known to have very steep slopes, dose progression factors smaller than the default should be chosen. ( Paragraph ( m)( 3) of this guideline relates choice of dose progression to assumed slope and sigma and discusses test performance. Paragraph ( m)( 1) of this guideline includes a table of dose progressions for whole number slopes ranging from 1 to 8 with starting dose 175 mg/ kg.) ( iv) Stopping rules. Dosing continues depending on the fixed­ time interval ( e. g., 48­ hours) outcomes of all the animals up to that time. The testing stops when one of the following stopping criteria first is met: ( A) 3 consecutive animals survive at the upper bound; ( B) 5 reversals occur in any 6 consecutive animals tested; ( C) At least 4 animals have followed the first reversal and the specified likelihood­ ratios exceed the critical value. ( See paragraphs ( k)( 2)( iv) and ( m)( 2) of this guideline). Calculations are made at each dosing, following the fourth animal after the first reversal.). ( v) Total number of doses. For a wide variety of combinations of LD50 and slopes, stopping rule in paragraph ( i)( 3)( iii)( C) of this guideline will be satisfied with 4 to 6 animals after the test reversal. In some cases for chemicals with shallow slope dose­ response curves, additional animals ( up to a total of fifteen tested) may be needed. ( vi) Calculation. When the stopping criteria have been attained, the estimated LD50 should be calculated from the animal outcomes at test termination using the method described in paragraphs ( k)( 1)( i) and ( k)( 2)( i) of this guideline. ( vii) Humane practices. Moribund animals killed for humane reasons are considered in the same way as animals that died on test. If an animal unexpectedly dies late in the study and there are other survivors at that dose or above, it is appropriate to stop dosing and observe all animals to see if other animals will also die during a similar observation period. 11 If subsequent survivors also die, and it appears that all dose levels exceed the LD50 it would be most appropriate to start the study again beginning at least two steps below the lowest dose with deaths ( and increasing the observation period) since the technique is most accurate when the starting dose is below the LD50. If subsequent animals survive at or above the dose of the animal that dies, it is not necessary to change the dose progression since the information from the animal that has now died will be included into the calculations as a death at a lower dose than subsequent survivors, pulling the LD50 down. ( j) Observations. Animals are observed individually at least once during the first 30 minutes after dosing, periodically during the first 24 hours ( with special attention given during the first 4 hours), and daily thereafter, for a total of 14 days, except where they need to be removed from the study and humanely killed for animal welfare reasons or are found dead. However, the duration of observation should not be fixed rigidly It should be determined by the toxic reactions and time of onset and length of recovery period, and may thus be extended when considered necessary The times at which signs of toxicity appear and disappear are important especially if there is a tendency for toxic signs to be delayed ( see paragraph ( n)( 15) of this guideline). All observations of toxic signs are systematically recorded with individual records being maintained for each animal. Additional observations will be necessary if the animals continue to display signs of toxicity. ( 1) Toxic signs. Observations should include changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behavior pattern Attention should be directed to observations of tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma. The principles and criteria summarized in the Humane Endpoints Guidance Document ( see paragraph ( n)( 11) of this guideline) should be taken into consideration. Animals found in a moribund condition and animals showing severe pain and enduring signs of severe distress should be humanely killed. When animals are killed for humane reasons or found dead, the time of death should be recorded as precisely as possible. ( 2) Body weight. Individual weights of animals should be determined shortly before the test substance is administered and at least weekly thereafter Weight changes should be calculated and recorded. At the end of the test surviving animals are weighed and then humanely killed. ( 3) Pathology. All animals ( including those which die during the test or are removed from the study for animal welfare reasons) should be subjected to gross necropsy. All gross pathological changes should be recorded for each animal. Microscopic examination of organs showing evidence of gross pathology in animals surviving 24 or more hours after the 12 initial dosing may also be considered because it may yield useful information ( k) Data and reporting ( 1) Data. Individual animal data should be provided. Additionally, all data should be summarized in tabular form, showing for each test dose the number of animals used, the number of animals displaying signs of toxicity ( see paragraph ( n)( 15) of this guideline the number of animals found dead during the test or killed for humane reasons, time of death of individual animals, a description and the time course of toxic effects and reversibility, and necropsy findings. A rationale for the starting dose and the dose progression and any data used to support this choice should be provided. ( 2) Calculation of LD50 for the main test ( i) Maximum likelihood The LD50 is calculated using the maximum likelihood method, except in the exceptional cases described in paragraphs ( k)( 2)( ii) and ( m)( 3) of this guideline. The Agency­ developed software program ( AOT425StatPgm) available on EPA's Internet Web site at http:// www. epa. gov/ oppfead1/ harmonized should be used to perform this calculation The following statistical details may be helpful in implementing the maximum likelihood calculations suggested ( with an assumed sigma). All deaths, whether immediate or delayed or humane kills, are incorporated for the purpose of the maximum likelihood analysis. Following Dixon ( see paragraph ( n)( 5) of this guideline), the likelihood function is written as follows: L = L1 L2 .... Ln , where L is the likelihood of the experimental outcome, given µ and sigma, and n the total number of animals tested. Li = 1 ­ F( Zi) if the ith animal survived, or Li = F( Zi) if the ith animal died, where F = cumulative standard normal distribution, Zi = [ log( di) ­ µ ] / sigma di = dose given to the ith animal, and sigma = standard deviation in log units of dose ( which is not the log standard deviation). An estimate of the log of the true LD50 is given by the value of µ that maximizes the likelihood L ( see paragraph ( k)( 2)( iii) of this guideline 13 An estimate of sigma of 0.5 is used unless a better generic or casespecific value is available. ( ii) Special circumstances. Under some circumstances, statistical computation will not be possible or will likely give erroneous results. Special means to determine/ report an estimated LD50 are available for these circumstances as described in the following paragraphs ( k)( 2)( ii)( A), ( k)( 2)( ii)( B), and ( k)( 2)( ii)( C). If none of these situations occurs, then the LD50 is calculated using the maximum likelihood method. ( A) If testing stopped based on the criterion in paragraph ( i)( 3)( iii)( C) of this guideline ( i. e., a boundary dose was tested repeatedly), or if the upper bound dose ended testing, then the LD50 is reported to be above the upper bound. ( B) If all the dead animals have higher doses than all the live animals ( or if all live animals have higher doses than all the dead animals, although this is practically unlikely), then the LD50 is between the doses for the live and the dead animals. These observations give no further information on the exact value of the LD50. Still, a maximum likelihood LD50 estimate can be made provided there is a prior value for sigma. The LD50 estimate is only as good as the validity of the assumed signa. However, Case 3 as described in paragraph ( m)( 3)( iii) of this guideline and here is most likely to occur because the dose progression ( based on the assumed signma) is too wide. The stopping criterion in paragraph ( i)( 3)( iii)( C) describes one such circumstance. ( C) If the live and dead animals have only one dose in common and all the other dead animals have higher doses and all the other live animals lower doses, or vice versa, then the LD50 equals their common dose. If a closely related substance is tested, testing should proceed with a smaller dose progression. ( iii) Maximum likelihood calculation. Maximum likelihood calculation should be performed using a dedicated program developed by and available from EPA ( see paragraph ( n)( 16) of this guideline). If other computer programs are used, the laboratory should take care in handling special cases described in this guideline and the documentation of test performance available on EPA's Internet Web site at http:// www. epa. gov/ oppfead1/ harmonized. Typical instructions for these packages are given in appendices to the ASTM Standard E 1163­ 87 ( see paragraph ( n)( 9) of this guideline). ( The sigma used in the BASIC program in ( see paragraph ( n)( 9) of this guideline) will need to be edited to reflect the parameters of the UDP.) The program's output is an estimate of log ( LD50) and its standard error. ( iv) Stopping rule. The likelihood­ ratio stopping rule in paragraph ( i)( 3)( iii)( C) of this guideline is based on three measures of test progress, that are of the form of the likelihood in paragraph ( k)( 2) of this guideline, 14 with different values for µ . Comparisons are made after each animal tested after the sixth that does not already satisfy the criteria in paragraph ( i)( 3)( iii)( A) or paragraph ( i)( 3)( iii)( B) guideline. The equations for the likelihood­ ratio criteria are provided by following the steps in paragraph ( m)( 2)( vii) of this guideline. These comparisons are most readily performed in an automated manner and can be executed repeatedly, for instance by a spreadsheet routine such as that also provided in paragraph ( m)( 2)( vii) of this guideline. If the criterion is met, testing stops and the LD50 can be calculated by the maximum likelihood method. ( 3) Computation of CI. ( i) Following the main test and estimated LD50 calculation, it may be possible to compute interval estimates for the LD50. The Agency­ developed software program AOT425StatPgm will perform the calculations. Any of these CIs provides valuable information on the reliability and utility of the main test that was conducted. A wide CI indicates that there is more uncertainty associated with the estimated LD50. In this case, the reliability of the estimated LD50 is low and the usefulness of the estimated LD50 may be marginal. A narrow interval indicates that there is relatively little uncertainty associated with the estimated LD50. In this case, the reliability of the estimated LD50 is high and the usefulness of the estimated LD50 is good. This means that if the main test were to be repeated, the new estimated LD50 is expected to be close to the original estimated LD50 and both of these estimates are expected to be close to the true LD50. ( ii) Depending on the outcome of the main test, one of two different types of interval estimates of the true LD50 is calculated: ( A) When at least three different doses have been tested and the middle dose has at least one animal that survived and one animal that died, a profile­ likelihood­ based computational procedure is used to obtain a CI that is expected to contain the true LD50 95% of the time. However, because small numbers of animals are expected to be used, the actual level of confidence is generally not exact ( see paragraph ( n)( 19) of this guideline The random stopping rule improves the ability of the test overall to respond to varying underlying conditions, but also causes the reported level of confidence and the actual level of confidence to differ somewhat ( see paragraph ( n)( 18) of this guideline). ( B) If all animals survive at or below a given dose level and all animals die when dosed at the next higher dose level, an interval is calculated that has as its lower limit the highest dose tested where all the animals survive and has as its upper limit the dose level where all the animals died. This interval is labeled as `` approximate.'' The exact confidence level associated with this interval cannot be specifically determined. However because this type of response would only occur when the dose­ response is steep, in most cases, the true LD50 is expected to be contained 15 within the calculated interval or be very close to it. This interval will be relatively narrow and sufficiently accurate for most practical use. ( iii) In some instances, CIs are reported as infinite, through including either zero at the lower end or infinity at the upper end, or both. Such intervals may occur, for example, when the response profile is relatively flat or relatively uncertain. ( iv) Implementing this set of procedures requires specialized computation which is either by use of a dedicated program to be available through the Environmental Protection Agency ( EPA) or OECD or developed following technical details available from the EPA or OECD. Achieved coverage of these intervals and properties of the dedicated program are described in a report ( see paragraph ( n)( 16) of this guideline) also available through the EPA. Paragraph ( m)( 3) of this guideline provides information on choice of dose progression and initial dose level for the UDP and describes test performance under a variety of circumstances. ( l) Test reporting. The test report must include the following information ( 1) Test substance: ( i) Physical nature, purity and physicochemical properties ( including isomerization); ( ii) Identification data. ( 2) Vehicle ( if appropriate): Justification for choice of vehicle, if other than water. ( 3) Test animals: ( i) Species/ strain used; ( ii) Microbiological status of the animals, when known; ( iii) Number, age and sex of animals; ( iv) Rationale for use of males instead of females; ( v) Source, housing conditions, diet, etc.; ( vi) Individual weights of animals at the start of the test, at day 7, and at day 14. ( 4) Test conditions: ( i) Rationale for initial dose level selection, dose progression factor and for follow­ up dose levels; ( ii) Details of test substance formulation; 16 ( iii) Details of the administration of the test substance; ( iv) Details of food and water quality ( including diet type/ source, water source). ( 5) Results: ( i) Body weight/ body weight changes; ( ii) Tabulation of response data by sex ( if both sexes are used) and dose level for each animal ( i. e., animals showing signs of toxicity including nature, severity, duration of effects, and mortality); ( iii) Time course of onset of signs of toxicity and whether these were reversible for each animal; ( iv) Necropsy findings and any histopathological findings for each animal, if available; ( v) LD50 and CI ( which the AOT425StatPgm software package uses); ( vi) Statistical treatment of results ( description of computer routine used and spreadsheet tabulation of calculations). If other than Agency­ supplied software is used, give explanation of now the program was verified against Agency software. ( 6) Discussion and interpretation of results. ( 7) Conclusions. ( m) Additional guidance for toxicologists ( 1) Dosing procedure dose sequence for main test. ( i) Up­ and­ down dosing procedure. For each run, animals are dosed, one at a time, usually at 48­ hour intervals. The first animal receives a dose a step below the level of the best estimate of the LD50. This selection reflects an adjustment for a tendency to bias away from the LD50 in the direction of the initial starting dose in the final estimate ( see paragraph ( e)( 2)( ii) of the guideline). The overall pattern of outcomes is expected to stabilize as dosing is adjusted for each subsequent animal. Paragraph ( m)( 1)( iii) of this guideline provides further guidance for choice of dose spacing factor. ( ii) Default dose progression. Once the starting dose and dose spacing are decided, the toxicologist should list all possible doses including the upper bound ( usually 2000 or 5000 mg/ kg). Doses that are close to the upper bound should be removed from the progression. The stepped nature of the UDP design provides for the first few doses to function as a selfadjusting sequence. Because of the tendency for positive bias, in the event that nothing is known about the substance, a starting dose of 175 mg/ kg is recommended. If the default procedure is to be used for the main test, dosing will be initiated at 175 mg/ kg and doses will be spaced by a factor of 0.5 on a log dose scale. The doses to be used include 1.75, 17 5.5, 17.5, 55, 175, 550, 2000 or, for specific regulatory needs, 1.75, 5.5, 17.5, 55, 175, 550, 1750, 5000. For certain highly toxic substances, the dosing sequence may need to be extended to lower values. ( iii) In the event a dose progression factor other than the default is deemed suitable, the following Table 1 provides dose progressions for whole number multiples of slope, from 1 to 8. ( See paragraph ( m)( 3) of this guideline for discussion of influence of dose progression on test performance 18 Table 1. Dose Progressions for UDP ( Choose a Slope and Read Down the Column. All doses in mg/ kg body weight) Slope = 1 2 3 4 5 6 7 8 0.175* 0.175* 0.175* 0.175* 0.175* 0.175* 0.175* 0.175* ...................... ...................... ...................... ...................... ...................... ...................... 0.243* 0.233* ...................... ...................... ...................... ...................... 0.28 0.26 ...................... ...................... ...................... ...................... ...................... 0.31 ...................... ...................... 0.34 0.31 ...................... ...................... 0.38 ...................... ...................... 0.38 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 0.41 ...................... ...................... ...................... ...................... 0.44 ...................... 0.47 ...................... ...................... 0.55 ...................... .55 ...................... 0.55 ...................... 0.55 ...................... ...................... ...................... 0.70 ...................... 0.65 ...................... ...................... ...................... ...................... ...................... ...................... ...................... 0.74 ...................... ...................... .81 ...................... ...................... .81 ...................... ...................... ...................... ...................... ...................... 0.98 ...................... ...................... 0.91 0.98 ...................... ...................... ...................... ...................... 110 1.19 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 1.26 1.31 1.75 1.75 1.75 1.75 1.75 1.75 1.75 1.75 ...................... ...................... ...................... ...................... ...................... ...................... 2.43 2.33 ...................... ...................... ...................... ...................... 2.8 2.6 ...................... ...................... ...................... ...................... ...................... 3.1 ...................... ...................... 3.4 3.1 ...................... ...................... 3.8 ...................... ...................... 3.8 ...................... ...................... ...................... ...................... ...................... ...................... 4.4 ...................... ...................... 4.1 ...................... ...................... ...................... ...................... ...................... ...................... 4.7 ...................... ...................... 5.5 ...................... 5.5 5.5 ...................... 5.5 ...................... ...................... ...................... ...................... 7.0 ...................... 6.5 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 7.4 ...................... ...................... 8.1 ...................... ...................... 8.1 ...................... ...................... ...................... ...................... ...................... 9.8 ...................... ...................... 9.1 9.8 ...................... ...................... ...................... ...................... 11.0 11.9 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 12.6 13.1 17.5 17.5 17.5 17.5 17.5 17.5 17.5 17.5 ...................... ...................... ...................... ...................... ...................... ...................... 24.3 23.3 ...................... ...................... ...................... ...................... 28 26 ...................... ...................... ...................... ...................... ...................... 31 ...................... ...................... 34 31 ...................... ...................... 38 ...................... ...................... 38 ...................... ...................... ...................... ...................... ...................... ...................... 44 ...................... ...................... 41 ...................... ...................... ...................... ...................... ...................... ...................... 47 ...................... ...................... 55 ...................... 55 ...................... 55 ...................... 55 ...................... ...................... ...................... ...................... ...................... ...................... 65 ...................... ...................... ...................... ...................... ...................... 70 ...................... ...................... 74 ...................... ...................... 81 ...................... ...................... 81 ...................... ...................... ...................... ...................... ...................... 98 ...................... ...................... 91 98 ...................... ...................... ...................... ...................... 110 119 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 126 131 175 175 175 175 175 175 175 175 ...................... ...................... ...................... ...................... ...................... ...................... 243 233 ...................... ...................... ...................... ...................... 280 260 ...................... ...................... ...................... ...................... ...................... 310 ...................... ...................... 340 310 ...................... ...................... 380 ...................... ...................... 380 ...................... ...................... ...................... ...................... ...................... ...................... 440 ...................... ...................... 410 ...................... ...................... ...................... ...................... ...................... ...................... 470 ...................... ...................... 550 ...................... 550 ...................... 550 ...................... 550 ...................... ...................... ...................... ...................... ...................... ...................... 650 ...................... ...................... ...................... ...................... ...................... 700 ...................... ...................... 740 ...................... ...................... 810 ...................... ...................... 810 ...................... ...................... ...................... ...................... ...................... 980 ...................... ...................... 910 980 ...................... ...................... ...................... ...................... 1100 1190 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 1260 1310 1750 1750 1750 1750 1750 1750 1750 1750 ...................... ...................... ...................... ...................... ...................... ...................... 2430 2330 ...................... ...................... ...................... ...................... 2800 2600 ...................... ...................... ...................... ...................... ...................... 3100 ...................... ...................... ...................... 3100 ...................... ...................... ...................... ...................... ...................... 3800 3400 ...................... ...................... ...................... ...................... ...................... ...................... ...................... ...................... 4100 5000 5000 5000 5000 5000 5000 5000 5000 * If lower doses are needed, continue progressions to a lower dose ( 2) Computations for the likelihood­ ratio stopping rules. ( i) As described in paragraph ( i)( 3)( iii) of this guideline, the main test may be completed on the basis of the first of three stopping criteria to occur. In any case, even if none of the stopping criteria is satisfied, dosing would stop when 15 animals are dosed. Tables 2, 4, and 6 in paragraphs ( m)( 2)( ii), ( m)( 2)( iii), and ( m)( 2)( iv), respectively, of this guideline illustrate examples where testing has started with no information, so the rec­ 19 ommended default starting value, 175 mg/ kg, and the recommended default dose progression factor, 3.2 or one half log, have been used. Tables 3, 5, and 7 in paragraphs ( m)( 2)( ii), ( m)( 2)( iii), and ( m)( 2)( iv), respectively illustrate how Tables 2, 4, and 6, respectively, would appear in the dedicated program referenced in paragraph ( k)( 3)( iv) ( see also paragraph ( n)( 16)). ( ii) The following Tables 2 and 3 show how the main test would stop if 3 animals have survived at the limit dose of 5000 mg/ kg. ( This example illustrates situations where a limit test was not thought appropriate a priori). Table 2. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( A) using 5000 mg/ kg. 1 2 3 4 5 6 7 8 9 10 11 12 Step ( I) nclude; Dose ( X) response Included log10 LD50 = # DIV/ 0! LD50 = # DIV/ 0! LD50 = # DIV/ 0! ( E) xclude ( O) non­ resp. in nominal Dose Prob. of likelihood Prob. of likelihood Prob. of likelihood n response contribn. response contribn. response contribn. OK ( ln Li ) ( ln Li ) ( ln Li ) 1 I 175 O no 2.2430 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 2 I 550 O no 2.7404 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 3 I 1750 O no 3.2430 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 4 I 5000 O no 3.6990 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 5 I 5000 O no 3.6990 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 6 I 5000 O no 3.6990 # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! # DIV/ 0! 7 E ­ ­ ­ ­ ­ ­ ­ 8 E ­ ­ ­ ­ ­ ­ ­ 9 E ­ ­ ­ ­ ­ ­ ­ 10 E ­ ­ ­ ­ ­ ­ ­ 11 E ­ ­ ­ ­ ­ ­ ­ 12 E ­ ­ ­ ­ ­ ­ ­ 13 E ­ ­ ­ ­ ­ ­ ­ 14 E ­ ­ ­ ­ ­ ­ ­ 15 E ­ ­ ­ ­ ­ ­ ­ Nominal Sample size = 0 Actual number tested = 6 Calculated maximum likelihood estimate of LD50 = none Stop after animal # 6 because 3 animals survive at limit of 5000 mg/ kg (# 4­# 6). Ignore all calculation cells. No reversal in direction of response. Maximum Likelihood Calculations cannot be completed. LD50 is greater than 5000 mg/ kg. Table 3. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( A) of this Guideline Using 5000 mg/ kg 22 ( iii) The following Tables 4 and 5 show how a particular sequence of 5 reversals in 6 tested animals could occur and allow test completion. Table 4. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( B). 1 2 3 4 5 6 7 8 9 10 11 12 Step ( I) nclude; Dose ( X) response Included log10 LD50 = 31.0 LD50 = 12.4 LD50 = 77.6 ( E) xclude ( O) non­ resp. in nominal Dose Prob. of likelihood Prob. of likelihood Prob. of likelihood n response contribn. response contribn. response contribn. OK ( ln Li ) ( ln Li ) ( ln Li ) 1 I 175 X no 2.2430 0.9335 ­ 0.0688 0.9892 ­ 0.0108 0.7602 ­ 0.2742 2 I 55 X yes 1.7404 0.6905 ­ 0.3703 0.9020 ­ 0.1031 0.3826 ­ 0.9607 3 I 17.5 O yes 1.2430 0.3095 ­ 0.3703 0.6174 ­ 0.9607 0.0980 ­ 0.1031 4 I 55 X yes 1.7404 0.6905 ­ 0.3703 0.9020 ­ 0.1031 0.3826 ­ 0.9607 5 I 17.5 O yes 1.2430 0.3095 ­ 0.3703 0.6174 ­ 0.9607 0.0980 ­ 0.1031 6 I 55 X yes 1.7404 0.6905 ­ 0.3703 0.9020 ­ 0.1031 0.3826 ­ 0.9607 7 I 17.5 O yes 1.2430 0.3095 ­ 0.3703 0.6174 ­ 0.9607 0.0980 ­ 0.1031 8 E ­ ­ ­ ­ ­ ­ ­ 9 E ­ ­ ­ ­ ­ ­ ­ 10 E ­ ­ ­ ­ ­ ­ ­ 11 E ­ ­ ­ ­ ­ ­ ­ 12 E ­ ­ ­ ­ ­ ­ ­ 13 E ­ ­ ­ ­ ­ ­ ­ 14 E ­ ­ ­ ­ ­ ­ ­ 15 E ­ ­ ­ ­ ­ ­ ­ Nominal Sample size = 6 Actual number tested = 7 Dose­ averaging estimator 31.02 log10 = 1.492 log­ likelihood sums: ­ 2.2906 ­ 3.2021 ­ 3.4655 likelihoods: 0.1012 0.0407 0.0313 likelihood ratios: 2.4880 3.2378 Individual ratios exceed critical value? critical= 2.5 FALSE TRUE Both ratios exceed critical value? FALSE Calculated maximum likelihood estimate of LD50 = 29.6 Stop after animal # 7 because 5 reversals in 6 consecutive animals tested (# 2­# 7). Automated calculation; not relevant to this case. Final estimate obtained from Maximum Likelihood Calculations Table 5. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( B) of this Guideline. 25 ( iv) Finally, the following Tables 6 and 7 illustrate a situation several animals into a test, where neither the criterion in paragraph ( i)( 3)( iii)( A) nor the criterion in paragraph ( i)( 3)( iii)( B) of this guideline has been met, a reversal of response has occurred followed by 4 tested animals, and, consequently, the criterion in paragraph ( i)( 3)( iii)( C) of this guideline must be evaluated as well. Table 6. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( C). Assumed slope 2 sigma = 0.5 Parameters of convergence criterion critical LR 2.5 Result: The LR criterion is met factor of LD50 2.5 1 2 3 4 5 6 7 8 9 10 11 12 Step ( I) nclude; Dose ( X) response Included log10 Contrib. to LD50 = 1292.8 LD50 = 517.1 LD50 = 3232.0 ( E) xclude ( O) non­ resp. in nominal Dose DAE Prob. of likelihood Prob. of likelihood Prob. of likelihood n response contribn. response contribn. response contribn. OK ( ln Li ) ( ln Li ) ( ln Li ) 1 I 175 O no 2.2430 0.0000 0.0412 ­ 0.0421 0.1733 ­ 0.1903 0.0057 ­ 0.0057 2 I 550 O yes 2.7404 2.7404 0.2289 ­ 0.2600 0.5214 ­ 0.7368 0.0620 ­ 0.0640 3 I 1750 X yes 3.2430 3.2430 0.6037 ­ 0.5046 0.8552 ­ 0.1564 0.2971 ­ 1.2138 4 I 550 O yes 2.7404 2.7404 0.2289 ­ 0.2600 0.5214 ­ 0.7368 0.0620 ­ 0.0640 5 I 1750 X yes 3.2430 3.2430 0.6037 ­ 0.5046 0.8552 ­ 0.1564 0.2971 ­ 1.2138 6 I 550 O yes 2.7404 2.7404 0.2289 ­ 0.2600 0.5214 ­ 0.7368 0.0620 ­ 0.0640 7 I 1750 O yes 3.2430 3.2430 0.6037 ­ 0.9257 0.8552 ­ 1.9323 0.2971 ­ 0.3525 8 I 5000 X yes 3.6990 3.6990 0.8800 ­ 0.1279 0.9756 ­ 0.0247 0.6477 ­ 0.4344 9 I 1750 X yes 3.2430 3.2430 0.6037 ­ 0.5046 0.8552 ­ 0.1564 0.2971 ­ 1.2138 10 E ­ 0.0000 ­ ­ ­ ­ ­ ­ 11 E ­ 0.0000 ­ ­ ­ ­ ­ ­ 12 E ­ 0.0000 ­ ­ ­ ­ ­ ­ 13 E ­ 0.0000 ­ ­ ­ ­ ­ ­ 14 E ­ 0.0000 ­ ­ ­ ­ ­ ­ 15 E ­ 0.0000 ­ ­ ­ ­ ­ ­ Nominal Sample size = 8 Actual number tested = 9 Dose­ averaging estimator 1292.78 log10 = 3.112 log­ likelihood sums: ­ 3.3894 ­ 4.8270 ­ 4.6260 likelihoods: 0.0337 0.0080 0.0098 likelihood ratios: 4.2104 3.4436 Individual ratios exceed critical value? critical= 2.5 TRUE TRUE Both ratios exceed critical value? TRUE Calculated maximum likelihood estimate of LD50 = 1329.6 Stop when LR criterion is first met, here at animal # 9. Check LR criterion starting at animal # 6. Final estimate obtained from Maximum Likelihood Calculations Table 7. Example of Stopping Criterion in Paragraph ( i)( 3)( iii)( C) of this Guideline. 28 ( v) Criterion in paragraph ( i)( 3)( iii)( C) of this guideline calls for a likelihood­ ratio stopping rule to be evaluated after testing each animal, starting with the fourth tested following the reversal. Three `` measures of test progress'' are calculated. Technically, these measures of progress are likelihoods, as recommended for the maximum­ likelihood estimation of the LD50. The procedure is closely related to calculation of a CI by a likelihood­ based procedure. ( vi) The basis of the procedure is that when enough data have been collected, a point estimate of the LD50 should be more strongly supported than values above and below the point estimate, where statistical support is quantified using likelihood. Therefore three likelihood values are calculated A likelihood at an LD50 point estimate ( called the rough estimate or dose­ averaging estimate in the example), a likelihood at a value below the point estimate, and a likelihood at a value above the point estimate. Specifically, the low value is taken to be the point estimate divided by 2.5 and the high value is taken to be the point estimate multiplied by 2.5. ( vii) The likelihood values are compared by calculating ratios of likelihoods, and then determining whether these likelihood­ ratios ( LR) exceed a critical value. Testing stops when the ratio of the likelihood for the point estimate exceeds each of the other likelihoods by a factor of 2.5, which is taken to indicate relatively strong statistical support for the point estimate. Therefore two likelihood­ ratios ( LRs) are calculated, a ratio of likelihoods for the point estimate and the point estimate divided by 2.5, and a ratio for the point estimate and the estimate times 2.5. ( viii) The calculations are easily performed in any spreadsheet with normal probability functions. The calculations are illustrated in Tables 6 and 7 in paragraph ( m)( 2)( iv) of this guideline, which is structured to promote spreadsheet implementation. The computation steps are illustrated using an example where the upper limit dose is 5000 mg/ kg. ( A) Hypothetical example ( Tables 6 and 7 in paragraph ( m)( 2)( iv) of this guideline). In the hypothetical example utilizing an upper boundary dose of 5000 mg/ kg, the LR stopping criterion was met after nine animals had been tested. The first `` reversal'' occurred with the 3rd animal tested. The LR stopping criterion is checked when four animals have been tested following the reversal. In this example, the fourth animal tested following the reversal is the seventh animal actually tested. Therefore, for this example the spreadsheet calculations are only needed after the seventh animal had been tested and the data could be entered at that time. Subsequently, the LR stopping criterion would have been checked after testing the seventh animal, the eighth animal, and the ninth. The LR stopping criterion is first satisfied after the ninth animal is tested in this example. ( 1) Enter the dose­ response information animal by animal. 29 ( i) Column 1. Steps are numbered 1 15. No more than 15 animals may be tested. ( ii) Column 2. Place an I in this column as each animal is tested. ( iii) Column 3. Enter the dose received by the ith animal. ( iv) Column 4. Indicate whether the animal responded ( shown by an X) or did not respond ( shown by an O). ( 2) The nominal and actual sample sizes. The nominal sample consists of the two animals that represent the first reversal ( here the second and third animals), plus all animals tested subsequently. Here, Column 5 indicates whether or not a given animal is included in the nominal sample. ( i) The nominal sample size ( nominal n) appears in Row 16. This is the number of animals in the nominal sample. In the example, nominal n is 8. ( ii) The actual number tested appears in Row 17. ( 3) Rough estimate of the LD50. The geometric mean of doses for the animals in the current nominal sample is used as a rough estimate of the LD50 from which to gauge progress. In the table, this is called the `` dose­ averaging estimator.'' It is updated with each animal tested. This average is restricted to the nominal sample in order to allow for a poor choice of initial test dose, which could generate either an initial string of responses or an initial string of nonresponses. ( However, the results for all animals are used in the likelihood calculations for final LD50 calculation below.) Recall that the geometric mean of n numbers is the product of the n numbers, raised to a power of 1/ n. ( i) The dose­ averaging estimate appears in Row 18 ( e. g., ( 175 * 550 * ... * 1750) 1/ 8 = 1292.78). ( ii) Row 19 shows the logarithm ( base 10) of the value in Row 18 ( e. g., log10 1292.8 = 3.112). ( 4) Likelihood for the rough LD50 estimate. ( i) `` Likelihood'' is a statistical measure of how strongly the data support an estimate of the LD50 or other parameter. Ratios of likelihood values can be used to compare how well the data support different estimates of the LD50. ( ii) In Column 8 calculate the likelihood for Step C's rough LD50 estimate. The likelihood ( Row 21) is the product of likelihood contributions for individual animals ( see paragraph ( k)( 2) of this guideline). The likelihood contribution for the ith animal is denoted Li. 30 ( iii) Column 7. Enter the estimate of the probability of response at dose di, denoted Pi. Pi is calculated from a dose­ response curve. Note that the parameters of a probit dose­ response curve are the slope and the LD50, so values are needed for each of those parameters. For the LD50 the dose­ averaging estimate from Row 18 is used. For the slope in this example the default value of 2 is used. The following steps may be used to calculate the response probability Pi. 1. Calculate the base­ 10 log of dose di ( Column 6). 2. For each animal calculate the z­ score, denoted Zi ( not shown in the table), using the formulae sigma = 1 / slope, Zi = ( log10( di) ­ log10( LD50)) / sigma For example, for the first animal ( Row 1), sigma = 1 / 2 Z1 = ( 2.243 ­ 3.112) / 0.500 = ­ 1.738 3. For the ith dose the estimated response probability is Pi = F( Zi) where F denotes the cumulative distribution function for the standard normal distribution ( i. e., the normal distribution with mean 0 and variance 1). For example ( Row 1), P1 = F(­ 1.738) = 0.0412 The function F ( or something very close) is ordinarily what is given for the normal distribution in statistical tables, but the function is also widely available as a spreadsheet function. It is available under different names, for example the @ NORMAL function of Lotus 1­ 2­ 3 ( see paragraph ( n)( 19) of this guideline) and the @ NORMDIST function in Excel ( see paragraph ( n)( 20) of this guideline). To confirm that you have used correctly the function available in your software, you may wish to verify familiar values such as F( 1.96) 0.975 or F( 1.64) 0.95. ( iv) Column 8. Calculate the natural log of the likelihood contribution ( ln( Li)). Li is simply the probability of the response that actually was observed for the ith animal: Responding animals: ln( Li) = ln( Pi) Non­ responding animals: ln( Li) = ln( 1 ­ Pi) 31 Note that here the natural logarithm ( ln) is used, whereas elsewhere the base­ 10 ( common) logarithm was used. These choices are what are ordinarily expected in a given context. The steps above are performed for each animal. Finally: Row 20: Sum the log­ likelihood contributions in Column 8. Row 21: Calculate the likelihood by applying the exp function applied to the log­ likelihood value in Row 20 ( e. g., exp(­ 3.389) = e­ 3.389 = 0.0337). ( 5) Calculate likelihoods for two dose values above and below the rough estimate. If the data permit a precise estimate, then one expects the likelihood should be high if the estimate is a reasonable estimate of the LD50, relative to likelihoods for values distant from this estimate. Compare the likelihood for the dose­ averaging estimate ( 1292.8, Row 18) to values differing by a factor of 2.5 from that value ( i. e., to 1292.8* 2.5 and 1292.8/ 2.5). The calculations ( displayed in Columns 9 12) are carried out in a fashion similar to those described above, except that the values 517.1 (= 1292.8/ 2.5) and 3232.0 (= 1292.8* 2.5) have been used for the LD50, instead of 1292.8. The likelihoods and log­ likelihoods are displayed in Rows 20 21. ( 6) Calculate likelihood­ ratios. The three likelihood values ( Row 21) are used to calculate two likelihood­ ratios ( Row 22). A likelihood­ ratio is used to compare the statistical support for the estimate of 1292.8 to the support for each of the other values, 517.1 and 3232.0. The two likelihood ratios are therefore: LR1 = [ likelihood of 1292.8] / [ likelihood of 517.1] = 0.0337 / 0.0080 = 4.21 and LR2 = [ likelihood of 1292.8] / [ likelihood of 3232.0] = 0.0337 / 0.0098 = 3.44 ( 7) Determine if the likelihood­ ratios exceed the critical value. High likelihood­ ratios are taken to indicate relatively high support for the point estimate of the LD50. Both of the likelihood­ ratios calculated in paragraph ( m)( 2)( viii)( A)( 6) of this guideline ( 4.21 and 3.44) exceed the critical likelihood ratio, which is 2.5. Therefore the LR stopping criterion is satisfied and testing stops. This is indicated by a TRUE in Row 24 and a note at the top of the example spreadsheet that the LR criterion is met. Determination of the point estimate and CI is carried out separately. 32 ( B) [ Reserved] ( 3) Performance of the UDP. This section addresses choice of dose progression and initial dose level for the UDP and describes the performance of the test under a variety of circumstances. A companion document titled `` Toxicology Summary: Performance of the Up­ and­ Down Procedure provides assistance to the user in interpretation of the test results and is available on the ICCVAM web site at http:// iccvam. niehs. nih. gov/ methods/ udpdocs/ udprpt/ udp ciprop. htm. The statistical methods applied will depend upon the case into which the test response patterns fall ( see Table 8 in paragraph ( m)( 3)( iii) of this guideline. ( i) Adjusting the dose progression and initial dose. For optimum performance of the UDP, the dose progression used should be based on an accurate prior estimate of sigma. The following two cases describe the outcome when an accurate estimate of sigma is not available. In addition, to account conservatively for any bias in the LD50 estimate, it is essential that dosing be initiated below the actual LD50. ( A) Assumed sigma << true sigma: When the assumed sigma ( i. e., the sigma on which the dose progression is based) is much smaller than the true sigma of the actual test population, the estimated LD50 may be `` biased'' in the direction of starting dose. For example, if the starting dose is less than the true LD50 of the test population, the estimated LD50 will generally be below the true LD50. Also, if the starting dose is greater than the true LD50 of the test population, the estimated LD50 will tend to be greater than the true LD50. To minimize the chance of overestimating the LD50 due to this bias, the UDP guideline recommends a choice of starting dose just below the assumed LD50. ( B) Assumed sigma >> true sigma: If the assumed sigma on which the dose progression is based is much larger than the true sigma of the test population, the median estimated LD50 can be much larger or much smaller than the true LD50 depending on the starting dose. In this case, the LD50 can be estimated only within a range. ( This is Case 3 described below.) ( ii) CI. Coverage of the CI is the probability that a calculated CI encloses the true LD50 for an experimental sample. Because the profile likelihood method is approximate, coverage of the CI does not always correspond to its nominal value. For example, coverage falls below 95% for populations with shallow slopes and is better than 95% for populations with steep slopes. In addition, the width of the CI is limited by the dose progression chosen. Generally, no type of CI would be more narrow than the dose progression. ( iii) Response Patterns. Data gathered under the UDP fall into one of five animal response patterns. The five types of animal response patterns referred to as Case 1 through Case 5 in the following Table 8, can 33 be distinguished for the purpose of describing the performance of the UDP. These cases can be distinguished by looking at the experimental outcome ( survival or death) as reflected in the AOT425StatPgm Data Grid or Report windows ( see paragraph ( n)( 18) of this guideline). In considering these cases, note that doses can be repeated more than once in the course of sequential dosing. Table 8. Outcomes of the UDP: Cases and Confidence Intervals Case # Definition of Case Approach Proposed Possible Findings 1 ....................... No positive dose­ response association. ( 1a) All animals tested in the study responded or ( 1b) none responded, or ( 1c) the geometric mean dose is lower for animals that responded than for animals that did not respond. LD50 cannot be calculated. CI not applicable Possible inferences: ( 1a) LD50 < lowest dose; ( 1b) LD50 > highest dose; ( 1c) reverse dose­ response curve; unlikely test outcome. In case 1b, the highest dose tested is equivalent to a limit dose. 2 ....................... Multiple partial responses. One or more animals responded at a dose below some other dose where one or more did not respond. The conditions defining Case 1 do not hold. ( The definition of Case 2 holds if there are 2 doses with partial responses, but holds in some other cases as well.) Maximum likelihood estimate and profile likelihood computations of CI are straightforward. The LD50 can be estimated and its CI calculated. 3 ....................... No intermediate response fractions. One or more test doses is associated with 0% response and one or more is associated with 100% response ( all of the latter being greater than all of the former), and no test doses are associated with a partial response. Lower bound = highest test dose with 0% response. Upper bound = lowest test dose with 100% response. High confidence that the true LD50 falls between the two bounding doses. Any value of LD50 between highest dose with 0% response and lowest dose with 100% response is equally plausible 4 ....................... One partial response fraction, first subcase. An intermediate partial response is observed at a single test dose. That dose is greater than doses associated with 0% response and lower than doses associated with 100% response. The LD50 is set at the single dose showing partial response and its CI is calculated using profile likelihood method. The LD50 can be estimated and its CI calculated. 5 ....................... One partial response fraction, second subcase. There is a single dose associated with partial response, which is either the highest test dose ( with no responses at all other test doses) or the lowest test dose ( with 100% response at all other test doses). The LD50 is set at the dose with the partial response. A profile likelihood CI is calculated and may be finite or infinite. The true LD50 could be at the boundary of the testing range with more or less confidence. ( n) References. The following references should be consulted for additional background material on this test guideline. ( 1) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. Guideline 425: Acute Oral Toxicity Up­ and­ Down Procedure. Adopted: December 2001. ( 2) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. Guideline 420: Acute Oral Toxicity Fixed Dose Method. Adopted: December 2001. ( 3) Organization for Economic Cooperation and Development. OECD Guidelines for the Testing of Chemicals. Guideline 423: Acute Oral Toxcity Acute Toxic Class Method. Adopted: December 2001. ( 4) Dixon, W. J. and A. M. Mood. ( 1948). A Method for Obtaining and Analyzing Sensitivity Data. J. Amer. Statist. Assoc., 43, 109 126. 34 ( 5) Dixon, W. J. ( 1965). The Up­ and­ Down Method for Small Samples J. Amer. Statist. Assoc. 60, 967 978. ( 6) Dixon, W. J. ( 1991). Staircase Bioassay: The Up­ and­ Down Method Neurosci. Biobehav. Rev., 15, 47 50. ( 7) Dixon, W. J. ( 1991). Design and Analysis of Quantal Dose­ Response Experiments ( with Emphasis on Staircase Designs). Dixon Statistical Associates, Los Angeles CA, USA. ( 8) Bruce, R. D. ( 1985). An Up­ and­ Down Procedure for Acute Toxicity Testing. Fundam. Appl. Tox., 5, 151 157. ( 9) ASTM ( 1987). E 1163 87, Standard Test Method for Estimating Acute Oral Toxicity in Rats. American Society for Testing and Materials, Philadelphia Pa, USA. ( 10) Lipnick, R. L., J. A. Cotruvo, R. N. Hill, R. D. Bruce, K. A. Stitzel, A. P. Walker, I. Chu, M. Goddard, L. Segal, J. A. Springer, and R. C. Myers. ( 1995). Comparison of the Up­ and­ Down, Conventional LD50 and Fixed Dose Acute Toxicity Procedures. Fd. Chem. Toxicol., 33, 223 231. ( 11) Organization for Economic Cooperation and Development. ( 2000). Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Monograph Series on Testing and Assessment No. 19. ( 12) Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity. NIH Publication No. 01­ 4499. Research Triangle Park, NC: National Institute of Environmental Health Sciences, August 2001. ( 13) Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity. NIH Publication No. 01­ 4500. Research Triangle Park, NC: National Institute of Environmental Health Sciences, August 2001. ( 14) Spielmann, H. E., M. Genschow, M. Leibsch, and W. Halle. ( 1999). Determination of the Starting Dose for Acute Oral Toxicity ( LD50) Testing in the Up­ and­ Down Procedure ( UDP) from Cytotoxicity Data ATLA 27: 957 966. ( 15) Chan, P. K. and A. W. Hayes. ( 1994). Chap. 16. Acute Toxicity and Eye Irritancy. Principles and Methods of Toxicology. Third Edition. A. W. Hayes, Editor. Raven Press, Ltd., New York, USA. ( 16) Westat. ( 2001). Acute Oral Toxicity Software Program; AOT 425StatPgm; AOT425StatPgm Program User's Manual; and Simulation Results for the AOT425StatPgm Program. Reports prepared for U. S. 35 E. P. A. under Contract 68 W7 0025, Task Order 5­ 03. Currently available at web site: http:// iccvam. niehs. nih. gov/ methods/ udpdocs/ udprpt/ udp ciprop. htm ( 17) Rosenberger, W. F., Flournoy, N. and Durham, S. D. ( 1997). Asymptotic Normality of Maximum Likelihood Estimators from Multiparameter Response­ driven Designs. Journal of Statistical Planning and Inference 60, 69 76. ( 18) Jennison, C. and B. W. Turnbull. ( 2000). Group Sequential Methods with Applications to Clinical Trials. Chapman & Hall/ CRC: Boca Raton, FL. ( 19) Lotus Development Corporation. ( 1999). Lotus 1­ 2­ 3. Version 9.5, Millennium edition. Cambridge, MA, USA. ( 20) Microsoft Corporation. ( 1985 1997). Microsoft Excel. Version 5.0 or later. Seattle, WA, USA.

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2024-06-07T20:31:45.357435

regulations

EPA-HQ-OPP-2002-0325-0004

Supporting & Related Material

1 11/ 26/ 02 Response to Scientific Advisory Panel Comments on Applicability of the Up­ and­ Down Procedure Methodology for Acute Oral Toxicity Testing Comment 1: The Panel concluded that the Up­ and Down Procedure ( UDP) assay can be fairly and readily conducted inasmuch as any laboratory that can conduct a traditional LD50 test can conduct the UDP. Laboratory and animal issues unique to the UDP for acute testing include: ( i) individual animal dosing and prolonged study time utilizes laboratory space inefficiently and adds cost; and ( ii) maintenance of animal weights and age for the duration of the study is more difficult and could necessitate additional shipments of animals; and ( iii) special methods may be needed to ensure accurate dosing and dose dilution over time. Agency response: The Agency acknowledges that these issues require careful planning on the part of laboratories performing the UDP. However, the UDP guideline meets animal welfare goals; it calls for a reduced number of test subjects and incorporates OECD Humane Practices for animal treatment. Comment 2: Since the guideline calls for use of a single sex, in order to minimize population variance, it is important that the most sensitive sex be selected. In the majority of cases, females are more sensitive than males and would be the default choice in the absence of information to the contrary ( e. g., past experience with similar chemicals, knowledge of detoxification kinetics, etc.). Agency response: As noted in the text of the guideline, the emphasis is on utilization of all available information on related materials and mode of toxic information in order to determine which sex is likely to be most sensitive. Therefore, toxicologists should always carefully consider selection of animal sex and selection of the most sensitive sex should also be justified in test reports. Comment 3: An age range of 8­ 12 weeks for test animals, while giving needed flexibility for the staggered schedule of this study, may introduce variability because 8 week old rats are still in their rapid growth phase and may be different in dose response than ones of 12 weeks. Therefore, the Panel recommended use of a narrower age interval of 9 ­ 11 weeks. Agency response: Although a narrower age limit may be desirable, the Agency selected 8 ­ 12 weeks to harmonize with OECD practice for acute testing. Comment 4: The Panel agreed that histopathology would add no useful information. The suggestion that histopathology be considered in study design was viewed as adding no useful information. More useful pathology will be obtained from studies of longer duration, e. g. 28­ and 90­ day studies. 2 Agency response: Histopathology is not required in the guideline, but if it is performed, a standard reporting format is identified. Comment 5: The Panel agreed that selection of starting doses should not be a problem for informed toxicologists. The Panel also recognized that reducing step size [ too far] might result in too narrow a range of doses and give a poor LD50 estimate and suggested that additional information could be incorporated in a Bayesian analysis as an alternative to the profile likelihood analysis proposed. The Panel noted that if additional [ intermediate] doses are added after selection of initial sigma and dose progression, the software calculates the LD50 and profile likelihood. Calculation of the confidence interval remains valid. Agency response: Simulations show that the UDP works best when all available information is brought to bear when selecting starting dose and dose progression. If initial choice of sigma and dose progression appears to be too wide, the software can accept intermediate doses and will calculate an acceptable LD50s, but the confidence interval provided will not be accurate, posing significant problems in interpretation of test results. Flexible stopping rules tend to compensate if choice of step size is too narrow. Sequential frequentist and Bayesian analyses are a new direction for acute testing analyses in general, and the statistical community is being encouraged to explore how the design and estimation may be improved by their consideration. Incorporation of additional information, as through use of Bayesian statistical analysis, may be feasible in the future as the science develops. Comment 6: The Panel agreed with the 48 hour dosing interval. Agency response: The Agency takes note of this comment. Of course, the guideline specifies 48 hours as normative and for certain chemicals this dosing time interval can be changed. Comment 7: The Panel agreed with the Agency that LD50 estimates generated from the UDP will be sufficient for hazard classification and labeling of products and noted that the point estimates will be especially useful in the classification of mixtures. However, the Panel cautioned that, due to the small number of animals used, the confidence interval must be considered inexact and, in many instances, it will be very wide. Even for hazard classification, the Panel noted, there is the possibility that a small error in estimation could put a chemical into a different hazard class. The Panel cited the fact that the Agency suggested that whenever there was uncertainty at a boundary, the chemical or mixture would be assigned to the more toxic class. Agency response: The Agency agrees that a primary application of the UDP guideline is for hazard classification and labeling of products. As it interprets acute testing results, the Agency will carefully consider the caveats identified in the Scientific Advisory Panel report in order to maintain protection of human health. Comment 8: The Panel pointed out that the UDP will not be sufficient for risk assessment 3 procedures that require information on the slope or shape of the dose­ response curve especially for tiered ecological risk assessments. In cases where the confidence bounds on a probabilistic risk assessment are too wide, the Agency will have to add additional animals to the UDP or perform a LD50 test with standard techniques traditionally used. Limitations of the UDP for ecological risk assessments are as follows and should be clearly recognized. ( 1) UDP test results do not lend themselves to the generation of a NOAEL or an estimate of the NOAEL by means of a point estimate such as the LDx; ( 2) The proposed UDP test does not provide information about the slope of the dose­ response curve, especially when a minimal number of animals are used and no partial kills are obtained; ( 3) Reduction in the number of animals, while beneficial from one perspective, makes it more likely that the confidence interval will be larger, increasing the uncertainty in the LD50 value, raising issues of what is an acceptable confidence interval and when should additional animals be tested. In consequence, LD50 values obtained via this methodology will often have limited utility for risk assessment procedures where exposure and effects curves are compared since a reliable dose­ response curve will not be available from the acute rat test without additional testing. Agency Response: The Agency recognizes these limitations of the UDP for tiered ecological risk assessment purposes and certain health effects purposes. However, in preparation for the transition to alternative testing approaches, Agency scientists and statisticians performed simulations of performance of the acute oral study utilizing the minimum of three groups of five animals. These simulations showed confidence intervals for slope in such traditional tests could be fairly wide and not necessarily suited to risk assessment purposes. Comment 9: Current Agency policy requires a tiered approach for product evaluation under FIFRA in order to protect wildlife from adverse effects that may be manifested following pesticide exposure. Current ecological risk assessment procedures are thought to provide some measure of protection for wildlife. However, in the future, for ecological assessments which rely upon rat studies to estimate risk to other mammals, the Agency must be cautious that free­ ranging mammals are not placed at substantial risk. Agency response: The Agency agrees and is developing additional guidance consistent with Part 158 for higher tier testing to reduce uncertainty in ecological risk assessment. Comment 10: At the first tier of the ecological risk assessment process, an LD50 is required for deterministic assessment. This estimate must be accurate enough to prevent erroneous conclusions progressing to higher tiers. Substantial concern exists that uncertainties at the screening level are already too great to provide useful decisions. Known biases in the UDP may impact the validity of assumptions made in current early tier/ level ecological risk assessments. If tests which provide data for screening level assessments are altered, the alteration must not result in wider confidence limits and a reduced level of certainty in screening or higher­ level assessments. Agency response: In determining the need for the wild mammal test for terrestrial ecological effects, Part 158 calls for the Agency to consider results of acute and subacute testing at Tier 1, 4 along with use pattern and environmental fate characteristics. Results of simulations show that if the initial dose and dose progression for the UDP are chosen in the optimum fashion described in the guideline, the confidence interval which describes uncertainty in the LD50 may be relatively narrow. However, until the results of laboratory testing of pesticides are available, the degree to which the UDP will be useful in Tier 1 ecological risk assessment is uncertain. The Agency recognizes that the confidence interval from UDP tests submitted for registration or reregistration may not always be sufficiently narrow for use in Tier 1 ecological risk assessments and is developing a policy, including consideration of higher tier testing such as wild mammal testing, to address this. Comment 11: The Panel noted that multiple LD 50 values for different ( mammalian) species are utilized to identify the most sensitive species. Full dose response data for most of these ( focal) species are not typically available and are not needed to develop the acute 5th percentile species. Utilization of LD 50 values generated with the up­ down procedure are not expected to significantly affect the outcome of this procedure. However, lack of dose­ response data from an up­ down test for a key focal species or for the 5th percentile species would prevent accurate probabalistic risk assessment ( PRA) for that species, i. e., it would not be possible to accurately assess effects on that species due to exposures above or below the LD 50 exposure level. Without slope information, the dose response for a given species will be largely unknown and the confidence bound placed on modeled probabilistic risk assessments may be unacceptably wide. Agency response: The Agency will take note of these points as it continues to develop approaches for probabilistic risk assessment for terrestrial species. Comment 12: Overall, the guideline, additional guidance, software and software documentation provide sufficient guidance, supplemented with the Interagency Coordinating Committee on the Validation of Alternative Methods ( ICCVAM) report and special simulation results. Specific suggestions are as follows: ( i) the quality of the written guideline is adequate, but could be improved; although the panel recognizes that EPA must follow certain formatting rules. In addition, the Panel recommended that the following topics be moved from " Additional Guidance" to an Appendix: the linear probit dose response model; the likelihood function; the assumption of constant variance; the maximum likelihood estimation of LD50; the stopping rule; and the profile likelihood confidence bounds. and ( ii) a better illustration should be provided of procedural sequence in the course of testing and calculation for test scenarios. Agency response: For point ( i), the EPA guideline format has been adjusted in so far as possible to provide clear headings for many of the topics identified by the Panel. Additional definitions also provide clarification. Because the EPA 870.1100 guideline must track the OECD 425 guideline, the order of sections has not been changed. In addition, the Agency has developed a web site, to be used with the guideline, containing the AOT425StatPgm software and additional background material and guidance addressing these topics. 5 For point ( ii), as an illustration of procedural sequence and calculation, the Agency has added a diagram of the computer screen to illustrate each software image. Comment 13: The Panel noted that documentation of AOT425StatPgm software for implementing the UDP dosing and LD50 calculations is well written and provides sufficient guidance to the user. The Panel suggests that the Agency simplify installation procedures to make it efficient and errorfree from user perspective. Agency response: The software has been fixed to eliminate the need for the user to change installation file names or to ` ignore' error messages. Comment 14: The Panel recommended that the Agency include an initial schematic that outlines the relation of the program's Data Edit and Report, the window task bars, and menu choices to provide the user an overview and facilitate migration between windows, tasks and options. Agency response: These recommendations will be addressed in future revision of the AOT425StatPgm software. Comment 15: The Panel recommended establishment of a data set and test protocol for verification of installation and software operation of the AOT425StatPgm on the users' computers. Agency response: The Agency agreed with this comment and developed a test data collection consisting of a set of 15 sample experiments which can be used to verify the proper installation and operation of the software on the user's computer. The test data sets, instructions, and solutions to the sample runs are included on the EPA web site at www. epa. gov/ oppfead1/ harmonization, along with the AOT425StatPgm program , Users' Manual, and other related documents. The Users' Manual also includes instructions on how comments and questions pertaining to the software program can be directed to a specific AOT425 email address at EPA. Comment 16: The Panel recommended that the software output show explicit calculations for: the linear probit dose­ response model; the likelihood function; the assumption of constant variance; the maximum likelihood estimate of LD50; the stopping rule; and the profile likelihood confidence bounds. Agency response: The Agency agrees that it would be valuable for the output of the software to provide explicit calculations and will include such calculations and other changes in the next generation of the software, after more experience has been gained in its use.

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regulations

EPA-HQ-OPP-2002-0326-0001

Supporting & Related Material

72846 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 `` Protection of Children from Environmental Health Risks and Safety Risks'' ( 62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards ( VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( 15 U. S. C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 ( 44 U. S. C. 3501 et seq.). The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 804 exempts from section 801 the following types of rules: ( 1) Rules of particular applicability; ( 2) rules relating to agency management or personnel; and ( 3) rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non­ agency parties. 5 U. S. C. 804( 3). EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability. Under section 307( b)( 1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 7, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. ( See section 307( b)( 2).) List of Subjects in 40 CFR Part 52 Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements. Dated: November 7, 2002. Bharat Mathur, Acting Regional Administrator, Region 5. For the reasons stated in the preamble, part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows: PART 52 [ AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U. S. C. 7401 et seq. Subpart P Indiana 2. Section 52.770 is amended by adding paragraph ( c)( 155) to read as follows: § 52.770 Identification of plan. ( c) * * * ( 155) On October 17, 2002, the State submitted revised particulate matter emission limits for the Knauf Fiber Glass in Shelby County for incorporation into the Indiana SIP. ( i) Incoropration by reference. ( A) Indiana Administrative Code Title 326: Air Pollution Control Board, Article 11 Emission Limitations for Specific Types of Operations, Rule 4 Fiberglass Insulation Manufacturing, Paragraph 5 Shelby County ( 326 IAC 11 4 5). Adopted by the Indiana Air Pollution Control Board on May 1, 2002. Filed with the Secretary of State on August 28, 2002. Published in the Indiana Register, Volume 26, Number 1, October 1, 2002, effective September 27, 2002. [ FR Doc. 02 30937 Filed 12 6 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0326; FRL 7282 1] Carboxin; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for combined residues of carboxin ( 5,6­ dihydro­ 2­ methyl­ Nphenyl 1,4­ oxathiin­ 3­ carboxamide) and its metabolite 5,6­ dihydro­ 3­ carboxanilide­ 2­ methyl­ 1,4­ oxathiin­ 4­ oxide ( calculated as carboxin) ( from treatment of seed prior to planting) in or on canola, seed. Gustafson LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA) , as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective December 9, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0326, must be received on or before February 7, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 9354; e­ mail address: waller. mary@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS Code 111) Animal production ( NAICS Code 112) Food manufacturing ( NAICS Code 311) Pesticide manufacturing ( NAICS Code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72847 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0326. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings In the Federal Register of February 23, 2000 ( 65 FR 8970) ( FRL 6390 1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104 170), announcing the filing of a pesticide petition ( PP 9F6036) by Gustafson LLC, 1400 Preston Road, Suite 400, Plano, Texas 75093. That notice included a summary of the petition prepared by Gustafson, LLC, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.301 be amended by establishing a tolerance for combined residues of the fungicide carboxin, 5,6­ dihydro­ 2­ methyl­ 1,4­ oxathiin­ 3­ carboxanilide] and its sulfoxide metabolite 5,6­ dihydro­ 3­ carboxanilide­ 2­ methyl­ 1,4­ oxathiin­ 4­ oxide], each expressed as the parent compound], in or on canola, seed at 0.03 parts per million ( ppm). Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997 ( 62 FR 62961) ( FRL 5754 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a tolerance for combined residues of carboxin ( 5,6­ dihydro­ 2­ methyl­ N­ phenyl­ 1,4­ oxathiin­ 3­ carboxamide) and its metabolite 5,6­ dihydro­ 3­ carboxanilide­ 2­ methyl­ 1,4­ oxathiin­ 4­ oxide ( calculated as carboxin) ( from treatment of seed prior to planting) on canola, seed at 0.03 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by carboxin are discussed in Table 1 of this unit as well as the no observed adverse effect level ( NOAEL) and the lowest observed adverse effect level ( LOAEL) from the toxicity studies reviewed. TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90 Day oral toxicity in rats NOAEL = Males: not identified; Females: 10 mg/ kg/ day LOAEL = Males: 10 mg/ kg/ day based on chronic nephritis, increased urea nitrogen, increased creatinine; Females: 40 mg/ kg/ day based on chronic nephritis 870.3200 21/ 28 Day dermal toxicity Not available 870.3465 90 Day inhalation toxicity Not available VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72848 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Continued Guideline No. Study Type Results 870.3700 Prenatal developmental in rats Maternal NOAEL = 10 milligrams/ kilogram/ day ( mg/ kg/ day) LOAEL = 90 mg/ kg/ day based on decreased body weights and body weight gain, decreased food consumption, and increased hair loss Developmental NOAEL = 175 mg/ kg/ day LOAEL = not identified 870.3700 Prenatal developmental in rabbits Maternal NOAEL = 75 mg/ kg/ day LOAEL = 375 mg/ kg/ day based on increased abortions Developmental NOAEL = 75 mg/ kg/ day LOAEL = 375 mg/ kg/ day based on increased abortions 870.3800 Reproduction and fertility effects in rats Parental NOAEL = Males and Females: 1 mg/ kg/ day LOAEL = Males: 10 mg/ kg/ day based on decreased body weight gains in F1 parents, gross and histopathological changes in kidneys; Females: 15 mg/ kg/ day based on equivocal histopathological changes in kidneys Reproductive NOAEL = Males: 10 mg/ kg/ day; Females: 15 mg/ kg/ day LOAEL = Males: 20 mg/ kg/ day; Females: 30 mg/ kg/ day based on decreased fertility indices for F1b parents due to decreased number of pregnancies for F2b generation Offspring NOAEL = Males: 10 mg/ kg/ day; Females: 15 mg/ kg/ day LOAEL = Males: 20 mg/ kg/ day; Females: 30 mg/ kg/ day based on decreased body weights for F2b male pups 870.4100 Chronic toxicity in dogs NOAEL = Males: 16 mg/ kg/ day; Females: 1.3 mg/ kg/ day LOAEL = Males: 158 mg/ kg/ day based on decreased RBC, hematocrit and hemoglobin increased MCH and MCV, increased alkaline phosphatase and cholesterol, increased liver weights; Females: 15 mg/ kg/ day based on decreased body weight gains 870.4300 Combined Chronic/ Carcinogenicity in rats NOAEL = Males: 0.8 mg/ kg/ day; Females: 1.0 mg/ kg/ day LOAEL = Males: 9 mg/ kg/ day based on decreased body weight and body weight gain, increased urea nitrogen and creatinine, increased water consumption and urine volume decreased urine specific gravity, histopathological changes in kidneys; Females 16 mg/ kg/ day based on histopathological changes in kidneys Negative for carcinogenicity 870.4200 Carcino­ genicity in mice NOAEL = Males: 752 mg/ kg/ day; Females: 9 mg/ kg/ day LOAEL = Males: not identified; Females: 451 mg/ kg/ day based on increased mortality Negative for carcinogenicity 870.5100 Bacterial reverse mutation assay ( Ames test) Negative with or without S­ 9 activation at 5.000 µ g/ plate and less 870.5375 In vitro mammalian chromosome aberration ( CHO cells) Negative without S­ 9 activation Positive with S­ 9 activation. Highly significant increases in chromosomal aberrations at several toxic dose levels ranging from 400 to 1,400 Fg/ mL 870.5385 In vivo mammalian chromosome aberration ( rat bone marrow) Negative at all dose levels up to 48­ hours post­ dosing Study is unacceptable due to lack of clinical toxicity, lack of a multiple dosing schedule and/ or lack of evidence of transport to target tissue 870.5385 In vivo mammalian chromosome aberration ( rat bone marrow) Negative at all dose levels tested 870.5385 In vivo mammalian chromosome aberration ( rat bone marrow) Positive. Dose­ related statistically significant increased percent of aberrant cells at 191 mg/ kg/ day 870.5450 Dominant lethal assay in rats Not available VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72849 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations TABLE 1. SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Continued Guideline No. Study Type Results 870.5550 UDS in primary rat hepatocytes Positive. Dose­ dependent positive responses were observed at treatment levels from 5.13 to 103 µ g/ mL in the absence of moderate to severe toxicity 870.7485 Metabolism and pharmaco kinetics in rats Following oral treatment of rats with phenyl­ UL­ C14 carboxin, approximately 78.3 81.1% and 77.0 81.5% of the low and high doses, respectively, were recovered. Urine was the major route of excretion. The major urinary metabolites were 4­ acetamidophenol and its glucuronide, acetanilide, and hydroxylated carboxin sulfoxide B. Toxicological Endpoints The dose at which NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non­ dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10­ 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non­ linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for carboxin used for human risk assessment is shown in Table 2 of this unit: TABLE 2. SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CARBOXIN FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute dietary all populations Acute RfD = not required No toxicological endpoint attributable to a single exposure was identified None Chronic dietary all populations NOAEL = 0.8 mg/ kg/ day UF = 100 Chronic RfD = 0.008 mg/ kg/ day FQPA SF = 3 cPAD = chr RfD FQPA SF = 0.00267 mg/ kg/ day Combined chronic/ carcinogenicity ­ rat LOAEL = Males: 9 mg/ kg/ day based on decreased body weight and body weight gain, increased urea nitrogen and creatinine increased water consumption and urine volume, decreased urine specific gravity, histopathological changes in kidneys Females: 16 mg/ kg/ day based on histopathological changes in kidneys Cancer ( oral, dermal, inhalation Not likely to be carcinogenic to humans Negative for carcinogenicity in rats and mice Combined chronic/ carcinogenicity ­ rat and carcinogenicity ­ mouse * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.301) for the combined residues of carboxin and its sulfoxide metabolite, in or on a variety of raw agricultural commodities ( RAC). Risk assessments were conducted by EPA to assess dietary exposures from VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72850 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations carboxin and its sulfoxide metabolite in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on carboxin. As a result, an acute endpoint was not identified and an acute dietary exposure assessment was not performed. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the Department of Agriculture ( USDA) 1989 1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The chronic dietary exposure analysis was an unrefined assessment. Tolerance level residues and 100% crop treated assumptions were used. iii. Cancer. Carboxin was classified as `` not likely to be carcinogenic to humans.'' Therefore, a cancer dietary exposure assessment was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for carboxin and its sulfoxide metabolite] in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of carboxin and its sulfoxide metabolite. The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI­ GROW model is used to predict pesticide concentrations in shallow ground water. For a screening­ level assessment for surface water EPA will use FIRST ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes a percent crop ( PC) area factor as an adjustment to account for the maximum PC coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to carboxin and its sulfoxide metabolite they are further discussed in the aggregate risk sectionsin Unit E. Based on the FIRST and SCI­ GROW models the estimated environmental concentrations ( EECs) of carboxin and its sulfoxide metabolite for acute exposures are estimated to be 29.6 parts per billion ( ppb) for surface water and 0.09 ppb for ground water. The EECs for chronic exposures are estimated to be 0.63 ppb for surface water and 0.09 ppb for ground water. 3. From non­ dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non­ dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Carboxin is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether carboxin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, carboxin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that carboxin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997). D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. The developmental toxicity and reproduction studies performed with carboxin did not indicate evidence for enhanced susceptibility to the fetuses/ offspring of rats or rabbits. Neither quantitative nor qualitative increased susceptibility was observed in the developmental toxicity study in rats, the developmental toxicity study in rabbits, or the 2­ generation reproduction toxicity study in rats. In none of the toxicity studies on carboxin was there any toxicologically significant evidence of treatment­ related neurotoxicity. A developmental neurotoxicity study in rats is not required. There is, however, a concern for possible germinal cell toxicity. In genotoxicity studies, carboxin demonstrated clear evidence of clastogenic potential. It was also noted that in the 2­ generation reproduction study in rats, treatment­ related decreased fertility indices for the F1b male and female parents ( due to a decreased number of pregnancies for the F2b generation) were observed. Based on these considerations, the registrant will be required to submit a germinal VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72851 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations cell assay, specifically a dominant lethal assay in rats, to the Agency in order to evaluate possible interaction between carboxin and germinal cell targets. 3. Conclusion. Based upon clear evidence of clastogenic activity and the requirement for a dominant lethal study, EPA concluded that a FQPA safety factor of 3X is appropriate for this risk assessment. The safety factor of 10X was reduced to 3X because: i. There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/ or postnatal exposure; ii. A developmental neurotoxicity study is not required; iii. The dietary ( food and drinking water) exposure assessments will not underestimate the potential for exposures to infants and children; and iv. There are no registered residential uses for carboxin. E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model EECs of a pesticide. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD ­ ( average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening­ level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short­ term, intermediate­ term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. No toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on carboxin. As a result, carboxin is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to carboxin and its sulfoxide metabolite from food will utilize 41% of the cPAD for the U. S. population and 92% of the cPAD for children 1 6 years, the most highly exposed population. There are no residential uses for carboxin. In addition, there is potential for chronic dietary exposure to carboxin and its sulfoxide metabolite in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3: TABLE 3. AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON­ CANCER) EXPOSURE TO CARBOXIN AND ITS SULFOXIDE METABOLITE Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb) U. S. population 0.00267 41 0.63 0.09 56 Children 1 6 years 0.00267 92 0.63 0.09 2 3. Short­ term and Intermediate­ term risk. Both short­ term aggregate exposure and intermediate­ term aggregate exposure take into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Since carboxin is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern as described in Table 3. 4. Aggregate cancer risk for U. S. population. Carboxin was classified as `` not likely to be carcinogenic to humans.'' Therefore, carboxin is not expected to pose a cancer risk. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of carboxin and its sulfoxide metabolite. IV. Other Considerations A. Endocrine Disruptor Effects FQPA requires EPA to develop a screening program to determine whether certain substances ( including all pesticides and inerts or inactive ingredients) `` may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect...'' EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. In the available toxicity studies for carboxin, there is no evidence of endocrine disruptor effects. When appropriate screening and/ or testing protocols being considered under the Agency's Endocrine Disruptor Screening Program have been developed, carboxin may be subjected to further screening and/ or testing to better characterize effects related to endocrine disruption. B. Analytical Enforcement Methodology The current available enforcement methods for tolerances of the combined residues of carboxin and its carboxin sulfoxide metabolite are described in the Pesticide Analytical Manual ( PAM) VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72852 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations Vol. II. Method I is a colorimetric method which is used for determination of residues in or on corn, peanuts, rice, rice straw, sorghum, soybeans, eggs, meat, and milk. Method II and its modification, Method A, are gas liquid chromatography ( GLC) methods which are used for wheat, oats, barley, peanuts, peanut oil and meal, sorghum, cottonseed, and cottonseed oil and meal. Adequate recovery data were submitted to validate the methods used in the canola field trials. Residues in canola seeds were converted to aniline, which was derivatized with heptafluorobutyric anhydride prior to gas chromatography mass selective detector ( GC/ MSD) analysis. Recoveries were 100 103% for 0.025 ppm fortifications in canola seeds. Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, U. S. Environmental Protection Agency, 701 Mapes Road, Fort George G. Meade, MD 20755 5350; telephone number: ( 410) 305 2905; e­ mail address: griffith. francis@ epa. gov. C. International Residue Limits There are no CODEX, Canadian, or Mexican maximum residue levels ( MRLs) for carboxin in/ on onion seed. As a result, harmonization of tolerances is not an issue. V. Conclusion Therefore, the tolerance is established for combined residues of carboxin, ( 5,6 dihydro­ 2­ methyl­ N­ phenyl­ 1,4­ oxathiin­ 3­ carboxamide) and its metabolite 5,6­ dihydro­ 3­ carboxanilide­ 2­ methyl­ 1,4­ oxathiin­ 4­ oxide ( calculated as carboxin) ( from treatment of seed prior to planting) insert regulated chemical, in or on canola, seed at 0.03 ppm. VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'''' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0326 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 7, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA;. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603 0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP 2002 0326, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72853 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). VII. Regulatory Assessment Requirements This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 26, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 371. 2. Section 180.301 is amended by alphabetically adding the commodity `` canola, seed'' to the table in paragraph ( a) to read as follows: § 180.301 Carboxin; tolerances for residues. ( a) * * * Commodity Parts per million * * * * * Canola, seed 0.03 * * * * * VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. SGM 09DER1 72854 Federal Register / Vol. 67, No. 236 / Monday, December 9, 2002 / Rules and Regulations * * * * * [ FR Doc. 02 31010 Filed 12 6 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [ OPPT 2002 0043; FRL 7279 1] RIN 2070 AD43 Perfluoroalkyl Sulfonates; Significant New Use Rule AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: EPA is issuing a significant new use rule ( SNUR) under section 5( a)( 2) of the Toxic Substances Control Act ( TSCA) for 75 substances including perfluorooctanesulfonic acid ( PFOSH) and certain of its salts ( PFOSS), perfluorooctanesulfonyl fluoride ( POSF), certain higher and lower homologues of PFOSH and POSF, and certain other chemical substances, including polymers, that are derived from PFOSH and its homologues. These chemicals are collectively referred to as perfluoroalkyl sulfonates, or PFAS. This rule requires manufacturers and importers to notify EPA at least 90 days before commencing the manufacture or import of these chemical substances for the significant new uses described in this document. EPA believes that this action is necessary because the PFOSH component of these chemical substances may be hazardous to human health and the environment. The required notice will provide EPA with the opportunity to evaluate an intended new use and associated activities and, if necessary, to prohibit or limit that activity before it occurs. DATES: This final rule is effective on January 8, 2003. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 202) 554 1404; e­ mail address: TSCA­ Hotline@ epa. gov. For technical information contact: Mary Dominiak, Chemical Control Division ( 7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 202) 564 8104; e­ mail address: dominiak. mary@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you manufacture ( defined by statute to include import) any of the chemical substances that are listed in Table 1 of this unit. Persons who intend to import any chemical substance governed by a final SNUR are subject to TSCA section 13 ( 15 U. S. C. 2612) import certification requirements, and to the regulations codified at 19 CFR 12.118 through 12.127 and 12.728. Those persons must certify that they are in compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export any of the chemical substances listed in Table 1 are subject to the export notification provisions of TSCA section 12( b) ( 15 U. S. C. 2611( b)), and must comply with the export notification requirements in 40 CFR 721.20 and 40 CFR part 707, subpart D. Potentially affected entities may include, but are not limited to: Chemical manufacturers or importers ( NAICS 325), e. g., persons who manufacture ( defined by statute to include import) one or more of the subject chemical substances. Chemical exporters ( NAICS 325), e. g., persons who export, or intend to export, one or more of the subject chemical substances. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 721.5 for SNUR­ related obligations. Also, consult Unit II. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT. TABLE 1. CHEMICAL SUBSTANCES COVERED BY THIS RULE CAS No./ PMN CAS Ninth Collective Index Name 307 35 7 1­ Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­ heptadecafluoro­ 307 51 7 1­ Decanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10­ heneicosafluoro­ 376 14 7 2­ Propenoic acid, 2­ methyl­, 2­[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 383 07 3 2­ Propenoic acid, 2­[ butyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 423 50 7 1­ Hexanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,6­ tridecafluoro­ 423 82 5 2­ Propenoic acid, 2­[ ethyl[( heptadecafluorooctyl) sulfonyl] amino] ethyl ester 754 91 6 1­ Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­ heptadecafluoro­ 1652 63 7 1­ Propanaminium, 3­[[( heptadecafluorooctyl) sulfonyl] amino]­ N, N, N­ trimethyl­, iodide 1691 99 2 1­ Octanesulfonamide, N­ ethyl­ 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­ heptadecafluoro­ N­( 2­ hydroxyethyl)­ 1763 23 1 1­ Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­ heptadecafluoro­ 2795 39 3 1­ Octanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8­ heptadecafluoro­, potassium salt VerDate 0ct< 31> 2002 15: 04 Dec 06, 2002 Jkt 200001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 09DER1. 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Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 28, 2002 MEMORANDUM SUBJECT: Asulam. HED Human Health Assessment for the Tolerance Reassessment Eligibility Decision ( TRED). Chemical No. 106901/ 02. No MRID #. DP Barcode No. D276505. FROM: José J. Morales, Chemist/ Risk Assessor John Liccione, Toxicologist Barry O Keef, Residential Exposure Reregistration Branch 3 Health Effects Division ( 7509C) THRU: Catherine Eiden, Branch Senior Scientist Reregistration Branch 3 Health Effects Division ( 7509C) TO: Demson Fuller, Chemical Review Manager Special Review and Reregistration Division ( 7508C) This memorandum and attachments are the Health Effects Division's Tolerance Reassessment Eligibility Decision Document ( TRED) for asulam, taking into consideration requirements of the 1996 Food Quality Protection Act ( FQPA). This assessment only discusses the human health risk assessment required for reassessment of tolerances and does not include an occupational risk assessment required for reregistration of products. Cumulative risk assessment considering risks from other pesticides which may have a common mechanism of toxicity is also not addressed in this document. Attachments: Hazard Identification Review Committee ( HIARC) report ( J. Liccione, 12/ 6/ 01) FQPA Committee Report ( C. Christensen, 2/ 5/ 02) Toxicology Chapter ( J. Liccione, 12/ 12/ 01) Chemistry Chapter ( J. Morales, 12/ 6/ 01) Dietary Exposure Analysis ( J. Morales, 12/ 18/ 01) Drinking Water Assessment to Support the TRED for Asulam ( N. Birchfield, 1/ 8/ 02) ASULAM HED s HUMAN HEALTH RISK ASSESSMENT 1.0 Executive Summary The Health Effects Division ( HED) has conducted a human health risk assessment for asulam for the purpose of making a Tolerance Reassessment Eligibility Decision. HED evaluated the toxicology, residue chemistry, and residential databases for asulam and determined that the data are adequate to support a Tolerance Reassessment Eligibility Decision ( TRED). Use Profile Asulam ( methyl sulfanilylcarbamate) is a selective, postemergent systemic, carbamate herbicide whose chemical structure and biological properties differ considerably from those of carbamate insecticides. It is structurally related to chlorpropham and phenmedipham. It has no registered residential uses. Therefore, potential residential exposures are not anticipated as a result of applications of asulam. Use sites include sugarcane ( the only registered food use), Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non­ crop land ( e. g., rights­ of­ way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; therefore, the remaining five percent is utilized on the other use sites. Hazard Profile The toxicity database for asulam included asulam technical ( 98 ­ 100% ai) and the sodium salt of asulam ( 88% ai). The acute toxicity of asulam is low. The acute oral LD50 for asulam in rats exceeded 5000 mg/ kg. The acute inhalation LC50 was greater than 5 mg/ L in rats. The acute dermal LD50 for asulam in rabbits exceeded 4000 mg/ kg. Application of technical asulam to rabbit eyes produced mild chemosis, irritation, and redness which cleared by day seven post­ treatment. Asulam was not an irritant in a primary skin irritation study in rabbits. It did not cause dermal sensitization in guinea pigs. Subchronic and chronic toxicity studies demonstrate that the thyroid gland is a target organ for asulam in the rat and dog. Thyroid findings, consisting of hyperplastic changes in thyroid follicular cells in male rats reported in a two­ year combined chronic/ oncogenicity feeding study were observed at the lowest­ observed­ adverse­ effect­ level ( LOAEL) of 180 mg/ kg/ day; the no­ observed­ adverse­ effect­ level ( NOAEL) was 36 mg/ kg/ day. The chronic RfD for asulam is derived from the NOAEL of 36 mg/ kg/ day, based on thyroid follicular hyperplasia at 180 and 953 mg/ kg/ day. An uncertainty factor of 100 was applied to the NOAEL for interspecies extrapolation and intraspecies variability. Thyroid weights were not monitored in the study. Other toxicological effects included adrenal medullary hyperplastic alterations in male rats, and decreased body weight gains in male and female rats. In a six­ month dog study, increased thyroid weights ( elevated absolute weights in females at 300 mg/ kg/ day and elevated absolute and relative weights in males and females at 1500 mg/ kg/ day) were reported. Similar findings were noted in a three­ month gavage study in the dog. Asulam is classified as Group C, possible human carcinogen, based on thyroid and adrenal tumors in the rat study. The Cancer Peer Review Committee determined that a low dose linear extrapolation risk model was not appropriate for asulam ( memorandum dated 2/ 17/ 88). The 12/ 06/ 01 HIARC document, has concluded that the submission and review of a new mouse study did not impact the current classification of asulam as a Group C, possible human carcinogen or the CARC conclusion that a cancer risk assessment is not required. A two­ generation reproduction study in the rat study provided evidence for a quantitative increased susceptibility of the rat fetus to asulam exposure relative to adults. Additionally, the HIARC determined that a comparative thyroid rat assay in adults and offspring be conducted. In the rat reproductive toxiciity study, significantly fewer mean live births per litter were observed at 250 mg/ kg/ day and 1250 mg/ kg/ day in the first generation. A dose­ response relationship was evident. The LOAEL for offspring effects was 250 mg/ kg/ day. No effects on mean live births per litter were observed at 50 mg/ kg/ day, the NOAEL for offspring toxicity. The LOAEL for parental systemic toxicity is 1250 mg/ kg/ day and was based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females; increased absolute and relative liver weights in F1 females; and increased ovarian weights in F1 females at 31 days old, but not at terminal necropsy). The NOAEL for parental systemic toxicity is 250 mg/ kg/ day. Asulam has been evaluated for potential developmental effects in the rat and the rabbit. There was no indication of treatment­ related effects on developmental parameters ( at dose levels up to 750 mg/ kg/ day) in a developmental toxicity study in the rabbit. In the developmental study in the rat, a slight­ to­ moderate increase in preimplantation loss was observed at the high dose level ( 1,500 mg/ kg/ day). Decreased maternal body weight gain was noted at 1,500 mg/ kg/ day, but not at 1,000 mg/ kg/ day. In a developmental toxicity study in the rabbit, decreased maternal body weight gain was observed at a LOAEL of 750 mg/ kg/ day; the NOAEL is 300 mg/ kg/ day. Asulam was tested in several genetic toxicology studies, which included assessments of gene mutation, chromosomal aberrations, and cell transformation. All assays were negative. FQPA Safety Factor Based upon the developmental studies reviewed, there does not appear to be any quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure to asulam. However, there was evidence of quantitative susceptibility for offspring ( significantly fewer mean live births) in a two­ generation reproduction study in the rat. Although neurotoxicity studies were not performed, there was no indication of neurotoxicity in the submitted studies or in the published literature. A developmental neurotoxicity study was not required by HIARC, however a comparative thyroid rat assay in adults and offspring is being required. The FQPA Safety Factor Committee ( 12/ 10/ 01) determined that for asulam, the 10­ fold safety factor for the protection of infants and children should be retained because: 1) There was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat; and, 2) HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring and this is considered a data gap for asulam. 3 Toxic Endpoints Selected for Risk Assessment The HED Hazard Identification Assessment Review Committee ( HIARC) met on 11/ 13/ 01 to select endpoints for human health risk assessments and to reevaluate increased susceptibility of offspring and fetuses to asulam exposures. The quality of the toxicity studies for asulam provided reasonable confidence in the toxicity endpoints and doses selected for risk assessment. All doses for risk assessment purposes were assessed along with the uncertainty factors of 10X for interspecies extrapolation and 10X for intraspecies variability. No acute dietary toxicity endpoint was identified because no adverse effect attributable to a single dose of asulam was observed. A chronic Reference Dose ( cRfD) of 0.36 mg/ kg/ day was established based on the NOAEL of 36 mg/ kg/ day, and a 100X uncertainty factor for interspecies extrapolation, and intraspecies variability. An additional safety factor of 10X was applied to the cRfD to account for quantitative increased susceptibility in offspring/ fetuses resulting in a chronic Population Adjusted Dose ( cPAD) of 0.036 mg/ kg/ day. A chronic dietary risk assessment was conducted to estimate risks from average exposures to asulam in foods. Short­, intermediate­, and long­ term dermal and inhalation endpoints were selected because there are occupational exposures. Although dermal and inhalation toxicity studies were available, these studies did not include an examination of the thyroid gland, the target organ for asulam. Therefore, oral endpoints were selected for dermal and inhalation endpoints. Because the risk assessments conducted for this document are intended to support a TRED, no occupational exposure and risk assessments were conducted. No endpoints for short­, or intermediate­ term incidental ingestion were selected. Although dermal and inhalation endpoints were selected, dermal and inhalation risk assessments for residential exposures were not conducted because there are no registered residential uses of asulam. Although asulam is classified as a C carcinogen, it has not been quantified as per the CARC ( memo dated 2/ 17/ 88). Therefore, a quantitative exposure and risk assessment for cancer has not been conducted. Chronic Dietary Risk Assessment The risk estimates for chronic dietary exposures to asulam analyses reflect a refined exposure assessment. Anticipated residues ( ARs) and percent crop treated information were incorporated in the analysis. ARs were calculated using field trial data. There are no monitoring data ( USDA PDP) available for asulam. Chronic dietary risk is estimated by using average consumption and residue values. A risk estimate that is less than 100% of the chronic Population Adjusted Dose ( cPAD) does not exceed HED s level of concern. The cPAD ( 0.036 mg/ kg/ day) is the RfD ( 0.36 mg/ kg/ day) divided by the FQPA safety factor ( 10x for asulam). Chronic dietary risks estimated using a cPAD of 0.036 mg/ kg/ day are below the Agency s level of concern (< 100% cPAD) for all population subgroups. The chronic dietary risk estimate for children 1­ 6 years ( the highest exposed population subgroup) is 1% of the cPAD. All other population subgroups have chronic dietary risk estimates that are < 1% of the cPAD. 4 Drinking Water Risk Assessment The Environmental Fate and Effects Division ( EFED) provided a drinking water assessment using simulation models to estimate the potential concentration of asulam and its degradates, sulfanilamide and sulfanilic acid, in surface water. Sulfanilamide is a major soil and water degradate of asulam ( Reregsitration Eligibility Decision ( RED) September 1995). EFED used the FIRST reservoir model to calculate estimated environmental concentrations ( EECs) in surface water. A prospective groundwater study was used to estimate the groundwater EEC for residues of asulam and the sulfanilamide degradate. Since no data are available on degradates, FIRST modeling assumed immediate conversion upon application to very persistent and mobile degradates. With respect to the exposure in surface water, conservative Tier I ( FIRST) modeling indicated that EECs in surface water are not likely to exceed an average concentration of 6.6 ppb for asulam, and an average concentration of 272 ppb for asulam plus the degradates ( sulfanilamide and sulfanilic acid) for use in chronic exposure assessments. Residues of asulam and sulfanilamide in ground water are not likely to exceed a maximum of 154 ppb, and an average of 43 ppb. These EECs represent upper bound concentrations for asulam residues in surface water and groundwater as can be seen by a comparison with monitoring data provided in the synopsis below. In a separate water monitoring study, asulam was detected in public drinking water sources from ground and surface water. At the request of EPA, Rhone­ Poulenc conducted a drinking water monitoring study in areas of high asulam use in Florida and Louisiana. The surface water study was designed to sample raw surface water in up to 15 community water systems in Florida and 4 systems in Louisiana. Samples were collected monthly for one year and analyzed for asulam and the metabolite sulfanilamide at a detection limit of 1 ppb. In addition to surface water collection, the study collected samples from potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area. Seven of the ten surface water community systems sampled contained traces (< 1 ppb) of asulam residues during May through June. Four of the community systems were located in Louisiana and three were in Florida. A total of 28 drinking water wells were sampled in Florida. Because of poor water quality in this area of Florida, many of the wells reportedly use some type of treatment system prior to use. Three wells contained quantifiable asulam residues up to 1.92 ppb. Ten other wells contained detectable traces (< 1 ppb). Reportedly, the depth of the well and distance to treated area did not have any statistically significant effects on the concentrations observed. No residues were detected in 12 wells sampled in the " sandier" areas of Hendry County. Rhone­ Poulenc reported that there was less intensive use of asulam in this area. No residues were detected in ground water samples in Louisiana. Occupational Risk Assessment Because this assessment is a TRED, occupational handler and post application scenarios will not be assessed. Residential Risk Assessment 5 Potential residential exposures are not anticipated as a result of applications of asulam. All end use product labels contain the following statements: FOR AGRICULTURAL OR COMMERCIAL USE ONLY and NOT FOR USE BY HOMEOWNERS . Use sites include sugarcane, Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non­ cropland ( e. g. rights­ of­ way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; so therefore, the remaining five percent is utilized on the other use sites. Based on the registrants total estimate of 235,000­ 245,000 gallons of asulam sold and used annually in the US, the amount used annual on use sites other than sugarcane is approximately 12,000 gallons. Of these use sites, no residential exposures would be anticipated from the Christmas tree plantings and non­ cropland sites. The use on turf is restricted to sod farms, and the application to the sod is made four to five months prior to the sod being pulled up and subsequently sold. Therefore, no residential exposures would be anticipated from the turf/ sod use. The registrant stated that use of asulam on ornamentals is very limited, since its cost is high. Use of asulam on ornamentals in a residential setting would not be expected. In summation, residential exposures are considered unlikely. Aggregate Risk Assessment In examining aggregate exposure, HED takes into account the available and reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and non­ occupational exposures, e. g., exposure to pesticides used in and around the home ( residential). Risk assessments for aggregate exposure consider both short­, intermediate­ and long­ term ( chronic) exposure scenarios considering the toxic effects which would likely be associated with each exposure duration. There are no residential uses of asulam. Therefore, the considerations for aggregate exposure are those from food and water. Since modeling was done to estimate concentrations in drinking water, Drinking Water Levels of Comparison ( DWLOCs) were calculated. A DWLOC is a theoretical upper concentration limit for a pesticide in drinking water based on how much of the PAD remains once exposures in food and in the home have been estimated and subtracted. For asulam, only chronic DWLOCs were calculated since an acute endpoint was not selected. HED compares DWLOCs to surface water and groundwater EECs. If the EECs for residues of asulam in surface water and groundwater are less than the DWLOCs for residues of asulam, HED has no concern for aggregate exposures to asulam residues in food and drinking water. Upon comparison of the chronic DWLOCs ( 1,254 ppb for males; 1,075 ppb for females; 355 ppb for children) with the EECs for residues of asulam in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Consequently, HED has no concerns for chronic exposures to combined residues of asulam in food and drinking water, regardless of the drinking water source ( surface water or groundwater). Table 1. Chronic DWLOCs Compared to Surface Water and Groundwater EECs Population Subgroups DWLOCs ( ppb) Surface Water EEC ( ppb) ( average concentration) Groundwater EEC ( ppb) ( maximum/ average concentration) Adult males 1254 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) Adult females 1075 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) 6 Children ( 1 to 6 years old) 335 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) 2.0 Physical/ Chemical Properties Characterization Asulam ( methyl sulfanilylcarbamate) is an herbicide used for weed control on sugarcane. Asulam is formulated into and applied as the asulam sodium salt. H2 N OH NO S CH3 OO Asulam Empirical Formula: Molecular Weight: CAS Registry No.: Shaughnessy No.: H2 N O Na+ NO S CH3 OO Asulam, sodium salt C8 H10 N2 O4 S ( asulam) C8 H9 N2 NaO4 S ( asulam sodium salt) 230.2 ( asulam) 252.2 ( asulam sodium salt) 3337­ 71­ 1 ( asulam) 2302­ 17­ 2 ( asulam sodium salt) 106901 ( asulam) 106902 ( asulam sodium salt) Asulam is a colorless crystalline solid with a melting point of 143­ 145 EC. Asulam sodium salt is a buff­ colored powder with a melting point of 212­ 215 EC. Asulam is soluble at approximately 0.5% in water, and moderately soluble in chlorinated hydrocarbons, petroleum oils, and hydroxylic solvents. Asulam sodium salt is soluble at > 100 g/ 100 mL in water at pHs 5, 6.5, and 9. 3.0 Hazard Characterization 3.1 Hazard Profile Toxicology data are used by HED to assess the potential hazards to humans. The data are derived from a variety of acute, subchronic, and chronic toxicity tests; developmental/ reproductive tests; and tests to assess mutagenicity and pesticide metabolism. The database for asulam is adequate to support this TRED 7 Acute toxicity values and toxicity categories for asulam are summarized in Table 2. The data indicate that asulam has low acute oral ( category IV), dermal ( category III), and inhalation ( category IV) toxicity. Asulam is category III with respect to ocular irritation. It is not a dermal sensitizer. A primary dermal irritation study shows that asulam is category III. Study Type Table 2. Acute Toxicity of Asulam MRID No.: Result 81­ 1. Acute Oral Toxicity ­ rat. Rhone­ Poulenc Ag Co., Study No.: 51­ 260, November 7, 1988 409605­ 01 LD50 > 5000 mg/ kg. Toxicity Category IV Classification: Guideline 81­ 2. Acute Dermal Toxicity ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: 51­ 260, November 8, 1988 409605­ 01 LD50 > 4000 mg/ kg. Toxicity Category III Classification: Guideline 81­ 3. Acute Inhalation Toxicity ­ rat. Rhone­ Poulenc Ag Co., Study No.: 51­ 583, November 7, 1988 409605­ 02 413616­ 01 LC50 > 5 mg/ L Toxicity Category IV Classification: Minmum 81­ 4. Primary Ocular Irritation ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: R. Tox. 57, June 1981 00098534 Some chemosis, redness, and irritation were noted, but eyes were clear by day 7. Toxicity Category III Classification: Minimum 81­ 5. Primary Dermal Irritation ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No dermal irritation was observed. Toxicity Category III Classification: Minimum 81­ 6. Dermal Sensitization ­ guinea pig. Rhone­ Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No evidence of sensitization in the Guinea Pig. Classification: Minimum. No subchronic oral toxicity studies in the rodent per se were identified in the data base for asulam. However, the chronic oral studies in the rodent provided frequent monitoring of clinical signs and interim measurements of body weights, food consumption, hematology, clinical chemistry and urinalysis, and the results provided insight into potential subchronic effects. In a subchronic oral ( 90­ day) study, dogs displayed increased thyroid weights. Although the study was classified as unacceptable guideline , it was supported by the findings of the 6­ month oral dog study. The results of the two studies were similar ( i. e., the LOAEL and NOAEL based on increased thyroid weights). A one­ month inhalation toxicity study and 21­ day dermal toxicity study were available; however, neither study included assessment of thyroid weights and pathology. The data base for 8 subchronic toxicity is considered complete for oral and dermal studies. A 28­ day subchronic inhalation study is required, one that includes examination of thyroid weights and thyroid pathology. The 21/ 28­ day dermal toxicity study in the rat showed that no apparent treatment­ related systemic effects were observed when body weight, food consumption, clinical pathology, organ weights, ophthalmology, urinalysis, and histopathology were examined. Also, local skin irritation, which was slight and transient, was observed in a small number of treated females. There are no 90­ day inhalation toxicity studies available on asulam. However, a one­ month inhalation toxicity study ( MRID # 00098537) in the rat was available. This study is limited because of the lack of thyroid weight measurements and pathological examination of the thyroid. Developmental studies in rats and rabbits, designed to identify possible adverse effects on the developing organism which may result from the in ­ utero exposure to the pesticide were also conducted. The data base for prenatal developmental toxicity is considered complete. The prenatal developmental toxicity study in the rat showed that there were no treatment­ related effects on other maternal parameters including mortality, clinical signs, and food consumption. A slight to moderate increase ( not statistically significant) in preimplantation loss was observed in the mid­ and high­ dose groups ( compared to controls). The slight increase in postimplantation loss at the high dose ( 1500 mg/ kg/ day) was not statistically significantly different from control values, and was not of any apparent biological significance. In the prenatal developmental toxicity study in rabbits, the high dose selected was 1,500 mg/ kg/ day. However, severe maternal toxicity ( greater than 20% weight loss, mortality, and signs of starvation) occurred after administration of the 1,500 mg/ kg/ day dose level. All animals in this group died or were sacrificed for humane reasons. A new group was added to the study using a lower dose of 750 mg/ kg/ day. Mean maternal body weight gain was markedly reduced ( 35% but not statistically significant) in the 750 mg/ kg/ day group than in controls during the dosing period. In addition, mean maternal body weight gains were markedly reduced during days 5­ 9, 5­ 13, and 5­ 17. During the postdosing period, mean body weights of rabbits treated with 750 mg/ kg/ day were comparable to those of controls, and rabbits displayed some improvement in body weight gain. Rabbits given 750 mg/ kg/ day exhibited a non­ statistically significant decrease in food consumption at several intervals during dosing. There were no apparent treatment­ related effects on mortality or clinical signs. The data base for reproductive toxicity is considered complete. No additional studies are required at this time. Systemic effects observed at the high dose ( 25,000 ppm) included decreased body weights in F0 males and F1 females, increased absolute and/ or relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females ( at age 31 but not at terminal necropsy). The LOAEL for systemic toxicity is 25,000 ppm ( 1250 mg/ kg/ day) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). 9 The data base for chronic toxicity is considered complete. No additional studies are required at this time. In the six­ month chronic toxicity study in the dog, there was no apparent relationship between test material administration and mortality. Treatment­ related findings included reductions in body weight gains and food consumption in the high­ dose males and females; increased frequency of emesis and diarrhea in the high­ dose males and females; increased absolute thyroid weights in the mid­ and high­ dose females and in the high­ dose males; increased relative ( to body weight) thyroid weights in the high­ dose males and females; decreased absolute testes and lung weights in the high­ dose males; decreased relative testes weights in the high­ dose males; and increased relative kidney weights in the high­ dose males. No histopathological effects of toxicological significance were observed. There were no apparent effects on prothrombin time, kaolin partial thromboplastin time or platelet counts in males. Platelet counts were slightly decreased in treated females; however, the decreases were not dose­ related at most intervals and control values appeared to be slightly elevated. Platelet count in the high­ dose females was significantly lower at the 26­ week interval only. Plasma and brain cholinesterase activities were not affected by treatment in either sex. The carcinogenicity data base for asulam is considered complete. There is one acceptable combined chronic toxicity/ oncogenicity dietary study in the rat, and one acceptable oncogenicity dietary study in the mouse. In a two­ year combined chronic feeding/ carcinogenicity study in the rat, there was a statistically significant increase in thyroid gland C­ cell carcinomas in both the low­ and mid­ dose males. There was also a statistically­ significant increase in adrenal medullary pheochromocytomas at the high dose in males. With the exception of a non­ dose­ related enlargement of the pituitary gland in female rats, no unusual toxicological findings occurred in the animals sacrificed at 78 weeks. In the two­ year carcinogenicity toxicity study in the mouse, increased mortality was observed in the high­ dose females; however, the number of high­ dose females was adequate to assess the carcinogenic potential of asulam. There was no treatment­ related effect on food consumption. Hematologic findings in the high­ dose males and females consisted of increased leukocyte counts, decreased erythrocyte counts, and decreased hematocrit levels. Organ weight changes included decreased brain weight in the high­ dose females, and increased spleen weight in the high­ dose males. There was an increased incidence of brown granular pigment deposits in the livers of males of all treatment groups and high­ dose females. Increased incidences of brown granular pigment deposits were also noted in the spleens of the high­ dose rats of both sexes. The brown granular pigment deposit was not identified, and is therefore of uncertain toxicological significance. There was no increase in the incidence of any tumors. With the exception of the dominant lethal mutation assay in mice, all other mutagenicity assays were found to be acceptable. These studies satistfy the pre­ 1991 guideline requirements for mutagenicity studies; no further testing is required at this time. The data indicate that there is no mutagenicity/ genetic toxicity concern. No acute, subchronic, or developmental neurotoxicity studies have been conducted. However, there is no evidence of neurotoxicity in the available acute, subchronic, chronic, and oncogenicity studies. In the March 31, 1998 HIARC meeting, the HIARC concluded: The data and information provided by the Registrant demonstrate that Asulam, being a carbamate herbicide 10 rather than a carbamate insecticide, has chemical structure and biological properties considerably different from those of the insecticides. Several studies were cited to illustrate the lack of cholinesterase inhibition and the absence of clinical signs suggestive of neurotoxicity. Based on these factors, the Agency waived the requirements for acute, subchronic, and developmental neurotoxicity studies ( memorandum, L. Taylor to C. Peterson, dated January 29, 1992. The data base for metabolism is considered to be complete. No additional studies are required at this time. The urinary route is the predominant route of elimination in the rat. Table 3. Toxicology Profile for Asulam Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90­ Day oral toxicity in rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study. 870.3150 90­ Day oral toxicity in nonrodents 00056414 ( 1968)/ Unacceptable/ Guideline/ 0, 5, 50 or 500 mg/ kg/ day. LOAEL = 500 mg/ kg/ day, based on increased absolute and relative thyroid weights in male and female dogs. NOAEL = 50 g/ kg/ day 870.3200 21­ Day dermal toxicity in rabbits 41076901 ( 1989) Acceptable/ Guideline/ 0 or 1000 mg/ kg/ day. NOAEL = 1000 g/ kg/ day 870.3250 90­ Day dermal toxicity No study. No study. 870.3465 90­ Day inhalation toxicity No study. No study 870.3700a Prenatal developmental in rodents 00098538/( 1981)/ Accept­ able/ guideline/ 0, 500, 1,000, or 1,500 mg/ kg/ day Maternal l LOAEL = 1,500 mg/ kg/ day based on body weight gain decrement. aternal Maternal NOAEL = 1,000 mg/ kg/ day. Developmental LOAEL = 1,500 mg/ kg/ day based on slight to moderate increase in preimplantation loss. Developmental NOAEL = 1,000 mg/ kg/ day. 870.3700b Prenatal developmental in rabbits 00098539/ 1981/ Acceptable/ Guideline/ 0, 60, 300, or 750 mg/ kg/ day Maternal LOAEL = 750 mg/ kg/ day based on decreased body weight during the dosing period. Maternal NOAEL = 300 mg/ kg/ day. Developmental NOAEL = 750 mg/ kg/ day. m m The m 11 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3800 Reproduction and fertility effects 00098540/ 1981/ Acceptable/ 0, 50, 250 or 1250 mg/ kg/ day. Parental/ Systemic LOAEL = 1250 g/ kg/ day ( HDT) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). Parental/ Systemic NOAEL = 250 mg/ kg/ day. Reproductive/ Offspring LOAEL = 250 mg/ kg/ day based on decreased mean live births per litter. Reproductive/ Offspring NOAEL = 50 mg/ kg/ day. 870.4100a Chronic toxicity rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study. 870.4100b Chronic toxicity dogs 00098536/ 1979/ Acceptable/ Nonguideline/ 0, 60, 300, or 1,500 mg/ kg/ day. LOAEL = g/ kg/ day, based on significant ( p < 0.05) increases in absolute thyroid weights in females. Absolute and relative thyroid weights were elevated at the high­ dose ( 1500 mg/ kg/ day) in both males and females. roid weights in the mid­ and high­ dose females appeared dose related. NOAEL = 60 mg/ kg/ day. 870.4200 Combined Chronic Feeding and Carcinogenicity rats 00098543/ 1981/ Acceptabl e­ Guideline/ 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females. LOAEL = 180 mg/ kg/ day, based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. NOAEL = 36 mg/ kg/ day. Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. m 300 m The increased absolute thy 12 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.4300 Carcinogenicity mice 42338201/ 1982/ Acceptable/ Guideline/ 0, 74, 730 and 8,040 mg/ kg/ day in males and 0, 95, 938 and 10,353 mg/ kg/ day in females LOAEL = 8,040 mg/ kg/ day in males, and 10,353 mg/ kg/ day in females, based on increased spleen weight and decreased body weight gain in males, and decreased brain weight and survival in females. NOAEL = 730 mg/ kg/ day in males and 938 mg/ kg/ day in females. Under the conditions of this study, there was no evidence of carcinogenicity of asulam. 870.4300 Carcinogenicity mice 00081183/ 1978/ Unacceptable/ Guideline/ 0, 225, and 750 mg/ kg/ day. LOAEL = 225 mg/ kg/ day, based on enlargement of the spleen in females, decreased absolute and relative thyroid weights in females, intestinal calcification in males and females, and a dose­ related increase in the incidence of mild skin/ subcutis hyperkeratosis in males. NOAEL was not achieved. Under the conditions of this study, there was no definitive evidence of carcinogenicity of asulam. One­ Month Inhalation study in the rat 00098537/ 1977/ Accept­ able Nonguideline/ nose­ only exposure at concentrations of 0, 1.6, 3.9, or 15.3 mg/ L for 4 hours per day, 5 days per week, for 4 weeks. NOAEL = 15.3 mg/ L ( HDT). Oral Range­ Finding in mice 42110002/ 1989/ Accept­ able Nonguideline/ 0, 512, 1,673, 5,103, and 9,022 mg/ kg/ day for males, and 0, 675, 2,263, 6,835, and 10,828 mg/ kg/ day for females LOAEL = 9,022 mg/ kg/ day based on decreased body weight and body weight gain in males. NOAEL is 5,103 mg/ kg/ day. Gene Mutation 870. A table presenting the mutagenicity data base is already included under section 4.7. 870.6200a Acute neurotoxicity screening battery No study. No study 13 Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.6200b Subchronic neurotoxicity screening battery No study. No study. 870.6300 Developmental neurotoxicity Not required. 870.7485 Metabolism and pharmaco­ kinetics 41345601 ( 1989) Metabolism studies in the rat demonstrate that asulam was rapidly eliminated, primarily in the urine, following administration of a single oral or intravenous dose, or after repeated intravenous doses for 14 days. No unusual localization of asulam occurred in tissues. Unchanged parent compound was identified as the major excretory product, with acetylasulam and acetylsulphanilamide as minor metabolites. 870.7600 Dermal absorpt­ ion No Study. No Study. 14 Table 4. Mutagenicity/ Genotoxicity Studies for Asulam Study Results Bacterial mutagenicity ( Ames test) ­ Salmonella typhimurium. Litton Bionetics, Inc., Study No.: E­ 9177, 1983. MRID No.: 40415302 Not mutagenic with and without metabolic activation at doses up to 2000 Fg/ plate. Classification: Acceptable­ Guideline Dominant lethal ­ Mouse ­ Hess & Clark ( Div. of Rhodia), Study No.: SEH­ 75, 1975 MRID No.: 00082250 No evidence of induction of dominant lethal effect at dietary concentrations of 1500 or 5000 ppm. Classification: Unacceptable because purity information on the test material was not provided. In vitro cell transformation assay in C3H/ 10T1/ 2 cells. Mason Research Institute. Study No.: 596­ 249­ 8, October 1979. MRID No.: 00098542 No evidence of induction of morphological transformation at dose levels of 256, 512, 1024, or 2048 Fg/ mL for 18 hours exposure. Cytotoxicity was apparent at 2048 Fg/ mL. Classification: Acceptable ( Nonguideline). In vitro cytogenetics in human lymphocytes. Litton Bionetics, Inc. Study No.: 20990, March 1984. MRID No.: 40415301 Cabinet d Etudes et de Recherches en Tox. Study No.: 658, May 10, 1982. MRID No.: 00144051 No evidence of induction of a clastogenic response at doses of 125­ 2500 Fg/ mL ( absence of metabolic activation) or 250­ 2500 Fg/ mL. Classification: Acceptable. 3.2 FQPA Considerations The FQPA Safety Factor Committee evaluated the available hazard and exposure data for asulam on December 10th , 2001 and made the recommendation for the FQPA safety factor to be used in human health risk assessments ( as required by Food Quality Protection Act of August 3, 1996). The committee concluded that the FQPA safety factor be retained ( 10x) in assessing the risk posed by this chemical. The Committee recommended that the FQPA safety factor be retained ( 10x) for the following reasons: There was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat; and, HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring and this is considered a data gap for asulam. The safety factor is required for all population subgroups when assessing chronic dietary exposure since the evidence for increase susceptibility was seen in the two­ generation study, and the results from the comparative thyroid study, may provide an endpoint for chronic risk assessment. 15 3.3 Dose Response Assessment On November 13, 2001, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for asulam with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for use as appropriate in occupational/ residential exposure risks assessments. This is the first re­ evaluation after a 1995 RED. Acute RfD: No appropriate toxicological endpoint clearly attributable to a single exposure was identified including the oral developmental toxicity studies in rats and rabbits. Chronic RfD: NOAEL of 36 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells observed in male rats at 180 mg/ kg/ day. An uncertainty factor of 100 was applied to this endpoint. This endpoint is of the appropriate route and duration of exposure and applies to the population of concern ( general population, including infants and children). Classification of Carcinogenic Potential: On November 12, 1987, the Carcinogenicity Peer Review Committee met to discuss and evaluate the weight­ of­ the evidence on asulam with particular reference to its carcinogenic potential ( Peer Review of Asulam ­ memo date 2/ 17/ 88). The Committee concluded that the available data for asulam provided limited evidence for the carcinogenicity of the chemical in rats, and asulam was classified as a Category C Carcinogen. The Committee recommended that the 18­ month carcinogenicity mouse study ( MRID 00081183; unacceptable­ guideline) be repeated and agreed to reevaluate the classification when a new mouse study on asulam was submitted and reviewed. A new mouse study ( MRID # 423382­ 01; discussed previously) was submitted by the registrant and reviewed. The committee considered the new mouse study to be acceptable. The dose levels tested in the mouse study were considered to be adequate for carcinogenicity testing. The high dose tested was higher than the limit dose level as specified under Subpart F of the Pesticide Assessment Guideline for carcinogenicity testing in mice. The treatment did not alter the spontaneous tumor profile for this strain of mouse. The Committee concluded that the new mouse study did not impact the current classification of asulam as a Group C, possible human carcinogen, not requiring a quantitative risk assessment. Short­ Term ( 1 Day ­ 1 Month) Incidental Oral Exposure: Since there are no residential uses, toxic endpoints were not selected. Intermediate­ Term ( 1­ 6 Months) Incidental Oral Exposure: Since there are no residential uses, toxic endpoints were not selected. Dermal Absorption Factor: 100%. There are no dermal absorption studies with asulam. Comparison of the developmental oral rabbit study to the dermal rabbit study is not appropriate. The dermal rabbit study did not include examination of the thyroid, the target organ. 16 Short­ Term Dermal ( 1 Day ­ 1 Month) Exposure: For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. A dermal absorption study was not available. A dermal absorption factor of 100% will be used for route­ to­ route extrapolation. Intermediate­ Term Dermal ( 1­ 6 Months) Exposure: For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. A dermal absorption study was not available. A dermal absorption factor of 100% will be used for route­ to­ route extrapolation. Long­ Term Dermal ( Longer than 6 Months) Exposure: A long­ term dermal toxicity study was not available. In addition, there was no dermal absorption study. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. An inhalation absorption factor of 100% will be used for route­ to­ route extrapolation. Short­ term Inhalation ( 1 Day ­ 1 Month) Exposure: For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. An inhalation absorption study was not available. An inhalation absorption factor of 100% will be used for route­ to­ route extrapolation. Intermediate­ term Inhalation ( 1­ 6 Months) Exposure: For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. An inhalation absorption study was not available. An inhalation absorption factor of 100% will be used for route­ to­ route extrapolation. Long­ term Inhalation ( Longer than 6 Months) Exposure: A long­ term inhalation toxicity study was not available. In addition, there was no inhalation absorption study. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. An inhalation absorption factor of 100% will be used for route­ to­ route extrapolation. Margins of Exposure for Occupational/ Residential Risk Assessments: A margin of exposure ( MOE) of 100 is adequate for dermal/ inhalation occupational exposure risk assessment. The acceptable MOEs for non­ occupational and dietary exposures will be determined by the FQPA SF Committee. Recommendation for Aggregate Exposure Risk Assessments: There are no residential uses for asulam. The chronic aggregate risk assessment is therefore limited to food and water. 17 The specific doses and endpoints are summarized as follows: Table 5. Summary of Toxicity Endpoints and Doses for Risk Assessment EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary An appropriate endpoint attributable to a single dose was not identified. Acute RfD = not established Chronic Dietary NOAEL = 36 mg/ kg/ day UF = 100 FQPA Safety Factor = 10 The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat Chronic RfD = 0.36 mg/ kg/ day Chronic PAD = 0.036 mg/ kg/ day Incidental Oral, Short­ Term A toxicity endpoint was not selected because there are no residential uses. Incidental Oral, Intermediate­ Term A toxicity endpoint was not selected because there are no residential uses. Dermal, Short­ Term Oral NOAELa = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Dermal, Intermediate­ Term Oral NOAELa = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Dermal, Long­ Term Oral NOAELa = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat Inhalation, Short­ Term Oral NOAELb = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Inhalation, Intermediate­ Term Oral NOAELb = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study in the rat Inhalation, Long­ Term Oral NOAELb = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat aApply 100% dermal absorption factor for route­ to­ route extrapolation. bAssume 100% inhalation absorption factor for route­ to­ route extrapolation. 3.4 Endocrine Disruption 18 EPA is required by FQPA, to develop a screening program to determine whether certain substances ( including all pesticide active and other ingredients) " may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC), EPA determined that there was scientific bases for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC s recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program ( EDSP). When the appropriate screening and/ or testing protocols being considered under the Agency s EDSP have been developed, asulam may be subjected to additional screening and/ or testing to better characterize effects related to endocrine disruption. 4.0 Exposure Assessment and Characterization 4.1 Summary of Registered Uses Asulam ( methyl­ 4­ sulfanilylcarbamate) is a postemergent systemic carbamate herbicide marketed under the trade name ASULOX ® Herbicide by Aventis CropScience. ASULOX ® contains the sodium salt of asulam and is registered for use on sugarcane as a 3.34 lb/ gal soluble concentrate/ liquid ( SC/ L) formulation. This formulation may be applied postemergence as a band or broadcast application using ground or aerial equipment or as a spot treatment. Apart from its food use on sugarcane, asulam is used on christmas tree plantations, ornamentals, turf ( sod farms only) and non­ cropland uses. Asulam is primarily used in agriculture with key markets in Florida and Louisiana. Sugarcane is the major use site for asulam ( 95% of the market). The asulam use rate, for sugarcane, ranges from 2.5 to 3.34 lbs a. i./ A and can applied up to two times per year. For all other uses, it can be applied only once. The average rate of 2.5 lbs ai/ acre is the typical labeled use rate for Sugarcane. Apart from its use on sugarcane, asulam is used on Christmas tree plantations, ornamentals, turf ( Sod Farms Only) and non­ cropland uses ( boundary fences, fencerows, hedgerows, lumberyards, storage areas and industrial plant sites, and warehouse lots). For Christmas trees and ornamentals, the label use rate is 3.34 lbs a. i./ A and can be applied once per year as a postemergent treatment. For turf, the label use rate is about 2 lbs. a. i./ A and can be applied once per year. For non­ cropland uses, the label use rate ranges between 2.9 lbs a. i./ A to 3.34 lbs a. i./ A and can be applied once per year. 4.2 Dietary Exposure/ Risk Pathway 19 4.2.1 Residue Profile A tolerance is established for negligible residues of asulam per se in/ on sugarcane at 0.1 ppm [ 40 CFR § 180.360]. HED has recommended that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. An adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety in/ on sugarcane. The qualitative nature of the residue in plants is adequately understood based on sugarcane metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4 ­ acetylasulam, and N4 ­ acetylsulfanilamide determined as a common moiety. The qualitative nature of the residue in animals is adequately understood based on acceptable poultry and ruminant metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4 ­ acetylasulam, and N4 ­ acetylsulfanilamide determined as a common moiety. 4.2.2 Acute Dietary An acute dietary risk assessment was not performed since there was no acute endpoint identified by HIARC. 4.2.3 Chronic Dietary The asulam chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model ( DEEM ) software Version 7.73, which incorporates consumption data from USDA s Continuing Surveys of Food Intake by Individuals ( CSFII), 1989­ 1992. The 1989­ 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique person days of data. Foods as consumed ( e. g., apple pie) are linked to raw agricultural commodities and their food forms ( e. g., apples­ cooked/ canned or wheat­ flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire US population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. Anticipated residues were calculated using field trial data. No monitoring data exist for asulam. In addition, estimates of percent crop treated (% CT) generated by BEAD were used to refine the assessment. This refined Tier 2/ 3 chronic dietary risk assessment was conducted for all supported ( i. e., currently registered and proposed) asulam food uses. For chronic exposure and risk assessment, an estimate of the residue level in each food or food­ form ( e. g., orange or orange­ juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates 20 are expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup. HED notes that there is a degree of uncertainty in extrapolating exposures for certain population subgroups from the general U. S. population which may not be sufficiently represented in the consumption surveys, ( e. g., nursing and non­ nursing infants or Hispanic females). Therefore, risks estimated for these population subgroups were included in representative populations having sufficient numbers of survey respondents ( e. g., all infants or females, 13­ 50 years). Exposures > 100% of the cPAD exceed HED s level of concern. That is, estimated exposures above this level are of concern, while estimated exposures at or below this level are not of concern. The DEEM analyses estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table 6 are for the U. S. Population ( total), all infants (< 1 year old), children 1­ 6, children 7­ 12, females 13­ 50, males 13­ 19, males 20+, and seniors 55+ years of age. The results for the other population subgroups are not reported in Table 6. This is because the numbers of respondents in the other subgroups were not sufficient, and thus the exposure estimates for these subgroups contained higher levels of uncertainty. However, the respondents in these subgroups were also part of larger subgroups which are listed in Table 6. For example, nursing and non­ nursing infants are included in all infants. The subgroups which are broken down by region, season, and ethnicity are also not included. This assessment concludes that for all commodities, the chronic risk estimates are below the Agency s level of concern (< 100% cPAD) for the general U. S. population (< 1% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for children 1­ 6 years [ highest exposed population subgroup] is 1% of the cPAD. Table 6. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.036 0.000157 < 1% All Infants (< 1 year) 0.036 0.000300 < 1% Children 1­ 6 years 0.036 0.000449 1% Children 7­ 12 years 0.036 0.000275 < 1% Females 13­ 50 years 0.036 0.000107 < 1% Males 13­ 19 years 0.036 0.000185 < 1% Males 20+ years 0.036 0.000105 < 1% Seniors 55+ years 0.036 0.000087 < 1% 4.2.4 Cancer Dietary A cancer dietary risk assessment is not required for asulam. 4.3 Water Exposure/ Risk Pathway 21 The Environmental Fate and Effects Division ( EFED) provided a drinking water assessment using simulation models to estimate the potential concentration of asulam and its degradates, sulfanilamide and sulfanilic acid, in surface water. Sulfanilamide is a major soil and water degradate of asulam ( Reregsitration Eligibility Decision ( RED) September 1995). EFED used the FIRST reservoir model to calculate estimated environmental concentrations ( EECs) in surface water. A prospective groundwater study was used to estimate the groundwater EEC for residues of asulam and the sulfanilamide degradate. Since no data are available on degradates, FIRST modeling assumed immediate conversion upon application to very persistent and mobile degradates. With respect to the exposure in surface water, conservative Tier I ( FIRST) modeling indicated that EECs in surface water are not likely to exceed an average concentration of 6.6 ppb for asulam, and an average concentration of 272 ppb for asulam plus the degradates ( sulfanilamide and sulfanilic acid) for use in chronic exposure assessments. Residues of asulam and sulfanilamide in ground water are not likely to exceed a maximum of 154 ppb, and an average of 43 ppb. These EECs represent upper bound concentrations for asulam residues in surface water and groundwater as can be seen by a comparison with monitoring data provided in the synopsis below. In a separate water monitoring study, asulam was detected in public drinking water sources from ground and surface water. At the request of EPA, Rhone­ Poulenc conducted a drinking water monitoring study in areas of high asulam use in Florida and Louisiana. The surface water study was designed to sample raw surface water in up to 15 community water systems in Florida and 4 systems in Louisiana. Samples were collected monthly for one year and analyzed for asulam and the metabolite sulfanilamide at a detection limit of 1 ppb. In addition to surface water collection, the study collected samples from potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area. Seven of the ten surface water community systems sampled contained traces (< 1 ppb) of asulam residues during May through June. Four of the community systems were located in Louisiana and three were in Florida. A total of 28 drinking water wells were sampled in Florida. Because of poor water quality in this area of Florida, many of the wells reportedly use some type of treatment system prior to use. Three wells contained quantifiable asulam residues up to 1.92 ppb. Ten other wells contained detectable traces (< 1 ppb). Reportedly, the depth of the well and distance to treated area did not have any statistically significant effects on the concentrations observed. No residues were detected in 12 wells sampled in the " sandier" areas of Hendry County. Rhone­ Poulenc reported that there was less intensive use of asulam in this area. No residues were detected in ground water samples in Louisiana. 4.4 Residential and Occupational Exposure/ Risk Pathway Because this assessment is for a TRED, occupational handler and post application scenarios will not be assessed. 22 Potential residential exposures are not anticipated as a result of applications of asulam. All end use product labels contain the following statements: FOR AGRICULTURAL OR COMMERCIAL USE ONLY and NOT FOR USE BY HOMEOWNERS . Use sites include sugarcane, Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non­ cropland ( e. g. rights­ of­ way, fence rows, etc.). Sugarcane represents 95 percent of asulam utilization; so therefore, the remaining five percent is utilized on the other use sites. Based on the registrants total estimate of 235­ 245,000 gallons of asulam sold and used annually in the US, the amount used annual on use sites other than sugarcane is approximately 12,000 gallons. Of these use sites, no residential exposures would be anticipated from the Christmas tree plantings and non­ cropland sites. The use on turf is restricted to sod farms, and the application to the sod is made four to five months prior to the sod being pulled up and subsequently sold. Therefore, no residential exposures would be anticipated from the turf/ sod use. The registrant stated that use of asulam on ornamentals is very limited, since its cost is high. Use of asulam on ornamentals in a residential setting would not be expected. In summation, residential exposures are considered unlikely. Spray drift is always a potential source of exposure to the public or near spraying operations. This is particularly the case with aerial application, but, to a lesser extent, could also be a potential source of exposure from groundboom application methods. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. The Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/ labeling. The Agency has completed its evaluation of the new data base submitted by the Spray Drift Task Force, a membership of U. S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the policy is in place, the Agency may impose further refinements in spray drift management practices to reduce off­ target and risks associated with aerial as well as other application types where appropriate. 5.0 Aggregate Risk Assessments and Risk Characterizations Because an acute toxicity endpoint was not identified by HIARC, an acute aggregate risk assessment is not required. In examining aggregate exposure, HED takes into account the available and reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and non­ occupational exposures, e. g., exposure to pesticides used in and around the home ( residential). Risk assessments for aggregate exposure consider both short­, intermediate­ and long­ term ( chronic) exposure scenarios considering the toxic effects which would likely be associated with each exposure duration. There are no residential uses of asulam. Therefore, the considerations for aggregate exposure are those from food and water. Since conservative modeling was done to estimate concentrations in drinking water, Drinking Water Levels of Comparison ( DWLOCs) were calculated. A DWLOC is a theoretical upper concentration limit for a pesticide in drinking water based on how much of the PAD remains once exposures in food and in the home have been estimated and subtracted. For asulam, only chronic DWLOCs were calculated since an acute endpoint was not selected. HED compares DWLOCs to surface water and groundwater EECs. 23 If the EECs for residues of asulam in surface water and groundwater are less than the DWLOCs for residues of asulam, HED has no concern for aggregate exposures to asulam residues in food and drinking water. Upon comparison of the chronic DWLOCs ( 1,254 ppb for males; 1,075 ppb for females; 355 ppb for children) with the EECs for residues of asulam in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Consequently, HED has no concerns for chronic exposures to combined residues of asulam in food and drinking water, regardless of the drinking water source ( surface water or groundwater). Table 7. Chronic DWLOCs Compared to Surface Water and Groundwater EECs Population Subgroups DWLOCs ( ppb) Surface Water EEC ( ppb) ( average concentration) Groundwater EEC ( ppb) ( maximum/ average concentration) Adult males 1254 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) Adult females 1075 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) Children ( 1 to 6 years old) 335 6.6 ( asulam)/ 272 ( asulam + degradates) 154 ( maximum)/ 43 ( average) 6.0 Cumulative The Food Quality Protection Act ( 1996) stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other non­ occupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the other substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe. Although asulam had been included in the list of potential carbamates for cumulative risk assessment of carbamates as a group, it will not be included in the carbamate cumulative assessment. The available data indicate that asulam is a carbamate herbicide that has chemical structure and biological properties that are considerably different from those of the carbamate insecticides. For instance, several studies on asulam ( e. g., chronic oral dog, combined chronic toxicity/ oncogenicity dietary rat) demonstrate the lack of cholinesterase inhibition and absence of clinical signs suggestive 24 of neurotoxicity. Acute studies reveal a low toxicity for asulam ( e. g., no deaths and clinical signs of nonspecific origin). There are no specific mechanism of toxicity studies on asulam. Before undertaking any cumulative risk assessment, HED will follow procedures for identifying chemicals that have a common mechanism of toxicity as set forth in the Guidance for Identifying Pesticide Chemicals and Other Substances that Have a Common Mechanism of Toxicity ( 64 FR 5795­ 5796, February 5, 1999). 25 7.0 Tolerance Reassessment Recommendations 7.1 Tolerance Reassessment Recommendation Table 8 summarizes the tolerance reassessment for asulam. Commodity Table 8. Tolerance Reassessment Summary Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment Tolerance listed under 40 CFR § 180.360 Sugarcane, cane 0.1 1.0 Tolerances to be Established Under 40 CFR § 180.360 Sugarcane, molasses 30 Milk 0.05 Cattle, meat Cattle, fat Goat, meat Goat, fat Hog, meat Hog, fat Horse, meat Horse, fat Sheep, meat Sheep, fat 0.05 Cattle, meat byproducts Goat, meat byproducts Hog, meat byproducts Horse, meat byproducts Sheep, meat byproducts 0.2 8.0 Data Needs/ Label Requirements 8.1Toxicology Comparative thyroid rat assay in adult and offspring. 21­ day Dermal Study in Rats with examination of thyroid weight and pathology. 28­ day Inhalation Study in Rats with examination of thyroid weight and pathology. 8.2 Product and Residue Chemistry 26 Because hydroquinone/ quinone remains a chemical of toxicological concern, if the registrant proposes new uses for this chemical, new plant metabolism studies m ust be performed ( relevant to the proposed new uses), aimed specifically at determining the presence and concentration of radiolabeled hydroquinone/ quinone. The registrant should also determine the naturally occurring background levels of hydroquinone/ quinone and arbutin in sugarcane. The Metabolism Committee will reconsider its position if new metabolism studies show that quinone/ hydroquinone/ arbutin comprises a significant portion of the radiolabeled residue. HED has recommended that the registrant request label amendments specifying a maximum of two asulam applications per year to sugarcane at a maximum single application rate of 3.34 lbs. a. i./ A, a PHI of 100 days for Louisiana, a PHI of 140 days for the remainder of the US mainland, and a PHI of 400 days for Hawaii. If the regsitrant requests the recommended label changes, no further sugarcane field trial data are required for asulam at this time. If the registrant does not propose the recommended label changes, existing labels must be supported by new field trials. The following product chemistry data guidelines remain unfulfilled for the technical asulam sodium salt: GLN 830.6317 ( Storage Stability) and 830.6320 ( Corrosion Characteristics). Tolerance Reassessment 1. The existing tolerance of 0.1 ppm for asulam residues on sugar cane established in 40 CFR § 180.360 has been reassessed. HED recommends the tolerance be raised to 1.0 ppm; 2. HED recommends a tolerance of 30 ppm for asulam residues in molasses from sugar cane be established in 40 CFR § 180.360; 3. HED recommends a tolerance of 0.05 ppm for asulam residues in milk, and meat and fat from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360; 4. HED recommends a tolerance of 0.2 ppm for asulam residues in meat byproducts from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360; 5. Because there are no poultry feed items associated with asulam's use, tolerances on poultry tissues and eggs are not warranted. 27

epa

2024-06-07T20:31:45.390858

regulations

EPA-HQ-OPP-2002-0329-0003

Supporting & Related Material

DATE: 12/ 05/ 2001 MEMORANDUM SUBJECT: ASULAM ­ 2nd Report of the Hazard Identification Assessment Review Committee. FROM: John J. Liccione, Toxicologist. Reregistration Branch­ 3 Health Effects Division ( 7509C) THROUGH: Jess Rowland, Co­ Chair and Elizabeth Doyle, Co­ Chair Hazard Identification Assessment Review Committee Health Effects Division ( 7509C) TO: Jose Morales, Risk Assessor Reregistration Branch­ 3 Health Effects Division ( 7509C) PC Code: 106901; 106902 On November 13, 2001, the Health Effects Division ( HED) Hazard Identification Assessment Review Committee ( HIARC) reviewed the recommendations of the toxicology reviewer for ASULAM with regard to the acute and chronic Reference Doses ( RfDs) and the toxicological endpoint selection for use as appropriate in occupational/ residential exposure risks assessments. This is the first re­ evaluation after a 1995 RED. The conclusions drawn at this meeting are presented in this report. Committee Members in Attendance Members present were: Ayaad Assaad, William Burnam, Jonathan Chen, Paula Deschamp, Pamela Hurley, John Liccione, Sue Makris, David Nixon, Jess Rowland, and Brenda Tarplee. Member( s) in absentia: Elizabeth Doyle. Data evaluation prepared by: John Liccione, Reregistration Branch­ 3 Also in attendance were: Steve Knizner, RRB­ 3, HED; Cathy Eiden, RRB­ 3, HED; Barry O Keefe, RRB­ 3, HED; Jose Morales, RRB­ 3, HED Data Evaluation / Report Presentation John J. Liccione Toxicologist 2 1. INTRODUCTION In a previous meeting ( March 19, 1998), the Health Effects Division s Hazard Identification Assessment Review Committee ( HIARC) met to evaluate the toxicology data base for asulam for risk assessment purposes. The present HIARC meeting ( November 13, 2001) is a revisit of asulam for toxicological endpoint selection for use in occupational/ residential exposure risk assessments. In addition, the potential for increased susceptibility of infants and children from exposure to ASULAM was re­ evaluated. 2. HAZARD IDENTIFICATION 2.1 Acute Reference Dose ( RfD) Study Selected: None Dose and Endpoint for Establishing RfD: Not applicable. Comments about Study/ Endpoint/ Uncertainty Factor: No appropriate toxicological endpoint clearly attributable to a single exposure was identified including the oral developmental toxicity studies in rats and rabbits. Although a slight to moderate increase ( non­ significant) in preimplantation loss was observed in a developmental rat study, the LOAEL for this effect was 1,500 mg/ kg/ day and the NOAEL was 1,000 mg/ kg/ day ( limit dose). 2.2 Chronic Reference Dose ( RfD) Study Selected: Combined Chronic Toxicity/ Oncogenicity feeding­ rat; OPPTS 870.4300 [ § 83­ 5] § MRID No.: 00098543 Executive Summary: In a two­ year combined chronic feeding/ carcinogenicity study ( MRID# 00098543), CD rats ( 50/ sex/ dose) were administered asulam ( 97.5­ 99.9%) at dose levels of 0, 1,000 ( low­ dose), 5,000 ( mid­ dose) or 25,000 ppm ( high­ dose). These dietary levels were equivalent to 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females, respectively. An additional group ( 15/ sex/ dose) was administered asulam for 78 weeks. Bodyweight change in the high­ dose animals for various intervals was more than 10% lower than controls. Mean bodyweight change was significantly lower than controls in high­ dose females from week 0­ 52 and in the mid­ and high­ dose females from weeks 6­ 52. Mean bodyweight change was significantly lower in the high­ dose males ( p< 0.01) from weeks 6­ 52. Hyperplastic changes were observed in the adrenal medulla and in thyroid follicular cells of males at the mid­ and high­ dose levels. There was a statistically significant increase in thyroid gland C­ cell carcinomas in both the low­ 3 and mid­ dose males. There was also a statistically­ significant increase in adrenal medullary pheochromocytomas at the high dose in males. With the exception of a non­ dose­ related enlargement of the pituitary gland in female rats ( 3/ 15 controls; 7/ 15 low­ dose; 8/ 15 mid­ dose; 7/ 15 high­ dose), no unusual toxicological findings occurred in the animals sacrificed at 78 weeks. The LOAEL is 5,000 ppm ( 180 mg/ kg/ day) based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. The NOAEL is 1,000 ppm ( 36 mg/ kg/ day). Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. Dosing is considered adequate to assess the oncogenic potential of asulam. This combined chronic toxicity/ carcinogenicity study in the rat is Acceptable­ Guideline, and does satisfy the guideline requirement for a combined chronic toxicity/ carcinogenicity study ( 83­ 5) in the rat. A minor study deficiency includes the lack of thyroid weight data. Dose and Endpoint for Establishing RfD: NOAEL of 36 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells observed in male rats at 180 mg/ kg/ day. Uncertainty Factor( s): 100 Comments about Study/ Endpoint/ Uncertainty Factor: This endpoint is of the appropriate route and duration of exposure and applies to the population of concern ( general population, including infants and children). This study was selected by the RfD/ Peer Review committee ( 1993) for the chronic RfD. Chronic RfD = 36 mg/ kg/ day ( NOAEL) = 0.36 mg/ kg/ day 100 ( UF) 2.3 Occupational/ Residential Exposure 2.3.1 Short­ Term ( 1 Day ­ 1 Month) Incidental Oral Exposure Since there are no residential uses, toxic endpoints were not selected. 2.3.2 Intermediate­ Term ( 1­ 6 Months) Incidental Oral Exposure 4 Since there are no residential uses, toxic endpoints were not selected. 2.3.3 Dermal Absorption Dermal Absorption Factor: 100% Comments about the Factor: There are no dermal absorption studies with asulam. Comparison of the developmental oral rabbit study to the dermal rabbit study is not appropriate. The dermal rabbit study did not include examination of the thyroid, the target organ. 2.3.4 Short­ Term Dermal ( 1 Day ­ 1 Month) Exposure Study Selected: Two­ Generation Reproduction Study Guideline #: 870.3800 MRID No.: 00098540 Executive Summary: In a two­ generation reproduction toxicity study ( MRID 00098540), groups of 12 male and 24 female Charles River CD rats were administered asulam ( 98.0­ 100.6 % a. i.) in the diet at concentrations of 0 ( control), 1,000, 5,000, or 25,000 ppm ( equivalent to approximately 50, 250, and 1250 mg/ kg/ day, respectively). F0 animals were mated after being on diet for 100 days. Following weaning, F1 animals ( 16 males and 32 females) continued treatment for a further 120 days prior to mating. Systemic effects observed at the high dose ( 25,000 ppm) included decreased body weights in F0 males and F1 females, increased absolute and/ or relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females ( at age 31 but not at terminal necropsy). The LOAEL for systemic toxicity is 25,000 ppm ( 1250 mg/ kg/ day) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). The NOAEL is 5,000 ppm ( 250 mg/ kg/ day). Significantly fewer mean live births per litter were observed at 5,000 and 25,000 ppm in the first generation. Also, a dose­ response relationship was evident. Fertility index was slightly lower in F1 parents at 5,000 and 25,000 ppm; however, the decreases were not statistically significant when compared to controls and did not display a dose response. The LOAEL for reproductive/ offspring toxicity is 5,000 ppm ( 250 mg/ kg/ day) based on significant decreases in mean live births per litter. The NOAEL for reproductive/ offspring toxicity is 1,000 ppm ( 50 mg/ kg/ day). 5 This two­ generation reproduction study in the rat is Acceptable­ Guideline, and does satisfy the guideline requirement for a reproduction study ( 83­ 4) in rats. Dose and Endpoint for Risk Assessment: Offspring NOAEL of 50 mg/ kg/ day, based on significant and dose­ related decreases in mean live births per litter in the first generation at a LOAEL of 250 mg/ kg/ day. Comments about Study/ Endpoint:. Although a 21­ day dermal toxicity study ( NOAEL = 1000 mg/ kg/ day) in the rabbit was available, the study did not include examination of thyroid weights and thyroid pathology, and does not evaluate offspring toxicity. A number of toxicity studies, including a carcinogenicity feeding study in the mouse ( MRID# 00081183), a combined chronic toxicity/ carcinogenicity rat study ( MRID# 00098543), a two­ generation rat reproduction study ( MRID# 00098540), a 3­ month oral dog study ( MRID# 00081183), a 6­ month oral dog study ( MRID # 00098536), and a combined chronic toxicity/ carcinogenicity rat study ( MRID# 00098543), indicate the thyroid as a target organ. Offspring toxicity was noted in the two­ generation reproduction study in the rat ( discussed above). For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects, and possibly protective of thyroid effects. A dermal absorption study was not available. A dermal absorption factor of 100% will be used for route­ to­ route extrapolation. 2.3.5 Intermediate­ Term Dermal ( 1­ 6 Months) Exposure Study Selected: Two­ Generation Reproduction Study Guideline #: 870.3800 MRID No.: 00098540 Executive Summary: See Short­ term Dermal Exposure Section. Dose/ Endpoint for Risk Assessment: Offspring NOAEL of 50 mg/ kg/ day, based on significant and dose­ related decreases in mean live births per litter in the first generation at a LOAEL of 250 mg/ kg/ day. Comments about Study/ Endpoint: Refer to Comments about Study/ Endpoint for Short­ term Dermal Exposure which provides a rationale for not selecting the 21­ day dermal toxicity study ( NOAEL = 1000 mg/ kg/ day) in rabbits for risk assessment. The 3­ month oral dog study ( which examined thyroid) was also considered for possible selection for this exposure scenario. Although the study was classified as nonacceptable guideline, it 6 was supported by the findings of the 6­ month oral dog study. The results of the two studies were similar ( i. e., the LOAEL and NOAEL ( based on increased thyroid weights) for the 6­ month dog study were 300 mg/ kg/ day and 60 mg/ kg/ day, respectively, while the LOAEL and NOAEL ( also based on increased thyroid weights) for the 3­ month dog study were 500 mg/ kg/ day and 50 mg/ kg/ day, respectively). The results of the dog studies with a NOAEL of 50 mg/ kg/ day ( 3­ month dog study) or 60 mg/ kg/ day ( 6­ month dog study) support the NOAEL from the two­ generation reproduction study. The two­ generation reproduction study is selected for the intermediate­ term dermal exposure. An 8­ week oral range­ finding study in mice ( MRID# 42110002) was also available, however, the thyroid was not examined. A dermal absorption factor of 100% will be used for route­ to­ route extrapolation. 2.3.6 Long­ Term Dermal ( Longer than 6 Months) Exposure Study Selected: Combined Chronic Toxicity/ Oncogenicity feeding­ rat; OPPTS 870.4300 [ § 83­ 5] MRID No.: 00098543 Executive Summary: See Section 2.2 Chronic Reference Dose ( RfD) Dose and Endpoint for Risk Assessment: NOAEL of 36 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells observed in male rats at 180 mg/ kg/ day. Comments about Study/ Endpoint: A long­ term dermal toxicity study was not available. In addition, there was no dermal absorption study. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. A dermal absorption factor of 100% will be used for route­ to­ route extrapolation. 2.3.7 Short­ term Inhalation ( 1 Day ­ 1 Month) Exposure Study Selected: Two­ Generation Reproduction Study Guideline #: 870.3800 MRID: 00098540 Executive Summary: See Short­ term Dermal Dose/ Endpoint for Risk Assessment: Offspring NOAEL of 50 mg/ kg/ day, based on significant and dose­ related decreases in mean live births per litter in the first generation at a LOAEL of 250 mg/ kg/ day. Comments about Study/ Endpoint: Although a 1­ month inhalation toxicity study in rats was available ( NOAEL = 15.3 mg/ L), thyroid weights and thyroid pathology were not 7 examined. As discussed previously, a number of toxicity studies, including carcinogenicity feeding study in the mouse ( MRID# 00081183), a combined chronic toxicity/ carcinogenicity rat study ( MRID# 00098543), a two­ generation rat reproduction study ( MRID# 00098540), a 3­ month oral dog study ( MRID# 00081183), a 6­ month oral dog study ( MRID # 00098536), and a combined chronic toxicity/ carcinogenicity rat study ( MRID# 00098543), indicate the thyroid as a target organ. Offspring toxicity was observed in the two­ generation reproduction study. For this exposure scenario, the two­ generation reproduction study in the rat ( MRID# 00098540) is selected for risk assessment because the decreased mean live births per litter occurred during days 0 ­ 30, which is the appropriate duration of exposure for this risk assessment. It is also protective of offspring/ reproductive effects. An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral absorption) will be used for route­ to­ route extrapolation. 2.3.8 Intermediate­ term Inhalation ( 1­ 6 Months) Exposure Study Selected: Two­ Generation Reproduction Study Guideline #: 870.3800 MRID: 00098540 Executive Summary: See Short­ term Dermal Dose/ Endpoint for Risk Assessment: Offspring NOAEL of 50 mg/ kg/ day, based on significant and dose­ related decreases in mean live births per litter in the first generation at a LOAEL of 250 mg/ kg/ day. Comments about Study/ Endpoint: Refer to Comments about Study/ Endpoint for Short­ term Inhalation Exposure which provides a rationale for not selecting the one­ month inhalation toxicity study in rats for risk assessment. The 3­ month oral dog study ( which examined thyroid) was also considered for possible selection for this exposure scenario. Although the study was classified as nonacceptable guideline, it was supported by the findings of the 6­ month oral dog study. The results of the two studies were similar ( i. e., based on increased thyroid weights, the LOAEL and NOAEL for the 6­ month dog study were 300 mg/ kg/ day and 60 mg/ kg/ day, respectively, while the LOAEL and NOAEL for the 3­ month dog study were 500 mg/ kg/ day and 50 mg/ kg/ day, respectively. The results of the dog studies with a NOAEL of 50 mg/ kg/ day ( 3­ month dog study) or 60 mg/ kg/ day ( 6­ month dog study) support the NOAEL from the two­ generation reproduction study. The two­ generation reproduction study is selected for the intermediate­ term inhalation exposure. An 8­ week oral range­ finding study in mice ( MRID# 42110002) was also available, however, the thyroid was not examined. An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral absorption) will be used for route­ to­ route extrapolation. 8 2.3.9 Long­ term Inhalation ( Longer than 6 Months) Exposure Study Selected: Combined Chronic Toxicity/ Oncogenicity feeding­ rat; OPPTS 870.4300 [ § 83­ 5] MRID: 00098543 Executive Summary: See Section 2.2 Chronic Reference Dose ( RfD) Dose/ Endpoint for Risk Assessment: NOAEL of 36 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells observed in male rats at 180 mg/ kg/ day. Comments about Study/ Endpoint: A long­ term inhalation toxicity study was not available. The combined chronic toxicity/ carcinogenicity oral study in the rat is of the appropriate duration of exposure. An inhalation absorption factor of 100% ( default value assuming equivalent inhalation and oral aborption) will be used for route­ to­ route extrapolation. 2.3.10 Margins of Exposure for Occupational/ Residential Risk Assessments A margin of exposure ( MOE) of 100 is adequate for dermal/ inhalation occupational exposure risk assessment. The acceptable MOEs for non­ occupational and dietary exposures will be determined by the FQPA SF Committee. 2.4 Recommendation for Aggregate Exposure Risk Assessments There are no residential uses for asulam. The chronic aggregate risk assessment is therefore limited to food and water. CLASSIFICATION OF CARCINOGENIC POTENTIAL 3.1 Combined Chronic Toxicity/ Carcinogenicity Study in Rats MRID No. 00098543 Executive Summary: In a two­ year combined chronic feeding/ carcinogenicity study ( MRID# 00098543), CD rats ( 50/ sex/ dose) were administered asulam ( 97.5­ 99.9%) at dose levels of 0, 1,000 ( low­ dose), 5,000 ( mid­ dose) or 25,000 ppm ( high­ dose). These dietary levels were equivalent to 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females, respectively. An additional group ( 15/ sex/ dose) was administered asulam for 78 weeks. Bodyweight change in the high­ dose animals for various intervals was more than 10% lower than controls. Mean bodyweight change was significantly lower than controls in high­ dose females from week 0­ 52 and in the mid­ and high­ dose females from weeks 6­ 52. Mean 9 3 bodyweight change was significantly lower in the high­ dose males ( p< 0.01) from weeks 6­ 52. Hyperplastic changes were observed in the adrenal medulla and in thyroid follicular cells of males at the mid­ and high­ dose levels. The LOAEL is 5,000 ppm ( 180 mg/ kg/ day) based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. The NOAEL is 1,000 ppm ( 36 mg/ kg/ day). This combined chronic toxicity/ carcinogenicity study in the rat is Acceptable­ Guideline, and does satisfy the guideline requirement for a combined chronic toxicity/ carcinogenicity study ( 83­ 5) in the rat. A minor study deficiency includes the lack of thyroid weight data. Discussion of Tumor Data: There was a statistically significant increase in thyroid gland C­ cell carcinomas in both the low­ and mid­ dose males. There was also a statistically­ significant increase in adrenal medullary pheochromocytomas at the high dose in males. With the exception of a non­ dose­ related enlargement of the pituitary gland in female rats ( 3/ 15 controls; 7/ 15 low­ dose; 8/ 15 mid­ dose; 7/ 15 high­ dose), no unusual toxicological findings occurred in the animals sacrificed at 78 weeks. Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. Adequacy of the Dose Levels Tested: Dosing is considered adequate to assess the oncogenic potential of asulam based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. 3.2 Carcinogenicity Study in Mice Selected Study: Oncogenicity study in mice Guideline #: 870.4300 MRID No.: 42338201 Executive Summary: In a two­ year carcinogenicity study with Charles River CD­ 1 mice ( MRID# 42338201), asulam ( 88% a. i.) was administered in the diet at 0, 500, 5,000 or 50,000 ppm. Concentrations were corrected for 88% a. i. These dietary levels were equivalent to 0, 74, 730 and 8,040 mg/ kg/ day in males and 0, 95, 938 and 10,353 mg/ kg/ day in females, respectively. Mean body weights of the high­ dose males were generally less than 6% lower than control values during the first 24 weeks of treatment, while body weights of females were less than 6% lower than control values throughout the study. The high­ dose males displayed a reduction ( greater than 10%) in mean body weight gain when compared to the control group at various intervals. Increased mortality was observed in the high­ dose females; however, the number of high­ dose females was adequate to assess the carcinogenic potential of asulam. There was no treatment­ related effect on food consumption. Hematologic findings in the high­ dose males and females consisted of increased leukocyte counts, decreased erythrocyte counts, and decreased hematocrit levels. Organ weight changes included decreased brain weight in the high­ dose 10 females, and increased spleen weight in the high­ dose males. There was an increased incidence of brown granular pigment deposits in the livers of males of all treatment groups and high­ dose females. Increased incidences of brown granular pigment deposits were also noted in the spleens of the high­ dose rats of both sexes. The brown granular pigment deposit was not identified, and is therefore of uncertain toxicological significance. There was no increase in the incidence of any tumors. The LOAEL is 50,000 ppm, based on increased spleen weight and decreased body weight gain in males, and decreased brain weight and survival in females. The NOAEL was 5,000 ppm. This carcinogenicity study in the mouse is Acceptable­ Guideline, and does satisfy the guideline requirement for a carcinogenicity study ( 83­ 2b) in this species. One limitation of the study is the lack of thyroid weight measurements. Discussion of Tumor Data: Under the conditions of this study, there was no evidence of carcinogenicity of asulam. Adequacy of the Dose Levels Tested: Dosing is considered adequate to assess the carcinogenic potential of asulam based on decreased body weight gain, spleen and brain weight changes, and decreased survival. 3.3 Classification of Carcinogenic Potential On November 12, 1987, the Carcinogenicity Peer Review Committee met to discuss and evaluate the weight­ of­ the evidence on asulam with particular reference to its carcinogenic potential ( Peer Review of Asulam ­ memo date 2/ 17/ 88). The Committee concluded that the available data for asulam provided limited evidence for the carcinogenicity of the chemical in rats, and asulam was classified as a Category C Carcinogen. The Committee recommended that the 18­ month carcinogenicity mouse study ( MRID 00081183; unacceptable­ guideline) be repeated and agreed to reevaluate the classification when a new mouse study on asulam was submitted and reviewed. A new mouse study ( MRID # 423382­ 01; discussed previously) was submitted by the registrant and reviewed. The committee considered the new mouse study to be acceptable. The dose levels tested in the mouse study were considered to be adequate for carcinogenicity testing. The high dose tested was higher than the limit dose level as specified under Subpart F of the Pesticide Assessment Guideline for carcinogenicity testing in mice. The treatment did not alter the spontaneous tumor profile for this strain of mouse. The Committee concluded that the new mouse study did not impact the current classification of asulam as a Group C, possible human carcinogen. 11 4 MUTAGENICITY CONCLUSION: The four mutagenicity studies have been reviewed. With the exception of MRID No. 00082250 ( dominant lethal mutations in mice) all other assays were found to be Acceptable. These studies satisfy the pre­ 1991 FIFRA guideline requirement for mutagenicity studies ( § 84­ 2); no further testing is required at this time. Presented below are the citations and Executive Summaries for the reviewed studies; the revised Data Evaluation Records ( DERs) are attached. CITATION: Hastings, S. E. and Huffman, K. W. ( 1975). Dominant Lethal Study of Asulam in Mice; Hess & Clark, Div of Rhodia, Ashland, OH; Study Report No. SEH­ 75: 94, Project No. CH­ 62; dated: August 29, 1975. ( Unpublished) MRID NUMBER: 00082250. EXECUTIVE SUMMARY: In a dominant lethal mutation assay ( MRID No. 00082250), groups of 15 male Carworth CF­ 1 mice received dietary administrations of 1500 or 5000 ppm Asulam ( unspecified purity) for 45 days. Fifteen males were in the vehicle control group and 10 males/ group were in the two positive control groups. After treatment, individual males were mated with two untreated virgin females ( CD­ 1 mice) for 1 week and remated at the same mating ratio of males to females ( 1: 2) for a second week. Females were sacrificed 13 days after the mid­ week of mating and uterine contents were examined. No adverse effects were seen in the males and no differences in the percent pregnancy, number of implants or early fetal deaths were observed in the females. The expected response was induced in animals administered the positive control. Means and standard error of the means indicated that there was no evidence that Asulam induced a dominant lethal effect. This study is classified as Unacceptable because purity information on the test material has not been provided. It does not satisfy the guideline requirements for a dominant lethal assay ( 84­ 2). CITATION: Ingham, R. ( 1979). Asulam C3H/ 10T1/ 2 Cell Transformation Assay: EG & G Mason Research Institute, Rockville, MD; Study No. 596­ 249­ 8; RES 3701; dated: October 5, 1979. ( Unpublished) MRID NUMBER: 00098542. EXECUTIVE SUMMARY: In an in vitro cell transformation assay ( MRID No. 00098542), C3H/ 10T1/ 2 cells were exposed to Asulam ( 98.0­ 99.9%) at doses of 256, 512, 1024 or 2048 µ g/ mL for 18 hours. Surviving cells were plated for 8 days to determine cloning efficiency ( CE); Type II and Type III foci were scored 35 days after treatment. An S9­ activated phase of testing was not included. The test material was delivered to the test system in acetone. Cytotoxicity, as indicated by a 50­ 75% reduction in the CE, was apparent at 2048 µ g/ mL. The positive control induced the expected increase in Type II transformed foci. There was, however, no evidence that Asulam induced morphological transformation. 12 This study is classified as Acceptable ( Nonguideline). CITATION: Galloway, S. M. and Myhr, B. C. ( 1984). Asulam: Mutagenicity Evaluation of Asulam Technical ( Dried) in an In Vitro Cytogenetics Assay measuring Chromosome Aberration Frequencies in Human Lymphocytes; Litton Bionetics, Inc., Kensington, MD; Study No. 20990; dated: March 1984. ( Unpublished) MRID NUMBER: 40415301. EXECUTIVE SUMMARY: In a mammalian cell cytogenetic assay ( MRID No. 40415301), cultured human lymphocytes were exposed to Asulam technical ( 97.5­ 99.8%) at doses ranging from 125­ 2500 µ g/ mL in the absence of metabolic activation or to S9­ activated doses of 250­ 2500 µ g/ mL and cells were harvested 48 hours post­ exposure. The S9 homogenate was derived from Aroclor 1254­ induced Sprague Dawley rat livers and the test material was delivered to the test system in dimethyl sulfoxide. Doses $ 1000 µ g/ mL ­ S9 were cytotoxic. No cytotoxicity was seen in the presence of S9 activation; however, results from the preliminary study suggested that Asulam was tested up to the highest subcytotoxic concentration. The positive controls induced the expected clastogenic responses with or without S9 activation. There was, however, no evidence that Asulam technical induced a clastogenic response either in the presence or the absence of S9 activation. This study is classified as Acceptable ( Guideline) and satisfies the guideline requirement for an in vitro mammalian cell cytogenetic assay ( § 84­ 2). CITATION: Hoorn, A. J. W. ( 1983). Asulam: Mutagenicity Evaluation of Asulam Technical ( Dried) in the Ames Salmonella/ Microsome Plate Test Preincubation Method; Litton Bionetics, Inc., Veenedaal, The Netherlands; Study No. E­ 9177 dated: October 1983. ( Unpublished) MRID NUMBER: 40415302. EXECUTIVE SUMMARY: In a microbial reverse gene mutation preincubation assay ( MRID No. 40415302), Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 were exposed to seven doses of Asulam technical ( 97.5­ 99.87%) ranging from 0.9­ 2000 µ g/ plate in both the presence and the absence of S9 activation. The S9 fraction was derived from Aroclor 1254­ induced Sprague Dawley male rat livers and the test material was delivered to the test system in dimethyl sulfoxide. Cytotoxicity was evident for the majority of strains at > 500 Fg/ plate­ S9 or at > 1000 Fg/ plate + S9. All strains responded in the expected manner to the appropriate positive control. There was, however, no evidence that Asulam technical induced a mutagenic effect in any strain. This study is classified as Acceptable ( Guideline) and satisfies the guideline requirements for a bacterial gene mutation assay ( 84­ 2). 13 5 FQPA CONSIDERATIONS 5.1 Adequacy of the Data Base The following acceptable studies are available: Developmental toxicity studies in the rat & rabbit Two­ Generation Reproduction Study 5.2 Neurotoxicity No acute, subchronic, or developmental neurotoxicity studies have been conducted. However, there is no evidence of neurotoxicity in the available acute, subchronic, chronic, and oncogenicity studies. In the March 31, 1998 HIARC meeting, the HIARC concluded: The data and information provided by the Registrant demonstrate that Asulam, being a carbamate herbicide rather than a carbamate insecticide, has chemical structure and biological properties considerably different from those of the insecticides. Several studies were cited to illustrate the lack of cholinesterase inhibition and the absence of clinical signs suggestive of neurotoxicity. Based on these factors, the Agency waived the requirements for acute, subchronic, and developmental neurotoxicity studies ( memorandum, L. Taylor to C. Peterson, dated January 29, 1992. 5.3 Developmental Toxicity Rat EXECUTIVE SUMMARY: In a developmental toxicity study ( MRID # 00098538), asulam ( 98.0­ 99.9 % a. i.) was administered to 23­ 27 pregnant Charles River ( CD) rats/ dose by oral gavage at dose levels of 0, 500, 1,000, or 1,500 mg/ kg/ day from days 5 through 17 of gestation. Mean maternal body weight gain ( days 5­ 18) was 9% lower in the high­ dose group than in controls. There were no treatment­ related effects on other maternal parameters including mortality, clinical signs, and food consumption. A slight to moderate increase ( not statistically significant) in preimplantation loss was observed in the high­ dose group ( compared to controls). The slight increase in postimplantation loss at the high dose ( 1500 mg/ kg/ day) was not statistically significantly different from control values, and was not of any apparent biological significance. The maternal LOAEL is 1,500 mg/ kg/ day based on body weight gain decrement. The maternal NOAEL is 1,000 mg/ kg/ day. The developmental LOAEL is 1,500 mg/ kg/ day based on slight to moderate increase in preimplantation loss. The developmental NOAEL is 1,000 mg/ kg/ day. This prenatal developmental toxicity study in the rat is Acceptable­ Guideline, and does satisfy 14 the guideline requirement for a developmental study ( 83­ 3) in the rat. The highest dose tested was 1,500 mg/ kg/ day. COMMENTS: In a memo dated May 24, 1994, a Toxicology Branch review of supplemental data to clarify the mating procedures utilized in the rat developmental study concluded that the study was acceptable. Rabbit EXECUTIVE SUMMARY: In a developmental toxicity study ( MRID # 00098539), asulam ( 98.0­ 99.9 % a. i.) was administered to 15­ 23 pregnant New Zealand rabbits/ dose by oral gavage at dose levels of 0, 60, 300, or 750 mg/ kg/ day from days 5 through 20 of gestation. Rabbits were sacrificed on gestation day 29. Originally, the high dose selected was 1,500 mg/ kg/ day. However, severe maternal toxicity ( greater than 20% weight loss, mortality, and signs of starvation) occurred after administration of the 1,500 mg/ kg/ day dose level. All animals in this group died or were sacrificed for humane reasons. A new group was added to the study using a lower dose of 750 mg/ kg/ day. Mean maternal body weight gain was markedly reduced ( 35%) in the 750 mg/ kg/ day group than in controls during the dosing period ( days 5 ­ 21). In addition, mean maternal body weight gains were markedly reduced during days 5­ 9, 5­ 13, and 5­ 17. During the postdosing period, mean body weight of rabbits treated with 750 mg/ kg/ day were comparable to those of controls, and rabbits displayed some improvement in body weight gain. Rabbits given 750 mg/ kg/ day exhibited a non­ statistically significant decrease in food consumption at several intervals during dosing ( days 5­ 9, 9­ 13, 13­ 17). There were no apparent treatment­ related effects on mortality or clinical signs. The maternal LOAEL is 750 mg/ kg/ day based on decreased body weight gain during the dosing period. The maternal NOAEL is 300 mg/ kg/ day. There were no apparent treatment­ related effects on developmental parameters at dose levels up to 750 mg/ kg/ day. The developmental NOAEL is 750 mg/ kg/ day. This prenatal developmental toxicity study in the rabbit is Acceptable­ Guideline, and does satisfy the guideline requirement for a developmental study ( 83­ 3) in the rabbit. The study employed an adequate number of animals, and the doses were high enough to challenge the animals. 5.4 Reproductive Toxicity Executive Summary: In a two­ generation reproduction toxicity study ( MRID 00098540), groups of 12 male and 24 female Charles River CD rats were administered asulam ( 98.0­ 100.6 % a. i.) in the diet at concentrations of 0 ( control), 1,000, 5,000, or 25,000 ppm ( equivalent to approximately 50, 250, and 1250 mg/ kg/ day, respectively). F0 animals were mated after being on diet for 100 15 days. Following weaning, F1 animals ( 16 males and 32 females) continued treatment for a further 120 days prior to mating. Systemic effects observed at the high dose ( 25,000 ppm) included decreased body weights in F0 males and F1 females, increased absolute and/ or relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females ( at age 31 but not at terminal necropsy). The LOAEL for systemic toxicity is 25,000 ppm ( 1250 mg/ kg/ day) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). The NOAEL is 5,000 ppm ( 250 mg/ kg/ day). Significantly fewer mean live births per litter were observed at 5,000 and 25,000 ppm in the first generation. Also, a dose­ response relationship was evident. Fertility index was slightly lower in F1 parents at 5,000 and 25,000 ppm; however, the decreases were not statistically significant when compared to controls and did not display a dose response. The LOAEL for reproductive/ offspring toxicity is 5,000 ppm ( 250 mg/ kg/ day) based on decreased mean live births per litter. The NOAEL is 1,000 ppm ( 50 mg/ kg/ day). This two­ generation reproduction study in the rat is Acceptable­ Guideline, and does satisfy the guideline requirement for a reproduction study ( 83­ 4) in rats. COMMENTS: The original DER identified a reproductive NOEL of 1000 ppm based on fewer live births/ litter at 5,000 and 25,000 ppm, and a slightly lower fertility index in F1 parents at 5,000 and 25,000 ppm. However, a previous HIARC committee review ( HED DOC. NO. 012556; March 31, 1998) disagreed with this NOEL, and concluded that the reproductive NOEL should be set at 25000 ppm ( 1250 mg/ kg/ day) based on the following reasons regarding fewer live births per litter and lower fertility index: ( 1) The observation was not statistically significant between treated and control groups; ( 2) There was no dose relationship; ( 3) The observations were not seen in the next generation; and ( 4) There was no developmental effects in the developmental toxicity study in rats at 1000 mg/ kg/ day. Also, fewer live births per litter was not seen in the developmental studies. The reviewer notes however that the decreases in mean numbers of live pups per litter from birth until day 30 at 5,000 ppm and 25,000 ppm in the first generation were statistically significant and displayed a dose response relationship. The mean numbers of live pups per litter from birth until day 30 were also lower in the 5,000 ppm and 25,000 ppm groups ( compared to control group) in the second generation; however, statistical significance was only observed for the 5,000 ppm group at day 0. The reviewer considers the offspring LOAEL to be 5,000 ppm. In a memo dated May 24, 1994, a Toxicology Branch review of supplemental information on the dietary concentrations, stability, and homogeneity of the test material utilized in the study concluded that the supplemental information was adequate and that the reproduction study was 16 acceptable. Another memo ( 7/ 7/ 87) discusses the results of a T­ test of controls vs. low dose in the reproduction study. The memo concluded that there was no significant difference in the average litter size between the controls and low dose group ( 1000 ppm) for the F0 and F1 females when tested by the one sided t­ test. 5.5 Additional Information from Literature Sources ( if available) No relevant literature was found. 5.6 Determination of Susceptibility There is no quantitative/ qualitative evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure to asulam in the developmental toxicity studies in these species. However, there was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat. In this study, the decreased mean live births per litter ( offspring NOAEL = 50 mg/ kg/ day) was observed at lower dose levels than that associated with parental/ systemic toxicity ( NOAEL = 250 mg/ kg/ day). 5.7 Recommendation for a Developmental Neurotoxicity Study HIARC concluded that a developmental neurotoxicity study was not needed. However, HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring. It was further recommended that the adult study should include interim measures ( e. g., 7, 14, and 28 days). HIARC also recommended that thyroid parameters selected for the comparative study should be based on Agency guidelines ( under current development) for thyroid toxicity testing. 5.7.1 Evidence that suggest requiring a Developmental Neurotoxicity study: Asulam is listed as a potential endocrine disruptor on EPA s Endocrine Disruptor Screening and Testing Advisory Committee ( EDSTAC) list. Increased thyroid weights have been observed in rats, mice and dogs following subchronic and chronic exposures. In addition, hyperplastic changes in the thyroid follicular cells and thyroid gland C­ cell carcinomas were observed in male rats. None of the available toxicity studies examined potential changes in thyroid hormone levels. During development, thyroid hormone is essential for growth, brain development and nervous system maturation. Based on structure activity relationships ( discussed in detail below), there is some support for a potential hormonal mechanism of thyroid toxicity associated with asulam. No chemical­ specific information pertaining to the potential mechanism by which asulam causes endocrine effects was identified in the available database ( pesticide study submissions and recent literature search). However, the Toxicology Branch Peer Review Committee on November 12, 1987 identified three compounds with some structural similarity to asulam, and which have been tested for oncogenic effects in rodents. These compounds included: 1) oryzalin, a sulfanilamide compound that was 17 classified as a category C carcinogen on the basis of producing benign thyroid, skin and mammary tumors in male and female F344 rats; 2) sulfamethoxazole, a sulfonamide that produced thyroid gland hyperplasia, nodules and adenomas in rats; and 3) sulphisoxazole, another sulfonamide which was negative for oncogenicty in rats and mice. In the case of oryzalin and sulfamethoxazole, the induction of thyroid tumors was considered to be due to indirect anti­ thyroid effects ( Oryzalin Peer Review memorandum of 3/ 12/ 86). The Committee also recognized that a minor sulfanilamide metabolite of asulam, 4­ acetylsulfanilamide, was detected in rat urine. There was no toxicity information on this metabolite. In the weight­ of­ evidence evaluation of asulam, the Committee noted that asulam produced two types of endocrine gland tumors in male Sprague Dawley CR­ CD rats. These included thyroid gland C­ cell carcinomas and combined C­ cell adenomas/ carcinomas, and benign adrenal gland pheochromocytomas. In addition, hyperplasia was observed in the thyroids and adrenals of asulam­ treated male rats. The Oryzalin Peer Review memorandum of 3/ 12/ 86 presented a discussion of structure activity considerations for oryzalin. Oryzalin is a parasubstituted aniline derivative and also a sulfanilamide compound. The Peer Review Committee considered data indicating that dietary administration of another para­ substituted aniline derivative, 2,4­ diaminoanisole sulfate, to rats increased the incidences of malignant tumors of the thyroid gland and the skin in both sexes at 5000 ppm. In B6C3F1 mice, dietary administration of 2,4­ diaminoanisole sulfate at 2400 ppm induced thyroid tumors in each sex. In addition, data on two sulfonamides, sulfamethoxazole and sulphisoxazole, were considered. Orally administered sulfamethoxazole produced thyroid gland hyperplasia and neoplasia ( nodules and adenomas) in rats, whereas sulphisoxazole was negative for oncogenicity in rats and mice. The Oryzalin Peer Review Committee concluded that there is presumptive evidence to believe that the thyroid gland tumors produced by oryzalin in male and female rats were due to an anti­ thyroid effect of the compound. In addition, the Committee noted that anti­ thyroid effects have previously been reported for para­ substituted aniline derivatives ( of which the sulfonamides make up the greatest number) in rats, mice, and dogs. The Committee further stated ­ Although no biochemical tests were performed to evaluate an effect of oryzalin on thyroid function in the data available for review, several morphological changes were observed in the thyroid gland in the chronic rat bioassays in addition to the tumors. These included: ( a) increased thyroid gland weights in high­ dose ( 2700 ppm) males in one of the two chronic studies; ( b) a dose­ related increase in cystic follicles of the thyroid in males ( controls, 3/ 59, low­ dose, 5/ 59, mid­ dose, 12/ 57, high­ dose, 19/ 56) and females ( controls, 2/ 55, low­ dose, 8/ 59, mid­ dose, 13/ 57, high­ dose, 15/ 55), and ( c) focal follicular hyperplasia, particularly at the high­ dose level, in males and females. Furthermore, on the basis of this information, the panel considered that oryzalin might act to cause thyroid tumors by inhibiting the formation of thyroxin, resulting in positive feedback stimulation of the pituitary gland to 18 release TSH, thereby causing thyroid gland hypertrophy ( goiter) and the ensuing hyperplasia and tumor formation. Recent data further support the anti­ thyroidal effects of sulfonamides. Sulfamethazine, the most widely used sulfonamide, has been reported to cause thyroid follicular adenomas in rats and mice. Residues of this sulfonamide have been detected in milk and meat products. Sulfamethazine has also been reported to result in hypersensitivity reactions, including hypothyroidism, in humans. Doerge and Decker ( 1994) provided evidence that the primary mechanism for sulfamethazine­ induced hypothyroidism is via the reversible inhibition of thyroid peroxidase­ mediated thyroid hormone synthesis, rather than the formation and covalent binding of reactive N­ oxygenated metabolites. The subsequent alterations in thyroid hormone levels can influence the pituitary­ thyroid feedback system that regulates thyroid homeostasis. The feedback system responds to the decreased thyroid hormone levels by releasing thyroid­ stimulating hormone. Thyroid­ stimulating hormone produces a generalized growth stimulus to the thyroid causing an increasing nuclear expression of genes coding for proteins associated with thyroid hormone synthesis. Moreover, thyroid­ stimulating hormone is thought to select proliferative cells, resulting in clonal expansion of a transformed phenotype. The postulated mechanism of action for sulfamethazine is consistent with a hormonal mechanism for thyroid carcinogenesis mediated by thyroid­ stimulating hormone ( Doerge and Decker 1994). This mechanism is considered not to be a genotoxic one. In the two­ generation reproduction rat study, increased absolute brain weight in F1 males, and increased relative brain weight in F1 females, were observed. However, no brain weight changes were observed in the F2 parents. Decreased brain weight was observed in high­ dose females in a 2­ year carcinogenicity study ( MRID 42338201). 5.7.2 Evidence that do not support a need for a Developmental Neurotoxicity study: No developmental CNS malformations were observed in the developmental toxicity studies with asulam. There was no evidence of neurotoxicity ( clinical signs or pathology) in subchronic and chronic toxicity studies in the rat, dog, or mouse. Note: the Agency waived the requirements for acute, subchronic, and developmental neurotoxicity studies ( memorandum, L. Taylor to c. Peterson, dated January 29, 1992). 19 6.0 HAZARD CHARACTERIZATION Asulam is a post­ emergent systemic herbicide used for weed control on sugarcane, Christmas tree plantations, ornamentals, turf, and noncropland uses. Potential residential exposures are not anticipated as a result of applications of asulam. Asulam is classified as Category IV for acute oral toxicity, acute inhalation toxicity and primary dermal irritation; Category III for acute dermal toxicity and primary eye irritation. Asulam is a nonsensitizer. Several studies in rodents and dogs demonstrate that asulam affects the endocrine system, in particular, the thyroid. The Reference Dose ( RfD) is 0.36 mg/ kg/ day based on a chronic dietary feeding study in rats. The No­ observed­ Adverse­ Effect­ Level ( NOAEL) in this study was 36 mg/ kg/ day, based on thyroid follicular hyperplasia at 180 and 953 mg/ kg/ day. An uncertainty factor of 100 was used to account for interspecies extrapolation and intraspecies variability. There is no quantitative/ qualitative evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure to asulam in the developmental toxicity studies in these species. However, there was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat. In this study, the significant decreases in mean live births per litter ( offspring NOAEL = 50 mg/ kg/ day) was observed at lower dose levels associated with parental/ systemic toxicity ( NOAEL = 250 mg/ kg/ day). Asulam was not mutagenic in the studies that have been performed. The Agency classified asulam as a Group C, possible human carcinogen, based on thyroid and adrenal tumors in the rat study. The Agency has decided not to quantify the carcinogenic risk by low dose extrapolation. DATA GAPS Comparative thyroid rat assay in adult and offspring ( see Section 5.7). 21­ day Dermal Study in Rats with examination of thyroid weight and pathology. 28­ day Inhalation Study in Rats with examination of thyroid weight and pathology. 20 ACUTE TOXICITY Acute Toxicity of Asulam. Guideline No. Study Type MRID #( S). Results Toxicity Category 81­ 1 Acute Oral 409605­ 01 LD50 => 5000 mg/ kg IV 81­ 2 Acute Dermal 409605­ 01 LD50 = > 4000 mg/ kg III 81­ 3 Acute Inhalation 409605­ 02 413616­ 01 LC50 => 5 mg/ L IV 81­ 4 Primary Eye Irritation 00098534 Mild Irritation III 81­ 5 Primary Skin Irritation 00098535 Not an Irritant IV 81­ 6 Dermal Sensitization 00098535 No sensitization NA 21 SUMMARY OF TOXICOLOGY ENDPOINT SELECTION The doses and toxicological endpoints selected for various exposure scenarios are summarized below. EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary An appropriate endpoint attributable to a single dose was not identified. Acute RfD = not established Chronic Dietary NOAEL = 36 mg/ kg/ day UF = 100 The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncogenicity in the rat Chronic RfD = 0.36 mg/ kg/ day Incidental Oral, Short­ Term Incidental Oral, Intermediate­ Term A toxicity endpoint was not selected because there are no residential uses. A toxicity endpoint was not selected because there are no residential uses. Dermal, Short­ Term Dermal, Intermediate­ Term Oral NOAELa = 50 mg/ kg/ day Oral NOAELa = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study Two Generation Reproduction Study 22 Dermal, Long­ Term Oral NOAELa = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncogenicity in the rat Inhalation, Short­ Term Inhalation, Intermediate­ Term Oral NOAELb = 50 mg/ kg/ day Oral NOAELb = 50 mg/ kg/ day The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. The LOAEL was 250 mg/ kg/ day based on significant decreases in mean live births per litter. Two Generation Reproduction Study Two Generation Reproduction Study Inhalation, Long­ Term Oral NOAELb = 36 mg/ kg/ day The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncogenicity in the rat aApply 100% dermal absorption factor for route­ to­ route extrapolation. bAssume 100% inhalation absorption factor for route­ to­ route extrapolation. 23

epa

2024-06-07T20:31:45.402984

regulations

EPA-HQ-OPP-2002-0329-0004

Supporting & Related Material

TXR NO. 0050454 February 5, 2002 MEMORANDUM SUBJECT: ASULAM­ Report of the FQPA Safety Factor Committee FROM: Carol Christensen, Acting Executive Secretary FQPA Safety Factor Committee Health Effects Division ( 7509C) THROUGH: Ed Zager, Chair FQPA Safety Factor Committee Health Effects Division ( 7509C) TO: Jose Morales Reregistration Branch III Health Effects Division ( 7509C) PC Code: 106901; 106902 The FQPA Safety Factor Committee evaluated the available hazard and exposure data for asulam on December 10th , 2001 and made the recommendation for the FQPA safety factor to be used in human health risk assessments ( as required by Food Quality Protection Act of August 3, 1996). The committee concluded that the FQPA safety factor be retained ( 10x) in assessing the risk posed by this chemical. I. HAZARD ASSESSMENT ( Memorandum: J. Morales to C. Christensen dated December 3rd , 2001) A. Adequacy of the Toxicology Database The toxicology data base for asulam is complete for FQPA assessment. The toxicology database for asulam was reviewed by the Hazard Identification Assessment Review Committee ( HIARC) on November 13th , 2001. Asulam was also reviewed by the Mechanism of Toxicity Assessment Review Committee ( MTARC) on September 27, 2001 to consider the mechanism of thyroid toxicity. Prenatal developmental toxicity studies in the rat and rabbit and a two­ generation reproduction study are available with asulam. The HIARC determined that a developmental neurotoxicity ( DNT) study is not required. However, HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring. ( See HIARC Report TXR­ 0050324) B. Determination of Susceptibility No quantitative or qualitative evidence of increased susceptibility was demonstrated in either the prenatal developmental toxicity study in rats or in the prenatal developmental toxicity study in rabbits. There was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat. II. EXPOSURE ASSESSMENTS A. Dietary Food Exposure Considerations ( Memorandum: J. Morales to C. Christensen on December 3rd, 2001) Asulam ( methyl­ 4­ sulfanilylcarbamate) is a postemergent systemic carbamate herbicide marketed under the trade name ASULOX ® Herbicide by Aventis CropScience. Asulam is primarily used in agriculture with key markets in Florida and Louisiana. ASULOX ® contains the sodium salt of asulam and is registered for use on sugarcane as a 3.34 lb/ gal soluble concentrate/ liquid ( SC/ L) formulation. This formulation may be applied postemergence as a band or broadcast application using ground or aerial equipment or as a spot treatment. The asulam use rate, for sugarcane, ranges from 2.5 to 3.34 lbs a. i./ A and can applied up to two times per year. Tolerances are listed at 40 CFR 180.360 and range from 0.05­ 30 ppm. Apart from its food use on sugarcane, asulam is used on Christmas tree plantations, ornamentals, turf ( sod farms only) and non­ cropland uses. The qualitative nature of the residue in plants is adequately understood based on sugarcane metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4 ­ acetylasulam, and N4 ­ acetylsulfanilamide determined as a common moiety. Hydroquinone/ quinone remains a chemical of toxicological concern. However, hydroquinones are naturally occurring in plants. Relative to naturally occurring hydroquinones, hydroquinones residues from asulam use on sugar is 2 insignificant and does not increase risk. No new metabolism studies are needed on asulam on sugar to address the hydroquinone issue unless the registrant requests a new use for asulam. Monitoring data are not available for this crop use. Therefore, anticipated residues will be generated using field trial data and percent crop treated information from BEAD. A DEEM Tier II dietary exposure analysis will be performed. The Committee recognizes that further refinement to the dietary food exposure analyses may be required as the risk assessment is developed. Therefore, provided the final dietary food exposure assessment includes the metabolites of toxicological concern and does not underestimate the potential risk for infants and children, the safety factor recommendations of this Committee stand. B. Dietary Drinking Water Exposure Considerations ( Correspondence: J. Morales to C. Christensen on December 3rd, 2001) The fate and mobility studies are generally adequate for asulam. Available fate data suggests the chemical is moderately persistent and mobile. Degradates of toxicological concern include sulfanilamide and sulfanilic acid. The magnitude of individual degradates in many fate studies cannot be determined from available data, however, from an aged leaching column study, the sulfanilamide degradate appears to be less mobile than the parent asulam. The chemical structures of sulfanilamide and sulfanilic acid are similar to the structure of the parent compound. Runoff to surface water and leaching to ground water are expected to occur at relatively high levels from both the parent and degradates of concern. The Environmental Fate and Effects Division ( EFED) has expressed some concerns for the presence of asulam and its metabolites in surface and ground water. EFED assumed immediate conversion of asulam upon application to these degradates in their screening­ level modeling with FIRST ( surface water) and Sci­ Grow ( groundwater). Their modeling exercise further assumed these compounds to be very persistent and very mobile in water. Therefore, the estimated environmental concentrations ( EECs) for residues of asulam reported from EFED for surface and ground water represent upper bound concentrations for residues of asulam, sulfanilamide and sulfanilic acid in water. Because monitoring data exceeded groundwater model estimates, monitoring data were used for ground water drinking water concentrations. The FQPA Safety Factor Committee recognizes that further refinement to the dietary water exposure analyses may be required as the risk assessment is developed. Therefore, provided the final dietary water exposure assessment includes all metabolites of toxicological concern and does not underestimate the potential risk for infants and children, the safety factor recommendations of this Committee stand. 3 C. Residential Exposure Considerations There are no residential uses registered for this chemical. SAFETY FACTOR RECOMMENDATION AND RATIONALE A. Recommendation of the Factor The Committee recommended that the FQPA safety factor be retained ( 10x). B. Rationale for Retaining the FQPA Safety Factor The Committee concluded that the safety factor is necessary when assessing the risk posed by asulam because: 1. There was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat; and, 2. HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring and this is considered a data gap for asulam. C. Application of the Safety Factor ­ Population Subgroups: The safety factor is required for all population subgroups when assessing chronic dietary exposure since the evidence for increase susceptibility was seen in the two­ generation study, and the results from the comparative thyroid assay may provide an endpoint for chronic risk assessment. 4

epa

2024-06-07T20:31:45.410372

regulations

EPA-HQ-OPP-2002-0329-0005

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 October 12, 2001 MEMORANDUM Subject: EPA Id #. Asulam. Toxicology Chapter of the RED. TXR No.: . PC Code No.: 106901; 106902 DP Barcode No.: Submission No.: From: John J. Liccione ReRegistraion Branch III Health Effects Division 7509C To: Jose Morales Risk Assessor ReRegistration Branch III Health Effects Division 7509C Through: Catherine Eiden Branch Senior Scientist ReRegistration Branch III Health Effects Division 7509C OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES Attached is the Toxicology Chapter for the RED for asulam. An electronic copy is available in the LAN or in the IHAD system. 1 EPA Reviewer: John J. Liccione , Date ReRegistration Branch III ( 7509C) Secondary Reviewer: Catherine Eiden , Date ReRegistration Branch III ( 7509C) 2 TABLE OF CONTENTS 1.0 HAZARD CHARACTERIZATION ........................................... 4 2.0 REQUIREMENTS ........................................................ 5 3.0 DATA GAP( S) ........................................................... 7 4.0 HAZARD ASSESSMENT .................................................. 7 4.1 Acute Toxicity........................................................ 7 4.2 Subchronic Toxicity ................................................... 8 4.3 Prenatal Developmental Toxicity ........................................ 10 4.4 Reproductive Toxicity................................................. 11 4.5 Chronic Toxicity ..................................................... 12 4.6 Carcinogenicity ...................................................... 13 4.7 Mutagenicity ........................................................ 14 4.8 Neurotoxicity ....................................................... 15 4.9 Metabolism ......................................................... 15 4.10 Special/ Other Studies No special studies pertaining to asulam have been identified. ............ 16 5.0 TOXICITY ENDPOINT SELECTION........................................ 16 5.1 See Section 9.2 for Endpoint Selection Table. .............................. 16 5.2 Dermal Absorption ................................................... 16 5.3 Classification of Carcinogenic Potential................................... 16 6.0 FQPA CONSIDERATIONS ................................................ 17 6.1 Special Sensitivity to Infants and Children................................. 17 6.2 Recommendation for a Developmental Neurotoxicity Study ................... 17 7.0 OTHER ISSUES No other special issues have been identified. ............................... 17 8.0 REFERENCES .......................................................... 18 9.0 APPENDICES........................................................... 23 9.1 Toxicity Profile Summary Tables ........................................ 24 9.1.1 Acute Toxicity Table ......................................... 24 9.1.2 Subchronic, Chronic and Other Toxicity Tables .................... 24 3 Asulam ( December, 2001) RED Toxicology Chapter 1.0 HAZARD CHARACTERIZATION The acute toxicity of asulam is low. The acute oral LD50 for asulam in rats exceeded 5000 mg/ kg. The acute inhalation LC50 was greater than 5 mg/ L in rats. The acute dermal LD50 for asulam in rabbits exceeded 4000 mg/ kg. Application of technical asulam to rabbit eyes produced mild chemosis, irritation, and redness which cleared by day seven post­ treatment. Asulam was not an irritant in a primary skin irrigation study in rabbits. It did not cause dermal sensitization in guinea pigs. Reproductive toxicity. The potential reproductive toxicity of asulam was examined in a two­ generation reproduction study in the rat. In this study, significantly fewer mean live births per litter were observed at 250 mg/ kg/ day and 1250 mg/ kg/ day in the first generation; the LOAEL for offspring toxicity is 250 mg/ kg/ day. A dose­ response relationship was evident. No effects on mean live births per litter were observed at 50 mg/ kg/ day, the NOAEL for offspring toxicity. The LOAEL for parental systemic toxicity is 1250 mg/ kg/ day and was based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females; increased absolute and relative liver weights in F1 females; and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). The NOAEL for parental systemic toxicity is 250 mg/ kg/ day. This study provided evidence for a quantitative increase susceptibility of the rat fetus. Developmental toxicity. Asulam has been evaluated for potential developmental effects in the rat and the rabbit. In the developmental study in the rat, a slight to moderate increase in preimplantation loss was observed at the high dose level ( 1,500 mg/ kg/ day); the developmental NOAEL was 1,000 mg/ kg/ day. Decreased maternal body weight gain was noted at 1,500 mg/ kg/ day ( maternal LOAEL), but not at 1,000 mg/ kg/ day ( maternal NOAEL). There was no indication of treatment­ related effects on developmental parameters ( at dose levels up to 750 mg/ kg/ day) in a developmental toxicity study in the rabbit; the NOAEL for developmental toxicity is 750 mg/ kg/ day. Decreased maternal body weight gain was observed at 750 mg/ kg/ day ( the NOAEL is 300 mg/ kg/ day). Systemic toxicity. Subchronic and chronic toxicity studies demonstrate that the thyroid gland is a target organ for asulam in the rat and dog. Thyroid findings, consisting of hyperplastic changes in thyroid follicular cells in male rats ( LOAEL = 180 mg/ kg/ day; NOAEL = 36 mg/ kg/ day), were reported in a two­ year combined chronic/ oncogenicity feeding study. Thyroid weights were not monitored in the study. Other toxicological effects included adrenal medullary hyperplastic alterations in male rats, and decreased body weight gains in male and female rats. The chronic RfD for asulam is derived from the NOAEL of 36 mg/ kg/ day, based on thyroid follicular hyperplasia at 180 and 953 mg/ kg/ day. An uncertainty factor of 100 was used to account for interspecies extrapolation and intraspecies variability. In a six­ month dog study, increased thyroid weights ( elevated absolute weights in females at 300 mg/ kg/ day and elevated absolute and relative weights in males and females at 1500 mg/ kg/ day) were reported. Similar findings were noted in a three­ month gavage study in the dog. In a 18­ month carcinogenicity study with Carworth CF­ 1 outbred albino mice, decreased 4 Asulam ( December, 2001) RED Toxicology Chapter absolute and relative thyroid weights were observed in females administered 225 or 750 mg/ kg/ day in the diets. However, this study was classified as unacceptable. No pathological effects in the thyroid were reported in a repeat two­ year feeding study in the mouse; the strain was Charles River CD­ 1 mice. However, thyroid weights were not assessed in this study. Carcinogenicity. A combined chronic toxicity/ oncogenicity study in the rat provided limited evidence for the carcinogenicity of asulam in this species. There was a statistically significant increase in thyroid gland C­ cell carcinomas in male rats fed diets containing 36 and 180 mg/ kg/ day asulam. There was also a statistically significant increase in adrenal medullary pheochromocytomas in males administered 953 mg/ kg/ day ( high dose tested). In a two­ year feeding study in the mouse, no evidence of carcinogenicity was found. Asulam has been classified as a Group C carcinogen ( possible human carcinogen) by the Agency. The Agency decided not to quantify the carcinogenic risk for asulam. Neurotoxicity. No neurotoxicity studies were available for asulam. There was no evidence of neurotoxicity ( clinical signs, cholinesterase inhibition, or pathology) in subchronic and chronic toxicity studies in the rat, dog, or mouse. Immunotoxicity. None of the available data on asulam suggest an immunotoxic potential for this chemical. The mutagenicity/ genetic toxicity data base is considered complete and there is no concern for adverse mutagenicity effects. Inhalation toxicity. Data regarding the potential inhalation toxicity of asulam are limited to a one­ month inhalation and an acute inhalation study in the rat. No effects of apparent toxicological significance were noted in rats exposed ( nose­ only) to asulam at concentrations up to 15.3 mg/ L for 4 hours per day, 5 days per week, for 1 month. However, there was no examination of thyroid weights or thyroid pathology. Metabolism. Metabolism studies in the rat demonstrate that asulam was rapidly eliminated, primarily in the urine, following administration of a single oral or intravenous dose, or after repeated intravenous doses for 14 days. No unusual localization of asulam occurred in tissues. Unchanged parent compound was identified as the major excretory product, with acetylasulam and acetylsulphanilamide as minor metabolites. The dermal absorption of asulam has not been determined. 2.0 REQUIREMENTS The data requirements ( CFR 158.340) for the several uses for Asulam are in Table 1. Use of the new guideline numbers does not imply that the new ( 1998) guideline protocols were used. Most studies were conducted well before the 1998 guidelines and follow earlier guidelines. Note: The data gaps and additional data required are more simply presented in the following section ( 3.0 below). 5 Asulam ( December, 2001) RED Toxicology Chapter Table 1. Test Technical Required Satisfied 870.1100 Acute Oral Toxicity ........................... 870.1200 Acute Dermal Toxicity ........................ 870.1300 Acute Inhalation Toxicity ...................... 870.2400 Primary Eye Irritation ......................... 870.2500 Primary Dermal Irritation ...................... 870.2600 Dermal Sensitization .......................... Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 870.3100 Oral Subchronic ( rodent) ....................... 870.3150 Oral Subchronic ( nonrodent) .................... 870.3200 21­ Day Dermal .............................. 870.3250 90­ Day Dermal .............................. 870.3465 90­ Day Inhalation ............................ Yes Yes Yes No ( c) ( a) Yes ( b) N/ A No 870.3700a Developmental Toxicity ( rodent) ................ 870.3700b Developmental Toxicity ( nonrodent) ............. 870.3800 Reproduction ................................ Yes Yes Yes Yes Yes Yes 870.4100a Chronic Toxicity ( rodent) ...................... 870.4100b Chronic Toxicity ( nonrodent) ................... 870.4200a Oncogenicity ( rat) ............................ 870.4200b Oncogenicity ( mouse) ......................... 870.4300 Chronic/ Oncogenicity ......................... Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 870.5100 Mutagenicity Gene Mutation ­ bacterial .......... 870.5300 Mutagenicity Gene Mutation ­ mammalian ....... 870.5xxx Mutagenicity Structural Chromosomal Aberrations 870.5xxx Mutagenicity Other Genotoxic Effects ........... Yes Yes Yes Yes Yes Yes Yes Yes 870.6100a Acute Delayed Neurotox. ( hen) .................. 870.6100b 90­ Day Neurotoxicity ( hen) .................... 870.6200a Acute Neurotox. Screening Battery ( rat) ........... 870.6200b 90 Day Neuro. Screening Battery ( rat) ............ 870.6300 Develop. Neuro .............................. No No ( d) ( d) No ­­ N/ A N/ A N/ A 870.7485 General Metabolism .......................... 870.7600 Dermal Penetration ........................... Yes No Yes N/ A Special Studies for Ocular Effects Acute Oral ( rat) .............................. Subchronic Oral ( rat) .......................... Six­ month Oral ( dog) ......................... No No No N/ A N/ A N/ A ( a) Interim data from the chronic toxicity satisfy this requirement. ( b) A 21­ day dermal toxicity study in the rat was available, however, the study did not include an examination of the thyroid gland, the target organ for asulam. The HIARC ( 11/ 13/ 01) determined that a 21­ day dermal toxicity study, with examination of thyroid weight and pathology, is required. ( c) A one­ month inhalation toxicity study was available; however, this study did not examine the thyroid gland, the target organ. The HIARC ( 11/ 13/ 01) determined that a 28­ day inhalation toxicity study, with examination of thyroid weight and pathology, is required. HIARC did not identify a need for a 90­ day inhalation study. 6 Asulam ( December, 2001) RED Toxicology Chapter ( d) The HIARC determined that the acute, subchronic, and developmental neurotoxicity studies were not required. HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring. It was further recommended that the adult study should include interim measures ( e. g., 7, 14, and 28 days). The HIARC also recommended that thyroid parameters selected for the comparative study should be based on Agency guidance ( under current development) for thyroid toxicity testing. 3.0 DATA GAP( S) On November 13, 2001, the HIARC identified the following data gaps: Comparative thyroid rat assay in adult and offspring. It was further recommended that the adult study should include interim measures ( e. g., 7, 14, and 28 days). HIARC also recommended that thyroid parameters selected for the comparative study should be based on Agency guidelines ( under current development) for thyroid toxicity testing. 21­ day Dermal Study in Rats with examination of thyroid weight and pathology. 28­ day Inhalation Study in Rats with examination of thyroid weight and pathology. 4.0 HAZARD ASSESSMENT 4.1 Acute Toxicity Adequacy of data base for acute toxicity: The data base for acute toxicity is considered complete. The acute toxicity data on asulam is summarized below in Table 2. Table 2. Acute Toxicity of asulam. Study Type MRID No.: Result 81­ 1. Acute Oral Toxicity ­ rat. Rhone­ Poulenc Ag Co., Study No.: 51­ 260, November 7, 1988 409605­ 01 LD50 > 5000 mg/ kg. Toxicity Category IV Classification: Guideline 81­ 2. Acute Dermal Toxicity ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: 51­ 260, November 8, 1988 409605­ 01 LD50 > 4000 mg/ kg. Toxicity Category III Classification: Guideline 7 Asulam ( December, 2001) RED Toxicology Chapter 81­ 3. Acute Inhalation Toxicity ­ rat. Rhone­ Poulenc Ag Co., Study No.: 51­ 583, November 7, 1988 409605­ 02 413616­ 01 LC50 > 5 mg/ L Toxicity Category IV Classification: Minmum 81­ 4. Primary Ocular Irritation ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: R. Tox. 57, June 1981 00098534 Some chemosis, redness, and irritation were noted, but eyes were clear by day 7. Toxicity Category III Classification: Minimum 81­ 5. Primary Dermal Irritation ­ rabbit. Rhone­ Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No dermal irritation was observed. Toxicity Category III Classification: Minimum 81­ 6. Dermal Sensitization ­ guinea pig. Rhone­ Poulenc Ag Co., Study No.: RES 2853, March 1977 00098535 No evidence of sensitization in the Guinea Pig. Classification: Minimum. Subchronic Toxicity Adequacy of data base for subchronic toxicity: No subchronic oral toxicity studies in the rodent per se were identified in the data base for asulam. However, the chronic oral studies in the rodent provided frequent monitoring of clinical signs and interim measurements of body weights, food consumption, hematology, clinical chemistry and urinalysis, and the results provided insight into potential subchronic effects. In a subchronic oral ( 90­ day) study, dogs displayed increased thyroid weights. Although the study was classified as unacceptable guideline , it was supported by the findings of the 6­ month oral dog study. The results of the two studies were similar ( i. e., the LOAEL and NOAEL ( based on increased thyroid weights) for the 6­ month dog study were 300 mg/ kg/ day and 60 mg/ kg/ day, respectively, while the LOAEL and NOAEL ( also based on increased thyroid weights) for the 3­ month dog study were 500 mg/ kg/ day and 50 mg/ kg/ day, respectively). A one­ month inhalation toxicity study and 21­ day dermal toxicity study were available; however, neither study included assessment of thyroid weights and pathology. The data base for subchronic toxicity is considered complete for oral and dermal studies. A 28­ day subchronic inhalation study is required, one that includes examination of thyroid weights and thyroid pathology. 870.3100 90­ Day Oral Toxicity ­ Rat Refer to the chronic toxicity studies below. 870.3150 90­ Day Oral Toxicity ­ Dog Executive Summary. In a subchronic toxicity study ( MRID# 00056414), asulam ( purity not stated) 8 4.2 Asulam ( December, 2001) RED Toxicology Chapter was administered to beagle dogs ( 3 dogs/ sex/ group) by gavage at dose levels of 0, 5, 50, or 500 mg/ kg/ day for three months. All but one dog were apparently infected with ascarids. An increase in white blood cell counts, most likely reflecting infection, was observed in all control and treated females, and in the low­ and high­ dose males, toward the end of the study. In addition, diarrhea was present in all dogs during the last 3 weeks of the study. The diarrhea may have been associated with ascarid infection. At the end of the treatment period, mean body weights of treated males were lower than those of controls, while mean body weights of treated females were higher than controls. Interpretation of the body weight differences is complicated by the differences in initial body weights of the control dogs ( i. e., control male body weight was more than 10% greater, while control female body weight was 5­ 15% lower, than those of treated animals). Overall mean body weight gains ( day 0 ­ 91) in treated dogs were for the most part higher than those of control dogs. Absolute and relative thyroid weights were elevated in both high­ dose males and females. There were no apparent treatment­ related effects on survival or pathology findings. The LOAEL is 500 mg/ kg/ day based on increased absolute and relative ( to body weight) thyroid weights in male and female dogs. The NOAEL is 50 mg/ kg/ day. Classification: This subchronic study in the dog is Unacceptable­ Guideline, and does not satisfy the guideline requirement for a subchronic nonrodent study ( 82­ 1) in this species. No information on purity of the test material, no food consumption data, the lack of individual pathology sheets, no information on the care and feeding of the dogs, the failure to randomize animals to groups on the basis of body weights so that initial body weights were comparable between groups, and no rationale provided for dose selection. Although the sample size was less than guideline requirements ( i. e., 3 rather than 4 dogs), the thyroid weight effects observed in this study are supported by a six­ month dog study ( MRID No. 00098536); the LOAEL in the six­ month dog study was 300 mg/ kg/ day, while the NOAEL was 60 mg/ kg/ day. 870.3200 21/ 28­ Day Dermal Toxicity Rat Executive Summary. In a repeat­ dose dermal toxicity study ( MRID # 41076901), asulam ( 88% a. i.) was applied to the clipped skin of 10 New Zealand rabbits/ sex/ dose at dose levels of 0 ( carboxymethylcellulose vehicle control) or 1,000 mg/ kg/ day ( limit dose), once daily for 7 days/ week during a 21­ day period. No apparent treatment­ related systemic effects were observed when body weight, food consumption, clinical pathology, organ weights, ophthalmology, urinalysis, and histopathology were examined. The NOAEL is greater than or equal to 1,000 mg/ kg/ day. Local skin irritation, which was slight and transient, was observed in a small number of treated females. Classification: This 21­ day dermal toxicity study is classified as Acceptable­ Guideline. 870.3465 90­ Day Inhalation Rat 9 Asulam ( December, 2001) RED Toxicology Chapter There are no 90­ day inhalation toxicity studies available on asulam. However, a one­ month inhalation toxicity study ( MRID # 00098537) in the rat was available. In the one­ month inhalation study, asulam ( purity not stated) was administered to 15 CD rats/ sex/ group by nose­ only exposure at concentrations of 0, 1.6, 3.9, or 15.3 mg/ L for 4 hours per day, 5 days per week, for 4 weeks. Control rats were exposed to clean air only. The estimated mass median diameter of the particles was 4.5 Fm. No effects due to exposure were observed, as judged by survival, clinical signs, body weights, food consumption, ophthalmoscopic examinations, hematology, clinical chemistry, urinalysis, and pathology. Although several significant organ weight changes ( i. e., increased absolute and relative lung, heart and adrenal weights; decreased absolute and relative spleen weights; increased relative pituitary weights) were observed in high­ dose males immediately following exposure, these changes were not seen in the high­ dose males sacrificed 5­ 7 days after final dosing ( suggesting reversibility of the effects). In addition, there were no corresponding histological lesions in these organs. Females sacrificed 5­ 7 days after final dosing displayed increased absolute and relative liver and heart weights. However, the liver and heart weight alterations were not accompanied by histological findings. The organ weight changes in the males and females are of equivocal toxicological significance. The NOAEL is 15.3 mg/ L. This study is limited because of the lack of thyroid weight measurements and pathological examination of the thyroid. Prenatal Developmental Toxicity Adequacy of data base for prenatal developmental toxicity: The data base for prenatal developmental toxicity is considered complete. 870.3700a Prenatal Developmental Toxicity Study ­ Rat Executive Summary. In a developmental toxicity study ( MRID # 00098538), asulam ( 98.0­ 99.9 % a. i.) was administered to 23­ 27 pregnant Charles River ( CD) rats/ dose by oral gavage at dose levels of 0, 500, 1,000, or 1,500 mg/ kg/ day from days 5 through 17 of gestation. Mean maternal body weight gain ( days 5­ 18) was 9% lower in the high­ dose group than in controls. There were no treatment­ related effects on other maternal parameters including mortality, clinical signs, and food consumption. A slight to moderate increase ( not statistically significant) in preimplantation loss was observed in the mid­ and high­ dose groups ( compared to controls). The slight increase in postimplantation loss at the high dose ( 1500 mg/ kg/ day) was not statistically significantly different from control values, and was not of any apparent biological significance. The maternal LOAEL is 1,500 mg/ kg/ day based on body weight gain decrement. The maternal NOAEL is 1,000 mg/ kg/ day. The developmental LOAEL is 1,500 mg/ kg/ day based on slight to moderate increase in preimplantation loss. The developmental NOAEL is 1,000 mg/ kg/ day. Classification: This prenatal developmental toxicity study in the rat is Acceptable­ Guideline. 870.3700b Prenatal Developmental Toxicity Study ­ Rabbit 10 4.3 Asulam ( December, 2001) RED Toxicology Chapter Executive Summary. In a developmental toxicity study ( MRID # 00098539), asulam ( 98.0­ 99.9 % a. i.) was administered to 15­ 23 pregnant New Zealand rabbits/ dose by oral gavage at dose levels of 0, 60, 300, or 750 mg/ kg/ day from days 5 through 20 of gestation. Rabbits were sacrificed on gestation day 29. Originally, the high dose selected was 1,500 mg/ kg/ day. However, severe maternal toxicity ( greater than 20% weight loss, mortality, and signs of starvation) occurred after administration of the 1,500 mg/ kg/ day dose level. All animals in this group died or were sacrificed for humane reasons. A new group was added to the study using a lower dose of 750 mg/ kg/ day. Mean maternal body weight gain was markedly reduced ( 35% but not statistically significant) in the 750 mg/ kg/ day group than in controls during the dosing period ( days 5 ­ 21). In addition, mean maternal body weight gains were markedly reduced during days 5­ 9, 5­ 13, and 5­ 17. During the postdosing period, mean body weights of rabbits treated with 750 mg/ kg/ day were comparable to those of controls, and rabbits displayed some improvement in body weight gain. Rabbits given 750 mg/ kg/ day exhibited a non­ statistically significant decrease in food consumption at several intervals during dosing ( days 5­ 9, 9­ 13, 13­ 17). There were no apparent treatment­ related effects on mortality or clinical signs. The maternal LOAEL is 750 mg/ kg/ day based on decreased body weight during the dosing period. The maternal NOAEL is 300 mg/ kg/ day. There were no apparent treatment­ related effects on developmental parameters at dose levels up to 750 mg/ kg/ day. The developmental NOAEL is 750 mg/ kg/ day. Classification: This prenatal developmental toxicity study in the rabbit is Acceptable­ Guideline. Reproductive Toxicity Adequacy of data base for Reproductive Toxicity: The data base for reproductive toxicity is considered complete. No additional studies are required at this time. 870.3800 Reproduction and Fertility Effects ­ Rat Executive Summary. In a two­ generation reproduction toxicity study ( MRID 00098540), groups of 12 male and 24 female Charles River CD rats were administered asulam ( 98.0­ 100.6 % a. i.) in the diet at concentrations of 0 ( control), 1,000, 5,000, or 25,000 ppm ( equivalent to approximately 50, 250, and 1250 mg/ kg/ day, respectively). F0 animals were mated after being on diet for 100 days. Following weaning, F1 animals ( 16 males and 32 females) continued treatment for a further 120 days prior to mating. Systemic effects observed at the high dose ( 25,000 ppm) included decreased body weights in F0 males and F1 females, increased absolute and/ or relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females ( at age 31 but not at terminal necropsy). The LOAEL for 11 4.4 Asulam ( December, 2001) RED Toxicology Chapter systemic toxicity is 25,000 ppm ( 1250 mg/ kg/ day) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). The NOAEL is 5,000 ppm ( 250 mg/ kg/ day). Significantly fewer mean live births per litter were observed at 5,000 and 25,000 ppm in the first generation. Also, a dose­ response relationship was evident. Fertility index was slightly lower in F1 parents at 5,000 and 25,000 ppm; however, the decreases were not statistically significant when compared to controls and did not display a dose response. The LOAEL for reproductive/ offspring toxicity is 5,000 ppm ( 250 mg/ kg/ day) based on decreased mean live births per litter. The NOAEL is 1,000 ppm ( 50 mg/ kg/ day). Classification: This two­ generation reproduction study in the rat is Acceptable­ Guideline Chronic Toxicity Adequacy of data base for chronic toxicity: The data base for chronic toxicity is considered complete. No additional studies are required at this time. 870.4100a ( 870.4300) Chronic Toxicity Rat Refer to the Combined Chronic Feeding/ Carcinogenicity study below. 870.4100b Chronic Toxicity ­ Dog Executive Summary. In a six­ month toxicity study ( MRID # 40977601), asulam ( 98.0­ 100.6% a. i.) was administered to 6 beagle dogs/ sex/ dose by oral gavage at dose levels of 0, 60, 300, or 1,500 mg/ kg/ day. Doses were selected on the basis of the results of preliminary acute, subacute, and subchronic studies. There was no apparent relationship between test material administration and mortality. Treatment­ related findings included reductions in body weight gains and food consumption in the high­ dose males and females; increased frequency of emesis and diarrhea in the high­ dose males and females; increased absolute thyroid weights in the mid­ and high­ dose females and in the high­ dose males; increased relative ( to body weight) thyroid weights in the high­ dose males and females; decreased absolute testes and lung weights in the high­ dose males; decreased relative testes weights in the high­ dose males; and increased relative kidney weights in the high­ dose males. No histopathological effects of toxicological significance were observed. There were no apparent effects on prothrombin time, kaolin partial thromboplastin time or platelet counts in males. Platelet counts were slightly decreased in treated females; however, the decreases were not dose­ related at most intervals and control values appeared to be slightly elevated. Platelet count in the high­ dose females was significantly lower at the 26­ week interval only. Plasma and brain cholinesterase activities were not affected by treatment in either sex. The LOAEL is 300 mg/ kg/ day, based on significant ( p < 0.05) increases in absolute thyroid weights in females. Absolute and relative thyroid weights were elevated at the high­ dose ( 1500 mg/ kg/ day) in both males and females. The increased absolute thyroid weights in the mid­ and high­ dose females appeared dose related. Although histological effects in the 12 4.5 Asulam ( December, 2001) RED Toxicology Chapter thyroid were not observed in the dog study, the duration of the study was 6 months, which is less than recommended by guidelines ( i. e., 12 months). The NOAEL is 60 mg/ kg/ day. Classification: This chronic oral study in the dog is Acceptable­ Nonguideline. 4.6 Carcinogenicity Adequacy of data base for Carcinogenicity: The carcinogenicity data base for asulam is considered complete. There is one acceptable combined chronic toxicity/ oncogenicity dietary study in the rat, and one acceptable oncogenicity dietary study in the mouse. 870.4200a Carcinogenicity Study ­ rat Executive Summary. In a two­ year combined chronic feeding/ carcinogenicity study ( MRID# 00098543), CD rats ( 50/ sex/ dose) were administered asulam ( 97.5­ 99.9%) at dose levels of 0, 1,000 ( low­ dose), 5,000 ( mid­ dose) or 25,000 ppm ( high­ dose). These dietary levels were equivalent to 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females, respectively. An additional group ( 15/ sex/ dose) was administered asulam for 78 weeks. Bodyweight change in the high­ dose animals for various intervals was more than 10% lower than controls. Mean bodyweight change was significantly lower than controls in high­ dose females from week 0­ 52 and in the mid­ and high­ dose females from weeks 6­ 52. Mean bodyweight change was significantly lower in the high­ dose males ( p< 0.01) from weeks 6­ 52. Hyperplastic changes were observed in the adrenal medulla and in thyroid follicular cells of males at the mid­ and high­ dose levels. There was a statistically significant increase in thyroid gland C­ cell carcinomas in both the low­ and mid­ dose males. There was also a statistically­ significant increase in adrenal medullary pheochromocytomas at the high dose in males. With the exception of a non­ dose­ related enlargement of the pituitary gland in female rats ( 3/ 15 controls; 7/ 15 low­ dose; 8/ 15 mid­ dose; 7/ 15 high­ dose), no unusual toxicological findings occurred in the animals sacrificed at 78 weeks. The LOAEL is 5,000 ppm ( 180 mg/ kg/ day) based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. The NOAEL is 1,000 ppm ( 36 mg/ kg/ day). Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. Dosing is considered adequate to assess the oncogenic potential of asulam. Classification: This combined chronic toxicity/ carcinogenicity study in the rat is Acceptable­ Guideline. 870.4200b Carcinogenicity ( feeding) ­ Mouse 13 Asulam ( December, 2001) RED Toxicology Chapter Executive Summary. In a two­ year carcinogenicity study with Charles River CD­ 1 mice ( MRID# 42338201), asulam ( 88% a. i.) was administered in the diet at 0, 500, 5,000 or 50,000 ppm. Concentrations were corrected for 88% a. i. These dietary levels were equivalent to 0, 74, 730 and 8,040 mg/ kg/ day in males and 0, 95, 938 and 10,353 mg/ kg/ day in females, respectively. Mean body weights of the high­ dose males were generally less than 6% lower than control values during the first 24 weeks of treatment, while body weights of females were less than 6% lower than control values throughout the study. The high­ dose males displayed a reduction ( greater than 10%) in mean body weight gain when compared to the control group at various intervals. Increased mortality was observed in the high­ dose females; however, the number of high­ dose females was adequate to assess the carcinogenic potential of asulam. There was no treatment­ related effect on food consumption. Hematologic findings in the high­ dose males and females consisted of increased leukocyte counts, decreased erythrocyte counts, and decreased hematocrit levels. Organ weight changes included decreased brain weight in the high­ dose females, and increased spleen weight in the high­ dose males. There was an increased incidence of brown granular pigment deposits in the livers of males of all treatment groups and high­ dose females. Increased incidences of brown granular pigment deposits were also noted in the spleens of the high­ dose rats of both sexes. The brown granular pigment deposit was not identified, and is therefore of uncertain toxicological significance. There was no increase in the incidence of any tumors. The LOAEL is 50,000 ppm, based on increased spleen weight and decreased body weight gain in males, and decreased brain weight and survival in females. The NOAEL was 5,000 ppm. Under the conditions of this study, there was no evidence of carcinogenicity of asulam. Dosing is considered adequate to assess the carcinogenic potential of asulam based on decreased body weight gain, spleen and brain weight changes, and decreased survival. Classification: This carcinogenicity study in the mouse is Acceptable­ Guideline 4.7 Mutagenicity Adequacy of data base for Mutagenicity: With the exception of the dominant lethal mutation assay in mice, all other mutagenicity assays were found to be acceptable. These studies satistfy the pre­ 1991 guideline requirements for mutagenicity studies; no further testing is required at this time. The data indicate that there is no mutagenicity/ genetic toxicity concern. The following table summarizes the mutagenicity/ genetic toxicity data base. Study Results Bacterial mutagenicity ( Ames test) ­ Salmonella typhimurium. Litton Bionetics, Inc., Study No.: E­ 9177, 1983. MRID No.: 40415302 Not mutagenic with and without metabolic activation at doses up to 2000 Fg/ plate. Classification: Acceptable­ Guideline 14 Asulam ( December, 2001) RED Toxicology Chapter Study Results Dominant lethal ­ Mouse ­ Hess & Clark ( Div. of Rhodia), Study No.: SEH­ 75, 1975 MRID No.: 00082250 No evidence of induction of dominant lethal effect at dietary concentrations of 1500 or 5000 ppm. Classification: Unacceptable because purity information on the test material was not provided. In vitro cell transformation assay in C3H/ 10T1/ 2 cells. Mason Research Institute. Study No.: 596­ 249­ 8, October 1979. MRID No.: 00098542 No evidence of induction of morphological transformation at dose levels of 256, 512, 1024, or 2048 Fg/ mL for 18 hours exposure. Cytotoxicity was apparent at 2048 Fg/ mL. Classification: Acceptable ( Nonguideline). In vitro cytogenetics in human lymphocytes. Litton Bionetics, Inc. Study No.: 20990, March 1984. MRID No.: 40415301 Cabinet d Etudes et de Recherches en Tox. Study No.: 658, May 10, 1982. MRID No.: 00144051 No evidence of induction of a clastogenic response at doses of 125­ 2500 Fg/ mL ( absence of metabolic activation) or 250­ 2500 Fg/ mL. Classification: Acceptable. 4.8 Neurotoxicity Adequacy of data base for Neurotoxicity: There are no series 81­ 8, 82­ 7 or 83­ 6 acute, subchronic or developmental neurotoxicity studies available. The HIARC ( November 13, 2001) determined that these neurotoxicity studies are not required. 870.6100 Delayed Neurotoxicity Study ­ Hen Asulam is not an organophosphate insecticide and this type of study is not required. 870.6200 Acute Neurotoxicity Screening Battery As per the November 13, 2001 HIARC recommendations, this study is not required. 870.6200 Subchronic Neurotoxicity Screening Battery As per the November 13, 2001 HIARC recommendations, this study is not required. 870.6300 Developmental Neurotoxicity Study As per the November 13, 2001 HIARC recommendations, this study is not required. 4.9 Metabolism Adequacy of data base for metabolism: The data base for metabolism is considered to be complete. No additional studies are required at this time. The urinary route is the predominant route of elimination in the rat. 870.7485 Metabolism ­ Rat 15 Asulam ( December, 2001) RED Toxicology Chapter Executive Summary: Metabolism studies were conducted in male and female Sprague­ Dawley rats ( MRID 41345601). The tests used a single oral or i. v. dose, or repeated oral doses for 14 days. The pharmacokinetics of asulam were similar after all dose regimens in both sexes. Peak blood levels were attained at 0.5 hours. No unusual localization of asulam occurred in tissues and all tissue levels were low at 72 hours. Asulam was rapidly eliminated, mostly within 24 hours. Most of the administered dose ( 76.5% to 101.5%) was eliminated in the urine, and 1.4% to 25.3% of the dose in feces. The major excretory product was unchanged parent compound ( 70% to 80­%), with acetylasulam ( 3% to 8%) and acetylsulphanilamide (< 3%) being the two major metabolites. Overall Conclusion. The metabolism of asulam in rats is considered to be demonstrated and no additional data are required at this time. Classification. 4.10 Special/ Other Studies No special studies pertaining to asulam have been identified. 5.0 TOXICITY ENDPOINT SELECTION 5.1 See Section 9.2 for Endpoint Selection Table. 5.2 Dermal Absorption Dermal Absorption Factor: 100%. There are no dermal absorption studies with asulam. HIARC ( 11/ 13/ 01) concluded that a comparison of the developmental oral rabbit study to the dermal rabbit study is not appropriate. The dermal rabbit study did not include examination of the thyroid, the target organ. 870.7600 Dermal Absorption ­ Rat No dermal absorption studies with asulam are available. 5.3 Classification of Carcinogenic Potential 5.3.1 On November 12, 1987 the HED Carcinogenicity Peer Review Committee classified asulam as Group C, a possible human carcinogen, based on thyroid and adrenal tumors in the rat sutdy ( MRID 00098543). They also recommended that the mouse study be repeated and agreed to reconsider the cancer classification upon receipt and evaluation of the new mouse study. On September 22, 1994 the HED RfD peer Review committee met to review the new mouse study ( MRID 42338201). The committee concluded that the findings of the new mouse study have no impact on the current classification of the chemical as a Group C, possible human carcinogen, They determined that a low dose linear extrapolation risk model was not appropriate for asulam. 5.3.2 Classification of Carcinogenic Potential 16 Asulam ( December, 2001) RED Toxicology Chapter The Agency has classified asulam as Group C, possible human carcinogen. 5.3.3 Quantification of Carcinogenic Potential Not applicable. 6.0 FQPA CONSIDERATIONS 6.1 Special Sensitivity to Infants and Children The HIARC concluded that there is no quantitative/ qualitative evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure to asulam in the developmental toxicity studies in these species. However, there was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat. In this study, the decreased mean live births per litter ( offspring NOAEL = 50 mg/ kg/ day) was observed at lower dose levels than that associated with parental/ systemic toxicity ( NOAEL = 250 mg/ kg/ day). 6.2 Recommendation for a Developmental Neurotoxicity Study The HIARC concluded that a developmental neurotoxicity study was not needed. However, HIARC recommended the requirement for a comparative thyroid rat assay in adults and offspring. It was further recommended that the adult study should include interim measures ( e. g., 7, 14, and 28 days). HIARC also recommended that thyroid parameters selected for the comparative study should be based on Agency guidelines ( under current development) for thyroid toxicity testing. 7.0 OTHER ISSUES No other special issues have been identified. 17 Asulam ( December, 2001) RED Toxicology Chapter 8.0 REFERENCES in MRID order 00056414 Farr, M. J.; Heath, S. A. B.; Rivett, K. F.; et al. ( 1968) Herbicides: Asulam: Chronic Oral Toxicity in the Dog: PRG/ 180. ( Unpublished study received Jun 11, 1972 under 2G1200; prepared by May & Baker, Ltd., submitted by Rhodia, Inc., New Brunswick, N. J.; CDL: 091017­ Q). 00081183 Hastings, S. E.; Winbigler, J. C.; Page, J. G.; et al. ( 1978) Eighteen Month Carcinogenicity Study of Asulam Technical in Mice: Report No. SEH 77: 1. ( Unpublished study received Apr 12, 1979 under 359­ 662; submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 238026­ A; 238027; 238028). 00082250 Hastings, S. E.; Huffman, K. W. ( 1975) Dominant Lethal Study of Asulam in Mice: Report No. SEH 75: 94. ( Unpublished study re­ ceived Dec 17, 1975 under 6F1717; submitted by Rhodia, Inc., New Brunswick, N. J.; CDL: 098085­ E). 00083453 Hastings, S. E.; Huffman, K. W. ( 1975) Dominant Lethal Study of Asulam in Mice: Report No. SEH 75: 94. ( Unpublished study re­ ceived on unknown date under 6F1716; submitted by Rhodia, Inc., New Brunswick, N. J.; CDL: 097998­ J). 00098533 Brentnall, D. W. ( 1977) Asulam: Acute Inhalation Toxicity of the Dry Powder in Rats: RES. No. 2938. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., Eng­ land, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junc­ tion, N. J.; CDL: 070776­ C) 00098534 Ward, R. J. ( 1981) Asulam ( Technical Grade): Primary Eye Irrita­ tion Study in the Rabbit: Report Ref. R. Tox. 57. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 070776­ D) 00098535 Dale, E. A.; Grimmett, J. E. ( 1977) Asulam: Tests for Primary Skin Irritation in Rabbits and Skin Sensitization in Guinea Pigs: RES/ 2853. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 070776­ E) 00098536 Dale, E. A.; Ingham, B.; Woolf, N.; et al. ( 1979) Asulam: Six Month Oral Toxicity Study in Beagles: Report Ref. RES 3699. ( Unpub­ lished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical 18 Asulam ( December, 2001) RED Toxicology Chapter Co., Monmouth Junction, N. J.; CDL: 070776­ F) 00098537 Brentnall, D. W.; Farr, M. J.; Woolf, N. ( 1977) Asulam: 1 Month Inhalation Toxicity of the Dry Powder in Rats: RES/ 3014. ( Un­ published study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 070776­ G) 00098538 Copping, G. P. ( 1981) Asulam: Teratogenicity Study by the Oral Route in the Rat: Report Ref. R. Tox. 11. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Mon­ mouth Junction, N. J.; CDL: 070776­ H) 00098539 Copping, G. P. ( 1981) Asulam: Teratogenicity Study by the Oral Route in the Rabbit: Report Ref. R. Tox. 37. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Mon­ mouth Junction, N. J.; CDL: 070776­ I) 00098540 Brentnall, D. W.; Woolf, N. ( 1981) Asulam: Two Generation Repro­ duction Study in the Rat: Report Ref. R. Tox. 34. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by May & Baker, Ltd., England, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 070776­ J) 00098541 McGregor, D. B.; Crichton, C. ( 1977) Mutagenicity Testing of Asulam, M & B 9057: Report No. 807. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by Inveresk Research International, Scotland, submitted by Rhone­ Poulenc Chemical Co., Monmouth Junction, N. J.; CDL: 070776­ K). 00098543 Hunter, B.; Barnard, A. V.; Street, A. E.; et al. ( 1981) Asulam: Tox­ icity and Tumorigenicity in Prolonged Dietary Administration to Rats: HRC Report No. M & B 95/ 80554. Final rept. ( Unpublished study received Apr 16, 1982 under 359­ 662; prepared by Hunting­ don Research Centre, England, submitted by Rhone­ Poulenc Chem­ ical Co., Monmouth Junction, N. J.; CDL: 070777­ A). 00108811 Rhone­ Poulenc Chemical Company ( 1981?) Animal: Metabolism Studies with Asulam|. ( Unpublished study received Apr 16, 1982 under 359­ 662; CDL: 070778­ C). 40415301 Galloway, S.; Myhr, B. ( 1984) Asulum: Mutagenicity Evaluation of Asulum Technical ( Dried) in an in vitro Cytogenetic Assay Meas­ uring Chromosome Aberration Frequencies in Human Lymphocytes: LBI Proj. No. 20990. Unpublished study prepared by Litton Bio­ netics, Inc. 24 p. 19 Asulam ( December, 2001) RED Toxicology Chapter 40415302 Hoorn, A. ( 1983) Asulum: Mutagenicity Evaluation of Asulam Techni­ cal in the Ames Salmonella/ Microsome Plate Test Preincubation Method: Genetics Assay No. E­ 9177. Unpublished study prepared by Litton Bionetics, Inc. 22 p. 40960501 Myers, R.; Christopher, S. ( 1988) Asulam Sodium Salt: Acute Peroral ( Rat) and Percutaneous ( Rabbit) Toxicity Studies: Laboratory Project ID 51­ 620. Unpublished study prepared by Union Carbide Bushy Run Research Center. 16 p. 40960502 Nachreiner, D.; Klonne, D. ( 1988) Asulam ( Sodium Salt): Acute Dust Aerosol Inhalation Toxicity Test in Rats: Laboratory Project ID 51­ 583. Unpublished study prepared by Union Carbide Bushy Run Research Center. 28 p. 40977601 Dale, E.; Ingham, B.; Woolf, N.; et al ( 1980) Asulum: Six Month Oral Toxicity Study in Beagles: Supplemental Raw Data: Proj. ID RES/ 3699. Unpublished study prepared by Rhone­ Poulenc Ag Co. 207 p. 41361601 Nachreiner, D.; Klonne, D. ( 1988) Asulam ( Sodium Salt): Acute Dust Aerosol Inhalation Toxicity Test in Rats: Lab Project Number: 51­ 583. Unpublished study prepared by Bushy Run Research Cent­ er. 28 p. 42110001 Cummins, H. ( 1987) FR 1398/ 1: Acute Oral Toxicity Study in the Rat: Lab Project Number: 87/ MBL071/ 011. Unpublished study prepared by Life Science Research Ltd. 20 p. 42110002 Blair, M. ( 1989) Eight­ Week Range­ Finding Dietary Toxicity Study in Mice: Lab Project Number: 347­ 033. Unpublished study prepared by International Research and Development Corp. 182 p. 42338201 Blair, M. ( 1992) Two Year Dietary Oncogenicity Study in Mice: Asulam Sodium Salt: Lab Project Number: 347­ 036. Unpublished study prepared by International Research and Development Corp. 2959 p. 43185701 Godward, P. ( 1980) Asulam Content of Fortified Rat Diets Used in a Reproduction Study: Lab Project Number: AR/ 1715. Unpublished study prepared by May & Baker Ltd. 28 p. 20 Asulam ( December, 2001) RED Toxicology Chapter 43185702 Copping, G. ( 1981) Mating Records and Randomization Procedures for the Asulam: Teratogenicity Study by the Oral Route in the Rat ( MRID 00098538): Supplement: Lab Project Number: R/ TOX/ 11: 39361. Unpublished study prepared by May & Baker Ltd. 8 p. 44052001 Brentnall, D.; Woolf, N. ( 1981) Asulam: Two Generation Reproduction Study in the Rat: Replacement of MRID 98540: Lab Project Number: R. TOX. 34. Unpublished study prepared by May & Baker, Ltd. and Middlesex Hospital Medical School. 206 p. 21 Asulam ( December, 2001) RED Toxicology Chapter 22 Asulam ( December, 2001) RED Toxicology Chapter 9.0APPENDICES Tables for Use in Risk Assessment 23 Asulam ( December, 2001) RED Toxicology Chapter 9.1 Toxicity Profile Summary Tables 9.1.1 Acute Toxicity Table ­ See Section 4.1 9.1.2 Subchronic, Chronic and Other Toxicity Tables Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3100 90­ Day oral toxicity in rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study. 870.3150 90­ Day oral toxicity in nonrodents 00056414 ( 1968)/ Unacceptable/ Guideline/ 0, 5, 50 or 500 mg/ kg/ day. LOAEL = 500 mg/ kg/ day, based on increased absolute and relative thyroid weights in male and female dogs. NOAEL = 50 g/ kg/ day 870.3200 21­ Day dermal toxicity in rabbits 41076901 ( 1989) Acceptable/ Guideline/ 0 or 1000 mg/ kg/ day. NOAEL = 1000 g/ kg/ day 870.3250 90­ Day dermal toxicity No study. No study. 870.3465 90­ Day inhalation toxicity No study. No study 870.3700a Prenatal developmental in rodents 00098538/( 1981)/ Accept ­ able/ guideline/ 0, 500, 1,000, or 1,500 mg/ kg/ day Maternal l LOAEL = 1,500 mg/ kg/ day based on body weight gain decrement. aternal Maternal NOAEL = 1,000 mg/ kg/ day. Developmental LOAEL = 1,500 mg/ kg/ day based on slight to moderate increase in preimplantation loss. Developmental NOAEL = 1,000 mg/ kg/ day. 870.3700b Prenatal developmental in rabbits 00098539/ 1981/ Acceptable/ Guideline/ 0, 60, 300, or 750 mg/ kg/ day Maternal LOAEL = 750 mg/ kg/ day based on decreased body weight during the dosing period. Maternal NOAEL = 300 mg/ kg/ day. Developmental NOAEL = 750 mg/ kg/ day. m m The m 24 Asulam ( December, 2001) RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.3800 Reproduction and fertility effects 00098540/ 1981/ Acceptable/ 0, 50, 250 or 1250 mg/ kg/ day. Parental/ Systemic LOAEL = 1250 g/ kg/ day ( HDT) based on decreased body weights ( F0 males, F1 females) and organ weight effects ( increased absolute and relative thyroid weights in F1 males and F2 males and females, increased absolute and relative liver weights in F1 females, and increased ovarian weights in F1 females at 31 days old but not at terminal necropsy). Parental/ Systemic NOAEL = 250 mg/ kg/ day. Reproductive/ Offspring LOAEL = 250 mg/ kg/ day based on decreased mean live births per litter. Reproductive/ Offspring NOAEL = 50 mg/ kg/ day. 870.4100a Chronic toxicity rodents See combined chronic feeding and carcinogenicity study. See combined chronic feeding and carcinogenicity study. 870.4100b Chronic toxicity dogs 00098536/ 1979/ Acceptable/ Nonguideline / 0, 60, 300, or 1,500 mg/ kg/ day. LOAEL = g/ kg/ day, based on significant ( p < 0.05) increases in absolute thyroid weights in females. roid weights were elevated at the high­ dose ( 1500 mg/ kg/ day) in both males and females. roid weights in the mid­ and high­ dose females appeared dose related. NOAEL = 60 mg/ kg/ day. 870.4200 Combined Chronic Feeding and Carcinogenicity rats 00098543/ 1981/ Acceptab le­ Guideline/ 0, 36, 180 and 953 mg/ kg/ day in males and 0, 47, 243 and 1,280 mg/ kg/ day in females. LOAEL = 180 mg/ kg/ day, based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. NOAEL = 36 mg/ kg/ day. Under the conditions of this study, there was evidence of an increase in tumor incidence in males when compared to controls. Therefore, asulam is a potential oncogen in this study. 870.4300 Carcinogenicity mice 42338201/ 1982/ Acceptable/ Guideline/ 0, 74, 730 and 8,040 mg/ kg/ day in males and 0, 95, 938 and 10,353 mg/ kg/ day in females LOAEL = 8,040 mg/ kg/ day in males, and 10,353 mg/ kg/ day in females, based on increased spleen weight and decreased body weight gain in males, and decreased brain weight and survival in females. NOAEL = 730 mg/ kg/ day in males and 938 mg/ kg/ day in females. Under the conditions of this study, there was no evidence of carcinogenicity of asulam. m 300 m Absolute and relative thy The increased absolute thy 25 Asulam ( December, 2001) RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.4300 Carcinogenicity mice 00081183/ 1978/ Unacceptable/ Guideline/ 0, 225, and 750 mg/ kg/ day. LOAEL = 225 mg/ kg/ day, based on enlargement of the spleen in females, decreased absolute and relative thyroid weights in females, intestinal calcification in males and females, and a dose­ related increase in the incidence of mild skin/ subcutis hyperkeratosis in males. NOAEL was not achieved. Under the conditions of this study, there was no definitive evidence of carcinogenicity of asulam. One­ Month Inhalation study in the rat 00098537/ 1977/ Accept­ able Nonguideline/ nose­ only exposure at concentrations of 0, 1.6, 3.9, or 15.3 mg/ L for 4 hours per day, 5 days per week, for 4 weeks. NOAEL = 15.3 mg/ L ( HDT). Oral Range­ Finding in mice 42110002/ 1989/ Accept­ able Nonguideline/ 0, 512, 1,673, 5,103, and 9,022 mg/ kg/ day for males, and 0, 675, 2,263, 6,835, and 10,828 mg/ kg/ day for females LOAEL = 9,022 mg/ kg/ day based on decreased body weight and body weight gain in males. NOAEL is 5,103 mg/ kg/ day. Gene Mutation 870. A table presenting the mutagenicity data base is already included under section 4.7. 870.6200a Acute neurotoxicity screening battery No study. No study 870.6200b Subchronic neurotoxicity screening battery No study. No study. 870.6300 Developmental neurotoxicity Not required. 26 Asulam ( December, 2001) RED Toxicology Chapter Guideline No./ Study Type MRID No. ( year)/ Classification / Doses Results 870.7485 Metabolism and pharmaco­ kinetics 41345601 ( 1989) Metabolism studies in the rat demonstrate that asulam was rapidly eliminated, primarily in the urine, following administration of a single oral or intravenous dose, or after repeated intravenous doses for 14 days. No unusual localization of asulam occurred in tissues. Unchanged parent compound was identified as the major excretory product, with acetylasulam and acetylsulphanilamide as minor metabolites. 870.7600 Dermal absorpt­ ion No Study. No Study. 27 9.2 Summary of Toxicological Dose and Endpoints for Asulam for Use in Human Risk Assessment1 Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary No appropriate study for a single dose risk assessment. Chronic Dietary all populations NOAEL= 36 mg/ kg/ day UF = 100 Chronic RfD = 0.36 mg/ kg/ day FQPA SF = cPAD = chr RfD FQPA SF = mg/ kg/ day Combined Chronic Toxicity/ Oncogenicity study ( MRID No.: 00098543). LOAEL = 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in the thyroid follicular cells of males. Short­ Term Oral ( 1­ 30 days) ( Residential) A toxicity endpoint was not selected because there are no residential uses. Intermediate­ Term Oral ( 30 days to six months) ( Residential) A toxicity endpoint was not selected because there are no residential uses. Short­ Term Dermal ( 1­ 30 days) ( Occupational) Oral study NOAEL= 50 mg/ kg/ day LOC for MOE = 100 ( Occupational) Two­ Generation Reproduction Study ( MRID No.: 00098540). LOAEL = 250 mg/ kg/ day based on significant decreases in mean live births per litter. Intermediate­ Term Dermal ( 30 days to six months) ( Occupational) Oral study NOAEL= 50 mg/ kg/ day LOC for MOE = 100 ( Occupational) Two­ Generation Reproduction Study ( MRID No.: 00098540). LOAEL = 250 mg/ kg/ day based on significant decreases in mean live births per litter. Long­ Term Dermal ( several months ­ lifetime) ( Occupational) NOAEL= 36 mg/ kg/ day LOC for MOE = 100 ( Occupational) Combined Chronic Toxicity/ Oncogenicity study ( MRID No.: 00098543). LOAEL = 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in the thyroid follicular cells of males. Asulam ( December, 2001) RED Toxicology Chapter 28 Asulam ( December, 2001) RED Toxicology Chapter Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Short­ Term Inhalation ( 1­ 30 days) ( Occupational) Oral study NOAEL= 50 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational) Two­ Generation Reproduction Study ( MRID No.: 00098540). LOAEL = 250 mg/ kg/ day based on significant decreases in mean live births per litter. Intermediate­ Term Inhalation ( 30 days to six months) ( Occupational) Oral study NOAEL= 50 mg/ kg/ day LOC for MOE = 100 ( Occupational) Two­ Generation Reproduction Study ( MRID No.: 00098540). LOAEL = 250 mg/ kg/ day based on significant decreases in mean live births per litter. Long­ Term Inhalation ( several months ­ lifetime) ( Occupational) NOAEL= 36 mg/ kg/ day LOC for MOE = 100 ( Occupational) Combined Chronic Toxicity/ Oncogenicity study ( MRID No.: 00098543). LOAEL = 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in the thyroid follicular cells of males. Cancer Classified as a Group C carcinogen ( possible human carcinogen). No quantification of carcinogenic risk. Not Applicable Not Applicable 1 UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose ( a = acute, c = chronic) RfD = reference dose, LOC = level of concern, MOE = margin of exposure 29

epa

2024-06-07T20:31:45.413847

regulations

EPA-HQ-OPP-2002-0329-0006

Supporting & Related Material

MEMORANDUM Subject: Asulam ( List A, Case 0265, Chemical 106901/ 02). Tolerance Reassessment Eligibility Decision Document. Product and Residue Chemistry Chapter. DP Barcode D278884. From: José J. Morales, Chemist Reregistration Branch III Health Effects Division ( 7509C) Through: Catherine Eiden, Branch Senior Scientist Reregistration Branch III Health Effects Division ( 7509C) To: Demson Fuller, Chemical Review Manager Reregistration Branch I Special Review and Reregistration Division ( 7508W) SRRD has requested that HED conduct a Tolerance Reassessment Eligibility Decision Document for asulam. The Asulam Reregistration Standard Guidance Document was issued 12/ 87 and was based on the Asulam Reregistration Standard Science Chapter dated 8/ 28/ 87. The Asulam Product and Residue Reregistration Standard Update was completed 1/ 15/ 91. The Product Chemistry Chapter and the Residue Chemistry Chapter for the Asulam Reregistration Eligibility Document ( RED) were completed on 04/ 16/ 94 ( DP Barcodes D193175 and D198030; CBRS Nos. 12299 and 13041). A revision to the chronic anticipated residues ( Table C) was subsequently made ( S. Funk, DP Barcode D208551, CBRS No. 14623, 12/ 06/ 94). The Metabolism Committee met on 12/ 13/ 94 and decided that the metabolite quinone/ hydroquinone need not be considered further in risk assessments ( S. Funk, 01/ 18/ 95 Memorandum of Committee Meeting). The Residue Chemistry Chapter was revised ( 1/ 24/ 95, D198030, S. Funk) to incorporate the deletion of quinone/ hydroquinone from the residue of concern, the revised anticipated residues, and the review of a registrant submission on storage stability received after the original Chapter date ( 04/ 94). A tolerance is established for negligible residues of asulam per se in/ on sugarcane at 0.1 ppm [ 40 CFR § 180.360]. HED has recommended that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. An adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety in/ on sugarcane. Conclusion All residue chemistry deficiencies noted in the 1/ 24/ 95 Residue Chemistry Chapter of the Asulam RED have been adequately addressed. Sufficient data are now available to reassess all tolerances associated with asulam use listed in 40 CFR § 180.360. Some product chemistry deficiencies remain outstanding, but they do not impact the tolerance reassessment decision. Background Asulam ( methyl­ 4­ sulfanilylcarbamate) is a postemergent systemic carbamate herbicide marketed under the trade name ASULOX ® Herbicide by Aventis CropScience. ASULOX ® contains the sodium salt of asulam and is registered for use on sugarcane as a 3.34 lb/ gal soluble concentrate/ liquid ( SC/ L) formulation. This formulation may be applied postemergence as a band or broadcast application using ground or aerial equipment or as a spot treatment. Apart from ITS food use on sugarcane, asulam is used on christmas tree plantations, ornamentals, turf ( sod farms only) and non­ cropland uses. Asulam is primarily used in agriculture with key markets in Florida and Louisiana. Sugarcane is the major use site for asulam ( 95% of the market). The asulam use rate, for sugarcane, ranges from 2.5 to 3.34 lbs a. i./ A and can applied up to two times per year. For all other uses, it can be applied only once. The average rate of 2.5 lbs ai/ acre is the typical labeled use rate for Sugarcane. Apart from its use on sugarcane, asulam is used on Christmas tree plantations, ornamentals, turf ( Sod Farms Only) and non­ cropland uses ( boundary fences, fencerows, hedgerows, lumberyards, storage areas and industrial plant sites, and warehouse lots). For Christmas trees and ornamentals, the label use rate is 3.34 lbs a. i./ A and can be applied once per year as a postemergent treatment. For turf, the label use rate is about 2 lbs. a. i./ A and can be applied once per year. For non­ cropland uses, the label use rate ranges between 2.9 lbs a. i./ A to 3.34 lbs a. i./ A and can be applied once per year. Detailed Considerations The following deficiencies were noted in the 1/ 24/ 95 HED Residue Chemistry Chapter: GLN 860.1200: Directions for Use The registrant must submit label amendment requests for the use of asulam on sugarcane. The amendments must include lower maximum application rates and/ or longer PHIs, must be region specific, and must be supported by new field trials. 2 GLN 860.1300: Nature of the Residue ­ Plants The HED Metabolism Committee has determined that the presence or absence of radiolabeled quinone and/ or hydroquinone must be determined by a new sugarcane metabolism study. It was also concluded that determination of asulam, free and conjugated, sulfanilamide, N4 ­ acetylasulam, and N4 ­ acetylsulfanilamide as a common moiety is acceptable. GLN 860.1500: Crop Field Trials New field trials are required for sugarcane using modified PHIs and application rates; current data show an overtolerance situation for the combined residue of asulam and its sulfanilamide­ containing metabolites. GLN 860.1850: Confined Accumulation in Rotational Crops A confined rotational crop study is required. A preliminary report was submitted ( MRID 41857701), but contained no details on the isolation and characterization/ identification of the radiolabeled residues. A plantback interval of at least 6 months is required. These deficiencies have been addressed in the following reviews: The HED Metabolism Committee Meeting Held on December 13, 1994: Quinone/ Hydroquinone Metabolite of Asulam ( S. Funk, 1/ 24/ 95, DP Barcode none). Asulam ( List A, Case 0265, Chemical 106901/ 02). Sugarcane Field Trials ( S. Funk, DP Barcode D219787, 2/ 23/ 96). Asulam ( List A, Case 0265, Chemical 106901/ 02). RPAC Response to the Reregistration Eligibility Decision Document. MRID 43902500 ( Product Chemistry). MRID 43902501 ( Confined Rotational Crop). S. Funk, DP Barcode D223175, 5/ 14/ 96. The following deficiencies remain outstanding: 1. The registrant proposes a tolerance for asulam residue in/ on cane of 0.5 ppm, resulting from 2 applications, each 3.34 lbs. a. i./ Acre, with a 100 day PHI. The data do not support this tolerance. For the proposed use pattern, the maximum residue, corrected for loss in storage, is 0.71 ppm. A tolerance of 1.0 ppm is appropriate for residues of asulam and the sulfanilamide­ containing metabolites in/ on sugarcane. This replaces the original tolerance of 0.1 ppm or the reevaluated tolerance of 15 ppm from the Reregistration Eligibility Decision Document ( S. Funk, 1/ 24/ 95, D198030). 2. HED recommends that the registrant request label amendments specifying a maximum of two asulam applications per year to sugarcane at a maximum single application rate of 3 3.34 lbs. a. i./ A, a PHI of 100 days for Louisiana, a PHI of 140 days for the remainder of the US mainland, and a PHI of 400 days for Hawaii. If the registrant requests the suggested label changes, no further sugarcane field trial data are required for asulam at this time. No plantback restrictions are required on the label. 3. Based on the highest average field trial residue and the concentration factor from processing, a tolerance of 30 ppm is needed for asulam and sulfanilamide­ containing metabolite residues in molasses. 4. The decrease in the sugarcane tolerance for asulam and its sulfanilamide containing metabolites from the reevaluated 15 ppm to 1 ppm does not alter the previous conclusion that residues of asulam and the sulfanilamide­ containing metabolites are anticipated in ruminant commodities from a diet containing 10% molasses. Animal commodity tolerances should be proposed, 0.05 ppm for ruminant milk and meat and fat and 0.2 ppm for ruminant meat byproducts. There are no significant poultry feed items; poultry commodity tolerances are not needed. 5. Due to the small incremental upper bound risk from hydroquinone/ quinone on sugarcane from the use of asulam when compared to natural background levels of quinone/ hydroquinone on other commodities, no further risk assessment will be required for the asulam metabolite hydroquinone/ quinone. 6. Because hydroquinone/ quinone remains a chemical of toxicological concern, if the registrant proposes new uses for this chemical, new plant metabolism studies must be performed ( relevant to the proposed new uses), aimed specifically at determining the presence and concentration of radiolabeled hydroquinone/ quinone. The registrant should also determine the naturally occurring background levels of hydroquinone/ quinone and arbutin in sugarcane. The Metabolism Committee will reconsider its position if new metabolism studies show that quinone/ hydroquinone/ arbutin comprises a significant portion of the radiolabeled residue. 7. The following product chemistry data guidelines remain unfulfilled for the technical asulam sodium salt: GLN 830.6317 ( Storage Stability) and 830.6320 ( Corrosion Characteristics). The tolerance reassessment is shown in Table 1. 4 Commodity Table 1. Tolerance Reassessment Summary Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment Tolerance listed under 40 CFR § 180.360 Sugarcane 0.1 1.0 Tolerances to be Established Under 40 CFR § 180.360 Molasses 30 Milk 0.05 Meat and Fat of Cattle, Goat, Hogs, Horses, Sheep 0.05 Meat byproducts of Cattle, Goat, Hogs, Horses, Sheep 0.2 Attachments: Asulam ( List A, Case 0265, Chemical 106901/ 02). Update to Residue Chemistry Chapter for the Reregistration Eligibility Decision Document ( S. Funk, 1/ 24/ 95, DP Barcode D198030). The HED Metabolism Committee Meeting Held on December 13, 1994: Quinone/ Hydroquinone Metabolite of Asulam ( S. Funk, 1/ 24/ 95, DP Barcode none). Asulam ( List A, Case 0265, Chemical 106901/ 02). Sugarcane Field Trials ( S. Funk, DP Barcode D219787, 2/ 23/ 96). Asulam ( List A, Case 0265, Chemical 106901/ 02). RPAC Response to the Reregistration Eligibility Decision Document. MRID 43902500 ( Product Chemistry). MRID 43902501 ( Confined Rotational Crop). S. Funk, DP Barcode D223175, 5/ 14/ 96. 5

epa

2024-06-07T20:31:45.421758

regulations

EPA-HQ-OPP-2002-0329-0007

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: December 18, 2001 SUBJECT: Asulam. Chronic Dietary Exposure Assessment for the Tolerance Reassessment Eligibility Decision Document ( TRED); PC codes 106901; DP Barcode D279592. FROM: José J. Morales, Chemist Reregistration Branch III Health Effects Division ( 7509C) THROUGH: Catherine Eiden, Branch Senior Scientist Reregistration Branch III Health Effects Division ( 7509C) and Chemistry Science Advisory Council ( Chem SAC) Health Effects Division ( 7509C) and Jennifer Tyler Sherrie Kinard Dietary Exposure Science Advisory Council ( DESAC) Health Effects Division ( 7509C) TO: Demson Fuller, Chemical Review Manager Reregistration Branch I Special Review and Reregistration Division ( 7508C) [ D279592] ~ DRAFT ~ [ Asulam / 106901] 1 EPA Reviewer: , Date STUDY TYPE: Asulam. Chronic Dietary Exposure Assessment for the Tolerance Reassessment Eligibility Decision Document ( TRED). ACTIVE INGREDIENT: Sodium Asulam SYNONYMS: Asulox ® RESIDUE OF CONCERN: The qualitative nature of the residue in plants is adequately understood based on sugarcane metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4­ acetylasulam, and N4­ acetylsulfanilamide determined as a common moiety. The qualitative nature of the residue in animals is adequately understood based on acceptable poultry and ruminant metabolism studies. The terminal residues of concern are free and conjugated asulam, sulfanilamide, N4­ acetylasulam, and N4­ acetylsulfanilamide determined as a common moiety. Executive Summary A chronic dietary exposure assessment was requested to determine the dietary exposure estimates associated with the use of asulam in/ on sugarcane to support the Tolerance Reassessment Eligibility Document. Sugarcane is the only registered use for this chemical. Anticipated residues were calculated using field trial data. No monitoring data exist for asulam. In addition, estimates of percent crop treated (% CT) generated by BEAD were used to refine the assessment. Risk estimates were generated for chronic ( longer­ term) dietary exposure using the most recent version of the Dietary Exposure Evaluation Model ( DEEM , Version 7.73), and toxicological doses and endpoints selected by the HED Hazard Identification Assessment Review Committee [ D279592] ~ DRAFT ~ [ Asulam / 106901] 2 ( HIARC) for asulam risk assessments. The committee did not select an acute dietary endpoint for asulam. A refined Tier 2/ 3 chronic dietary risk assessment was conducted for all supported ( i. e., currently registered and proposed) asulam food uses. Dietary risk estimates are provided for the general U. S. population and various population subgroups. This assessment concludes that for all commodities, the chronic risk estimates are below the Agency's level of concern (< 100% cPAD1) for the general U. S. population (< 1% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for children 1­ 6 years [ highest exposed population subgroup] is 1% of the cPAD. I. Introduction Exposure to pesticides can occur through food, water, residential and occupational means. Risk assessment incorporates both exposure and toxicity of a given pesticide. The risk is expressed as a percentage of a dose that could be expressed as a daily or a long term dose, to pose no unreasonable adverse effects. This is called the population adjusted dose ( PAD), and is expressed as % PAD. References are available on the EPA/ pesticides web site which discuss the acute and chronic risk assessments in more detail: " Available Information on Assessing Exposure from Pesticides, A User's Guide", 6/ 21/ 2000, web link: http:// www. epa. gov/ fedrgstr/ EPA­ PEST/ 2000/ July/ Day­ 12/ 6061. pdf ; or see SOP 99.6, 8/ 20/ 99. The purpose of this memorandum is to summarize the results of the dietary risk assessment for the general U. S. population and various population subgroups resulting from exposure to asulam through food. This risk assessment is the first dietary risk analysis that has been conducted for asulam under FQPA. A previous chronic dietary risk assessment was done by the former Science Analysis Branch in HED using DRES ( E. Doyle, 1/ 3/ 95, no DP Barcode). II. Toxicological Information In a previous meeting ( March 19, 1998), the Health Effects Division's Hazard Identification Assessment Review Committee ( HIARC) met to evaluate the toxicology data base for asulam and to select doses and endpoints for the human health risk assessment. The HIARC met again on November 13, 2001 for a revisit of asulam for toxicological endpoint selection for use in occupational/ residential exposure risk assessments. In addition, the potential for increased susceptibility of infants and children from exposure to asulam was re­ evaluated. The FQPA Safety Factor Committee met on 12/ 10/ 01 to evaluate both the hazard and exposure databases and recommended that the 10x FQPA Safety Factor for asulam be retained. A summary of the doses and endpoints relevant to dietary exposure assessment are presented in Table [ D279592] ~ DRAFT ~ [ Asulam / 106901] 3 I. Table I. Summary of Toxicological Dose and Endpoints for Asulam for Use in Dietary Exposure Assessment Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary An appropriate endpoint attributable to a single dose was not identified. Chronic Dietary all populations NOAEL= [ 36 ] mg/ kg/ day UF = [ 100 ] Chronic RfD = [ 0.36 ] mg/ kg/ day FQPA SF = [ 10x ] cPAD = chronic RfD / FQPA SF = [ 0.036 ] mg/ kg/ day Combined Chronic Toxicity/ Oncogenicity in the rat. The LOAEL was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Cancer The Carcinogenicity Peer Review Committee classified asulam as a " Group C," possible human carcinogen. III. Residue Information Asulam Use: A tolerance is established for negligible residues of asulam per se in/ on sugarcane at 0.1 ppm [ 40 CFR § 180.360]. HED has recommended that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. An adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety in/ on sugarcane. HED's recommendations as to tolerance reassessment are summarized below: Tolerance Reassessment for Asulam 1. The existing tolerance of 0.1 ppm for asulam residues on sugar cane established in 40 CFR § 180.360 has been reassessed. HED recommends the tolerance be raised to 1.0 ppm; [ D279592] ~ DRAFT ~ [ Asulam / 106901] 4 2. HED recommends a tolerance of 30 ppm for asulam residues in molasses from sugar cane be established in 40 CFR § 180.360; 3. HED recommends a tolerance of 0.05 ppm for asulam residues in milk, and meat and fat from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360; 4. HED recommends a tolerance of 0.2 ppm for asulam residues in meat byproducts from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360; 5. Because there are no poultry feed items associated with asulam's use, tolerances on poultry tissues and eggs are not warranted. Chronic Assessment: There are no available monitoring data for asulam. Residue data were reviewed in the following document: " Asulam ( List A, Case 0265, Chemical 106901/ 02). Sugarcane Field Trials. CBRS No. 16299. DP Barcode D219787. S. Funk. 2/ 22/ 96." The highest residue found for a use pattern of 2 X 3.34 lbs. a. i./ A and a 100 day PHI is 0.213 ppm. Correction for loss in storage gives a residue value of 0.71 ppm. Thus, an appropriate tolerance for the combined residue of asulam and sulfanilamide­ containing metabolites in/ on sugarcane is 1 ppm. Asulam residues concentrate in blackstrap molasses by a factor of about 48X ( S. Funk, CBRS None, DP Barcode None, 01/ 21/ 95). Molasses is considered to be ready­ to­ eat as an animal feed item. Therefore, a tolerance of 30 ppm ( 48 X 0.167 HAFT ppm / 0.30) would be appropriate for asulam residues in molasses [ the highest average field trial residue ( 2 X 3.34 lbs. a. i./ A, 100 day PHI) is 0.167 ppm, and this value is corrected for 70% loss in storage]. Table II ( 09/ 95) lists " molasses" as a processed commodity, and " molasses" encompasses both blackstrap and human food molasses. Most molasses mixtures are prepared from A­ strike sugar and would be expected to contain pesticide residue equal or less in concentration than those of refined sugar. Because Table II does not distinguish animal feed blackstrap from human molasses, the chronic residue value calculated for blackstrap should be used in dietary exposure analysis for human molasses. Sugarcane and sugarcane molasses are considered blended commodities ( HED SOP 99.6, [ D279592] ~ DRAFT ~ [ Asulam / 106901] 5 8/ 20/ 99). The anticipated residues for chronic dietary risk assessment are presented in Table II. Table II. Asulam Anticipated Residues for Chronic Dietary Risk Assessment Commodity Asulam and Sulfanilamide­ Containing Metabolites Existing Tolerance ( ppm) Revised Tolerance ( ppm) Chronic Anticipated Residue ( ppm) Sugar3 0.1 1 0.51 Molasses None 30 242,4 1 The average of the average residues for mainland trials, corrected for 70% loss, or 0.126 / 0.30 = 0.42. Percent crop treated ( 42%) was not incorporated in the calculations. 2 The chronic anticipated residue for sugar ( 0.5 ppm) multiplied by the concentration factor for processing from cane to blackstrap, 48, or 48 X 0.5 = 24, and rounded to two significant figures. Percent crop treated ( 42%) was not incorporated in the calculations. 3 No significant concentration ( 1 ­ 1.3X) occurred in processing cane into refined sugar. 4 The highest average field trial result ( HAFT) multiplied by the 48X concentration factor for the conversion of cane to blackstrap molasses. Blackstrap molasses, defined as the final strike residue or C molasses from conventional sugarcane processing, is not a significant human food item. However, these values should be used for human molasses, prepared from A­ strike sugar. Animal Commodity Tolerances The reassessed tolerance of 1 ppm for asulam in sugarcane yields a maximum ruminant diet of 4 ppm asulam, resulting from ingestion of molasses ( 10% diet, tolerance 30 ppm, 75% dry matter). Based on the 5 ppm feeding study level ( See Table III below) and the results of the animal metabolism study, the anticipated residues in animal commodities are summarized, as follows in Table IV: [ D279592] ~ DRAFT ~ [ Asulam / 106901] 6 Table III. Asulam Residues from Feeding Study Commodity Asulam and Sulfanilamide­ Containing Metabolites 5 ppm Diet ( 1.2X) 50 ppm Diet ( 12X) 20 ppm Radiolabeled2 ( 7 days) Milk1 < 0.025 0.11 0.021 Fat < 0.05 < 0.05 < 0.005 Kidney 0.12 0.34 0.162 Liver < 0.05 0.08 0.090 Muscle < 0.05 < 0.05 < 0.005 1 The residue plateaued in milk on day 13. 2 TRR, including all radiolabeled residue. Table IV. Asulam Anticipated Residues for Animal Commodities Commodity Asulam and Sulfanilamide­ Containing Metabolites Initial Tolerance ( ppm) Reassesse d Tolerance ( ppm) Anticipated Residue1 ( ppm) Milk None 0.05 0.025 Cattle, meat None 0.05 0.05 Cattle, mbyp None 0.2 0.12 Cattle, fat None 0.05 0.05 Goats, meat None 0.05 0.05 Goats, mbyp None 0.2 0.12 Goats, fat None 0.05 0.05 Hogs, meat None 0.05 0.05 Hogs, mbyp None 0.2 0.12 Hogs, fat None 0.05 0.05 Horses, meat None 0.05 0.05 Horses, mbyp None 0.2 0.12 [ D279592] ~ DRAFT ~ [ Asulam / 106901] 7 Horses, fat None 0.05 0.05 Sheep, meat None 0.05 0.05 Sheep, mbyp None 0.2 0.12 Sheep, fat None 0.05 0.05 1 Anticipated residue for determination of human dietary risk. Percent crop treated ( 42%) was not incorporated in the calculations. Percent Crop Treated Information: Based on pesticide usage information mainly for 1992 through 2000 for agriculture and 1994 through 1999 for non­ agriculture, total annual domestic usage of sodium asulam is approximately 1.3 million pounds active ingredient ( a. i.) allocated by site mainly to sugarcane ( 95%), lawn care operators and sod farms ( 2% each) and institutional turf ( 1%). The average percent crop treated for sugarcane, the only registered agricultural crop, is about 42%. States of most usage are Florida, Louisiana and Texas ( A. Halvorson, 7/ 25/ 01). This information was incorporated into the dietary assessment. IV. DEEM Program and Consumption Information Asulam chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model ( DEEM ) software Version 7.73, which incorporates consumption data from USDA's Continuing Surveys of Food Intake by Individuals ( CSFII), 1989­ 1992. The 1989­ 92 data are based on the reported consumption of more than 10,000 individuals over three consecutive days, and therefore represent more than 30,000 unique " person days" of data. Foods " as consumed" ( e. g., apple pie) are linked to raw agricultural commodities and their food forms ( e. g., apples­ cooked/ canned or wheat­ flour) by recipe translation files internal to the DEEM software. Consumption data are averaged for the entire US population and within population subgroups for chronic exposure assessment, but are retained as individual consumption events for acute exposure assessment. For chronic exposure and risk assessment, an estimate of the residue level in each food or food­ form ( e. g., orange or orange­ juice) on the commodity residue list is multiplied by the average daily consumption estimate for that food/ food form. The resulting residue consumption estimate for each food/ food form is summed with the residue consumption estimates for all other food/ food forms on the commodity residue list to arrive at the total estimated exposure. Exposure estimates are expressed in mg/ kg body weight/ day and as a percent of the cPAD. This procedure is performed for each population subgroup. HED notes that there is a degree of uncertainty in extrapolating exposures for certain population [ D279592] ~ DRAFT ~ [ Asulam / 106901] 8 subgroups from the general U. S. population which may not be sufficiently represented in the consumption surveys, ( e. g., nursing and non­ nursing infants or Hispanic females). Therefore, risks estimated for these population subgroups were included in representative populations having sufficient numbers of survey respondents ( e. g., all infants or females, 13­ 50 years). V. Results/ Discussion Exposures > 100% of the cPAD exceed HED's level of concern. That is, estimated exposures above this level are of concern, while estimated exposures at or below this level are not of concern. The DEEM analyses estimate the dietary exposure of the U. S. population and 26 population subgroups. The results reported in Table V are for the U. S. Population ( total), all infants (< 1 year old), children 1­ 6, children 7­ 12, females 13­ 50, males 13­ 19, males 20+, and seniors 55+ years of age. The results for the other population subgroups are not reported in Table V. This is because the numbers of respondents in the other subgroups were not sufficient, and thus the exposure estimates for these subgroups contained higher levels of uncertainty. However, the respondents in these subgroups were also part of larger subgroups which are listed in Table V. For example, nursing and non­ nursing infants are included in all infants. The subgroups which are broken down by region, season, and ethnicity are also not included. Chronic Dietary Exposure Analysis Table V. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.036 0.000157 < 1% All Infants (< 1 year) 0.036 0.000300 < 1% Children 1­ 6 years 0.036 0.000449 1% Children 7­ 12 years 0.036 0.000275 < 1% Females 13­ 50 years 0.036 0.000107 < 1% Males 13­ 19 years 0.036 0.000185 < 1% Males 20+ years 0.036 0.000105 < 1% [ D279592] ~ DRAFT ~ [ Asulam / 106901] Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD 9 Seniors 55+ years 0.036 0.000087 < 1% VI. Discussion of Uncertainties This tier 2/ 3 dietary risk assessment is the most refined to date for asulam. However, there are some uncertainties associated with this assessment as follows: C Residue Issues No available residue data exist for asulam. The anticipated residues were calculated using field trial data. The anticipated residues were adjusted by percent crop treated data provided by BEAD. Tolerances for this chemical were based on quantifiable residues found in the field trials. Also, the residue values from the field trials were adjusted for 70% loss in storage. This would tend to overestimate the exposure of asulam in sugarcane. Use of molassess AR in the assessment: the molassess AR is based on residues expected in the animal feed " black­ strap" molassess. These residues are expected to overestimate residues in human food molassess. C Processing Factors DEEM default processing factors for dry beef were used. C DEEM Uncertainties HED notes that there is a degree of uncertainty in extrapolating exposures for certain population subgroups which may not be sufficiently represented in the consumption surveys, ( e. g., nursing and non­ [ D279592] ~ DRAFT ~ [ Asulam / 106901] 10 nursing infants or Hispanic females). Therefore, risks estimated for these subpopulations were included in representative populations having sufficient numbers of survey respondents ( e. g., all infants or females, 13­ 50 years). VII. Conclusions A Tier 2/ 3 chronic dietary risk assessment was conducted for all supported asulam food uses. Dietary risk estimates are provided for the general U. S. population and various population subgroups. This assessment concludes that for all supported registered commodities, the chronic risk estimates are below the Agency's level of concern (< 100% cPAD) for the general U. S. population (< 1% of the cPAD) and all population subgroups. The chronic dietary exposure estimate for children 1­ 6 years ( the highest exposed population subgroup) is 1.2% of the cPAD. Table VI. Summary of Dietary Exposure and Risk for Asulam Population Subgroup** Chronic Dietary Dietary Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.000157 < 1% All Infants (< 1 year) 0.000300 < 1% Children 1­ 6 years 0.000449 1% Children 7­ 12 years 0.000275 < 1% Females 13­ 50 0.000107 < 1% Males 13­ 19 0.000185 < 1% Males 20+ years 0.000105 < 1% Seniors 55+ 0.000087 < 1% cc: Jose Morales ( RRB3), RRB3 Reading File RDI: C. Eiden ( 12/ 18/ 01); J. Tyler ( 12/ 18/ 01); S. Kinard ( 12/ 17/ 01) [ D279592] ~ DRAFT ~ [ Asulam / 106901] 11 VIII. Attachments U. S. Environmental Protection Agency Ver. DEEM Chronic analysis for ASULAM 1989­ 92 Residue file: C:\ My DEEM\ Asulam\ chronic. RS7 Adjust. # 2 Analysis Date 12­ 10­ 2001 Residue file dated: 12­ 10­ 2001/ 15: 36: Reference dose ( RfD) = 0.036 mg/ kg bw/ day Comment: Chronic Run for the TRED ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­ Food Crop RESIDUE Adj. Factors Comment Code Grp Food Name ( ppm) # 1 # 2 ­­­­ ­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­ ­­­­­­ ­­­­­­ ­­­­­­­ 283 O Sugar­ cane 0.500000 1.000 0.420 284 O Sugar­ cane/ molasses 13­ Baked 24.000000 1.000 0.420 98­ Refined 24.000000 1.000 0.420 318 D Milk­ nonfat solids 0.025000 1.000 0.420 319 D Milk­ fat solids 0.025000 1.000 0.420 321 M Beef­ meat byproducts 0.120000 1.000 0.420 322 M Beef­ other organ meats 0.120000 1.000 0.420 323 M Beef­ dried 0.050000 1.920 0.420 324 M Beef­ fat w/ o bones 0.050000 1.000 0.420 325 M Beef­ kidney 0.120000 1.000 0.420 326 M Beef­ liver 0.120000 1.000 0.420 327 M Beef­ lean ( fat/ free) w/ o bones 0.050000 1.000 0.420 328 M Goat­ meat byproducts 0.120000 1.000 0.420 329 M Goat­ other organ meats 0.120000 1.000 0.420 330 M Goat­ fat w/ o bone 0.050000 1.000 0.420 331 M Goat­ kidney 0.120000 1.000 0.420 332 M Goat­ liver 0.120000 1.000 0.420 333 M Goat­ lean ( fat/ free) w/ o bone 0.050000 1.000 0.420 334 M Horsemeat 0.050000 1.000 0.420 335 M Rabbit 0.050000 1.000 0.420 336 M Sheep­ meat byproducts 0.120000 1.000 0.420 337 M Sheep­ other organ meats 0.120000 1.000 0.420 338 M Sheep­ fat w/ o bone 0.050000 1.000 0.420 339 M Sheep­ kidney 0.120000 1.000 0.420 340 M Sheep­ liver 0.120000 1.000 0.420 341 M Sheep­ lean ( fat free) w/ o bone 0.050000 1.000 0.420 342 M Pork­ meat byproducts 0.120000 1.000 0.420 [ D279592] ~ DRAFT ~ [ Asulam / 106901] 12 343 M Pork­ other organ meats 0.120000 1.000 0.420 344 M Pork­ fat w/ o bone 0.050000 1.000 0.420 345 M Pork­ kidney 0.120000 1.000 0.420 346 M Pork­ liver 0.120000 1.000 0.420 347 M Pork­ lean ( fat free) w/ o bone 0.050000 1.000 0.420 398 D Milk­ based water 0.025000 1.000 0.420 424 M Veal­ fat w/ o bones 0.050000 1.000 0.420 425 M Veal­ lean ( fat free) w/ o bones 0.050000 1.000 0.420 426 M Veal­ kidney 0.120000 1.000 0.420 427 M Veal­ liver 0.120000 1.000 0.420 428 M Veal­ other organ meats 0.120000 1.000 0.420 429 M Veal­ dried 0.050000 1.920 0.420 430 M Veal­ meat byproducts 0.120000 1.000 0.420 [ D279592] ~ DRAFT ~ [ Asulam / 106901] 13 U. S. Environmental Protection Agency Ver. DEEM Chronic analysis for ASULAM ( 1989­ 92 Residue file name: C:\ My DEEM\ Asulam\ chronic. RS7 Adjustment factor # 2 used. Analysis Date 12­ 10­ 2001/ 15: 41: 38 Residue file dated: 12­ 10­ 2001/ 15: 36: 16/ 8 Reference dose ( RfD, Chronic) = .036 mg/ kg bw/ day COMMENT 1: Chronic Run for the TRED ============================================================================== = Total exposure by population subgroup ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­ Total Exposure ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ Population mg/ kg Percent of Subgroup body wt/ day Rfd ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­ U. S. Population ( total) 0.000157 0.4% U. S. Population ( spring season) 0.000156 0.4% U. S. Population ( summer season) 0.000160 0.4% U. S. Population ( autumn season) 0.000161 0.4% U. S. Population ( winter season) 0.000152 0.4% Northeast region 0.000153 0.4% Midwest region 0.000170 0.5% Southern region 0.000155 0.4% Western region 0.000150 0.4% Hispanics 0.000173 0.5% Non­ hispanic whites 0.000156 0.4% Non­ hispanic blacks 0.000156 0.4% Non­ hisp/ non­ white/ non­ black 0.000158 0.4% All infants (< 1 year) 0.000300 0.8% Nursing infants 0.000075 0.2% Non­ nursing infants 0.000394 1.1% Children 1­ 6 yrs 0.000449 1.2% Children 7­ 12 yrs 0.000275 0.8% [ D279592] ~ DRAFT ~ [ Asulam / 106901] 14 Females 13­ 19 ( not preg or nursing) 0.000147 0.4% Females 20+ ( not preg or nursing) 0.000092 0.3% Females 13­ 50 yrs 0.000107 0.3% Females 13+ ( preg/ not nursing) 0.000130 0.4% Females 13+ ( nursing) 0.000120 0.3% Males 13­ 19 yrs 0.000185 0.5% Males 20+ yrs 0.000105 0.3% Seniors 55+ 0.000087 0.2% Pacific Region 0.000144 0.4% ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­ [ D279592] ~ DRAFT ~ [ Asulam / 106901] 15 Quantitative Usage Analysis for Sodium Asulam Case No. 265 PC Code No. 106902 Date: 7­ 25­ 01 Analyst: Alan Halvorson Based on pesticide usage information mainly for 1992 through 2000 for agriculture and 1994 through 1999 for non­ agriculture, total annual domestic usage of sodium asulam is approximately 1.3 million pounds active ingredient ( a. i.) allocated by site mainly to sugarcane ( 95%), lawn care operators and sod farms ( 2% each) and institutional turf ( 1%). The average percent crop treated for sugarcane, the only registered agricultural crop, is about 42%, while its average use rate per acre is 2.5 pounds a. i. per application and 3.0 pounds a. i. per year. States of most usage are Florida, Louisiana and Texas. Sodium Asulam Case #: 265 AI #: 106902 EPA QUANTITATIVE USAGE ANALYSIS Analyst: Alan Halvorson 7­ 25­ 01 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­ Acres Acres Treated ( 000) % Crop Treated Lb AI Appl'd ( 000) Avg Applic Rates/ Acre States of Most Usage ( 000) ­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­­­­­­­­­­­­­­ (% of total lb ai Site Grown Est Est Est lb ai/ # appl/ lb ai/ used by these states) Avg Max Avg Max Avg Max year year appl ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­ Sugarcane 939 398 498 42% 53% 1,211 1,513 3.04 1.2 2.46 FL LA TX 100% Lawn Care Operators(*) ­ ­ ­ ­ ­ 26 40 ­ ­ ­ FL 100% Sod Farms ­ ­ ­ ­ ­ 21 32 ­ ­ ­ FL ( most) Institutional Turf(**) ­ ­ ­ ­ ­ 17 25 ­ ­ ­ ­ Ornamentals ­ ­ ­ ­ ­ 3 4 ­ ­ ­ FL TX ­ Golf Courses ­ ­ ­ ­ ­ 2 3 ­ ­ ­ FL GA ­ TOTAL 1,280 1,600 FL LA 97% ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ ­­­­­­­­­­­­ NOTES ON TABLE DATA ­­­­­­­­­­­­­­­­­­­ ­ Usage data primarily cover 1992 ­ 2000 for agriculture and 1994 ­ 1999 for non­ agriculture. ­ Calculations of the above numbers may not appear to agree with each other because they are displayed as rounded. [ D279592] ~ DRAFT ~ [ Asulam / 106901] 16 ­ A dash(­) indicates that information is not readily available or is not applicable. CROP/ SITE GROUPS AND DEFINITIONS ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ (*) Lawn care operators make applications to commercial, not residential, turf. (**) Institutional turf consists of maintained turf of educational facilities, cemeteries and parks. DATA SOURCES ­­­­­­­­­­­­ ­ US EPA, proprietary data, 1994 ­ 2000. ­ NCFAP, circa 1992. cc: Include typical reviewer information here. Include one copy for ( HED Staff/ CEB1), where staff = Mohsen Sahafeyen or LaShonia Richardson). Include names of secondary reviewers and review dates.

epa

2024-06-07T20:31:45.425227

regulations

EPA-HQ-OPP-2002-0329-0008

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES PC Code: 106901 DP BARCODE: D279761 MEMORANDUM January 3, 2002 SUBJECT: Asulam: Revised Tier I Drinking Water EECs for Use in the Human Health Risk Assessment. TO: Jose Morales Catherine Eiden Health Effects Division ( 7509C) FROM: Norman Birchfield ERB4/ EFED ( 7507C) THRU: Dirk Young Betsy Behl, Chief ERB4/ EFED ( 7507C) This memo is a revision to the previous Tier I estimated environmental concentrations ( EECs) for asulam in surface water and in ground water for use in the human health risk assessments ( memo from Dirk Young to T. Truesdale January 23, 2001, DP Barcode D272000). This revision is required to 1) Update surface water modeling using the FIRST reservoir model 2) Provide an upper bound estimate for EECs on degradates in surface and ground water 3) Estimate longer term ground water concentrations The EECs are summarized in Table 1. EFED used FIRST to calculate the surface water EECs and used a prospective groundwater study to estimate the groundwater EEC. For the surface water assessment, the application rate for sugarcane was used, which represents the highest labeled rate for any crop. A summary of the model input parameters is given in Table 2. All parameters for asulam were taken according to standard EFED practice. Since no data is available on degradates FIRST modeling assumed immediate conversion upon application to very persistent and mobile degradates. The FIRST output file is located in Attachment 1. For estimated groundwater exposure, the highest observed concentration in the prospective groundwater ( PGW) study for turf ( MRID 42224701) was used. Three PGW studies ( Florida turf, Louisiana sugarcane, and Florida sugarcane) were previously reviewed in a 1994 memo ( 1). In the study associated with asulam use on Florida turf, asulam and the sulfanilamide were detected in shallow wells at a combined concentration of 59 ppb. The average concentration of combined residues over the 14 month sampling period was 14.0 ppb. The above values are not corrected for incomplete recovery. The average spike recoveries for asulam and the sulfanilamide degradate were 39.4% and 38.3%, respectively. After correcting for recovery the values are 154 ppb ( peak) and 37 ppb ( 14 month average). The recommended EEC for groundwater is 154 ppb based on the peak value ( Table 1). The low spike recoveries indicate problems with the analytical method. The site and conditions monitored compensates somewhat for the uncertainty in the analytical method. The monitoring scenario is a highly vulnerable situation with sandy soil and shallow ground water ( 2.14 m). Wells of this type are not generally expected to be used for drinking water purposes, although many wells in Florida less than 17 m deep are used for drinking water. In a separate water monitoring study asulam was detected in public drinking water sources from ground and surface water. At the request of EPA, Rhone­ Poulenc conducted a drinking water monitoring study in areas of high asulam use in Florida and Louisiana. The surface water study was designed to sample raw surface water in up to 15 community water systems in Florida and 4 systems in Louisiana. Samples were collected monthly for one year and analyzed for asulam and the metabolite sulfanilamide at a detection limit of 1 ppb. In addition to surface water collection, the study collected samples from potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area. Seven of the ten surface water community systems sampled contained traces (< 1 ppb) of asulam residues during May through June. Four of the community systems were located in Louisiana and three were in Florida. A total of 28 drinking water wells were sampled in Florida. Because of poor water quality in this area of Florida, many of the wells reportedly use some type of treatment system prior to use. Three wells contained quantifiable asulam residues up to 1.92 ppb. [ Note that these asulam concentration are considerably greater than the SCIGROW prediction of 0.95 ppb ( see Attachment 2).] Ten other wells contained detectable traces (< 1 ppb). Reportedly, the depth of the well and distance to treated area did not have any statistically significant effects on the concentrations observed. No residues were detected in 12 wells sampled in the " sandier" areas of Hendry County. Rhone­ Poulenc reported that there was less intensive use of asulam in this area. No residues were detected in ground water samples in Louisiana. 2 ­­ Table 1. Tier I EECs for Drinking Water Surface Water Surface Water Ground Water Peak EEC Chronic EEC1 EEC Asulam 305 µ g/ L 6.6 µ g/ L Asulam + 380 µ g/ L 2 272 µ g/ L 2 154 µ g/ L3 degradates 1 Based on 56­ day average immediately following pesticide input to water body. 2 Based on FIRST modeling with upper bound assumptions on mobility and persistence. 3 From groundwater study, see reference 1. This concentration is representative of asulam and the sulfnilamide degradate. Table 2. FIRST environmental fate input parameters chemical asulam asulam + degradates Solubility 4000 mg L­ 1 10,000 mg L­ 1 Hydrolysis aqueous photolysis half life ( near surface) stable 0.0625 days stable stable aerobic soil metabolism half life 28 days ( highest available value) stable aerobic aquatic metabolism half life 105 days ( single value) stable soil organic carbon partitioning ( Koc) 18 L kg­ 1 ( lowest available value) 1 L kg­ 1 crop sugarcane sugarcane application rate 3.624 lb a. i. acre­ 1 * 3.624 lb a. i. acre­ 1 * number of applications 1 per season 1 per season application method aerial granular ( no drift) * highest labeled rate; information supplied by BEAD. REFERENCES 1. Memo to Linda Propst, from Elizabeth Behl, Environmental Fate and Ground Water Branch Review Action, Review of small­ scale prospective groundwater monitoring study results. Feb 2, 1994. DPBarcodes: D162492, D175842, D180962, D181508, D185103, D190979, D190980. 3 ATTACHMENT 1: FIRST Files RUN No. 1 FOR asulam ON sugarcane * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Koc ( PPM ) (% DRIFT) AREA ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 3.624( 3.624) 1 1 18.0 4000.0 AERIAL( 16.0) 87.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES.­ EFF) ( RESER.) ( RESER.) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 28.00 2 N/ A .06­ 7.75 105.00 7.22 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 MAY 16, 2001 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 305.275 6.605 RUN No. 1 FOR asulam residues ON sugarcane * INPUT VALUES * ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ RATE (#/ AC) No. APPS & SOIL SOLUBIL APPL TYPE % CROPPED INCORP ONE( MULT) INTERVAL Koc ( PPM ) (% DRIFT) AREA ( IN) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 3.624( 3.624) 1 1 1.010000.0 GRANUL( .0) 100.0 .0 FIELD AND RESERVOIR HALFLIFE VALUES ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED ( FIELD) RAIN/ RUNOFF ( RESERVOIR) ( RES.­ EFF) ( RESER.) ( RESER.) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .00 2 N/ A .00­. 00 .00 .00 UNTREATED WATER CONC ( MICROGRAMS/ LITER ( PPB)) Ver 1.0 MAY 16, 2001 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ PEAK DAY ( ACUTE) ANNUAL AVERAGE ( CHRONIC) CONCENTRATION CONCENTRATION ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 379.819 272.174 4 ATTACHMENT 2: SCIGROW File RUN No. 1 FOR asulam INPUT VALUES ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ APPL (#/ AC) APPL. URATE SOIL SOIL AEROBIC RATE NO. (#/ AC/ YR) KOC METABOLISM ( DAYS) ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 3.624 1 3.624 63.0 23.0 GROUND­ WATER SCREENING CONCENTRATIONS IN PPB ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ .950323 ­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ A= 18.000 B= 68.000 C= 1.255 D= 1.833 RILP= 2.721 F= ­. 581 G= .262 URATE= 3.624 GWSC= .950323 5

epa

2024-06-07T20:31:45.430473

regulations

EPA-HQ-OPP-2002-0329-0009

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES, AND TOXIC SUBSTANCES PC Code: 106901 DP BARCODE: D282962 MEMORANDUM July 24, 2002 SUBJECT: Asulam: Response to Registrant Comments on Drinking Exposure Estimates. TO: Demson Fuller Special Review and Reregistration Division ( 7508C) FROM: Norman Birchfield, Ph. D. Biologist Environmental Risk Branch 4 Environmental Fate and Effects Division ( 7507C) THRU: Betsy Behl, Chief Environmental Risk Branch 4 Environmental Fate and Effects Division ( 7507C) Aventis has submitted brief comments titled Asulam: Revised Tier 1 Drinking Water EECs for use in the Human Health Risk [ Asessment] on the drinking water assessment conducted for asulam ( January 3, 2002, D279761). EFED has reviewed the Aventis comments a determined that no change is necessary in the current drinking water assessment. EFED has identified environmental fate studies necessary to confirm the conclusions of the drinking water assessment. Aventis disagrees with the proposed drinking water exposure values determined by EFED through analysis of groundwater monitoring data and FIRST surface water modeling: Groundwater: Aventis states that detections of asulam in groundwater outside the application area were a result of contamination from applications of asulam applied around the wells to prevent weeds from growing up around the wells ( a use not registered for asulam) and from contamination resulting from alleged spills at mixer loader sites. Neither of these scenarios proposed to result in the groundwater contamination levels described in the January 3, 2002 drinking water assessment were documented and appear to be speculation. The registrant also states that the analytical results on asulam concentrations in groundwater do not need to be corrected for incomplete recovery but fails to state why. EFED maintains that the groundwater concentrations presented in the January 3, 2002 drinking water assessment reflects the current understanding of the environmental fate and behavior of asulam. Surface Water: Aventis states that the surface water monitoring study conducted in Florida and Louisiana provides a more accurate estimates of drinking water exposure and that EFED s FIRST model estimates are more than 100­ times higher than monitoring results. The FIRST model is intended to estimate conservative acute and chronic drinking water concentrations. FIRST estimated concentrations are unlikely to be measured in a small scale monitoring study because they would not occur often and or be widespread. Monitoring studies such as that conducted by the registrant are useful for characterizing exposure, however, due to the monthly sampling frequency, small number of sampling locations, and short study duration, these studies are not normally adequate to provide a conservative estimate of exposure via drinking water. EFED maintains that the FIRST estimates provided in the January 3, 2002 drinking water assessment are presently the most reliable conservative estimates of exposure to asulam via drinking water derived from surface water. In reviewing the data set for asulam, a number of deficiencies were noted. The following studies are requested to confirm fate parameters used to estimate drinking water exposures: 162­ 1 ( 835.4100) Aerobic Soil Metabolism ( three soils) 162­ 2 ( 835.4200) Anaerobic Soil Metabolism 162­ 3 ( 835.4400) Anaerobic Aquatic Metabolism 162­ 4 ( 835.4300) Aerobic Aquatic Metabolism Previously conducted studies did not adequately identify major asulam degradates. Page 2 of 2

epa

2024-06-07T20:31:45.433536

regulations

EPA-HQ-OPP-2002-0329-0010

Supporting & Related Material

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES August 2, 2002 CERTIFIED MAIL Dear Registrant: This is to inform you that the Environmental Protection Agency ( hereafter referred to as EPA or the Agency) has completed its tolerance reassessment decision for Asulam. This letter, signed on August 2, 2002, and the attached Overview document serve as EPA s Report of the Food Quality Protection Act ( FQPA) Tolerance Reassessment Progress and Risk Management Decision ( TRED) for Asulam. A Notice of Availability soliciting public comment for a 30­ day period will be published in the Federal Register ( FR) shortly. FFDCA, as amended, requires EPA to reassess all the tolerances that were in effect for registered chemicals on or before the date of the enactment of FQPA in August of 1996 against the new safety standard adopted in the FQPA. In reassessing these tolerances, the Agency must consider, among other things, aggregate risks from non­ occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a modification or revocation occurs. A reregistration eligibility decision ( RED) for asulam was completed in September 1995 prior to FQPA enactment. Therefore, it needed to be updated to reassess the tolerances under the FQPA standard. The Agency has evaluated the dietary risks associated with asulam and has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to asulam when considering dietary exposure and all other non­ occupational sources of pesticide exposure for which there is reliable information. Therefore, no mitigation measures are needed, and the tolerances established for residues of asulam are now considered reassessed as safe under section 408( q) of the FFDCA. FQPA requires that EPA consider available information concerning the cumulative effects of a particular pesticide s residues and other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low­ level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the other substances individually. EPA did not perform a cumulative risk assessment as part of this review of asulam because the Agency has not determined that there are any other chemical substances that have a mechanism of toxicity in common with asulam. If EPA identifies other substances that share a common mechanism, then a cumulative risk assessment will be conducted that includes asulam once EPA s final framework for conducting cumulative risk assessments is available. Further, EPA is in the process of developing criteria for characterizing and testing endocrine disrupting chemicals and plans to implement an Endocrine Disruptor Screening Program. Asulam will be reevaluated at that time and additional studies may be required. The Agency s human health findings for the pesticide asulam were discussed in a closure conference call on July 25, 2002, and are summarized in the attached, Overview of Asulam Risk Assessment. The risk assessment and other documents pertaining to the asulam tolerance reassessment decision are listed at the end of this document and are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket for viewing. Tolerances are established for residues of asulam in/ on raw agricultural commodities as defined in 40 CFR 180.180.360. The Agency recommends that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. An adequate enforcement method is available for the determination of combined residues of asulam and all metabolites containing the sulfanilamide moiety in/ on sugarcane. Additional data are required at this time. The registrant must submit label amendment requests for the use of asulam on sugarcane. The amendments must include lower maximum application rates and longer PHIs, and must be region specific, as given below. If the registrant request the suggested label changes, no further sugarcane field trial data are required for asulam at this time. No plantback restrictions are required on the label. The Agency recommends that the registrant request label amendments specifying a maximum of two asulam applications per year to sugarcane at a maximum single application rate of 3.34 lbs. a. i./ A, a PHI of 100 days for Louisiana, a PHI of 140 days for the remainder of the US mainland, and a PHI of 400 days for Hawaii. If the registrant does not propose the recommended label changes, existing labels must be supported by new field trials. In addition, the following product chemistry data guidelines remain unfulfilled for the technical sodium salt: GLN 830.6317 ( Storage Stability) and 830.6320 ( Corrosion Characteristics). The following tolerances have been reassessed: The registrant proposes for asulam residue in/ on cane of 0.05 ppm, resulting from 2 applications, each 3.34 lbs. a. i./ Acre, with a 100 day PHI. The data do not support this tolerance. For the proposed use pattern, the maximum residue, corrected for loss in storage, is 0.71 pp. A tolerance of 1.0 ppm is appropriate for residues of asulam and the sulfanilamide­ containing metabolites in/ on sugarcane. This replaces the current tolerance of 0.1 ppm. Based on the highest average field trial residue and the concentration factor from processing, a tolerance of 30 ppm is needed for asulam and sulfanilamide­ containing metabolite residues in molassess. The decrease in the sugarcane tolerance for asulam and its sulfanilamide containing metabolites from the reevaluated 15 ppm to 1 ppm does not alter the previous conclusion that residues of asulam and the sulfanilamide­ containing metabolites are anticipated in ruminant commodities from a diet containing 10% molasses. Animal commodity tolerances should be proposed, 0.05 ppm for ruminant milk and meat and fat and 0.2 ppm for ruminant meat byproducts. There are no significant poultry feed items; poultry commodity tolerances are not needed. TOLERANCE REASSESSMENT SUMMARY Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment Tolerances listed under 40 CFR § 180.360 Sugarcane, cane 0.1 1.0 Tolerances to be Established Under 40 CFR § 180.360 Sugarcane, molasses ­ 30 Milk ­ 0.05 Cattle, meat Cattle, fat Goat, meat Goat, fat Hog, meat Hog, fat Horse, meat Horse, fat Sheep, meat Sheep, fat ­. 05 Cattle, meat byproducts Goat, meat byproducts Hog, meat byproducts Horse, meat byproducts Sheep, meat byproducts ­. 2 0 0 This document also contains a generic Data Call­ In ( DCI) that outlines further data requirements for this chemical. Note that registrants of asulam must respond to DCIs issued by the Agency within 90 days of receipt of this letter. If you have questions on this document, please contact the Chemical Review Manager, Demson Fuller , at ( 703) 308­ 8062. Sincerely, Lois A. Rossi, Director Special Review and Reregistration Division Attachments: List of Supporting Documents Overview of Asulam Risk Assessment Generic Data Call­ In ( DCI) List of Documents Supporting the Asulam Reassessment Decision The Tolerance Reassessment Decision for asulam is based on the revised human health risk findings, disciplinary chapters, and other supporting documentation as follows: Asulam. HED Human Health Assessment for the tolerance Reassessment Eligibility Decision ( TRED). Chemical No. 106901/ 02. No MRID #. DP Barcode No. D276505. Jose Morales ( February 28, 2002) Asulam ­ 2nd Report of the Hazard Identification Assessment Review Committee. John Liccione ( December 5, 2001) Asulam ­ Report of the FQPA Safety Factor Committee. Carol Christensen ( February 5, 2002) Asulam. Toxicology Chapter of the RED. John Liccione ( October 12, 2001) Asulam ( List A, Case 0265, Chemical 106901/ 02). Tolerance Reassessment Eligibility Decision Document. Product and Residue Chemistry Chapter. DP Barcode D278884. Jose Morales ( December 6, 2001) Asulam. Chronic Dietary Exposure Assessment for the Tolerance Reasssement Eligibility Decision Document ( TRED), PC Codes 106901/ 02; DP Barcode D279592. Jose Morales ( December 18, 2001) Asulam: Revised Tier I Drinking Water EECs for Use in the Human Health Risk Assessment. Jose Morales ( January 3, 2002) Quantitative Usuage Analysis for Asulam. Alan Halvorson ( July 25, 2001) Generic Data Call­ In [ place holder ­­ to be generated]

epa

2024-06-07T20:31:45.435885

regulations

EPA-HQ-OPP-2002-0329-0011

Supporting & Related Material

OVERVIEW OF ASULAM RISK ASSESSMENT Introduction August 2, 2002 The Agency has completed its review and announces the tolerance reassessment decision for asulam. This decision also releases to the public the human health assessment, as presented fully in the document entitled Asulam: HED Human Health Assessment for the Tolerance Reassessment Eligibility Decision ( TRED) dated February 28, 2002, and related documents supporting this decision. The purpose of this overview is to assist the reader by identifying the key features and findings of this risk reassessment in order to better understand the conclusions reached in the tolerance reassessment. This overview was developed in response to comments and requests from the public, which indicated that the risk assessments ( and other like documents) were difficult to understand, that they were too lengthy, and that it was not easy to compare the assessments for different chemicals due to the use of different formats. FFDCA requires the Agency to review all the tolerances for registered chemicals in effect on or before the date of the enactment of FQPA. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non­ occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a tolerance revocation occurs. A reregistration eligibility decision ( RED) for asulam was completed in September 1995, prior to FQPA enactment; therefore it needed to be updated to consider the provisions of the Act. FQPA requires that the Agency, when considering whether to establish, modify, or revoke a tolerance, consider available information concerning the cumulative effects of the particular pesticide s residues and other substances that have a common mechanism of toxicity. The Agency does not, at this time, have sufficient reliable information available to determine whether asulam has a common mechanism of toxicity with other substances. Therefore, for the purposes of this risk assessment, the Agency has not assumed that asulam has a common mechanism of toxicity with other substances. If EPA identifies other substances that share a common mechanism of toxicity with asulam, a cumulative risk assessment for those substances will be performed. The risk assessment and documents pertaining to the Agency s report on FQPA tolerance reassessment progress and decision for asulam are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket. Because the risks posed by the use of asulam are low and not of concern to the Agency, the normal process of meeting stakeholders ( i. e., growers, extension offices, environmental and commodity groups, and other government offices) to discuss risks of concern and solicit input on risk mitigation strategies was not necessary for this chemical. Rather, the Agency s report on FQPA tolerance reassessment progress and interim risk management decision for asulam will be announced in the Federal Register. Since there are no risk concerns for asulam alone, no further actions are warranted at this time pending a determination of whether a cumulative risk assessment for asulam may be needed and is completed. Risks summarized in this document are those that result only from the use of asulam. The Food Quality Protection Act ( FQPA) requires that the Agency consider available information concerning the cumulative effects of a particular pesticide s residues and other substances that have a common mechanism of toxicity. Since it is possible that this chemical and other substances could share a common mechanism of toxicological action, adverse health effects and cumulative low­ level exposures, this review needs to consider this potential interaction.. The Agency did not perform a cumulative risk assessment as part of this tolerance reassessment of asulam because the Agency has not yet initiated a review to determine if there are any other chemical substances that have a mechanism of toxicity common with that of asulam. If the Agency identifies other substances that share a common mechanism of toxicity with asulam, then a cumulative risk assessment will be conducted that includes asulam once the final framework the Agency will use for conducting cumulative risk assessments is available. Asulam s potential contribution to cumulative risk be reevaluated at that time and additional studies may be required. Use Profile Herbicide: Asulam ( methyl sulfanilylcarbamate) is a selective postemergent systemic carbamate herbicide registered for sugarcane, Christmas tree plantations, ornamentals, turf ( use for sod farms only) and non­ cropland uses ( boundary fences, fencerows, hedgerows, lumberyards, storage areas and industrial facilities, and warehouse lots). There are no residential uses for asulam products. Targeted Weeds: western brackenfern, marestail, horseweed, alexandergrass, barnyardgrass, broadleaf panicum, bullgrass, crabgrass, foxtail, goosegrass, itchgrass, johnsongrass, paragrass, and sandbur. Formulations: The only end­ use formulation of asulam is the sodium salt of asulam ( sodium salt of methyl sulfanilylcarbamate) which is formulated as soluble concentrate/ liquid ( 36.2% a. i.). Methods of Application: Apply to sugarcane as broadcast, band, or spot treatment with ground equipment or broadcast by air at 3.34 pounds active ingredient/ acre ( lb ai/ A). Apply to Christmas trees as a delayed dormant spray with air or ground equipment at 3.34 lb ai/ A. Apply to ornamental and/ or shade trees or ornamental woody shrubs and vines as a postemergence ground broadcast at 3.34 lb ai/ A. Apply to ornamental lawns and turf as a postemergence spray with ground equipment at 2.088 lb ai/ A. Apply to industrial areas ( outdoor), nonagricultural rights­ of­ way/ fencerows, or nonagricultural uncultivated areas when needed as spray with ground equipment at 3.34 lb ai/ A. 2 Use Summary: Based on pesticide usage information mainly for 1992 through 2000 for agriculture and 1994 through 1999 for non­ agriculture, total annual domestic usage of sodium asulam is approximately 1.3 million pounds active ingredient allocated by site mainly to sugarcane ( 95%), lawn care operators and sod farms ( 2% each) and institutional turf ( 1%). The average percent crop treated for sugarcane, the only registered agricultural crop, is about 42%, while its average use rate per acre is 2.5 pounds a. i. per application and 3.0 pounds a. i. per year. Generally, asulam is applied once per season with a follow­ up spot application to clean up field ends. States with the most usage are Florida, Louisiana, and Texas. Registrant: Aventis CropScience Classification: General Use Table 1. Asulam Usage Crop Acres Grown ( 000) Acres Treated ( 000) Avg Max Sugarcane 939 398 498 Lawn Care Operators1 ­­­ Sod Farms ­­­ Institutional Turf2 ­­ Ornamentals ­­­ Golf Courses ­­­ TOTALS ­­­ ­ COLUMN HEADINGS % Crop Treated Lbs A. I. Applied ( 000) States of Most Usage (% of lbs a. i. Used) Avg Max Avg Max 42% ­ ­ ­ ­ ­ ­ 53% 1,211 1,513 FL LA TX ( 100%) ­ 26 40 FL 100% ­ 21 32 FL ( most) ­ 17 25 ­ ­ 3 4 FL TX ­ 2 3 FL GA ­ 1,280 1,600 FL LA ( 97%) Avg = Weighted average in which the most recent years and more reliable data are weighted more heavily. Max = Estimated maximum, which is estimated from available data. 1 Lawn Care operators make applications to commercial, not residential, turf 2 Institutional turf consists of maintained turf of educational facilities, cemeteries, and parks. Human Health Risk Assessment Hazard The acute toxicity of asulam is low. The acute oral LD50 for asulam in rats exceeded 5000 mg/ kg. The acute inhalation LC50 was greater than 5 mg/ L in rats. The acute dermal LD50 for asulam in rabbits exceeded 4000 mg/ kg. Application of technical asulam to rabbit eyes produced mild chemosis, irritation, and redness which cleared by day seven post­ treatment. Asulam was not an irritant in a primary skin irritation study in rabbits. It did not cause dermal sensitization in guinea pigs. 3 Acute Dietary ( Food) Risk Acute dietary risk is estimated based on may be eaten in one day. Acute dietary exposure that is less than 100% of the acute Population Adjusted Dose ( aPAD) does not exceed the Agency s level of concern. The aPAD is the reference dose ( RfD) adjusted for the FQPA Safety Factor. The acute RfD is the dose at which an individual could be exposed in a single day with no adverse health effects expected. An acute dietary risk assessment was not conducted for asulam because no appropriate toxicological endpoint clearly attributable to a single exposure was identified. Therefore, an acute reference dose ( aRfD) was not established. Chronic Dietary ( Food) Risk Chronic dietary risk is calculated by using the average consumption values for food and average residue values on those foods over a lifetime or the duration of exposure assessed ( i. e., 1 year for infants, 6 years for children ages 1­ 6 years and 37 years for females of childbearing age 13­ 50 years old.). Chronic dietary exposure that is less than 100% of the chronic Population Adjusted Dose ( cPAD) does not exceed the Agency s level of concern. The cPAD is the chronic reference dose ( cRfD) adjusted for the FQPA Safety Factor. The chronic RfD is the dose at which an individual could be exposed over the course of a lifetime with no adverse health effects expected. The chronic dietary assessment for asulam and its degradate sulfanilamide was conducted using a Tier II analysis which assumes anticipated residues from field trial data and includes percent crop treated estimates. No monitoring data exist for asulam. The chronic dietary exposure analysis is conducted using the Dietary Exposure Evaluation Model ( DEEM ) . A three­ day average of consumption for each subpopulation is combined with tolerance residues in commodities to determine average exposures in mg/ kg/ day. The toxicity endpoint for the chronic dietary was based on hyperplastic changes in the adrenal medulla and thyroid follicular cells on males in a rat study ( NOAEL= 36 mg/ kg/ day). The effects were observed at 180 mg/ kg/ day ( LOAEL). The uncertainty factor is 1000x; 10x for individual variability and 10x for intraspecies extrapolation. An additional 10x was added due to increased susceptibility in offspring/ fetuses based on evidence of mean live births per litter. The FQPA Safety Factor was retained because ( i) there was evidence of quantitative susceptibility in a two­ generation reproduction study in the rat; and, ( ii) the Agency does not have data that includes an examination of the thyroid gland; therefore, the Agency recommended the requirement for a comparative thyroid rat assay in adults and offspring to examine thyroid weight and pathology. A chronic Reference Dose ( cRfD) of 0.36 mg/ kg/ day was established based on the NOAEL of 36 mg/ kg/ day, and a 100X uncertainty factor for interspecies extrapolation, 4 and intraspecies variability. An additional safety factor of 10X was applied to the cRfD to account for quantitative increased susceptibility in offspring/ fetuses resulting in a chronic Population Adjusted Dose ( cPAD) of 0.036 mg/ kg/ day. Chronic dietary ( food) risks for asulam and its degradate are below the Agency s level of concern for the general U. S. population and all population subgroups (< 1% of the cPAD). Table 2. Summary of Toxicity Endpoints and Doses for Risk Assessment EXPOSURE SCENARIO DOSE ( mg/ kg/ day) ENDPOINT STUDY Acute Dietary An appropriate endpoint attributable to a single dose was not identified. Acute RfD = not established Chronic Dietary NOAEL1 = 36 mg/ kg/ day UF = 100 FQPA Safety Factor = 10 The LOAEL2 was 180 mg/ kg/ day based on hyperplastic changes in the adrenal medulla and in thyroid follicular cells of males. Combined Chronic Toxicity/ Oncog enicity in the rat Chronic RfD = 0.36 mg/ kg/ day Chronic PAD = 0.036 mg/ kg/ day NOAEL1 = no observed adverse effect level. LOAEL2 = lowest observed adverse effect level. Table 3. Results of Chronic Dietary Exposure Analysis Population Subgroup cPAD ( mg/ kg/ day) Exposure ( mg/ kg/ day) % cPAD U. S. Population ( total) 0.036 0.000157 < 1% All Infants (< 1 year) 0.036 0.000300 < 1% Children 1­ 6 years 0.036 0.000449 1% Children 7­ 12 years 0.036 0.000275 < 1% Females 13­ 50 years 0.036 0.000107 < 1% Males 13­ 19 years 0.036 0.000185 < 1% Males 20+ years 0.036 0.000105 < 1% Seniors 55+ years 0.036 0.000087 < 1% Cancer Dietary ( Food) Risk EPA previously classified Asulam as a Group C, possible human carcinogen, based on available studies in rats and mice. Based on the weight­ of­ evidence of all available data, a quantitative estimation of cancer risk to humans was not performed. A recent re­ evaluation of the data ( including a second mouse study) reaffirmed the Agency's previous conclusion that a quantitative estimation of cancer risk to humans is not appropriate. 5 Drinking Water Dietary Risk Drinking water exposure to pesticides can occur through surface and/ or ground water contamination. EPA considers acute ( one day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is carried out in tiers of further refinement, and is designed to provide a high­ end estimate of exposure. To determine the maximum allowable contribution from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food and then determines a Drinking Water Level of Comparison ( DWLOC) to ascertain whether modeled or monitored Estimated Environmental Concentrations ( EECs) exceed this level. EECs that are above the corresponding DWLOC are of concern to the Agency. Based on environmental fate data, asulam is very mobile and has a strong potential to leach into ground water or move offsite into surface water. Sulfanilamide is a major soil and water degradate of asulam. Since there are no residential uses associated with asulam, only dietary exposure from food is considered for purposes of calculating the DWLOC. A drinking water assessment for asulam involved analysis of FIRST ( Tier I­ surface water) computer modeling to estimate surface water concentrations. Estimated drinking water concentrations for ground water are based on a groundwater study that sampled potable wells in Florida and Louisiana that were located within 1,000 feet of an asulam treated area. The monitoring study was compared to SCI­ GROW ( Tier I­ ground water) modeling which had lower detectable traces of asulam residues. This assessment includes concentrations of parent asulam and the degradate sulfanilamide. For chronic risk, potential exposure to asulam ( combined with sulfanilamide) from drinking water derived from surface water results in a chronic EEC of 272 ppb, and for groundwater the chronic EEC is 154 ppb. Upon comparison of the chronic DWLOCs ( 1,254 ppb for males; 1,075 ppb for females; and 355 ppb for children) with the EECs for residues in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Therefore, the Agency is not concerned with potential chronic exposure to asulam through surface and groundwater. Table 4. Drinking Water DWLOC and EEC Comparisons Population Subgroup EECs ( ppb) Chronic Ground Water Surface Water Adult males 1254 154 272Adult Females 1075 Children ( 1­ 6 years) 335 6 Residential Risk Potential residential exposures are not anticipated as a result of applications of asulam. Use sites include Christmas tree plantings, turf ( for sod only), ornamentals ( junipers & yews only), and non­ cropland ( e. g. rights­ of­ way, fence rows, etc.). The amount of asulam used annually on use sites other than sugarcane is approximately 12,000 gallons. Of these use sites, no residential exposures would be anticipated from the Christmas tree plantings and non­ cropland sites. The use on turf is restricted to sod farms, and the application to the sod is made four to five months prior to the sod being pulled up and subsequently sold. Therefore, no residential exposures would be anticipated from the turf/ sod use. The registrant stated that use of asulam on ornamentals is very limited, since its cost is high. Use of asulam on ornamentals in a residential setting would not be expected. Aggregate Risk In examining aggregate exposure, EPA takes into account the available and reliable information concerning exposures from pesticide residues in food and other exposures including drinking water and non­ occupational exposures, e. g., exposure to pesticides used in and around the home ( residential). The aggregate risk assessment for asulam considered only chronic exposures since acute dietary and water exposures are not expected to be toxicologically significant. There are no residential uses of asulam. Therefore, the considerations for aggregate exposure are those from food and water. Combining both the chronic dietary ( food) risk estimates with the surface and ground water estimated concentrations ( drinking water) for asulam, the chronic aggregate ( food + drinking water) are below EPA levels of concern. Chronic dietary risks estimates for all populations are less than 100% of the cPAD. Upon comparison of the chronic DWLOCs with the EECs for residues of asulam in surface and groundwater, all EECs are less than the chronic DWLOCs for all populations. Occupational and Ecological Risk Because asulam is under review for tolerance reassessment only, no occupational or ecological risk assessment was conducted for this TRED. Occupational and ecological risk management decisions were made as part of the 1995 Asulam RED and have been implemented. Tolerance Reassessment Summary Sufficient data are now available to reassess all tolerances associated with asulam use listed in 40 CFR § 180.360. The Agency recommends that the tolerance expression be revised to include all metabolites containing the sulfanilamide moiety. Some product chemistry deficiencies remain outstanding, but they do not impact the tolerance reassessment eligibility decision. However, the registrant needs to resolve all outstanding deficiencies as listed below. The existing tolerance of 0.1 ppm for asulam residues on sugar cane established in 40 CFR § 180.360 has been reassessed. The Agency recommends the tolerance be raised to 7 1.0 ppm. EPA recommends a tolerance of 30 ppm for asulam residues in molasses from sugarcane be established in 40 CFR § 180.360. Based on diets containing 10% molasses in feed, EPA recommends a tolerance of 0.05 ppm for asulam residues in milk, meat, and fat from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360. Based on diets containing 10% molasses in feed, EPA recommends a tolerance of 0.2 ppm for asulam residues in meat byproducts from cattle, goats, hogs, horses, and sheep be established in 40 CFR § 180.360. Table 5. Tolerance Reassessment Summary Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment Tolerances listed under 40 CFR § 180.360 Sugarcane, cane 0.1 1.0 Tolerances to be Established Under 40 CFR § 180.360 Sugarcane, molasses ­ 30 Milk ­ 0.05 Cattle, meat Cattle, fat Goat, meat Goat, fat Hog, meat Hog, fat Horse, meat Horse, fat Sheep, meat Sheep, fat ­. 05 Cattle, meat byproducts Goat, meat byproducts Hog, meat byproducts Horse, meat byproducts Sheep, meat byproducts ­. 2 0 0 8 Summary of Pending Data The following deficiencies were noted and remain outstanding: GLN 860.1200: Directions for Use GLN 830.6317: Storage Stability GLN 830.6320: Corrosion Characteristics GLN 870.3200: 21­ day Dermal Study in Rats with examination of thyroid weight and pathology No GLN: 28 ­ day Inhalation Study in Rats with examination of thyroid weight and pathology. The guidelines for this study are under development. No GLN: Comparative thyroid rat assay in adult and offspring. The adult study should include interim measures ( e. g., 7,14, and 28 days). The thyroid parameters selected for the comparative study should be based on Agency guidelines ( under current development) for thyroid testing. 9

epa

2024-06-07T20:31:45.439847

regulations

EPA-HQ-OPP-2002-0332-0001

Notice

Pesticide Products; Registraiton Applicaitons

72671 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices ERP No. F FHW G40167 LA LA 1 Improvements Project, Golden Meadow to Port Fourchon Highway Construction, Funding, U. S. Army COE Section 10 and 404, NPDES and U. S. Coast Guard Bridge Permits Issuance, Lafoufche Parish, LA. Summary: EPA has no objection to the selection and implementation of the preferred alternative. ERP No. F IBR K61154 AZ Reach 11 Recreation Master Plan, Central Arizona Project ( CAP) Canal, Between Cave Creek and Scottsdale Roads for Recreational Purposes and a Flood Detention Basin, City of Phoenix, Maricopa County, AZ. Summary: EPA found that the Final EIS adequately addresses the issues raised in our comment letter on the Draft EIS. ERP No. FA FRC L05208 WA Rocky Creek Hydroelectric Project, ( FERC No. 10311 002) Construction and Operation of a 8.3 Megawatt ( Mw) Project, License Application, Rocky Creek, Skagit County, WA. Summary: EPA continues to have environmental objections to the proposed project because it would: ( 1) Pose a high risk of landslides that could significantly impact aquatic and terrestrial habitat and water quality, ( 2) degrade water quality in Martin Creek, designated an `` extraordinary'' water body by the State of Washington and ( 3) undermine the environmental and biological protection provisions of the State of Washington Habitat Conservation Plan. Dated: December 3, 2002. B. Katherine Biggs, Associate Director, NEPA Compliance Division, Office of Federal Activities. [ FR Doc. 02 30949 Filed 12 5 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0332; FRL 7282 6] Pesticide Products; Registration Applications AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces receipt of applications to register pesticide products containing new active ingredients not included in any previously registered products pursuant to the provisions of section 3( c)( 4) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended. DATES: Written comments, identified by the docket ID number OPP 2002 0332, must be received on or before January 6, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Richard Keigwin, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 7618; e­ mail address: keigwin. richard@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: Crop production ( NAICS 111) Animal production ( NAICS 112) Food manufacturing ( NAICS 311) Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0332. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72672 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0332 The system is an`` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0332. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC, 20460 0001, Attention: Docket ID Number OPP 2002 0332. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall# # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP 2002 0332. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the registration activity. 7. Make sure to submit your comments by the deadline in this notice. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. Registration Applications EPA received applications as follows to register pesticide products containing active ingredients not included in any previously registered products pursuant to the provision of section 3( c)( 4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications. Products Containing Active Ingredients not Included in any Previously Registered Products 1. File Symbol: 352 ANL. Applicant: E. I. du Pont de Nemours and Company. Product Name: DuPont Famoxadone ( DPX­ JE874) Technical Fungicide. Fungicide. Active ingredient: VerDate 0ct< 31> 2002 13: 52 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1 72673 Federal Register / Vol. 67, No. 235 / Friday, December 6, 2002 / Notices Famoxadone at 97.8%. Proposed classification/ Use: None. For the manufacture of fungicides only. 2. File Symbol: 352 ANU. Applicant: E. I. du Pont de Nemours and Company. Product Name: DPX­ KP481 50DF Fungicide. Fungicide. Active ingredients: Famoxadone at 25% and Cymoxanil at 25%. Proposed classification/ Use: None. For control of downy mildew in cucurbits and lettuce and for the control of early blight and late blight in potatoes and fruiting vegetables. 3. File Symbol: 3125 LLN. Applicant: Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. Product Name: KWG 4168 300 CS. Fungicide. Active ingredient: Spiroxamine at 30.9%. Proposed classification/ Use: None. For control of powdery mildew on grapes. 4. File Symbol: 3125 LLR. Applicant: Bayer CropScience. Product Name: Spiroxamine Technical. Fungicide. Active ingredient: Spiroxamine at 96.6%. Proposed classification/ Use: None. For use in the manufacture of fungicides. 5. File Symbol: 7969 ROA. Applicant: BASF Corporation, P. O. Box 13528, Research Triangle Park, NC 27709 3528. Product Name: BAS510 02F Turf Fungicide. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 70.0%. Proposed classification/ Use: None. For disease control on golf course turfgrass. 6. File Symbol: 7969 ROI. Applicant: BASF Corporation. Product Name: BAS510 F Manufacturing Use Product. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 99.0%. Proposed classification/ Use: None. For use in fungicide formulations. 7. File Symbol: 7969 ROO. Applicant: BASF Corporation. Product Name: BAS516 02 F Crop Fungicide. Fungicide. Active ingredients: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 25.2% and pyraclostrobin at 12.8%. Proposed classification/ Use: None. For use on berries, bulb vegetables, grapes, carrots, pistachio, tree nuts, stone fruits, and strawberries. 8. File Symbol: 7969 ROT. Applicant: BASF Corporation. Product Name: BAS510 02 F Crop Fungicide. Fungicide. Active ingredient: 3­ Pyridinecarboxamide, 2­ chloro­ N­( 4'­ chloro( 1,1'­ biphenyl)­ 2­ yl) at 70.0%. Proposed classification/ Use: None. For use on berries, dry and succulent beans, bulb vegetables, canola, carrots, fruiting vegetables, grapes, lettuce, peanuts, pistachio, potatoes, tree nuts, stone fruits, and strawberries. 9. File Symbol: 11656 OI. Applicant: Western Farm Services, Inc., P. O. Box 1168, Fresno, CA 93715. Product Name: Bud Break Plant Growth Regulator. Plant Growth Regulator. Active ingredients: Ammonium nitrate at 36.0% and Calcium nitrate at 31.0%. Proposed classification/ Use: None. For agricultural use only. 10. File Symbol: 62719 GTG. Applicant: Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 1054. Product Name: Quinoxyfen Technical. Fungicide. Active ingredient: Quinoxyfen at 97.7%. Proposed classification/ Use: None. For manufacturing use only. 11. File Symbol: 62719 GTL. Applicant: Product Name: Quintec. Fungicide. Active ingredient: Quinoxyfen at 22.58%. Proposed classification/ Use: None. A protectant fungicide for the control of powdery mildew on grapes and hops. 12. File Symbol: 62719 GTU. Applicant: Dow AgroSciences LLC. Product Name: Quinoxyfen Manufacturing Use Concentrate. Fungicide. Active ingredient: Quinoxyfen at 53.5%. Proposed classification/ Use: None. For manufacturing use only. List of Subjects Environmental protection, Pesticides and pest. Dated: November 26, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 02 30945 Filed 12 5 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0316; FRL 7281 5] Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request for amendments by registrants to delete uses in certain pesticide registrations. Section 6( f)( 1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be amended to delete one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any request on the Federal Register. DATES: The deletions are effective on June 4, 2003, or on January 6, 2003 for product registration 019713 00263, unless the Agency receives a withdrawal request on or before dates given above. The 30 day comment period applies to product registration 019713 00263 only. Users of these products who desire continued use on crops or sites being deleted should contact the applicable registrant on or before dates given above. ADDRESSES: Withdrawal requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP 2002 0316 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Hollins, Office of Pesticide Programs ( 7502C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5761; e­ mail address: hollins. james@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0316. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the VerDate 0ct< 31> 2002 17: 30 Dec 05, 2002 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 06DEN1. SGM 06DEN1

epa

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regulations

EPA-HQ-OPP-2002-0334-0001

Notice

Exposure Modeling Work Group; Notice of Public Meeting

77059 Federal Register / Vol. 67, No. 241 / Monday, December 16, 2002 / Notices DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Project No. 2852 015] New York State Electric & Gas Corporation, New York; Notice of Availability of Environmental Assessment December 11, 2002. In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Energy Regulatory Commission's ( Commission) regulations, 18 CFR part 380 ( Order No. 486, 52 FR 47897), the Office of Energy projects staff have reviewed the application for a nonpower license for the Keuka Hydroelectric Project, located between Waneta Lake and Lamoka Lake impoundments, and Keuka Lake in Steuben and Schuyler Counties, New York and have prepared an Environmental Assessment ( EA) for the project. The EA contains the staff's analysis of the potential environmental effects of the proposed action by the applicant, the proposed action with additional staff­ recommended measures, and no­ action. A copy of the EA is available for review in the public Reference Branch, Room 2 A, of the Commission's office at 888 First Street, NE., Washington, DC 20426. The EA may also be viewed on the web at http:// www. ferc. gov using the `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, please contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at ( 866) 208 3676, or for TTY, contact ( 202) 502 8659. Any comments should be filed within 30 days from the date of this notice and addressed to Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. Please affix `` Keuka Hydroelectric Project, FERC No. 2852 015'' to all comments. Comments may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001( a)( 1)( iii) and the instructions on the Commission's Web site under the `` e­ Filing'' link. The Commission strongly encourages electronic filings. For further information, contact Patti Leppert at ( 202) 502 6034 or by E­ mail at patricia. leppert@ ferc. gov. Magalie R. Salas, Secretary. [ FR Doc. 02 31597 Filed 12 13 02; 8: 45 am] BILLING CODE 6717 01 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0334; FRL 7283 5] Exposure Modeling Work Group; Notice of Public Meeting AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: The Exposure Modeling Work Group ( EMWG) will hold a 1 day meeting on December 17, 2002. This notice announces the location and time for the meeting and sets forth the tentative agenda topics. DATES: The meeting will be held on Tuesday, December 17, 2002, from 9 a. m. to 3 p. m. ADDRESSES: The meeting will be held at the Office of Pesticide Programs ( OPP), Environmental Protection Agency, Crystal Mall # 2, Room 311, 1921 Jefferson Davis Hwy., Arlington, VA. FOR FURTHER INFORMATION CONTACT: Michael R. Barrett, Environmental Fate and Effects Division ( 7507C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 6391; fax number: ( 703) 308 6309; email address: barrett. michael@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under the Toxic Substances Control Act ( TSCA), the Federal Food, Drug, and Cosmetic Act ( FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0334. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crstal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background The Exposure Modeling Workgroup meets on a roughly quarterly interval to discuss current issues in modeling pesticide fate, transport, and exposure to pesticides in support of risk assessments in a regulatory context. III. How Can I Request to Participate in this Meeting? You may submit a request to participate in this meeting to the person listed under FOR FURTHER INFORMATION CONTACT. IV. Tentative Agenda This unit provides tentative agenda topics for the 1 day meeting. 1. Welcome and introductions. 2. Old action items. 3. Brief Updates EPA's pesticide root zone model/ exposure analysis modeling system ( PRZM/ EXAMS) model. Spray drift task force progress. Rice modeling. European union activities. United States Department of Agriculture ( USDA) agricultural research service activities. VerDate 0ct< 31> 2002 15: 13 Dec 13, 2002 Jkt 200001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16DEN1. SGM 16DEN1 77060 Federal Register / Vol. 67, No. 241 / Monday, December 16, 2002 / Notices Environmental fate data base. New meteorological files. Turf umbrella. WARP model. 4. Major Topics EFED water quality priorities for FY 2003 ­ themes for 2003. European Union activities: FOCUS ground water and surface water assessment methods, mitigation measures and processes for refining risk assessments. Prospective ground water data base ­ data reporting and formatting issues. USDA research service ­ efforts to address needs of regulators in their pesticide mitigation and modeling research, results of recent workshop. List of Subjects Environmental protection, Pesticides and pests. Dated: December 10, 2002. Steven Bradbury, Director, Environmental Fate and Effects Division, Office of Pesticide Programs. [ FR Doc. 02 31613 Filed 12 12 02; 9: 03 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPPT 2002 0072; FRL 7284 9] Certain New Chemicals; Receipt and Status Information AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: Section 5 of the Toxic Substances Control Act ( TSCA) requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice ( PMN) or an application for a test marketing exemption ( TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from November 2, 2002 to November 19, 2002, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. DATES: Comments identified by the docket ID number OPPT 2002 0072 and the specific PMN number or TME number, must be received on or before January 15, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics ( 7408M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 202) 554 1404; e­ mail address: TSCAHotline epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT 2002 0072. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102­ Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566 1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566 0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the VerDate 0ct< 31> 2002 15: 13 Dec 13, 2002 Jkt 200001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 16DEN1. SGM 16DEN1

epa

2024-06-07T20:31:45.449421

regulations

EPA-HQ-OPP-2002-0342-0001

Notice

Imazamox; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

78229 Federal Register / Vol. 67, No. 246 / Monday, December 23, 2002 / Notices SIP, the order requires EPA Region 8 to review the SIP itself to determine whether emissions exception provisions are contrary to EPA policy. Finally, the Administrator's order denies the petition's claim that `` new information'' about smoke filling the town of Buffalo, Wyoming, and the source's compliance history show a need for continuous monitoring. The petitioner's request is denied because the issue of monitoring has been adequately addressed above, and petitioners failed to demonstrate that any applicable requirement is missing from the permit or that the permit otherwise fails to comply with the requirements of the regulation. Additional explanation for the Administrator's decision can be found in the order. Patricia D. Hull, Acting Regional Administrator, Region 8. [ FR Doc. 02 32261 Filed 12 20 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0342; FRL 7284 5] Imazamox; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0342, must be received on or before January 22, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 308 3194; e­ mail address: brothers. shaja@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0342. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards roviding electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical VerDate 0ct< 31> 2002 15: 36 Dec 20, 2002 Jkt 200001 PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23DEN1. SGM 23DEN1 78230 Federal Register / Vol. 67, No. 246 / Monday, December 23, 2002 / Notices objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0342 The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0342. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0342. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0342. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. VerDate 0ct< 31> 2002 15: 36 Dec 20, 2002 Jkt 200001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23DEN1. SGM 23DEN1 78231 Federal Register / Vol. 67, No. 246 / Monday, December 23, 2002 / Notices Dated: December 12, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408( d)( 3). The summary of the petition was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. Interregional Research Project Number 4 and BASF Corporation PP 2E6472 EPA has received a pesticide petition ( 2E6472) from Interregional Research Project Number 4 ( IR 4), 681 U. S. Highway # 1 South, North Brunswick, NJ 08902 3390 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180. Subpart D by establishing an exemption from the requirement of a tolerance for imazamox,( )­ 2­ 4,5­ dihydro­ 4­ methyl­ 4­( 1­ methylethyl)­ 5­ oxo­ 1H­ imidazol­ 2­ yl­ 5­ ( methoxymethyl)­ 3­ pyridinecarboxylic acid in or on all raw and processed agricultural commodities. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. This notice includes a summary of the petition prepared by BASF Corporation, Research Triangle Park, 27709. A. Residue Chemistry 1. Plant metabolism. EPA has concluded that the nature of the residue is adequately understood and the residues of concern are the parent imazamox only. 2. Analytical method. Since imazamox and its metabolic degradates are not of toxicological concern, analytical methods are not applicable. 3. Magnitude of residues. Since imazamox and its metabolic degradates are not of toxicological concern, and this petition is a request for an exemption from a tolerance, the magnitude of residues is not applicable. B. Toxicological Profile 1. Acute toxicity. Imazamox technical is considered to be nontoxic ( toxicity category IV) to the rat by the oral route of exposure. In the acute oral toxicity study in rats, the lethal dose LD50 value of imazamox technical was greater than 5,000 milligram/ kilogram body weight ( mg/ kg bwt) for males and females. The results from the acute dermal toxicity study in rabbits indicate that imazamox is slightly toxic ( toxicity category III) to rabbits by the dermal exposure. The dermal LD50 value of imazamox technical was greater than 4,000 mg/ kg bwt for both male and female rabbits. Imazamox technical is considered to be nontoxic ( toxicity category IV) to the rat by the respiratory route of exposure. The 4 hour lethal concentration LC50 value was greater than 6.3 milligrams/ Liter ( mg/ L) ( analytical) for both males and females. Imazamox technical was shown to be non­ irritating to slightly irritating to rabbit skin ( toxicity category IV). Based on the results of a dermal sensitization study ( Buehler), imazamox technical is not considered a sensitizer in guinea pigs. 2. Genotoxicity. Imazamox technical was tested in the following four assays measuring several different endpoints of potential genotoxicity. Collective results from these studies indicate that imazamox does not pose a mutagenic or genotoxic risk. i. Bacterial mutagenicity assay ­ negative. ii. In vitro structural chromosomal aberration assay ­ negative. iii. In vitro chinese hampster ovary/ hypoxanthine guanine phophoribosyl transferase ( CHO/ HGPRT) assay ­ negative. iv. In vivo micronucleus aberration assay ­ negative. 3. Reproductive and developmental toxicity. The development toxicity study in rats conducted with imazamox technical showed no evidence of teratogenic effects in fetuses and no evidence of developmental toxicity. Thus, imazamox is neither a developmental toxicant nor a teratogen in the rat. The results from this study supported a no observed adverse effect level ( NOAEL) for developmental toxicity of 1,000 mg/ kg bwt/ day, the highest dose tested ( HDT) and limit dose. The NOAEL for maternal toxicity was 500 mg/ kg bwt/ day, based on reduced mean body weights, weight gains and food consumption at 1,000 mg/ kg bwt/ day. Results from a developmental toxicity study in rabbits conducted with imazamox technical also indicated no evidence of teratogenicity or developmental toxicity. Thus, imazamox technical is neither a developmental toxicant nor a teratogen in the rabbit. In the rabbit developmental toxicity study, the NOAEL for maternal toxicity was 300 mg/ kg bwt/ day, based on decreased food consumption at 600 mg/ kg bwt/ day, the next HDT. The NOAEL for developmental toxicity was 900 mg/ kg bwt/ day, the HDT. The results from the 2 generation reproduction toxicity study in rats with imazamox technical support a NOAEL for parental and reproductive toxicity of 20,000 parts per million ( ppm) ( or approximately 1,639 mg/ kg bwt/ day, calculated from the food consumption data), the highest concentration tested ( HCT). The NOAEL for growth and development of offspring is also 20,000 ppm ( or approximately 1,639 mg/ kg bwt/ day). Results from the reproduction study and the developmental toxicity studies conducted with imazamox technical show no increased sensitivity to developing offspring as compared to parental animals, because the NOAELs for growth and development of offspring were equal to or greater than the NOAELs for parental or maternal toxicity. 4. Subchronic toxicity. No treatmentrelated adverse effects were noted in subchronic toxicity studies at the HDT. A short­ term ( 28 day) dermal study in rabbits was conducted with imazamox technical. No dermal irritation or systemic toxicity was observed at dose levels up to and including 1,000 mg/ kg bwt/ day HDT, supporting a NOAEL of 1,000 mg/ kg bwt/ day. In a subchronic ( 13 week) dietary toxicity study in rats with imazamox technical, no signs of systemic toxicity were noted, supporting a NOAEL of 20,000 ppm ( or approximately 1,661 mg/ kg bwt/ day, calculated from food consumption data), the HCT. In a subchronic ( 90 day) dietary toxicity study in dogs with imazamox technical, no signs of systemic toxicity were noted, supporting a NOAEL of 40,000 ppm ( or approximately 1,368 mg/ kg bwt/ day, calculated from the food consumption data), the HCT. 5. Chronic toxicity. The low order of mammalian toxicity of imazamox technical is also evident from the chronic dietary toxicity studies. These studies showed no increased mortalities or clinical signs of toxicity attributed to imazamox treatment. Moreover, there were no treatment­ related effects on food consumption, body weights, organ weights, or hematology, clinical chemistry, urinalysis or ophthalmologic parameters. There was no gross or microscopic evidence of treatmentrelated lesions or carcinogenicity in the VerDate 0ct< 31> 2002 15: 36 Dec 20, 2002 Jkt 200001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23DEN1. SGM 23DEN1 78232 Federal Register / Vol. 67, No. 246 / Monday, December 23, 2002 / Notices three chronic studies conducted in dogs, mice or rats. A 1 year dietary study was conducted with imazamox technical in dogs at dietary concentrations of 0, 1,000, 10,000, and 40,000 ppm. The NOAEL for this study was 40,000 ppm ( or approximately 1,165 mg/ kg bwt/ day, based on food consumption), the HCT. A chronic feeding/ carcinogenicity study was conducted with imazamox technical in male and female rats at dietary concentrations of 0, 1,000, 10,000, and 20,000 ppm. The NOAEL for systemic toxicity and carcinogenicity was 20,000 ppm ( or approximately 1,167 mg/ kg bwt/ day, based on food consumption) the HCT. A chronic feeding/ carcinogenicity study was conducted with imazamox technical in male and female mice at dietary concentration of 500, 3,500, and 7,000 ppm. The NOAEL for systemic toxicity and carcinogenicity was 7,000 ppm ( or approximately 1,201 mg/ kg bwt/ day, based on food consumption), the HCT. 6. Animal metabolism. The qualitative nature of the residues of imazamox and its metabolites CL 263284 and CL 263284' s carboxylate AC 312622 in animals is adequately understood. Based on metabolism studies with goats, hens and rats, there is no reasonable expectation that measurable imazamoxrelated residues will occur in meat, milk, poultry or eggs from the proposed use. 7. Metabolite toxicology. No toxicologically significant metabolites were detected in plant or animal metabolism studies for soybeans or the rest of the crops in the legume vegetable crop grouping ( 6) or canola. Therefore, no metabolites need to be regulated in these crops. The plant metabolism study in wheat indicated very low residues of concern. A very small amount of the metabolite CL 263284 was found in the wheat grain. The plant metabolism in alfalfa indicated very low residues in the alfalfa seed. However, the parent imazamox underwent metabolism to the metabolite CL 263284 ( the same metabolite seen in wheat). This metabolite was captured by a glucose molecule to form the glucose conjugate CL 189215 and the hydroxymethyl AC 263284 was also further oxidized to the carboxylate metabolite CL 312622. Both metabolites, CL 263284 and CL 312622 were present in the rat metabolism study. No additional toxicologically significant metabolites were detected in any plant or animal studies. 8. Endocrine disruption. Collective organ weight data and histopathological findings from the 2 generation rat reproductive study, as well as from the sub­ chronic and chronic toxicity studies conducted in two or more animal species, demonstrate no apparent estrogenic effects or effects on the endocrine system. There is no information available that suggests that imazamox would be associated with endocrine effects. C. Aggregate Exposure 1. Dietary exposure i. Food. Residues of imazamox and its metabolic degradates are not of toxicological concern. Therefore, dietary exposure through he food is not a concern. ii. Drinking water. Residues of imazamox and its metabolic degradates are not of toxicological concern. Therefore, dietary exposure through water is not a concern. 2. Non­ dietary exposure. There is no available information quantifying nondietary exposure to imazamox. However, based on the physical and chemical characteristics of the compound, the proposed use pattern and available information concerning its environmental fate, non­ dietary exposure is not expected. D. Cumulative Effects Because of the low toxicity of imazamox and its metabolic degradates, there is no concern regarding the potential for cumulative effects of imazamox and its degradates with other substances with a common mode of action. Imazamox belongs to the imidazolinone class of chemistry. The herbicidal activity of the imidazolinones is due to the inhibition of acetohydroxy acid synthase ( AHAS), an enzyme only found in plants. AHAS is part of the biosynthetic pathway leading to the formation of branched­ chain amino acids. Animals lack AHAS and this biosynthetic pathway. This lack of AHAS contributes to the low toxicity of imazamox in mammals. We are aware of no information to indicate or suggest that imazamox has any toxic effects on mammals that would be cumulative with those of any other chemical. Since imazamox is relatively non­ toxic, cumulative effects of residues of imazamox and other chemicals are not anticipated. Therefore, for the purposes of this tolerance petition, no assumption has been made with regard to cumulative exposure with other chemicals having a common mode of herbicidal action. E. Safety Determination 1. U. S. population. Because imazamox and its degradates are not of toxicological concern and there is low exposure to imazamox and its degradates, this exemption from the requirement of a tolerance in or on all raw agricultural commodities will not pose a dietary risk under reasonably foreseeable circumstances. 2. Infants and children. Likewise, because imazamox and its degradates are not of toxicological concern and there is low exposure to imazamox and its degradates, this exemption from the requirement of a tolerance in or on all raw agricultural commodities will not pose a dietary risk under reasonably foreseeable circumstances to the U. S. population sub­ group of infants and children. F. International Tolerances There is no Codex maximum residue level established for residues of imazamox on any crops. FR Doc. 02 32260 Filed 12 20 02; 8: 45 a. m.] BILLING CODE 6560 50 S FARM CREDIT ADMINISTRATION Farm Credit Administration Board; Special Meeting AGENCY: Farm Credit Administration. SUMMARY: Notice is hereby given, pursuant to the Government in the Sunshine Act ( 5 U. S. C. 552b( e)( 3)), of the special meeting of the Farm Credit Administration Board ( Board). DATE AND TIME: The special meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on December 20, 2002, from 9 a. m. until such time as the Board concludes its business. FOR FURTHER INFORMATION CONTACT: Jeanette C. Brinkley, Acting Secretary to the Farm Credit Administration Board, ( 703) 883 4009, TTY ( 703) 883 4056. ADDRESSES: Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102 5090. SUPPLEMENTARY INFORMATION: This meeting of the Board will be open to the public ( limited space available). In order to increase the accessibility to Board meetings, persons requiring assistance should make arrangements in advance. The matters to be considered at the meeting are: Open Session A. Approval of Minutes November 7, 2002 ( Open and Closed) B. Reports FCS Building Association's Quarterly Report Federal Farm Credit Banks Funding Corporation Update C. New Business Regulations Proposed Rule Disclosure of Effective Interest Rates VerDate 0ct< 31> 2002 15: 36 Dec 20, 2002 Jkt 200001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 23DEN1. SGM 23DEN1

epa

2024-06-07T20:31:45.453127

regulations

EPA-HQ-OPP-2002-0343-0001

Notice

Prosulfuron; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical in or on Food

79914 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices conference meeting. See below for time limitations on public comments. Members of the public desiring additional information about the meeting locations must contact Ms. Zisa Lubarov­ Walton, EPA Science Advisory Board ( 1400A), Suite 6450FF, U. S. EPA, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone/ voice mail at ( 202) 564 4533; fax at ( 202) 501 0582; or via e­ mail at lubarovwalton zisa@ epa. gov. A copy of the draft agenda, and other information for the review for each meeting, will be posted on the SAB Web site ( www. epa. gov/ SAB/ whatsnew. htm) approximately 10 days before that meeting. ( a) Availability of Review Materials Materials that are the subject of this review are available from Ms. Laura Miner­ Nordstrom, Office of the Chief Financial Officer or from Mr. Kevin Teichman, Office of Research and Development. Ms. Laura Miner­ Nordstrom can be reached on ( 202) 564 1601 or by e­ mail at Miner­ Nordstrom. Laura@ epa. gov and Mr. Teichman can be reached on ( 202) 564 6705 or via e­ mail on teichman. kevin@ epa. gov. ( b) Meeting Access Individuals requiring special accommodation at this meeting, including wheelchair access to the conference room, should contact Mr. Miller at least five business days prior to the meeting so that appropriate arrangements can be made. ( c) General Information Additional information concerning the Science Advisory Board, its structure, function, and composition, may be found on the SAB Web site ( http:// www. epa. gov/ sab) and in the Science Advisory Board FY2001 Annual Staff Report which is available from the SAB Publications Staff at ( 202) 564 4533 or via fax at ( 202) 501 0256. 4. Providing Oral or Written Comments at SAB Meetings It is the policy of the EPA Science Advisory Board to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EPA Science Advisory Board expects that public statements presented at its meetings will not be repetitive of previously submitted oral or written statements. Oral Comments: In general, each individual or group requesting an oral presentation at a face­ to­ face meeting will be limited to a total time of ten minutes ( unless otherwise indicated). For teleconference meetings, opportunities for oral comment will usually be limited to no more than three minutes per speaker and no more than fifteen minutes total. Deadlines for getting on the public speaker list for a meeting are given above. Speakers should bring at least 35 copies of their comments and presentation slides for distribution to the reviewers and public at the meeting. Written Comments: Although the SAB accepts written comments until the date of the meeting ( unless otherwise stated), written comments should be received in the SAB Staff Office at least one week prior to the meeting date so that the comments may be made available to the review panel for their consideration. Comments should be supplied to the appropriate DFO at the address/ contact information noted above in the following formats: one hard copy with original signature, and one electronic copy via e­ mail ( acceptable file format: Adobe Acrobat, WordPerfect, Word, or Rich Text files ( in IBM­ PC/ Windows 95/ 98 format). Those providing written comments and who attend the meeting are also asked to bring 35 copies of their comments for public distribution. Dated: December 24, 2002. Robert Flaak, Acting Director, EPA Science Advisory Board Staff Office. [ FR Doc. 02 32987 Filed 12 30 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0343; FRL 7284 7] Prosulfuron; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of prosulfuron in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0343, must be received on or before January 30, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 5697; e­ mail address: tompkins. jim@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Crop production ( NAICS code 111) Animal production ( NAICS code 112) Food manufacturing ( NAICS code 311) Pesticide manufacturing ( NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0343. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00014 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79915 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0343. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0343. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0343. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0343. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79916 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 20, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petitions The petitioner's summary of the pesticide petitions is printed below as required by FFDCA section 408( d)( 3). The summary of the petitions was prepared by the petitioner and represents the view of the petitioner. The petitions summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. EPA has received pesticide petitions ( PP 5F4469) and ( PP 4F4336), from Syngenta Crop Protection, Inc., P. O. Box 18300, Greensboro, NC 27419 8300 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing a tolerance for residues of prosulfuron, 1­( 4­ methoxy­ 6­ methyl­ triazin­ 2­ yl)­ 3­ [ 2­( 3,3,3­ trifluoropropyl)­ phenylsulfonyl]­ urea in or on the raw agricultural commodities, cereal grains group ( except rice and wild rice) grain at 0.01 parts per million ( ppm), cereal grains group ( except rice and wild rice) forage at 0.10 ppm, cereal grains group ( except rice and wild rice) fodder at 0.01 ppm, cereal grains group ( except rice and wild rice) straw at 0.02 ppm, cereal grains group ( except rice and wild rice) hay at 0.20 ppm, milk at 0.01 ppm, meat, fat, kidney, liver, and meat byproducts of cattle, goats, hogs, horses, and sheep at 0.05 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. This is a revised notice of filing to amend a previous notice of filing published in the Federal Register of August 25, 1999 ( FR 64 46382) ( FRL 6093 7), to propose permanent tolerances, instead of the current timelimited tolerances for prosulfuron. A. Residue Chemistry 1. Plant metabolism. The nature of the residue of prosulfuron in corn is adequately understood. Significant pathways involve oxidation of the phenyl ring to give 5 hydroxy prosulfuron, which is followed by sugar conjugation. Hydrolytic cleavage of the sulfonylurea bridge occurs for both prosulfuron and 5 hydroxy prosulfuron, yielding the corresponding sulfonamide and triazine amine moieties. The sulfonamide metabolites are subsequently conjugated with sugars. Demethylation of the triazine amine results in the formation of the corresponding hydroxy triazine, which is further hydrolyzed at the amino group to form the dihydroxy triazine. 2. Analytical method. Adequate analytical methods exist for the detection and measurement of residue levels of prosulfuron in or on raw and processed commodities of cereal grains, and for meat, milk and eggs. The limit of quantitation ( LOQ) is 0.01 ppm for crop commodities, processed fractions and milk, and 0.05 ppm for meat and eggs. The method is based on commodity­ specific cleanup procedures followed by determination by high performance liquid chromatography with ultraviolet ( UV) detection. 3. Magnitude of residues. Complete, full geography residue programs, including processing, have been conducted on corn, wheat and grain sorghum. A three­ level dairy animal feeding study to determine the transfer of residues of prosulfuron from animal feed commodities to meat and milk has also been conducted. B. Toxicological Profile 1. Acute toxicity. EPA has set an acute reference dose of 0.1 milligram/ kilogram/ day ( mg/ kg/ day) based upon a no observed adverse effect level ( NOAEL) of 10 mg/ kg/ day from the rat acute neurotoxicity study ( lowest observed adverse effect level ( LOAEL) of 250 mg/ kg/ day due to reduced motor activity and body temperature in males and impaired righting reflex in females) and a 100 fold uncertainty factor ( UF). 2. Genotoxicty. Prosulfuron was negative for mutagenic/ genotoxic effects when tested in a bacterial reverse gene mutation assay with and without metabolic activation using different S. typhimurium and E. coli stains; in a mammalian gene mutation study using V79 cells; in an in vitro mammalian cytogenetic test using Chinese hamster ovary ( CHO) cells with and without metabolic activation; in a micronucleus test in mice; and in a DNA­ repair using freshly isolated rat liver hepatocytes. 3. Reproductive and developmental toxicity. The data base on prosulfuron relative to prenatal and postnatal effects for children is considered to be essentially complete with no data gaps. The developmental and reproductive toxicity data do not indicate increase susceptibility of rats or rabbits to in utero and/ or postnatal exposure to VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79917 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices prosulfuron. In a rat teratology study, evidence of maternal toxicity ( decreased body weight gain and reduced food consumption) and developmental toxicity ( increased incidence of skeletal variations that was not significantly different from the historical control) was found at the maximum tolerated dose of 400 mg/ kg. There was no evidence of teratogenicity at any dose, and the maternal and developmental NOAELs were established at 200 mg/ kg. In a rabbit teratology study, maternal toxicity ( decreased body weight gain and reduced food consumption) was observed in the 100 mg/ kg dose group. There was no evidence of teratogenicity at any dose. Since a range­ finding rabbit teratology study had seen additional clinical findings and fetotoxicity at maternally toxic doses ( 150 mg/ kg) but not in the definitive study at up to 100 mg/ kg, a second rabbit teratology study was conducted at doses of 0, 20, 100, and 200 mg/ kg/ day. Maternal toxicity was observed at 200 mg/ kg. The developmental NOAEL was 100 mg/ kg and the maternal NOAEL was 20 mg/ kg in this study. There was no evidence of teratogenicity at any dose. A rat multigenerational reproduction study indicated reproductive and systemic NOAELs of 13.3 mg/ kg/ day based on decreased mean body weights and body weight gain observed at 136 mg/ kg/ day for both pups and parental animals. No treatment­ related effects on reproductive performance ( i. e., to produce, deliver or raise litters), litter sizes, viability of pups, and necropsy findings in parental animals and offspring were noted up to the highest dose level. 4. Subchronic toxicity. The liver was identified as a target organ at high doses in the rat, mouse, and dog as indicated by slightly increased liver enzymes and liver weights. No histomorphologic correlates of liver damage was noted in the 90 day studies except in the mouse study where centrilobular hypertrophy was found in males at feeding levels 1,750 ppm and in females at levels 3,500 ppm. In general, NOAELs for target organ effects were established at doses that were much higher than overall study NOAELs, which were based on other indicators of toxicity such body weight gain. 5. Chronic toxicity. In the 1 year dog chronic dosing study, the NOAEL was 1.84 mg/ kg/ day based on hematologic and clinical chemistry effects and incidence of lipofuscin accumulation in the liver at 18.6 mg/ kg/ day. In the 18 month mouse carcinogenicity study, there was no evidence of carcinogenic effects up to the highest dose tested ( HDT) of 1,062 mg/ kg/ day. The NOAEL was 1.71 mg/ kg/ day in males, and 100 mg/ kg/ day in females based on increased incidence/ severity of centrilobular hepatocellular hypertrophy. A 2 year chronic feeding/ carcinogenicity study in rats indicated systemic NOAEL of 7.9 mg/ kg/ day was based on decreased body weight and body weight gain, hematopoietic effects ( males), and possibly increased serum GGT and decreased liver, kidney, and adrenal weights ( females) at 79.9 mg/ kg/ day. There was uncertain evidence of carcinogenicity with slight increases in the incidence of mammary gland adenocarcinomas in females at 95.7 and 205.8 mg/ kg/ day, slight increase in incidence of benign testicular interstitial cell tumors at 79.9 and 160.9 mg/ kg/ day ( significant trend only). Considering the weight of the evidence, the EPA Reference Dose Committee previously concluded that the chemical should be classified as a Group D carcinogen ( inadequate evidence), not classifiable as to human carcinogenicity. The HIARC ( meeting December 2, 1999) accepted the previous conclusions and updated the cancer classification to the new classification: `` data are inadeqate,'' with no new studies required. EPA has set a chronic reference dose of 0.02 mg/ kg based on a NOAEL of 1.84 mg/ kg in a dog feeding study and a 100 fold UF. 6. Animal metabolism. The metabolic pathways in the rat, goat, and hen are similar and are adequately understood. Prosulfuron is rapidly absorbed from the gastrointestinal ( GI) tract of rats and is rapidly excreted. Approximately 90% of the administered dose is excreted during the first 48 hours, predominately via urine. Tissue residues are low. Prosulfuron is metabolized primarily via hydroxylation at side chain and phenyl ring positions and O­ demethylation of the triazyl methoxy group. Minor pathways include unsaturation of the trifluoropropyl side chain, hydrolysis of the phenylsulfonylurea bridge and oxidative/ hydrolytic cleavage of the triazine ring system. In the goat, the orally administered prosulfuron is quickly eliminated primarily via the urine as prosulfuron. The metabolism of prosulfuron in the goat follows a similar pathway as observed in the rat although not as extensive. The majority of the residues were accounted for as prosulfuron, the triazine amine, which results from bridge hydrolysis ( CGA 150829) and the triazinyl hydroxymethyl metabolite ( CGA 273437). In the hen, metabolism is similar to that observed in the rat and goat. The major residues found in edible tissues and eggs were prosulfuron, the triazine amine ( CGA 150829), and the sulfonamide ( CGA 159902) which results from hydrolysis of the sulfonylurea bridge. 7. Metabolite toxicology. Metabolic pathways of prosulfuron in plants and animals are comparable and no detectable residues are found in or on crops. All relevant plant metabolites are observed in the animals and are thus toxicologically covered. The remaining plant metabolites are toxicologically insignificant. Therefore, parent prosulfuron is the appropriate compound for the tolerance expression and analytical monitoring. 8. Endocrine disruption. Prosulfuron does not belong to a class of chemicals known for having significant adverse effects on the endocrine system. Developmental toxicity studies in rats and rabbits and reproduction study in rats gave no indication that prosulfuron might have any effects on endocrine function related to development and reproduction. The subchronic and chronic studies also showed no evidence of a long­ term effect related to the endocrine system. C. Aggregate Exposure 1. Dietary exposure. Acute and chronic dietary exposure assessments were conducted for prosulfuron using tolerance values published in 40 CFR 180.481. In both assessments it was assumed that 100% of all corn and cereal grains were treated with prosulfuron ( 100% market share). The exposure analyses was conducted using food consumption data from USDA's 1994 1996 Continuing Survey of Intake by Individuals ( CSFII) and Novigen Sciences, Inc. Dietary Exposure Evaluation Model ( DEEM). i. Food. Chronic exposure was compared to a RfD of 0.02 mg/ kg based on a NOAEL of 1.84 mg/ kg in a dog feeding study and a 100 fold UF. This exposure analysis showed that the U. S. population had an exposure of less than 1% of the chronic RfD. The most sensitive subpopulation was children ( 1 6 years old) with a chronic exposure of 2.4%. Acute exposure was compared to an acute RfD of 0.1 mg/ kg, which was based on a NOAEL of 10 mg/ kg from an acute neurotoxicity study in the rat and a 100 fold UF. The most sensitive subpopulation was all infants with an exposure of 2.2% of the acute RfD. The U. S. population showed an exposure of 1.5% of the RfD. These results show that there is more than a reasonable certainty of no harm, through exposure to prosulfuron residues in the diet. ii. Drinking water. For estimated surface water concentrations using generic expected environmental concentration ( GENEEC), the peak day VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79918 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices 0 estimate, 1.86 parts per billion ( ppb), was used in the acute exposure analysis and the corrected 56 day drinking water concentration of 0.4667 ppb was used in the chronic exposure analysis. The SCIGROW estimated ground water concentration for the prosulfuron uses of 0.406585 ppb contributed little to the overall exposure. The acute drinking water levels of concern ( DWLOC) for prosulfuron were based on the acute RfD, a margin of exposure ( MOE), the 99.9th percentile of the acute dietary exposure for U. S. population subgroups and the body weight ­ daily water consumption of each respective subgroup. The calculated acute DWLOC values for the population subgroups ranged from 978 3447 ppb. The estimated ground water concentration ( 0.406585 ppb) and the peak day 0 surface water concentration ( 1.86 ppb) of prosulfuron did not exceed the acute DWLOC values. The chronic ( noncancer DWLOC for prosulfuron were based on the chronic RfD, any estimated residential exposure, the chronic dietary exposure for select U. S. population subgroups and the body weight ­ daily water consumption of each respective subgroup. The calculated chronic DWLOC values for the population subgroups ranged from 197 694. The estimated ground water concentration ( 0.406585 ppb) and the corrected average 56 day surface water concentration ( 0.4667 ppb) of prosulfuron did not exceed the chronic DWLOC values. Therefore, there is reasonable certainty that the residues of prosulfuron in the drinking water would not result in unacceptable levels of acute or chronic aggregate human health risk, and that such exposure would not exceed the exposure allowable by the risk cup. Nondietary exposure. Nondietary exposure to prosulfuron is considered negligible as the chemical is registered for agricultural use only. For workers handling this chemical, acceptable MOE ( in the range of thousands) have been obtained for both acute and chronic scenarios. D. Cumulative Effects Consideration of a common mechanism of toxicity is not appropriate at this time since there is no information to indicate that toxic effects produced by prosulfuron would be cumulative with those of any other types of chemicals. E. Safety Determination 1. U. S. population. The calculation shows that less than 1% of the RfD will be utilized for the U. S. population based on chronic toxicity endpoints. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. It is concluded that there is a reasonable certainty that no harm will result from aggregate exposure to prosulfuron residue. 2. Infants and children. The calculated percent of the RfD that will be utilized by aggregate exposure to residues of prosulfuron is only 2.4% for children ( 1 to 6 years old), the most impacted subpopulation. There were no adverse reproductive or developmental effects indicated in the prosulfuron toxicity data base, which is considered to be essentially complete with no data gaps. It is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to prosulfuron residues. F. International Tolerances No codex MRLs have been established for residues of prosulfuron. [ FR Doc. 02 32988 Filed 12 30 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0349; FRL 7285 6] Flumioxazin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0349, must be received on or before January 30, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 6224; e­ mail address: Miller. Joanne@ epamail. epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Crop production ( NAICS 111) Animal production ( NAICS 112) Food manufacturing ( NAICS 311) Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0349. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1

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EPA-HQ-OPP-2002-0346-0002

Supporting & Related Material

Page 1 of 9 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 14, 2002 MEMORANDUM SUBJECT: Propionic Acid. HED Science Assessment for Tolerance Reassessment Eligibility Decision. PC Code 077702. DP Barcode D279285. FROM: Christina Jarvis, Environmental Protection Specialist Reregistration Branch II Health Effects Division ( 7509C) THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division ( 7509C) TO: Joseph Nevola, Chemical Review Manager Special Review Branch Special Review and Reregistration Division ( 7508W) Attached is the tolerance reassessment decision document for propionic acid, prepared by the Health Effects Division ( HED). This decision document updates the tolerance exemptions for propionic acid issued by the EPA in May, 1984, based on a review of the toxicology database and available information on propionic acid. In summary, HED concludes that propionic acid and its sodium and calcium salts are exempt from all tolerance requirements when used as an active ingredient and/ or as inert ingredients. Furthermore, a FQPA safety factor analysis is not required for propionic acid. Page 2 of 9 1.0 EXECUTIVE SUMMARY 1.1 Background Information and Statement of Purpose The Reregistration Eligibility Decision ( RED) Document for propionic acid ( PC Code 077702) was completed in September 1991 and concluded that all products containing propionic acid as the active ingredient were eligible for reregistration. However, since the RED was issued prior to the passage of the Food Quality Protection Act ( FQPA) of 1996, a tolerance reassessment eligibility decision, or TRED, is now required by the Agency for propionic acid. This document addresses possible exposures to residues of propionic acid in food, drinking water, and from residential sources as pursuant to FQPA, and makes a conclusion on the tolerance reassessment of propionic acid. 1.2 Regulatory History Active Ingredient Status Propionic acid was first registered for pesticidal use in the early 1970' s. As an active ingredient, it is formulated into products that control fungi and bacteria in stored grains, hay, storage areas for silage and grains, poultry litter, and poultry and livestock drinking water. Calcium and sodium propionate ( salts of propionic acid) are not currently registered for use as pesticide active ingredients. The tolerance exemptions that were established for calcium and sodium propionate in 40 CFR 180.2( a) and 40 CFR 180.1015 have been revoked. Inert Status Propionic acid, calcium propionate, and sodium propionate may be found as inert ingredients in various pesticide formulations. An inert ingredient is defined by the Agency as " any ingredient in the product that is not intended to affect a target pest." The law does not require inert ingredients, or " other ingredients," to be identified by name and percentage on the label, but the total percentage of such ingredients must be declared. Propionic acid and sodium propionate are both identified on the Agency's " List 4B" of inert ingredients. Inert ingredients listed on List 4B have sufficient data to substantiate they can be used safely in pesticide products. When an inert reaches List 4B, no further regulatory action is anticipated. Calcium propionate is identified on the Agency's " List 3" of inert ingredients, meaning that it is of " unknown toxicity." While the Agency has reclassified many List 3 inerts as List 4B inerts, it is uncertain whether or not calcium propionate is one of these inerts. The Office of Pesticide Program's Inerts Workgroup recommends that calcium propionate be classified as a List 4B inert ingredient. Page 3 of 9 Affirmation as GRAS In May 1984, propionic acid, calcium propionate, and sodium propionate were affirmed as Generally­ Recognized­ As­ Safe ( GRAS) by the Food and Drug Administration ( FDA) for use as direct food additives ( i. e., as chemical preservatives and antimicrobial agents in food). The specifications for the affirmation of propionic acid, calcium propionate, and sodium propionate as GRAS chemicals are listed in 21 CFR 184.1081, 184.1221, and 184.1784, respectively, and can be summarized as follows: " The ingredient is used in food with no limitation other than current good manufacturing practice." Tolerance Exemptions The following tolerance exemptions for propionic acid are listed in 40 CFR 180.1023: 1. Residues in/ on the following raw agricultural commodities following postharvest application ( as a fungicide): alfalfa, barley grain, Bermuda grass, bluegrass, brome grass, clover, corn grain, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard grass, peanut hay, peavine hay, rye grass, sorghum grain, soybean hay, sudan grass, timothy, vetch, and wheat grain. 2. Residues in/ on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, and eggs when applied as a bactericide/ fungicide to livestock drinking water, poultry litter, and storage areas for silage and grain. 3. Residues in/ on the following raw agricultural commodities following postharvest application ( as a fungicide): cottonseed, peanuts, rice grain, and soybeans. Propionic acid is also exempt from the requirement for a tolerance when used in accordance with good agricultural practice as inert ( or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest as described in 40 CFR 180.1001( c). 1.3 Use Profile Active Ingredient Uses Propionic acid is a fungicide and bactericide registered to control fungi and bacteria in stored grains, hay, grain storage areas, poultry litter, and drinking water for livestock and poultry. A search of REFS on 11/ 07/ 01 shows propionic acid is formulated as a soluble concentrate ( 10 percent a. i. to 70.5 percent a. i.), ready­ to­ use solution ( 39.2 percent a. i. to 100 percent a. i.), and as a granular ( one formulation; 15 percent a. i.). The Agency notes that REFS incorrectly lists Page 4 of 9 EPA Reg. No. 53824­ 2 ( P­ 7 Grain Preservative) as a granular formulation. A review of the P­ 7 Grain Preservative label shows that it is actually a liquid. The are currently 17 active products containing propionic acid. Labels state that propionic acid may be applied using a low­ pressure spray system equipped with adequately arranged and calibrated nozzles to provide the desired coverage to grain as it is moved into storage, or to hay just prior to baling and stacking. For use on poultry litter, it is diluted with water and applied to the surface of the litter as a spray. For grain storage areas ( silos), it is diluted with water and applied to the surfaces of the storage areas as a spray. Propionic acid is poured directly into drinking water for livestock and poultry. Other application methods may include low­ and high­ pressure hand wands, and a backpack sprayer. Application rates of propionic acid depend on the moisture content of the grain at the time it is placed in storage, and also vary depending on whether the grains are in " open" storage or " closed" storage. A review of the 17 current propionic acid labels shows that application rates range from 1.25 lb ai/ gallon ( approximately 6 lbs. ai/ ton of grain) to 8.28 lb ai/ gallon ( approximately 31 lbs. ai/ ton of grain). Other Uses ( including use as a direct food additive) Naturally­ occurring propionic acid is consumed by humans in animal and dairy products, such as butter and cheese ( swiss cheese may contain as much as one percent propionic acid). Propionic acid and its salts are also consumed as added ingredients in other foods. For example, propionic acid and its salts may be used as chemical preservatives in jams, jellies, and jelly­ filled baked goods, and as antimicrobial agents in cheese and bread. When used as a direct food additive, propionic acid and its salts are " generally recognized as safe" for human consumption ( 21 CFR 184.1081, 184.1221, and 184.1784). Propionic acid is also a normal component of metabolism in the human body. Page 5 of 9 2.0 PHYSICAL/ CHEMICAL PROPERTIES SUMMARY Chemical Name: Propionic Acid Chemical Structure: Empirical Formula: CH 3 CH 2 COOH Molecular Weight: 74.08 Boiling Point ( oC): 140.7 Melting Point ( oC): ­ 21.5 Vapor Pressure: 3 mm Hg at 20oC P ow: 2.1 CAS Number: 79­ 09­ 4 PC Code: 077702 Propionic acid is a colorless, oily liquid at room temperature with a rancid, pungent odor. It is completely soluble in water, ethanol, chloroform, and diethyl ether. Propionic acid occurs naturally in animals and in dairy products in small amounts. 3.0 HAZARD CHARACTERIZATION At the time that the propionic acid RED was completed in 1991, the toxicological database was determined to be adequate for the purposes of supporting reregistration eligibility, and no further toxicity data on propionic acid were required by the Agency. A comprehensive open literature search, conducted from 1991 ( the date of the RED) to the present and including databases such as Medline and Toxline, has not revealed any new studies on propionic acid that would alter the toxicological conclusions of the RED. A search of the Pesticide Data Management System ( PDMS) conducted in April, 2001 has also not revealed any new toxicity studies that would have a significant impact on the toxicological findings for propionic acid. Therefore, the Agency concludes that the toxicology determinations made in the propionic acid RED ( September 1991) are still valid. A summary of these toxicology findings is presented below: 3.1. Hazard Profile 3.1.1 Acute Toxicity Technical propionic acid is of moderate to low acute toxicity via the oral, dermal, and inhalation routes of exposure ( toxicity category of III), and is not a skin sensitizer. However, propionic acid is acutely toxic in eye and dermal irritation tests ( toxicity category 1). Page 6 of 9 3.1.2 Subchronic Toxicity No subchronic toxicity data are available on propionic acid itself; however, data on calcium and sodium propionate can be used to assess subchronic toxicity. Rats fed calcium or sodium propionate at one percent of the diet ( equivalent to 750 mg/ kg/ day of propionic acid) for four weeks followed by three percent ( equivalent to 1200 mg/ kg/ day of propionic acid) for three weeks showed no changes in weight gain compared to the controls. Rats fed five percent propionic acid in the diet ( approximately 5000 mg/ kg body weight) for 110 days developed lesions of the forestomach. Propionic acid was given in the feed to dogs at 220, 735, or 2066 mg/ kg/ day for 90 days. The high dose dogs showed reduced food consumption, increased incidence of epithelial hyperplasia in the esophagus, and increased nitrite in the urine. These effects were no longer present in dogs held for a six week recovery period. A limited study with calcium propionate in dogs for 90 days showed vomiting and diarrhea in animals fed 2523 mg/ kg/ day. It is noted that when a human adult male was fed 6.0 grams sodium propionate a day, the only effect noted was slightly alkaline urine. 3.1.3 Chronic Toxicity, Reproduction, and Teratology Twenty male rats per group were fed four percent propionic acid in the diet for two years. The highest dose animals had hyperplasia and hyperplastic ulcers in the forestomach. Available data on calcium and sodium propionate indicate the following: ° Rats fed bread containing sodium propionate ( 4000 mg/ kg/ day) for a year showed no adverse effects, nor did rats fed a similar diet for 32 weeks, other than an initial depression of growth. ° No maternal or fetal effects were seen upon feeding calcium propionate to pregnant animals at rates up to 300 mg/ kg/ day for rats and mice, or up to 400 mg/ kg/ day for hamsters and rabbits. ° No teratogenicity was found in developing chick embryos when up to 100 mg/ kg calcium propionate was injected into the yolk or air cell, although there was increased mortality at 5 and 10 mg/ kg. 3.1.4 Mutagenicity Propionic acid gave negative results in mutagencity assays in five strains of S. typhimurium and one strain of S. cerevisiae, with and without activation. Additional data on calcium and sodium propionate indicated that both tested negative for mutagenicity in S. typhimurium and S. cerevisiae. 3.1.5 Metabolism Page 7 of 9 Propionic acid is rapidly absorbed from the mammalian gastrointestinal tract. Propionic acid is a normal intermediary metabolite in the body. It is utilized by most organs and tissues, and can be metabolized to glucose, carbohydrates, amino acids, and lipids. It is produced in large quantities in ruminants, and is one of the metabolic products from the breakdown of several amino acids in nonruminants. Propionic acid is formed in the oxidation of fatty acids and from the side chain of cholesterol. 3.2 FQPA Considerations Based on a review of available toxicology data, and based on general knowledge of propionic acid, HED concludes that a FQPA safety factor analysis for propionic acid is not required. Propionic acid is of very low acute toxicity via the oral, dermal, and inhalation routes of exposure. The toxicology database is complete, and no data gaps have been identified. There are no indications of special sensitivity of infants or children resulting from exposure to propionic acid. HED's review of propionic acid reaffirms the FDA GRAS designation. 3.3 Dose Response Assessment Toxicity endpoints for use in risk assessment have not been established for propionic acid, due to its low toxicity. 4.0 EXPOSURE ASSESSMENT 4.1 Dietary Exposure Products containing propionic acid are registered for use as fungicides and bactericides on stored grains, hay, grain storage areas, poultry litter, and drinking water for livestock and poultry. Propionic acid is exempt from tolerances following postharvest application ( as a fungicide) on the following: alfalfa, barley grain, Bermuda grass, bluegrass, brome grass, clover, corn grain, cottonseed, cowpea hay, fescue, lespedeza, lupines, oat grain, orchard grass, peanuts, peanut hay, peavine hay, rice grain, rye grass, sorghum grain, soybean hay, soybeans, sudan grass, timothy, vetch, and wheat grain. Tolerance exemptions are also in place for residues of propionic acid in/ on meat and meat byproducts of cattle, sheep, hogs, goats, horses, and poultry, milk, and eggs when applied as a bactericide/ fungicide to livestock. Propionic acid and its salts are also added directly to food as chemical preservatives and antimicrobial agents. For example, propionic acid and its salts may be added to jam­ and jellyfilled baked goods ( such as doughnuts), pizza crust, various cheeses, and breads. The use of propionic acid, calcium propionate, and sodium propionate as direct food additives is affirmed by the FDA as " generally recognized as safe." Dairy products ( such as milk and cheese) may also contain propionic acid as a naturally­ occurring component. Since residues from the pesticidal use of propionic acid are considered negligible, the likelihood of Page 8 of 9 any significant dietary exposure to humans is very low. Potential exposure and risk from the use of propionic acid as a direct food additive is also considered to be very low. This conclusion is strengthened by the presence of propionic acid as a normal component of metabolism in the human body, and because propionic acid is a naturally occurring component in dairy products such as butter and cheese. When considered together, these facts all support HED's conclusion that dietary exposure and dietary risk to propionic acid is extremely low. A dietary risk assessment has not been conducted and is not required. 4.2 Drinking Water Exposure Environmental fate data requirements for propionic acid have been waived based on its labeled use pattern. Information on environmental fate was found in previous reviews conducted by the Environmental Fate and Effects Division ( EFED) and in open literature. In summary, biodegradation of propionic acid is likely to be the most important degradation pathway in aerobic soil and water. Propionic acid is used as a carbon source by microbes which rapidly mineralize to the metabolic products of carbon dioxide and water. Propionic acid is expected to be highly mobile in soil. EFED has conducted a review of propionic acid ( both as an active ingredient and as an inert ingredient) to determine potential concentrations in drinking water. Based on its review, EFED has concluded that propionic acid drinking water concentrations as a result of its use as an active ingredient are expected to be negligible. EFED believes that propionic acid exposures in drinking water will be driven more by its use as an inert ingredient than by its use as an active ingredient. Concentrations of propionic acid in drinking water, when applied as an inert ingredient, were calculated using screening­ level modeling ( FIRST and SCI­ GROW). Estimated concentrations are as follows: 92 ppb ( acute) and 6 ppb ( chronic) in surface water, and 1.3 ppb ( acute and chronic) in ground water. It is important to note that these these concentrations are based on a number of uncertainties, such as an assumed maximum application rate of 1 lb ai/ acre and limited fate data. Since HED does not have any information on what products are formulated with propionic acid as an inert ingredient, or the actual rate at which propionic acid is applied as an inert ingredient. Therefore, no further analysis has been conducted. 4.3 Non­ Occupational ( Residential) Exposure Propionic acid is not registered for any non­ occupational ( residential) uses. Post­ application exposure of homeowners to residues of propionic acid is also not expected to occur, as propionic acid is used mainly on stored grains and in grain storage areas. Due to the use pattern of propionic acid, exposure from spray drift is also not expected to be of concern. Therefore, nonoccupational exposure was not considered in this tolerance reassessment. Page 9 of 9 5.0 CONCLUSIONS Based on its low toxicity, limited use pattern, and affirmation as a GRAS chemical when used as a food additive, propionic acid is not expected to result in any adverse health effects via the food, drinking water, or residential exposure pathways. There is a possibility of eye and skin irritation to occupational handlers; this was mitigated through the reregistration process, on a product­ byproduct basis, by the requirement for personal protective equipment on existing propionic acid labels. A review of the toxicology database, with an emphasis on sensitivity of infants and children, shows no significant findings since the date of the original propionic acid RED from 1991. HED concludes that a FQPA safety factor analysis is not required for propionic acid. Propionic acid, calcium propionate, and sodium propionate will be exempt from all tolerance requirements. The Agency notes that propionic acid and its calcium and sodium salts are included on the Agency's list of chemicals included in the High Production Volume ( HPV) Challenge Program. HPV chemicals are those that are manufactured or imported into the United States in volumes greater than one million pounds per year. There are approximately 3,000 HPV chemicals that are produced or imported into the United States. The HPV Challenge Program is a voluntary partnership between industry, environmental groups, and the EPA which invites chemical manufacturers and importers to provide basic hazard data on the HPV chemicals they produce/ import. The goal of this program is to facilitate the public's right­ to­ know about the potential hazards of chemicals found in their environment, their homes, their workplace, and in consumer products. The Agency has received at least one full commitment from a company or consortium to sponsor propionic acid and its calcium salt as part of the Agency's HPV Challenge Program. The sodium salt is not currently being sponsored; however, it is within the scope of the HPV Challenge Program and is currently available for sponsorship. Based on toxicity data already submitted on propionic acid, and the completeness of the propionic acid toxicity data base ( including subchronic, chronic, reproduction, teratology, and mutagenicity studies), the Agency feels confident in proceeding with this tolerance reassessment decision. Any submission of data by current or future sponsors of propionic acid and its sodium and calcium salts as part of the HPV Challenge Program may, in the future, be used by the Office of Pesticide Programs to revise or update their tolerance reassessment decision for propionic acid and its sodium and calcium salts as deemed necessary and appropriate.

epa

2024-06-07T20:31:45.514505

regulations

EPA-HQ-OPP-2002-0346-0003

Supporting & Related Material

Page 1 of 8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 8, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: November 27, 2001, Meeting of the IIFG Decision Memo Please find attached the Inert Ingredient Focus Group recommendations for the inert and active ingredient propionic acid and its calcium and sodium salts. Page 2 of 8 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Propionic Acid and its Calcium and Sodium Salts Petition No.: 6F4770 Tolerance Reassessments?: yes Chemical Name( s): propionic acid propionic acid, sodium salt propionic acid, calcium salt CAS Index Name: propanoic acid Chemical Category/ Group: organic acid and salts CAS Reg. No.: propionic acid ( 79­ 09­ 4) propionic acid, sodium salt ( 137­ 40­ 6) propionic acid, calcium salt ( 4075­ 81­ 9) PC Code: propionic acid ( active: 077702, inert: 900316) propionic acid, sodium salt ( 877703) propionic acid, calcium salt ( 877701) HPV Chemical: yes ( acid and calcium salt) Data Posted: no Use Pattern ( pesticidal): As an active ingredient, propionic acid is used to control fungi and bacteria in stored grains, hay, grain storage areas, poultry litter, and drinking water for livestock and poultry. Propionic acid is also used in food­ contact surface sanitizing solutions. The current petition is requesting use on sugarbeets, potatoes, and sweet potatoes. Use Pattern ( non­ pesticidal): Propionic acid and its sodium and calcium salts are affirmed GRAS direct food additives ( 21 CFR 184.1081, 184.1221, 184.1784) used as food and feed preservatives. Introduction: Page 3 of 8 The meeting of the Inert Ingredient Focus Group to discuss propionic acid was held on November 27, 2001. Focus Group members in attendance were: Kathryn Boyle ( RD), Kerry Leifer ( RD), Robert Forrest ( RD), Mark Perry ( SRRD), Pauline Wagner ( HED), Tom Brennan ( HED) and Sid Abel ( EFED). The presenters were: Michele Mahoney ( EFED) and Christina Jarvis ( HED). The Executive Secretaries were Steve Schaible ( RD) and Jeanie McAndrew ( RD). Also in attendance was Stephen Dapson ( HED). This meeting addressed the available human health effects and ecological information on propionic acid ( and its calcium and sodium salts), considering both active and inert uses, to determine if the tolerance exemptions established prior to the passage of FQPA could continue to be supported [ refer to 40CFR 180.1001( c) and 180.1023]. The List classification of propionic acid and its salts was also discussed. Calcium and sodium propionate are not currently registered pesticide active ingredients, and tolerance exemptions that were established for calcium and sodium propionate [ 40 CFR 180.2( a) and 40 CFR 180.1015] have been revoked. For the purposes of this evaluation however, these sodium and calcium salts are considered representative of the acid form. Propionic acid occurs naturally in animal and dairy products, such as butter and cheese. Propionic acid and its salts are also consumed as added ingredients in jams, jellies, and jelly­ filled baked goods, and as antimicrobial agents in cheese and bread. Propionic acid, calcium propionate, and sodium propionate have been affirmed as Generally­ Recognized­ As­ Safe ( GRAS) by the Food and Drug Administration ( FDA) for use as a direct food additive. This GRAS finding specifies that " The ingredient is used in food with no limitation other than current good manufacturing practice." As indicated above, data from the HPV Challenge Program is available for propionic acid and its sodium/ calcium salts. HPV data for propionic acid include acute toxicity, mutagenicity, ecotoxicity, and environmental fate. For the sodium salt, acute toxicity, mutagenicity, and ecotoxicity data are available; and for the calcium salt, acute toxicity, developmental/ reproductive toxicity, and mutagenicity data have been provided. HPV data on two propionic acid derivatives were also considered in this evaluation. Additional data received through the HPV Challenge Program on propionic acid and its sodium and calcium salts may have potential impacts on the Agency's tolerance reassessment decision for these chemicals. The Agency may revise or update their tolerance decision for propionic acid and its sodium and calcium salts as considered appropriate by any incoming data generated as part of this program. 1. Physical/ Chemical Properties: Propionic Acid Parameter Test Results physical form: liquid molecular weight: 74.08 solubility ( water): determined to be completely soluble Page 4 of 8 vapor pressure: 3 mm Hg @ 20 oC melting point: ­ 21.5 oC boiling point: 140.7 oC 2. Toxicological Profile: The toxicological database for propionic acid was determined to be adequate for reregistration eligibility at the time the RED was completed ( 9/ 91). A comprehensive search of the open literature from 1991 forward and a search for in­ house toxicological data, failed to reveal new information on propionic acid which would compromise the toxicological findings in the RED document. Therefore, the toxicological findings/ data from the propionic acid RED ( which also addresses the calcium and sodium salts) have been used for the current evaluation. Acute Toxicity: Technical propionic acid is of moderate to low acute toxicity via the oral, dermal, and inhalation routes of exposure ( toxicity category of III), and is not a skin sensitizer. However, propionic acid is acutely toxic in eye and dermal irritation tests ( toxicity category 1). Subchronic Toxicity: No subchronic toxicity data are available on propionic acid itself, however, data on calcium and sodium propionate can be used to assess subchronic toxicity. Rats fed calcium or sodium propionate at one percent of the diet ( equivalent to 750 mg/ kg/ day of propionic acid) for four weeks followed by three percent ( equivalent to 1200 mg/ kg/ day of propionic acid) for three weeks showed no changes in weight gain compared to the controls. Rats fed five percent propionic acid in the diet ( approximately 5000 mg/ kg body weight) for 110 days developed lesions of the forestomach. Propionic acid was given in the feed to dogs at 220, 735, or 2066 mg/ kg/ day for 90 days. The high dose dogs showed reduced food consumption, increased incidence of epithelial hyperplasia in the esophagus, and increased nitrite in the urine. These effects were no longer present in dogs held for a six week recovery period. A limited study with calcium propionate in dogs for 90 days showed vomiting and diarrhea in animals fed 2523 mg/ kg/ day. A human adult male was fed 6.0 grams sodium propionate a day, with slightly alkaline urine as the only effect. Chronic Toxicity: Twenty male rats per group were fed four percent propionic acid in the diet for two years. The highest dose animals had hyperplasia and hyperplastic ulcers in the forestomach. Available data on calcium and sodium propionate indicate the following: Rats fed bread containing sodium propionate ( 4000 mg/ kg/ day) for a year showed no adverse effects, nor did rats fed a similar diet for 32 weeks, other than an initial depression of growth. Reproduction, and Teratology: Page 5 of 8 No maternal or fetal effects were seen upon feeding calcium propionate to pregnant animals at rates up to 300 mg/ kg/ day for rats and mice, or up to 400 mg/ kg/ day for hamsters and rabbits. No teratogenicity was found in developing chick embryos when up to 100 mg/ kg calcium propionate was injected into the yolk or air cell, although there was increased mortality at 5 and 10 mg/ kg. Mutagenicity: Propionic acid gave negative results in mutagencity assays in five strains of S. typhimurium and one strain of S. cerevisiae, with and without activation. Additional data on calcium and sodium propionate indicated that both tested negative for mutagenicity in S. typhimurium and S. cerevisiae. Metabolism: Propionic acid is rapidly absorbed from the mammalian gastrointestinal tract. Propionic acid is a normal intermediary metabolite in the body. It is utilized by most organs and tissues, and can be metabolized to glucose, carbohydrates, amino acids, and lipids. It is produced in large quantities in ruminants, and is one of the metabolic products from the breakdown of several amino acids in nonruminants. Propionic acid is formed in the oxidation of fatty acids and from the side chain of cholesterol. 1. Hazard Characterization: Propionic acid, calcium propionate and sodium propionate have FDA affirmed GRAS status as a direct food additive. Neither propionic acid nor its salts are expected to result in any adverse health effects via the food, drinking water, or residential exposure pathways. 2. Type of risk assessment: qualitative 3. Sensitivity of Infants and Children: These chemicals have low toxic potential. In addition, humans of all ages are highly exposed to them from natural sources. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. 4. Fate Assessment: Biodegradation of propionic acid is expected to be the most important degradation pathway in aerobic soil and water. Data indicate that propionic acid degrades in an anaerobic aquatic system with a half­ life of 21 days. Although data are not available, EFED expects that the half­ life in aerobic environments will be much lower than 21 days since biodegradation of propionic acid occurs rapidly under aerobic conditions. Based on an estimated K oc value of 1.2 ( Syracuse Research Corporation, SRC, structure estimation method using molecular connectivity indices), propionic acid is expected to be highly mobile in soil. Page 6 of 8 5. Ecotoxicity Assessment: Aquatic Organisms: The toxicity data indicate that propionic acid is slightly toxic to aquatic organisms. Toxicity data are not available to assess chronic risk to freshwater organisms or acute and chronic risks to estuarine/ marine organisms. Acute Toxicity of Propionic Acid to Freshwater Aquatic Organisms ( based on application rate of 1 lb ai/ A) Organism Exposure Type Most Sensitive Species Toxicity ( ppm) EEC ( ppm) 1 Risk Quotient ( EEC/ Toxicity) Freshwater Fish Acute Rainbow trout LC50= 51 0.06 < 0.05 Freshwater Invertebrates Acute Daphnia magna EC50= 22.7 0.06 < 0.05 1 Maximum EEC generated using the GENEEC 2.0 model. Terrestrial Organisms: The toxicity data indicate that propionic acid is practically non­ toxic to birds and mammals. EFED does not expect risk to birds and mammals on an acute basis at application rates 20.7 and 5.7 lb ai/ A, respectively. Chronic risks to terrestrial organisms could not be determined because toxicity data are not available. Acute Toxicity of Propionic Acid to Terrestrial Wildlife Animal Group Exposure Type Most Sensitive Species Toxicity ( mg/ kg) EEC ( ppm) 1 Risk Quotient Birds Acute Mallard LD 50 > 10000 240 < 0.1 Mammals Acute Rat2 LD 50 = 2600 240 < 0.1 1 The highest terrestrial residue anticipated. RQs were calculated using ELLFate 2 Accession No. 091024 6. Exposure Assessments Presentation of Dietary ( food) Exposure Assessment: Dietary exposure and dietary risk to propionic acid is extremely low. A dietary risk assessment has not been conducted and is not required. Presentation of Drinking Water Exposure Assessment: As with most acids, propionic acid would be expected to be mobile. Biodegradation should be rapid under aerobic conditions. Modeling was performed to estimate the possible water concentrations. Page 7 of 8 Assumptions: 1 lb/ Acre Modeling Used: FIRST, SCIGROW 2 FIRST TIER I Concentration ( ppb) of propionic acid in surface water Method of Application Application Rate ( lbs ai/ A) Peak ( Acute) ( ppb) Annual Average ( Chronic) ( ppb) Aerial 1 92 6 Groundwater Screening Concentrations for Propionic Acid using SCIGROW 2 Application Rate ( lbs ai/ A) Groundwater Screening Concentration ( ppb) a 1 1.3 a These concentrations are the screening concentrations for acute, chronic, and cancer risks. Given the lower toxicity profile of propionic acid, no adverse effects as a result of exposure through drinking water are expected from either the active or inert ingredient uses. A drinking water risk assessment is not required. Currently there are no active ingredient registrations for residential uses. However, the potential for use in residential products as an inert ingredient does exist. Given the lower toxicity of propionic acid, and that its uses generally are related to agricultural and dietary ( food) uses, adverse effects as a result of any residential uses are not expected. 7. Cumulative Exposure: Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." EPA does not have, at this time, data available to determine whether propionic acid and its salts have a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. 8. Summary of Exposure/ Risk Characterization: Based on its low toxicity, and affirmation as a GRAS chemical when used as a direct food additive, propionic acid is not expected to result in any adverse health effects via the food, drinking water, or residential exposure pathways. Page 8 of 8 9. Qualitative Evaluation of Worker Risks: The possibility of eye and skin irritation to occupational handlers is addressed on a product­ specific basis. 10. IIFG Recommendations: By consensus there were no objections to the following: ° The petition may be granted. The inert and active uses should be harmonized. ° The tolerance exemptions for propionic acid under 40CFR 180.1001( c) and 180.1023 are reassessed. ° The tolerance exemption for sodium propionate under 40CFR 180.1001( c) is reassessed. ° A tolerance exemption for calcium propionate may be established. ° Propionic acid, sodium propionate and calcium propionate are to be reclassified as List 4B. Attachments: ( 1) EFED review ( 2) HED review

epa

2024-06-07T20:31:45.527221

regulations

EPA-HQ-OPP-2002-0347-0001

Rule

Pyrithiobac Sodium (sodium 2-chloro-6-(4,6-dimethoxyprimidin-2-yl) thio benzoate); Pesticide Tolerance

72104 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations physically appear as illustrated in § 1200.2, with no alterations. ( e) Only use the official seal for the time period designated in the approval letter ( example: for the duration of a conference or exhibit). Subpart D Penalties for Misuse of NARA Seals § 1200.16 Will I be penalized for misusing the official seals? ( a) If you falsely make, forge, counterfeit, mutilate, or alter official seals, replicas, reproductions or embossing seals, or knowingly use or possess with fraudulent intent any altered seal, you are subject to penalties under 18 U. S. C. 506. ( b) If you use the official seals, replicas, reproductions, or embossing seals in a manner inconsistent with the provisions of this part, you are subject to penalties under 18 U. S. C. 1017 and to other provisions of law as applicable. Dated: November 26, 2002. John W. Carlin, Archivist of the United States. [ FR Doc. 02 30766 Filed 12 3 02; 8: 45 am] BILLING CODE 7515 01 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0005; FRL 7279 5] Pyrithiobac Sodium ( sodium 2­ chloro­ 6­[( 4,6­ dimethoxypyrimidin­ 2­ yl) thio] benzoate); Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule. SUMMARY: This regulation establishes a tolerance for residues of pyrithiobac sodium ( sodium 2­ chloro­ 6­[( 4,6­ dimethoxypyrimidin­ 2­ yl) thio] benzoate) in or on cotton, undelinted seed and cotton gin byproducts. DuPont Agricultural Products, Wilmington, DE requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. DATES: This regulation is effective December 4, 2002. Objections and requests for hearings, identified by docket ID number OPP 2002 0005, must be received on or before February 3, 2003. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP 2002 0005 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins, Product Manager ( PM) 25, Registration Division 7505C, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305 5697; e­ mail address: tompkins. jim@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Categories NAICS codes Examples of potentially affected entities Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0005. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 4 0cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Background and Statutory Findings In the Federal Register of September 24, 1997 ( 62 FR 49979) ( FRL 5745 8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U. S. C. 346a, as amended by the FQPA of 1996 ( Public Law 104 170), announcing the filing of a pesticide petition PP 4F4391 by DuPont Agricultural Products, Wilmington, DE. This notice included a summary of the petition prepared by DuPont Agricultural Products, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.487 be amended by establishing a tolerance for residues of the herbicide pyrithiobac sodium, ( sodium 2­ chloro­ 6­ [( 4,6­ dimethoxypyrimidin­ 2­ yl) thio] benzoate), in or on cotton, undelinted seed at 0.02 parts per million ( ppm) and cotton gin byproducts at 0.1 ppm. The Registrant subsequently amended the petition by VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72105 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations increasing the tolerance request for cotton gin byproducts to 0.15 ppm. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances November 26, 1997, ( 62 FR 62961) ( FRL 5754 7). III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2), for a tolerance for residues of pyrithiobac sodium on cotton, undelinted seed at 0.02 ppm and cotton gin byproducts at 0.15 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows. A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pyrithiobac sodium are discussed below. This discussion refers to the no observed effect level ( NOEL) and the lowest observed effect level ( LOEL) from the toxicity studies reviewed rather than the no observed adverse effect level ( NOAEL) and the lowest observed adverse effect level ( LOAEL) because the toxicity studies for pyrithiobac sodium were reviewed prior to adoption in 1998 of the NOAEL/ LOAEL terminology by EPA's Office of Pesticide Programs ( OPP) and its Health Effects Division ( HED). At the time of the switch to the revised terminology, HED noted that the new terminology was unlikely to have any substantive effect on its hazard evaluations: `` In a practical sense, the terms NOEL and NOAEL have been used interchangeably in OPP. As a general rule, OPP would consider as appropriate for hazard identification and risk assessment only those effects which are adverse or potentially adverse. This inclusion of the term NOAEL should not change any of our hazard endpoints for regulation but add to the quality of the risk assessment.'' HED Standard Operating Procedure ( SOP) 98.3 1. A rat acute oral study with a LD50 of 3,300 milligrams/ kilogram ( mg/ kg) for males and a LD50 of 3,200 mg/ kg for females. 2. A 90 day rat feeding study with a NOAEL of 50 parts per million ( ppm) ( 3.25 mg/ kg/ day for males and 4.14 mg/ kg/ day for females) and a LOAEL of 500 ppm ( 31.8 mg/ kg/ day for males and 40.5 mg/ kg/ day for females based on decrease body weight gains and increased rate of hepatic beta­ oxidation in males. 3. A 90 day mouse feeding study with a NOAEL of 500 ppm ( 83.1 mg/ kg/ day for males and 112 mg/ kg/ day for females) and a LOAEL of 1,500 ppm ( 263 mg/ kg/ day for males and 384 mg/ kg/ day for females) based on increased liver weight and an increased incidence of hepatocellular hypertrophy in males and decreased neutrophil count in females. 4. A 3 month dog feeding study with a NOAEL of 5,000 ppm ( 165 mg/ kg/ day) and a LOAEL of 20,000 ppm ( 626 mg/ kg/ day), based on decrease red blood cell count, hemoglobin, and hematocrit in females and increased liver weight in both sexes. 5. A 21 day rat dermal study with a Dermal Irritation NOAEL of 50 mg/ kg/ day and, a Dermal Irritation LOAEL of 500 mg/ kg/ day based on increased incidence of erythema and edema, and with a Systemic Dermal NOAEL of 500 mg/ kg/ day and a Systemic Dermal LOAEL of 1,200 mg/ kg/ day based on body weight gain inhibition. 6. A 90 day rat neurotoxicity screening battery with a Systemic NOAEL of 7,000 ppm ( 466 mg/ kg/ day for males and 588 mg/ kg/ day for females) and a Systemic LOAEL of 20,000 ppm ( 1,376 mg/ kg/ day for males and 1,609 mg/ kg/ day for females), based on deceased hind grip strength and increased foot spay in males, and a Neurotoxicity NOAEL of 20,000 ppm highest dose tested ( HDT). 7. A 78 week dietary carcinogenicity study in mice with a NOAEL of 1,500 ppm 217 mg/ kg/ day ( males) and 319 mg/ kg/ day ( females) and a LOAEL of 5,000 ppm 745 mg/ kg/ day ( males) and 1,101 mg/ kg/ day ( females) based on decreased body weight gain in both sexes, treatment related increase in the incidence of foci/ focus of hepatocellular alternation in males, and increased incidence of glomerulonephropathy ( murine) in both sexes, and an increased incidence of infarct in the kidney and keratopathy of the eyes. There was evidence of carcinogenicity based on significant differences in the pair­ wise comparisons of hepatocellular adenomas and combined adenoma/ carcinoma in the 150 ppm and 1,500 ppm dose groups ( but not at the high dose of 5,000 ppm) with the controls. The carcinogenic effects observed are discussed below. 8. A 23 month rat chronic toxicity/ carcinogenicity study with a Systemic NOAEL of 1,500 ppm ( 58.7 mg/ kg/ day) for males and 5,000 ppm ( 278 mg/ kg/ day) for females, and with a Systemic LOAEL of 5,000 ppm ( 200 mg/ kg/ day) for males and 15,000 ppm ( 918 mg/ kg/ day) for females, based on deceased body weight, body weight gain and food efficiency for females, the increased incidence of eye lesions in both sexes, mild changes in hematology and urinalysis in both sexes, clinical signs suggestive of urinary tract dysfunction in males and females, increased incidence of focal cystic degeneration in the liver in males, increased rate of hepatic peroxisomal beta­ oxidation in males and an increased incidence of inflammatory and degenerative lesions in the kidney in females. There was evidence of carcinogenicity based on significant dose­ related increasing trend in kidney tubular combined adenoma/ carcinoma in male rats and a significant dose related increasing trend in kidney tubular bilateral and/ or unilateral adenomas in females. The carcinogenic effects observed are discussed further below. 9. A 1 year dog chronic toxicity study with a NOAEL of 5,000 ppm ( 143 mg/ kg/ day for males and 166 mg/ kg/ day for females) and a LOAEL of 20,000 ppm ( 580 mg/ kg/ day for males and 647 mg/ kg/ day for females) based on decreases in body weight gain, increase thyroid VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72106 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations and liver weights, and microscopic findings in the liver and kidneys. 10. A 2­ generation reproduction study in rats with a NOAEL for maternal toxicity of 1,500 ppm ( 103 mg/ kg/ day) and a maternal LOAEL of 7,500 ppm ( 508 mg/ kg/ day), based on decreased body weight, body weight gain and food efficiency. The NOAEL for paternal toxicity is 1,500 ppm ( 86 mg/ kg/ day), while the LOAEL is 7,500 ppm ( 439 mg/ kg/ day), based on decreased body weight, body weight gain and food efficiency. The NOAEL for reproductive effects can be set at 7,500 ppm ( 508 mg/ kg/ day), the LOAEL at 20,000 ppm ( 1,551 mg/ kg/ day), based on decreased pup body weight. The NOAEL for effects on offspring is 7,500 ppm ( 508 mg/ kg/ day), and the LOAEL at 20,000 ppm ( 1,551 mg/ kg/ day), based on decreased pup body weight. 11. A 13 day dosing ( gestation days 7 19) developmental toxicity study in rabbits with a maternal NOAEL of 300 mg/ kg and a maternal LOAEL of 1,000 mg/ kg based on deaths, decreased body weight gain and feed consumption, and an increase in early resorptions. There is developmental toxicity observed at 1,000 mg/ kg based on decreased fetal body weights. 12. A 10 day dosing ( gestation days 7 16) developmental toxicity study in rats wth a maternal NOAEL of 200 mg/ kg and maternal LOAEL of 600 mg/ kg due to increased incidence of peritoneal staining. The developmental NOAEL is 600 mg/ kg and the developmental LOAEL is 1,800 mg/ kg based on the increased incidence of skeletal variations. 13. No evidence of gene mutation was observed in a test for induction of forward mutations at the hypoxanthine guanine phophoribosyl transferase ( HGPRT) locus in Chinese hamster ovary cells. No evidence was observed for inducing reverse gene mutation in two independent assays with Salmonella typhimurium with and without mammalian metabolic activation. Pyrithiobac sodium was negative for the induction of micronuclei in the bone marrow cells of mice, and negative for induction of unscheduled DNA synthesis in rat primary hepatocytes. Pyrithiobac sodium was positive for inducing chromosome aberrations assay in human lymphocytes. 14. A rat metabolism study showed that radio labeled pyrithiobac sodium is excreted in urine and feces with > 90% being eliminated within 48 hours. A sex difference was observed in the excretion and biotransformation. Females excreted a greater amount of the radiolabel in the urine than males following all regimens, with a corresponding lower amount being eliminated in the feces compared to the males. B. Toxicological Endpoints The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the LOAEL at which effects of concern are identified is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor. For non­ dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 106 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non­ linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for pyrithiobac sodium used for human risk assessment is as follows: 1. Acute toxicity. EPA has concluded that no endpoint exists to suggest any evidence of significant toxicity from 1 day or single­ event exposure. 2. Short­ term and intermediate­ term toxicity. EPA has concluded that available evidence does not indicate any evidence of significant toxicity from short­ term and intermediate­ term exposure. 3. Chronic toxicity. EPA has established the RfD for pyrithiobac sodium at 0.587 mg/ kg/ day. This RfD is based on the systemic NOAEL of 58.7 mg/ kg/ day for males in the rat chronic feeding study with a 100­ fold safety factor to account for interspecies extrapolation and intraspecies variability. 4. Carcinogenicity. EPA has concluded that the available data provide limited evidence of the carcinogenicity of pyrithiobac sodium in mice and rats and has classified pyrithiobac sodium as a Group C ( possible human carcinogen with limited evidence of carcinogenicity in animals) in accordance with Agency guidelines, published in the Federal Register of ( September 24, 1986, 51 FR 33992) and recommended that for the purpose of risk characterization a low dose extrapolation model should be applied to the experimental animal tumor data for quantification for human risk ( Q1*). This decision was based on liver adenomas, carcinomas and combined adenoma/ carcinomas in the male mouse and rare kidney tubular adenomas, carcinomas and combined adenoma/ carcinomas in male rats. The unit risk, Q1* ( mg/ kg/ day)­ 1, of pyrithiobac sodium is 1.05 x 10 3 ( mg/ kg/ day)­ 1 in human equivalents based on male kidney tumors. C. Exposure Assessment 1. Dietary exposure from food and feed uses. Permanent tolerances have been requested to replace the time limited tolerance in/ on cottonseed 40 CFR 180.487 at 0.02 ppm, and a new tolerance for the residues of pyrithiobac sodium, in or on cotton gin byproducts at 0.1 ppm. The requested tolerance for cotton gin byproducts has been amended to 0.15 ppm based on the results of the submitted field residue trials, and cottonseed was changed to cotton, undelinted seed. Processing studies for cotton have shown that VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72107 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations pyrithiobac sodium does not concentrate in cottonseed processed food/ feed commodities. No requested tolerances were necessary for meat, milk, and eggs because detectible residues are not expected in these commodities from this use on cotton. Risk assessments were conducted by EPA to assess dietary exposures from pyrithiobac sodium in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. EPA has concluded that no endpoint exists to suggest any evidence of significant toxicity from one­ day or single­ event exposure; therefore, an acute exposure assessment is not applicable. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEMTM analysis evaluated the individual food consumption as reported by respondents in the Department of Argiculture ( USDA) 1989 1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. EPA assumed that all commodities for which tolerances exist and all cotton food commodities had pyrithiobac sodium residues at the appropriate tolerance level. iii. Cancer. The cancer exposure assessment relied upon the same data and assumptions as the chronic exposure assessment. iv. Anticipated residue and percent crop treated ( PCT) information. Tolerance level residues and treatment of 100% of the crop was assumed. Anticipated residues and PCT information was not used. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for pyrithiobac sodium in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of pyrithiobac sodium. The Agency uses the GENEEC or the PRZM/ EXAMS to estimate pesticide concentrations in surface water and SCIGROW which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model) for a screening­ level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop ( PC) area factor as an adjustment to account for the maximum PC coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to pyrithiobac sodium they are further discussed in the aggregate risk sections in Unit E. Based on the GENEEC and SCI­ GROW models the EECs of pyrithiobac sodium for chronic exposures are estimated to be 7.76 parts per billion ( ppb) for surface water and 0.778 ppb for ground water. 3. From non­ dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non­ dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Pyrithiobac sodium is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether pyrithiobac sodium has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pyrithiobac sodium does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that pyrithiobac sodium has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( November 26, 1997, 62 FR 62961). D. Safety Factor for Infants and Children 1. In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for pre­ natal and post­ natal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Pre­ natal and post­ natal sensitivity. In a preliminary review, EPA concluded that data do not indicate that there is a significant potential for reproductive or developmental effects from pyrithiobac sodium as tested. 3. Conclusion. There is a complete toxicity data base for pyrithiobac sodium and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Pyrithiobac sodium has not been formally reviewed by the Agency regarding the need to retain the additional 10X safety factor for the protection of infants and children. Thus, despite the completeness of the database and the lack of any indication of significant potential for reproductive or developmental effects, EPA has retained the additional 10X safety factor until a full review can be completed. Retention of the additional safety factor yields a VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72108 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations cPAD for pyrithiobac sodium of 0.0587 mg/ kg/ day. E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD ­ ( average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA Office of Water are used to calculate DWLOCs: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening­ level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short­ term, intermediate­ term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. Pyrithiobac sodium is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water. 1. Acute risk. EPA has concluded that no endpoint exists to suggest any evidence of significant toxicity from acute exposures from the use of pyrithiobac sodium on cotton. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyrithiobac sodium from food and water will utilize less than 0.2% of the cPAD for the U. S. population, and less than 0.2% of the cPAD for children 1 to 6 years at greatest exposure to both food and water. There are no residential uses for pyrithiobac sodium that result in chronic residential exposure to pyrithiobac sodium. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Due to the low exposure for the U. S. population ( less than 0.2%) and for children 1 to 6 years ( less than 0.2%) for both food and water, the calculated DWLOC is approximately equal to the cPAD. 3. Short­ term risk. EPA has concluded that no endpoint exists to suggest any evidence of significant toxicity from short­ term exposures from the use of pyrithiobac sodium on cotton. 4. Intermediate­ term risk. EPA has concluded that no endpoint exists to suggest any evidence of significant toxicity from intermediate­ term exposures from the use of pyrithiobac sodium on cotton. 5. Aggregate cancer risk for U. S. population. Based on the upper bound potency factor ( Q* 1) of 1.05 x 10 3 ( mg/ kg/ day)­ 1, the aggregate upper bound lifetime cancer risk from the use of pyrithiobac sodium on cotton from worst case estimates of residues in food and drinking water is 2.3 x 10 7. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to pyrithiobac sodium residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology high performance liquid chromotography using ultra­ violent detection ( HPLC­ UV) with column switching) is available to enforce the tolerance expression. The method may be requested from: Paul Golden, U. S. Environmental Protection Agency, Office of Pesticide Programs, BEAD, ACB, Environmental Science Center, 701 Mapes Road Fort Meade, MD 20755 5350; Telephone ( 410) 305 2960. B. International Residue Limits There are no established Codex maximum residue levels ( MRLs) for pyrithiobac sodium on cottonseed. An established Mexican tolerance for pyrithiobac sodium on cottonseed is identical to the U. S. tolerance. Compatibility of tolerance levels is not an issue at this time. C. Conditions There are no conditions. Adequate residue data has been submitted to support the tolerances established in this Federal Register Notice. V. Conclusion Therefore, the tolerance is established for residues of pyrithiobac sodium, ( sodium 2­ chloro­ 6­[( 4,6­ dimethoxypyrimidin­ 2­ yl) thio] benzoate), in or on cotton, undelinted seed at 0.02 ppm and cotton gin byproducts at 0.15 ppm. VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days. A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP 2002 0005 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 3, 2003. VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72109 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 202) 260 4865. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305 5697, by e­ mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 2. Mail your copies, identified by docket ID number OPP 2002 0005, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. You may also send an electronic copy of your request via e­ mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32). VII. Regulatory Assessment Requirements This final rule establishes a tolerance under FFDCA section 408( d) in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104 4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408( d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1 72110 Federal Register / Vol. 67, No. 233 / Wednesday, December 4, 2002 / Rules and Regulations any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government andIndian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 8, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 [ AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U. S. C. 321( q), 346( a) and 374. 2. Section 180.487 paragraph ( a) is revised to read as follows: § 180.487 Pyrithiobac sodium; tolerances for residues. ( a) General. Tolerances are established for residues of the herbicide, pyrithiobac sodium, ( sodium 2­ chloro­ 6­ [( 4,6­ dimethoxypyrimidin­ 2­ yl) thio] benzoate), resulting from the application of the pesticide chemical in or on the following foods/ feeds: Commodity Parts per million Cotton gin byproducts .......................................................................................... 0.15 Cotton, undelinted seed ....................................................................................... 0.02 * * * * * [ FR Doc. 02 30472 Filed 12 3 02; 8: 45 am] BILLING CODE 6560 50 S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [ I. D. 112702C] Notification of U. S. Fish Quotas and an Effort Allocation in the Northwest Atlantic Fisheries Organization ( NAFO) Regulatory Area AGENCY: National Marine Fisheries Service ( NMFS), National Oceanic and Atmospheric Administration ( NOAA), Commerce. ACTION: Notification of U. S. fish quotas and an effort allocation. SUMMARY: NMFS announces that fish quotas and an effort allocation are available for harvest by U. S. fishermen in the NAFO Regulatory Area. This action is necessary to make available to U. S. fishermen a fishing privilege on an equitable basis. DATES: All fish quotas and the effort allocation are effective January 1, 2003, through December 31, 2003. Expressions of interest regarding U. S. fish quota allocations for all species except 3L shrimp will be accepted throughout 2003. Expressions of interest regarding the U. S. 3L shrimp quota allocation and the 3M shrimp effort allocation will be accepted through January 3, 2004. ADDRESSES: Expressions of interest regarding the U. S. effort allocation and quota allocations should be made in writing to Patrick E. Moran in the NMFS Office of Sustainable Fisheries, at 1315 East­ West Highway, Silver Spring, MD 20910 ( phone: 301 713 2276, fax: 301 713 2313, e­ mail: pat. moran@ noaa. gov). Information relating to NAFO fish quotas, NAFO Conservation and Enforcement Measures, and the High Seas Fishing Compliance Act ( HSFCA) Permit is available from Jennifer L. Anderson at the NMFS Northeast Regional Office at One Blackburn Drive, Gloucester, Massachusetts 01930 ( phone: 978 281 9226, fax: 978 281 9394, e­ mail: jennifer. anderson@ noaa. gov) and from NAFO on the World Wide Web at http:/ / www. nafo. ca. FOR FURTHER INFORMATION CONTACT: Patrick E. Moran, 301 713 2276. SUPPLEMENTARY INFORMATION: Background NAFO has established and maintains conservation measures in its Regulatory Area that include one effort limitation fishery as well as fisheries with total allowable catches ( TACs) and member nation quota allocations. The principal species managed are cod, flounder, redfish, American plaice, halibut, capelin, shrimp, and squid. At the 2002 NAFO Annual Meeting, the United States received fish quota allocations for three NAFO stocks and an effort allocation for one NAFO stock to be fished during 2003. The species, location, and allocation ( in metric tons or effort) of these U. S. fishing opportunities are as follows: ( 1) Redfish NAFO Division 3M 69 mt ( 2) Squid NAFO Subareas 3 & 4 453 mt ( 3) Shrimp NAFO Division 3L 67 mt ( 4) Shrimp NAFO Division 3M 1 vessel/ 100 days Additionally, U. S. vessels may fish any portion of the 7,500 mt TAC of oceanic redfish in NAFO Subarea 2 and Divisions 1F and 3K. This opportunity is available only to members of NAFO that are not members of the North East Atlantic Fisheries Commission, on a first­ come, first­ served basis. Allocations are also available to U. S. VerDate 0ct< 31> 2002 14: 33 Dec 03, 2002 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 04DER1. SGM 04DER1

epa

2024-06-07T20:31:45.532790

regulations

EPA-HQ-OPP-2002-0349-0001

Notice

Flumioxazin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food

79918 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices 0 estimate, 1.86 parts per billion ( ppb), was used in the acute exposure analysis and the corrected 56 day drinking water concentration of 0.4667 ppb was used in the chronic exposure analysis. The SCIGROW estimated ground water concentration for the prosulfuron uses of 0.406585 ppb contributed little to the overall exposure. The acute drinking water levels of concern ( DWLOC) for prosulfuron were based on the acute RfD, a margin of exposure ( MOE), the 99.9th percentile of the acute dietary exposure for U. S. population subgroups and the body weight ­ daily water consumption of each respective subgroup. The calculated acute DWLOC values for the population subgroups ranged from 978 3447 ppb. The estimated ground water concentration ( 0.406585 ppb) and the peak day 0 surface water concentration ( 1.86 ppb) of prosulfuron did not exceed the acute DWLOC values. The chronic ( noncancer DWLOC for prosulfuron were based on the chronic RfD, any estimated residential exposure, the chronic dietary exposure for select U. S. population subgroups and the body weight ­ daily water consumption of each respective subgroup. The calculated chronic DWLOC values for the population subgroups ranged from 197 694. The estimated ground water concentration ( 0.406585 ppb) and the corrected average 56 day surface water concentration ( 0.4667 ppb) of prosulfuron did not exceed the chronic DWLOC values. Therefore, there is reasonable certainty that the residues of prosulfuron in the drinking water would not result in unacceptable levels of acute or chronic aggregate human health risk, and that such exposure would not exceed the exposure allowable by the risk cup. Nondietary exposure. Nondietary exposure to prosulfuron is considered negligible as the chemical is registered for agricultural use only. For workers handling this chemical, acceptable MOE ( in the range of thousands) have been obtained for both acute and chronic scenarios. D. Cumulative Effects Consideration of a common mechanism of toxicity is not appropriate at this time since there is no information to indicate that toxic effects produced by prosulfuron would be cumulative with those of any other types of chemicals. E. Safety Determination 1. U. S. population. The calculation shows that less than 1% of the RfD will be utilized for the U. S. population based on chronic toxicity endpoints. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. It is concluded that there is a reasonable certainty that no harm will result from aggregate exposure to prosulfuron residue. 2. Infants and children. The calculated percent of the RfD that will be utilized by aggregate exposure to residues of prosulfuron is only 2.4% for children ( 1 to 6 years old), the most impacted subpopulation. There were no adverse reproductive or developmental effects indicated in the prosulfuron toxicity data base, which is considered to be essentially complete with no data gaps. It is concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to prosulfuron residues. F. International Tolerances No codex MRLs have been established for residues of prosulfuron. [ FR Doc. 02 32988 Filed 12 30 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPP 2002 0349; FRL 7285 6] Flumioxazin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities. DATES: Comments, identified by docket ID number OPP 2002 0349, must be received on or before January 30, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 6224; e­ mail address: Miller. Joanne@ epamail. epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to: Crop production ( NAICS 111) Animal production ( NAICS 112) Food manufacturing ( NAICS 311) Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0349. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79919 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e­ mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0349. The system is an `` anonymous access'' system, which means EPA will not know your identity, e­ mail address, or other contact information unless you provide it in the body of your comment. ii. E­ mail. Comments may be sent by e­ mail to opp­ docket@ epa. gov, Attention: Docket ID Number OPP 2002 0349. In contrast to EPA's electronic public docket, EPA's e­ mail system is not an `` anonymous access'' system. If you send an e­ mail comment directly to the docket without going through EPA's electronic public docket, EPA's e­ mail system automatically captures your e­ mail address. E­ mail addresses that are automatically captured by EPA's e­ mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0349. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0349. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1. D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e­ mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79920 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Make sure to submit your comments by the deadline in this notice. 7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. II. What Action is the Agency Taking? EPA has received a pesticide petition as follows proposing the establishment and/ or amendment of regulations for residues of a certain pesticide chemical in or on various food commodities under section 408 of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a. EPA has determined that this petition contains data or information regarding the elements set forth in FFDCA section 408( d)( 2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: December 20, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner summary of the pesticide petitions is printed below as required by FFDCA section 408( d)( 3). The summary of the petitions was prepared by the petitioner and represents the view of the petitioner. The petition summary announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the pesticide chemical residues or an explanation of why no such method is needed. Valent U. S. A. Corporation 1F6296 and 0F6171 EPA has received pesticide petitions ( PP 1F6296, 0F6171) from Valent U. S. A. Corporation, 1333 North California Boulevard, Suite 600, Walnut Creek, California 94596­ 8025 proposing, pursuant to section 408( d) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a( d), to amend 40 CFR part 180 by establishing a tolerance for residues of the herbicide chemical flumioxazin, 2­[ 7­ fluoro­ 3,4­ dihydro­ 3­ oxo­ 4­( 2­ propynyl)­ 2H­ 1,4­ benzoxazin­ 6­ yl]­ 4,5,6,7­ tetrahydro­ 1H­ isoindole­ 1,3( 2H)­ dione, in or on the raw agricultural commodities cotton at 0.02 parts per million ( ppm), cotton, gin byproducts at 0.60 ppm, grape at 0.02 ppm, almonds at 0.02 ppm, almond, hulls at 0.70 ppm and sugarcane at 0.20 ppm. EPA has determined that the petitions contain data or information regarding the elements set forth in section 408( d)( 2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. Metabolism of 14C­ flumioxazin labeled in the phenyl­ or tetrahydrophthalimido­ rings has been studied in soybeans, peanuts, grapes and corn. Flumioxazin was rapidly and extensively metabolized to many metabolites in all plants. Even with exaggerated treatment, individual metabolites and parent were only found at very low concentrations. Comparisons of metabolites detected and quantified from plants and animals show that there are no significant aglycones in plants which are not also present in the excreta or tissues of animals. The residue of concern is best defined as the parent. 2. Analytical method. Practical analytical methods for detecting and measuring levels of flumioxazin have been developed and validated in/ on all appropriate agricultural commodities and respective processing fractions. The extraction methodology has been validated using aged radiochemical residue samples from 14C­ metabolism studies. The enforcement method has been validated in soybean at an independent laboratory and by EPA. The limit of quantitation ( LOQ) of flumioxazin in the method is 0.02 ppm which will allow monitoring of food with residues at the levels proposed for the tolerances. 3. Magnitude of residues i. Cotton. Thirteen field trials in cotton were conducted in 1999 in EPA Regions II ( 1 trial), IV ( 4 trials), VI ( 1 trial), VIII ( 4 trials), and X ( 3 trials), representing approximately 97% of the U. S. cotton growing regions. Seasonal treatment ranged from 0.190 to 0.375 pounds active ingredient per acre [ two applications of 0.095 lb. a. i./ A each or two applications of 0.187 lb. a. i./ A each], 1.5­ to 3­ times the proposed application rate for high organic soils. Application of VALOR was done lay­ by and post direct to the soil and not over the top. Finite residues of flumioxazin were detected in 7 of 26 duplicate samples cottonseed and in 14 of the 16 duplicate samples of gin trash. The LOQ of the residue method was 0.01 ppm, and the limit of detection ( LOD) was 0.005 ppm. No residues of 1­ OH­ HPA were detected (< 0.005 ppm) in any cottonseed or gin trash sample, including samples from trial treated at the 2X rate. The data demonstrate that 1­ OH­ HPA is not a residue of concern in cottonseed or cotton gin trash. No residues of flumioxazin or its degradate were found in the processed commodities treated ginned seed, hulls, solvent extracted meal and refined oil. All these data support proposed tolerance for flumioxazin in/ on cotton at 0.02 ppm, and in/ on cotton, gin byproducts at 0.60 ppm. No separate tolerances are needed for cotton processed commodities. ii. Grapes. Twelve field trials in grapes were conducted in 1999 in EPA Regions I ( 2 trials) Region X ( 9 trials) and Region XI ( 1 trial), representing approximately 96% of the U. S. grapes growing regions. Seasonal treatment ranged from 0.75 to 3.75 pounds active ingredient per acre [ two applications of 0.375 lb. a. i./ A each or two applications of 1.87 lb. a. i./ A each] 1 to 5­ times the proposed application rate. Application on grapes was post direct and not over the top. At the proposed maximum seasonal rate of 0.75 lb. a. i./ A, no residues of flumioxazin were found in/ on grapes from all 12 trials. Residues of flumioxazin were detected in only one of six samples treated at 2X application rate ( seasonal total of 1.5 lb. a. i./ A). The residue found, 0.005 ppm, was below the LOQ of 0.01 ppm. VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79921 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices Grapes treated at 5X ( seasonal total of 3.75 lb. a. i./ A) the proposed use rate were processed into grape juice and raisins. The RAC grapes contained 0.006 ppm flumioxazin. No residues (< 0.005 ppm) of flumioxazin were found in grape juice. In raisins 0.007 ppm flumioxazin was detected. These residues were below the LOQ of 0.01 ppm. The data demonstrate no concentration of flumioxazin residues in juice and raisins. All these data support a proposed tolerance for flumioxazin in/ on grapes of 0.02 ppm. No separate tolerances are needed for grapes processed commodities. iii. Almond. Five field trials in almonds were conducted in 1999 in EPA Regions X, representative of all U. S. almond growing regions. Seasonal treatment ranged from 0.75 to 1.5 pounds active ingredient per acre [ two applications of 0.375 lb. a. i./ A each or two applications of 0.75 lb. a. i./ A each] 1 to 2­ times the proposed application rate. Application on almonds was done post direct and not over the top. At the proposed maximum seasonal rate of 0.75 lb. a. i./ A, no residues of flumioxazin were found in/ on almond nutmeat greater than the LOQ ( 0.01 ppm). The highest average field Trial for residues of flumioxazin in/ on almond hulls was 0.552 ppm. Residues of 1­ OHHPA were not detected in any sample of almond hulls (< 0.05 ppm). The LOQ and LOD of the residue method for 1­ OHHPA in/ on almond hulls were 0.1 ppm and 0.05 ppm, respectively. All these data support a proposed tolerance for flumioxazin in/ on almond of 0.02 ppm, and in/ on almond hulls of 0.6 ppm. iv. Sugarcane. Nine field trials in sugarcane were conducted in 1998 in EPA Regions III ( 4 trials), IV ( 3 trials), VI ( 1 trial), and XIII ( 1 trial), representative of all of the U. S. sugarcane growing regions. Treatments ranged from 0.37 to 1.12 pounds active ingredient per acre, 1­ to 3­ times the proposed application rate for high organic soils. Finite residues of flumioxazin were detected in 14 of 18 duplicate samples. Residues of flumioxazin averaged 0.039 ppm ( standard deviation = 0.033 ppm) from the trials conducted at the proposed maximum application rate. Analysis for the major plant metabolite, 1­ OH­ HPA, was conducted on all cane samples including those from the two 3X processing trials. No residues of the degradate were found in any cane sample. No residues of flumioxazin or its degradate were found in the processed commodity refined sugar. In molasses, produced from cane treated at three times the proposed label rate, flumioxazin was detected ( 0.055 ppm) at approximately half of the concentration in the starting sugarcane. The degradate, 1­ OH­ HPA, was also detected in molasses ( 0.036 ppm). Because these detections were in a processed sample from cane treated at 3X, and are still less than the proposed RAC tolerance, no separate processed product tolerances are necessary. All these data support a proposed tolerance for flumioxazin in/ on sugarcane at 0.20 ppm. No separate tolerances for parent or degradate are needed for processed commodities. B. Toxicological Profile 1. Acute toxicity. The acute toxicity of technical grade flumioxazin is low by all routes. The battery of acute toxicity studies place flumioxazin in Toxicity Category III. i. No abnormal clinical signs, body weight changes, or gross pathological findings were observed and no rats died following administration of an oral dose of 5 g/ kg of flumioxazin technical. The LD50 was greater than 5 g/ kg. ii. No deaths, abnormal clinical signs, body weight changes, or gross pathological findings were observed in rats exposed to a 2.0 g/ kg dermal dose of flumioxazin technical. The LD50 was greater than 2.0 g/ kg. iii. Rats were exposed to a dust aerosol of flumioxazin technical for 4 hours at measured concentrations of 1.55 or 3.93 mg/ l, the maximum attainable concentration. Irregular respiration, bradypnea and a decrease in spontaneous activity were observed in many of the rats, but these effects disappeared within 2 hours after termination of the exposure. No deaths, body weight changes, gross pathological findings or histopathological changes in the respiratory organs were observed. The LC50 for flumioxazin technical was determined to be greater than 3.93 mg/ l. iv. Flumioxazin technical produced minimal eye irritation in rabbits which cleared within 48 hours. v. Flumioxazin technical did not produce any signs of skin irritation in abraded or intact skin of rabbits. vi. Flumioxazin technical was not a skin sensitizer when tested in guinea pigs using the Magnussen and Kligman maximization test methodology. 2. Genotoxicty. Flumioxazin does not present a genetic hazard. Flumioxazin was evaluated in the following tests for mutagenicity: i. A reverse gene mutation assay in Salmonella typhimurium and Escherichia coli was negative with or without metabolic activation. ii. An in vitro chromosome aberration assay using Chinese hamster ovary ( CHO) cells was negative in the absence of metabolic activation. However, an increase in cells with aberrations was observed at doses of 1 x 10­ 4 M and higher in the presence of S9. iii. An in vivo chromosomal aberration study in the rat was negative. No significant increase in the incidence of chromosomal aberrations in bone marrow cells was observed following treatments as high as 5,000 mg/ kg. iv. An in vitro unscheduled DNA synthesis ( UDS) assay with rat hepatocytes was negative. v. A mouse micronucleus assay was negative following intraperitoneal injection of 5,000 mg/ kg. 3. Reproductive and developmental toxicity. Flumioxazin shows developmental toxicity in the absence of maternal toxicity in rats. Mechanistic studies demonstrate that the effect is specifically related to the inhibition of heme synthesis, that the effect shows considerable species specificity, and that the rat is a conservative surrogate species for the potential for developmental toxicity in man. No developmental toxicity was observed in rabbits. Developmental toxicity to the pups was seen in the rat reproduction study at doses that were not toxic to the parental animals. i. Rat­­ developmental toxicity. A pilot dose range­ finding study was conducted to determine appropriate doses for the definitive oral developmental toxicity study. Flumioxazin technical was administered by oral gavage at dosages of 0, 30, 100, 200 and 500 mg/ kg/ day to pregnant rats on days 6 through 15 of gestation. No animals died during the course of this study and maternal toxicity was limited to decreased weight gain associated with high embryolethality observed in all dose groups. Fetuses obtained from the 30 mg/ kg/ day dams had significantly reduced body weights and were found to have both skeletal and visceral abnormalities­­ primarily wavy ribs and ventricular septal defects ( VSD). Because of the high degree of embryolethality at doses of 100 mg/ kg/ day and greater, the highest dose selected for the definitive study was 30 mg/ kg/ day. In the definitive study, pregnant rats were administered oral doses of 0, 1, 3, 10 or 30 mg/ kg/ day of flumioxazin technical on days 6 through 15 of gestation. No maternal deaths were observed at any dosage and no treatment­ related effects on clinical signs or food consumption were noted. VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79922 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices A decrease in maternal body weight gain was found at 30 mg/ kg/ day. The number of live fetuses and fetal body weights were decreased in the 30 mg/ kg/ day group and the incidence of embryo mortality tended to be higher but was not statistically significant. No effects on the number of implantations, sex ratios, or external abnormalities were found. The incidence of fetuses with cardiovascular abnormalities, primarily VSD, was increased in the 30 mg/ kg/ day group. Other developmental effects observed at 30 mg/ kg/ day included an increase in the incidence of wavy ribs and curvature of the scapula, and a decrease in the number of ossified sacrococcygeal vertebral bodies. Based on these findings, a maternal NOEL of 30 mg/ kg/ day and a developmental NOEL of 3 mg/ kg/ day are proposed. In a range­ finding dermal developmental toxicity study flumioxazin technical was administered dermally at levels of 100, 200, 400 and 800 mg/ kg/ day in corn oil. No adverse effects on the dams were observed at doses up to 800 mg/ kg/ day. Because of the high degree of embryolethality at doses of 400 mg/ kg/ day and greater, the highest dose selected for the definitive study was 300 mg/ kg/ day. On days 6­ 15 of gestation, pregnant rats were exposed dermally to dose levels of 30, 100, or 300 mg/ kg/ day of flumioxazin technical in corn oil. No adverse effects were observed in the dams throughout the study. Increased fetal mortality was accompanied by decreases in the number of live fetuses and fetal body weights at doses of 300 mg/ kg/ day. No external abnormalities were observed at any dose level. An increase in cardiovascular abnormalities, primarily VSD, an increase in wavy ribs and a decrease in the number of ossified sacrococcygeal vertebral bodies was observed at 300 mg/ kg/ day. Based on these results, a maternal NOEL of 300 mg/ kg/ day and a developmental NOEL of 30 mg/ kg/ day are proposed. To measure the dermal penetration of flumioxazin under the conditions of the dermal teratology study, 13­ day pregnant rats were dermally exposed to [ phenyl­ 14C] flumioxazin. The systemic absorption ranged from 3.8% at 2 hours to 6.9% of the recovered 14C at 48 hours. ii. Mechanistic studies. A series of scientific studies were conducted to examine the mechanism and species differences in the production of developmental toxicity by flumioxazin. This research demonstrates clear species differences between rats, rabbits, mice, and ( in vitro) humans and indicates a high degree of correlation between the interruption of heme synthesis and the production of developmental toxicity in rats. The data support that the rat is a conservative model for use in the risk assessment for humans. Specifically the studies demonstrate that: Flumioxazin interferes with normal heme biosynthesis resulting in sidroblastic anemia and porphyria in adult rats. 14C­ Flumioxazin administered to pregnant rats on day 12 of gestation crosses the placenta and reaches the rat fetus at maximum levels of radiocarbon ( and flumioxazin), 4 hours later. No clear pattern of adsorption, distribution, metabolism, or excretion was evident which could account for the species­ specific development toxicity in rats. The critical period of sensitivity to the developmental effects of flumioxazin in rats is day 12 of gestation. This correlates with the peak period of protoporphyrin IX ( PPIX) accumulation in maternal rat liver and the rat fetus. A histological examination of rat fetus indicated signs of fetal anemia within 6 hours after dosing, but no histological changes in the fetal rat heart were observed until 36 or 48 hour after treatment. No effects were observed in rabbit fetus treated in the same manner as the rats. Other observations in the pathogenesis of the developmental effects of flumioxazin in rat fetuses included: enlarged heart, edema, anemia ( decreased red blood cell count and hemoglobin), delayed closure of the interventricular foramen, reduced serum protein and incomplete/ delayed ossification of the ribs. The observation of enlarged heart, edema and anemia preceding the occurrence of fetal mortality suggest these effects may be instrumental in the cause of fetal deaths. The occurrence of an enlarged heart preceding the failure of interventricular foramen closure could be related to the pathogenesis rather than a direct toxic effect of flumioxazin on cardiac tissue. A strong correlation exists between PPIX accumulation, an indicator of disrupted heme synthesis, and developmental toxicity. Evidence of this correlation exists on the basis of species differences between rats and rabbits; the critical period of sensitivity in the rat; and compound­ specific differences with two chemicals structurally related to flumioxazin, one which produces developmental effects in rats and one which does not. iii. Rabbits. In a pilot dose rangefinding study in rabbits, flumioxazin technical was administered to rabbits on days 7 through 19 of gestation via oral intubation at dosages of 0, 300, 500, 1,000 and 1,500 mg/ kg/ day. Clinical observations were recorded and on day 29 of gestation, all does were sacrificed, caesarean sectioned, and examined for gross lesions, number of corpora lutea, and number and placement of implantation sites, early and late resorptions and live and dead fetuses. No deaths, abortions or premature deliveries occurred during this study. Dosages of flumioxazin technical as high as 1,500 mg/ kg/ day did not result in significant clinical or necropsy observations nor affect maternal body weight gains or feed consumption values. Similarly, there were no adverse effects of dosages of flumioxazin technical up to 1,500 mg/ kg/ day on embryo­ fetal viability, sex ratios, body weights or external morphology. Based on these results, pregnant rabbits were administered 0, 300, 1,000, or 3,000 mg/ kg/ day of flumioxazin technical on days 7 ­ 19 of gestation by oral gavage. The highest dose was well in excess of the 1,000 mg/ kg/ day limit dose for developmental toxicity studies. The 3,000 mg/ kg/ day dosage tended to reduce maternal body weight gains and relative and absolute feed consumption values. No gross lesions were produced at any dose level. The 3,000 mg/ kg/ day dosage group litters tended to have reduced fetal body weights but these differences were not statistically different. No fetal external, soft tissue, or skeletal malformations or variants were attributable to the test substance. Based on these data, the maternal NOEL was 1,000 mg/ kg/ day and the developmental NOEL was 3,000 mg/ kg/ day. iv. Reproduction. Two pilot rangefinding rat reproduction studies were conducted with flumioxazin technical at dosages from 100 to 5,000 ppm in the diet. In the definitive two­ generation reproduction study in the rat dietary levels of 0, 50, 100, 200 and 300 ppm established a systemic NOEL of 200 ppm based on increased clinical signs ( both sexes and generations); mortality, gross and histopathology findings in the liver ( F1 females); decreased body weight/ weight gain ( F0 and F1 females during gestation, F1 males during premating) and decreased food consumption ( F0 and F1 females during lactation). The reproductive NOEL of 100 ppm was mainly based on developmental toxicity at 200 ppm. Observed at 200 ppm were a decreased number of live­ born pups and reduced pup body weights. At 300 ppm the following effects were observed: decreased pup body weight ( both generations); decreased number of live pups/ litter and viability index ( both VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79923 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices generations); increased incidence of abnormalities of the reproductive organs ( predominately atrophied or hypoplastic testes and/ or epididymides in F1 males); decreased gestation index ( F0 females); decreased mating and fertility indices ( F1 males) and increased clinical signs ( F1 pups). 4. Subchronic toxicity. Subchronic toxicity studies conducted with flumioxazin technical in the rat ( oral and dermal), mouse and dog indicate a low level of toxicity. Effects observed at high dose levels consisted primarily of anemia and histological changes in the spleen, liver and bone marrow related to the anemia. i. Rats. A 90­ day subchronic toxicity study was conducted in rats, with dietary intake levels of 0, 30, 300, 1,000 and 3,000 ppm flumioxazin technical ( 98.4% purity). The no­ observed­ effectlevel ( NOEL) of 300 ppm was based on decreased body weights; anemia; increases in absolute and/ or relative liver, kidney, brain heart and thyroid weights; and histological changes in the spleen, liver and bone marrow related to the anemia. A second 90 day subchronic toxicity study was conducted with a sample of Flumioxazin Technical of typical purity ( 94.8%) at dietary concentrations of 0, 30, 300, 1,000 and 3,000 ppm. The NOEL was 30 ppm based on anemia and related hematological changes; increases in liver, heart, kidney and thyroid weights; and histological changes in the spleen, liver and bone marrow related to the anemia. ii. Mice. Dose levels for the mouse oncogenicity study were selected on the basis of results from a 4 week study of flumioxazin in the diets of mice at levels of 0, 1,000, 3,000 and 10,000 ppm. In this range­ finding study, increases in absolute and/ or relative liver weights were noted for males at 10,000 ppm and at 3,000 and 10,000 ppm for females. iii. Dogs. A 90 day study was conducted in dogs given gelatin capsules containing 0, 10, 100 or 1,000 mg/ kg/ day. The NOEL of 10 mg/ kg/ day for this study was based on a slight prolongation of activated partial thromboplastin time; increased total cholesterol and phospholipid and elevated alkaline phosphatase activity; increased absolute and relative liver weights; and histological changes in the liver. iv. Rats. A 21 day dermal toxicity study was conducted in rats at dose levels of 0, 100, 200 or 1,000 mg/ kg/ day. The NOEL was determined to be 300 mg/ kg/ day based on significantly decreased hemoglobin and hematocrit values for females. 5. Chronic toxicity. Flumioxazin technical has been tested in chronic studies with dogs, rats and mice. Valent proposes a chronic oral endpoint of 1.8 mg/ kg bw/ day, based on the NOEL for male rats in the two­ year chronic toxicity oncogenicity feeding study. i. Rats. In a 2 year study in rats, flumioxazin technical administered in the diet at levels of 0, 50, 500, and 1,000 ppm produced anemia and chronic nephropathy in rats of the 500 and 1,000 ppm groups. The anemia lasted throughout the treatment period, however, it was not progressive nor aplastic in nature. No evidence of an oncogenic effect was observed in rats and the NOEL for this study was 50 ppm ( 1.8 mg/ kg/ day for males and 2.2 mg/ kg/ day for females). ii. Mice. Flumioxazin technical was administered to mice at doses of 0, 300, 3,000, and 7,000 ppm in diet for 78 weeks. An increased incidence of hypertrophy of centrilobular hepatocytes was observed in males of the 3,000 and 7,000 ppm groups. Increases in the incidence of diffuse hypertrophy and single cell necrosis of hepatocytes were observed in females of the 3,000 and 7,000 ppm groups. There was no evidence of any treatmentrelated effect on the incidence of tumors. Flumioxazin technical was not carcinogenic to mice, and the NOEL for this study was 300 ppm ( 31.1 mg/ kg/ day for males and 36.6 mg/ kg/ day for females). iii. Dogs. Flumioxazin technical was administered to dogs in capsules at daily doses of 0, 10, 100, and 1,000 mg/ kg bw/ day for 1 year. Treatment­ related changes in blood biochemistry included increased total cholesterol and phospholipid values, elevated alpha­ 2­ globulin ratio at 1,000 mg/ kg/ day and increased alkaline phosphatase activity in the 100 and 1,000 mg/ kg/ day groups. The absolute and/ or relative liver weights were elevated in one animal in the 100 mg/ kg/ day group and four animals of the 1,000 mg/ kg/ day group. Minimal treatment­ related histological changes were noted in the livers of animals at the 1,000 mg/ kg/ day group. Based on these data the NOEL was determined to be 10 mg/ kg/ day. iv. Carcinogenicity. Flumioxazin is not a carcinogen. Adequately designed studies with both rats and mice have shown that repeated high dose exposures produced anemia, liver effects and nephropathy, but did not produce cancer in test animals. No oncogenic response was observed in a rat 2 year chronic feeding/ oncogenicity study or in a 78 week study on mice. Valent anticipates that the oncogenicity classification of flumioxazin will be `` E'' ( no evidence of carcinogenicity for humans). 6. Animal metabolism. The absorption, tissue distribution, metabolism and excretion of phenyl­ 14Clabeled flumioxazin were studied in rats after single oral doses of 1 or 100 mg/ kg, and after a single oral dose of 1 mg/ kg following 14 daily oral doses at 1 mg/ kg of unlabelled material. For all dose groups, most ( 97.9­ 102.3%) of the administered radiolabel was excreted in the urine and feces within 7 days after radiolabeled test material dosing. Radiocarbon tissue residue levels were generally low on the seventh day postdosing Radiocarbon residues were higher in blood cells than tissues. Tissue 14C­ residue levels, including those for fat, were lower than blood levels which suggests little potential for bioaccumulation. Urinary radiocarbon excretion was greater in females than males in all dose groups. Flumioxazin was extensively metabolized by rats and 35 metabolites were detected and quantitated. The main metabolic reactions in rats were ( 1) hydroxylation of the tetrahydrophthalimide moiety; ( 2) incorporation of the sulfonic acid group into the tetrahydrophthalimide moiety; ( 3) cleavage of the imide linkage; ( 4) cleavage of the benzoxazinoneamide and;( 5) acetylation of the aniline nitrogen group. 7. Metabolite toxicology. Metabolism studies of flumioxazin in rats, goats, hens, soybeans, and peanuts, as well as the fish bioaccumulation study demonstrate that the parent is very rapidly metabolized and, in animals, eliminated. The metabolites detected and quantified from plants and animals show that there are no significant aglycones in plants which are not also present in the excreta or tissues of animals. Because parent and metabolites are not retained in the body, the potential for acute toxicity from in situ formed metabolites is low. The potential for chronic toxicity is adequately tested by chronic exposure to the parent at the MTD and consequent chronic exposure to the internally formed metabolites. 8. Endocrine disruption. No special studies to investigate the potential for estrogenic or other endocrine effects of flumioxazin have been performed. However, as summarized above, a large and detailed toxicology database exists for the compound including studies in all required categories. These studies include acute, sub­ chronic, chronic, developmental, and reproductive toxicology studies including detailed histology and histopathology of numerous tissues, including endocrine organs, following repeated or long term VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79924 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices exposures. These studies are considered capable of revealing endocrine effects. The results of all of these studies show no evidence of any endocrine­ mediated effects and no pathology of the endocrine organs. Consequently, it is concluded that flumioxazin does not possess estrogenic or endocrine disrupting properties. C. Aggregate Exposure 1. Dietary exposure. A full battery of toxicology testing including studies of acute, chronic, oncogenicity, developmental, mutagenicity, and reproductive effects is available for flumioxazin. In these risk assessments Valent has chosen as the chronic oral toxic endpoint the NOEL for males from the rat chronic/ oncogenicity feeding study, 1.8 mg/ kg/ day; and as the acute oral toxic endpoint the NOEL ( proposed by EPA) from the rat oral developmental toxicity study of 3.0 mg/ kg/ day. Because the acute oral endpoint is for fetal toxicity to rats, Valent has chosen to use the full, extra 10X uncertainty factor for appropriate sub­ groups of the population as mandated by FQPA. i. Food. a. Acute dietary exposures to flumioxazin residues were calculated for the U. S. population, Women 13 years and older, and five children subgroups. The calculated exposure values are very conservative because tolerance­ level residues and 100% of the crop treated are assumed. For refined sugar from sugarcane and juice from grapes for which processing is required, concentration factors were considered. The calculated exposures and margins of exposure ( MOE) for the higher exposed proportions of the subgroups are listed below. In all cases, margins of exposure relative to the acute endpoint from the rat oral developmental toxicity study exceed 1,000. TIER I CALCULATED ACUTE DIETARY EXPOSURES TO THE TOTAL U. S. POPULATION AND SELECTED SUB­ POPULATIONS TO FLUMIOXAZIN RESIDUES IN FOOD Population Subgroup 95th Percentile 99.9th Percentile Exposure ( mg/ kg/ day) MOE Exposure ( mg/ kg/ day) MOE Total U. S. Population 0.000063 47,737 0.000287 10,442 Women 13 Years and Older 0.000040 74,350 0.000128 23,527 Children 7 to 12 Years 0.000076 39,620 0.000310 9,675 Children 1 to 6 Years 0.000153 19,583 0.000599 5,008 All Infants 0.000205 14,608 0.000800 3,750 Non­ Nursing Infants (< 1 yr old) 0.000217 13,807 0.000799 3,753 Nursing Infants (< 1 yr old) 0.000106 28,357 0.000283 10,612 b. Chronic dietary exposures to flumioxazin residues were calculated for the U. S. population and 25 population subgroups. This modified Tier I analysis assumes tolerance­ level residues, processing factors for grape and cane sugar, and 100 percent of the crops treated. The results from several representative subgroups are listed below. All calculated chronic dietary exposures were below 5% of the c­ PAD. The c­ PAD was defined as the NOEL from the rat oral two­ year combined chronic toxicity oncogenicity study ( 1.8 mg/ kg/ day for males) divided by the 100X uncertainty factor for the adult exposures ( 0.018 mg/ kg/ day), or divided by 1,000 to include the extra 10X uncertainty factor for adult females of child­ bearing age and infant and children population subgroups ( 0.0018 mg/ kg/ day). Generally speaking, the Agency has no cause for concern if total residue contribution for published and proposed tolerances is less than 100 percent of the c­ PAD. TIER I CALCULATED CHRONIC DIETARY EXPOSURES TO THE TOTAL U. S. POPULATION AND SELECTED SUBPOPULATIONS TO FLUMIOXAZIN RESIDUES IN FOOD Population Subgroup Exposure ( mg/ kg/ day) Percent of c­ PAD Total U. S. Population ( total) ( 0.018)* 0.000020 0.11 Females 13+ ( nursing) ( 0.0018)* 0.000016 0.89 Females 13+ ( preg./ not nursing) ( 0.0018)* 0.000015 0.83 Children 7­ 12 yrs ( 0.018)* 0.000030 0.17 Children 1­ 6 yrs ( 0.0018)* 0.000052 2.89 All Infants (< 1 year) ( 0.0018)* 0.000067 3.72 TIER I CALCULATED CHRONIC DIETARY EXPOSURES TO THE TOTAL U. S. POPULATION AND SELECTED SUBPOPULATIONS TO FLUMIOXAZIN RESIDUES IN FOOD Continued Population Subgroup Exposure ( mg/ kg/ day) Percent of c­ PAD Non­ Nursing Infants ( 0.0018)* 0.000082 4.56 Nursing Infants ( 0.0018)* 0.000016 0.89 * c­ PAD value used to calculate percent of occupancy. ii. Drinking water. Since flumioxazin is applied outdoors to growing agricultural crops, the potential exists for the parent or its metabolites to reach ground or surface water that may be used for drinking water. Because of the physical properties of flumioxazin, it is unlikely that flumioxazin or its metabolites can leach to potable groundwater. To quantify potential exposure from drinking water, surface water concentrations for flumioxazin were estimated using GENEEC 1.2. Because KOC could not be measured VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79925 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices directly in adsorption­ desorption studies because of chemical stability, GEEC values representative of a range of KOC values were modeled. The simulation that was selected for these exposure estimates used an average KOC of 385, indicating high mobility. The peak GEEC concentration predicted in the simulated pond water was 9.8 ppb. Using standard assumptions about body weight and water consumption, the acute exposure from this drinking water would be 0.00028 and 0.00098 mg/ kg/ day for adults and children, respectively. The 56­ day GEEC concentration predicted in the simulated pond water was 0.34 ppb. Chronic exposure from this drinking water would be 0.0000097 and 0.000034 mg/ kg/ day for adults and children, respectively; 1.9 percent of the c­ PAD of 0.0018 mg/ kg/ day for children. Based on this worse case analysis, the contribution of drinking water to the dietary exposure is comparable to that from food, but the risk is still negligible. 2. Non­ dietary exposure. Flumioxazin is proposed only for agricultural uses and no homeowner or turf uses. Thus, no non­ dietary risk assessment is needed. D. Cumulative Effects Section 408( b)( 2)( D)( v) requires that the Agency must consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' Available information in this context include not only toxicity, chemistry, and exposure data, but also scientific policies and methodologies for understanding common mechanisms of toxicity and conducting cumulative risk assessments. For most pesticides, although the Agency has some information in its files that may turn out to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity with any other substances, EPA does not at this time have the methodologies to resolve the complex scientific issues concerning common mechanism of toxicity in a meaningful way. There are other pesticidal compounds that are structurally related to flumioxazin and have similar effects on animals. In consideration of potential cumulative effects of flumioxazin and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by flumioxazin would be cumulative with those of other chemical compounds. Thus, only the potential risks of flumioxazin have been considered in this assessment of aggregate exposure and effects. Valent will submit information for EPA to consider concerning potential cumulative effects of flumioxazin consistent with the schedule established by EPA at 62 FR 42020 ( Aug. 4, 1997) and other subsequent EPA publications pursuant to the Food Quality Protection Act. E. Safety Determination 1. U. S. population i. Acute risk. The potential acute exposure from food to the U. S. population and various nonchild infant population subgroups provide MOE values exceeding 1,000. Addition of the worse case, but small `` background'' dietary exposure from water reduces the MOE value at the 99.9th percentile from 10,442 to 5,291. In a conservative policy, the Agency has no cause for concern if total acute exposure to adults calculated for the 95th percentile ( for the Tier I calculated acute dietary exposure using tolerance level residues and 100% crops treated) yields a MOE of 100 or larger. For women of child bearing age where an MOE of 1,000 or larger is appropriate, the addition of water to the diet of women, 13 years and older, reduces the MOE ( 99.9th percentile) from 23,527 to 7,353. It can be concluded that there is a reasonable certainty that no harm will result to the overall U. S. Population and many non­ child/ infant subgroups from aggregate, acute exposure to flumioxazin residues. ii. Chronic risk. Using the dietary exposure assessment procedures described above for flumioxazin, calculated chronic dietary exposure resulting from residue exposure from proposed uses of flumioxazin is minimal. The estimated chronic dietary exposure from food for the overall U. S. Population and many non­ child/ infant subgroups is 0.11 to 0.89% of the appropriate c­ PAD. Addition of the small but worse case potential exposure from drinking water ( calculated above) increases exposure by 0.0000097 mg/ kg / day and the maximum occupancy of the c­ PAD from 0.89 to 1.43% ( women 13 +). Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the appropriate c­ PAD. It can be concluded that there is a reasonable certainty that no harm will result to the overall U. S. Population and many non­ child/ infant subgroups from aggregate, chronic exposure to flumioxazin residues. 2. Infants and children safety factor for infants and children. In assessing the potential for additional sensitivity of infants and children to residues of flumioxazin, FFDCA section 408 provides that EPA shall apply an additional margin of safety, up to tenfold for added protection for infants and children in the case of threshold effects unless EPA determines that a different margin of safety will be safe for infants and children. i. Children. The toxicological database for evaluating pre­ and post­ natal toxicity for flumioxazin is complete with respect to current data requirements. Developmental toxicity was observed by both oral and dermal routes in rats. Therefore, reliable data support use of the standard 100­ fold uncertainty factor and an additional uncertainty factor of 10X for flumioxazin to be further protective of infants and children. ii. Developmental toxicity studies. Flumioxazin shows developmental toxicity in the absence of maternal toxicity in rats. Mechanistic studies demonstrate that the effect is specifically related to the inhibition of heme synthesis, that the effect shows considerable species specificity, and that the rat is a conservative surrogate species for the potential for developmental toxicity in man. No developmental toxicity was observed in rabbits. Developmental toxicity to the pups was seen in the rat reproduction study at doses that were not toxic to the parental animals. a. Rats. In the definitive rat oral developmental toxicity study, pregnant rats were administered oral doses of 0, 1, 3, 10 or 30 mg/ kg/ day of flumioxazin technical on days 6 through 15 of gestation. No maternal deaths were observed at any dosage and no treatment­ related effects on clinical signs or food consumption were noted. A decrease in maternal body weight gain was found at 30 mg/ kg/ day. The number of live fetuses and fetal body weights were decreased in the 30 mg/ kg/ day group and the incidence of embryo mortality tended to be higher but was not statistically significant. No effects on the number of implantations, sex ratios, or external abnormalities were found. The incidence of fetuses with cardiovascular abnormalities, primarily VSD, was increased in the 30 mg/ kg/ day group. Other developmental effects observed at 30 mg/ kg/ day included an increase in the incidence of wavy ribs and curvature of the scapula, and a decrease in the number of ossified sacrococcygeal vertebral bodies. Based on these findings, a maternal NOEL of 30 mg/ kg/ day and a developmental NOEL of 3 mg/ kg/ day are proposed. On days 6­ 15 of gestation, pregnant rats were exposed dermally to dose levels of 30, 100, or 300 mg/ kg/ day of flumioxazin technical in corn oil. No VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79926 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices adverse effects were observed in the dams throughout the study. Increased fetal mortality was accompanied by decreases in the number of live fetuses and fetal body weights at doses of 300 mg/ kg/ day. No external abnormalities were observed at any dose level. An increase in cardiovascular abnormalities, primarily VSD, an increase in wavy ribs and a decrease in the number of ossified sacrococcygeal vertebral bodies was observed at 300 mg/ kg/ day. Based on these results, a maternal NOEL of 300 mg/ kg/ day and a developmental NOEL of 30 mg/ kg/ day are proposed. To measure the dermal penetration of flumioxazin under the conditions of the dermal teratology study, 13­ day pregnant rats were dermally exposed to [ phenyl­ 14C] flumioxazin. The systemic absorption ranged from 3.8% at 2 hours to 6.9% of the recovered 14C at 48 hours. b. Mechanistic studies. A series of scientific studies were conducted to examine the mechanism and species differences in the production of developmental toxicity by flumioxazin. This research demonstrates clear species differences between rats, rabbits, mice, and ( in vitro) humans and indicates a high degree of correlation between the interruption of heme synthesis and the production of developmental toxicity in rats. The data support that the rat is a conservative model for use in the risk assessment for humans. Specifically the studies demonstrate that: Flumioxazin interferes with normal heme biosynthesis resulting in sidroblastic anemia and porphyria in adult rats. 14C­ Flumioxazin administered to pregnant rats on day 12 of gestation crosses the placenta and reaches the rat fetus at maximum levels of radiocarbon ( and flumioxazin), 4 hours later. No clear pattern of adsorption, distribution, metabolism, or excretion was evident which could account for the species­ specific development toxicity in rats. The critical period of sensitivity to the developmental effects of flumioxazin in rats is day 12 of gestation. This correlates with the peak period of protoporphyrin IX ( PPIX) accumulation in maternal rat liver and the rat fetus. A histological examination of rat fetus indicated signs of fetal anemia within 6 hours after dosing, but no histological changes in the fetal rat heart were observed until 36 or 48 hour after treatment. No effects were observed in rabbit fetus treated in the same manner as the rats. Other observations in the pathogenesis of the developmental effects of flumioxazin in rat fetuses included: enlarged heart, edema, anemia ( decreased red blood cell count and hemoglobin), delayed closure of the interventricular foramen, reduced serum protein and incomplete/ delayed ossification of the ribs. The observation of enlarged heart, edema and anemia preceding the occurrence of fetal mortality suggest these effects may be instrumental in the cause of fetal deaths. The occurrence of an enlarged heart preceding the failure of interventricular foramen closure could be related to the pathogenesis rather than a direct toxic effect of flumioxazin on cardiac tissue. A strong correlation exists between PPIX accumulation, an indicator of disrupted heme synthesis, and developmental toxicity. Evidence of this correlation exists on the basis of species differences between rats and rabbits; the critical period of sensitivity in the rat; and compound­ specific differences with two chemicals structurally related to flumioxazin, one which produces developmental effects in rats and one which does not. c. Rabbits. Pregnant rabbits were administered 0, 300, 1,000, or 3,000 mg/ kg/ day of flumioxazin technical on days 7 ­ 19 of gestation by oral gavage. The highest dose was well in excess of the 1,000 mg/ kg/ day limit dose for developmental toxicity studies. The 3,000 mg/ kg/ day dosage tended to reduce maternal body weight gains and relative and absolute feed consumption values. No gross lesions were produced at any dose level. The 3,000 mg/ kg/ day dosage group litters tended to have reduced fetal body weights but these differences were not statistically different. No fetal external, soft tissue, or skeletal malformations or variants were attributable to the test substance. Based on these data, the maternal NOEL was 1,000 mg/ kg/ day and the developmental NOEL was 3,000 mg/ kg/ day. iii. Reproductive toxicity study. In the two­ generation reproduction study in the rat dietary levels of 0, 50, 100, 200 and 300 ppm established a systemic NOEL of 200 ppm based on increased clinical signs ( both sexes and generations); mortality, gross and histopathology findings in the liver ( F1 females); decreased body weight/ weight gain ( F0 and F1 females during gestation, F1 males during premating) and decreased food consumption ( F0 and F1 females during lactation). The reproductive NOEL of 100 ppm was mainly based on developmental toxicity at 200 ppm. Observed at 200 ppm were a decreased number of live­ born pups and reduced pup body weights. At 300 ppm the following effects were observed: decreased pup body weight ( both generations); decreased number of live pups/ litter and viability index ( both generations); increased incidence of abnormalities of the reproductive organs ( predominately atrophied or hypoplastic testes and/ or epididymides in F1 males); decreased gestation index ( F0 females); decreased mating and fertility indices ( F1 males) and increased clinical signs ( F1 pups). iv. Prenatal and postnatal sensitivity. Flumioxazin interferes with normal heme biosynthesis resulting in sidroblastic anemia and porphyria in adult rats. Clear species differences between rats, rabbits, mice, and ( in vitro) humans were demonstrated. There is a high degree of correlation between the interruption of heme synthesis, consequent PPIX accumulation, and the production of developmental toxicity in rats. The data support that the rat is a conservative model for use in the risk assessment for humans. v. Acute exposure and risk. The potential acute exposure from food to the various child and infant population subgroups all provide MOE values exceeding 1,000. Addition of the worse case, but small `` background'' dietary exposure from water ( 0.00098 mg/ kg/ day) to the 99.9th percentile food exposure for infants reduces the MOE value from 3,753 to 1,686. In a conservative policy with the addition of the FQPA extra 10X uncertainty factor, the Agency has no cause for concern if total acute exposure to infants and children calculated for the 95th percentile for the Tier I acute dietary exposure yields a MOE of 1,000 or larger. It can be concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate, acute exposure to flumioxazin residues. vi. Chronic exposure and risk. Using the conservative exposure assumptions described above, the percentage of the c­ PAD that will be utilized by dietary ( food only) exposure to residues of flumioxazin ranges from 0.17% for children 7­ 12 years, to 4.6% for Non­ Nursing Infants. Adding the worse case potential incremental exposure to infants and children from flumioxazin in drinking water ( 0.000034 mg/ kg/ day) increases the aggregate, chronic dietary exposure by 1.9%. The addition of the exposure attributable to drinking water increases the occupancy of the c­ PAD for Non­ Nursing Infants to 6.44%. EPA generally has no concern for exposures below 100% of the c­ PAD because the c­ PAD, in this case including the extra 10X FQPA uncertainty factor, represents the level at or below which daily VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1 79927 Federal Register / Vol. 67, No. 251 / Tuesday, December 31, 2002 / Notices aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. It can be concluded that there is a reasonable certainty that no harm will result to infants and children from aggregate, chronic exposure to flumioxazin residues. vii. Determination of safety Summary. Aggregate acute or chronic dietary exposure to various subpopulations of children and adults demonstrate acceptable risk. Chronic dietary exposures to flumioxazin occupy considerably less than 100% of the appropriate c­ PAD, and all acute dietary MOE values exceed 1,000. Chronic and acute dietary risk to children from flumioxazin should not be of concern. Further, flumioxazin has only agricultural uses and no other uses, such as indoor pest control, homeowner or turf, that could lead to unique, enhanced exposures to vulnerable subgroups of the population. It can be concluded that there is a reasonable certainty that no harm will result to the U. S. Population or to any sub­ group of the U. S. population, including infants and children, from aggregate chronic or aggregate acute exposures to flumioxazin residues resulting from proposed uses. F. International Tolerances Flumioxazin has not been evaluated by the World Health Organization, Joint Meeting on Pesticide Residues ( JMPR) and there are no Codex Maximum Residue Limits ( MRL) for flumioxazin. MRL values have been established to allow the following uses of flumioxazin in the following countries. Country Crop MRL ( ppm) Brazil Soybean 0.05 Argentina Soybean Sunflower 0.015 0.02 Paraguay Soybean 0.015 South Africa Soybean Groundnut 0.02 0.02 [ FR Doc. 02 32990 Filed 12 30 02; 8: 45 am] BILLING CODE 6560 50 S ENVIRONMENTAL PROTECTION AGENCY [ OPPT 2002 0077; FRL 7286 8] Certain New Chemicals; Receipt and Status Information AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: Section 5 of the Toxic Substances Control Act ( TSCA) requires any person who intends to manufacture ( defined by statute to include import) a new chemical ( i. e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5( d)( 2) and 5( d)( 3) of TSCA, EPA is required to publish a notice of receipt of a premanufacture notice ( PMN) or an application for a test marketing exemption ( TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from November 20, 2002 to December 10, 2002, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period. DATES: Comments identified by the docket ID number OPPT 2002 0077 and the specific PMN number or TME number, must be received on or before January 30, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics ( 7408M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 202) 554 1404; e­ mail address: TSCAHotline epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitter of the premanufacture notices addressed in the action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT 2002 0077. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102­ Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566 1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566 0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the VerDate Dec< 13> 2002 16: 26 Dec 30, 2002 Jkt 200001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 31DEN1. SGM 31DEN1

epa

2024-06-07T20:31:45.544327

regulations

EPA-HQ-OPPT-2002-0002-0001

Notice

TSCA Section 8(c) Health and Safety Data Reporting Rule; Request for Comment on Renewal of Information Collection Activities

epa

2024-06-07T20:31:45.555421

regulations

EPA-HQ-OPPT-2002-0002-0002

Notice

TSCA Section 8(c) Health and Safety Data Reporting Rule; Request for Comment on Renewal of Information Collection Activities; Extension of Comment Period

epa

2024-06-07T20:31:45.556312

regulations

EPA-HQ-OPPT-2002-0002-0006

Supporting & Related Material

Supporting Statement for a Request for OMB Review under The Paperwork Reduction Act 1 IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title and Number of the Information Collection Title: TSCA Section 8( c) Health and Safety Data Reporting Rule EPA ICR No.: 1031.07 OMB Control No.: 2070­ 0017 1( b) Short Characterization Section 8( c) of TSCA, 15 U. S. C. 2607( c), P. L. 94­ 469 (see Attachment 1), requires that "any person who manufactures, processes, or distributes in commerce any chemical substance or mixture" must keep "records of significant adverse reasons to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture." EPA promulgated 40 CFR 717, "Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment; Subpart A ­­ Recordkeeping and Reporting," on August 22, 1983 (48 FR 38178) (see Attachment 2). This rule became effective on November 21, 1983. The rule requires manufacturers and processors of chemical substances and mixtures to keep records of "significant adverse reactions" alleged to have been caused bysuch substances or mixtures. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator. TSCA section 8( c) requires that allegations of adverse reactions to the health of employees be kept for thirty years, and all other allegations be kept for five years. 2 NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection TSCA section 8( c) requires any person who manufactures, processes, or distributes in commerce any chemical substance or mixture to maintain records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. Since the rule contains no automatic reporting provision, the only way EPA can obtain and use t he information contained in company files is to either inspect the files or require reporting of records that relate to specific substances of concern. 40 CFR 717.17 contains such authority to inspect and require such reporting. EPA will review relevant TSCA section 8( c) records in connection with its existing chemical assessment activities. 2 All studies submitted to EPAwill be verified and the contents of the submissions recorded and inspected for the inclusion of confidential business information. Photocopies of the documents will then be prepared and distributed, based on the associated chemical identity, to program offices at EPA and/ or to other federal agencies for scientific analysis. A coding form will be completed to capture certain descriptive information such as identity, document control number, confidentiality indicator, document title, document date, receipt date and chemical identity. The document will be microfiched and stored for archival purposes. 2( b) Use/ Users of the Data Information contained in the TSCA section 8( c) allegation reports will have several uses. The information collected will be used on a case specific basis to corroborate suspected adverse health or environmental effects of a chemical substance or mixture already under assessment by OPPT. Most of these substances will be "existing" chemicals, e. g., chemicals for test rule consideration, substances that are the subject of a section 8( e) notice of substantial risk, or substances or mixtures brought to the attention of OPPT by other EPA programs, other government agencies, industry, or the public. However, TSCA section 8( c) reports also may be required on "new" chemicals as one means of monitoring for any suspected or potential hazards identified during the premanufacture notification (PMN) review period. By using TSCA section 8( c) 's reporting authority, EPA can examine such records whenever a chemical is discovered to present possible risks to human health or the environment. On a case­ specific basis, requiring reporting of TSCA section 8( c) records will also serve as a discovery function. It will help identify trends of adverse affects across the industry that may not be apparent to any one company. It will also serve as a long­ term trend identification function because of the 30­ year recordkeeping feature of the statute. As the recordkeeping and reporting provisions of section 8( c) are of central importance in the administration of section 8 of TSCA, EPA would not be able t o meet it s obligation under TSCA without having the capability to carry them out. 3 NON­ DUPLICATION, CONSULTATIONS ANDOTHERCOLLECTIONCRITERIA 3( a) Non­ Duplication Information recorded and reported is kept specifically for compliance with the TSCAsection 8( c) rule. There are no other EPA programs or other agencies/ departments that would have this specific information nor does any other program have direct authority to access such information. 3 3( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA provided a 60­ day public notice and comment period that ended on June 17, 2002 (67 FR 18604, April 16, 2002; and 67 FR 34705, May 15, 2002). EPA received one comment during the comment period, from the American Chemistry Council. EPA addresses the comment and EPA's response to it in an attachment to this ICR; see Attachment 3. 3( c) Consultations Prior to proposing the TSCA section 8( c) rule, EPA held information meetings with the following groups: " Oil, Chemical, and Atomic Workers Union " AFL/ CIO " Environmental Defense Fund " American Textile Manufacturing Association " Chemical Manufacturers Association " Chemical Specialty Manufacturers Association " Rubber Manufacturers Association " National Congress of Petroleum Retailers " National Association of Chain Drugstores During the public comment period, EPA received 160 comments from a wide variety of groups including the Chemical Manufacturers Association, American Petroleum Institute, chemical manufacturers and processors, chemical industry representatives, and environmental and labor organizations. In addition, EPA held public meetings on the proposed rule in Washington, D. C., Newark, New Jersey, and Houston, Texas. In promulgating the final TSCA section 8( c) rule, EPA contacted Allied Chemical, American Cyanamid, Monsanto, Proctor and Gamble, Stauffer Chemical, and Union Carbide to obtain industry estimates on the number of expected allegations and company indirect costs. In addition, the TSCA section 8( c) final rule concept was reviewed by the Administrator's Toxic Substance Advisory Committee, which is composed of representatives of business and environmental groups. Since promulgation, provisions of the final rule have been thoroughly discussed in briefings with representatives of the chemical industry. Also, certain aspects of the rule were subsequently modified based upon recommendations by members of the industry and after full consideration of comments from representatives of both industry and environmental groups. OPPT has provided continuing interpretive guidance to interested parties whenever the need has arisen. In July of 1986, OPPT conducted a seminar for industry representatives on TSCA that included information exchange regarding TSCA section 8( c). Another such industry seminar was conducted in 1990. 4 3( d) Effects of Less Frequent Collection Currently, EPA uses its authority to collect information pursuant to the TSCA section 8( c) rule sparingly. It would be irresponsible and contrary to the intent of TSCA to arbitrarily limit the number of collections available to EPAunder TSCAsection 8( c). Currently, EPAanticipates issuing infrequent requests (< 2/ year) for TSCA section 8( c) reporting. However, reporting requests may occur more frequentlybecause individualrulemakings containing such TSCAsection8( c) notices may be clustered in the same year. If EPA were limited to only two such rules or act ions per year, it would prevent the agency from exercising its responsibility under the law. In addition, chemical disasters such as the Bhopal incident are obviously unpredictable. OPPT must reserve the capability to require records submission on an as­ needed basis in order to gather relevant information related to such matters. TSCA section 8( c) allegation records are part of such related information. 3( e) General Guidelines The record retention provisions of TSCA section 8( c) and 40 CFR part 717 exceed the Paperwork Reduction Guidelines (5 CFR1320.6) inthat theyrequire respondents to maintain records other than health, medical, or tax records, for more than three years. TSCA section 8( c) authorizes EPA to require persons (i. e., manufacturers, processors, or distributors) to maintain records of adverse reactions to the health of employees for a period of 30 years from the date such reactions were first reported or known to the person maintaining the record. Any other record of such adverse reactions (e. g., to the environment, non­ employees) is required to be retained for a period of 5 years. 40 CFR part 717 incorporates these record retention provisions authorized by TSCA. 3( f) Confidentiality Respondents may assert a claim of business confidentiality with respect to all or part of an allegation submission. Such submissions will be handled in accordance with the provisions at 40 CFR art 2. 3( g) Sensitive Questions This section is not applicable. The information does not include information of a sensitive nature. 4 THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondent NAICS Codes Respondents affected bythis collection activityare mainlyNAICS categories 325 ­ Chemicals and Allied Products Manufacturers and 32411­ Petroleum Refining. 5 4( b) Information Requested (i) Data Items Records maintained pursuant to 40 CFR Part 717 must consist of the following: a. The original allegation as received. b. An abstract of the allegation and other pertinent information as follows: 1. The name and address of the plant site that received the allegation. 2. The date the allegation was received at that site. 3. The implicated substance, mixture, article, company process or operation, or site discharge. 4. A description of the alleger (e. g., employee, neighbor), including age and sex, if ascertainable. 5. A description of the alleged health effects, including explanation of how the effects became known and the route of exposure, if explained in the allegation. c. The results of any self initiated investigation with respect to an allegation. (EPA does not require such investigation.) d. Copies of any further required records relating to the allegation (e. g., record required under OSHA). Each person who is required to keep records under this part must submit copies of those records to EPA as required by the Administrator or appropriate designee. EPA will notify those responsible for reporting by letter or will announce any such requirements by notice in the Federal Register. (ii) Respondent Activities Respondents must do two things: (1) maintain records of significant adverse reactions, and (2) submit copies of these allegation records when required by EPA. Persons subject to the rule must record significant reactions alleged to have been caused by substances or mixtures that they manufacture, import, or process. These firms must establish a recordkeeping systemfor such allegations and monitor incoming complaints to determine if theymeet the criteria for filing. Allegations that are filed must be retained for 30 years if they are employee related and for 5 years for all other types/ sources of allegations. Firms subject to the rule must keep their TSCAsection 8( c) records at company headquarters or at a site central to their chemical operations. A multi­ site company will usually require the responsible official at the individual plant site to forward potentially recordable TSCA section 8( c) allegations to a designated TSCA coordinator at their operations headquarters. Depending on the 6 size of the company, such allegations will be reviewed by a committee to determine if the allegations relate to the company's product, operations, or discharges. If so, the effects cited in the allegation are compared against the rule's definition and examples of "significant adverse reaction." If the allegation meets this test, it is recorded. The actual allegation record is to be comprised of an abstract of the allegation along with a record of any company initiated investigation and other pertinent documents. The rule does not require further investigation. EPA requires that allegations be filed so that they may be readily retrievable by "cause" of the reaction. EPA does not, however, require a specific form under this rule. Firms subject to this rule must maintain an awareness of their reporting requirements. A reporting requirement will t ake the form of a letter directed to selected respondents or it will be a notice in the Federal Register. Respondents are responsible for monitoring the Federal Register for such notices. Whenever feasible, EPAwill also notify those companies that can be identified with the production or processing of a substance or mixture in question. Respondents must then determine if they manufacture or process the chemical substance or mixture. If so, they must conduct a search of their TSCA section 8( c) files to determine if there are any relevant records of significant adverse reactions alleged to have been caused by the substance or mixture. If such records are present, they must make a photocopy of the abstract of the records and mail it with a cover letter to EPA. The company will note that they have submitted such records to EPA so that future duplicative reporting will not occur. 5 THE INFORMATION COLLECTED ­ AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities OPPT is the primary user of the information gathered under the authority of this rule. In addition, information may be gathered for other EPA programoffices/ regions, and other Federal or state health or environmental agencies. EPA personnel involved in monitoring recordkeeping, initiating report ing requests, and reviewing responses will be staff of the Chemical Information and Testing Branch (CITB) of the Chemical Control Division (CCD), the Director of CCD and the Director of the Office of Pollution Prevention and Toxics (OPPT). (For more information about the Chemical Testing Program, go to: http:// www. epa. gov/ opptintr/ chemtest/ index. htm.) As OPPT receives submissions, they will be logged in and reviewed for confidentiality considerat ions. Copies of submissions will be made available to offices within OPPT that are assessing the substances of concern. Non­ confidential versions of the submissions will be placed in a public docket and will be available for review by other government agencies and the public. 7 5( b) Collection Methodology and Management EPA has not been able to identify a more efficient, less expensive or more flexible means of obtaining the required data. There is no new technology applicable to the collection of this information that would minimize the collection burden. Any reporting requirements will have a minimum reporting schedule of forty­ five days as outlined in the regulation. Neither the rule nor EPA requires the use of any particular methodology or technology for the retention or transmittal of TSCA section 8( c) records. To aid persons subject to this information collection, OPPT has set up a TSCA Hotline that provides information regarding TSCAsection 8( c) reporting as well as other regulatory information. When Hotline staff are unable to answer questions regarding TSCA section 8( c), the questions are referred to OPPT/ CCD staff for appropriate resolution. 5( c) Small Entity Flexibility Unlike section 8( a) of TSCA, Congress did not include a specific exemption of small businesses in TSCA section 8( c). This rule does not exempt small manufacturers or processors of chemicals from its provisions. This is due to EPA's belief that workers, plant neighbors and consumers may be adversely affected by products, emissions, etc., produced or created by firms of all sizes. However, the TSCA section 8( c) rule was written to concentrate the recordkeeping and reporting burdens on those firms generally associated with the mainstream chemical industry. EPA specifically eliminated most distributors and effectively limits the number of processors subject to the rule. By doing so, EPA has eliminated a large number of small businesses from the purview of the rule without compromising its objectives. 5( d) Collection Schedule If EPA publishes a reporting requirement relating to a chemical substance or mixture, or requests reporting by letter, then manufacturers and processors of such substance or mixture must submit a copy of relevant allegation records in their files. TSCA section 8( c) reporting requirements will be developed on an as­ needed basis and will require only the submission of an abstract of the allegation record, which is generally one page in length, not the full allegation file. 1 USEPA. Comparison of Data Sources for Characterizing Manufacturers and Processors, Draft Report, Prepared by Centaur Associates, Inc. under EPA contract No. 68­ 02­ 3980, Washington, DC, November 6, 1986. 2 Ed Coe, Economic Impact Analysis of the TSCA Section 8( c) Significant Adverse Reaction Recordkeeping and Reporting Rule, OTS/ ETD/ RIB, prepared by Kearney/ Centaur, EPA Contract No. 68­ 02­ 4297, Alexandria, VA, May 1989. 3 Abt Associates, Inc. "ICR Burden Estimates: SIC 28 and SIC 2911." Memorandum to Wendy Hoffman, RIB/ OPPT/ EPA, September 22, 1995. 8 6 ESTIMATING THE BURDEN AND COST OF THE COLLECTION This section presents the estimates of the industry burden hours and costs associated with TSCA section 8( c) activities. The specific action required to comply with a TSCA section 8( c) reporting are assumed to include review of the Federal Register for notices regarding specific chemicals, recording pertinent information on allegations and storing such records, and reporting allegations to EPA when required. 6( a) Estimating Respondent Cost and Burden Steps required to estimate burden associated with these activities include estimating the number of affected firms, the number of allegations, and number of reports. Unit estimates of burden for the various activities are also required. These unit estimates are then coupled with the number of allegations, reports, and notice reviews to develop total burden estimates for the industry. Estimates of costs require estimation of wage rates for personnel who are expected to participate in TSCA section 8( c) activities. These, coupled with the burden hours associated with the various tasks, provide the basis for industry cost estimates. Estimate of the Number of Firms EPA investigated potential data sources of numbers of firms/ plants and their employment and parent company sales to estimate the number of firms subject to TSCA section 8( c) requirements. EPA concluded that a Dun and Bradstreet database, Dun's Market Identifiers, (DMI), provided the most complete and timely data. 1 The DMI data base contains employment data for each of a firm's plants as well as parent firm sales data. The DMI database was analyzed in detail for the previous ICRs 2, 3 . The first step in the analysis was the creation of a database containing records for each plant site engaged in manufacturing or processing activities described by NAICS code 325 (Chemical and Allied Products) or NAICS code 32411 (PetroleumRefining and Related Industries). EPA chose those NAICS codes to define the firms who manufacture and process chemical substances. 9 From the DMI database, EPA also developed a distribution of firms by annual sales. Consist ent with the small business definition for information collection rules under section 8( a) of TSCA, firms with annual sales of less than $40 million were classified as small firms, while those owned by companies with sales of greater than $40 million were classified as large firms (CFR 704.3). The number of employees for these firms was calculated using only employment figures from those plants that fall under NAICS 325 or NAICS 32411. Many firms or parent companies have facilities that do not engage in chemical activities. Because these employees are not expected to make allegations regarding substances at the chemical plants, they have not been included in the estimated number of employees. The estimated average number of employees was further broken down between small and large firms. The following t able lists the number of firms and employees by size category identified by DMI data analysis. Table 1. Numbers of Firms and Employees by Firm Size Firm Size Number of Firms Number of Employees Small 10,957 47 (average) Large 1, 330 435 (average) Total 12,287 1,000,000+ (estimate) Estimate of the Number of Allegations of Significant Adverse Health Reactions The total number of allegations was based upon the average number of employees per firm and number of firms in each size category, multiplied by a standard annual allegation rate per employee. The Agency received numerous public comments following the issuance of the initial TSCA section 8( c) proposal, including many comments about t he Agency's estimate of the number of allegations. In response to these comments, EPA contacted a number of firms to develop a consensus estimate. According to the 1983 ICR, the consensus opinion of the firms contacted was that recordable TSCA section 8( c) allegations are likely to made by 0. 5 percent of the workforce. For the 1983 ICR, EPA assumed that the allegation rate made by the general public would be about one­ third the employee allegation rate. Based on the average number of employees per firm, the estimated annual per firmallegations for each of the firmsize categories is presented below. For example, for small firms, the calculation is 47 employees x 0. 005 allegations per employee = 0. 24 average annual number of employee allegations per firm. 4 Abt Associates, Inc. "ICR Burden Estimates: SIC 28 and SIC 2911." Memorandum to Wendy Hoffman, RIB/ OPPT/ EPA, September 22, 1995. 5 USEPA, Chemical on Reporting Rules Database (CORR), CCD and CSB, June 30, 1990, and EPA, Chemical on Reporting Rules Database (CORR): Update, CCD and CSB, October 31, 1992. 6 USEPA, [Untitled Computer Printout], IMD, June 3, 1992. 7 Sherlock, Scott, Information Management Division. Phone conversation with Wendy Hoffman based upon TSCA Reports to Congress for EPA Fiscal Years 1992­ 93, August 1994. 8 USEPA, "Response times and Labor Costs Final Data Element List Comprehensive Assessment Information Rule," prepared by Centaur Associates, Inc. under Contract No. 68­ 02­ 3980, Washington, D. C., April 30, 1985, pp. 94­ 106. 10 Table 2. Estimated Number of Allegations Firm Size Number of Employees Average Annual # of Allegations Employee Public Total Small 47 0. 24 0. 08 0. 32 Large 435 2.20 0.73 2.93 For the 10,957 small firms and 1, 330 large firms, the weighted average annual number of allegations per firm is 0.602 ([( 10,957*. 32) + (1,330* 2.93) / 12,287]. Estimate of the Number of Reports For previous TSCA section 8( c) ICR analyses, EPAestimated that it would issue a maximum of six industry­ wide notices per year requiring reporting on a maximum of 100 chemicals. The Agency estimated that an average of approximately five firms per chemical would actually be subject to reporting, resulting in the submission of an industry­ wide total of 500 reports. However, to date, only a very limited amount of reporting has been required under TSCA section 8( c), and this is not expected to change during the period covered by this ICR 4 . To date, only two reporting rules have been issued under TSCA section 8( c) 5 . These rules covered two chemicals and two chemical categories. A total of 31 reports have been received under TSCA section 8( c) 6 7 . This represents an average of only about 1.75 reports per year since the rule was promulgated in 1983. Estimated Wage Rates The basic methodology for estimating the industry wage rates used in this analysis was developed for the Comprehensive Assessment Information Rule (CAIR). 8 Itisthesamemethodology 9 See Lehman, Timothy. "Methodology for Section 8( a) Cost and Burden Analysis," May 1995. 10 EPA, Economic Analysis of TSCA Section 8( c) Significant Adverse Reaction Recordkeeping Rule, OTS/ ETD/ RIB, January 1983. 11 used in the previous ICR, with some refinements. 9 Wage data used to develop the basic industry wage rates are derived from the U. S. Department of Labor, Bureau of Labor Statistics (BLS), Employment Cost Index 2000 for all goodsproducing private industries. The annual salary estimates were adjusted to 2000 dollars using the BLS Employment Cost Index (ECI) for white­ collar occupations for all private industries. An overhead rate of 17 percent was applied to all wages based on information provided by the chemical industry and chemical industry trade associations. Benefit rates were applied to wages as follows: managerial, 41 percent; technical, 43 percent; and clerical, 44 percent. Total loading factors are 58 percent for managerial labor, 60 percent for technical labor, and 61 percent for clerical labor. All loaded annual salaries are divided by 2,080 hours, the average number of hours worked per year by a full­ time employee, to yield a loaded hourly wage for each labor category. The previous and updated hourly wage and load rates (overhead and benefits) are presented below. Table 4. HourlyWage andLoadRates Labor Category Previous ICR Rates (Dec. 1998) Updated Rates (2000) 2000 Load Rates Managerial $ 90.65 $95.55 58% Technical $ 67.12 $65.96 60% Clerical $ 26.79 $27.37 61% Unit Burden Hours and Costs Unit costs for each of the burdens associated with the TSCA section 8( c) requirements are calculated in this section using the wage rates presented above (see Table 5). i.. Unit Recordkeeping Burden and Costs Based on the original TSCA section 8( c) analysis, EPA estimates that a firm's TSCA section 8( c) coordinator will spend 2 to 3 hours to determine the status of an allegation. 10 For the purposes of this analysis, it is assumed that 3 hours are needed. This level of effort will occur for all allegations received. If the allegation is found to be recordable, the coordinator completes a form, has it typed 12 and checks it for accuracy. This will require 0.5 hours of clerical time and an additional 0.5 hours of managerial time. Assuming that all allegations are recordable, a total of 4 hours are expended per allegation (3. 5 hours managerial plus 0. 5 hours clerical). Storage costs for the allegations are believed to be negligible. ii. Unit Reporting Burden and Costs Based on the original TSCA section 8( c) analysis, EPA estimates that a management level company official will spend one hour reviewing the Federal Register notice or letter from EPA to determine whether the company manufactures or processes substances subject to the reporting requirement. Technical personnel would then spend an estimated two hours conducting a search of the company's TSCA section 8( c) files for any relevant allegation records. Once the file search is complete, EPA estimates that a managerial employee would spend two hours preparing a transmittal letter and other explanatory material to accompany the allegation records. An upper level management official would spend an additional two hours reviewing these materials. One hour of clerical labor would be required to prepare and mail the response. A total of eight hours is expended per report (five managerial hours, two technical hours and one clerical hour) (See Table 5). iii. Unit Reviewing Burden and Cost Based on the originalTSCAsection 8( c) analysis, EPAestimates that 0. 25 hour ofmanagerial labor would be required to review each Federal Register notice (see Table 5). Table 5. Unit Respondent Burden and Cost Estimates Activity Clerical Hours Technical Hours Manager Hours Total Hours Total Cost Recordkeeping, per allegation 0.5 3. 5 4.0 $348.11 Reporting, per report 1. 0 2.0 5. 0 8.0 $637.04 Federal Register Notice review, per Notice 0.25 0.25 $ 23.89 Total unit burden per respondent 1.5 2. 0 8.75 12.25 $1,009.04 13 Total Industry Costs and Burden The total annual cost to the industry have been calculated for small firms with annual sales less than $40 million, and for large firms with annual sales of $40 million or higher. i. Total Recordkeeping Costs and Burden The unit cost for recordkeeping is multiplied by the average annual number of allegations per firm. This figure is then multiplied by the number of firms for each size category. The totals for each category are also summed. These results are presented in the table below. Table 7. Total Industry Recordkeeping Costs Firm Size # of Firms Aver. # of Allegations per Firm Average Cost per Allegation Total Cost Small 10,957 0.32 $348.11 $1,220,557 Large 1, 330 2.93 $348.11 $1,356,550 Total 12,287 $2,577,107 Table 8. Total Industry Recordkeeping Burden # of Firms Weighted Average Annual # of Allegations Hours per Allegation Total Burden Hours 12,287 0.602 4 29,587 Total annual burden hours is 29,587 hours (the product of the three items in the table). ii. Total Reporting Burden and Cost The EPA assumes that 1. 75 TSCA section 8( c) reports will be required annually. The cost of submitting these reports is determined by multiplying the annual number of reports by the unit reporting cost. Table 9. Industry Reporting Cost Annual # of Reports Cost per Report Total Cost 1.75 $637.04 $1,114.82 14 Total burden hours are 1. 75 reports x 8 hours/ report (fromUnit Reporting Burden and Costs) =14 hours. iii. Federal Register Notice Review Burden and Cost Historically, the Agency has published an average of only 0.11 notices each year. Therefore, each firm would require only slightly more than two minutes, or 0. 03 hour of managerial labor, per year for notice review. The total cost to industry of reviewing the Federal Register notices is estimated below. Table 10. Federal Register Notice Review Cost Firm Size # of Firms Cost per Firm Total Review Cost Small 10,957 $2.87 $31,447 Large 1, 330 $2.87 $ 3, 817 Total 12,287 $2.87 $35,264 Total Federal Register notice review cost is $35,264 Table 11. Federal Register Notice Review Burden # of Firms # Notices/ Firm Hours/ Notice Total Hours 12,287 0.11 0.25 338 Total burden is estimated to be 338 hours. Table 12. Annual Burden to Industry Collection Activity Hours per Respondent Respondents per Year Hours per Year Recordkeeping 4. 00 7, 397 (1) 29,587 Reporting 8. 00 1. 75 14 Notice Review 0.25 1,351 (2) 338 Annual Burden Hours 12.25 29,939 (1) Calculated as 12,287 firms subject to Recordkeeping x 0. 602 weighted average number of allegations per firm each year = 7, 397. (2) Historically, EPA has issued an average of only 0. 11 notices per year. Therefore, on an average annual basis, 1, 351 of the estimated total of 12, 287 firms subject to TSCA section 8( c) would conduct notice reviews. 15 iv. Total Industry Burden and Costs The total economic burden on the regulated community imposed by TSCAsection 8( c) is the sumof the three components identified above (recordkeeping, reporting and Federal Register notice review. These costs, shown in the table below, would be incurred in each of the three years covered by this ICR. Table 13. Total Industry Costs and Burden Collection Activity Total Annual Cost Total Annual Burden Recordkeeping $2,577,107 29,587 Reporting $1,115 14 Federal Register Review $35,264 338 Total $2,613,486 29,939 Regulatory Flexibility Analysis TSCA section 8( c) does not include a specific exemption of small businesses. The costs of TSCA section 8( c) for small businesses (annual parent company sales of less than $40 million), which were calculated in the previous section of this analysis, are listed below. Table 14. Average Total Costs per Small Firm Type of Cost Cost Avg. recordkeeping costs $132.28 (1) Reporting costs per firm $ 0.09 (2) Federal Register notice review costs per firm $ 2. 87 (3) Avg. total cost per firm $135.24 Avg. sales per small firm $12 million (1) Calculated as the average cost per allegation times the average number of allegations per year ($ 348.11 x 0. 38 = $132.28). (2) Calculated as the total industry reporting costs divided bythe total number of firms ($ 1,115/ 12,2287 = $0.09). This cost is independent of firm size. (3) Calculated as the total industry review costs divided by the total number of firms ($ 35,264/ 12,2287 = $2.87). This cost is independent of firm size. The average recordkeeping, reporting and review costs to small firms are less than 0. 001 percent of their annual sales ($ 112.12/$ 12 million). Therefore these requirements do not appear to 16 impose a significant additional burden on small firms. 6( c) Estimating Agency Burden and Cost Annual costs to the EPA for TSCA section 8( c) for each of the three years covered by this ICR are estimated to be $41,812. The cost to the EPA for TSCA section 8( c) was calculated from cost estimates provided in the 1986 and 1989 ICRs. These costs were adjusted based on the 2001 GS­ Schedule. Annual costs to EPA associated with the recordkeeping portion of the rule include general administration of the rule, education and outreach activities, and compliance monitoring. Costs associated with reporting involve preparation of reporting notices, Federal Register printing costs, document control, and document review. Annual costs to EPA were derived based on an analysis of the cost of performing these various activities. The various elements involved in calculating EPA costs are described in more detail below. o Each year, general administration of the rule involves approximately one­ tenth of a staff specialist's time plus approximately one weeks time each for two management personnel at the branch, division and OPPT Office Director's level. o Education and outreach activities will include ongoing rule support by the Environmental Assistance Division (EAD) in OPPT. o Compliance monitoring costs primarily involve the costs of the TSCA section 8( c) portion of inspection carried out by regional personnel and other administrative costs for headquarters personnel to target and review results of such inspections. o EPA previously estimated that a maximum of six industry­ wide reporting notices involving a total of 100 chemicals would be developed each year. However, to date only two notices involving two chemicals and two chemical categories have been issued. EPA also estimated that the notices would generate a maximum 500 reports per year. To date, however, a total of only 30 reports have been received. Based on historical data, over the life of the rule an average of only 0. 11 notices have been issued per year and an average of only 1.75 reports received. The Agency believes that reporting activity under TSCA section 8( c) will remain at this low level during the period covered by the ICR. Therefore, EPA costs associated with reporting have been adjusted to reflect this large decrease in the level of expected activity. Labor involved in developing the reporting notices will require several decision meetings and either the development of letters, separate Federal Register notices, or the insertion of brief boilerplate segments in other rule preambles. o Time will be required to process submissions based upon such reporting requirements and to review them for confidentiality considerations. 17 o The Federal Register notices will be reviewed by the office directly requesting the information as well as by the Chemical Testing and Information Branch (CTIB). Information in the submission will be coded into a computer data base by CTIB staff and non­ confidential versions of the submissions records will be retained by CTIB as well as by the OPPT public files. EPA will incur costs related to the above activities in each of the three years covered by the ICR. The following table provides the projected annual costs to the government for activities related to TSCA section 8( c). These costs and their associated burden are presented in Table 15. Table 15. Annual Burden and Cost to the Federal Government Activity Hourly Wage Burden Hours Annual Cost Administrative maintenance $48.62/$ 67.59 (1) 288.0 $15,521 Education/ Outreach $40.89 (2) 240.0 $9,814 Compliance monitoring $40.89 (2) 400.0 $16,356 Develop reporting notices $40.89 (2) 1.1 $45 Document control functions $40.89 (2) 0.75 $31 Notice review, referral and data entry $40.89 (2) 1.1 $45 Totals 931 $41,812 (1) This activity is estimated to require 208 hours at the GS­ 13 level and 80 hours at the GS­ 15 level. The base wage for a GS­ 13, Step 1 is $63,211, plus 60 percent overhead and benefits of $37,927, for a total of $101,138. Dividing this by the number of hours in a work year, 2080, yields an hourly wage rate of $48.62. The base wage for a GS­ 15, Step 1 is $87,864, plus overhead and benefits of $52,718, for a total of $140,582. Dividing this by the number of hours in a work year, 2080, yields an hourly wage rate of $67.59. (2) The estimated total cost to the EPA of an average full time employee (FTE) at a GS 12, Step 1 level for 2001 is $85,050. This includes a base wage of $53,156, and 60 percent for overhead and benefits, or $31,894. Dividing this by the number of hours in a work year, 2080, yields an hourly wage rate of $40.89. 6( e) Reasons for Change in Burden There is a decrease of 340 hours (from 30,279 hours to 29,939 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This decrease primarily reflects a reduced estimated burden for respondents in reviewing Federal Register notices. Based on experience over the life of the rule, the average annual number of notices the Agency is expected to issue fell froman estimated 0. 22 in the most recent ICR, to 0.11 notices per year estimated in this renewal. An additional small reduction is attributable to reduced industry reporting requirements, which have fallen from an estimated two reports per year (31 reports total/ 15 years of the rule), to 1.7 reports per year, over the 18 years of the rule (31 reports/ 18 years). None of the unit burden estimates have been changed since the previous ICR renewal, nor do these changes reflect any actual changes in the collection activity. 18 6( f) Burden Statement The annual public burden for this collection of information, which is approved under OMB Control No. 2070­ 0034, is estimated to range between 0.25 hours and 8.0 hours per response. According to the Paperwork Reduction Act, "burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways t o comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above. In addition, the OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency (Mail Code 2822), 1200 Pennsylvania Ave. N. W., Washington, D. C. 20460. Include the OMB control number in any correspondence, but do not submit the requested information to this address. The requested information should be submitted in accordance with the instructions accompanying the form, or as specified in the corresponding regulation. ATTACHMENT 1 Toxic Substances Control Act Section 8( c) 15 USC 2607( c) US Code as of: 01/ 23/ 00 Sec. 2607. Reporting and retention of information *** (c) Records Any person who manufactures, processes, or distributes in commerce any chemical substance or mixture shall maintain records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. Records of such adverse reactions to the health of employees shall be retained for a period of 30 years fromthe date such reactions were first reported to or known by the person maintaining such records. Any other record of such adverse reactions shall be retained for a period of five years from the date the information contained in the record was first reported to or known by the person maintaining the record. Records required to be maintained under this subsection shall include records of consumer allegations of personal injury or harmto health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source. Upon request of any duly designated representative of the Administrator, each person who is required to maintain records under this subsection shall permit the inspection of such records and shall submit copies of such records. ATTACHMENT 2 Records and Reports of Allegations that Chemical Substances Cause Significant Adverse Reactions to Health or the Environment 40 CFR 717 Code of Federal Regulations Revised as of July 1, 2000 TITLE 40­­ PROTECTION OF ENVIRONMENT CHAPTER I­­ ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PART 717­­ RECORDS AND REPORTS OF ALLEGATIONS THAT CHEMICAL SUBSTANCES CAUSE SIGNIFICANT ADVERSE REACTIONS TO HEALTH OR THE ENVIRONMENT­­ Table of Contents Subpart A­­ General Provisions Sec. 717.1 Scope and compliance. Section 8 (c) of the Toxic Substances Control Act (TSCA) requires manufacturers, processors, and distributors of chemical substances and mixtures: (a) To keep "records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture." (b) To "permit inspection and submit copies of such records," upon request of any designated representative of the Administrator. This rule implements section 8( c) of TSCA. It describes the records to be kept and prescribes the conditions under which certain firms must submit or make the records available to a duly designated representative of the Administrator. Sec. 717.3 Definitions. The definitions set forth in section 3 of TSCA and the following definitions apply to this part: (a) Allegation means a statement, made without formal proof or regard for evidence, that a chemical substance or mixture has caused a significant adverse reaction to health or the environment. (b) Firm or company means any person, that is subject to this part, as defined in Sec. 717.5. (c)( 1) Known human effects means a commonly recognized human health effect of a particular substance or mixture as described either in: (i) Scientific articles or publications abstracted in standard reference sources. (ii) The firm's product labeling or material safety data sheets (MSDS). (2) However, an effect is not a "known human effect" if it: (i) Was a significantly more severe toxic effect than previously described. (ii) Was a manifestation of a toxic effect after a significantly shorter exposure period or lower exposure level than described. (iii) Was a manifestation of a toxic effect by an exposure route different from that described. (d) Manufacture or process means to manufacture or process for commercial purposes. (e)( 1) Manufacture for commercial purposes means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, and includes, among other things, such "manufacture" of any amount of a chemical substance or mixture: (i) For distribution in commerce, including for test marketing. (ii) For use by the manufacturer, including use for product research and development, or as an intermediate. (2) Manufacture for commercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substances or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose. (f) Person includes any individual, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, and any department, agency, or instrumentally of the Federal Government. (g) Process for commercial purposes means the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical substance or mixture is included. If a chemical substance or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes. (h) Retailer means a person who distributes in commerce a chemical substance, mixture, or article to ultimate purchasers who are not commercial entities. (i) Significant adverse reactions are reactions that may indicate a substantial impairment of normal activities, or long­ lasting or irreversible damage to health or the environment. (j) Site means a contiguous property unit. Property divided only by a public right­ of­ way is considered one site. There may be multiple manufacturing, processing, or distribution activities occurring within a single site. (k) Substance means a chemical substance or mixture unless otherwise indicated. Sec. 717.5 Persons subject to this part. (a) Manufacturers. (1) All manufacturers of chemical substances are subject to this part except as provided in Sec. 717.7( a). If manufacture of a chemical substance occurs at any site owned or controlled by a firm then that firm is subject to this part. (2) A manufacturer must collect: (i) Any allegation identifying a chemical substance it manufactures and any allegation identifying the operations in the manufacture of any chemical substance it manufactures. (ii) Any allegation identifying any of its own processing or distribution in commerce activities with respect to any chemical substance it manufactures. (iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph. (iv) Any allegation identifying a substance produced coincidentally during processing, use, storage or disposal of a chemical substance it manufactures. (3) For the purpose of this part, owned or controlled means ownership of 50 percent or more of a firm's voting stock or other equity rights, or the power to control the management and policies of that firm. (b) Processors. (1) A person who processes chemical substances, who is not also a manufacturer of those chemical substances, is subject to this part if (i) the person processes chemical substances to produce mixtures, or (ii) the person repackages chemical substances or mixtures. (2) As a processor subject to this part such person must collect: (i) Any allegation identifying any mixture it produces and distributes in commerce and any allegation identifying any chemical substance or mixture it repackages and distributes in commerce. (ii) Any allegation identifying any of its own further processing or distribution in commerce activities of the products described in paragraph (b)( 2)( i) of this section. (iii) Any allegation identifying emissions, effluents, or other discharges from activities described in this paragraph. (iv) Any allegation identifying a substance produced coincidentally during the processing, use, storage or disposal of the products described in paragraph (b)( 2)( i) of this section. (c) SIC code. SIC codes applicable to this part are published in Standard Industrial Classification Manual­­ 1972 and the 1977 Supplement. This manual and supplement may be obtained from the U. S. Government Printing Office, Washington, D. C. 20402­­ stock number 4101­ 0006 and stock number 003­ 005­ 0170­ 0 respectively. Where there is a conflict between the SIC code use of a term and the definition of that term in this part, the definition in this part applies. [48 FR 38187, Aug 22, 1983, as amended at 50 FR 46769, Nov. 13, 1985] Sec. 717.7 Persons not subject to this part. (a) Manufacturers. (1) Persons or site activities are exempt from this part if the means by which they manufacture a chemical substance solely involves mining or other solely extractive functions, e. g., those companies or sites within a company whose sole function is to mine mineral ores, extract petroleum or natural gas, quarry non­ metallic minerals (including extraction of salts from seawater or brines), mine or otherwise extract coal, or separate gases from the atmosphere. This exemption may include, but is not necessarily limited to, firms engaged in activities as described in SIC Division B­­ Mining and SIC Code 2813­­ Industrial Gases. (2) A person is not subject to this part if the chemical substances that person causes to be produced are limited to: (i) Chemical substances that result from chemical reactions that occur incidental to exposure of another chemical substance, mixture, or article to environmental factors such as air, moisture, microbial organisms, or sunlight. (ii) Chemical substances that result from chemical reactions that occur incidental to storage or disposal of other chemical substances, mixtures, or articles. (iii) Chemical substances that result from chemical reactions that occur upon end use of other chemical substances, mixtures, or articles such as adhesives, paints, miscellaneous cleaners or other housekeeping products, fuel additives, water softening and treatment agents, photographic films, batteries, matches, or safety flares, and that are not themselves manufactured or imported for distribution in commerce for use as chemical intermediates. (iv) Chemical substances that result from chemical reactions that occur upon use of curable plastic or rubber molding compounds, inks, drying oils, metal finishing compounds, adhesives, or paints, or other chemical substance formed during the manufacture of an article destined for the marketplace without further chemical change of the chemical substance. (v) Chemical substances that result from chemical reactions that occur when (A) a stabilizer, colorant, odorant, antioxidant, filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor, antifoamer or defoamer, dispersant, precipitation­ inhibitor, binder, emulsifier, deemulsifier, dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH adjuster, sequestrant, coagulant, flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended, or (B) a chemical substance, which is intended solely to impart a specific physicochemical characteristic, functions as intended. (b) [Reserved] (c) Sole distributors. A person solely engaged in the distribution of chemical substances is exempt from this part, unless such person is also a manufacturer or processor subject to this part. For example, a "distributor" who repackages chemical substances or mixtures is considered to be a processor and, thus, is not a sole distributor. Sole distributors may include, but are not limited to, those firms that distribute chemical substances as described in the wholesale trade SIC codes 5161­­ Chemicals and Allied Products, 5171­­ Petroleum Bulk Stations and Terminals, and 5172­­ Petroleum and Petroleum Products Wholesalers, Except Bulk Stations and Terminals. (d) Retailers. A person who is a retailer is exempt from this part unless such person is also a manufacturer or a processor subject to this part. [48 FR 38187, Aug 22, 1983, as amended at 50 FR 46770, Nov. 13, 1985] Sec. 717.10 Allegations subject to this part. (a) Allegations subject to this part are those allegations received on or after November 21, 1983 by persons subject to this part. (b) Allegations subject to this part are those that: (1) Are submitted either in writing and are signed by the alleger, or are submitted orally. In the case of an oral allegation, the firm must transcribe the allegation into written form, or it must inform the alleger that such allegation may be subject to this part and request that the alleger submit such allegation to the firm in writing and signed. (2) Implicate a substance that caused the stated significant adverse reaction by one of the following: (i) Naming the specific substance. (ii) Naming a mixture that contains a specific substance. (iii) Naming an article that contains a specific substance. (iv) Naming a company process or operation in which substances are involved. (v) Identifying an effluent, emission, or other discharge from a site of manufacturing, processing or distribution of a substance. (c) Allegations subject to this part may be made to a firm by any person, such as an employee of the firm, individual consumer, a neighbor of the firm's plant, another firm on behalf of its employees or an organization on behalf of its members. (d) EPA intends that firms should, to the maximum practical extent, provide allegers with information regarding the ultimate disposition of their allegations. For example, firms could provide a brief notice to the alleger stating that a record was created under this part based upon their allegation, or that a record was not created and briefly explain the reasons why not. Sec. 717.12 Significant adverse reactions that must be recorded. (a) Except as provided in paragraph (b) of this section, significant adverse reactions to human health that must be recorded include but are not limited to: (1) Long­ lasting or irreversible damage, such as cancer or birth defects. (2) Partial or complete impairment of bodily functions, such as reproductive disorders, neurological disorders or blood disorders. (3) An impairment of normal activities experienced by all or most of the persons exposed at one time. (4) An impairment of normal activities which is experienced each time an individual is exposed. (b) Firms are not required to record significant adverse reactions that are known human effects as defined in Sec. 717.3( c). (c) Except as provided in paragraph (d) of this section, significant adverse reactions to the environment that must be recorded, even if restricted to the environs of a plant or disposal site, include but are not limited to: (1) Gradual or sudden changes in the composition of animal life or plant life, including fungal or microbial organisms, in an area. (2) Abnormal number of deaths of organisms (e. g., fish kills). (3) Reduction of the reproductive success or the vigor of a species. (4) Reduction in agricultural productivity, whether crops or livestock. (5) Alterations in the behavior or distribution of a species. (6) Long lasting or irreversible contamination of components of the physical environment, especially in the case of ground water, and surface water and soil resources that have limited self­ cleansing capability. (d) Firms are not required to record a significant adverse reaction to the environment if the alleged cause of that significant adverse reaction can be directly attributable to an accidental spill or other accidental discharge, emission exceeding permitted limits, or other incident of environmental contamination that has been reported to the Federal Government under any applicable authority. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993] Sec. 717.15 Recordkeeping requirements. (a) Establishment and location of records. A firm subject to this part shall establish and maintain records of significant adverse reactions alleged to have been caused by chemical substances or mixtures manufactured or processed by the firm. Such records shall be kept at the firm's headquarters or at any other appropriate location central to the firm's chemical operations. (b) Content of records. The record shall consist of the following: (1) The original allegation as received. (2) An abstract of the allegation and other pertinent information as follows: (i) The name and address of the plant site which received the allegation. (ii) The date the allegation was received at that site. (iii) The implicated substance, mixture, article, company process or operation, or site discharge. (iv) A description of the alleger (e. g., "company employee," "individual consumer," "plant neighbor"). If the allegation involves a health effect, the sex and year of birth of the individual should be recorded, if ascertainable. (v) A description of the alleged health effect( s). The description must relate how the effect( s) became known and the route of exposure, if explained in the allegation. (vi) A description of the nature of the alleged environmental effect( s), identifying the affected plant and/ or animal species, or contaminated portion of the physical environment. (3) The results of any self­ initiated investigation with respect to an allegation. (EPA does not require persons subject to this part to investigate allegations received, and no provision of this part shall be construed to imply that EPA recommends, encourages or requires such investigation.) (4) Copies of any further required records or reports relating to the allegation. For example, if an employee allegation results in a requirement for the firm to record the case on Occupational Safety and Health Form 101 or appropriate substitute (see 29 CFR part 1904 for requirements under the Occupational Safety and Health Act of 1970), a copy of that OSHA record must be included in the allegation record. (c) File structure. Records must be retrievable by the alleged cause of the significant adverse reaction, which cause may be one of the following: (1) A specific chemical identity. (2) A mixture. (3) An article. (4) A company process or operation. (5) A site emission, effluent or other discharge. (d) Retention period. Records of significant adverse reactions to the health of employees shall be retained for a period of 30 years from the date such reactions were first reported to or known by the person maintaining such records. This provision requires persons subject to this part to retain for 30 years an employee health related allegation, arising from any employment related exposure, whether or not such allegation was submitted by or on the behalf of that recordkeeper's own employee. Any other record of significant adverse reactions shall be maintained for a period of five years from the date the information contained in the record was first reported to or known by the person maintaining the record. (e) Transfer of records. (1) If a firm ceases to do business, the successor must receive and keep all the records that must be kept under this part. (2) If a firm ceases to do business and there is no successor to receive and keep the records for the prescribed period, these records must be transmitted to EPA. See Sec. 717.17( c) for the address to which such records must be sent. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 58 FR 34204, June 23, 1993] Sec. 717.17 Inspection and reporting requirements. (a) Inspection. Firms must make records of allegations available for inspection by any duly designated representative of the Administrator. (b) Reporting. Each person who is required to keep records under this part must submit copies of those records to the Agency as required by the EPA Administrator or appropriate designee. EPA will notify those responsible for reporting by letter or will announce any such requirements for submitting copies of records by a notice in the Federal Register. Such letter or notice will be signed by the Administrator or appropriate designee, and will specify which records or portion of records must be submitted. The reporting period will be specified by the letter or notice but in no case will such reporting period be less than 45 days from the date of the letter or the effective date of the notice. (c) How to report. When required to report, firms must submit copies of records (preferably by certified mail) to the Document Control Office (7407), Office of Pollution Prevention and Toxics, U. S. Environmental Protection Agency, Room G­ 099, 401 M St., SW., Washington, DC., 20460, ATTN: 8( c) Allegations. [48 FR 38187, Aug. 22, 1983, as amended at 49 FR 23183, June 5, 1984; 52 FR 20084, May 29, 1987; 53 FR 12523, Apr. 15, 1988; 58 FR 34204, June 23, 1993; 60 FR 34464, July 3, 1995] Sec. 717.19 Confidentiality. (a) Any person submitting copies of records may assert a business confidentiality claim covering all or part of the submitted information. Any information covered by a claim will be disclosed by EPA only as provided in procedures set forth at part 2 of this title. (b) If no claim accompanies a document at the time it is submitted to EPA, the document will be placed in an open file available to the public without further notice to the respondent. (c) To asset a claim of confidentiality for information contained in a submitted record, the respondent must submit two copies of the document. (1) One copy must be complete. In that copy, the respondent must indicate what information, if any, is claimed as confidential by marking the specific information on each page with a label such as "confidential," "proprietary," or "trade secret" and briefly state the basis of the claim. (2) If some information is claimed as confidential, the respondent must submit a second copy of the record. The second copy must be complete, except that all information claimed as confidential in the first copy must be deleted. (3) The first copy will be for internal use by EPA. The second copy will be placed in an open file to be available to the public. (4) Failure to furnish a second copy when information is claimed as confidential in the first copy will be considered a presumptive waiver of the claim of confidentiality. EPA will notify the respondent by certified mail that a finding of a presumptive waiver of the claim of confidentiality has been made. The respondent will be given 30 days from the date of receipt of notification to submit the required second copy. If the respondent fails to submit the second copy within the 30 days, EPA will place the first copy in the public file. ATTACHMENT 3 Comment Received from American Chemistry Council during the Public Notice and Comment Period, and EPA's Response [Verbatim extract from comment, letter from American Chemistry Council, dated June 14, 2002] Re: Request for Comment on Information Collection Request (ICR): TSCA Section 8( c) Health and Safety Data Reporting Rule (EPA ICR No. 1031.07, OMB No. 2070­ 0017, Docket Control No. OPPT 2002­ 0002, AR No. AR­ 239) (67 FR 18604, April 16, 2002) Dear Sir or Madam: The American Chemistry Council is pleased to submit these comments on EPA's Information Collection Request (ICR): TSCA Section 8( c) Health and Safety Data Reporting Rule. The Council believes that EPA has not appropriately considered all the factors involved with TSCA Section 8( c) reporting requirements and suggests that a reanalysis of the burden be considered. The current estimate included in the ICR is too low and as a consequence, the cumulative regulatory impact of TSCA on industry is greater than indicated in EPA's documentation. The American Chemistry Council represents the leading companies engaged in the business of chemistry. Council members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. The Council is committed to improved environmental, health and safety performance through Responsible Care ® , common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $460 billion enterprise and a key element of the nation's economy. It is the nation's largest exporter, accounting for ten cents out of every dollar in U. S. exports. Chemistry companies invest more in research and development than any other business sector. The American Chemistry Council's member companies manufacture, process and distribute chemical substances regulated under the Toxic Substances Control Act (TSCA). As such, they are obligated to adhere to TSCA 8( c), which requires that companies maintain records of significant adverse reactions to health or the environment alleged to have been caused by the companies' substances. Allegations of adverse reactions to the health of employees must be kept for thirty years and all other allegations must be kept for five years. Consequently, the Council's members are directly affected by and have a significant interest in this ICR. According to the Federal Register notice, ..." burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information." Clearly, reporting burden is more than simply sending in a written report to the Agency. It includes ensuring staff understanding of what is required of them under the regulation, it includes storage of records associated with submitted reports, and it includes development of procedures to collect the needed information. Most importantly, it must include a means to affirmatively implement the regulatory requirements. Nonetheless, EPA's calculation of burden for this ICR focuses solely on the number of allegations related to TSCA 8( c). The burden estimate does not include any consideration of time needed for internal training of personnel, for developing reporting procedures, or for storage and maintenance of records. To ensure that TSCA 8( c) requirements are fully met, companies need to spend significant amounts of time in training staff. Proper training is essential to ensure that TSCA 8( c) allegations are appropriately documented and maintained. Training must occur for all staff that would have the opportunity to address potential allegations. This includes plant managers and medical staff, as well as customer service and sales personnel. Some companies extend this training to nonplant staff as well. By not including staff training as a burden in its ICR estimate, EPA seriously underestimated the overall cost associated with TSCA 8( c). Furthermore, despite the fact that records are required to maintained (sic) for five to thirty years, depending on the type of allegation, EPA does not include any estimates related to burden. In fact, the Supporting Statement indicates, "... storage costs for the allegations are believed to be negligible." Given the extremely long storage requirements for allegations, EPA should devote more analysis to the burden presented by this requirement. Accurately maintaining and securing files that are subject to EPA inspection and compliance verification requires a significant amount of time and resources – particularly when the length of retention time can be measured in decades. EPA's dismissal of this burden is inappropriate. Finally, EPA's calculation of managerial burden appears to be generated using a singleactor model. The Supporting Statement outlines costs associated with one person being responsible for reading a Federal Register notice concerning a TSCA 8( c) rule. However, in medium to large companies, there will be several such managers – all reading the same Federal Register report and going through the same motions outlined with the single manager. EPA's cost estimate neglects to address the increased managerial burden for larger companies. In this and all its ICRs, EPA should strive to provide OMB with information that reflects actual industry practices and associated costs. In the TSCA 8( c) report, the total burden to industry is underestimated. Before the ICR is presented to OMB, EPA should reanalyze the factors associated with TSCA 8( c) reporting and appropriately adjust the burden estimate. By doing so, EPA will provide OMB and the public with a more accurate assessment of the cumulative burden of TSCA regulations. If you have any questions on the Council's concerns, please fell free to contact Kathleen Roberts at 703/ 741­ 5222. Sincerely, /s/ Larry W. Rampy Co­ Leader Product Stewardship Team [EPA analysis and response] August 28, 2002 MEMORANDUM SUBJECT: Response to Comment Received on the TSCA Section 8( c) Information Collection Request Renewal (1031) FROM: Charles M. Auer, Director Chemical Control Division (7405) TO: Angela Hoffman, Director Regulatory Coordination Staff (7101) BACKGROUND Section 8( c) of the Toxic Substances Control Act (TSCA), 15 U. S. C. 2607( c), P. L. 94­ 469 requires that any person who manufactures, processes, or distributes in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as prescribed by 40 CFR 717, alleged to have been caused by the substance or mixture. TSCA section 8( c) requires that allegations of significant adverse reactions to the health of employees be kept for thirty years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator. Only the American Chemistry Council (ACC) responded to the Federal Register notice (67 FR 18604, April 16, 2002) announcing EPA's intent to submit the ICR renewal for TSCA section 8( c) to OMB. ACC's comments and EPA's responses are contained herein. COMMENTS/ RESPONSES 1. In the opening paragraph, the ACC states "The current estimate included in the ICR is too low and as a consequence, the cumulative regulatory impact of TSCA on industry is greater than indicated in EPA's documentation." EPA believes that the annual hours estimates calculated for the record­ keeping, reporting, and notice review associated with TSCA section 8( c) are based on best available data at the time of calculation. If the ACC has better or more accurate data, EPA would be willing to evaluate and consider these in estimating burdens. Any specifics would be greatly appreciated. 2. In the fifth paragraph, the ACC says "The burden estimate does not include any consideration of time needed for internal training of personnel, for developing reporting procedures, or for storage and maintenance of records." Subsequent paragraphs in the ACC's letter further discuss each of these concerns in very general terms. EPA follows all requirements of the Paperwork Reduction Act in developing the methodologies used in estimating required respondent activities of recordkeeping, reporting, and notice review associated with this specific ICR. EPA agrees that training is very important. Burden includes the time to train. Section 8( c) instruction would be part of any existing and ongoing training programs related to TSCA or worker safety and health. Section 8( c) requirements are little changed since initial implementation in 1983; those changes being the result of industry recommendations. Again, specific information would guide us in further assessing any additional burden of section 8( c) as a component of providing TSCA or health and safety training. Given the estimated average number of annual allegations for a large firm is less than 3 per year, EPA believes that its statement of negligible storage and maintenance costs are valid. An ICR renewal concerns itself with only three years at a time; thus, an average of fewer than 9 allegations would be received for storage and maintenance during this renewal period. 3. The ACC in its third from last paragraph says "Finally, EPA's calculation of managerial burden appears to be generated using a `single­ actor' model.." as it relates to them reading a Federal Register concerning a TSCA 8( c) rule. They go on to say that in medium to large companies several such managers would all be doing the same thing. In the ICR, EPA does state that respondents are responsible for monitoring the Federal Register for possible reporting requirements. The ICR also says that EPA will attempt to identify and notify any companies that would be subject to reporting. In the nineteen years since implementation of the rule, only 31 reports have been received based on a request; none in over ten years. In addition, the TSCA section 8( c) rule states that firms are to keep significant adverse reaction allegations "at the firm's headquarters or at any other appropriate location central to the firm's chemical operations" (CFR 717.15). Thus any reporting requirements are the responsibility of a central location which for burden estimation should be virtually a single actor. We appreciate the general comments in the letter submitted by the American Chemistry Council. If you have any questions about this matter, please contact Gerry Brown at 202­ 564­ 8086 or Dave Williams at 202­ 564­ 8179. cc: Frank Kover Dave Williams Paul Campanella Gerry Brown Ron Carlson

epa

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regulations

EPA-HQ-OPPT-2002-0003-0001

Notice

Forum on State and Tribal Toxics Action; Notice of Public Meeting

epa

2024-06-07T20:31:45.575078

regulations

EPA-HQ-OPPT-2002-0004-0001

Notice

TSCA Section 5(a)(2) Significant New Use Rules for Existing Chemicals; Request for Comment on Renewal of Information Collection Activities

epa

2024-06-07T20:31:45.576074

regulations

EPA-HQ-OPPT-2002-0004-0003

Notice

TSCA Section 5(a)(2) Significant New Use Rule for Existing Chemicals; Request for Comment on Renewal of Information Collection Activities; Extension of Comment Period

epa

2024-06-07T20:31:45.577093

regulations

EPA-HQ-OPPT-2002-0005-0001

Notice

Data Submissions for the Voluntary Children's Chemical Evaluation Program; Request for Comment on Information Collection Activities

epa

2024-06-07T20:31:45.578042

regulations

EPA-HQ-OPPT-2002-0005-0003

Notice

Data Submissions for the Voluntary Children's Chemical Evaluation Program; Request for Comment on Information Collection Activities; Ext. of Comment Period

epa

2024-06-07T20:31:45.578891

regulations

EPA-HQ-OPPT-2002-0005-0007

Supporting & Related Material

PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503. 1. Agency/ Subagency originating request EPA, Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. O None a.__ __ __ __ ­ 2 0 7 0 3. Type of information collection ( check one) a. O New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency ­ Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes G No For b­ f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. O Three years from approval date b. G Other Specify: / /___ 7. Title Data Submission for the Voluntary Children's Chemical Evaluation Program ( VCCEP) 8. Agency form number( s) ( If applicable) EPA ICR # 2055.01 9. Keywords Environmental Protection; Hazardous Substances; Reporting and Recordkeeping Requirements 10. Abstract This information collection involves a voluntary program intended to obtain data on health effects, exposure, risk, and other information needed to evaluate the safety of chemicals to which children have a high likelihood of exposure, and thereby enable the public to understand the potential health risks to children associated with exposure to such chemicals. 11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for­ profit e. Federal Government c. Not­ for­ profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. P Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 23 b. Total annual responses 297 1. Percentage of these responses collected electronically Unknown % c. Total hours requested 154,332 d. Current OMB inventory 0 e. Difference 154,332 f. Explanation of difference 1. Program Change 154,332 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. G Recordkeeping b. G Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi­ annually 6. G Annually 7. G Biannually 8. G Other ( describe) 17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff Phone: 202­ 564­ 0258 OMB 83­ I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9. NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions. The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology. If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83­ I 10/ 95

epa

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regulations

EPA-HQ-OPPT-2002-0006-0049

Supporting & Related Material

Safe Handling I Mixing Program AVANTI INTERNATIONAL 822 Bay Star Blvd. l Webster, TX 77598 l (281) 486­ 5600 l 800­ 877­ 2570 l Fax (281) 486­ 7300 www. AvantiGrout. com Hazardous Materials Classifications `, _, 2 `. ­^­_­­..­ ­. ­..­­~ i ­­ CD Chemical Grout ,. . . ,' ' Mixing & Safe Handling Presented by Jay Guillot t 2 ternational History .: x ._ ," ,,~ Avanti was established in 1978. Avanti is leading supplier of Acrylamide,. Acrylic, and Urethane chemical grouts. Avanti also supplies pumps, injection equipment, and safety gear, 1, Personal Safety I 2. Understanding Placards and MSDS 3m Personal Protective Equipment ­ PPE 4, Housekeeping 5. Storage 6& Transportation 7. Disposal Issues ­ Containers and Grout I. AV­ 100 AM Powder Mixing 2. AV­ 100 Blend Powder Mixing 3. AV­ 100 Liquid Mixing 4, AV­ 118 Liquid Mixing 5. Grout Additives 6. Question and Answer Session 7. Test for Certification Who is responsible for your safety everyday? you 14 I I 0 mer .,~ ",,­ I "._ Section 3: Physical/ Chemical Characteristics Appearance and Odor: Odorless white crystalline powder much like table salt. Boiling Point: N/ L Vapor Pressure( mm Hg.): 0.03 (extremely low) Vapor Density( Air= l): N/ L Specific Gravity( Water =I): l. 222g/ cm3 @ 86° F (30%) Melting Point: N/ L Evaporation Rate( Butyl Acetate= 1): N/ L Solubility in Water: 58g/ lOOg (680F/ 20° C) 15 AV­ 102 ersulfate Section 3: Physical/ Chemical Characteristics Appearance and Odor: Odorless, white crystals. Boiling Point: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Density( Air= l): N/ A Specific Gravity( Water = 1): 1.98 Melting Point: Decomposes Evaporation Rate( Butyl Acetate= 1): N/ A Solubility in Water: 510/ 0 @ 77° F (25° C) I ,,~ "2 onomer Section 4: Fire and Explosion Hazard Data I 16 Flash Point: 273.2OF (134° C) Seta flash Closed­ cup Flammable Limits: Not applicable, although dust in air may be explosive. Extinguishing Media: Water spray, carbon dioxide, or dry chemical. Special Fire Fighting Procedures: Avoid skin contamination and inhalation by wearing full protective clothing and self contained breathing apparatus. Approach fire from upwind to avoid hazardous vapors and toxic decomposition products. Unusual Fire and Explosion Hazards: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. 17 rsulfate I / Section 4: Fire and Explosion Hazard Data Flash Point: N/ A Flammable Limits: N/ A Extinguishing Media: Flood with water. Special Fire Fighting Procedures: Fire fighters should wear selfcontained breathing apparatus and full protective clothing. Do not use carbon dioxide or other gas­ filled fire extinguishers, they will have no effect on decomposing Persulfate. Use water sprav to cool nearbv containers and structures exposed to fire. Unusual Fire and Explosion Hazards: Decomposition of material releases oxygen that may intensify fire. The presence of water accelerates decomposition. 1 / x onomer Section 5: Reactivity Data Stability: Not stable; heating to more than 140° F (60° C) or exposinq to direct sunliqht may cause polvmerization. Incompatibility( Materials to Avoid): Avoid acids, alkalis, peroxides, oxidizing and reducing agents, or carbon steel. Decomposition: Thermal decomposition or combustion may generate toxic gases including carbon monoxide, ammonia, and hydrogen cyanide. Polymerization: May occur. Store at 80° F (60° C) with no exposure to direct sunlight. 18 19 onium P ,, Section 5: Reactivity Data Stability: Stable (becomes unstable in presence of moisture). Incompatibility( Materials to Avoid): Acids, alkalis, halides, reducing agents, combustible materials, and heavy metals. Decomposition: Will liberate oxwen that supports combustion, and oxides of sulfur and nitroaen. Polymerization: Will not occur, 20 nomer Section 6: Storage, Disposal And Spill Information Storage and Handling: Store in a cool, dry place and away from heat. Do not leave product container open to atmosphere. Take measures not to raise dust, mist, or vauor, Disposal Method: Incinerate or treat at a sewerage plant in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Collect into a closed container and dispose of in accordance with governmental regulations. Wash out the area with nlentv of water. Other Precautions: Wear motective clothinu when handlinq this product. 21 AV­ 102 nium ersulfate ii 1 Section 6: Storage, Disposal And Spill Information 1 Storage and Handling: Store in a cool, dry place away from sources of heat. Disposal Method: Dilute with plenty of water and dispose in accordance with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Put material in an approved DOT container or dilute with a larae cluantitv of water, Other Precautions: u se protective clothing when handling this product. (Use clean plastic or stainless steel scoops only.) AV­ 100 AM I i ( 5 i 22 Section 7: Precautionary Measures Respiratory Protection: NIOSH( National Institute for Occupational Safety and Health) Approved organic vapor respirator, full face piece respirator preferred. Ventilation: Local exhaust. Protective Clothing: Tychem Suit. Eye Protection: Goggles, if using a half face piece respirator. Other Protective Equipment: Chemical resistant gloves and boots. Work/ Hygienic Practices: Shower at the end of each shift. I 1 Section 7: Precautionary Measures Respiratory Protection: Use NIOSH approved respirator. Ventilation: Mechanical/ local exhaust capable of minimizing dust emissions. Protective Clothing: Tychem suit. Eye Protection: Chemical goggles or full face piece respirator. Other Protective Equipment: Chemical resistant gloves and boots. Work/ Hygienic Practices: Wash with soap and water. Remove contaminated clothing. 23 n er 24 Section 8: Health Related Data I I Primary Route( s) of Entry: Skin absorption, Eve contact, and Inhalation. Health Hazards: Repeated exposure may result in more than one disease of the nervous system. Eye Contact: Eye contact may cause conjunctival irritation and cornea1 injury. Skin Contact: Skin contact causes irritation, reddening, and peeling. Inhalation: Repeated inhalation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flush with water for 15 minutes. Get medical attention. Skin: Wash thoroughly with soap and water. Get medical attention. Inhalation: Remove to fresh air. Get medical attention. Ingestion: Drink water and induce vomiting. Take 50 grams of activated charcoal by mouth. Get immediate medical attention. (Never give anything by mouth to an unconscious or convulsing person.) 25 nium Persulfate Section 8: Healt Primary Route( s) of Entry: Skin, inhalation and Eve contact. Health Hazards: Exposure to high levels of dust may cause difficulty in breathing in sensitive persons. Eye Contact: Dust may irritate the eyes. Skin Contact: Prolonged or repeated contact with dust may cause dermatitis. Inhalation: Breathing dust may irritate nose, throat, and lungs. Prolonged exposure may cause difficulty in breathing. Ingestion: N/ L First Aid Procedures: Eyes: Immediately flush with running water for 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Immediately wash contaminated area with water. Remove contaminated clothing/ shoes and wash before reuse. If irritation persists, get medical attention. Inhalation: Remove to fresh air. If difficulty in breathing occurs, get immediate medical attention. Ingestion: Rinse mouth with water. Do not induce vomiting. Get medical attention. (Never give anything by mouth to an unconscious or convulsing person.) 26 Section 9: Toxicity Data , ­ I Carcinogenicity: This material is listed as a potential carcinogen by the IARC( IWernationa/ Agency fir Research on Cancer). In January 1992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and "acrylamide is not carcinogenic in humans as shown by two epidemiological studies." LD,,: Oral( rat): 175 mg/ kg 27 ersulfate ,, 1 Section 9: Toxicity Data Carcinogenicity: This material is not considered a carcinogen. LD,,: Oral (rat): 495 mg/ kg Dermal (rabbit): 2000 mg/ kg 28 tective ipment i Respirators Chemical Resistant Gloves Chemical Resistant Boots Splash Goggles Safety Glasses Chemical Resistant Suit f `:. apor/ PlOO Cartridges Mliwsjil~ b>"~~~~ r­ 3M 60921 BEST COPY AVAILABLE i % 32 Formaldehyde/ Organic Vapor 1 3M 60925 1 BESTCOPYAVAILABLE 33 ong with this picture? 34 ry Protection Standard ^ _, ", If you are required to wear a respirator, your employer is responsible for following: 1, Medical evaluation 2, Fit testing 3, Training 35 BEST COPY AVAILABLE Uvex Safety Goggles Model 9301 36 Coolest 1 StarLite Part # 468M 1 37 h Wall Station BEST COPY AVAlLABeE Eyesaline When do we read the directions for use? 3 8 e BEST COPY AVAILABLE 1 Model 727 / 3 9 BEST COPY AVAILABLE N­ DEX 7005 40 t s i 1 SFTY­ Boots / DuPont Protective Apparel Tip: Beware of the "Take­ Home" Problem "To prevent hazardous materials from traveling from the workplace into your car or home, always wear the proper apparel in the correct manner. Take care to doff garments without contaminating your skin, hair or street clothing. Showering provides an added precaution but cannot totally eliminate contaminants from skin and hair. And never take contaminated garments home for any reason." 42 The best equipment in the world will not protect an employee unless it is used and c 43 / Inspect all PPE before each use. NEVER use damaged or contaminated items, 1 Wear, store, and clean PPE according to manufacturers guidelines. ' BEST COPY AVAILABLE 45 Which chemicals are not compatible? Where do we find this information? MSDS Sheets! I ­7 I i r 1 I 3 ­­ 4 r R C C T PT\ DV A\/ Ali ARI LL 72 :: .­ ., ". l .,^, * 73 I ; `. BEST COPY AVAILABLE 1 AV­ 100 Liquid in I BEST COPY AVAILABLE 93 I AV­ 100 Liquid 25 BESTCOPYAVAILABLE BESYCOPYAVALABLE BEST COPY AVAILABLE ernational .*, h% ,Y i *W Y > .^. * (281) 486­ 5600 800­ 877­ 2570 Toll­ free U. S. and Canada (281) 486­ 7300 Fax www. AvantiGrout. com Hazardous Materials Classifications Page 2 of 2 March 12,200l Material Safety Data Sheet Product Name: Acme /Gordon's BARRIER 50W Dichlobenil Herbicide MSDS No.: 507­ a Version No.: 013 EPA Registration No.: 2227­ 676 Handling and Storage (Continued) Precautions to be Taken: STORAGE: Do not contaminate water, food, or feed by storage or disposal. Store product in original container only and in a locked storage area. For disposal, rinse thoroughly and securely wrap original container in several layers of newspaper and discard in trash. Do not reuse empty container. Other Precautions: NI IK! rx Exp osure Controls/ Personal Protection: Ventilation Requirements: Good local ventilation is required. Personal Protective Equipment: CAUTION: Harmful if swallowed or absorbed through the skin. Avoid breathing spray mist. Avoid contact with skin, eyes or clothing. Wear protective clothing including rubber gloves when handling. PROTECTIVE CLOTHING: Wear long sleeves and pants; chemical­ resistant gloves and shoes with socks. EYE PROTECTION: Wear safety glasses or goggles. RESPIRATORY PROTECTION: If exposure limits may be exceeded, wear dust/ mist filtering respirator (MSHAINIOSH approval number prefix TC­ 21 C), or a NIOSH approved respirator with any N, R, P or HE filter. IX Physical and Chemical Properties: Boiling Point: Nl Melting Point: Nl Evaporation Rate (Butyi Acetate q 1) : NI Vapor Pressure (mm Hg.): See below Vapor Density (Air q 1): Nl Specific Gravity (l­ i20 q 1): o.~~ o Solubility in Water: Wettable powder. Appearance and Odor: Tan powder; aromatic. Other Information: NI Stability and Reactivity: Stability: Stable. Incompatibility (Materials to Avoid): Strong oxidizing agents, and/ or extreme heat. Decomposition/ By­ Products: Burning may produce chloride and nitrogen oxide gases. Hazardous Polymerization: Will not occur. /XZ Toxicological Information: Dermal LDSO: >2 g/ kg body weight. XII. Ecological Information: Do not apply directly to lakes, ponds, or streams. Do not contaminate water when disposing of equipment washwater. For terrestrial uses, do not apply directly to water, or to areas where surface water is present, or to intertidal areas below the mean high water mark. Do not allow spray to drift onto Ecological Information (Continued) nontarget crops or vegetation. KIII. Disposal Considerations: PESTICIDE DISPOSAL: Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. CONTAINER DISPOSAL: Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, or incineration, or if allowed by state and local authorities by burning. If burned stay out of smoke. KIV. Transport IFformation: The following guidelines apply for domestic ground transport. If shipping by air or ocean, please contact our Transportation Dept. Freight Class: Herbicides, NOI ­ NMFC #50320 In our current available sizes, this product does not qualify as a Hazardous Material. bV; Regulatory Irzformation: OSHA STATUS: This product is hazardous under the criteria of the Federal OSHA Hazard Communication Standard 29 CFR 1910.1200. TSCA STATUS: This product is exempt from TSCA Regulation under FIFRA Section 3( 2)( B)( ii) when used as a pesticide. CERCLA REPORTABLE QUANTITY: 200 pounds of the formulation which contains 100 pounds of Dichlobenil SARA TITLE Ill: SECTION 302 EXTREMELY HAZARDOUS SUBSTANCES: None SECTION 31 l/ 312 HAZARD CATEGORIES: Immediate Health Hazard, Delayed Health Hazard SECTION 313 TOXIC CHEMICALS: None RCRA STATUS: if discarded in its purchased form, this product would not be a hazardous waste either by listing or by characteristic. However, under RCRA it is the responsibility of the product user to determine at the time of disposal, whether a material containing the product or derived from the product should be classified as a hazardous waste. (40 CFR 261.20­ 24) /Xv7 Other Information: REASON FOR ISSUE: To revise MSDS to the ANSI 2400.1­ 1996 format NOTE: NI means not indicated. The information and statements in this Material Safety Data Sheet are believed to accurately reflect the scientific evidence used in making the hazard determination, but is not to be construed as a warranty or representation for which we assume legal responsibility. Additional information may be necessary or desirable depending on particular, exceptional or variable conditions or circumstances of use or storage or because of locally applicable laws or government regulations. Therefore, you should use this information only as a supplement to other information available to you and must make independent determinations of the suitability of the information for your particular circumstances or conditions and of the completeness of the information available from all sources to assure both the proper use of the material described herein, and the safety and health of employees. Page 1 of 2 March 12,200l Material `Safety Data Sheet Product Name: Acme /Gordon's BARRIER 50W Dichlobenil Herbicide MSDS No.: 5078 I. Basic Information: Version No.: 013 EPA Registration No.: 2217 I Manufacturer: PBl/ Gordon Corporation Address: 1217 West 12th Street City, State Zip: Kansas City, MO 64101­ 1407 Information Contact: Environmental; Health, & Safety Dept. Information Telephone Number: (816) 421­ 4070 Emergency Contact: Chemtrec Emergency Telephone Number: (800) 424­ 9300 1 Health 1 Flammability 0 Reactivity E Pen. Protection Last Update: 11/ 21/ 00 Chemical State: B Liquid 0 Gas q Solid Chemical Type: Pure q Mixture II. Ingredients: q Trade Secret (ND =Nor Disclosed) CAS No. Chemical Name % Range E H S IARC SARA 313 OSHA ACGIH O t h e r NTP SUB Z 1 PEL TLV Limits 1194656 2,6­ Dichlorobenzonitrile (Dichlobenil) 1332587 Kaolin clay 14808607 Q u a r t z 50.0 N N N NN NI NI NI 36.6 N N N Y N 5 mg/ m3R 2 mg/ m3R 5 mgfm3R <2 N Y Y Y N 0.1 mg/ m3 .05 mglm3 .05 mg/ m3 EHazardous Identification: Hazard Catagory: cl X Acute NChronic q Fire q Pressure q Reactive Hazardous Identification Information: Aromatic tan powder. Irritant. May be harmful if absorbed through the skin, or if swallowed. kK First Aid Measures: Route( s) of Entry: Contact, inhalation, ingestion. Health Hazards (Acute and Chronic): EYES: Contact may cause irritation. SKIN: Contact may cause skin irritation. May be harmful if absorbed through the skin. INHALATION: May cause irritation to the respiratory tract. INGESTION: May cause irritation to the gastrointestinal tract. May be harmful if swallowed. Signs and Symptoms: NI Medical Conditions Generally Aggravated by Exposure: NI Emergency First Aid Procedure: EYES: Flush with clean water for 1 O­ 1 5 minutes, holding lids open. If irritation persists, seek medical attention. SKIN: Bathe and shampoo with soap and water to remove chemicals from skin and hair. If irritation persists, seek medical attention. Launder contaminated clothing separately prior to reuse. First Aid Measures (Continued) INHALATION: Remove victim to fresh air. Apply artificial respiration if needed. If irritation persists, seek medical attention. INGESTION: Call physician or Poison Control Center. Drink 1 or 2 glasses of water and induce vomiting by touching back of throat with finger. G e t medical attention. Other Health Warnings: Do not eat, drink or smoke when handling product. Avoid contact with skin, eyes and clothing. K Fire Fighting Measures: Flash Point: NI F. P. Method: Lower Explosive Limit: NI Upper Explosive Limit: NI Fire Extinguishing Media: Foam, C02, Dry Chemical, Water. Special Fire Fighting Procedures: Wear self­ contained breathing apparatus. Unusual Fire and Explosion: Extreme heat may release chloride and nitrogen oxide gases. Runoff from fire control may cause pollution to surface water. If pollution occurs, notify local authorities. PT. Accidental Release Measures: Steps to be Taken in Case Material is Released or Spilled: Do not touch spilled material. See Section 8 for Personal Protective Equipment. Contain and collect the spilled product for reuse or disposal. Cover and label the containers. Wash area with water if possible. VTI. Handling and Storage: I MSDS for Potassium Ferricyanide A. R. AVANTI INTERNATIONAL Page 2 of 2 a­ RECAUTIONARY MEASURES Respiratory Protection: If material is heated or reacted with acid, wear a NIOSH approved respirator suitable for cyanides. Ventilation: Local and mechanical exhaust systems. Protective Clothing: Rubber gloves, long­ sleeved shirt, trousers, rubber apron. Eye Protection: Safety glasses with side shields. Other Protective Equipment: Eye wash and safety shower. Work/ Hygienic Practices: Wash with soap and water after handling. ) HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption and inhalation. Health Hazards: Fumes resulting from thermal decomposition are highly toxic. Eye Contact: May cause irritation. Skin Contact: May cause irritation. Inhalation: May cause irritation. Ingestion: Causes nausea and stomach pain. First Aid Procedures: Eyes: Flush with water for 15 minutes. If irritation develops, get medical attention. Skin: Wash thoroughly with soap and water. If irritation develops, get medical attention. Inhalation: Remove to fresh air. If difficulty in breathing develops, inhale amyl nitrate vapor five times every 15 seconds; give artificial respiration if necessary. Ingestion: If conscious, induce vomiting. (Never give anything by mouth to an unconscious or convulsing person.) ( TOXICITY DATA *­. D LO: Oral( rat): 1600 mg/ kg AThe information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the t use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined NIL =Not Listed Date Issued: September 15, 1999 Page 1 of 2 MATERIAL SAFETY DATA SHEET AVANTI INTERNATIONAL CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 822 Bay Star Blvd. Product Data Information: (281) 486­ 5600 Webster, TX 77598 1 IDENTIFICATION Trade Name: Potassium Ferricyanide A. R. Ingredient( s): Potassium Ferricyanide Percent: 100 CAS Number: 13746­ 66­ 2 OSHA PEL: N/ E ACGIH TLV: N/ E ~, HAZARD RATINGS NFPA: Health: 3 Fire: 0 Reactivity: 0 Special: None 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Orange to reddish crystals. Boiling Point: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Density( Air= l): N/ A Specific Gravity( Water = 1): 1.85 Melting Point: N/ L Evaporation Rate( Butyl Acetate= l): N/ A Solubility in Water: Soluble j FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A Flammable Limits: N/ A Extinguishing Media: Use any material suitable for products in the same area. Special Fire Fighting Procedures: Wear a self­ contained breathing apparatus. Unusual Fire and Explosion Hazards: Decomposition can produce toxic fumes of cyanides. / REACTIVITY Stability: Stable under normal conditions Incompatibility( Materials to Avoid): Acids, ammonia, chromic anhydride, and copper sulfate. Decomposition: Will emit toxic fumes of cyanides. Polymerization: N/ L 1 STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry area. Disposal Method: Dispose of in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Sweep into appropriate containers. Other Precautions: N/ L N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed \r5 MSDS for AV­ 257 lcoset AVANTI INTERNATIONAL Page 2 of 2 `RECAUTIONARY MEASURES ­Respiratory Protection: No respiratory protection should be needed. Ventilation: General ventilation. Protective Clothing: Long­ sleeved shirt, trousers. Eye Protection: Safety glasses. Other Protective Equipment: N/ L Work/ Hygienic Practices: Wash with soap and water after handling. 7 [ HEALTH RELATED DATA : Primary Route( s) of Entry: Inhalation, skin and eye contact. Health Hazards: N/ L Eye Contact: May cause temporary eye irritation. Skin Contact: Short single exposure is not likely to cause significant skin irritation. Prolonged or repeated exposure may cause skin irritation. Material may stick to skin causing irritation upon removal. Skin absorption unlikely. Inhalation: Single exposure to vapors is not likely to be hazardous. Ingestion: No hazards anticipated from swallowing small amounts incidental to normal handling operations. First Aid Procedures: Eyes: Flush with plenty of water. Skin: Wash off in flowing water or shower. Inhalation: Remove to fresh air. Ingestion: Do not induce vomiting unless directed by medical personnel. Get medical attention. (Never give anything by mouth to an unconscious or convulsing person.) "LTOXICITY DATA larcinogenicity: N/ L LDso: Oral( rat): ~5000 mg/ kg Dermal: N/ D The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined /y6 NIL =Not Listed Date issued: June 15,200O Page 1 of 2 ~ MATERIAL SAFETY DATA SHEET I AVANT1 INTERNATIONAL CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 822 Bay Star Blvd. Product Data Information: (281) 486­ 5600 Webster, TX 77598 1 IDENTIFICATION Trade Name: AV­ 257 lcoset Ingredient( s): Proprietary carboxylated styrene/ butadiene polymer CAS Number: Proprietary OSHA PEL: N/ L ACGIH TLV: N/ L Water CAS Number: 7732­ l 8­ 5 Percent: 40­ 62 Percent: 38­ 60 1 HAZARD RATINGS N/ L 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Milky white liquid emulsion, slight odor. Boiling Point: 212° F (lOO° C) Vapor Pressure( mm Hg.): 17.5 @ 68° F (20° C) Vapor Density: 0.624 @ 80° F (26° C) Specific Gravity( Water = 1): .980 ­ 1.040 Melting Point: N/ L Evaporation Rate( Butyl Acetate): N/ L Solubility in Water: Product as sold is dilutable. Polymer component is insoluble. 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A Flammable Limits: N/ A Extinguishing Media: Water fog, carbon dioxide, dry chemical, or foam. Special Fire Fighting Procedures: Wear positive­ pressure, self­ contained breathing apparatus and full protective gear. Unusual Fire and Explosion Hazards: This material will not burn until the water has evaporated. Residue can burn. Smoke may contain unidentified toxic and/ or irritating compounds. 1 REACTliflTY Stability: Stable. lncompatibility( Materials to Avoid): N/ A Decomposition: If burned, smoke may contain unidentified toxic and/ or irritating compounds. Polymerization: Will not occur. 1 STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store at temperatures between 40° F and 110° F. May coagulate in freezing temperatures (< 32" F/ O" C). Material may develop bacteria odor on long­ term storage. Disposal Method: Do not dump into any sewers, on the ground, or into any body of water. Any disposal practice must comply with Federal, State, and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Avoid dilution of spill. Collect with absorbent material and transfer to appropriate containers for disposal. Water may be used for final cleaning of affected area. Other Precautions: N/ L N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 118 Duriflex AVANTI INTERNATIONAL Page 2 of 2 LsJ ORAGE, DISPOSAL AND SPILL INFORMATION ­ ~~~ `age and Handling: Store in cool, dry place (between 36° F and 85° F) in tightly closed original containers away from light and heat. Do not reuse containers, Disposal Method: Dispose of in accordance with Federal, State and Local regulations. If possible, catalyze to form a gel for disposal (the gel formed by the polymer and water is non­ hazardous). Steps to Be Taken in Case Material is Released or Spilled: Evacuate area. Wear appropriate protective gear. Dike area to prevent runoff. Do not flush into drains. If recovery is not possible, catalyze substance to form a gel. Ventilate and wash spill area with plenty of water. Large Spill: Pump any free liquid into an appropriate closed container. Small Spill: Absorb with inert absorbent material. Sweep into appropriate closed container. Other Precautions: Do not let monomeric solution dry in air. Avoid introducing polymerization catalysts into the commercial product unless it is diluted with water. PRECAUTIONARY MEASURES Respiratory Protection: Wear a NIOSH approved full face­ piece respirator for organic vapors. If airborne concentrations exceed permissible exposure limits, wear a NIOSH approved supplied air respirator or self­ contained breathing apparatus. Ventilation: Use local ventilation when possible. Mixing tanks should be vented to the outside of the truck. Protective Clothing: Wear chemically resistant boots, gloves, and chemical suit (Tychem or equivalent). Eye Protection: Use full face­ piece respirator for mixing and cleaning operations, and chemical splash proof goggles when not wearing respirator. Other Protective Equipment: Eyewash station and sink should be readily available. Work/ Hygienic Practices: Shower at the end of each shift, Clean and inspect PPE before reuse. Do not eat, drink, or smoke in work area. 1 HEALTH RELATED DATA Pamary Route( s) of Entry: Skin absorption and inhalation. lth Hazards: Immediate acute health hazard. Delayed chronic health hazard. Prolonged contact may cause muscle weakness, bluish cold hands, peeling of the palms, pain, numbness, and a tingling sensation in the limbs. Accumulative effects may lead to central nervous system disturbances. Eye Contact: May cause redness and irritation. Skin Contact: Harmful if absorbed through the skin; may cause irritation, redness, and inflammation. Inhalation: Vapor or mist may cause upper respiratory tract irritation. Ingestion: Moderately toxic by ingestion; can cause nausea, diarrhea, and abdominal cramps. First Aid Procedures: Eyes: Flush with water for 15 minutes. If irritation persists, get medical attention. Skin: Wash with soap and water. Remove contaminated clothing. Get medical attention. Inhalation: Remove from area. If necessary, administer oxygen. If signs of intoxication exist, get medical attention. Ingestion: Drink l­ 2 glasses of water and induce vomiting. Get immediate medical attention. (Never give anything by mouth to an unconscious or convulsing person.) Note to Physician: Treat symptomatically; no specific antidote is available. [ TOXICITY DATA 7 Carcinogenicity: Carcinogenicity for this product has not been determined. Acrylamide and Formaldehyde are considered probable­ or suspected hum& carcinogens by OSHA, NTP, IARC or ACGIH. Formaldehyde is a chemical known to the state of California to cause cancer. LDso: Oral (rat): 500 mg/ kg Dermal (rabbit): 1830 mg/ kg 1 I le information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined NIL =Not Listed Date Issued: May I% 2002 Page 1 of 2 1 MATERIAL SAFETY DATA SHEET I AVANTI INTERNATIONAL CHEMTREC Emergency Phone: l­ 800­ 424­ 9300 822 Bay Star Blvd. Product Data Information: (281) 486­ 5600 Webster, TX 77598 j IDENTIFICATION Trade Name: AV­ 118 Duriflex Ingredient( s): Water CAS Number: 7732­ l 8­ 5 OSHA PEL: N/ A ACGIH TWA: N/ A N­ Methylolacrylamide CAS Number: 924­ 42­ 5 OSHA PEL: N/ E ACGIH TWA: N/ E Acrylamide CAS Number: 79­ 06­ I OSHA PEL: 0.3 mg/ m3 ACGIH TWA: 0.03 mg/ m3 Formaldehyde CAS Number: 50­ 00­ o OSHA TWA: .75 ppm ACGIH STEL: 0.3 ppm N, N­ Methylenebisacrylamide CAS Number: 110­ 26­ g OSHA PEL: N/ E ACGIH TWA: N/ E Percent: 247 Percent: 238 Percent: <5 Percent: <5 Percent: 12 ) HAZARD RATINGS NFPA: Health: 2 Fire: 1 Reactivity: 0 Special: None / PHYSICALI6HEMICAL CHARACTERISTICS. Appearance and Odor: Colorless liquid, slight formaldehyde odor. Boiling Point: 214° F (101° C) @ 760mmHg Vapor Pressure( mm Hg.): <I7 @ 77° F (25° C) Vapor Density( Air= l): N/ D Specific Gravity( Water = 1): N/ D Melting Point: N/ D Evaporation Rate( Butyl Acetate= l): N/ A Solubility in Water: Dispersible II / FIRE AND EXPLOSION HAZARD DATA Flash Point: >200° F (93° C) Flammable Limits: N/ E Extinguishing Media: Water spray, carbon dioxide, or dry chemical. Special Fire Fighting Procedures: Wear NIOSH approved self­ contained breathing apparatus and full protective clothing. Unusual Fire and Explosion Hazards: High temperatures and fire conditions may cause rapid and uncontrolled polymerization that can result in explosions and the violent rupture of storage vessels or containers. / REACTIVITY Stability: Stable under normal handling and storage conditions. Incompatibility( Materials to Avoid): Aluminum, iron, copper, bases, acids, oxidizing agents, reducing agents, chelating agents, peroxides Decomposition: Thermal decomposition may produce ammonia, formaldehyde, oxides of nitrogen, and oxides of carbon. Polymerization: May occur. Avoid temperatures above 85° F (29° C) and incompatible materials N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined 194 N/ L =Not Listed MSDS for AV­ 105 Ethylene Glycol AVANTI INTERNATIONAL Page 2 of 2 ** TORAGE, DISPOSAL AND SPILL INFORMATION i storage and Handling: Keep container closed. Product may become a solid at temperatures below 8° F (­ 13° C). Do not store near foodstuff or potable water su. pplies. Product on surfaces can cause slippery conditions. Disposal Method: Dispose of in accordance with Federal, State, and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Do not this allow material to enter sewers, public water supplies, or any body of water. Soak small spills up with an absorbent material. For large spills, dike and pump into appropriate containers for disposal. Other Precautions: N/ L 1 PRECAUTIONARY MEASURES 1 Respiratory Protection: For most conditions, no respiratory protection should be needed. However, if material is heated or sprayed, an approved air­ purifying respirator should be used. Ventilation: General and/ or local exhaust to maintain levels below exposure limits. Protective Clothing: Long­ sleeved shirt, trousers, impervious boots, Eye Protection: Safety glasses or full ace shield. Other Protective Equipment: Impervious gloves and apron. Work/ Hygienic Practices: Wash thoroughly after handling, and before eating, drinking, smoking or using toilet facilities. [ HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption, eye contact, and inhalation. Health Hazards: Preexisting skin, eye, and respiratory disorders may be aggravated by exposure to this product. Eye Contact: Vapors, mists, and direct contact may cause temporary eye irritation. Cornea1 injury is unlikely. Skin Contact: Essentially nonirritating to the skin, Repeated contact to large quantities may result in absorption of harmful amounts. Contact with damaged skin may result in absorption of harmful amounts. `" 3halation: Excessive exposure may cause irritation to upper respiratory tract. At room temperature, exposures to vapors dre minimal due to physical properties; higher temperatures may generate vapor levels sufficient to cause adverse effects. Ingestion: Single dose oral toxicity is considered to be moderate. Small amounts swallowed incidental to normal handling operations are not likely to cause injury; however, swallowing large amounts may cause serious injury, even death. First Aid Procedures: Eyes: Flush with plenty of water. Skin: Wash off with flowing water. Inhalation: Remove to fresh air. Consult a physician if breathing becomes difficult. Ingestion: Induce vomiting immediately as directed by medical personnel. Get medical attention. (Never give anything by mouth to an unconscious or convulsing person.) I TOXICITY DATA I Carcinogenicity: N/ L LD5, j: Oral( rat): 4700 mg/ kg Dermal( rabbit): N/ D , The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no ?xpress or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the , use or handling of this product. N/ A =Not Applicable N/ E =Not Established f PO N/ D =Not Determined N/ L =Not Listed Date issued: September 15, 2000 Page 1 of 2 1 MATERIAL SAFETY DATA SHEET I AVANTI INTERNATIONAL CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 822 Bay Star Blvd. Product Data Information: (281) 4865600 Webster, TX 77598 j IDENTIFICATION Trade Name: AV­ 105 Ethylene Glycol Ingredient( s): Ethylene Glycol CAS Number: 107­ 21­ I OSHA PEL: 50 pprn ACGIH TLV: 100 mg/ m3 Percent: >99 ( HAZARD RATINGS NFPA: Health: 1 Flammability: 1 Reactivity: 0 Special: None PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Colorless liquid, slight odor. Boiling Point: 387° F (197° C) Vapor Pressure( mm Hg.): 0.12 @ 77° F (25° C) Vapor Density( Air= l): 2.14 Specific Gravity( Water = 1): 1 .I 155 @ 68/ 68" F (20/ 2O" C) Melting Point: N/ L Evaporation Rate( Butyl Acetate= l): N/ L Solubility in Water: Complete 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: 247" F/ 119" C (Setaflash) Flammable Limits: LEL: 3.2 UEL: N/ D Extinguishing Media: Water fog or fine spray, carbon dioxide, dry chemical. Alcohol resistent foams are preferred. Do not use direct water stream. Special Fire Fighting Procedures: DO NOT use direct water stream. Use self­ contained breathing apparatus and full protective clothing. Unusual Fire and Explosion Hazards: N/ L / REACTIVITY Stability: Stable. Incompatibility( Materials to Avoid): Oxidizing materials, strong bases, and acids. Decomposition: Hazardous decomposition products depend upon temperature, air supply, and the presence of other materials. Polymerization: Will not occur. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 103 Catalyst SP AVANTI INTERNATIONAL Page 2 of 2 ,~ TORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place away from sources of heat. Disposal Method: Dilute with plenty of water and dispose in accordance with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Put material in an approved DOT container (use clean plastic or stainless steel scoops only) and dilute with a large quantity of water. Other Precautions: N/ L 1 PRECAUTIONARY MEASURES Respiratory Protection: Use NIOSH approved dust respirator, Ventilation: Mechanical/ local exhaust capable of minimizing dust emissions. Protective Clothing: Long­ sleeved shirt, trousers, rubber or neoprene shoes. Eye Protection: Chemical goggles or full facepiece mask. Other Protective Equipment: Rubber or neoprene gloves. Work/ Hygienic Practices: Wash with soap and water. Remove contaminated clothing. 1 HEALTH RELATED DATA Primary Route( s) of Entry: Skin and eye contact, inhalation. Health Hazards: Exposure to high levels of dust may cause difficulty in breathing in sensitive persons. Eye Contact: Dust may irritate the eyes. Skin Contact: Prolonged or repeated contact with dust may cause dermatitis. Inhalation: Breathing dust may irritate nose, throat, and lungs. Prolonged exposure may cause difficulty in breathing. Ingestion: N/ L First Aid Procedures: Eyes: Immediately flush with running water for 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Immediately wash contaminated area with water. Remove contaminated clothing/ shoes and wash before reuse. If irritation persists, get medical attention. Inhalation: Remove to fresh air. If difficulty in breathing occurs, get immediate medical attention. Ingestion: Rinse mouth with water. Do not induce vomiting. Get medical attention. (Never give anything by mouth to an unconscious or convulsing person.) j TOXICITY DATA Carcinogenicity: This material is not considered a carcinogen. LD50: Oral (rat): 895 mg/ kg Dermal (rabbit): 10 g/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined NIL =Not Listed 62 Date Issued: June 7,200O MATERIAL SAFETY DATA SHEET Page 1 of 2 AVANTI INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDEN~ ltiTlON I Trade Name: AV­ 103 Catalyst SP Ingredient( s): Sodium Persulfate CAS Number: 7775­ 27­ l OSHA PEL: N/ E ACGIH TWA: 0.1 mg/ m3 Percent: 99 HAZARD RATINGS NFPA 704: Health: 1 Fire: 0 Reactivity: 1 Special: OXY [ PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Odorless, white crystals. Boiling Point: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Density( Air= l): N/ A Specific Gravity( Water = 1): 2.6 Melting Point: Decomposes Evaporation Rate( Butyl Acetate= l): N/ A Solubility in Water: 43% @ 77° F (25° C) 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A Flammable Limits: N/ A Extinguishing Media: Flood with water. Special Fire Fighting Procedures: Fire fighters should wear self­ contained breathing apparatus and full protective clothing. Do not use carbon dioxide or other gas­ filled fire extinguishers, they will have no effect on decomposing persulfates. Use water spray to cool nearby containers and structures exposed to fire. Unusual Fire and Explosion Hazards: Decomposition of material releases oxygen that may intensify fire. The presence of water accelerates decomposition. 1 R E A C T I V I T Y Stability: Stable (becomes unstable in presence of moisture). lncompatibility( Materials to Avoid): Acids, alkalis, halides, reducing agents, combustible materials, and heavy metals. Decomposition: Will liberate oxygen that supports combustion, and oxides of sulfur and nitrogen. Polymerization: Will not occur. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 102 Catalyst AP AVANTI INTERNATIONAL Page 2 of 2 "~; T~ RAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place away from sources of heat. Disposal Method: Dilute with plenty of water and dispose in accordance with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Put material in an approved DOT container (use clean plastic or stainless steel scoops only) and dilute with a large quantity of water. Other Precautions: N/ L 1 PRECAUTIONARY MEASURES Respiratory Protection: Use NIOSH approved dust respirator. Ventilation: Mechanical/ local exhaust capable of minimizing dust emissions. Protective Clothing: Long­ sleeved shirt, trousers, rubber or neoprene shoes. Eye Protection: Chemical goggles or full facepiece mask. Other Protective Equipment: Rubber or neoprene gloves. Work/ Hygienic Practices: Wash with soap and water. Remove contaminated clothing. / HEALTH RELATED DATA 1 Primary Route( s) of Entry: Skin and eye contact, inhalation. Health Hazards: Exposure to high levels of dust may cause difficulty in breathing in sensitive persons. Eye Contact: Dust may irritate the eyes. Skin Contact: Prolonged or repeated contact with dust may cause dermatitis. Inhalation: Breathing dust may irritate nose, throat, and lungs. Prolonged exposure may cause difficulty in breathing. Ingestion: N/ L First Aid Procedures: /YUI. Eyes: Immediately flush with running water for 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Immediately wash contaminated area with water. Remove contaminated clothing/ shoes and wash before reuse. If irritation persists, get medical attention. Inhalation: Remove to fresh air. If difficulty in breathing occurs, get immediate medical attention. Ingestion: Rinse mouth with water. Do not induce vomiting. Get medical attention. (Never give anything by mouth to an unconscious or convulsing person.) 1 TOXICITY DATA Carcinogenicity: This material is not considered a carcinogen. LD50: Oral (rat): 495 mg/ kg Dermal (rabbit): 2000 mg/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express. or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handlina of this DrOdUCt. IN A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed 1­ 5Ls Date Issued: June 15,200O MATERIAL SAFETY DATA SHEET Page 1 of 2 AVANTI INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDENTIFICATION Trade Name: AV­ 102 Catalyst AP Ingredient( s): Ammonium Persulfate CAS Number: 7727­ 54­ O OSHA PEL: N/ E ACGIH TWA: 0.1 mg/ m3 Percent: 99 [ HAZARD RATINGS NFPA 704: Health: 1 Fire: 0 Reactivity: 1 Special: OXY 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Odorless, white crystals. Boiling Point: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Density( Air= l): N/ A Specific Gravity( Water = 1): 1.98 Melting Point: Decomposes Evaporation Rate( Butyl Acetate= l): N/ A Solubility in Water: 51% @ 77° F (25° C) j FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A Flammable Limits: N/ A Extinguishing Media: Flood with water. Special Fire Fighting Procedures: Fire fighters should wear self­ contained breathing apparatus and full protective clothing. Do not use carbon dioxide or other gas­ filled fire extinguishers, they will have no effect on decomposing persulfates. Use water spray to cool nearby containers and structures exposed to fire. Unusual Fire and Explosion Hazards: Decomposition of material releases oxygen that may intensify fire. The presence of water accelerates decomposition. ) REACTIVITY Stability: Stable (becomes unstable in presence of moisture). Incompatibility( Materials to Avoid): Acids, alkalis, halides, reducing agents, combustible materials, and heavy metals. Decomposition: Will liberate oxygen that supports combustion, and oxides of sulfur and nitrogen. Polymerization: Will not occur. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 101 Catalyst T AVANTI INTERNATIONAL Page 2 of 2 ,* TORAGE. DISPOSAL AND SPILL INFORMATION , storage and Handling: Store in a cool, dry, well­ ventilated place. Keep containers tightly closed. Do not use pressure to empty containers. Disposal Method: Comply with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Wear protective equipment and clothing. For small spills or drips, mop or wipe up and dispose of in DOT­ approved waste contain& s. For large spills, same as above, or contain by diking with soil or other non­ combustible absorbent materials, and then pump into DOT­ approved waste containers. Other Precautions: Keep out of sewers, storm drains, surface waters and soil. Do not cut grind, weld or drill on or near a container. 1 PRECAUTIONARY MEASURES Respiratory Protection: NIOSH approved organic cartridge respirator. Ventilation: Local exhaust. Protective Clothing: Rubber gloves, long­ sleeved shirt, trousers, rubber apron. Eye Protection: Chemical goggles or full face­ piece respirator. Other Protective Equipment: Eyewash and safety shower. Work/ Hygienic Practices: Wash thoroughly after handling. j HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption and inhalation. Health Hazards: Prolonged or repeated exposure may result in delayed liver or kidney damage. Eye Contact: Irritation. Skin Contact: Dryness, irritation, possible dermatitis. A single prolonged exposure is not likely to result in harmful amounts being absorbed. ,""" nhalation: Vapors and mists irritate the nose and throat. Inhalation of higher concentrations may cause headaches, rausea, vomiting and coma. Ingestion: Pain or discomfort in mouth, chest and abdomen. May cause nausea, vomiting, diarrhea, dizziness, faintness and coma. First Aid Procedures: Eyes: Flush with water for 15 minutes. Skin: Wash thoroughly with soap and water. Inhalation: Remove to fresh air. Ingestion: Induce vomiting with water. (Never give anything by mouth to an unconscious or convulsing person.) 1 TOXICITY DATA Carcinogenicity: No data for the blend. However, the individual components are not considered carcinogens by NTP, IARC or OSHA. LDso: No data found for the blend; however, for its components: Triethanolamine: Ethylene Glycol: Oral( rat): 8680 mglkg Oral (rat): 4700 mg/ kg Dermal( rabbit): >2.0 g/ kg Dermal (rabbit): 19.5 g/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no "" ­express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the Jse or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed Date Issued: September 15, 2000 MATERIAL SAFETY DATA SHEET Page 1 of 2 AVANTI I'NTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDENTIFICATION Trade Name: AV­ 101 Catalyst T Ingredient( s): Triethanolamine CAS Number: 102­ 71­ 6 OSHA PEL: 3 ppm ACGIH TLV: 3 ppm Ethylene Glycol CAS Number: 107­ 21­ I OSHA PEL: 50 ppm ACGIH TLV: 50 ppm Deionized Water CAS Number: 7732­ l 8­ 5 OSHA PEL: N/ E Percent: 70­ 80 Percent: 1 O­ 20 Percent: l­ l 0 ( HAZARD RATINGS NFPA: Health: 2 Fire: 1 Reactivity: 0 Special: None 1 [ PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Colorless liquid, slight ammoniacal odor. Boiling Point: >387" F (197° C) Vapor Pressure( mm Hg.): Nil Vapor Density( Air= l): 6.0 est. Specific Gravity( Water = 1): 1 .I 04 Melting Point: N/ A Evaporation Rate( Butyl Acetate= l): cl Solubility in Water: Soluble FIRE AND EXPLOSION HAZARD DATA Flash Point: >24O" F (115° C) (COC) Flammable Limits: LELf i5.3 (est.) UEL: 3.2 (est.) Extinguishing Media: Water spray, dry chemical, carbon dioxide, alcohol foam. Do not use direct water stream. Special Fire Fighting Procedures: Wear self­ contained breathing apparatus and full protective clothing. Use water spray to cool nearby containers and structures exposed to fire. Unusual Fire and Explosion Hazards: This product should not be heated above 40° F (4° C) in the presence of aluminum due to excessive corrosion and the potential for a chemical reaction releasing flammable hydrogen gas. [ REACTIVITY Stability: Stable under normal conditions. Avoid exposure to heat, sparks and open flames. Incompatibility( Materials to Avoid): Avoid acids and oxidizing materials. Decomposition: May liberate carbon monoxide, carbon dioxide, oxides of nitrogen. Polymerization: Will not occur. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed \ sl MSDS for AV­ 100 Chemical Grout (Liquid) AVANTI INTERNATIONAL Page 2 of 2 1 STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place and away from heat. Take measures not to raise dust, mist and vapor. Provide good ventilation. Wear protective clothing, gloves, boots, goggles and respirators, and clean them daily when contaminated. Disposal Method: Incinerate or treat at a sewerage plant in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Collect into a closed container and dispose of in accordance with governmental regulations. Wash out the area with plenty of water. Do not create dust. Other Precautions: Store below 104° F (40° C) with no exposure to direct sunlight. Do not leave open to the atmosphere. Store at a fixed place. Keep emptied bags or drums at a fixed place until proper disposal. Clean up the work area if contaminated. Wash thoroughly in case of skin or eye contact. 1 PRECAUTIONARY MEASURES Respiratory Protection: Wear a NIOSH approved full face­ piece respirator for organic vapors. If airborne concentrations exceed permissible exposure limits, wear a NIOSH approved supplied air respirator or self­ contained breathing apparatus. Ventilation: Use local ventilation when possible. Mixing tanks should be vented to the outside of the truck. Protective Clothing: Wear chemically resistant boots, gloves, and chemical suit (Tychem or equivalent). Eye Protection: Use full face­ piece respirator for mixing and cleaning operations, and chemical splash proof goggles when not wearing respirator. Other Protective Equipment: Eyewash station and sink should be readily available. Work/ Hygienic Practices: Shower at the end of each shift. Clean and inspect PPE before reuse. Do not eat, drink, or smoke in work area. *y*. 1 HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption, inhalation and ingestion. Health Hazards: Repeated exposure affects central nervous system Eye Contact: Eye irritant. Skin Contact: Skin Irritant, causing peeling and redness. Penetrates skin easily. Inhalation: Repeated inhalation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flush with water for 15 minutes. Skin: Wash thoroughly with soap and water. Inhalation: Remove to fresh air. Ingestion: Induce vomiting with water. (Never give anything by mouth to an unconscious or convulsing person.) 1 TOXICITY DATA Carcinogenicity: This material is listed as a potential carcinogen by the IARC. In January 1992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and "acrylamide is not carcinogenic in humans as shown by two epidemiological studies." LDsO: (Acrylamide Monomer) Acute Oral( rat): 294 mg/ kg Acute Dermal( rabbit): 252 mglkg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting &­­ from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed 6­ 2 Date Issued: May I% 2002 Page 1 of 2 MATERIAL SAFETY DATA SHEET / AVANTI INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data information: (281) 486­ 5600 1 IDENTIFICATION Trade Name: AV­ 100 Chemical Grout (Liquid) Ingredient( s): Water CAS Number: 7732­ l 8­ 5 Acrylamide CAS Number: 79­ 06­ l OSHA PEL: 0.3 mg/ m3 ACGIH TLV: 0.03 mg/ m3 Percent: 60 Percent: 40 1 HAZARD RATINGS NFPA: Health: 2 Fire: 2 Reactivity: 2 Special: None 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Clear, odorless liquid. Boiling Point: 212° F Vapor Pressure( mm Hg.): 0.03 @ 104° F (40° C) Vapor Density( Air= l): 2.45 Specific Gravity( Water = 1): 1.05 Melting Point: N/ A Evaporation Rate( Butyl Acetate= l): N/ L Solubility in Water: N/ A 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A. Flammable Limits: N/ A Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam. Special Fire Fighting Procedures: Avoid skin contamination and inhalation by wearing full protective clothing and positive pressure respirator. Approach fire from upwind to avoid hazardous vapors and toxic decomposition products. Unusual Fire and Explosion Hazards: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. Closed containers may rupture violently when heated. 1 REACTIVITY Stability: Stable under normal conditions. lncompatibility( Materials to Avoid): Avoid acids, alkalis, peroxides, oxidizing and reducing agents, carbon steel or rust. Decomposition: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. Polymerization: May occur. Store below 104° F (40° C) with no exposure to direct sunlight. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 100 Chemical Grout AVANTI INTERNATIONAL Page 2 of 2 1 STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place and away from heat. Take measures not to raise dust, mist and vapor. Provide good ventilation. Wear protective clothing, gloves, boots, goggles and respirators, and clean them daily when contaminated. Disposal Method: Incinerate or treat at a sewerage plant in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Collect into a closed container and dispose of in accordance with governmental regulations. Wash out the area with plenty of water. Do not create dust. Other Precautions: Store below 104° F (40° C) with no exposure to direct sunlight. Do not leave open to the atmosphere. Store at a fixed place. Keep emptied bags or drums at a fixed place until proper disposal. Clean up the work area if contaminated. Wash thoroughly in case of skin or eye contact. / PRECAUTIONARY MEASURES I Respiratory Protection: Wear a NIOSH approved full face­ piece respirator for organic vapors and particulates. If airborne concentrations exceed permissible exposure limits, wear a NIOSH approved supplied air respirator or selfcontained breathing apparatus. Ventilation: Use local ventilation when possible. Mixing tanks should be vented to the outside of the truck. Protective Clothing: Wear chemically resistant boots, gloves, and chemical suit (Tychem or equivalent). Eye Protection: Use full face­ piece respirator for mixing and cleaning operations, and chemical splash proof goggles when not wearing respirator. Other Protective Equipment: Eyewash station and sink should be readily available. Work/ Hygienic Practices: Shower at the end of each shift. Clean and inspect PPE before reuse. Do not eat, drink, or smoke in work area. "R­ 1 HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption, inhalation and ingestion. Health Hazards: Repeated exposure affects central nervous system Eye Contact: Eye irritant. Skin Contact: Skin Irritant, causing peeling and redness. Penetrates skin easily. Inhalation: Repeated inhalation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flush with water for 15 minutes. Skin: Wash thoroughly with soap and water. Inhalation: Remove to fresh air. Ingestion: Induce vomiting with water. (Never give anything by mouth to an unconscious or convulsing person.) ­. / TOXICITY DATA Carcinogenicity: This material is listed as a potential carcinogen by the IARC. In January 1992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and "acrylamide is not carcinogenic in humans as shown by two epidemiological studies." LDxI: (Acrylamide Monomer) Acute Oral( rat): 294 mg/ kg Acute Dermal( rabbit): 252 mg/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes am1 no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed /fC Date issued: May 15, 2002 Page 1 of 2 MATERIAL SAFETY DATA SHEET / AVANTI INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDENTIF, lCATION Trade Name: AV­ 100 Chemical Grout ingredient( s): Acrylamide CAS Number: 79­ 06­ I OSHA PEL: 0.3 mg/ m3 ACGIH TLV: 0.03 mg/ m3 N, N' Methylenebisacrylamide CAS Number: 11 O­ 26­ 9 OSHA PEL: N/ D ACGIH TWA: N/ D Percent: z95 Percent: 5 1 HAZARD RATINGS NFPA: Health: 2 Fire: 2 Reactivity: 2 Special: None 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: White, crystalline powder, odorless. Boiling Point: N/ L Vapor Pressure( mm Hg.): 0.01 @ 68° F (20° C) Vapor Density( Air= l): N/ L Specific Gravity( Water = 1): 1 .150g/ cm3 @ 86° F (30° C) Melting Point: 184° F (85° C) Evaporation Rate( Butyl Acetate= l): N/ L Solubility in Water: 2009 /lOOg @ 68° F (20° C) [ FIRE AND EXPLOSION HAZARD DATA Flash Point: N/ A. Flammable Limits: N/ A Extinguishing Media: Water spray, carbon dioxide, dry chemical, foam. Special Fire Fighting Procedures: Avoid skin contamination and inhalation by wearing full protective clothing and positive pressure respirator, Approach fire from upwind to avoid hazardous vapors and toxic decomposition products Unusual Fire and Explosion Hazards: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. Closed containers may rupture violently when heated. / REACTIVITY Stability: Stable under normal conditions. Incompatibility( Materials to Avoid): Avoid acids, alkalis, peroxides, oxidizing and reducing agents, carbon steel or rust. Decomposition: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. Polymerization: May occur. Store below 104° F (40° C) with no exposure to direct sunlight. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed MSDS for AV­ 100 MBA Methylenebisacrylamide AVANTI INTERNATIONAL Page 2 of 2 ­wr­. / REACTIVITY i Stability: Stable. lncompatibility( Materials to Avoid): Oxidizing and reducing agents. Decomposition: Thermal decomposition or combustion may produce carbon monoxide, carbon dioxide, ammonia, and oxides of nitrogen. Polymerization: May occur. ( STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place and away from heat. Disposal Method: Dispose of in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Dike area to prevent entry into sewers or waterways. Recover with absorbent material and place in approved containers. Other Precautions: Wear protective clothing when handling this product. / PRECAUTIONARY MEASURES Respiratory Protection: NIOSH approved respirator. Ventilation: Local exhaust. Protective Clothing: Long­ sleeved shirt, trousers. Eye Protection: Goggles. Other Protective Equipment: Rubber or neoprene gloves and boots. Work/ Hygienic Practices: Shower at the end of each shift and wash contaminated clothes before re­ use. [ HEALTH RELATED DATA . ,. CI, b Primary Route( s) of Entry: Skin absorption, eye contact, and inhalation. Health Hazards: Exposure may aggravate existing liver or kidney disorders. Eye Contact: May cause irritation. Skin Contact: May cause skin irritation. Inhalation: May produce symptoms of central nervous system depression including headache, dizziness, and nausea. Ingestion: N/ L First Aid Procedures: Eyes: Flush with water for 15 minutes. If irritation develops, consult a physician. Skin: Wash thoroughly with soap and water. If irritation develops, consult a physician. Inhalation: Remove to fresh air. If breathing is difficult, administer oxygen and get medical attention. Ingestion: Get medical attention. j TOXICITY DATA LDs0: N, N' Methylenebisacrylamide: Oral( rat) = 390 mg/ kg Ethylene Glycol: Oral( rat) = 4700 mg/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. NIA =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed /­ `2 Date Issued: September 15, 2000 Page 1 of 2 MATERIAL SAFETY DATA SHEET AVANTI INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDENTIFICATION Trade Name: AV­ 100 MBA Methylenebisacrylamide ingredient( s): N, N' Methylenebisacrylamide CAS Number: 11 O­ 26­ 9 OSHA PEL: N/ D ACGIH TWA: N/ D Water CAS Number: 7732­ l 8­ 5 OSHA PEL: N/ A ACGIH TWA: N/ A Ethylene Glycol CAS Number: 107­ 21­ I OSHA PEL: 50 ppm ACGIH TWA: N/ D Surfactant CAS Number: Proprietary OSHA PEL: N/ L ACGIH TWA: N/ L Stabilizer CAS Number: Proprietary OSHA PEL: N/ L ACGIH TWA: N/ L Percent: 38 Percent: 38 Percent: 23 Percent: cl Percent: 4 1 HAZARD RATINGS NFPA: N/ L 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Viscous white liquid with mild odor. Boiling Point: N/ A Vapor Pressure( mm Hg.): N/ L Vapor Density( Air4): N/ L Specific Gravity( Water = I): N/ L Melting Point: N/ L Evaporation Rate( Butyl Acetate= l): N/ L Solubility in Water: Slight 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: >2OO" F Flammable Limits: N/ A Extinguishing Media: Water spray, carbon dioxide, or dry chemical. Special Fire Fighting Procedures: Avoid skin contamination and inhalation by wearing full protective clothing and self contained breathing apparatus. Unusual Fire and Explosion Hazards: N/ L N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed lb3 MSDS for AV­ 100 AM Acrylamide Monomer Page 2 of 2 AVANTI INTERNATIONAL rruI / STORAGE, DISPOSAL AND SPILL INFORMATION Storage and Handling: Store in a cool, dry place and away from heat. Do not leave product container open to atmosphere. Take measures not to raise dust, mist, or vapor. Disposal Method: Incinerate or treat at a sewerage plant in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Collect into a closed container and dispose of in accordance with governmental regulations. Wash out the area with plenty of water. Other Precautions: Wear protective clothing when handling this product. / PRECAUTIONARY MEASURES Respiratory Protection: Wear a NIOSH approved full face­ piece respirator for organic vapors and particulates. If airborne concentrations exceed permissible exposure limits, wear a NIOSH approved supplied air respirator or selfcontained breathing apparatus. Ventilation: Use local ventilation when possible. Mixing tanks should be vented to the outside of the truck. Protective Clothing: Wear chemically resistant boots, gloves, and chemical suit (Tychem or equivalent). Eye Protection: Use full face­ piece respirator for mixing and cleaning operations, and chemical splash proof goggles when not wearing respirator. Other Protective Equipment: Eyewash station and sink should be readily available. Work/ Hygienic Practices: Shower at the end of each shift. Clean and inspect PPE before reuse. Do not eat, drink, or smoke in work area. 1 HEALTH RELATED DATA Primary Route( s) of Entry: Skin absorption, eye contact, and inhalation. ;­ Health Hazards: Repeated exposure may result in more than one disease of the nervous system. Eye Contact: Eye contact may cause conjunctival irritation and cornea1 injury. Skin Contact: Skin contact causes irritation, reddening, and peeling. Inhalation: Repeated inhalation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flush with water for 15 minutes. Get medical attention. Skin: Wash thoroughly with soap and water. Get medical attention. Inhalation: Remove to fresh air. Get medical attention. Ingestion: Drink water and induce vomiting. Take 50 grams of activated charcoal by mouth. Get immediate medical attention. (Never give anything by mouth to an unconscious or convulsing person.) / TOXICITY DATA Carcinogenic@: This material is listed as a potential carcinogen by the IARC. In January 1992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and "acrylamide is not carcinogenic in humans as shown by two epidemiological studies." LDsO: Oral( rat): 175 mg/ kg The information on this MSDS is accurate to the best of Avanti International's knowledge. Avanti International makes .­ no express or implied warranty, and in no case shall be liable for consequential, special or indirect damages resulting from the use or handling of this product. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined NIL =Not Listed Date Issued: May 15,2002 Page 1 of 2 I MATERIAL SAFETY DATA SHEET I AVANT1 INTERNATIONAL 822 Bay Star Blvd. Webster, TX 77598 CHEMTREC Emergency Phone: I­ 800­ 424­ 9300 Product Data Information: (281) 486­ 5600 1 IDENTIFICATION Trade Name: AV­ 100 AM Acrvlamide Monomer Ingredient( s): Acrylamide CAS Number: 79­ 06­ l OSHA PEL: 0.30 mg/ m3 ACGIH TWA: 0.03 mg/ m3 Percent: nlO0 [ HAZARD RATINGS NFPA: Health: 2 Fire: 2 Reactivity: 2 Special: None 1 PHYSICAL/ CHEMICAL CHARACTERISTICS Appearance and Odor: Odorless, white crystalline powder. Boiling Point: N/ L Vapor Pressure( mm Hg.): N/ L Vapor Density( Air= l): N/ L Specific Gravity( Water = 1): 1 .222g/ cm3 @ 86° F (30%) Melting Point: N/ L Evaporation Rate( Butyl Acetate= l): N/ L Solubility in Water: 58g/ 106g (68" F/ 2O" C) 1 FIRE AND EXPLOSION HAZARD DATA Flash Point: 273.2" F (134° C) Setaflash Closed­ cup Flammable Limits: Not applicable, although dust in air may be explosive. Extinguishing Media: Water spray, carbon dioxide, or dry chemical. Special Fire Fighting Procedures: Avoid skin contamination and inhalation by wearing full protective clothing and self contained breathing apparatus. Approach fire from upwind to avoid hazardous vapors and toxic decomposition products. Unusual Fire and Explosion Hazards: Thermal decomposition or combustion may generate toxic gases including carbon monoxide and ammonia. 1 R E A C T I V I N Stability: Not stable; heating to more thanl40" F (60° C) or exposing to direct sunlight may cause polymerization. Incompatibility( Materials to Avoid): Avoid acids, alkalis, peroxides, oxidizing and reducing agents, or carbon steel. Decomposition: Thermal decomposition or combustion may generate toxic gases including carbon monoxide, ammonia, and hydrogen cyanide. Polymerization: May occur. Store below 140° F (60° C) with no exposure to direct sunlight. N/ A =Not Applicable N/ E =Not Established N/ D =Not Determined N/ L =Not Listed (65 SECTION I: PRODUCT IDENTIFICATION IDENTITY OF THE PRODUCT: The identifying chemical name or product name should be the same as that on the container label. EMERGENCY TELEPHONE NUMBER: Must be included, but it does not need to be toll free. TELEPHONE NUMBER FOR INFORMATION: May be the same as above for small companies. NAME OF THE MANUFACTURER OR IMPORTER: Be sure that this name is exactly the same as the name of the manufacturer listed on the product label. Small manufacturers sometimes send out MSDS from the manufacturer of the raw materials they mixed to make the product or that they repackaged; this is improper. ADDRESS OF THE MANUFACTURER OR IMPORTER: Complete address should be listed here. DATE PREPARED: MSDS prepared more than three years ago are acceptable in the U. S., but an attempt should be made to get an updated version. Three­ year­ old MSDS are invalid in Canada. SIGNATURE OF THE PREPARER: Signature is optional. SECTION II: HAZARDOUS INGREDIENTS/ IDENTITY INFORMATION SPECIFIC CHEMICAL NAME/ IDENTITY: Product name should be as listed on the label. COMMON NAME( S): Synonyms should be listed here. z+. s CAS#: The number assigned by the Chemical Abstracts Service for the chemical or material is optional. CHEMICALS IN PRODUCTS WHICH ARE MIXTURES: It used to be common for MSDS to list only ingredients which had TLVs or PELs. Now any chemical for which there is even one study which shows it may be capable of causing harm should be listed. Toxic chemical comprising more than 1% of the product by weight must be listed. Cancer­ causing chemicals which comprise 0.1% of the product must be listed. It exposure to amounts even smaller than the required 1.0 or 0.1 % k known to be hazardous, the manufacturer also must list these ingredients. In practice, however, such hazardous ingredients often go unlisted. For example, trace amounts of extremely toxic dioxins and PCB's in many pigments usually are not reported. Another example was seen recently when interior paint containing a mercury preservative off­ gassed from walls and poisoned a young child and his family. Investigation revealed that it was common practice not to list mercury preservatives on MSDS because they are present in amounts under 1% withheld by the manufacturer it they are trade secrets or proprietary. The MSDS should state by whose authority (usually the state health department) the product's identity can be withheld. Trade secret products should be avoided whenever possible since it is very difficult and time­ consuming for medical personnel to get this data if there is an accident or illness. Even then, the medical person must withhold from the victim the name of the chemical that caused his/ her problem. OSHA PEL: Here the eight­ hour time weighted average (PEL/ lWA) should be listed. The PEL/ TWA is the amount of the substance In the air to which most healthy adult workers may be exposed each work day, day after day without adverse effect. In general, the smaller the PEL the more toxic the substance although other factors such as evaporation rate should be considered. PELs are enforced by OSHA. ACGIH TLV: Here the eight­ hour time weighted average (TLV/ lWA) should be listed. TLV/ TWAs are standards for workplace air quality (developed by the American Conference of Government Industrial Hygienists (ACGIH). In general, the smaller the TLV, the more toxic the substance although other factors such as evaporation rate should be considered. TLC are standards and are not enforced by OSHA. OTHER LIMITS (OPITIONAL): NIOSH REL's (Recommended Exposure Limits), MRLs (manufacturer's recommended limits), MAKs (Federal Republic of Germany Maximum Concentration Values In the Workplace) and others may be listed here. ODOR THRESHOLD (OPTIONAL): The odor threshold (OT) is required on Canadian MSDS and is sometimes included by U. S. manufacturers who sell to both countries. OTs are very useful. They are the concentrations in air at which most people can smell the chemicals. If the OT is smaller than the TLV, then the chemical provides warning before health effects are expected. It the OT is larger than the TLV, one is already at risk by the time the odor can be detected. PERCENT (OPTIONAL): If the percentages are listed, check to see if they add up to 100%. Check to see if toxic substances are a small or large proportion of the product. SECTIONIII: PHYSICAL/ CHEMICALCHARACTERISTICS This section provides a physical profile of the chemical through its various characteristics. Some physical data may be omitted on the MSDS when it is not applicable. For example, some chemicals have no boiling point because they do not boil. However, this same chemical may dissociate (break down) with heat, and this fact and the chemicals into which it dissociates should appear on a good MSDS. If data does not exist, the line on the MSDS where it ordinarily would appear must be filled in to indicate this. Blank spaces are not proper. BOILING POINT (BP): The BP is the temperature at which the substance changes rapidly, usually with bubbling, from a liquid to a vapor. Sometimes called the "vaporization point," liquids with low BPS usually expose workers to large amounts of the vapor. If the vapor is also flammable, liquids with low BPS are also fire hazards. A common error is the assumption that no vapor is formed (e. g. from metals) until the BP is reached. However, vapor is formed at far lower temperatures, just as water which boils at 212OF evaporates at room temperature. VAPOR PRESSURE (mm Hg): VP is the pressure exerted by a saturated vapor above its own liquid in a closed container. VPs combined with evaporation rates are useful in determining how quickly materials become airborne, and thus how quickly a worker is exposed to it. They are usually reported in millimeters of mercury (mm Hg) at 68OF (ZOOC) unless otherwise stated. Substances with VPs above 20mm Hg may present a hazard due to their extreme volatility. VAPOR DENSrrY (AIR = 1): VD is the weight of a vapor or gas compared to an equal volume of air. Materials with a VD less than 1.0 are lighter than air. Materials with a VD greater than 1.0 are heavier than air. While all vapors and gases will mix with air and disperse, large quantities of unmixed vapor or gas in locations without much air movement such as storage rooms will tend to rise or sink depending on their VD. Flammable vapors that are heavier than air can spread to sources of ignition and flash back to the source. SOLUBILIlY IN WATER: This term represents the amount by weight that will dissolve in water at ambient temperature. Solubility Is important in determining suitable clean up and extinguishing methods. Solubility is usually reported in grams per liter (g/ l) or general categories such as: negligible or insoluble = < 0.1 percent slight= 0.1 ­ 1.0 percent moderate = 1 ­ 10 percent appreciable = > 10 percent complete = soluble in all proportions APPEARANCE AND ODOR: Comparing this description to the actual product is a way to be sure the right MSDS has been obtained. SPECIFIC GRAVITY (SG): The SG describes the heaviness of a material compared to a reference substance. When the reference substance is water (Hz0 = l), it indicates whether it will float or sink in water. SG for solids and liquids compared to water numerically equals density (see above). SG for gases does not equal density because the density of air is not 1.0, but 1.29. MELTING POINT: This is only applicable to solid materials. The MP is the temperature at which a solid changes to a liquid. EVAPORATION RATE: This is the rate at which a material will vaporize (volatilize, evaporate} from the liquid or said state when compared to another material. The two common liquids used for comparison are butyl acetate and ethyl ether. WHEN BUTYL ACETATE = 1.0 > WHEN ETHYL ETHER = 1.0 >3.0= FAST < 3.0 = FAST 0.8 3.0 = MEDIUM 3.0­ 9.0 = MEDIUM ~0.8 = SLOW >9.0 = SLOW SECTION IV: FIRE AND EXPLOSION HAZARD DATA FLASH POINT: The lowest temperature at which a flammable liquid gives of sufficient vapor to form an ignitable mixture with air near its surface or within a vessel. Combustion does not continue. The METHOD USED should also be designated here. There are various tests for determining flash point and these should also be designated here for accuracy. The four test methods recognized by the National Fire Protection Association (NFPA) are: Tag Open Cup test, Tag Closed Cup test, Cleveland Open Cup, and Pensky­ Martens closed cup. .. a,", FLAMMABLE LIMITS: Only applicable to flammable liquids and gases, these are the minimum and maximum concentrations In air between which Ignition can occur. Concentrations below the lower flammable limit (LFL are too lean to burn, while concentrations above the upper flammable limit (UFL) are too rich. All concentrations in between can burn or explode. (Sometimes called lower and upper explosion limits, LEL and UEL.) EXfINGUISHING MEDIA: The type of extinguisher or suppression system needed to put out a fire involving the substance. SPECIAL FIRE FIGHTING PROCEDURES: Lists any special methods needed to fight fires involving the substance. Peroxides like those used to cure polyester resins, for example, supply oxygen when burned and cannot be extinguished by ordinary methods that smother or cut off air. UNUSUAL FIRE AND EXPLOSION HAZARD: Unusual hazards such as those of some organic peroxides that ignite spontaneously under certain conditions or that become explosive when old. SECTION V: REACTIVITY DATA This section must be completely understood before doing any kind of experimenting with the material. Theater craftspeople also should be aware that the manufacturer usually has no liability for damages cause when their products not used as directed. STABIlJTY (Stable/ Unstable): Stability is the ability of the material to remain unchanged under reasonable conditions of storage and use. CONDIlIONS TO AVOID: Conditions which will render a material more unstable. For example, storage at above normal temperatures causes some materials to change rapidly. INCOMPATIBILITY: Here the MSDS should list substances which will react dangerously with the product. Workers should also use this to determine which substances also should not be stored in proximity to the product. HAZARDOUS DECOMPOSITION PRODUCTS: This section should list any hazardous chemicals given off when the product burns or when it degrades or decomposes without burning. However, manufacturers often only report the results of high temperature incineration with all the oxygen necessary for complete combustion. Under these conditions, most organic chemicals will give off carbon dioxide, water, and a few other low molecular weight chemicals. Actual burning in open air, heating with torches, hot wire cutting, or other methods of rapid decomposition usually will produce very different results. Workers should be aware that this section may not be relevant to the way in which the product is actually burned or decomposed. HAZARDOUS POLYMERIZATION: Polymerization is the process by which the molecules of a chemical can combine to form larger molecules. Examples include the setting up of epoxy or polyester resins. Polymerization is hazardous if during the reaction excessive heat, gases, or some other byproduct is given off in amounts sufficient to cause fires, burst containers, or cause some other kind of harm. CONDITIONS TO AVOID: Here should be listed conditions such as high temperatures which must be avoided to prevent hazardous polymerization from occurring. SECTION VI: HEALTH HAZARD DATA ROUTES OF ENTRY: The ways chemicals can enter the body. INHALATION: The most common route. For example, vapors or dusts can be inhaled and absorbed by the body. SKIN: If this route is checked the material can be absorbed by the skin in significant amounts. Often it is also checked if it only damages the skin itself. Good MSDS clarify whether skin damage and/ or absorption can occur. INGESTION: If this route is checked, the material can be eaten, drunk, or swallowed, or inhaled particles can be expelled from the lungs and swallowed. HEALTH HAZARDS, ACUTE AND CHRONIC: This section usually varies greatly in quality. Some manufacturers supply detailed data on both chronic and acute health effects. Others provide very little. Workers should not consider this section sufficient and should supplement it from additional references. ACUTE: Information about short­ term exposure hazards belong here. Many MSDS report OSHA and ACGIH shortterm exposure limits (STELs) and Ceiling limits (CLs) here. The OSHA PEL/ mL and the ACGIH TLV/ STEL usually are for 15­ minute exposures, while the Ceiling limits (PELC and TLVC) are instantaneous limits and not to be exceeded at any time. Other data commonly found here are LD50s and LC5Os. The LC50 is the concentration in the air that will kill 50 % of the test animals when administered in a single exposure in a specific time period, usually 1 hour. LD50 it the single dose that will kill 50 % of the test animals by any route other than inhalation such as by ingestion or skin contact. These tests establish the degree to which a chemical is acutely hazardous and determine if it will be designated "Nontoxic", "Toxic" or "Highly Toxic". LABEL DEFINITIONS OF TOXICITY IN THE U. S. AND CANADA: ILD50 LC50 Nontoxic > 5.0 g/ kg* >20,000 ppm** Toxic 0.055.0 g/ kg 200­ 20,000 ppm Highly Toxic < O. O5g/ kg < 200 ppm *grams per kilogram of body weight ** part per million: part of substance in 1 million parts of air As defined by the Federal Hazardous Substances Act (FHSA). in the U. S., and the Federal Hazardous Products Act in Canada, "nontoxic" means anything the passes the LD50 and LC50 animal tests. Workers need to know that long­ term damage such as cancer and birth defects are not detected by these tests. Since these tests reflect only acute hazards, powdered asbestos can legitimately be called nontoxic under these rules. In fact, even asbestos is nontoxic because it won't harm any animals in two weeks (the duration of the tests). CHRONIC: This section should report any known chronic hazards such as cancer, reproductive or developmental damage, neurological or other organ damage to animals or humans related to repeated or long term exposure. Unfortunately, a great number of the chemicals used in paints, dyes, and other theater materials have never been studied for long­ term hazards. Failure to see data in this section should not be taken to mean that the material has no chronic hazards. CARCINOGENICTPI: There are three agencies whose opinions regarding carcinogenicity must be reported on MSDS. They are NTP (the National Toxicology Program), IMC (the International Agency for Research on Cancer), and OSHA. The cancer ratings assigned by each agency are as follows: IARC 1. Carcinogenic to humans: sufficient evidence of carcinogenicity. 2A. Probably carcinogenic to humans; limited human evidence; sufficient evidence in experimental animals. 2B. Possibly carcinogenic to humans; limited human evidence in the absence of sufficient evidence in experimental animals. 3. Not classifiable as to carcinogenicity to humans. 4. Probably not carcinogenic to humane. NTP 1. Known to be carcinogenic, with evidence from human studies. 2. Reasonably anticipated to be a carcinogen, with limited evidence in humans or sufficient evidence in experimental animals. OSHA Carcinogens are defined with no further categorization. SIGNS AND SYMPTOMS OF EXPOSURE: These are usually acute or sub­ acute manifestations of the chemical, since chronic exposure often produces no clear symptoms for years. If chronic symptoms are given they usually are identified as such. MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Here the MSDS should list medical conditions which are known or suspected to be exacerbated by the chemical. For example, chemicals, which are respiratory irritants, may aggravate chronic lung conditions such as asthma or emphysema. EMERGENCY AND FIRST AID PROCEDURES: Recommended procedures should be listed here. SECTION VII: PRECAUTIONS FOR SAFE HANDLING AND USE STEPS TO BE TAKEN IF MATERIAL IS RELEASED OR SPILLED: The MSDS should list preferred methods for spill control (e. g. chemical absorbents, Fuller's earth, etc.) and protective equipment (respirators, gloves, emergency ventilation, etc.) needed to keep workers safe during clean up of large spills or accidents. WASTE DISPOSAL METHOD: Unless the material can be rendered completely innocuous, the MSDS can only tell users to dispose of the material In accordance with local, state, and federal regulations. Disposal has become an extraordinarily complex problem and cannot be addressed in a few lines on an MSDS. It is likely that substances which pose severe environmental threats or whose release (spills) must be reported to the EPA will soon have to be identified here. Some manufacturers have already begun including this information. PRECAUTIONS TO BE TAKEN IN HANDLING AND STORING: Here the MSDS should list safe storage conditions (e. g. cool, dry area). OTHER PRECAUTIONS: If needed, should include any special equipment that would be needed or which is required to be in a storage area with the material. SECTION VIII: CONTROL MEASURES This section should provide information about protective equipment needed under normal use of the product. The manufacturer decides what constitutes this "Normal use". If there is any doubt about what is normal, or if any unusual or experimental use is contemplated, the employer should contact the manufacturer first about additional protection. Manufacturers are usually not liable for damages if their products are used other than directed. For this reason, questions about the hazards of using the product in unusual circumstances should be answered in writing by the manufacturer or an industrial hygienist. RESPIRATORY PROTECTION (SPECIFIC TYPE): If needed during normal use, a good MSDS explains precisely what type of respirator is proper. Even the type of cartridge type for air purifying respirators should be specified. VENTILATION: If needed during normal use, a good MSDS specifies the type of ventilation system that provides proper protection. This includes recommendations about the use of general (mechanical) ventilation, local exhaust (which captures the contaminants at their source), or any special ventilation system which might be needed. EYE PROTECTION: If needed, goggles or face­ shields should be listed here. OTHER PROTECTIVE CLOTHING OR EQUIPMENT: Aprons, boots, gloves, or eye wash stations should be listed here if needed. WORK/ HYGIENIC PRACTICES: Practices such as proper daily clean up methods and equipment after normal use should be detailed here. ~ ~~ Respirator Fit Testing Procedure Fit Testing Procedures Part I. OSHA­ Accepted Fit Test Protocols A. Fit Testing Procedures­ General Requirements The employer shall conduct fit testing using the following procedures. The requirements in this appendix apply to all OSHA­ accepted fit test methods, both QLFT and QNFT. 1) 2) 3) 4) 5) 6) MI 7) 8) 9) The test subject shall be allowed to pick the most acceptable respirator from a sufficient number of respirator models and sizes so that the respirator is acceptable to, and correctly fits, the user. Prior to the selection process, the test subject shall be shown how to put on a respirator, how it should be positioned on the face, how to set strap tension and how to determine an acceptable fit. A mirror shall be available to assist the subject in evaluating the fit and positioning of the respirator. This instruction may not constitute the subject's formal training on respirator use, because it is only a review. The test subject shall be informed that he/ she is being asked to select the respirator that provides the most acceptable fit. Each respirator represents a different size and shape, and if fitted and used properly, will provide adequate protection. The test subject shall be instructed to hold each chosen face piece up to the face and eliminate those that obviously do not give an acceptable fit. The more acceptable face pieces are noted in case the one selected proves unacceptable; the most comfortable mask is donned and worn at least five minutes to assess comfort. Assistance in assessing comfort can be given by discussing the points in the following item A. 6. If the test subject is not familiar with using a particular respirator, the test subject shall be directed to don the mask several times and to adjust the straps each time to become adept at setting proper tension on the straps. Assessment of comfort shall include a review of the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator: a) Position of the mask on the nose b) Room for eye protection c) Room to talk d) Position of mask on face and cheeks The following criteria shall be used to help determine the adequacy of the respirator fit: a) Chin properly placed b) Adequate strap tension, not overly tightened c) Fit across nose bridge d) Respirator of proper size to span distance from nose to chin e) Tendency of respirator to slip f) Self­ observation in mirror to evaluate fit and respirator position. The test subject shall conduct a user seal check, either the negative and positive pressure seal checks described in Appendix G3 of this section or those recommended by the respirator manufacturer which provide equivalent protection. hfore conducting the negative and positive pressure checks, the subject shall be told to seat the mask on the face by moving the head from side­ to­ side and up and down slowly while taking in a few slow deep breaths. Another face piece shall be selected and retested if the test subject fails the user seal check tests. The test shall not be conducted if there is any hair growth between the skin and the face piece sealing surface, such as stubble beard growth, beard, mustache or sideburns which cross the respirator sealing surface. Any type of apparel which interferes with a satisfactory fit shall be altered or removed. ,/,/ SW 10) If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician or other licensed health care professional, as appropriate, to determine whether the test subject can wear a respirator while performing her or his duties. 11) If the employee finds the fit of the respirator unacceptable, the test subject shall be given the opportunity to select a different respirator and to be retested. 12) Exercise regimen. Prior to the commencement of the fit test, the test subject shall be given a description of the fit test and the test subject's responsibilities during the test procedure. The description of the process shall include a description of the test exercises that the subject will be performing. The respirator to be tested shall be worn for at least 5 minutes before the start of the fit test. 13) The fit test shall be performed while the test subject is wearing any applicable safety equipment that may be worn during actual respirator use which could interfere with respirator fit. 14) Test Exercises. The following test exercises are to be performed for all fit testing methods prescribed in this appendix, except for the CNP method. A separate fit testing exercise regimen is contained in the CNP protocol. The test subject shall perform exercises, in the test environment, in the following manner: a) Normal breathing. In a normal standing position, without talking, the subject shall breathe normally. b) Deep breathing. In a normal standing position, the subject shall breathe slowly and deeply, taking caution so as not to hyperventilate. c) Turning head side to side. Standing in place, the subject shall slowly turn his/ her head from side to side between the extreme positions on each side. The head shall be held at each extreme momentarily so the subject can inhale at each side. d) Moving head up and down. Standing in place, the subject shall slowly move his/ her head up and down. The subject shall be instructed to inhale in the up position (i. e., when looking toward the ceiling). e) Talking. The subject shall talk out loud slowly and loud enough so as to be heard clearly by the test conductor. The subject can read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song. Rainbow Passage When the sunlight strikes raindrops in the air, they act like a prism and form a rainbow. The rainbow is a division of white light into many beautiful colors. These take the shape of a long round arch, with its path high above, and its two ends apparently beyond the horizon. There is, according to legend, a boiling pot of gold at one end. People look, but no one ever finds it. When a man looks for something beyond reach, his friends say he is looking for the pot of gold at the end of the rainbow. f) Grimace. The test subject shall grimace by smiling or frowning. (This applies only to QNFT testing; it is not performed for QLFT) g) Bending over. The test subject shall bend at the waist as if he/ she were to touch his/ her toes. Jogging in place shall be substituted for this exercise in those test environments such as shroud type QNFf or QLFf units that do not permit bending over at the waist. h) Normal breathing. Same as exercise (1). 15) Each test exercise shall be performed for one minute except for the grimace exercise which shall be performed for 15 seconds. The test subject shall be questioned by the test conductor regarding the comfort of the respirator upon completion of the protocol. If it has become unacceptable, another model of respirator shall be tried. The respirator shall not be adjusted once the fit test exercises begin. Any adjustment voids the test, and the fit test must be repeated. I75 Maintenance and Shutdown Checklists /fI .­­_­.­ DAILY SHUTDOWN CHECKLIST Unit Number: Date: Operator: Review and check off items daily to place equipment in a shutdown condition at the end of day. Q Thoroughly clean the complete packer assembly. c3 Remove the mixing stem from the packer (if applicable) and clean. D Wash off the quick­ disconnects and check the nipple seals for cuts or debris. D Inspect the check valves for leaking chemical. If leaking at a high rate, clean or disassemble and rebuild. CI Drain the air­ receiver tank. Q Flush out and clean the H­ block assembly. c1 Check chemical tanks to ensure lids are closed and pinned, Cl Ensure all electrical equipment in the vehicle is turned off. Ll Other CI Other Q Other CI Other EXTENDED SHUTDOWN CHECKLIST Unit Number: Date: Operator: 0 Clear the quad­ hose by blowing air down the lines. 0 Drain the water tank. Cl Drain the chemical tanks. II Clear the air/ water test line by blowing air down the line. Cl Open inline filters and clean thoroughly. Q Drain air receiver tank. 0 Clean packer and remove the packer stem. Cl Remove the transducer from the H­ block assembly and clean the H­ block. 0 Perform the WASH DOWN AND BLOW DOWN CHECKOFF LIST. Q Other # Other D Other Cl Other AVANTI lNTERNATlONAL WASH DOWN AND BLOW DOWN CHECKLIST Unit Number: Date: Operator: Wash down and blow down procedures are accomplished along with the weekly maintenance routine or whenever extended/ winter shutdown procedures are performed. During winter shutdown, wash down should be performed first, followed by a blow down to completely dry the lines. NOTE: Be sure to adhere to all of the noted safety precautions when handling quad­ hose and related equipment. Review and check off items weekly to ensure all procedures are performed. CI 1 Slightly loosen the check valve on the blue chemical line. Do not unscrew. ." CC WARNING: Never handle quad­ hose or chemicals without wearing a minimum of rubber gloves, safety goggles, and waterproof shoes. Follow all prescribed safety precautions. The quad­ hose is still under pressure. Place a rag over the check valve to deflect any leaking chemical before loosening the valve any further. Cl 2 Slowly untighten the check valve and allow the pressure to bleed off. Remove the check valve. LI 3 Hang the quad­ hose into the manhole. CI 4 Remove the blue chemical line from the discharge side of the grout pump. For blow down (air): CI 5 Attach the air blow down fitting to the grout pump end of the chemical line. CI 6 Attach the high pressure air line from the compressor to the air blow down and continue to supply with air until no fluid flows from the line. 0 7 Disconnect the high pressure air line and remove the fitting from the quad­ hose line. WARNING: Disconnect the blow down fitting carefully, back­ pressure will be present. For wash down (water): Q 8 Connect the water wash down fitting to the grout pump end of the chemical line. Cl 9 Attach a garden hose to the end of the wash down fitting and attach the other end of the hose to a standard external spigot or the spigot in the vehicle (if available). CI 10 Turn on the water until liquid flows from the end of the quad­ hose line. Allow the water to flow for five (5) minutes or until clear. Cl 11 Turn off the water and disconnect the hose and fitting. WARNING: Disconnect the wash down fitting carefully, back­ pressure will be present. Repeat for the red chemical line. AVANTI INTERNATlONAL WEEKLY MAINTENANCE CHECKLIST Unit Number: Date: Operator: Perform the following preventive maintenance to maximize reliable operation of the equipment. These items would be carried out after the daily shutdown has been accomplished. tl Remove the check valves and quick­ disconnects from the quad­ hose ends. 0 Drain and flush the chemical from the quad­ hose (do not store grout in the quad­ hose over the weekends). If using a water base grout, the quad­ hose, chemical tanks and pump may be flushed with water to remove the chemical from the system. Cl Check the inline chemical tank filters for debris and clean. Before replacing the filters, make sure the filter seals are clean, undamaged and sealed properly. It Visually inspect the pump assembly and check the oil level in the throat seal reservoir. The oil level should be two­ thirds (213) full. If chemical is visible in the oil or the oil looks milky, tighten the throat seal bowl clockwise to compress the seal rings. If this does not stop the contamination, the pump may need rebuilding. II Check the packer sleeves for cuts or tears. Replace if necessary. 0 Check for frayed cables. Repair or replace if required. Q Ensure all equipment is clean and properly stored. CI Perform the WASH DOWN AND BLOW DOWN CHECKOFF LIST. 0 Other CL Other CI Other Test Employee Test Name Date Company 1). Who is directly responsible for your safety? A. Your supervisor B. The rig operator c. You D. The company 2). Which items of Personal Protective Equipment (PPE) should be worn during mixing operations? A. Respirator 8. Chemical protective suit C. Gloves D. All of the above 3). Where do you find the most complete product safety information? A. Product guide B. Material Safety Data Sheets (MSDS) C. Mixing instructions D. Avanti brochures 4) When mixing powder grouts, the main safety hazard is from A. Splashes B. Spills C. Inhaling the powder D. Skin contact 5). When placing the packer inside the sewer line, what type of footwear should be used? A. Tennis shoes B. Leather steel­ toed boots C. Chemical­ resistant steel­ toed boots D. Cowboy boots 6). Where should smoking be allowed during grouting operations? A. In the cab of the truck B. In the camera area of the truck C. In the mixing area of the truck D. Nowhere inside the truck 7). How often should work clothes be washed? A. Weekly B. Daily C. Monthly D. Every full moon 8). A full face piece respirator and approved cartridge/ filter can be used when the exposure to a compound is A. Above the OSHA PEL B. Below the OSHA PEL C. Equal to the OSHA PEL D. The PEL doesn't matter. . . _ ­­­­ 9). When transporting grouting chemicals in the grout truck, which precautions should be taken? A. Strap securely in place B. Keep in original containers whenever possible C. Keep different chemicals apart D. All of the above 10). When using a pump to transfer liquids, the pump parts that contact the grout must be made of A. Iron B. Any metal C. Either stainless steel or plastic D. Titanium 11). At the end of every work day workers should A. Shower completely and wash hair thoroughly B. Wash their hands before going home C. Shower, wash hair thoroughly, and clean their PPE (safety equipment) D. Think about dinner 12). PPE should be inspected and cleaned A. Weekly 8. Monthly C. Annually D. Daily 13). When mixing AV­ 100 products using the standard mix instructions with 72OF water, the gel time should be approximately A. 10 seconds B. 2 minutes C. 25 seconds D. 25 minutes 14). As the temperature of the water increases by 10 degrees, the gel time A. Decreases by one half 6. Increases by one half C. Decreases by 5 percent D. Temperature does not effect gel time 15). Which additive listed below is used to increase gel times (slow down gelation)? A. Latex B. Ethylene Glycol C. KFe (Potassium Ferricyanide) D. AC­ 50W­ A Norosac 16). As a minimum requirement, safety glasses should be worn in which of the following locations? A. Inside the grout truck 8. While working on hose reel C. When cleaning the packer D. All of the above. 17). Routes of entry for AV­ 100 products are, A. Skin 6. Eyes C. Inhalation D. All of the above 18). The storage area for chemical grouts and their additives must be a secure area capable of being locked. A. True B. False 19). Violent chemical reactions are possible if different grout compounds are mixed together due to spill or improper storage. A. True B. False 20). Empty product drums may be used for other purposes if properly cleaned. A. True B. False 21). Eyewash stations and showers should be available in or near the storage area. A. True B. False 22). During grouting operations field personnel can wear short­ sleeved shirts. A. True 8. False 23). Once leather boots have become contaminated with actylamide, rinsing them off with water removes the acrylamide. A. True B. False 24). Sharing PPE with your coworkers is a good idea. A. True B. False 25). Measuring the temperature of the water in the grout tanks is a good way to determine if your gel times have decreased substantially during the day. A. True B. False 26). Goggles should be worn instead of safety glasses when there is a higher chance of being splashed, such as when grouting in a manhole or mixing chemicals. A. True B. False 27). The effects of acute exposure are immediate A. True 8. False 28). What word best describes exposure to AV­ lOO? A. Acute 8. Chronic 29). Respirator cartridges should protect against vapors as well as particulate matter. A. True 6. False 30). DuPont TyChem protective suit is the only protective clothing recommended for mixing AV­ 100 products. A. True B. False 31). What property of AV­ 100 AM makes it difficult to be aware of exposure. A. Odorless B. Powder C. Color D. All of the above 32). What item listed below in not covered by the NFPA placard? A. Health B. Flammability C. Fire Hazard D. Specific Gravity r" 33 An oxidizing agent causes materials that do not normally burn to burn readily. A. True B. False 34). When added to the grout tank AV­ 257 Icoset, A. Inhibits freezing B. Extends Gel time C. Increases compressive strength D. Inhibits root growth 35). Adding 2lbs. AV­ 101 to the grout tank and 2lbs of AV­ 102 to the Catalyst tank will, A. Increase Gel time B. Decrease Gel time C. Increase the viscosity D. None of the above 36. Add the correct ingredients to each Tank for a conventional grout mix using AV­ 100 or AV­ 118. Tank A Tank B 37. Using your conventional mix above, circle the correct Tank for each of these materials. Tank AV­ 105 A B AV­ 257 A B Kfe A B Norosac A B 38). If a cup test reveals a 60 second gel time, what steps are needed to achieve and approximate gel time of 25 seconds? 39). What is the weight of one scoop = (W 40). What is the volume of one pitcher= (qt.) BONUS 41) What factors could contribute to your gel time increasing even though your temperature and mix is the same? Safe Handling and Mixing Program Name (Please Print) Date Company Signature Test Results (Minimum acceptable score 80%) Number correct: 40 = 100% 39 = 98% 38 = 95% 37 = 93% 36 = 90% 35 = 88% 34 = 85% 33 = 83% 32 = 80% rY7 .__"...­_ Employer Certification ­ Storage Facilities Buyers of acrylamide or acrylic grouting products from Avanti International must perform an on­ site job inspection to affirm compliance with the Safe Operating Practices Program on an annual basis. Each storage facility and each operating unit must be inspected. This site inspection is an annual requirement of the program. Operators, helpers, warehousemen, and shop personnel associated with grouting operations also should be tested annually to determine their knowledge and safety awareness of acrylamide and/ or acrylic grouts. The checklist below and the one on the following page must be completed and returned to Avanti International, along with the SOPP Verification form in Section 13, before orders of AV100 or AV­ 118 chemical grouts can be shipped. Yes N o Are the grouts and related products stored in bags and in closed fiber drums? Are fiber drums being re­ used for other purposes? Are the grouts, AV­ 101 Cat­ T+, and AV­ 102 AP stored separately? Is safety equipment available in the storage areas? Are eyewashes and showers readily available? Is spill clean­ up equipment available in the storage areas? Are all storage areas locked? Are all storage areas properly ventilated? Are signs posted on storage areas to describe the contents? Do all facilities have water available for protection and flushing? Facility Address Date of Inspection Inspection Performed by Title Signature of Inspector Describe any problems noted and corrective actions taken to maintain storage areas in compliance with this program. Yes Employer Certification ­ Operating Units/ Equipment No __ Is equipment in good condition and operating as designed? __ Do all grout tanks have covers? ­ Are disposal containers for waste materials on each unit? ­ Is safety equipment for worker protection on each unit? Is spill clean­ up equipment available on each unit? r. Is water available for worker protection and flushing? ­ Are all chemicals stored in tightly closed containers? ­ Is ventilation adequate on each unit? ­ Is the power vent working as designed? ­ Is there an eyewash station on the unit? ___ Are grouts and additives properly stored and secured? ­ Are MSDS available for all products on unit? ­ Is there a cleaning and maintenance schedule for each unit? Unit Number Date of Inspection Inspection Performed by Title Signature of Inspector License Number Describe any problems noted and corrective actions taken. I ._.." ­...­ . . .._. 11" ..­...., l" l^.­­ l.. Employee Certification I I I I (, .d­.., D I This certifies that I am an employee of and I have received technical and safety handling training in the use of grout. The classroom instruction portion of this program was completed on I 20 or repeated on and was originally prepared by: III Present Employer a Previous Employer Name Address I 20 City/ State LI Other (Specify) I also certify that I have read, understood, and will comply with all of the sections in Avanti International Safe Operating Practices Program. Signed Name Home Address Date Company b Avanti International AvantiGrout News Acrylamide Provides lasting Help for United States Government by Brent Keller, M. E., Industrial Sales Manager Beginning in 1985, federal and state regulatory agencies began close monitoring of the waste management operations at the United States Oak Ridge National Laboratory (ORNL), as well as other Department of Energy (DOE) sites. They discovered that remote monitoring wells at ORNL were registering levels of radioactivity originating from radioactive solid wastes that had been deposited in numerous burial trenches dating back to 1951, including the active days of the Manhattan Project. They concluded that these agencies of the United States government did not have adequate solutions for long­ term containment or abatement of toxic pollution to the environment. Therefore, a comprehensive study was undertaken to find a lasting method of radioactive waste containment and environmental remediation/ restoration. Since the source of the ground and surface water contamination was generally known, Oak Ridge engineers immediately began testing grouting applications and soil stabilization methods to alter the localized soil and reduce permeability. Several different grout formulations were evaluated for their ability to penetrate and reduce hydraulic conductivity or ground water transmission. Lime­ fly ash, fly ash­ cement­ bentonite, and bentonite alone were unsuccessful in permeation of the sample columns and were therefore eliminated. Sodium silicate, 1,3 benzenediol, and polyacrylamide acrylamide grout were able ". . . the half­ life for the undisrupted to successfully penetrate soil and sand columns and reduce hydraulic conduc­ L­ 1 Acryhmrde grout wus determrnecf to tivities, but only the acrylamide grout was able to reduce the mean hydraulic conductivities from 104m/ s to <10­ 8m/ s (exact reduction was unknown because performance exceeded capabilities of monitoring equipment). For this reason, the acrylamide chemical grout was selected and subjected to the next phase of testing. Acrylamide chemical grout had passed the first set of tests, but the big question was whether it could perform long­ term in the field, especially in such a contaminated environment. Two of the smaller trenches were chosen for field testing and Continued on page 2 Avanti International Continued from page 1 Reference: Farmer, C. D., L. K. Hyder, S. Y. Lee, and injected with the acrylamide chemical grout. Based on B. I'. Spalding. 1986. Demonstration ofIn Situ Immobiliprevious measurements, it was concluded that "the zationofBuried Transuranic WasteusingAcylamideGrout. void space within the trenches was totally filled by the Martin Marietta Energy Systems, Inc., U. S. Dept. of grout and that the intratrench hydraulic conductivity Energy, under contract no. DE­ AC05­ 840R21400, was reduced to below field­ measurable values. The Publication no. RAP86­ 69, Environmental Sciences grout was also completely contained within the two Division Oak Ridge National Laboratory, Oak Ridge, trenches as no grout constituents were observed in the twelve perimeter groundwater monitoring wells." These results proved that the acrylamide grout had properly cured and stabilized the soil even in the presence of radioactive waste. The stabilized trenches were monitored over several months to determine the degradation rates of the organic acrylamide grout. These rates were established by monitoring the rates of carbon dioxide evolution from amended soils as microorganisms metabolized the grout as a carbon and energy source. Microbiological half­ lives were estimated from this rate of carbon dioxide evolution and from samples returned to the lab for a six­ month observation period. Upon the completion of the carbon dating" process, the half­ life for the undisrupted acrylamide chemical grout was determined to be approximately 115 years. Due to its successful field demonstration and superior performance in laboratory degradation studies, the acrylamide chemical grout received final approval for use in immobilization and remediation of buried radioactive waste. T N 37831. l Full­ scale grouting of the buried radioactive waste trenches began in the summer of 1996 and continued to the end of that year. A reduction in the quantity of radioactive waste was immediately detected at adjacent monitoring wells, and a hydrologic monitoring system was established to determine the overall longterm effectiveness of the project. Six years from the date of the original project, acrylamide chemical grout is still providing insitu isolation of buried waste. Calendar of Events SME February 25­ 27 l Phoenix, AZ Avanti Booth #1917 PCEE February 28 ­ Mar. 2 l Nashville, TN Avanti Booth #906 ICRl March 6­ 8 l Charleston, SC CIGMAT March 15 l Houston. TX APWA­ Florida March 25­ 28 l Jacksonville, FL Avanti Booth #527 TEXAS WATER April 2­ 5 l San Antonio, TX ASCE August 4­ 7 l Cleveland, OH WEFTEC September 28 ­ Oct. 2 l Chicago, IL At the onset of this project, the DOE required lowlevel waste disposal applications to have performance lifetimes of approximately 200 years for the isolation of hazardous radionuclides; acrylamide chemical grouts were evaluated using these government standards and performed within the parameters. Avanti International makes every effort to enwre the accuracy and validity of all editorial and advertising content. This publication is independent in its views and does no+ support, endorse or guarantee any data, statements or opinions which appear under any reference or ore attributed to or quoted from any known source. The views expressed by @ 2002 Avanti International. All rights reserved. 2 AvantiGrout News/ Issue 1, 2002 Safe Operating Practices Program Version 2.1 0 2002 Avanti International 822 Bay Star Blvd. l Webster, TX 77598 l (281) 486­ 5600 l www. AvantiGrout. com .. I­­­( ,,­^. .I__.­ . ..­.. ..­ .­­ I I I I I I "d­ 8. II Table of Contents introduction . ..________....___...­.­­­­­­­.­..­­­­­­­­­­....­­­­­­.­.­­.­­­­­­­..­­­­­.­.......­­­­­­.­­ ­­ ._______...__.______­...­­.­­­­­­­ 1 Commitment to Safety ..________ _ . .._______________________ _______ _ _________... Personal Protective Equipment Respiratory Protection Program .._______. _ _.__________. _ _______._._.________. _________._ ­_­­ .________________. 1 Respirators and Cartridges ______________________.._ _ _____ ­_­ _.__________.. _ _.____.___________________ _ . . .._______ 1 Chemical Protective Clothing, General 2 ___________________...~~~..~~~~~.~..~.~~~~._.._________________~... Chemical Protective Clothing, Suits 2 _________________._..~~~~~~~...~~~.~~~.~~~~~~~~~~~~~~~.~~~~..~~~~~~..~~~. Chemical Protective Clothing, Gloves _______ ..___________ _ _________ ­_ ____.____ ­­­ __________________...... 3 Chemical Protective Clothing, Boots _____ _ ________.__ _ ____________________.­­­­­­­­­­­­­. ________________. 3 Chemical Protective Clothing, Splash Goggles & Safety Glasses ._________________. 3 Use and Care of Personal Protective Equipment ._.._________.. _ _.________...._______________.... 4 Recap: PPE as a Protective System _.___­________.__________ _ ___________._______ _­ __.___._____________ ­... 4 Housekeeping Housekeeping ._._______ _ .________.__ _ ________ ___ _______ _ ___________._________.._________.________ _ _._________________....­­­ 5 AV­ 100 Chemical Grout (AM Powder) Product Descriptions ,_._________..._____­­­­­­­­­.­­..­.­­­­­­...­­­­­­­­­­..­­­­­­.­­ ..________. ­.­ __._____________... 6 Storage Requirements ________.________._.­­­­­­.­....­­­­......­­­­­­­...­­­­­.­.­­­­­­­­.­­ .____________ _ ___.__..__ 6 Disposal of Product ____._._._________._~~..~~..~~~~~~.~~..._______.._________ .._______.._._______­...­.­­­­.­­­.­­­­­ ­7 Mixing Instructions ,.__________________~~..~~~~~~...~.~..~~.~..~~~~~~~~~~ _ ________.._____________ _ ______________._ _ ________ 8 AV­ 100 Chemical Grout [Powder Blend) Product Descriptions .___________________ _ ___________.___._.___.._______._________ _­ ________ ­__­ __________.._.__________ 11 Storage Requirements ________.__________.______.._________.._._______ ___________._______...­­­­­­­­­­.­­­..­.­ _ _____ 11 Disposal of ProducL ________________________________________­...­­­­­.­­­....­..­ _ .________.._________~~~. ­..­ ________ 12 Mixing Instructions .____._.________ _ ._________. _ ______._._______ __.__ _____ _._________.______..­­­­.­­­­­.­­­­­­­.­ ____ ____ 13 AV­ 100 Chemical Grout (Liquid) Product Descriptions ,______...__________..­.­­....­­.­­....­­­­­­­­.­.­­­..­­­­­..­­­­­.. .___________. _ ._.____________. 16 Storage Requirements 16 ____________________­­­­..­­­­­­­~....­­­­­­­­­­­­­­­~­­..­­­­­.­...­­­...­.­­­..­­­­­­­..­­­­­. Disposal of Product ____________._______­.­.­­­­­­­.­­..­­­­­­­....­­­­­­ ._________._______....­.­..­­­.­­...­.­­­­­­­­­. 17 Mixing Instructions ____.._.._____.____________ _ _____ ___.______.__.______­..­­­­­.­..­­­­­­­­­­­..­­­­­­­­.­.­­­ _________ 18 AV­ 118 Duriflex Product Descriptions ..________..______... _ ______._.________.. _ ..__________________________ ­_.­ ________._...____________ 21 Storage Requirements _____.._______. _ ____.___.________...________. ________. _ ______....__________...­­­­­­­­­­­..­... 21 Disposal of Product ________... _ ______._.________.._­­.­­...­­.­­­.__._.______. _ .._____..__________....­­­­­.­­­­.­ __ ._._. 22 Mixing Instructions ______..._________...­..­..­..­­.­­..­..­­­­.­.­.­.­­.­..­. _ ______ .._____ .__.___________.__. _ ..______ 23 Additives Product Descriptions . .._.________...____­­­...­­­­­­....­­......­­­­­ ._________...____._____ __.._____.__.___... ______ 26 Storage Requirements ______....______......~~~.~..~.__.____.___.____..._~~~~~~~.~ . . ..__________ ­­ _____.____ ________ 26 Disposal of Product _.______.____.______~.....___..._..___.___....~...~.....~~~~~..... ­___­ _________...__...___..­­­­­..­. 27 We are glad you have chosen to work with Avanti International products and we hope you find this guide to be helpful in maintaining a safe working environment. Avanti International, the leading supplier of chemical grouts in the United States, has established this training guide for the safe use and handling of its acrylamide and acrylic products. This Safe Operating Practices Program (SOPP) has been developed in cooperation with our suppliers and customers. This SOPP is a tool for our customers to protect their employees and the environment from potential hazards associated with the use of acrylamide and acrylic chemical grouts. Despite its scope and breadth, the Avanti International SOPP is not an attempt to address comprehensively all safety considerations. This program is designed to be the minimum standard for safety, training, and the use of personal protective equipment for the grouting industry using acrylamide and acrylic chemical grouts. It is not intended, however, to cover every specific situation, problem, or eventuality. Please contact Avanti International if you have .questions. This SOPP provides guidance only and does not alter or determine legal compliance responsibilities, which are set forth in Occupational Safety and Health Administration (OSHA) standards and the Occupational Safety and Health Act. The reader must refer to the appropriate standards to ensure compliance. Moreover, because interpretations and enforcement policy may change over time, for additional guidance on OSHA compliance requirements, the reader should consult current administrative interpretations and decisions by the Occupational Safety and Health Review Commission and the courts. The Environmental Protection Agency (EPA) has expressed an interest in the safe use and handling of chemical grouts, and recommendations it has made concerning specific items of personal `protective equipment and other safety­ enhancing measures have been incorporated into the SOPP. This SOPP is the product of many years of experience with chemical grouts and many hours of hard work by Avanti International personnel. We are pleased to share it with our customers and their employees, for whom it was developed. Neither Avanti International, its employees, or consultants, however, makes any express or implied warranty about the completeness or accuracy of the information in the SOPP, nor assumes any liability or responsibility for any use, or the results of such use, of this information. Also, while Avanti International will endeavor to advise its customers of any significant changes in the content of the SOPP, please be aware that the information is subject to change without notice. I au7 Avanti International hereby grants a nonexclusive, royalty­ free license to the purchasers of its products to retain a copy of the SOPP for reference and training purposes and to reproduce and distribute it for employee use, subject to the following conditions and limitations: The SOPP is the copyrighted material of Avanti International. Copies of the SOPP are not intended for sale or for use by parties other than the purchasers of Avanti International's products and their employees, except for such other uses as Avanti International may authorize in writing. The SOPP may not be altered, abridged, revised, translated, or otherwise modified without Avanti International's written consent. In the event that such consent is given, Avanti International assumes no responsibility for the completeness, or overall quality of any alteration, abridgment, revision, translation, or other modification of this SOPP. Buyers of Avanti International acrylamide and acrylic grouting products must perform an annual inspection to affirm compliance with the SOPP. Copies of the completed employer certification and SOPP verification forms (in Sections 12 and 13) are to be returned to Avanti International. Copies of completed employee certification forms (in Section 11) also are to be provided to Avanti International following employee training in the handling and use of the appropriate grouting materials, including review of the SOPP and acceptable performance on the employee test (in Section 10). Each customer must submit renewals annually for all employees involved in grouting operations. Employees transferring from one division of a company to another and/ or new employees should complete the SOPP training within the first 30 days of transfer or employment. Thank you for your cooperation in maintaining a safe working environment for your employees and for using Avanti International's acrylamide and acrylic chemical grouts in a responsible manner. We would be pleased to answer any questions you may have. Sincerely, AVANTI INTERNATIONAL F. David Magill, Jr., P. E. President Personal Protective Equipment The proper use of personal protective equipment, commonly called PPE, requires that employees recognize the need for its use. If employees do not understand the reason for wearing each piece of equipment, they may be risking unnecessary exposure. Employees must also understand the relationship of how all of the PPE works together to protect them. Employees must wear all of the recommended PPE for a given operation to be properly protected. If, for example, an employee is engaged in an operation that requires a chemical suit, respirator, gloves, and boots, and is not wearing approved boots but street shoes and a chemical spill occurs, the employee could be exposed unnecessarily. It is especially important to train employees to think of their PPE as a system and not individual pieces of equipment. This complete system approach is required so that all needed equipment is always worn during specific operations, such as mixing. The two most common routes of exposure to chemicals are inhalation hazards (the breathing of vapors or aerosols) and skin contact. In order to protect employees from inhalation hazards, a respirator must be worn during operations that might expose the employee to these hazards. Avanti International highly recommends the use of a full facepiece respirator, which provides increased respiratory protection and also protects the face and eyes. OSHA's Respiratory Standard and Respiratory Protection Program When an employer requires the use of a respirator during specific operations, the provisions of OSHA's respiratory protection standard must be met. The respiratory protection standard requires employee medical evaluations, fit testing, and respirator training; the specific requirements can be found at http:// www. osha. goviTraining/ major­ req­ RPS­ 191 O­ l 34. pdf. In addition to meeting the terms of the standard, OSHA requires that your company (I) Develop a written respiratory program with procedures that are specific to your worksite; (2) Implement the program and update it as necessary; and 3) Assign a qualified program administrator to run and evaluate the program. The applicable regulations are at http:// www. osha. gov/ SLTC/ respiratory­ advisor/ oshafiles/ wri~ enprograml . html. For assistance, you can download a copy of OSHA's Small Entity Compliance Guide at http:// www. oshasic qov/ oshdoc/ additional. html# seoc­ rps. The Small Entity Compliance Guide includes a sample written respiratory protection program. Respirators and Cartridges Respirators and their associated cartridges are designed to protect the lungs. Avanti International recommends the use of chemical respirators as a part of the personal protective equipment package during specific operations. The specific operations where chemical respirators must be worn include transferring and mixing chemical grouts in the mixing tanks; and cleaning the tanks, lines or packers. Manhole grouting with acrylamide also requires the use of chemical respirators. Full facepiece respirators offer protection of the face, eyes and lungs and are highly recommended. The 3M brand 6800 Full Facepiece Respirator used with the appropriate cartridge filter, or a comparable product, is designed to provide effective protection when exposure levels of acrylamide are below the OSHA PEL of 0.3 mg/ m3, and concentrations of formaldehyde are below the OSHA PEL of 0.75mg/ m3. ­­ p..­ The 3M brand 60921 Organic Vapor Cartridge/ P100 Filter, or a comparable product, is designed to be effective for use with AV­ 100 liquids and powders when concentrations of acrylamide are below the OSHA PEL of 0.3mg/ m3. The 3M brand 60925 Formaldehyde/ Organic Vapor Cartridge/ PI 00 Filter, or a comparable product, is designed to be effective for use with AV­ 118, when concentrations of formaldehyde are below the OSHA PEL of 0.75mg/ m3 and concentrations of acrylamide are below the OSHA PEL of 0.3mg/ m3. If a cartridge/ filter becomes damaged or soiled, or if breathing becomes difficult, the employee should leave the area and replace the cartridge/ filter. If used in an environment containing oil aerosols, replace the cartridge/ filter after 40 hours of use or 30 days, whichever comes first. Employees should not share respirators and should keep their respirator in a sealed bag in a secure location. Chemical Protective Clothing, General (CPC) As noted above, the various PPE recommendations and requirements should be addressed as a single unit. A unit approach to PPE requires that all PPE recommended for a specific operation always be worn during that operation. It is imperative that employees understand that PPE is not just a pair of goggles and gloves, but includes suits and boots, as well as eye protection, gloves and respirators. Chemical Protective Clothing, Suits ­. Chemical suits are designed as body protection. Even though physical contact with acrylamide powder or liquid is unlikely, chemical suits are an essential part of an employee's personal protective equipment package during specific operations. EPA has advised that the DuPont brand TychemB model (SL) protection suit provides excellent protection against potential acrylamide exposure hazards. The Tychem@ SL suit is a lightweight, comfortable garment specifically designed for easy wear. It has been tested with acrylamide and shows an average normalized breakthrough time in minutes to be greater than 480. If other products offer protection comparable to that of TychemB SL in standardized laboratory testing with acrylamide, these products would be considered effective as well. The specific operations where TychemB SL or comparable chemical suits must be worn include: transferring and mixing chemical grouts into the mixing tanks; cleaning the tanks, lines or packers. The use of such suits is also necessary during all in­ manhole operations that involve grouting with acrylamide. TychemB­ type suits are considered limited­ use disposable garments. DuPont describes the use characteristics of these garments as follows: "The exact number of wearings cannot be stated without knowledge of the specific end use. However, up to 5 wearings, under controlled conditions through a structured garment inspection program, are not uncommon in light­ tomoderate non­ hazardous activities." Once a garment is contaminated or damaged, it should be properly disposed of immediately. For any other operation in the truck in which TychemB or comparable suits are not required, the employee must be wearing a long­ sleeved shirt, full­ length pants and approved footwear as a minimum requirement. Chemical Protective Clothing, Gloves Chemical gloves are designed as protection of the hand, wrist and forearm, and must be used for any operation where chemical grout is present. These operations include transferring and mixing grouts, handling the packer, and all cleaning and testing operations. A suitable glove will exhibit good resistance to acrylamide, and is also important to specify the proper thickness (gauge). When choosing a glove it is important to specify the proper thickness (gauge). At this time, only the 15 mil (0.38 millimeter) Best brand Nitri­ Solve@ Model 727 has been tested and reported effective for exposure to acrylamide. If other products offer protection comparable to that of the Best Nitri­ Solve@ Model 727 gloves in standardized laboratory testing with acrylamide, these products would be considered effective as well. Gloves should cover the wrist and forearm and fit well enough so the employee has freedom of movement. Gloves may be reused if functioning properly and previous chemical exposure was light. Because the use of gloves and the extent of their exposure is unknown it would be prudent to limit their usage to 5 days or less. Gloves that are heavily contaminated should be changed on a more frequent basis. Gloves that are torn or abraded should be changed immediately, and disposed of properly. Chemical Protective Clothing, Boots Chemical boots are designed to protect the foot, ankle and lower leg, and must be used for any operation where chemical grout is present. These operations include transferring and mixing grouts, handling the packer, cleaning and testing operations, and all in­ sewer activities. Boots must exhibit good resistance to be effective. Boots should be cleaned on a daily basis if they have come into contact with chemical grout. Boots that are torn or are heavily worn should be replaced immediately. Leather footwear is prohibited if it can possibly come into contact with chemical grouts. Leather absorbs spills, creating a pathway for exposure and irritation of the feet and ankles. Once leather has become wet and contaminated, the leather remains contaminated even after drying. Chemical Protective Clothing, Splash Goggles and Safety Glasses Chemical goggles and safety glasses are designed as protection for the eyes. Unvented chemical splash goggles must be worn for any operation where chemical grout is present if a full facepiece respirator is not being worn. Splash goggles provide superior eye protection as compared to safety glasses. Avanti International recommends such splash goggles as Uvex futuraTM brand (model 9301) or comparable goggles that are specifically designed for splash protection. Damaged or severely scratched goggles must be discarded immediately. Splash goggles should be cleaned on a daily basis. Safety glasses may be worn for operations other than those listed above. Safety glasses that fully protect the eye should be chosen. Offering the employee a variety of safety glasses that are comfortable for the wearer will support their proper and consistent use. Use and Care of Personal Protective Equipment Properly maintaining and using personal protective equipment is an important step in the safe handling of chemical grouts. General guidelines for PPE use and care are as follows: l Inspect all PPE before each use. l NEVER use damaged or contaminated items. l Wear, store and clean PPE according to manufacturers' guidelines. l PPE fit is extremely important. If PPE does not fit well, employees tend not to use it, which defeats its basic purpose. The best equipment in the world will not protect an employee unless it is used correctly and consistently. Supervisors should recognize the signs that an employee is not properly using the provided PPE or is not following good safety procedures. No employee should be permitted to work independently with any of the chemical grouts until thoroughly and properly trained. The employee must be able to follow the procedures and required precautions. Employees MUST do their part to support the effective use of PPE, as follows: e Wear clean clothes each workday and wash before re­ use. l Shower and wash hair at end of each workday. l Wash hands and face before eating, drinking or smoking. l Keep food out of the work area. l Maintain a clutter­ free workspace. l Consult your supervisor if you do not understand how to use or maintain PPE correctly. Additional Equipment A dual 32­ oz., wall­ mounted eyewash station should be accessible to employees and maintained in good working order. Recap: PPE as a Protective System Respirators, chemical protective suits, gloves, boots and goggles are all part of an integrated system to assure that operations with chemical grouts are undertaken and completed safely. It is essential that all elements of the employees' PPE system are clean, functioning properly and property fitted. The employee is responsible for determining the status of each piece of his personal protective equipment. All PPE should be inspected before wearing it in an area or situation that may expose the wearer to hazardous chemicals: If any one piece of equipment is in unsatisfactory condition, the employee should not begin operations until the condition is corrected. PPE should be cleaned and inspected at the end of each shift and properly stored for future use. PPE by definition is an employee's last line of defense and should be treated accordingly. Avanti International has listed specific brands of PPE, including chemical protective clothing, as a convenience. It is the responsibility of each user of Avanti grouting products to determine the type and brand of equipment that is appropriate for their specific work environment. To promote employee safety, however, the equipment selected should provide protection at least equivalent to what the examples cited above would provide. I I I I I I I I I I I I I I I I I I I 4 2 I `2 I I I I I I I I I I I I I I I I I I I Housekeeping Good housekeeping in the work area is as important as the safe handling of chemical grouts. TV/ Grout rigs have very small work areas and should be organized to allow employees the greatest freedom of movement and the ability to perform their jobs in a safe manner. Time allotted to the maintenance of the interior of the truck is as valuable as changing the oil or inspecting the tires. Employees should become familiar with the checklist provided below and follow it as a minimum daily requirement for their housekeeping duties. The list is not meant to be exhaustive; any site­ specific or operation­ specific requirements should be added by the employer as needed. Along with the proper storage location for chemicals being transported, the employees should have designated locations for the disposal of empty containers and bags. Grouting equipment should be washed with clean water to limit accidental exposure from the handling of packers, scoops, mixing paddles, pitchers, cameras, and the hose reel. Good housekeeping in the cab area of the truck is also important. Employees should refrain from storing food and beverages in the open cab areas of the TV/ Grout rig. Do not eat or drink anywhere in the TV/ Grout rig. Smoking should never be permitted in a TV/ Grout rig. Daily Housekeeping Checklist Clean work area often and maintain it in good condition. Make sure water tank is full. This is important not only for making more grout, but it can be used for clean up and also can be used in case of an emergency. Mop the floors, wash down outside of grout tanks, and wash hose reel and packers with fresh water, making sure that excess water is directed into a sanitary sewer. Wash tools used to work on pumps, packers and hoses with fresh water, making sure that excess water is directed into a sanitary sewer. Immediately wash down any spills, that cannot be collected or gelled. Secure door to control room during the mixing process. When transporting the Triethanolamine (Cat T), it must always be kept away from either Ammonium Persulfate (AP) or Sodium Persulfate (SP). Seal all chemical containers immediately after use. Secure all chemical containers so as not to shift during transit. Always store chemicals in original containers. Remove empty containers from the TV/ Grout rig and d& pose of properly. Operator should clean steering wheel to prevent cross contamination. Assistant should inspect grouting system for leaks while in use and repair as necessary. Chemical protective clothing (CPC) should be cleaned thoroughly at the end of each shift. CPC should be stored in clean plastic bags away from the chemicals. CPC should be stored outside of the control room. CPC should be thoroughly inspected before being used. 5 213 AV­ IOO Chemical Grout (AM Powder) Product Descriptions AV­ 100 AM Acrylamide Monomer is the trade name for an acrylamide grout used for sewer line joint sealing, sewer line lateral sealing, manhole sealing, and soil stabilization. AV­ 100 AM is a white crystalline acrylamide powder (CAS number 79­ 06­ I) that dissolves completely and rapidly in water. Mixed in with the acrylamide is a small amount of copper sulfate (blue crystals) that stabilizes the product. AV­ 100 AM is sold in fiber drums containing four (4) 55 pound bags. The two­ layer bags are designed for the operator to lower the inner bag into the grout tank during the product transfer. AV­ 100 MBA Methylenebisacrylamide is the trade name for Methylenebisacrylamide (CAS number 110­ 26­ g). AV­ 100 MBA is a bluish white liquid that is a cross­ linker of acrylamide. The AV­ 100 MBA must be added to AV­ 100 AM. The AV­ 100 MBA liquid is packaged in 64­ ounce containers in an emulsion form for easier mixing. AV­ 101 Catalyst T+ is the trade name for a blend of Triethanolamine (CAS number 102­ 71­ 6) and proprietary additives. AV­ 101 is a thick colorless liquid that is used as an activator. The proprietary additives decrease the freezing point, which allows storage and transportation in temperatures at or below freezing. AV­ 101 is packaged in both 5gallon plastic drums and 55­ gallon lined metal drums. AV­ 102 Catalyst AP is the trade name for Ammonium Persulfate (CAS number 7727­ 54­ O). AV­ 102 is a white powder that is used as a polymerization initiator. It is packaged in 50­ pound plastic pails or 225 pound coated fiber drums with a plastic inner liner. Storage Requirements AV­ 100 AM: Store in a cool dry area away from heat. Provide good ventilation. Keep bags inside drums. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling this product. Store away from AV­ 101 Catalyst T+ and AV­ 102 Catalyst AP. AV­ 100 MBA: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Wear proper PPE when handling this product. Store away from AV­ 101 Catalyst T+ and AV102 Catalyst AP and AV­ 103 Catalyst SP. AV­ 101 Catalyst T+: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Store away from acids or oxides as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or AV­ 102 Catalyst AP. AV­ 102 Catalyst AP: Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling product. Store away from acids, alkalis, halides, reducing agents, combustible materials and heavy metals as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or AV­ 101 Catalyst T+. I I I I I I I I I I I I I I I I I I I General: Maintain first aid kit, gloves, respirators, aprons, and cleanup equipment in the storage area at all times. An emergency spill response kit should also be readily available. Foam, carbon dioxide, or dry chemical fire extinguishers should be easily accessible. Provide eyewash, shower, and a source of water in the storage area. Keep materials in original packaging whenever possible. Disposal of Product AV­ 100 AM: Powder product must be gelled or properly contained and incinerated. The best method for disposal is to gel the material,` as follows. Collect as much dry AV­ 100 as possible, taking all precautions to avoid creating dust while collecting the product. Add AV­ 101 Cat T+, and gel with water and AV­ 102 Catalyst AP, in this order. Gelled (catalyzed) materials pose little risk and may be sent to a landfill. Very small spills may be washed down with water, with the water being released into a sanitary sewer system for treatment. Keep emptied bags and drums at a fixed place until proper disposal. Drums must not be reused for any other purpose. If you are uncertain about how to properly dispose of the product, bags, or drums, contact a state­ registered hazardous materials disposal facility or an appropriate consultant. State or local waste agencies can also be helpful. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 100 MBA: Whatever cannot be saved for recovery or recycling should be handled in an appropriate Resource Conservation and Recovery Act (RCRA) approved waste disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 101 Catalyst T+: Whatever cannot be saved for recovery or recycling should be handled in an appropriate RCRA­ approved waste disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 102 Catalyst AP: Whatever cannot be saved for recovery or recycling should be handled as hazardous waste and sent to an appropriate RCRA­ approved waste disposal facility. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance w'ith federal, state and local requirements. Safety Information, Hazards and First Aid Consult Material Safety Data Sheets (MSDS). Shipping Information See Page 35. Mixing Instructions for AV­ IOO Chemical Grout (AM Powder) AV­ 100 AM Conventional Mix (11.6% Solids, approx. 25 Second Gel Time at 72° F) Before mixing procedures begin, the operator must determine 1) the necessary gel strength and gel time required for the specific application, 2) the availability of all necessary grout components, and 3) that all safety equipment is present and in good working order. Personal Protective Equipment (PPE) During transfer/ mixing operations, the minimum PPE consists of a cartridge respirator full facepiece type, a TychemB brand or equivalent chemical suit, and gloves and boots that meet the descriptions in Chapter 2. Product Information A single 55 pound bag of AV­ 100 AM Acrylamide Monomer powder, mixed with 64 ounces (2.75 pounds) of Methylenebisacrylamide (MBA) yields a 60 gallon batch of 11.5% (by weight) strength acrylamide grout. For best results, these grouts should be blended at concentrations of 10% or greater. Concentrations above 10% are favored for high­ strength gel applications or to handle dilution of more than 50% prior to gelation. Mixing Instructions (Conventional Mix) Tank A (Grout Tank) Tank B (Catalyst Tank) l AV­ 100 powder: 1 bag l AV­ 102 AP: 5 Ibs. (60 ounces by . MBA emulsion: 64 ounces by volume volume) l Water: Add enough water to make . AV­ 101 Cat­ T: 70 ounces by volume (5 Ibs.) a 30­ gallon batch . Water: Add enough water to make a 30­ gallon batch. The above conventional mixture can be­ modified to meet your specific application. The Methylenebisacrylamide (AV­ 100 MBA) is an emulsion that is a required grout compound. Always use the complete container for each batch. The AV­ 100 MBA is always added to the grout side tank. The Triethanolamine (AV­ 101 Cat­ T+) is a liquid that is a required grout compound and can be increased from a minimum of 35 ounces by volume (. 5% by weight, 2.5 Ibs.) to a maximum of 175 ounces by volume (2.5% by weight, 12.5 Ibs). Using more than 175 ounces by volume is not recommended, as it results in too fast a gel time. The AV­ 101 Cat­ T is always added into the same tank as the grout. The Ammonium Persulfate (AV­ 102 AP) is a powder that is a required grout compound and can be increased from 5 pounds (1% by weight, 60 ounces by volume) to a maximum of 15 pounds (3% by weight, 180 ounces by volume). The AV­ 102 is added to the catalyst tank. Sodium Persulfate (AV­ 103 SP) is a powder that may be used in place of Ammonium .Persulfate (AV­ 102 AP), although Avanti International considers AV­ 102 AP to be a more effective product for mixing AV­ 100 grouts. The same amount of AV­ 103 SP is used when replacing AV­ 102 AP. The AV­ 103 is added to the catalyst tank. Storage and disposal of AV­ 103 are addressed in the AV­ 118 section. I I I I I I I I I I I I I I I I I I I 8 Grout Transfer Method The operator and staff are at the highest risk for exposure to acrylamide when the powdered AV­ 100 is transferred from the bag into the grout tank. Every precaution should be taken to assure that the operator and other crewmembers are not exposed to the acrylamide powder either in the air or spilled in the vehicle. The following procedure, accompanied by the wearing of appropriate PPE, effectively reduces the possibility of chemical exposure. PPE Steel­ toed boots and protective gloves and goggles should be worn before moving the drum containing AV­ 100 powder from storage. During the transfer/ mixing process a cartridge respirator, appropriate boots and a TychemB brand or comparable chemical suit are required. Gloves approved for use with acrylamide must be worn in order to keep the liquid or powder from coming into contract with the skin. Avanti International highly recommends the use of a full face­ piece respirator during transfer/ mixing operations. Procedure Keep the bag of AV­ 100 intact whenever possible. Fill grout tank with approximately 15 gallons of water before introducing the AV­ 100 MBA or AV­ 100 powdered grout. Add 64 ounces of AV­ 100 MBA emulsion to grout side tank. Add small amount of water to container, rinse to remove any residue, mix all thoroughly. Do not let AV­ 100 MBA contact skin. Place the neck of the AV­ 100 powdered grout bag under the surface of the water as the grout is being poured into the grout tank. It is extremely important to take care that no powder is released into the air or spilled during transfer. Empty the bag of AV­ 100 powdered grout as completely as possible and roll the bag from bottom to top before carefully removing from the grout tank. Immediately wrap up the bag and place it in another bag so that no powder or liquid on the grout bag is released inside the vehicle. Add 70 fluid­ ounces by volume (5 Ibs.) of liquid AV­ 101 Cat T+ to the grout tank. Add 5 Ibs. (60 fluid­ ounces by volume) of powder AV­ 102 to the catalyst tank. Fill both tanks to the 30­ gallon level with water. Properly dispose of the bags and empty MBA containers, as described earlier in this chapter. The empty bags and containers must not be used for any other purposes. Field Conditions The temperature of the water in the tanks has a large impact on grout gel times. Therefore, water temperature should be measured throughout the day to help determine desired grout gel times. Since the gel time is greatly reduced with increasing temperatures, cup tests to monitor gel times should be conducted. As a general rule of thumb, gel time is reduced by one­ half for every 10° F rise in temperature. Water temperatures can vary dramatically between early morning and late afternoon. Trucks parked overnight or through a weekend can reach temperatures as high as 150° F. The grout side tank should not be exposed to direct sunlight as UV­ rays can accelerate polymerization. Optional Additives I There are several additives that can modify the behavior of the grout being used. Ethylene Glycol, Liquid (AV­ 105) Amount: Maximum of 2.5 gallons per tank. I Add equal amounts to both tanks, replaces water. Finish by filling tanks with water to 30­ gallon I line. Tanks should not exceed 30­ gallon fill line. Result: Enhances grouts ability to undergo freezing and dehydration. Lowers freezing temperature of the solution. I Icosetilatex, Liquid (AV­ 257) Amount: 2 to 3 gallons. I Add to grout side only, replaces water. Finish by filling tank with water to 30­ gallon line. Tank should not exceed 30­ gallon fill line. Result: increases compressive and tensile strength, also increases viscosity. I Potassium Ferricyanide, Powder (KFe) Amount: Very small amount, less than `I4 teaspoon to start. Add to grout side tank. Result: Extends gel times. Norosac, Powder (AC­ SOW­ A) Amount: 3.2 ounces by weight. This is equal to 5­ 0~ in an 8 fluid ounce measuring cup. Add to grout side tank. Results: Slows new growth of roots in the sewer joints. Additional information about these additives is found in Chapter 9. I I I I I I I I AV­ IOO Chemical Grout (Powder Blend) Product Descriptions AV­ 100 Powder Blend is the trade name for an acrylamide grout that contains MBA, used for sewer line joint sealing, sewer line lateral sealing, manhole sealing, and soil stabilization. AV100 AM is a white crystalline acrylamide powder (CAS number 79­ 06­ I) that dissolves completely and rapidly in water. Mixed in with the acrylamide is a small amount of copper sulfate (blue crystals) that stabilizes the product. The two­ layer bags are designed for the operator to lower the inner bag into the grout tank during the product transfer. AV­ 100 Powder Blend is sold in fiber drums containing four (4) 50 pound bags. AV­ 101 Catalyst T+ is the trade name for a blend of Triethanolamine (CAS number 102­ 71­ 6) and proprietary additives. AV­ 101 is a thick colorless liquid that is used as an activator. The proprietary additives decrease the freezing point, which allows storage and transportation in temperatures at or below freezing. AV­ 101 is packaged in both 5 gallon plastic drums and %­ gallon lined metal drums. AV­ 102 Catalyst AP is the trade name for Ammonium Persulfate (CAS number 7727­ 54­ O). AV­ 102 is a white powder that is used as a polymerization initiator. It is packaged in 50­ pound plastic pails or 225 pound coated fiber drums with a plastic inner liner. Storage Requirements AV­ 100 Powder Blend: Store in a cool dry area away from heat. Provide good ventilation. Keep bags inside drums. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling this product. Store away from AV­ 101 Catalyst T+ and AV­ 102 Catalyst AP. AV­ 101 Catalyst T+: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Store away from acids or oxides as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or AV­ 102 Catalyst AP. AV­ 102 Catalyst AP: Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling product. Store away from acids, alkalis, halides, reducing agents, combustible materials and heavy metals as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or AV­ 101 Catalyst T+. General Maintain first aid kit, gloves, respirators, aprons, and cleanup equipment in the storage area at all times. An emergency spill response kit should also be readily available. Foam, carbon dioxide, or dry chemical fire extinguishers should be easily accessible. Provide eyewash, shower, and a source of water in the storage area. Keep materials in original packaging whenever possible. Disposal of Product AV­ 100 Powder Blend: Powder product must be gelled or properly contained and incinerated. The best method for disposal is to gel the material, as follows. Collect as much dry AV­ 100 as possible, taking all precautions to avoid creating dust while collecting the product. Add AV­ 101 Cat T+, and gel with water and AV­ 102 Catalyst AP, in this order. Gelled (catalyzed) materials pose little risk and may be sent to a landfill. Very small spills may be washed down with water, with the water being released into a sanitary sewer system for treatment. Keep emptied bags and drums at a fixed place until proper disposal. Drums must not be reused for any other purpose. If you are uncertain about how to properly dispose of the product, bags, or drums, contact a state­ registered hazardous materials disposal facility or an appropriate consultant. State or local waste agencies can also be helpful. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 101 Catalyst T+: Whatever cannot be saved for recovery or recycling should be handled in an appropriate RCRA­ approved waste disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 102 Catalyst AP: Whatever cannot be saved for recovery or recycling should be handled as hazardous waste and sent to an appropriate RCRA­ approved waste disposal facility. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Safety Information, Hazards and First Aid Consult Material Safety Data Sheets (MSDS). Shipping Information See Page 35. ," C Mixing Instructions for AV­ IOO Chemical Grout (Powder Blend) AV­ 100 Powder Blend Conventional Mix (10.0% Solids, approx. 25 Second Gel Time at 72° F) Before mixing procedures begin, the operator must determine 1) the necessary gel strength and gel time required for the specific application, 2) the availability of all necessary grout components, and 3) that all safety equipment is present and in good working order, Personal Protective Equipment (PPE) During transfer/ mixing operations, the minimum PPE consists of a cartridge respirator full facepiece type, a TychemB brand or equivalent chemical suit, and gloves and boots that meet the descriptions in Chapter 2. Product Information A single 50 pound bag of AV­ 100 Powder Blend, containing Methylenebisacrylamide (MBA) yields a 60 gallon batch of 10.0% (by weight) strength acrylamide grout. For best results, these grouts should be blended at concentrations of 10% or greater. Concentrations above 10% are favored for high­ strength gel applications or to handle dilution of more than 50% prior to gelation. Mixing Instructions (Conventional Mix) Tank A (Grout Tank) 9 AV­ I 00 Powder Blend: 1 bag l AV­ 101 Cat­ T: 70 ounces by volume (5 Ibs.) l Water: Add enough water to make a 30­ gallon batch. Tank B (Catalyst Tank) l AV­ 102 AP: 5 Ibs. (60 ounces by volume) l Water: Add enough water to make a 30­ gallon batch The above conventional mixture can be modified to meet your specific application. The Triethanolamine (AV­ 101 Cat­ T+) is a liquid that is a required grout compound and can be increased from a minimum of 35 ounces by volume (5% by weight, 2.5 Ibs.) to a maximum of 175 ounces by volume (2.5% by weight, 12.5 Ibs). Using more than 175 ounces by volume is not recommended. The AV­ 101 Cat­ T is always added into the same tank as the grout. The Ammonium Persulfate (AV­ 102 AP) is a powder that is a required grout compound and can be increased from 5 pounds (1% by weight, 60 ounces by volume) to a maximum of 15 pounds (3% by weight, 180 ounces by volume). The AV­ 102 is added to the catalyst tank. Sodium Persulfate (AV­ 103 SP) is a powder that may be used in place of Ammonium Persulfate (AV­ 102 AP). The same amount of AV­ 103 SP is used when replacing AV­ 102 AP. Avanti International prefers AV­ 102 AP when mixing AV­ 100 grouts. The AV­ 103 is added to the catalyst tank. Storage and disposal issues of AV­ 103 are addressed in the AV118 section. Grout Transfer Method The operator and staff are at the highest risk for exposure to acrylamide when the powdered AV­ 100 is transferred from the bag into the grout tank. Every precaution should be taken to assure that the operator and other crewmembers are not exposed to the acrylamide powder either in the air or spilled in the vehicle. The following procedure, accompanied by the wearing of appropriate PPE, effectively reduces the possibility of chemical exposure. PPE Steel­ toed boots; and protective gloves and goggles should be worn before moving the drum containing AV­ 100 powder from storage. During the transfer/ mixing process a cartridge respirator, appropriate boots, and a Tychem@ brand or equivalent chemical suit are required. Gloves approved for use with acrylamide must be worn in order to keep the liquid or powder from coming into contract with the skin. Avanti International highly recommends the use of a full face­ piece respirator during transfer/ mixing operations. Procedure l Keep the bag of AV­ 100 intact whenever possible. l Fill grout tank with approximately 15 gallons of water before introducing the AV­ 100 Powder Blend grout. l Place the neck of the AV­ 100 Powder Blend grout bag under the surface of the water as the grout is being poured into the grout tank. ­ It is extremely important to take care that no powder is released into the air or spilled during transfer. l Empty the bag of AV­ 100 Powder Blend grout as completely as possible and roll the bag from bottom to top before carefully removing from the grout tank. l Immediately wrap up the bag and place it in another bag so that no powder or liquid on the grout bag is released inside the vehicle. l Add 70 fluid­ ounces by volume (5 Ibs.) of liquid AV­ 101 Cat T+ to the grout tank. l Add 5 Ibs. (60 fluid­ ounces by volume) of powder AV­ 102 to the catalyst tank. l Fill both tanks to the 30­ gallon level with water. Properly dispose of the bags and empty MBA containers, described earlier in this chapter. The empty bags and containers must not be used for any other purposes. Field Conditions The temperature of the water in the tanks has a large impact on grout gel times. Therefore, water temperature should be measured throughout the day to help determine desired grout gel times. Since the gel time is greatly reduced with increasing temperatures, cup tests to monitor gel times should be conducted. As a general rule of thumb, gel time is reduced by one­ half for every 10° F rise in temperature. Water temperatures can vary dramatically between early morning and late afternoon. Trucks parked overnight or through a weekend can reach temperatures as high as 150° F. The grout side tank should not be exposed to direct sunlight as UV­ rays can accelerate polymerization. Optional Additives There are several additives that can modify the behavior of the grout being used. Ethylene Glycol, Liquid (AV­ 105) Amount: Maximum of 2.5 gallons per tank. Add equal amounts to both tanks, replaces water. Finish by filling tanks with water to 30­ gallon line. Tanks should not exceed 30­ gallon fill line. Result: Enhances grouts ability to undergo freezing and dehydration. Lowers the freezing temperature of the solution. Icosetllatex, Liquid (AV­ 257) Amount: 2 to 3 gallons. Add to grout side only, replaces water. Finish by filling tank with water to 30­ gallon line. Tank should not exceed 30­ gallon fill line. Result: Increases compressive and tensile strength, also increases viscosity. Potassium Ferricyanide, Powder (KFe) Amount: Very small amount, less than % teaspoon to start. Add to grout side tank. Result: Extends gel times. Norosac, Powder (AC­ 50W­ A) Amount: 3.2 ounces by weight. This is equal to 5­ 0~ in an 8 fluid ounce measuring cup. Add to grout side tank. Results: Slows new growth of roots in the sewer joints. Additional information about these additives is found in Chapter 9. AV­ IOO Chemical Grout (Liquid) Product Descriptions AV­ 100 Chemical Grout is the trade name for a liquid acrylamide grout used for sewer line joint sealing, sewer line lateral sealing, manhole sealing, and soil stabilization. AV­ 100 is a clear, watery liquid (CAS number 79­ 06­ I). Included with the acrylamide is a small amount of copper sulfate that stabilizes the product. AV­ 100 is sold in plastic drums containing approximately 14 gallons. AV­ 101 Catalyst T+ is the trade name for a blend of Triethanolamine (CAS number 102­ 71­ 6) and proprietary additives. AV­ 101 is a thick, colorless liquid, that is used as an activator. The proprietary additives decrease the freezing point, which allows field use in temperatures at or below freezing. AV­ 101 is packaged in both 5gallon plastic drums and 55gallon lined metal drums. AV­ 102 Catalyst AP is the trade name for Ammonium Persulfate (CAS number 7727­ 54­ O). AV­ 102 is a white powder that is uses as a polymerization initiator. It is packaged in 50­ pound plastic pails or 225 pound coated fiber drums with a plastic inner liner. Storage Requirements AV­ 100 Chemical Grout: Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Do not use pressure to empty containers. Wear proper PPE when handling this product. Store away from AV­ 101 Catalyst T+ and AV­ 102 Catalyst AP. AV­ 101 Catalyst T+: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Store away from acids or oxides as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or AV­ 102 Catalyst AP. AV­ 402 Catalyst AP: Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling product. Store away from acids, alkalis, halides, reducing agents, combustible materials and heavy metals as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 100 Chemical Grouts or A& l01 Catalyst T+. General Maintain first aid kit, gloves, respirators, aprons, and cleanup equipment in the storage area at all times. An emergency spill response kit should also be readily available. Foam, carbon dioxide, or dry chemical fire extinguishers should be easily accessible. Provide eyewash, shower, and a source of water in the storage area. Keep materials in original packaging whenever possible. Disposal of Product AV­ 100 Chemical Grout: The best method for disposal is to gel the material. Collect as much liquid AV­ 100 as possible, add AV­ 101 Cat T+, and gel with AV­ 102 Catalyst AP mixed with water, in this order. Gelled (catalyzed) materials pose little risk and may be sent to a landfill. Very small spills may be washed down with water with the water being released into a sanitary sewer system for treatment. Keep emptied drums at a fixed place until proper disposal. Drums must not be reused for any other purpose. If you are uncertain about how to properly dispose of the product or drums, contact a state registered hazardous materials disposal facility or an appropriate consultant. State or local waste agencies can also be helpful. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 101 Catalyst T+: Whatever cannot be saved for recovery or recycling should be managed in an appropriate RCRA­ approved waste disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 102 Catalyst AP: Whatever cannot be saved for recovery or recycling should be handled as hazardous waste and sent to a RCRA­ approved waste facility. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Safety Information, Hazards and First Aid Consult Material Safety Data Sheets (MSDS). Shipping Information See Page 35. Mixing Instructions for AV­ IOO Chemical Grout (Liquid) Conventional Mix (10% Solids, approx. 25 Second Gel Time at 72° F) Before mixing procedures begin, the operator must determine 1) the necessary gel strength and gel time required for the specific application, 2) the availability of all necessary grout components, and 3) that all safety equipment is present and in good working order. Personal Protective Equipment (PPE) During transfer/ mixing operations, the minimum PPE consists of a cartridge respirator full facepiece type, a TychemB brand or equivalent chemical suit, and gloves and boots that meet the descriptions in Chapter 2. Product Information The 15gallon drum contains approximately 14 gallons of liquid grout, the equivalent of a single 50­ pound bag of AV­ 100 powder, including MBA, dissolved in water. Most manufacturers of equipment have standardized by providing two 30­ gallon chemical tanks. When properly mixed, one drum of liquid AV­ 100 acrylamide grout results in a 10% (by weight) strength grout solution of 60 gallons. Using two drums of AV­ 100 acrylamide grout results in a 20% (by weight) strength grout solution of 60 gallons. One 15gallon drum will make a 60­ gallon batch of grout. For best results, grouts should be blended at concentrations of 10% or greater. Concentrations above 10% are favored for highstrength gel applications or to handle dilution of more than 50% prior to gelation. Mixing Instructions (Conventional mix) Tank A (Blue Grout Tank) . AV­ 100 liquid: 1 drum l AV­ 101 Cat­ T: 70 ounces by volume (5 Ibs.) l Water: Add enough water to make a 30­ gallon batch. The above conventional mixture can be mo I Tank B (Red Tank) l AV­. I02 AP: 5 Ibs. (60 ounces by volume) l Water: Add enough water to make a 30­ gallon batch ed to meet your specific application. The Triethanolamine (AV­ 101 Cat­ T) is a liquid that is a required grout component and can be increased from a minimum of 35 ounces by volume (5% by weight, 2.5 Ibs.) to a maximum of 175 ounces by volume (2.5% by weight, 12.5 Ibs). Using more than 175 ounces by volume is not recommended. The AV­ 101 Cat­ T is always added into the same tank as the grout. The Ammonium Persulfate (AV­ 102 AP) is a powder that is a required grout component and can be increased from 5 pounds (1% by weight, 60 ounces by volume) to a maximum of 15 pounds (3% by weight, 180 ounces by volume). Sodium Persulfate (AV­ 103 SP) is a powder that may be used in place of Ammonium Persulfate (AV­ 102 AP). The same amount of AV­ 103 SP is used when replacing AV­ 102 AP. Avanti International prefers AV­ 102 AP when mixing AV­ 100 grouts. Grout Transfer Method Avanti highly recommends the use of a pump, hand or electric, to transfer liquid grout from the ­l5­ gallon drum into the grout tank. Using a pump minimizes worker exposure to grout spills or splashes. Another benefit of using a pump is that the empty grout drum will be rinsed and ready for disposal or recycling; that can be accomplished by adding the solution mix water to the empty grout drum and pumping it in the grout tank. The following procedure, accompanied by the wearing of appropriate PPE, effectively reduces the possibility of chemical exposure. PPE Steel­ toed boots; and protective gloves and goggles should be worn before moving the drum containing AV­ 100 liquid from storage. During the transfer/ mixing process a cartridge respirator, appropriate boots and a TychemB brand or equivalent chemical suit are required. Gloves approved for use with acrylamide must be worn in order to keep the liquid from coming into contract with the skin. Avanti International highly recommends the use of a full face­ piece respirator during transfer/ mixing operations. Procedure A power lift or two men should be used when lifting the 130­ pound grout drum into the back of the grout truck. Place the 15gallon grout drum within several'feet of the grout­ side mixing tank. Using a bung tool, remove the 2­ inch bung, being careful not to let surface contamination enter the drum. Caution: Wetted pump parts must be plastic or stainless steel only. Place the hand pump suction tube into the drum and secure by completely threading the down tube into the drum. Place pump discharge hose into grout tank extending the hose at least 113 of the way into the tank. Caution must be used to make sure the hose does not slip out of the tank during transfer. Maintain a steady flow while pumping grout. When the grout drum is empty, add 5 to 7 gallons of water to grout drum through the small l­ inch bung. Pump water from the grout drum into the grout tank. This process effectively rinses the drum. Remove hose from the grout tank. Remove pump from the grout drum. Wash and flush the pump, and hoses. Store pump and hoses in a clean environment. Properly dispose of drum or call a drum recycling company. This empty drum must not be used for any other purpose. Add 70 fluid­ ounces by volume (5 Ibs.) of liquid AV­ 101 Cat T+ to the grout tank. Add 5 Ibs. (60 fluid­ ounces by volume) of powder AV­ 102 to the catalyst tank. Fill both tanks to the 30­ gallon level with water. 19 @z&. 7 7 Field Conditions The temperature of the water in the tanks has a very large impact on grout gel times. Since the gel time is greatly reduced with increasing temperatures, gel times should be determined throughout the day. As a general rule of thumb, gel time is reduced by one­ half for every 10° F rise in temperature. Therefore, water temperature should be measured to help determine desired grout gel times. Water temperatures should also be monitored throughout grouting operations as temperatures can vary dramatically between early morning and late afternoon. Trucks parked overnight or through a weekend can reach temperatures as high as 150° F. The grout side tank should not be exposed to direct sunlight as UV­ rays can accelerate polymerization. Optional Additives There are several additives that can modify the behavior of the grout being used. Ethylene Glycol, Liquid (AV­ 105) Amount: Maximum of 2.5 gallons per tank. Add equal amounts to both tanks, replaces water. Finish by filling tanks with water to 30­ gallon line. Tanks should not exceed 30­ gallon fill line. Result: Enhances grout's ability to undergo freezing and dehydration. Lowers freezing temperature of the solution. Icoset/ Latex, Liquid (AV­ 257) Amount: 2 to 3 gallons. Add to grout side only; replaces water. Finish by filling tank with water to 30­ gallon line. Tank should not exceed 30­ gallon fill line. Result: Increases compressive and tensile strength, also increases viscosity. Potassium Ferricyanide, Powder (KFe) Amount: Very small amount, less than % teaspoon to start. Add to grout side tank. Result: Extends gel times. Norosac, Powder (AC­ 50­ A) Amount: 3.2 ounces by weight. Add to grout side tank. Results: Slows new growth of roots in the sewer joints. i Additional information about these additives is found in Chapter 9. AV­ 118 Duriflex Product Descriptions AV­ 118 Duriflex is the trade name for an acrylic grout used for sewer line joint sealing, sewer line lateral sealing, manhole sealing, and soil stabilization. AV­ 118 is a clear, watery liquid containing N­ Methylolacrylamide (CAS number 924­ 42­ 5). Included with the NMethylolacrylamide is 5% acrylamide and a small amount of copper sulfate that stabilizes the product. The AV­ 118 is packaged in a plastic drum containing 15 gallons. AV­ 101 Catalyst T+ is the trade name for a blend of Triethanolamine (CAS number 102­ 71­ 6) and proprietary additives. AV­ 101 is a thick, colorless liquid that is used as an initiator. The proprietary additives decrease the freezing point, which allows storage and transportation in temperatures at or below freezing. AV­ 101 is packaged in both 5­ gallon plastic drums and X­ gallon lined metal drums. AV­ 103 Catalyst SP is the trade name for Sodium Persulfate (CAS number 7775­ 27­ l). AV­ 103 is a white powder that is used as a polymerization initiator. It is packaged in 25­ pound plastic pails, 50­ pound plastic pails, and 225­ pound coated fiber drums with a plastic inner liner. Storage Requirements AV­ 118 Duriflek Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Do not use pressure to empty containers. Wear proper PPE when handling this product. Store away from AV­ 101 Catalyst T+ and AV­ 103 Catalyst SP. AV­ 101 Catalyst T+: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Store away from acids or oxides as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 118 Duriflex or AV­ 103 Catalyst SP. AV­ 103 Catalyst SP: Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright position. Take measures not to raise dust. Wear proper PPE when handling product. Store away from acids, alkalis, halides, reducing agents, combustible materials and heavy metals as violent reactions may occur if product comes in contact with these materials. Do not store near AV­ 118 Duriflex or AV­ 101 Catalyst T+. General: Maintain first aid kit, gloves, respirators, aprons, and cleanup equipment in the storage area at all times. Emergency spill response kit should also be readily available. Foam, carbon dioxide, or dry chemical fire extinguishers'should be easily accessible. Provide eyewash, shower, and a source of water in the storage area. Disposal of Product AV­ il8 Duriflex: The best method for disposal is to gel the material. Collect as much liquid AV­ 118 as possible, add AV­ 101 Cat T+, and gel with AV­ 103 Catalyst SP mixed with water, in this order. Gelled (catalyzed) materials pose little risk and may be sent to a landfill. Very small spills may be washed down with water and released into a sanitary sewer system for treatment. Keep emptied drums at a fixed place until proper disposal. Drums must not be reused for any other purpose. If you are uncertain about how to properly dispose of the product or drums, contact a state registered hazardous materials disposal facility or an appropriate consultant. State or local waste agencies can also be helpful. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 101 Catalyst T+: Whatever cannot be saved for recovery or recycling should be managed in an appropriate RCRA­ approved waste disposal facility. Dispose of properly rinsed container in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AV­ 103 Catalyst SP: Whatever cannot be saved for recovery or recycling should be handled as hazardous waste and sent to an RCRA­ approved waste facility. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Safety Information, Hazards and First Aid Consult Material Safety Data Sheets (MSDS). Shipping Information See Page 35. Mixing Instructions for AV­ 1 18 Duriflex Conventional Mix (10% Solids, approx. 25 Second Gel Time at 72° F) Before mixing procedures begin, the operator must determine 1) the necessary gel strength and gel time required for the specific application, 2) the availability of all necessary grout components, and 3) that all safety equipment is present and in good working order. Personal Protective Equipment (PPE) During transfer/ mixing operations, the minimum PPE consists of a cartridge respirator full facepiece type, a Tychem@ brand or equivalent chemical suit, and gloves and boots that meet the descriptions in Chapter 2. Product Information The 15gallon drum contains 15 gallons of liquid grout. Most manufacturers of equipment have standardized by providing two 30­ gallon chemical tanks. When properly mixed, one drum of liquid AV­ 118 acrylic grout results in a 10% (by weight) strength grout solution of 60 gallons. Using two drums of AV­ 118 acrylic grout results in a 20% (by weight) strength grout solution of 60 gallons. One 15gallon drum will make a 60­ gallon batch of grout. For best results, grouts should be blended at concentrations of 10% or greater. Concentrations above 10% are favored for highstrength gel applications or to handle dilution of: more than 50% prior to gelation. Mixing Instructions (Conventional Mix) Tank A (Blue Grout Tank) Tank B (Red Tank) l AV­ 118 liquid: 1 drum . AV­ 103 SP: 5 Ibs. (60 ounces by l AV­ 101 Cat­ T: 70 ounces by volume volume) (5 Ibs.) l Water: Add enough water to make l Water: Add enough water to make a 30­ gallon batch a 30­ gallon batch. The above conventional mixture can be modified to meet your specific application. The Triethanolamine (AV­ 101 Cat­ T) is a liquid that is a required grout component and can be increased from a minimum of 35 fluid ounces (5% by weight, 2.5 Ibs.) to a maximum of 175 ounces by volume (2.5% by weight, 12.5 Ibs). Using more than 175 ounces by volume is not recommended. The AV­ 101 Cat­ T is always added into the same tank as the grout. Sodium Persulfate (AV­ 103 SP) is a powder that is a required grout component and can be increased from 5 pounds (1% by weight, 60 ounces by volume) to a maximum of 15 pounds (3% by weight, 180 ounces by volume). Only Sodium Persulfate may be used with AV­ 118. Grout Transfer Method Avanti highly recommends the use of a pump, hand or electric, to transfer liquid grout from the 15gallon drum into the grout tank. Using a pump minimizes worker exposure to grout spills or splashes. Another benefit of using a pump is that the empty grout drum will be rinsed and ready for disposal or recycling; that can be accomplished by adding the solution mix water to the empty drum and pumping it to the grout tank. The following procedure, accompanied by the wearing of appropriate PPE, effectively reduces the possibility of chemical exposure. PPE Steel­ toed boots and protective gloves and goggles should be worn before moving the drum containing AV­ 100 powder from storage. During the transfer/ mixing process a cartridge ­ respirator, appropriate boots and a Tychem8 brand or equivalent chemical suit are required. Gloves approved for use with acrylamide must be worn in order to keep the liquid or powder from coming into contract with the skin. Avanti International highly recommends the use of a full face­ piece respirator during transfer/ mixing operations. Procedure A power lift or two men should be used when lifting the 130­ pound grout drum into the back of the grout truck. Place the 15­ gallon grout drum within several feet of the grout­ side mixing tank. Using a bung tool, remove the 2­ inch bung, being careful not to let surface contamination enter the drum. Caution: Wetted pump parts must be plastic or stainless steel only. Place the hand pump suction tube into the drum and secure by completely threading the down tube into the drum. Place pump discharge hose into grout tank extending the hose at least l/ 3 of the way into the tank. Caution must be used to make sure the hose does not slip out of the tank during transfer. Maintain a steady flow while pumping grout. When the grout drum is empty, add 5 to 7 gallons of water to grout drum through the small l­ inch bung. Pump water from the grout drum into the grout tank. This process effectively rinses the drum. Remove hose from the grout tank. Remove pump from the grout drum. Wash and flush the pump and hoses. Store pump and hoses in a clean environment. Properly dispose of drum or call a drum recycling company. This empty drum must not be used for any other purpose. Add 70 fluid­ ounces by volume (5 Ibs.) of liquid AV­ 101 Cat T+ to the grout tank. Add 5 Ibs. (60 fluid­ ounces by volume) of powder AV­ 102 to the catalyst tank. Fill both tanks to the 30­ gallon levei with water. Field Conditions The temperature of the water in the tanks has a very large impact on grout gel times. Since the gel time is greatly reduced with increasing temperatures, gel times should be determined throughout the day. As a general rule of thumb, gel time is reduced by one­ half for every 10° F rise in temperature. Therefore, water temperature should be measured to help determine desired grout gel times. Water temperatures should also be monitored throughout grouting operations as temperatures can vary dramatically between early morning and late afternoon. Trucks parked overnight or through a weekend can reach temperatures as high as 150° F. The grout side tank should not be exposed to direct sunlight as UV­ rays can accelerate polymerization. 24 Optional Additives There are several additives that can modify the behavior of the grout being used. Ethylene Glycol, Liquid (AV­ 105) Amount: Maximum of 2.5 gallons per tank. Add equal amounts to both tanks; replaces water. Finish by filling tanks with water to 30­ gallon line. Tanks should not exceed 30­ gallon fill line. Result: Enhances grout's ability to undergo freezing and dehydration. Lowers freezing temperature of the solution. Icoset/ Latex, Liquid (AV­ 257) Amount: 2 to 3 gallons. Add to grout side only; replaces water. Finish by filling tank with water to 30­ gallon line. Tank should not exceed 30­ gallon fill line. Result: Increases compressive and tensile strength, also increases viscosity. Potassium Ferricyanide, Powder (KFe) Amount: Very small amount, less than I4 teaspoon to start. Add to grout side tank. Result: Extends gel times. Norosac, Powder (AC­ 50­ A) Amount: 3.2 ounces by weight. Add to grout side tank. Results: Slows new growth of roots in the sewer. Additional information about these additives is found in Chapter 9. Additives Product Descriptions AV­ 105 Ethylene Glycol is the trade name for ethylene glycol used as an acrylamide and acrylic grout additive. AV­ 105 is a clear, oily liquid (CAS number 107­ 21­ l) that enhances grout's ability to undergo freezing and dehydration. AV­ 105 is packaged in 5gallon pails. AV­ 257 lcoset is the trade name for an acrylamide and acrylic grout additive. AV­ 257 is a milky­ white, liquid emulsion that increases compressive and tensile strength while increasing viscosity. AV­ 257 is packaged in 5­ gallon pails and 55gallon drums. AC­ 50W­ A Norosac is the trade name for the herbicide dichlobenil. AC­ 50W­ A is a crystalline powder (CAS number 141­ 30­ o) designed to slow root growth. AC­ 50W­ A is packaged in 4­ pound bags. Potassium Ferricyanide (KFe) is the chemical name of a grout additive. KFe is used to extend gel times of acrylamide and acrylic grouts. KFe is an orange, crystalline powder. KFe is packaged in one­ pound bottles. Storage Requirements AV­ 105 Ethylene Glycol: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. Store away from acids or oxides as violent reactions may occur if product contacts these materials. Do not store near AV­ 101 , AV­ 102, or AV­ 103. AV­ 257 Icoset: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed and in an upright position. Do not use pressure to empty containers. AC­ 50W­ A Norosac: Store in a cool dry area away from heat. Provide good ventilation. Keep containers tightly closed. Take measures not to raise dust. Wear proper PPE when handling product. Potassium Ferricyanide (KFe): Store in a cool dry area away from heat. Provide good ventilation. Keep container tightly closed and in an upright condition. Take measures not to raise dust. Wear proper PPE when handling product. General: Maintain first aid kit, gloves, respirators, aprons, and cleanup equipment in the storage area at all times. Emergency spill response kit should also be readily available. Foam, carbon dioxide, or dry chemical fire extinguishers should be easily accessible. Provide eyewash, shower, and a source of water in the storage area. 26 Disposal of Product AV­ 105 Ethylene Glycol: Whatever cannot be saved for recovery or recycling should be handled in an appropriate RCRA­ approved waste disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Pails or drums must not be reused for any other purpose. If you are uncertain about how to properly dispose of the product or containers, contact a state registered hazardous materials disposal facility or an appropriate consultant. State or local waste agencies can also be helpful. Dispose of container and unused contents in accordance with federal, state, and local requirements. AV­ 257 Icoset: Whatever cannot be saved for recovery or recycling should be handled in an appropriate RCRA­ approved disposal facility. If the container is rinsed out properly it may be disposed of in an approved landfill. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. AC­ SOW­ A Norosac: Whatever cannot be saved for recovery or recycling should be handled in an appropriate RCRA­ approved waste disposal facility. Take measures not to raise dust. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Potassium Ferricyanide (KFe): Whatever cannot be saved for recovery or recycling should be handled as hazardous waste and sent to a RCRA­ approved waste facility. Take measures not to raise dust. Processing, use, or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of container and unused contents in accordance with federal, state and local requirements. Safety Information, Hazards and First Aid Consult Material Safety Data Sheets (MSDS). Shipping Information See Page 35. 0 Chemical Grout Safe Handling & Mixing Program Date: How would you rate the material presented in this class? (1 being the lowest, 5 being the highest) 1 2 3 4 5 How would you rate the instructor? 1 2 3 4 5 Would you recommend this class to someone else? Yes No What information was the most valuable to you? What information was the least valuable? If there was material that should have been covered today that wasn't, what was it? Do you have any suggestions for improving this class? Other Comments: 0 CD UQ Notes

epa

2024-06-07T20:31:45.597710

regulations

EPA-HQ-OPPT-2002-0006-0050

Supporting & Related Material

Presented by Jay Guillot Chemical Grout Safe Handling & Mixing Avanti International History Avanti was established in 1978. Avanti also supplies pumps, injection equipment, and safety gear. Avanti is leading supplier of Acrylamide, Acrylic, and Urethane chemical grouts. 1. Personal Safety Session 1 4. Housekeeping 2. Understanding Placards and MSDS 7. Disposal Issues ­ Containers and Grout 5. Storage 6. Transportation 3. Personal Protective Equipment – PPE Session 2 1. AV­ 100 AM Powder Mixing 2. AV­ 100 Blend Powder Mixing 3. AV­ 100 Liquid Mixing 4. AV­ 118 Liquid Mixing 5. Grout Additives 7. Test for Certification 6. Question and Answer Session Personal Safety Who is responsible for your safety everyday? You NFPA Placard Fire Hazard Flash Points 4 – Below 73° F 3 – Below 100° F 2 – Below 200° F 1 – Above 200° F 0 – Will not burn Health Hazard 4 –Deadly 3 – Extreme danger 2 – Hazardous 1 – Slightly hazardous 0 – Normal material Reactivity 4 – May detonate 3 – Shock and heat may detonate 2 – Violent chemical change 1 – Unstable if heated 0 –Stable Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard Material Safety Data Sheets Section 1: Identification Section 2: Hazardous Ratings Section 3: Physical/ Chemical Characteristics Section 4: Fire and Explosion Hazard Data Section 8: Health Related Data Section 5: Reactivity Section 6: Storage, Disposal & Spill Info Section 7: Precautionary Measures Section 9: Toxicity Data CHRONIC ACUTE Trade Name: AV­ 00 AM Acrylamide Monomer Ingredient( s): Acrylamide Percent: 00 CAS Num er: 79­ 06­ Section 1: Product Identification AV­ 100 AM Acrylamide Monomer (Time Weighted A erage) (Permissible Exposure Limits) ACGIH TWA: 0. 03 mg/ m 3 OSHA PEL: 0. 30 mg/ m 3 AV­ 102 Ammonium Persulfate Section 1: Product Identification Trade Name: AV­ 02 Catalyst AP Ingredient( s): Ammonium Persulfate Percent: 99 CAS Num er: 7727­ 54­ 0 OSHA PEL: N/ E ACGIH TWA: 0. mg/ m 3 AV­ 101 Catalyst T Section 1: Product Identification Trade Name: AV­ 0 Catalyst T Ingredient( s): Triethanolamine Percent: 70­ 80 CAS Num er: 02­ 7 ­6 OSHA PEL: 3 ppm ACGIH TLV: 3 ppm Ethylene Glycol Percent: 0­ 20 CAS Num er: 07­ 2 ­ OSHA PEL: 50 ppm ACGIH TLV: 50 ppm Deionized Water Percent: ­ 0 CAS Num er: 7732­ 8­ 5 OSHA PEL: N/ E Trade Name: AV­ 8 DURIFLEX Ingredient( s): Water Percent: 47 CAS Num er: 7732­ 8­ 5 OSHA PEL: N/ A ACGIH TWA: N/ A N­ Methylolacrylamide CAS NUMBER: 924­ 42­ 5 OSHA PEL: N/ E ; ACGIH TWA: N/ E Formaldehyde CAS Num er 79­ 06­ 0 OSHA PEL: 0. 3 mg/ m ³ ACGIH TWA: 0. 03 mg/ m³ N, N­ Methylene isacrylamide CAS Num er: 0­ 26­ 9 Time Weighted A erage Permissible Exposure Limit Section 1: Product Identification AV­ 118 DURIFLEX AV­ 103 Sodium Persulfate Section 1: Product Identification Trade Name: AV­ 03 Catalyst SP Ingredient( s): Sodium Persulfate Percent: 99 CAS Num er: 7775­ 27­ OSHA PEL: N/ E ACGIH TWA: 0. mg/ m 3 AV­ 101 Catalyst T Section 1: Product Identification Trade Name: AV­ 0 Catalyst T Ingredient( s): Triethanolamine Percent: 70­ 80 CAS Num er: 02­ 7 ­6 OSHA PEL: 3 ppm ACGIH TLV: 3 ppm Ethylene Glycol Percent: 0­ 20 CAS Num er: 07­ 2 ­ OSHA PEL: 50 ppm ACGIH TLV: 50 ppm Deionized Water Percent: ­ 0 CAS Num er: 7732­ 8­ 5 OSHA PEL: N/ E AV­ 100 AM Acrylamide Monomer Section 2: Hazard Ratings NONE 2 2 2 Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard AV­ 102 Ammonium Persulfate OXY Section 2: Hazard Ratings 1 0 1 AV­ 101 Catalyst T Section 2: Hazard Ratings None 1 0 Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard 2 AV­ 118 Duriflex Section 2: Hazard Ratings NONE 2 1 0 Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard AV­ 103 Sodium Persulfate OXY Section 2: Hazard Ratings 1 0 1 AV­ 101 Catalyst T Section 2: Hazard Ratings None 1 0 Specific Hazard Oxidizer OXY Acid ACID Alkali ALKALI Corrosive COR Use NO WATER W Radiation Hazard 2 AV­ 100 AM Acrylamide Monomer Section 3: Physical/ Chemical Characteristics Appearance and Odor: white crystalline powder much like ta le salt. Bo l ng Po nt: N/ L Vapor Pressure( mm Hg.): 0. 03 ( extremely low) Vapor Dens ty( A r= 1): N/ L Spec c Grav ty( Water = 1): .222g/ cm 3 @ 86 ° ° ° ° F ( 30 ° ° ° ° C) Melt ng Po nt: N/ L Evaporat on Rate( Butyl Acetate= 1): N/ L Solub l ty n Water: 58g/ 00g ( 68 ° F/ 20 ° C) Odorless AV­ 102 Ammonium Persulfate Section 3: Physical/ Chemical Characteristics Appearance and Odor: Odorless, white crystals. Bo l ng Po nt: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Dens ty( A r= 1): N/ A Spec c Grav ty( Water = 1): .98 Melt ng Po nt: Decomposes Evaporat on Rate( Butyl Acetate= 1): N/ A Solub l ty n Water: 5 % @ 77 ° F ( 25 ° C) AV­ 101 Catalyst T Section 3: Physical/ Chemical Characteristics Appearance and Odor: Colorless liquid, slight ammoniacal odor. Bo l ng Po nt: >387 ° F ( 97 ° C) Vapor Pressure( mm Hg.): Nil Vapor Dens ty( A r= 1): <5. 0 est. Spec c Grav ty( Water = 1): . 04 Melt ng Po nt: N/ A Evaporat on Rate( Butyl Acetate= 1): < Solub l ty n Water: Solu le AV­ 118 Duriflex Section 3: Physical/ Chemical Characteristics Appearance and Odor: Colorless liquid, slight formaldehyde odor. Bo l ng Po nt: 2 4° F ( 0 °C)@ 776mmHg Vapor Pressure( mm Hg.): < 7@ 77° F ( 25° C) Vapor Dens ty( A r= 1): N/ D Spec c Grav ty( Water = 1): N/ D Melt ng Po nt: N/ D Evaporat on Rate( Butyl Acetate= 1): N/ A Solub l ty n Water: Dispersi le AV­ 103 Sodium Persulfate Section 3: Physical/ Chemical Characteristics Appearance and Odor: Odorless, white crystals. Bo l ng Po nt: N/ A Vapor Pressure( mm Hg.): N/ A Vapor Dens ty( A r= 1): N/ A Spec c Grav ty( Water = 1): 2. 6 Melt ng Po nt: Decomposes Evaporat on Rate( Butyl Acetate= 1): N/ A Solub l ty n Water: 43% @ 77 ° F ( 25 ° C) AV­ 101 Catalyst T Section 3: Physical/ Chemical Characteristics Appearance and Odor: Colorless liquid, slight ammoniacal odor. Bo l ng Po nt: >387 ° F ( 97 ° C) Vapor Pressure( mm Hg.): Nil Vapor Dens ty( A r= 1): <5. 0 est. Spec c Grav ty( Water = 1): . 04 Melt ng Po nt: N/ A Evaporat on Rate( Butyl Acetate= 1): < Solub l ty n Water: Solu le AV­ 100 AM Acrylamide Monomer Section 4: Fire and Explosion Hazard Data Flash Po nt: 273. 2 ° ° ° ° F ( 34 ° ° ° ° C) Seta flash Closed­ cup Flamma le Limits: Not applica le, although dust in air may e explosive. Ext ngu sh ng Med a: Water spray, car on dioxide, or dry chemical. Spec al F re F ght ng Procedures: Avoid skin contamination and inhalation y wearing full protective clothing and self contained reathing apparatus. Approach fire from upwind to avoid hazardous vapors and toxic decomposition products. Unusual F re and Explos on Hazards: Thermal decomposition or com ustion may generate toxic gases including car on monoxide and ammonia. AV­ 102 Ammonium Persulfate Section 4: Fire and Explosion Hazard Data Flash Point: N/ A Flamma le Limits: N/ A Extinguishing Media: Flood with water. Special Fire Fighting Procedures: Fire fighters should wear selfcontained reathing apparatus and full protective clothing. Do not use car on dioxide or other gas­ filled fire extinguishers, they will have no effect on decomposing Persulfate. Use water spray to cool near y containers and structures exposed to fire. Unusual Fire and Explosion Hazards: Decomposition of material releases oxygen that may intensify fire. The presence of water accelerates decomposition. OXIDIZER AV­ 101 Catalyst T Section 4: Fire and Explosion Hazard Data Flash Po nt: > 240 ° F ( 5 ° C) ( COC) Flammable L m ts: LEL: 5. 3 ( est.) UEL: 3. 2 ( est.) Ext ngu sh ng Med a: Water spray, dry chemical, car on dioxide, alcohol foam. Do not use direct water stream. Spec al F re F ght ng Procedures: Wear self­ contained reathing apparatus and full protective clothing. Use water spray to cool near y containers and structures exposed to fire. Unusual F re and Explos on Hazards: This product should not e heated a ove 40 ° F ( 4 ° C) in the presence of aluminum due to excessive corrosion and the potential for a chemical reaction releasing flamma le hydrogen gas. INCOMPATIBILITY AV­ 118 Duriflex Section 4: Fire and Explosion Hazard Data Flash Po nt: <200 ° ° ° ° F ( 93 ° ° ° ° C) Flamma le Limits: N/ E Ext ngu sh ng Med a: Water spray, car on dioxide, or dry chemical. Spec al F re F ght ng Procedures: Wear NIOSH approved self­ contained reathing apparatus and full protective clothing. Unusual F re and Explos on Hazards: High temperatures and fire conditions may cause rapid and uncontrolled polymerization that can result in explosions and the violent rupture of storage vessels or containers. AV­ 103 Sodium Persulfate Section 4: Fire and Explosion Hazard Data Flash Point: N/ A Flamma le Limits: N/ A Extinguishing Media: Flood with water. Special Fire Fighting Procedures: Fire fighters should wear selfcontained reathing apparatus and full protective clothing. Do not use car on dioxide or other gas­ filled fire extinguishers, they will have no effect on decomposing Persulfate. Use water spray to cool near y containers and structures exposed to fire. Unusual Fire and Explosion Hazards: Decomposition of material releases oxygen that may intensify fire. The presence of water accelerates decomposition. OXIDIZER AV­ 101 Catalyst T Section 4: Fire and Explosion Hazard Data Flash Po nt: > 240 ° F ( 5 ° C) ( COC) Flammable L m ts: LEL: 5. 3 ( est.) UEL: 3. 2 ( est.) Ext ngu sh ng Med a: Water spray, dry chemical, car on dioxide, alcohol foam. Do not use direct water stream. Spec al F re F ght ng Procedures: Wear self­ contained reathing apparatus and full protective clothing. Use water spray to cool near y containers and structures exposed to fire. Unusual F re and Explos on Hazards: This product should not e heated a ove 40 ° F ( 4 ° C) in the presence of aluminum due to excessive corrosion and the potential for a chemical reaction releasing flamma le hydrogen gas. INCOMPATIBILITY AV­ 100 AM Acrylamide Monomer Section 5: Reactivity Data Sta ility: Not sta le; heating to more than 40 ° ° ° ° F (60 ° ° ° ° C) or exposing to direct sunlight may cause polymerization. Incompati ility( Materials to Avoid): Avoid acids, alkalis, peroxides, oxidizing and reducing agents, or car on steel. Decomposition: Thermal decomposition or com ustion may generate toxic gases including car on monoxide, ammonia, and hydrogen cyanide. Polymerization: May occur. Store at 80 ° F ( 60 ° C) with no exposure to direct sunlight. AV­ 102 Ammonium Persulfate Section 5: Reactivity Data Sta ility: Sta le ( ecomes unsta le in presence of moisture). Incompati ility( Materials to Avoid): Acids, alkalis, halides, reducing agents, com usti le materials, and heavy metals. Decomposition: Will li erate oxygen that supports com ustion, and oxides of sulfur and nitrogen. Polymerization: Will not occur. Oxidizer AV­ 101 Catalyst T Section 5: Reactivity Data Sta ility: Sta le under normal conditions. Avoid exposure to heat, sparks and open flames. Incompati ility( Materials to Avoid): Avoid acids and oxidizing materials. Decomposition: May li erate car on monoxide, car on dioxide, oxides of nitrogen. Polymerization: Will not occur. AV­ 118 Duriflex Section 5: Reactivity Data Sta ility: Sta le under normal handling and storage Incompati ility( Materials to Avoid): Aluminum, iron, copper, ases, acids, oxidizing agents, reducing agents, chelating agents, peroxides. Decomposition: Thermal decomposition may produce ammonia, formaldehyde, oxides of nitrogen, and oxides of car on. Polymerization: May occur. Avoid temperatures a ove 85° F( 29° C) and incompati le materials. AV­ 103 Sodium Persulfate Section 5: Reactivity Data Sta ility: Sta le ( ecomes unsta le in presence of moisture). Incompati ility( Materials to Avoid): Acids, alkalis, halides, reducing agents, com usti le materials, and heavy metals. Decomposition: Will li erate oxygen that supports com ustion, and oxides of sulfur and nitrogen. Polymerization: Will not occur. Oxidizer AV­ 101 Catalyst T Section 5: Reactivity Data Sta ility: Sta le under normal conditions. Avoid exposure to heat, sparks and open flames. Incompati ility( Materials to Avoid): Avoid acids and oxidizing materials. Decomposition: May li erate car on monoxide, car on dioxide, oxides of nitrogen. Polymerization: Will not occur. AV­ 100 AM Acrylamide Monomer Section 6: Storage, Disposal And Spill Information Storage and Handling: Store in a cool, dry place and away from heat. Do not leave product container open to atmosphere. Disposal Method: Incinerate or treat at a sewerage plant in accordance with governmental regulations. Steps to Be Taken in Case Material is Released or Spilled: Collect into a closed container and dispose of in accordance with governmental regulations. Wash out the area with plenty of water. Other Precautions: Wear protective clothing when handling this product. Take measures not to raise dust, mist, or vapor. AV­ 102 Ammonium Persulfate Section 6: Storage, Disposal And Spill Information Storage and Handl ng: Store in a cool, dry place away from sources of heat. D sposal Method: Dilute with plenty of water and dispose in accordance with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Put material in an approved DOT container or dilute with a large quantity of water. Other Precautions : (Use clean plastic or stainless steel scoops only.) Use protective clot ing w en andling t is product. AV­ 101 Catalyst T Section 6: Storage, Disposal And Spill Information Storage and Handling: Store in a cool, dry, well­ ventilated place. Keep containers tightly closed. Do not use pressure to empty containers. Disposal Method: Comply with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Wear protective equipment and clothing. For small spills or drips, mop or wipe up and dispose of in DOT­ approved waste containers. For large spills, same as a ove, or contain y diking with soil or other non­ com usti le a sor ent materials, and then pump into DOTapproved waste containers. Other Precautions: Keep out of sewers, storm drains, surface waters and soil. Do not cut grind, weld or drill on or near a container. AV­ 118 Duriflex Section 6: Storage, Disposal And Spill Information Storage and Handling: Store in a cool, dry place( etween 36° F and 85° C) in tightly closed original containers away from light and heat. Do not reuse containers. Disposal Method: Dispose in accordance with Federal, State, and Local regulations. If possi le catalyze to form a gel for disposal ( the gel formed y the polymer and water is non­ hazardous. Steps to Be Taken in Case Material is Released or Spilled: Evacuate area. Wear appropriate p4rotective gear. Dike area to prevent runoff. Do not flush into drains. If recovery is not possi le, catalyze su stance to from a gel. Ventilate and wash spill area with plenty of water. Large spills: A sor with inert a sor ent material. Sweep into appropriate closed container. Other Precautions: Do not let monomeric solution dry in air. Avoid introduing polymerization catalysts into the commerical product unless it is diluted with water. Do not pre­ mix the catalyst efore introduction into the resin. AV­ 103 Sodium Persulfate Section 6: Storage, Disposal And Spill Information Storage and Handl ng: Store in a cool, dry place away from sources of heat. D sposal Method: Dilute with plenty of water and dispose in accordance with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Put material in an approved DOT container or dilute with a large quantity of water. Other Precautions : (Use clean plastic or stainless steel scoops only.) Use protective clot ing w en andling t is product. AV­ 101 Catalyst T Section 6: Storage, Disposal And Spill Information Storage and Handling: Store in a cool, dry, well­ ventilated place. Keep containers tightly closed. Do not use pressure to empty containers. Disposal Method: Comply with Federal, State and Local regulations. Steps to Be Taken in Case Material is Released or Spilled: Wear protective equipment and clothing. For small spills or drips, mop or wipe up and dispose of in DOT­ approved waste containers. For large spills, same as a ove, or contain y diking with soil or other non­ com usti le a sor ent materials, and then pump into DOTapproved waste containers. Other Precautions: Keep out of sewers, storm drains, surface waters and soil. Do not cut grind, weld or drill on or near a container. AV­ 100 AM Acrylamide Monomer Section 7: Precautionary Measures Respiratory Protection: NIOSH( National Institute for Occupational Safety and Health) Approved organic vapor respirator, full face piece respirator preferred. Ventilation: Local exhaust. Protective Clothing: Eye Protection: Goggles, if using a half face piece respirator. Other Protective Equipment: Chemical resistant gloves and oots. Work/ Hygienic Practices: Shower at the end of each shift. Tychem Suit. AV­ 102 Ammonium Persulfate Section 7: Precautionary Measures Respiratory Protection: Use NIOSH approved respirator. Ventilation: Mechanical/ local exhaust capa le of minimizing dust emissions. Protective Clothing: Tychem suit. Eye Protection: Chemical goggles or full face piece respirator. Other Protective Equipment: Chemical resistant gloves and oots. Work/ Hygienic Practices: Wash with soap and water. Remove contaminated clothing. AV­ 101 Catalyst T Section 7: Precautionary Measures Respiratory Protection: NIOSH approved organic cartridge respirator. Ventilation: Local exhaust. Protective Clothing: Ru er gloves, long­ sleeved shirt, trousers, ru er apron. Eye Protection: Chemical goggles or full face­ piece respirator. Other Protective Equipment: Eyewash and safety shower. Work/ Hygienic Practices: Wash thoroughly after handling. AV­ 118 Duriflex Section 7: Precautionary Measures Respiratory Protection: NIOSH( National Institute for Occupational Safety and Health) Approved organic vapor respirator, full face piece respirator preferred. If air orne concentrations exceed permissi le limits, wear NIOSH/ MSHA approved supplied air respirator or selfcontained reathing apparatus. Ventilation: Local exhaust. Protective Clothing: Impervious clothing, oots, gloves. Eye Protection: Goggles, if using a half face piece respirator. Other Protective Equipment: Chemical resistant gloves and oots. Work/ Hygienic Practices: Shower at the end of each shift. Tyc em suit. AV­ 103 Sodium Persulfate Section 7: Precautionary Measures Respiratory Protection: Use NIOSH approved respirator. Ventilation: Mechanical/ local exhaust capa le of minimizing dust emissions. Protective Clothing: Tychem suit. Eye Protection: Chemical goggles or full face piece respirator. Other Protective Equipment: Chemical resistant gloves and oots. Work/ Hygienic Practices: Wash with soap and water. Remove contaminated clothing. AV­ 101 Catalyst T Section 7: Precautionary Measures Respiratory Protection: NIOSH approved organic cartridge respirator. Ventilation: Local exhaust. Protective Clothing: Ru er gloves, long­ sleeved shirt, trousers, ru er apron. Eye Protection: Chemical goggles or full face­ piece respirator. Other Protective Equipment: Eyewash and safety shower. Work/ Hygienic Practices: Wash thoroughly after handling. AV­ 100 AM Acrylamide Monomer Section 8: Health Related Data Primary Route( s) of Entry: , and ealt azards: Repeated exposure may result in more t an one disease of t e nervous system. Eye Contact: Eye contact may cause conjunctival irritation and corneal injury. Skin Contact: Skin contact causes irritation, reddening, and peeling. In alation: Repeated in alation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flus wit water for 15 minutes. Get medical attention. Skin: Was t oroug ly wit soap and water. Get medical attention. In alation: Remove to fres air. Get medical attention. Ingestion: Drink water and induce vomiting. Take 50 grams of activated c arcoal by mout . Get immediate medical attention. (Never give anyt ing by mout to an unconscious or convulsing person.) Skin absorption Eye contact. In alation AV­ 102 Ammonium Persulfate Section 8: Health Related Data Primary Route( s) of Entry: and ealth azards: Exposure to high le els of dust may cause difficulty in breathing in sensiti e persons. Eye Contact: Dust may irritate the eyes. Skin Contact: Prolonged or repeated contact with dust may cause dermatitis. Inhalation: Breathing dust may irritate nose, throat, and lungs. Prolonged exposure may cause difficulty in breathing. Ingestion: N/ L First Aid Procedures: Eyes: Immediately flus wit running water for 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Immediately was contaminated area wit water. Remove contaminated clot ing/ s oes and was before reuse. If irritation persists, get medical attention. In alation: Remove to fres air. If difficulty in breat ing occurs, get immediate medical attention. Ingestion: Rinse mout wit water. Do not induce vomiting. Get medical attention. ( Never give anyt ing by mout to an unconscious or convulsing person.) Skin, Eye contact. inhalation AV­ 101 Catalyst T Section 8: Health Related Data Primary Route( s) of Entry: and ealt azards: Prolonged or repeated exposure may result in delayed liver or kidney damage. Eye Contact: Irritation. Skin Contact: Dryness, irritation, possible dermatitis. A single prolonged exposure is not likely to result in armful amounts being absorbed. In alation: Vapors and mists irritate t e nose and t roat. In alation of ig er concentrations may cause eadac es, nausea, vomiting and coma. Ingestion: Pain or discomfort in mout , c est and abdomen. May cause nausea, vomiting, diarr ea, dizziness, faintness and coma. First Aid Procedures: Eyes: Flus wit water for 15 minutes. Skin: Was t oroug ly wit soap and water. In alation: Remove to fres air. Ingestion: Induce vomiting wit water. (Never give anyt ing by mout to an unconscious or convulsing person.) Skin absorption in alation. AV­ 118 Duriflex Section 8: Health Related Data Primary Route( s) of Entry: , and ealt azards: Immediate acute ealt azard. Delayed c ronic ealt azard. Prolonged contact may cause muscle weakness, bluis cold ands, peeling of t e palms, pain, numbness, and a tingling sensation in t e limbs. Accumulative effects may lead to central nervous system disturbances. Eye Contact: Eye contact may cause conjunctival irritation and corneal injury. Skin Contact: Skin contact causes irritation, reddening, and peeling. In alation: Repeated in alation affects nervous system. Ingestion: Repeated ingestion affects nervous system. First Aid Procedures: Eyes: Flus wit water for 15 minutes. Get medical attention. Skin: Was t oroug ly wit soap and water. Get medical attention. In alation: Remove to fres air. If necessary administer oxygen. If signs of intoxication exist get medical attention. Ingestion: Drink 1 to 2water and induce vomiting Get immediate medical attention. (Never give anyt ing by mout to an unconscious or convulsing person.) Skin absorption Eye contact. In alation AV­ 103 Sodium Persulfate Section 8: Health Related Data Primary Route( s) of Entry: and ealth azards: Exposure to high le els of dust may cause difficulty in breathing in sensiti e persons. Eye Contact: Dust may irritate the eyes. Skin Contact: Prolonged or repeated contact with dust may cause dermatitis. Inhalation: Breathing dust may irritate nose, throat, and lungs. Prolonged exposure may cause difficulty in breathing. Ingestion: N/ L First Aid Procedures: Eyes: Immediately flus wit running water for 15 minutes, lifting upper and lower eyelids occasionally. Get medical attention if irritation persists. Skin: Immediately was contaminated area wit water. Remove contaminated clot ing/ s oes and was before reuse. If irritation persists, get medical attention. In alation: Remove to fres air. If difficulty in breat ing occurs, get immediate medical attention. Ingestion: Rinse mout wit water. Do not induce vomiting. Get medical attention. ( Never give anyt ing by mout to an unconscious or convulsing person.) Skin, Eye contact. inhalation AV­ 101 Catalyst T Section 8: Health Related Data Primary Route( s) of Entry: and ealt azards: Prolonged or repeated exposure may result in delayed liver or kidney damage. Eye Contact: Irritation. Skin Contact: Dryness, irritation, possible dermatitis. A single prolonged exposure is not likely to result in armful amounts being absorbed. In alation: Vapors and mists irritate t e nose and t roat. In alation of ig er concentrations may cause eadac es, nausea, vomiting and coma. Ingestion: Pain or discomfort in mout , c est and abdomen. May cause nausea, vomiting, diarr ea, dizziness, faintness and coma. First Aid Procedures: Eyes: Flus wit water for 15 minutes. Skin: Was t oroug ly wit soap and water. In alation: Remove to fres air. Ingestion: Induce vomiting wit water. (Never give anyt ing by mout to an unconscious or convulsing person.) Skin absorption in alation. AV­ 100 AM Acrylamide Monomer Section 9: Toxicity Data Carcinogenicity: This material is listed as a potential carcinogen y the IARC( International Agen y for Resear h on Can er). In January 992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and " acrylamide is not carcinogenic in humans as shown y two epidemiological studies." LD 50 : Oral( rat): 75 mg/ kg AV­ 102 Ammonium Persulfate Section 9: Toxicity Data Carcinogenicity: This material is not considered a carcinogen. LD 50 : Oral ( rat): 495 mg/ kg Dermal ( ra it): 2000 mg/ kg AV­ 101 Catalyst T Section 9: Toxicity Data Carcinogenicity: No data for t e blend. owever, t e individual components are not considered carcinogens by NTP, IARC or OS A. LD 50 : No data found for t e blend; owever, for its components: Triet anolamine: Et ylene Glycol: Oral( rat): 8680 mg/ kg Oral ( rat): 4700 mg/ kg Dermal( rabbit): > 2. 0 g/ kg Dermal ( rabbit): 19. 5 g/ kg AV­ 118 Duriflex Section 9: Toxicity Data Carcinogenicity: This material is listed as a potential carcinogen y the IARC( International Agen y for Resear h on Can er ). In January 992, American Cyanamid notified EPA that they had concluded that "acrylamide is not carcinogenic to mice" and " acrylamide is not carcinogenic in humans as shown y two epidemiological studies." LD50 : Oral( rat): 500 mg/ kg AV­ 103 Sodium Persulfate Section 9: Toxicity Data Carcinogenicity: This material is not considered a carcinogen. LD50 : Oral ( rat): 4700 mg/ kg Dermal ( ra it): N/ D AV­ 101 Catalyst T Section 9: Toxicity Data Carcinogenicity: No data for t e blend. owever, t e individual components are not considered carcinogens by NTP, IARC or OS A. LD 50 : No data found for t e blend; owever, for its components: Triet anolamine: Et ylene Glycol: Oral( rat): 8680 mg/ kg Oral ( rat): 4700 mg/ kg Dermal( rabbit): > 2. 0 g/ kg Dermal ( rabbit): 19. 5 g/ kg Personal Protective Equipment Chemical Resistant Gloves Chemical Resistant Boots Splash Goggles Safety Glasses Chemical Resistant Suit Respirators Full Face Piece Respirator 3M Model 6800 Half Face Piece Respirator 3M Model 6200 Organic Vapor/ P100 Cartridges 3M 60921 Formaldehyde/ Organic Vapor /P100 Cartridges 3M 60925 Half face piece shown with cartridges attached. What's wrong with this picture? Respiratory Protection Standard If you are required to wear a respirator, your employer is responsible for following: 1. Medical evaluation 2. Fit testing 3. Training Splash Goggles Uvex Safety Goggles Model 9301 Safety Glasses Cool Cooler Coolest StarLite Part # 468M Eye Wash Wall Station Eyesaline When do we read the directions for use? Best Nitri Solve Gloves N­ Dex Gloves N­ DEX 7005 PVC Steel Toed Boots SFTY­ Boots Tychem Suit © DuPont Protective Apparel Tip: Beware of the Beware of the " "Ta e Ta e­ ­Home Home" " Problem Problem "To prevent hazardous materials from traveling from the workplace into your car or home, always wear the proper apparel in the correct manner. Take care to doff garments without contaminating your skin, hair or street clothing. Showering provides an added precaution ut cannot totally eliminate contaminants from skin and hair. And never take contaminated garments home for any reason." The best equipment in the world will not protect an employee unless it is used and The Two Cs of PPE correctly consistently. Inspect all PPE before each use. Inspect PPE use damaged or contaminated items. Wear, store, and clean PPE according to manufacturers guidelines. NEVER Operator with Safety Gear Storage Issues Which chemicals are not compatible? Where do we find this information? MSDS Sheets! Chemical Incompatibilities Th s s why AV­ 101 Cat T, AV­ 102 AP, and AV­ 103 SP should not be stored near each other. Transportation Issues Keep chemicals separated during transport. Secure all chemicals while vehicle is in motion. Secure lid on grout tank. Secure lids on empty drums. Wrap empty AV­ 100 bags in plastic bags. Keep chemicals in original containers whenever possible. Disposal Issues The best method for disposal is to gel the material. Small spills may be washed down with water. Powder product must be gelled or properly contained and incinerated. Keep emptied bags and drums at a fixed place until proper disposal. Housekeeping Checklist Do not eat/ drin in open cab areas of TV/ grout truc Clean wor area regularly Mop floors once a wee Wipe down outside of grout tan s with fresh water and sponge or towel Remove empty conta ners rom truck at the end o each work sh t. Wash down any spill thoroughly Seal all chemical containers immediately after use and secure so as not to shift in transit Wash tools used to work on pumps, packers, and grout reel w th clean water Secure door to control room dur ng the m x ng process so as not to expose control room to any vapors or powder that may escape. Hose down hose reel w th cop ous amounts o clean water at the end o each sh t Hand soap and ac l t es to wash hands should be prov ded on the truck. PPE should be nspected, cleaned and stored n plast c bag, and stored away rom chem cals. Cont nued Housekeeping Checklist Housekeeping Checklist Operator w ll w pe steer ng wheel at end o each sh t or poss ble contam nat on rom d rty hands. Ass stant w ll nspect grout ng system wh le n use or leaks and repa r or report as necessary. Always store chem cal n or g nal conta ner, no except ons! Dummy plugs should be nserted n the qu ck d sconnects on the quad­ hose a ter packer s uncoupled, to prevent leak ng rom tt ngs. Tychem su ts, boots, and chem cal res stant gloves should be stored outs de o the control room and r nsed thoroughly at end o each sh t. Accessibility Organize Cleanliness Safety Tip A full face piece respirator and approved cartridge/ filter can be used when the exposure to a compound is Above the OSHA PEL Equal to the OSHA PEL Below the OSHA PEL The PEL doesn't matter. Session 1 Review * Session 1 Review The effects of acute exposure are immediate True False What word best describes exposure to AV­ 100? Acute Chronic * * Session 1 Review Continued Routes of entry to the body for AV­ 100 products are, Skin Eyes Inhalation All of the above * Session 1 Review Continued Dupont TyChem protective suit is the only clothing recommend for mixing AV­ 100 Products True False * What property of AV­ 100 AM makes it difficult to be aware of exposure ? Odorless Powder Color All of the above Session 1 Review Continued * Session 1 Review Continued During grouting operations field personnel can wear short sleeved shirts. True False * Session 1 Review Continued When mixing powder grouts, the main safety hazard is from, Splashes Spills Inhaling the powder Skin contact * Session 2 1. AV­ 100 AM Powder Mixing 2. AV­ 100 Blend Powder Mixing 3. AV­ 100 Liquid Mixing 4. AV­ 118 Mixing 5. Grout Additives 7. Test for Certification 6. Specific Applications AV­ 100 AM Powder AV­ 100 Shipping Container Grout Tank A Add 15 gallons of water to Tank A AV­ 100 AM Powder Add Water 10 15 20 25 30 Grout Tank A Add 1 bag AV­ 100AM, keeping neck of bag beneath surface of liquid. AV­ 100 AM Powder Add Grout 10 15 20 25 30 Emptying Bag of AV­ 100 AM Powder Dissolving AV­ 100 AM Powder in Water MBA Shipping Container 64 Ounce Container MBA Add 64 ounces of AV­ 100 MBA Emulsion Grout Tank A AV­ 100 AM Powder Add MBA 10 15 20 25 30 AV­ 100 AM Powder Adding MBA AV­ 101 Shipping Container Grout Tank A Add 70 ounces y volume (5 l s.) of AV­ 0 Cat T+ to the grout tank AV­ 100 AM Powder Add AV­ 101 Cat T+ 10 15 20 25 30 Adding AV­ 101 Cat­ T+ Add enough water to make 30 gallon batch 64 ounces of AV­ 00 MBA Emulsion 5 l s. of AV­ 0 Cat T+ AV­ 100 AM Powder Grout Tank A Bag AV­ 00 AM 10 15 20 25 30 5 Gallons of Water Mixture Complete Secured Tank Cover Add 20 gallons of water to Tank B AV­ 100 AM Powder Add Water 10 15 20 25 30 Catalyst Tank B AV­ 102 Shipping Container AV102 Ammonium Persulfate AV­ 100 AM Powder Add AV­ 102 AP 10 15 20 25 30 Add 5 lbs o Ammon um Persul ate Catalyst Tank B Adding AV­ 102 AP AV­ 100 AM Powder Catalyst Tank B 10 15 20 25 30 Mixture Complete Add enough water to make 30 gallon batch 5 l s of Ammonium Persulfate 20 Gallons of Water Secured Tank Cover AV­ 100 Powder Blend Shipping Container Grout Tank A Add 15 gallons of water to Tank A 10 15 20 25 30 AV­ 100 Powder Blend Add Water AV­ 100 Powder Blend Add Grout 10 15 20 25 30 Grout Tank A Add 1 bag AV­ 100 blend, keeping neck of bag beneath surface of liquid. Emptying Bag of AV­ 100 Powder AV­ 101 Shipping Container Grout Tank A AV­ 100 Powder Blend Add AV­ 101 Cat T+ 10 15 20 25 30 Add 70 ounces y volume (5 l s.) of AV­ 0 Cat T+ to the grout tank Pouring 2 Quarts of AV­ 101 Cat T+ Mixture Complete AV­ 100 Powder Blend Grout Tank A 10 15 20 25 30 Add enough water to make 30 gallon batch 5 l s. of AV­ 0 Cat T+ Bag AV­ 00 Blend 5 Gallons of Water Secured Tank Cover AV­ 100 Powder Blend Add Water 10 15 20 25 30 Catalyst Tank B Add 20 gallons of water to Tank B AV­ 100 Powder Blend Add AV­ 102 AP 10 15 20 25 30 Catalyst Tank B Add 5 lbs o Ammon um Persul ate Scoop of AV­ 102 AP AV­ 100 Powder Blend Catalyst Tank B 10 15 20 25 30 Mixture Complete Add enough water to make 30 gallon batch 5 l s of Ammonium Persulfate 20 Gallons of Water Secured Tank Cover AV­ 100 Liquid in Shipping Container 10 15 20 25 30 AV­ 100 Liquid Add Grout Add 1 Drum AV­ 100 l qu d grout Grout Tank A Transfer Pump 10 15 20 25 30 Flush trans er pump w th 5 gallons o water Grout Tank A AV­ 100 Liquid Add Water 10 15 20 25 30 Add 70 ounces y volume (5 l s.) of AV­ 0 Cat T+ to the grout tank Grout Tank A AV­ 100 Liquid Add AV­ 101 Cat T+ Pouring 2 Quarts of AV­ 101 Cat T+ AV­ 100 Liquid Grout Tank A 10 15 20 25 30 Mixture Complete Add enough water to make 30 gallon batch 5 l s. of AV­ 0 Cat T+ Drum AV­ 00 liquid 5 Gallons of Water Secured Tank Cover 10 15 20 25 30 Catalyst Tank B AV­ 100 Liquid Add Water Add 20 gallons of water to Tank B 10 15 20 25 30 AV­ 100 Liquid Add AV­ 102 AP Add 5 lbs o Ammon um Persul ate Catalyst Tank B Pouring AV­ 102 Catalyst SP 10 15 20 25 30 Mixture Complete Add enough water to make 30 gallon batch 5 l s of Ammonium Persulfate 20 Gallons of Water AV­ 100 Liquid Catalyst Tank B Secured Tank Cover AV­ 118 Duriflex is the trade name for an acrylic grout used for sewer line joint sealing, sewer line lateral sealing, manhole sealing, and soil stabilization. AV­ 118 is packaged in a 15 gallon plastic drum. AV­ 118 Duriflex Liquid AV­ 118 Duriflex Shipping Container 10 15 20 25 30 AV­ 118 Duriflex Add Grout Add 1 drum o AV­ 118 Grout Tank A 10 15 20 25 30 AV­ 118 Duriflex Add Water Flush trans er pump w th 5 gallons o water Grout Tank A Transfer Pump 10 15 20 25 30 Grout Tank A Add 70 ounces y volume (5 l s.) of AV­ 0 Cat T+ to the grout tank AV­ 118 Duriflex Add AV­ 101 Cat T+ Pouring AV­ 101 Cat T+ 10 15 20 25 30 Drum of AV­ 8 AV­ 118 Duriflex Grout Tank A Mixture Complete Add enough water to make 30 gallon batch 5 l s. of AV­ 0 Cat T+ 5 Gallons of Water Secured Tank Cover 10 15 20 25 30 AV­ 118 Duriflex Add Water Catalyst Tank B Add 20 gallons of water to Tank B AV­ 103 Shipping Container 10 15 20 25 30 Add 5 lbs o AV­ 103 ( SP) Catalyst Tank B AV­ 118 Duriflex Add AV­ 103 SP Pouring AV­ 102 Catalyst SP 10 15 20 25 30 AV­ 118 Duriflex Catalyst Tank B Mixture Complete Add enough water to make 30 gallon batch 5 l s of AV­ 03 ( SP) 20 Gallons of Water Secured Tank Cover AV­ 100 & AV­ 118 Additives AV­ 105 Ethylene Glycol AC­ 50W­ A AV­ 257 Icoset Dyes AV­ 105 Ethylene Glycol Amount: Maximum 2.5 of gallons per tank. Add equal amounts to both tanks, it replaces water. Result:
Enhances grouts ability to undergo freezing and dehydration
Lowers freezing temperature of solution AV­ 105 Shipping Containers AV­ 257 Icoset Amount: 2 to 3 gallons. Add to grout side only, it replaces water. Result:
Increases compressive and tensile strength
Increases viscosity Potassium Ferricyanide (KFe) Amount: Very small, < ½ teaspoon to start. Add to grout side tank. Result: Increases gel times. Root Inhibitor (AC­ 50W­ A) Result: Slows new root growth in sewer joints. Amount: 3.2 ounces by weight. This is equal to 5­ ounces in an 8­ ounce measuring cup. Add to grout side tank. Dye Additives Amount: Teaspoon to start. Add to catalyst tank. Result: Increases visibility. Special Applications How temperature affects gel time. A general rule of thumb is that for every 10° F rise in temperature , the gel time reduces by one half. Special Applications How temperature a ects gel t mes examples: A grout temperature o has a gel t me o seconds A grout temperature o has a gel t me o seconds. What gel t me can you expect w th 85° F water temperature? ___________ 65° F 40 75° F 20 10 seconds Special Applications Problem: My gel time is too fast. Solution: Reduce the temperature of the tanks by adding ice, beginning with 10 lbs. In each tank, more than two bags per tank is not recommended. Special Applications Problem: My gel time is too long and I only have 60° F water available. Solution: Add an extra 2 lbs of AV­ 101 Cat T+ and AV­ 102 AP to the typical recommendation of 5 lbs. Special Applications Problem: I have a more than normal flow of water. Solution: Reduce the amount of make up water in both tanks. You can only do this during mixing, so it is a good idea to anticipate this problem. Solution: Pump more grout than normal to compensate for the dilution. Abnormal Water Flow Joint Sealing Acrylamide Longevity In 1985, a DOE study at Oa Ridge National Laboratory found that Acrylamide had a half­ life of 115 years DOE requires wastes disposal applications to have performance life of 200 years, Acrylamide met these parameters How Much Grout is Enough? .33 Gallons per diameter inch up to 8­ inch pipe .5 Gallons per diameter inch above 8­ inch pipe Lateral Leaks Questions? Session 2 Review Which additive listed below is used to increase gel times (slow down gelation)? Latex Ethylene Glycol KFe (Potassium Ferricyanide) AC­ 50W­ A Norosac * Session 2 Review Continued As the temperature of the water increases by 10 degrees, the gel time Decreases by one half Increases by one half Decreases by 5 percent Temperature does not effect gel time * Session 2 Review Continued When mixing AV­ 100 products using the standard mix instructions with 72° F water, the gel time should be approximately 10 seconds 2 minutes 25 seconds 25 minutes * Session 2 Review Continued Measuring the temperature of the water in the grout tanks is a good way to determine if your gel times have decreased substantially during the day . True False * (281) 486­ 5600 800­ 877­ 2570 Toll­ free U. S. and Canada (281) 486­ 7300 Fax www. AvantiGrout. com Avanti International

epa

2024-06-07T20:31:45.623363

regulations

EPA-HQ-OPPT-2002-0008-0001

Notice

Certain New Chemicals; Receipt and Status Information

epa

2024-06-07T20:31:45.630916

regulations

EPA-HQ-OPPT-2002-0009-0001

Notice

Receipt of Test Data for the Section 4 Chemical Dimethyl Glutarate (DMG)

17430 Federal Register / Vol. 67, No. 69 / Wednesday, April 10, 2002 / Notices by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPPTS– 44654. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B– 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260– 7099. II. Test Data Submissions Under 40 CFR 790.60, all TSCA section 4 enforceable consent agreements/ orders must contain a statement that results of testing conducted pursuant to enforceable consent agreements/ orders will be announced to the public in accordance with section 4( d) of TSCA. Test data for 1,1,2­ Trichloroethane (TCE), a hazardous air pollutant (HAP) listed under section 112 of the Clean Air Act Amendments of 1990, were submitted by the HAP Task Force. These data were submitted pursuant to a TSCA section 4 enforceable consent agreement/ order and were received by EPA on February 7, 2002. The submission includes a final report entitled `` Acute Inhalation Toxicity (with Histopathology) Study of 1,1,2­ Trichloroethane (1,1,2­ TCE) in Rats by WIL Research Laboratories, Inc. '' 1,1,2 TCE is used as a feedstock intermediate in the production of vinylidene chloride and some tetrachloroethanes. It is used as a solvent where its high solvency for chlorinated rubbers and other substances is needed, and for pharmaceuticals and electronic components. EPA has initiated its review and evaluation process for this submission. At this time, the Agency is unable to provide any determination as to the completeness of the submission. Authority: 15 U. S. C. 2603. List of Subjects Environmental protection, Hazardous substances, Toxic substances. Dated: April 2, 2002. Ward Penberthy, Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics. [FR Doc. 02– 8536 Filed 4– 9– 02; 8: 45 am] BILLING CODE 6560– 50– S ENVIRONMENTAL PROTECTION AGENCY [OPPTS– 2002– 0009; FRL– 6833– 1] TSCA Chemical Testing; Receipt of Test Data AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces EPA's receipt of test data on dimethyl glutarate (DMG) (CAS No. 1119– 40– 0). These data were submitted pursuant to an enforceable testing consent agreement/ order issued by EPA under section 4 of the Toxic Substances Control Act (TSCA). FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 554– 1404; e­ mail address: TSCA­ Hotline@ epa. gov. SUPPLEMENTARY INFORMATION: I. Does this Action Apply to Me? This action is directed to the public in general. This action may, however, be of interest to those persons who are concerned about data on health and/ or environmental effects and other characteristics of this chemical. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. II. How Can I Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations, '' `` Regulations and Proposed Rules, '' and then look up the entry for this document under `` Federal Register— Environmental Documents. '' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. 2. In person. The Agency has established an official record for this action under docket control number OPPTS– 2002– 0009. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B– 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260– 7099. III. Test Data Submissions Under 40 CFR 790.60, all TSCA section 4 enforceable consent agreements/ orders must contain a statement that results of testing conducted pursuant to enforceable consent agreements/ orders will be announced to the public in accordance with section 4( d) of TSCA. VerDate 11< MAY> 2000 17: 50 Apr 09, 2002 Jkt 197001 PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 10APN1. SGM pfrm01 PsN: 10APN1 17431 Federal Register / Vol. 67, No. 69 / Wednesday, April 10, 2002 / Notices Test data for dimethyl glutarate were submitted by the Dibasic Esters Group comprised of the following companies: Aceto Corporation, E. I. duPont de Nemours and Company, and Solutia, Inc. These data were submitted pursuant to a TSCA section 4 enforceable consent agreement/ order and were received by EPA on February 25, 2002. The submission includes a final report titled `` Dimethyl Glutarate Mammalian Cell Mutation Assay. '' Dimethyl glutarate is one of three component chemicals that make up the class of chemicals known as dibasic esters (DBEs). DBEs are used in paint stripping formulations that are sold to the general public. Consumers can be significantly exposed to DBEs during use of these formulations. EPA has initiated its review and evaluation process for this submission. At this time, the Agency is unable to provide any determination as to the completeness of the submission. Authority: 15 U. S. C. 2603. List of Subjects Environmental protection, Hazardous substances, Toxic substances. Dated: April 3, 2002 Ward Penberthy, Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics. [FR Doc. 02– 8538 Filed 4– 9– 02; 8: 45 am] BILLING CODE 6560– 50– S FEDERAL MARITIME COMMISSION Notice of Agreement( s) Filed The Commission hereby gives notice of the filing of the following agreement( s) under the Shipping Act of 1984. Interested parties can review or obtain copies of agreements at the Washington, DC offices of the Commission, 800 North Capitol Street, NW., Room 940. Interested parties may submit comments on an agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within 10 days of the date this notice appears in the Federal Register. Agreement No.: 010979– 037. Title: Caribbean Shipowners Association. Parties: A. P. Moller­ Maersk Sealand Bernuth Lines, Ltd., CMA–– CGM SA, CMA– CGM The French Line Crowley Liner Services, Inc., Interline Connection, NV, Seaboard Marine, Ltd., Seafreight Line, Ltd., Tecmarine Lines, Inc., Tropical Shipping & Construction Co., Ltd. Synopsis: The proposed agreement amendment changes the basic agreement from a conference agreement to a discussion agreement. The amendment also deletes King Ocean Services S. A. as a member of the agreement. Agreement No.: 201022– 002. Title: New Orleans/ Coastal Terminal Agreement. Parties: The Board of Commissioners of the Port of New Orleans Coastal Cargo Company, Inc. Synopsis: The proposed amendment changes the annual guarantee from a tonnage basis to a financial basis. The agreement runs through March 31, 2007. Agreement No.: 201101– 002. Title: Tampa/ Tampa Bay Marine Terminal Wharfage Incentive Agreement. Parties: Tampa Port Authority Tampa Bay International Terminals, Inc. Synopsis: The amendment extends the terms of the agreement through March 31, 2003. Dated: April 5, 2002. By order of the Federal Maritime Commission. Bryant L. VanBrakle, Secretary. [FR Doc. 02– 8722 Filed 4– 9– 02; 8: 45 am] BILLING CODE 6730– 01– P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Revocations The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U. S. C. app. 1718) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, effective on the corresponding date shown below: License Number: 2794F. Name: Florida Overseas Services, Inc. Address: 7236 NW 70th Street, Miami, FL 33166. Date Revoked: March 21, 2002. Reason: Failed to maintain a valid bond. License Number: 3024F. Name: S. A. Chiarella dba S. A. Chiarella Forwarding Co. Address: 1650 W. Linda Vista Drive, Suite 107, San Marcos, CA 90269. Date Revoked: March 13, 2002. Reason: Failed to maintain a valid bond. Sandra L. Kusumoto, Director, Bureau of Consumer Complaints and Licensing. [FR Doc. 02– 8721 Filed 4– 9– 02; 8: 45 am] BILLING CODE 6730– 01– P FEDERAL MARITIME COMMISSION Ocean Transportation Intermediary License Reissuances Notice is hereby given that the following Ocean Transportation Intermediary licenses have been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984, as amended by the Ocean Shipping Reform Act of 1998 (46 U. S. C. app. 1718) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR part 515. License No. Name/ address Date reissued 3886F ........................... Goodship International, Inc., 1058 Tower Lane, Bensenville, IL 60106 ..................................... February 27, 2002. 16083F ......................... Palmetto Freight Forwarding Corp., 2577 West 80 Street, Hialeah, FL 33016 .......................... December 6, 2001. 3406F ........................... Simmons International Express, Inc., 101 E. Clarendon Street, Prospect Heights, IL 60070 ... January 4, 2002. Sandra L. Kusumoto, Director, Bureau of Consumer Complaints and Licensing. [FR Doc. 02– 8723 Filed 4– 9– 02; 8: 45 am] BILLING CODE 6730– 01– P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U. S. C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/ or to acquire the VerDate 11< MAY> 2000 17: 50 Apr 09, 2002 Jkt 197001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 10APN1. SGM pfrm01 PsN: 10APN1

epa

2024-06-07T20:31:45.633046

regulations

EPA-HQ-OPPT-2002-0010-0001

Proposed Rule

Perfluoroalkyl Sulfonates; Proposed Significant New Use Rule; Extension of Comment Period

epa

2024-06-07T20:31:45.635708

regulations

EPA-HQ-OPPT-2002-0011-0007

Notice

Regulatory Reinvention (XL) Pilot Projects

63250 Federal Register/ Vol. 65, No. 205 /Monday, October 23, 2000/ Notices zfl ~ " ~ Ij *% ­**I ," b­ `I _ *xc1_ "& all ~ Act, 33 1J. S. C. 1311( a), at the Waiau Generating Station in Pearl Cit , Hawaii. Procedures by which the puilic may c: omment on a proposed Class I1 penalty or participate in a Class I1 penalty proceeding are set forth in tho C: onsolidatcd Rules. Tlio deiidline for submitting public cctminmt on a proposed Class I1 penalty is forty days alter issuance of public notice. FOR FURTHER INFORMATION CONTACT: Persons wishing to recnivo a copy of EPA's Consolidated Rules, review the Complaints or other documents filed in these procec! dings, comment upon the proposed assessments, or otherwise participate in the proceedings should contact Danielle Carr, Regional Hearing Clerk, 1J. S. EPA, Region TX, 76 Hawthor~ ie Street, S m Francisco, C: alifornia 94105, (415) 744­ 1391. The administrative records for both of these proceedings are located in the EPA Regional Office identified above, and tho files will bo open for public inspection during normal business hours. All inforniation submitted by the Respondent is available as part of the administrative records, subject to prtt~ isions of law restricting puttlic disclosure of confidential informnation. In order to provide opportunity for public comment, EPA will issue no final orders assassing a penalty in those procoedings prior to forty (40) days after tho date of publication of this noticn. Thomas Huetteman, Actjng Director, I, Vatc? r Division. 1FKL) oc. 00­ 27151 Piled 10­ 20­ 00: 0: 45 urii hted: October 13, 2000. BILLING CODE 6560­ 50­ P ENVIRONMENTAL PROTECTION AGENCY [FRL­ 6889­ 41 Regulatory Reinvention (XL) Pilot Projects AGENCY: Environmental Protection Agency @PA). ACTION: Notice of Availability of Final Project Agreements and rclated documcnts for twenty­ two XL Projtxts: United States Postal Service (USPS)­ Denver; Mayport Naval Station­ Environmental Reinvestment (ENWEST); Stcele County, MN XL Communities (XLC:); (: eogia­ Pacific Black Liquor Casific: ation Systom; International Paper (IP) Androscoggin Mill­ Effluent Improvements; Progressive Insurance Company­ Pay As You Drive Auto Insurance; International Business Machines (1BM)­ Essex Junction, Vermont; Labs 21­ Environmental Performance at Laboratories; Project XLC Phase I (Planning): Clemiont County, OH, Kodak Company Pollution Prevention; PPG Industries, Inc.; Yolo County Accelerated Anaerobic 8: Aerobic Compos ting (Bioreactor); Buncombe County Leachwte Rec: irculation/ Gas Recovery (Bioreaclor) Landfill; Autoliv Automobile Safety Products, 1J. S. A.; Ortho­ McNeil Pliarniac: cuti(: al­ Lahorat ory­ Scale High­ Temperature Catalytic Oxidation Process to Treat Low­ Level Mixed Wastes; State of Pennsylvania Department of Environmental Protection (PADEP) Coal Romining and Reclamation; National Aeronautics and Space Administration (NASA) White Sands Test Fac: ility (WSTF); Narragansett Bay Conmiission (NBC) Pretreatment; Pugat Sound Naval Shipyard (PSNS) Phase I­ ENVVEST; USA Waste of Virginia, Inc., and King George Laudfills, Inc., wholly­ oumed subsidiaries of Waste Management, Inc:., Bioreactor Systems; International Business Machines (IBM) East Fisllkill Facility­ F00fi Sludge Rocpcling; and Lead­ Safe Boston. SUMMARY: EPA is announcing the signing of the Project XL Final Project Agreements (FPAs) for the following XL, XLC, and ENVVEST Projects: United States Postal Service (USPS)­ Denver (herealter "IJSPS"): Mayport Naval Station­ ENWEST (hereafter "Mayport"); Steele County, MN XL Communities (XLC) (liereaftor "Steele C: ounty"); Georgia­ Pacific Black Liquor Gasification System (hereafter "Cfiorgia­ Pacific"); Intornational Paper (IP) Aiidroscoggin Mill­ Eflluent Irn pro vements (hemafkr ` `IP­ Efff ucn t Improvements"); Progressive Insurance Company­ Pay As You Drive Auto In surance (hereafter "Progre s sivo Insurance"); International Business Machines (1BM)­ Essex Junction, Verniont (hereafter "IBM­ Verniont"); Labs 21­ Eiiviconmental Performauce at Laboratories (horeafier "Labs 21"): Project XLC Phase I (Planning): Clerniont County, OH (hereafter "Clerinont"); Kodak Company Pollution Prevention (hereafter "Kodak"); PPG Industries, Inc. (liereaftar "PPC"): Yolo County Accelerated Anaerobic Aerobic Cornposting (Bioreactor) (hereafter "Yolo County"): Buncombe County Leachate Rec: ircuIation/ Gas Recovery (Bioreactor) (hereafter "Buncombe County"); Autoliv Automobile Safety Products, U. S. A. (hereafter "Autoliv"); Ortho­ McNeil Pharmaceuticel­ LattoratorpSca2e High­ Temperaturf! Catalytic Oxidation Process to Treat Low­ Levvol Mixed Wastes (hereafter "Ortho­ Mc: Neil"); State of Pennsylvania Department of Environmental Protection (PADEP) Coal Remining and Reclamation (hereafter "Pt! nn, sylvzinia Coal"); National Aeronautics and Space Administration (NASA) White Sands Test Facility (WSTF) (hereafter "NASA WSTF"); Narragansett Bay Commission (NBC) Pre treatment (hereaftor "NBC"); Puget Sound Naval Shipyard (PSNS) Phase I­ ENWEST (hereafter "PSNS"); USA Waste of Virginia, Inc., and King George Landfills! Inc., wholly­ owned subsidiaries of Waste Management, Inc., Bioreactor Systems (hereafter "Virginia Landfills"); International Business Machines (IBM) East Fishkill Facility­ F006 Sludge Recycling (htireafter "IBM Fishkill"); and Load­ Safe Boston. DATES: The FPAs were signed on the following dates: IJSPS on May 22, 2000; Mayport on May 30,2000; Steele County on May 31, 2000; Georgia­ Pacific on May 31, 2000; IP­ Effluent Iniprovomonts c u i Junc 29, 2000; Progressive Insurance on July 27, 2000; IBM­ Vermont on July 31, 2000; Labs 21 on Soptombar 7, 2000; Clermont on Septonhr 6, 2000; Kodak on September 14, 2000; PPG on Sepbnitter 14, 2000; Yolo County on September 14, 2000; Buncombe County on Sqteniber 18, 2000; Autoliv on September 20, 2000; Ortho­ McNeil on September 22, 2000: Ponnsylvania Coal on September 22, 2000; NASA WSTF on September 22, 2000; NBC on September 25,2000; PSNS on September 25, 2000; Virginia Landfills nn St? ptember 29, 2000; IBM Fisllkill 011 Septcmber 29, 2000; and Lead­ Safe Boston on 0c: tober 2, 2000. ADDRESSES: To obtain copies or to make inquiries about the Final Project Agreements, Fact Sheets, or public comments rec: oivod coritact the following individuals: Mary Byrne, 303­ 312­ 6491, U. S. EPA Regiou VIII, 8P­ R, 999 18th Street, Suite 500, Denver, Colorado 80202­ 2466 (byrne. maryQopa. gov) for the IJSPS XL Project; Michelle Cook, 404­ 5fi2­ 8674, 1J. S. EPA Region IV, 61 Forsyth Street, SW., Atlanta, Georgia 30303­ 3104 (cook. michelleQopa.~ ov) for the Mayport ENWEST Project; Aboer Hashein, 312­ 886­ 1331, US. EPA Region V, WC­ 15J, 77 Wesl Jackson Blvd, Chicago, Illinois 60( 304­ 3507 (liasheni. abeerOepa. gov) for the Steele County XLC Project; Steven J, Donohue, 215­ 814­ 3215, U. S. EPA Region III, 30R00, 1650 Arch Street, Philadelphia, Pennsyhania 19103­ 2029 (donohue. stevenOepa. gov) for the Georgia­ Pacific XL Pmjoct; Chris Rasclier, 617­ 918­ 1834,1J. S. EPA Region I, SPP, 1 Congress Street, Suite 1100, Boston, Massachusetts W114­ 2023 (rascher. chris@ epa. gov) for the Federal Register / Vol. 65, No. 205 /Monday, October 23, 2000 /Notices 63251 IP­ Effluent Improvements XL Project; Janet Mumay, 202­ 260­ 7570, U. S. EPA, 1802, 1200 Pennsylvania Avenue, NW., Washington, DC 20460 (murray. j~ inetOapa. gov] for tha Progressive Ilisuranct? XL Projeci; John Region I, SPP, 1 Congress Streot, Suite 1100, Boston, Massachusetts 02114­ 2023 (nioskal. jolin~ ei~ a, jiov) for the IDM­ Vermont XL Project; Nina Bonnelycke, 202­ 260­ 3344, U. S. EPA, 1802,1200 Pennsylvania Avenue, N p ' V ., Washington, DC 20460 (~) onnelycke. ninaQepa. gov) for tho Labs 21 XL Project: Christopher Murphy, 312­ 886­ 0172, IJS. EPA Region V, Chicago, Illinois 60604­ 3 5 07 (murphy .cllristopherOepa. gov) for the Clsrniont XLC Project; Bill Waugh, 202­ Pennsylvania A\ 7enuc, NW., Washington, DC 20460 (~~ augh. billQepa. gnv) for tho Kodak XL Project; Bill Waugh, 202­ 260­ 3489, U. S. EPA, 7403, 1200 Pennsylvania Avenue, NW., Washington, DC; 20460 Iwaugh. M11@ epa. gov) for the PPC XL Project; Mark Samolis, 415­ 744­ 2331, US. EPA Region IX, SPE­ 1, 75 Hawthorne Street, Scan Francisco, CA 94105 (samo1is. markO~ pa. gov) for the Yolo County XL Project Michdlo Cook, 404­ 562­ 8674, TJ. S. EPA Region IV, fil Forsyth Street, SW., Atlanta, Georgia 30303­ 3 104 (cook. iniche1leOepa. gov) for the Buncombe County XL Project; Mary Byrne, 303­ 312­ 6491, LJ. S. EPA Region VIII, 8P­ R, 999 18th Street, Suite 500, Denver, Colorado 80202­ 246[ 3 (byrne. niary@ epa. gov) for the Autoliv XL Project; Charles Howland, 215­ 814­ 2645, IJ. S. EPA Rogion 111. 30R00, 1650 Arch Street, Philadelphia, Pennsylvania 1910:$­ 2029 (hotvland. c~ iarles@ pa. gov) for the Ortho­ McNeil XL Project; Steven J. Donohue, 215­ 814­ 3215, US. EPA Region 111, 30R00,1650 A x h Stmet. Philadelphia, Pennsylvania 19103­ 2029 (donohue. sl; oven~ pa. gov) for the Pennsylvania Coal XL Project; Adele Cardenas, 214­ 665­ 7210, U. S. EPA Region VI, BEN­ XP, 1445 Ross Avenun, Suite 1200, Dallas, TX 75202­ 2733 (cardenas. adeleOe~ a.~ ov) for the NASA WSTF XL Projecl; Chris Rascher, 617­ 918­ 1834, U. S. EPA Region I, SPP, 1 Congress Street, Suite 1100, Boston, (rascher. chris@ epa.~ ov) for the NBC: XL Project; Wilfiani Glasser, 206­ 553­ 7215, US. EPA Region X, 1200 Sixth Avenue, Seattb:, Washington 98101 (glasser. willianibep~ a. gov) for the PSNS ENVVEST Projwt; Chris Menon, 215­ 814­ 2786,1J. S. EPA Region 111, 3EI00, 1650 Arch Street, Philadelphia, Moskal, 617­ 918­ 1826, 1J. S. EPA WA­ l6J, 77 West JatkSoIi Blvcl, 260­ 3489, lJ. S. EPA, 7403,1200 Mas sachuse Lts 0 2 1 14­ 2 02 3 Pennsylvania 19'103­ 2029 (nienen. chrisOepa. gov) for the Virginia Landfills XL Projec: t; Sam Kerns, 212­ 637­ 4139, TJ. S. EPA Region 11, 290 Broadway, New York, New York 10007­ 18( i6 (keriis. sanlOopa. go\ r) for the IBM­ Fishkill XL Project; and Mike Hill, 617­ 918­ 1388, V. S. EPA Region I, CHW, I Congress Strect, Suite 1100, Boston, (~ iill. michaelQepa. gov) for the Lead­ Sxfe Boston XL Project. In addition public liles on each of the projects are locatcd at each of the EPA Regional or Headquarters offices listed. Additional information on Project XL, XLC, and ENVVEST, incliiding docuinents rt? feronc: od in this document, other EPA poIicy documents relatixi to Project XL, Regional and Headquarters coutacts, application information and descriptions of existing XL projects and proposals are avaikiblo via the Iiiterriet at "htti): ll\ YM` tv. epa. go~ I~ roj~! c~~ '. SUPPLEMENTARY INFORMATION: Final Project Agreements are voluntary agreements developed by projcct sponsors, stakeholders, the State in which the project is located and EPA. Project XL including XL projects for go\ xmment agencies regulated by EPA­ ENVVEST and XL for C: ommunities, announced in tho Federal Register on May 23,1995 (6O FR 27282) and November 1,1995 (60 FR 55569) respectively give regulated sources the opportunity to develop alternative strategies that will replace or modify specific regulatory rquirenients on the condition b t they producm greater environmnental benefits. Any legd inipleinenting mechanism intended to be used in a project is described in tho project's FPA. EPA announcod the availahili­ ty aid requested comments on FPA's in the Federal Register for the following XL, ENVVEST and XL Communities projects on: February 15, 2000 (65 FR 7547) IJSPS: May 1,2000 (65 FIX253271 Mayport; December 29, 1999 (64 FR 73047) Steele County; May 8, 2000 (65 FR 26606) Georgia­ Pacific; May 16, 2000 Iniprovemeiits; June 27,2000 (65 FR 39614) Progressive Insurance; June 16, 20110 (65 FR 37780) IBM­ Vermont; August 17, 2000 (65 FR 50200) Labs 21; August 16, 2000 (65 FR 49983) Clorniont; August 14, 2000 (65 FR 49571) Kodak; August 22,2000 (65 FR 50987) PPG: August 29, 2000 (65 FR 52426) Yolo County; July 28, 2000 (65 FR 46456) Bincornbe County; August 14, ZOO0 (65 FR 49571) Autoliv; Septomber 1, 2000 (65 FR 53297) Ortho­ McNeil; August 30, 2000 (ti5 FR 52751) Pennsylvania Coal; September 8, 2000 Massttchusetts 02 11 4­ 2 023 (65 FR 31120) IP­ Effl~ e11t (65 FR 54519) NASA WSTF; August 29, 2000 (65 FR 52425) NBC; August 31, 2000 (65 FR 53008) PSNS; Septenibcr 8, 2000 (65 FR 54520) Virginia Landfills; Septemlm 1, 2000 (65 FR 53298) IBM Fishkill; and Seplonilxr 7, 2000 (65 FR 54265) Lead­ Safe Boston. Descriptions of the projects are contained in each of ilia Federal Register noticm. EPA did not receive tidverse cornmnont 011 any oT these F'PRS. George Wyeth, Acting Director. Oljice of Environnimtal Policy lnnu vulion. I) aied: Octobsr 17, 2000. [FR UOC. 00­ 27153 Wt? d 10­ 20­ 00; 8: 45 all] BILLING CODE 6560­ 504' FEDERAL TRADE COMMISSION Agency information Collection Activities; Submission for OMB Review; Comment Request AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: The Federal Trade Commission (FTC) h s submitted to tho Office of Managomont and Budget (OMB) for review under the Paperwork Reduction Act (PRA) information collection requirements contained in its Alternative Fuel Rule. Thr! FTC is soliciting puhlic comments on the proposal to extend through NoveInher 30,2003 the currait PRA clearance for information collection requirements contained in the Rule. That cloarance expires on Novernbrir 50, 2000. DATES: CommcnLs must be filed by Noveriihor 22, 2000. ADDRESSES: Send written c: ominents to the Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10202, Washington, DC 20503, ATTN.: Desk Officer for tho Enderal Trade Conmission, and .to Secretary, Federal Trade Commission, Room H­ 159, 600 Potlnsylvariia Avo., NW., Washington. DC 20580. All comments should be captioned "Alternative Fuel Rule: Paperwork comment." FOR FURTHER INFORMATION CONTACT: Requests for copies of the collection of informat ion and sup porting docutlientation should he addmssod to Neil Blickman, Divisioii of Enforcemonl, Bureau of Consinner Proleclion, Federal Trade Comniission, Rooiii S­ 4302, fin1 ,.: > ­. ­­* Pennsylvania Ave., NW., Washington, DC 20580. SUPPLEMENTARY INFORMATION: On August 16, 2000, the FTC sought cornrnont on the information collection requirements associated with the Alternative Fuel

epa

2024-06-07T20:31:45.638615

regulations

EPA-HQ-OPPT-2002-0012-0001

Notice

Certain New Chemicals; Receipt and Status Information

epa

2024-06-07T20:31:45.644708

regulations

EPA-HQ-OPPT-2002-0013-0008

Proposed Rule

Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U.S. Territories Outside the Customs Territory of the United States; Proposed Rule

Wednesday, November 1, 2000 Part VIII Environmental Protection Agency 40 CFR Part 761 Polychlorinated Biphenyls (PCB's); Return of PCB Waste From U. S. Territories Outside the Customs Territory of the United States; Proposed Rule VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65654 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 761 [OPPTS± 66020; FRL± 6750± 6] Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U. S. Territories Outside the Customs Territory of the United States AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed Rule. SUMMARY: EPA is proposing to clarify that PCB waste in United States' territories and possessions outside the customs territory of the United States may be returned to the U. S. Customs Territory for proper disposal. This proposed rule interprets the prohibition on the manufacture of PCBs at Section 6( e) of the Toxic Substances Control Act (TSCA) to allow the movement of PCB waste among any States of the United States for the purpose of disposal, and that such movement is not considered `` import. '' This interpretation will allow U. S. territories and possessions which fall outside of the definition of `` customs territory of the United States'' to dispose of their PCB waste in the mainland of the United States where facilities are available that can properly dispose of PCB waste. Thus, this rule would ensure that a safe and viable mechanism exists for the protection of health and the environment for those citizens in areas of the United States where facilities are not available for the proper management and disposal of PCB waste. Because disposal of these wastes may occur only at approved facilities, no unreasonable risks to health or the environment on the mainland United States will be created by this rule. DATES: Comments, identified by the docket number OPPTS± 66020, must be received by EPA on or before December 1, 2000. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION section. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS± 66020 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7408), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: 202± 554± 1404; e­ mail address: TSCA­ Hotline@ epa. gov. For technical information contact: Peggy Reynolds, OPPT/ NPCD, 7404, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202± 260± 3965; fax number: 202± 260± 1724; e­ mail address: reynolds. peggy@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are in a United States territory or possession outside of the customs territory of the United States, and you manufacture, process, distribute in commerce, or use PCBs. Examples of such territories and possessions are Guam, American Samoa, the Commonwealth of the Northern Mariana Islands (CNMI) including Saipan, and the United States Virgin Islands. Potentially affected entities may include, but are not limited to: Types of entities NAICS codes Examples of potentially affected entities Crude Petroleum and Natural Gas Extraction 211111 Facilities that own electrical equipment containing PCBs Electric Power Generation; Transmission and Distribution 2211 Facilities that own electrical equipment containing PCBs Food Manufacturing 311 Facilities that own electrical equipment containing PCBs Petroleum and Coal Products Manufacturing 324 Facilities that own electrical equipment containing PCBs Chemical Manufacturing 325 Facilities that own electrical equipment containing PCBs Primary Metal Manufacturing 331 Facilities that own electrical equipment containing PCBs Waste Treatment and Disposal 5622 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Materials Recovery Facilities 56292 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Public Administration 92 Agencies that own electrical equipment containing PCBs This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR part 761. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed in the FOR FURTHER INFORMATION CONTACT section. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain copies of this document and certain other available documents from the EPA Internet Home Page at http// :www. epa. gov/. On the Home Page select `` Laws and Regulations'' and then look up the entry for this document under Federal RegisterÐ Environmental Documents. You can also go directly to the Federal Register listings at http// :www. epa. gov/ fedrgstr/. Information about the Office of Prevention, Pesticides and Toxic Substances (OPPTS) and OPPTS related programs is available from http// :www. epa. gov/ internet/ oppts/. If you want additional information about EPA's PCB regulations at 40 CFR part 761, go to http//: www. epa. gov/ pcb. 2. In person. The Agency has established an official record for this action under docket control number OPPTS± 66020. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65655 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Northeast Mall, Rm. B± 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from 12 noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260± 7099. C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS± 66020 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: the OPPT Document Control Office (DCO) in East Tower Rm. G± 099, Waterside Mall, 401 M St., SW., Washington, DC. The DCO is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the DCO is 202± 260± 7093. 3. Electronically. You may submit your comments electronically by E­ mail to: oppt. ncic@ epa. gov, or mail or deliver your computer disk to the addresses identified above. Do not submit any information electronically that you consider to be CBI. E­ mailed comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments will also be accepted on standard computer disks in WordPerfect 689 or ASCII file format. All comments in electronic form must be identified by the docket control number OPPTS± 66020. Electronic comments may also be filed online at many Federal Depository Libraries. D. How Should I Handle CBI That I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person identified in the FOR FURTHER INFORMATION CONTACT section. II. Background A. What Action is the Agency Taking? EPA proposes to amend the disposal regulations at 40 CFR 761.99 to allow certain PCB waste located anywhere in the United States, including the territories and possessions of the United States that are not inside the customs territory of the United States (hereafter `` territories and possessions''), to be moved to any area within the United States for disposal. The proposed rule would clarify that such movement is not considered `` import'' for purposes of the ban on manufacturing PCBs under TSCA section 6( e)( 3). B. What is the Agency's Authority for Taking this Action? EPA is taking this action to clarify its interpretation of the TSCA provisions relating to the manufacture of PCBs as an exercise of the agency's inherent authority to issue regulations interpreting the statutes it administers. This proposed regulation would codify EPA's interpretation of an undefined term, `` import'' in the definition of `` manufacture'' under section 3( 7) of TSCA, for purposes of section 6( e)( 3) of TSCA. EPA's definition of the term `` import'' for all other purposes under TSCA is not affected. III. Summary of the Proposed Action A. What Risks do PCBs Present and How are PCBs Regulated? PCBs cause significant ecological and human health effects, including cancer, neurotoxicity, reproductive and developmental toxicity, immune system suppression, liver damage, skin irritation, and endocrine disruption (Ref. 1). EPA has found that any exposure of humans or the environment to PCBs may be significant, depending on such factors as the quantity of PCBs involved in the exposure, the likelihood of exposure to humans and the environment, and the effect of exposure (40 CFR 761.20). PCBs are readily absorbed through the skin and at even faster rates when inhaled. Because PCBs are stored in animal fatty tissue, humans are also exposed to PCBs through ingestion of animal products. Significantly, bioaccumulated PCBs appear to be even more toxic than those found in the ambient environment, since the more toxic PCB congeners are more persistent and thus more likely to be retained (Ref. 1). Under section 6( e) of the Toxic Substances Control Act (TSCA), 15 U. S. C. 2605( e), and implementing regulations at 40 CFR part 761, the manufacture, processing, and distribution in commerce of PCBs are banned unless EPA issues a regulatory exemption to the ban. The ban on manufacture of PCBs was designed to prevent the creation or introduction to the United States of new PCBs, and it has been largely successful. Use of PCBs is banned except in a totally enclosed manner or as authorized by rule based on a finding that the use will not pose an unreasonable risk to human health or the environment. Disposal of PCBs is strictly controlled to minimize release to the environment. By enacting TSCA section 6( e), Congress established a presumption that PCBs pose an unreasonable risk of injury to health and the environment. See, Central and Southwest Services, et al. v. EPA, 220 F. 3d 683, 688 (5th Cir. 2000). Before the statutory ban was enacted in 1976, PCBs were widely used in industrial applications, particularly as insulating fluids in electrical equipment. Utilities and other industries lawfully manufactured and sold items such as PCB electrical equipment and hydraulic or heat transfer equipment. After TSCA's general bans on manufacture, processing, distribution in commerce, and use of such items went into effect, EPA authorized the continued use of much of this equipment subject to conditions that protect against an unreasonable risk to health or the environment from the PCBs in the equipment. As these items reach the end of their useful lives, the owners are responsible for disposing of them following the stringent requirements of 40 CFR part 761. Any PCBs that are released from the equipment also must VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65656 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules be disposed of following these requirements. TSCA was enacted to protect all of the citizens of the United States from unreasonable risk of injury to health or the environment from exposure to chemical substances. TSCA sections 3( 13) and 3( 14) define `` United States'' to include `` any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. '' Thus, the prohibitions and restrictions on PCBs under TSCA section 6( e) and its implementing regulations protect not only United States citizens in the 50 States, but United States citizens in all the territories and possessions of the United States. PCBs in the 50 States and in the territories and possessions must be managed and disposed of in a manner that does not present an unreasonable risk to health or the environment. B. What Special Problems Do PCBs Present in the Territories and Possessions? PCBs and PCB waste in the territories and possessions pose an especially great environmental threat. The territories and possessions have no permitted commercial PCB disposal facilities, so PCB waste is accumulated in long­ term storage. Many of the territories and possessions are subject to frequent typhoons and earthquakes, which can severely damage storage areas and other buildings. PCBs and PCB waste in storage therefore may present a greater risk to human health and the environment than PCBs stored in the mainland United States (Ref. 8). Between 1945 and 1990, within 180 nautical miles of Guam, there were 118 tropical storms (wind speed 40 to 72 mph), 36 typhoons (wind speed 75 to 149 mph), and 8 super­ typhoons (wind speed 150 mph or more). Between 1973 and 2000, Guam has seen an average of 18 earthquakes a year within a 100 kilometer radius. During the last 10 years, 12 earthquakes of magnitude 5 or higher have occurred within a 50 kilometer radius of Guam. The Commonwealth of the Northern Marianas Islands is 120 miles from Guam and shares similar geologic characteristics, so the risks would be similar (Ref. 8). The Samoas lie squarely within the South Pacific's notorious cyclone belt. In American Samoa, Cyclone Tusi caused extensive damage to property, vegetation, and wildlife in 1987. Cyclones occur, on average, every 10 to 15 years, but in the early 1990s, the Samoas were devastated by two of the strongest and most destructive storms on record. Cyclone Ofa struck in February, 1990, bringing winds of up to 250 kilometers per hour, killing 16 people and leveling much of the island of Savai'i. In 1991, Cyclone Val pummeled the islands for 5 days with winds up to 260 kilometers per hour and waves of up to 25 meters in height. Although the storm destroyed nearly three times as much as its predecessor, the death toll was the same. Total damage was estimated at $380 million (Ref. 8). PCBs that are released to the environment in the territories and possessions, through natural disasters or other events, can present significant exposure risks to residents of these areas. Many island residents consume fish for subsistence, and PCBs bioaccumulate in fish. In addition, island natural resources are severely limited and therefore vulnerable. Even a small quantity of PCBs seeping into the groundwater system could permanently eliminate an island's only source of clean drinking water (Ref. 8). Disposal of PCBs in the territories and possessions presents a special challenge. Most PCBs that are regulated for disposal must be disposed of in a TSCA­ approved facility, such as an incinerator or a chemical waste landfill (40 CFR part 761, subpart D). However, as noted above, there are no TSCAapproved commercial PCB disposal facilities in any of the territories or possessions of the United States (Ref. 6), so disposal in the territory or possession where the waste is generated is not possible in most cases. A recent survey of the status of PCB waste in the territories and possessions shows that, because of the lack of disposal options, PCB wastes have been placed in storage awaiting disposal in facilities that are not approved commercial storage facilities under TSCA. In some cases, spills or releases from these facilities are inadequately controlled, presenting risks to health and the environment (Ref. 8). The territories and possessions cannot dispose of their waste at facilities outside the United States if the PCB concentration is ³50 ppm because EPA regulations prohibit the export for disposal of such waste (see 40 CFR 761.97). Moreover, it is a violation of the PCB regulations to dilute PCB wastes to lower concentrations to avoid these restrictions on export (40 CFR 761.1( b)( 5)). Even if such export were not prohibited, it is not clear that export would be a viable option. Even assuming that foreign countries would be willing to accept PCB waste from the United States, there is some uncertainty about the disposal capacity at foreign disposal sites capable of managing PCBs (Ref. 17). Furthermore, EPA disfavors disposing of PCB wastes generated in the United States in other countries. The only remaining disposal option for most TSCA­ regulated PCB waste in the territories and possessions is disposal in one of the TSCA­ approved facilities in the mainland United States. However, EPA has historically interpreted TSCA in a way that made this option unavailable. Since 1979, TSCA section 6( e) has banned the manufacture of PCBs except under an exemption issued by rulemaking. TSCA section 3( 7) defines `` manufacture'' to include `` import into the customs territory of the United States (as defined in general note 2 of the Harmonized Tariff Schedule of the United States). '' General note 2 defines the `` customs territory of the United States'' as `` any State of the United States, the District of Columbia, and Puerto Rico. '' Thus, any movement of PCBs from a location outside the customs territory of the United States to a location inside the customs territory could be considered to be an import of PCBs into the customs territory of the United States. Since most of the territories and possessions, such as Guam and American Samoa, are not included within the definition of `` customs territory of the United States'' as found in the Harmonized Tariff Schedule, EPA has historically interpreted a movement of PCBs from one of these areas to a mainland State to be an `` import'' within the meaning of `` manufacture'' as it is used in TSCA section 6( e)( 3). EPA has in the past exercised limited discretion to allow the movement of PCB waste from U. S. territories and possessions to the mainland United States (Ref. 15). C. How Would This Proposed Rule Address Disposal of PCBs in the Territories and Possessions? EPA proposes to amend its regulations to allow the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14), regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs [or the PCB waste] were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and have remained within the United States since that date. EPA would not consider these movements to be imports subject to the ban on manufacturing under TSCA sections 3( 7) and 6( e)( 3) VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65657 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules As noted above, the territories and possessions are subject to all of TSCA's requirements. EPA is charged with implementing section 6( e) to protect the health and environment of all United States citizens, including the residents of the territories and possessions. To interpret the statute as prohibiting the movement of PCB waste from the territories and possessions to disposal facilities in the United States mainland puts the residents of the territories and possessions at a serious disadvantage compared to residents of areas that fall within the definition of the customs territory. Because there are no EPAapproved commercial PCB storage or disposal facilities outside the customs territory, and because of the unique environmental conditions in the territories and possessions, the Unites States citizens of these areas are subject to a higher likelihood of exposure to PCBs, and thus a higher risk of injury. Moreover, EPA is particularly concerned about the risks from improper disposal of PCBs wherever it may occur. PCBs are persistent in the environment and can become dispersed world­ wide. Research supporting EPA's report to Congress, Deposition of Air Pollutants to the Great Waters (Refs. 2, 3, 4 and 5), indicates that up to 89% of the PCB loading for Lake Superior occurs through air deposition, much of it from distant sources. Figures for the other Great Lakes range from 6% to 63%. Based on the persistence of PCBs in the global environment and EPA's finding that any exposure to human beings or the environment may be significant, EPA believes that the safe disposal of PCBs in approved United States facilities poses less risk of injury to health or the environment in the United States than the continued presence of PCBs in the territories and possessions, since proper disposal in this country provides protection against possible hazards from improper disposal elsewhere. EPA is also concerned that the only options currently available for handling PCBs in the territories and possessions may violate the requirements of TSCA and its implementing regulations. Indefinite storage of PCB waste is not lawful under EPA's regulations at 40 CFR 761.65. Disposal in a facility that is not EPA­ approved would also violate the regulations. As noted above, shipment of any wastes containing PCBs ³50 ppm to a foreign country for disposal would violate the export prohibition. In contrast, residents of areas inside the customs territory that do not have EPA­ approved PCB disposal facilities can simply ship their PCB wastes to an approved facility in another State. For example, the residents of Alaska and Hawaii, States in which no TSCA­ approved disposal facilities are located, can ship their PCBs to facilities in the mainland United States for disposal (Ref. 13), in spite of the fact that it is impossible to move wastes from those States to the mainland without either entering Canada or crossing international waters (40 CFR 761.99). EPA has determined that its previous interpretation of the definition of `` manufacture'' is not mandated by the language of TSCA, results in inequitable treatment among different areas within the United States, does not adequately protect health and the environment throughout the United States, and therefore is not in the public interest. EPA believes that the term `` import, '' as commonly understood, was not intended to include the movement of PCB waste that has never been outside the United States or outside the regulatory control of TSCA (after enactment) from one area of the United States (the territories and possessions) to another area of the United States (the mainland) for disposal. There is an obvious distinction between that type of movement and the introduction of a chemical into the United States from a foreign country, which is clearly an import. This latter category is much more analogous to the manufacture of a new chemical substance in the United States. Therefore, EPA proposes to interpret the movement of PCB waste from the territories and possessions into the customs territory of the United States for disposal not to be an import, and therefore not within the ban on manufacture under TSCA section 6( e). This proposed interpretive rule would allow the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14), regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs in the waste were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and has remained within the United States since that date. This would allow PCB waste that was present in the territories and possessions at the time TSCA's ban on manufacturing took effect, and that remained within the territories and possessions since that date, to be stored and disposed of in any facility in the United States that meets the requirements of 40 CFR part 761, subpart D. It would also allow PCBs that were present in the territories and possessions at the time TSCA's bans took effect, but were not designated as waste until after that date, to be stored and disposed of in any subpart D facility in the United States, as long as the PCBs and PCB waste had remained in the United States. Finally, it would allow PCBs or PCB wastes that were transferred from an area in the United States that is outside the territories and possessions, but that was moved to a territory or possession after January 1, 1979, and that has never left the United States, to be stored and disposed of in any subpart D facility in the United States. EPA would not consider movement of any of these wastes to the customs territory of the United States to be an import subject to the ban on manufacturing under TSCA section 6( e). This proposed rule would apply to PCB waste that is present in the territories and possessions as the result of conduct that was legal at the time it occurred (for example, PCB materials that were brought to the territories before TSCA's ban on distribution in commerce became effective), and that has been subject to regulation under TSCA throughout its lifespan; or PCB equipment that was lawfully in use in one of the States, that was transferred to a territory or possession for continued lawful use, and that reached the end of its useful life and became subject to disposal while in the territory or possession. This proposed amendment would also be consistent with EPA's longstanding policy that it does not interpret movement of PCBs purchased or procured in the United States by the Federal Government, taken overseas for use in United States Government facilities, remained under the control and jurisdiction of the United States Government, and subsequently returned to the United States for disposal in an approved facility as either exports or imports for purposes of TSCA section 6( e) (Refs. 14 and 16). EPA established this policy because the wastes had always been the property of the United States and disposal facilities for these wastes might not be readily available overseas. This proposed rule would not allow disposal in the United States of PCBs transported to the territories and possessions from foreign countries after the effective date of the ban on manufacture in TSCA section 6( e)( 3). The purpose of this proposal is to ensure that all United States PCB waste can be disposed of in compliance with the requirements of TSCA section 6( e) and its implementing regulations. This proposal is not intended to allow the territories and possessions to become a conduit to the United States for PCB waste generated in other countries. VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65658 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules Finally, EPA has not made a formal finding of `` no unreasonable risk'' for this proposed regulation. This regulation is not being proposed under TSCA section 6( e), but rather as an exercise of EPA's inherent authority to interpret the statutes it administers. IV. References and Documents in the Record As indicated in Unit I. B. 2., the official record for this rulemaking has been established under docket control number OPPTS± 66020, the public version of which is available for inspection as specified in Unit I. B. 2. The following is a listing of the documents that have already been placed in the official record for this rulemaking: A. Federal Register Notices 1. U. S. Environmental Protection Agency (USEPA). 44 FR 31514, May 31, 1979, `` Polychlorinated Biphenyls (PCBs); Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions: Final Rule. '' 2. USEPA. 45 FR 29115, May 1, 1980, `` Polychlorinated Biphenyls (PCBs); Expiration of the Open Border Policy for PCB Disposal: Notice. '' OPTS 62008. 3. USEPA. 59 FR 62788, December 6, 1994, `` Disposal of Polychorinated Biphenyls: Proposed Rule. '' OPPTS± 66009A. 4. USEPA. 61 FR 11096, March 18, 1996, `` Disposal of Polychlorinated Biphenyls; Import for Disposal: Final Rule. '' OPPTS± 66009B. 5. USEPA. 63 FR 35384, June 29, 1998, `` Disposal of Polychlorinated Biphenyls (PCBs): Final Rule. '' OPPTS± 66009C. B. Reference Documents 1. USEPA, Office of Research and Development (ORD). PCBs Cancer DoseResponse Assessment and Application to Environmental Mixtures. EPA600P± 96001F (September 1996): 75pp. OPPTS± 66009C. 2. USEPA, Office of Air Quality Planning and Standards (OAQPS). Deposition of Air Pollutants to the Great Waters, First Report to Congress. EPA± 453R± 93± 055 (May 1994): 136pp. OPPTS± 66009B. 3. USEPA, OAQPS. Identification of Sources Contributing to the Contamination of the Great Waters by Toxic Compounds. EPA± 453R± 94± 087 (March 17, 1993): 145pp. OPPTS± 66009B. 4. USEPA, OAQPS. Relative Atmospheric Loadings of Toxic Contaminants and Nitrogen to the Great Waters. EPA± 453R± 94± 086 (March 15, 1993): 142pp. OPPTS± 66009B. 5. USEPA. Chapter 2.2, Exposure and Effects of Airborne Contamination for the Great Waters Program Report. EPA± 453R± 94± 085 (December 22, 1992): 201pp. OPPTS± 66009B. 6. USEPA, Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Commercially Permitted PCB Disposal Companies (April 2000): 3pp. 7. USEPA, Office of Pollution Prevention and Toxics (OPPT). Excerpt from the PCB Waste Handler Database; Facility Information for U. S. Territories and Possessions (September 27, 2000): 12pp. 8. USEPA, Region IX. Memo from Lily Lee, Guam Program Manager, to Enrique Manzanilla, Director, Cross Media Division, Re: Summary of PCB Waste Quantities and Concentrations in the US Territories (July 19, 2000): 5pp. 9. Unitek Environmental­ Guam. Letter from LeRoy Moore, President, to John Malone [sic], Director, National Program Chemicals Division, Re: PCB Shipments from Guam and Possessions of the United States for Disposal in the Mainland United States (May 11, 2000): 2pp. 10. USEPA, OPPT. Note from Peter Gimlin to the File, Re: Unitek Environmental­ Guam (UEG) Meeting (September 27, 2000): 1p. 11. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol M. Browner, Administrator, EPA, Re: Disposal of Polychlorinated Biphenyls (PCBs) from Guam and the Other U. S. Territories (April 12, 2000): 2pp. 12. USEPA, Region IX. Letter from Felicia Marcus, Regional Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of Polychlorinated Biphenyl Waste (February 4, 2000): 2pp. 13. USEPA, OPPT. Memo from John W. Melone, Director, Chemical Management Division, to George Abel, Chief, Pesticides and Toxic Substances Branch, USEPA Region X, Re: Transit of PCB Waste Generated in the United States Through a Foreign Country (January 19, 1995): 2pp. 14. USEPA, OPPT. Letter from John W. Melone, Director, Chemical Management Division, to Arthur J. Brown, National Science Foundation, Re: Request to Return PCBs in Antarctica to the United States for Disposal (March 11, 1994): 3pp. 15. USEPA, OCM and OE. Letter from Michael F. Wood, Director, Compliance Division, and Michael J. Walker, Enforcement Counsel for the Toxics Litigation Division, to Marion P. Herrington, General Electric Company, Re: Transfer of PCB Waste Generated in A U. S. Territory to An Approved Disposal Facility in the Continental United States (August 14, 1992): 2pp. 16. USEPA, Office of Toxic Substances (OTS). Letter from Don R. Clay, Director to Colonel Joseph T. Cuccaro, Defense Logistics Agency, Re: USEPA Position on DOD Owned PCB Fluid Located Abroad and Returned to the U. S. for Disposal (February 7, 1984): 3pp. 17. United Nations Environment Programme (UNEP). Inventory of World­ wide PCB Destruction Capacity, First Issue (December 1998): 85pp. 18. U. S. Congress. Congressional Record from the House of Representatives, H8598, Guam's Environmental Problems (October 2, 2000): 1p. 19. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol Browner, Administrator, EPA, Re: Inability of Guam to Import PCBs into the U. S. Mainland for Proper Disposal (December 10, 1999): 2 pp. 20. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of PCB Waste in Guam (June 14, 2000): 2 pp. 21. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Meeting on PCB Waste in Guam (September 29, 2000): 2 pp. V. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this action is not a `` significant regulatory action'' subject to review by OMB, because this action is not likely to result in a rule that meets any of the criteria for a `` significant regulatory action'' provided in section 3( f) of the Executive Order. This proposed rule simply clarifies EPA's interpretation of the TSCA section 6( e) provisions relating to the manufacture of PCBs. B. Regulatory Flexibility Act (RFA) Pursuant to section 605( b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U. S. C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is that this action is not expected to result in any direct adverse impact for small entities. This rule interprets the prohibition on the `` manufacture of PCBs'' in a manner which affords U. S. citizens (including small entities) residing in U. S. territories and possessions located outside the `` customs territory of the United States'' an opportunity to dispose of PCB waste when facilities that require EPA approval to manage PCB waste are not readily available. This rule is being promulgated in the public interest to ensure equitable treatment among different areas within the United States and adequate protection of health and the environment throughout the United States. This rule provides a mechanism for the disposal of PCB waste resulting from natural disasters (e. g., tropical storms, cyclones, typhoons and hurricanes), former use of U. S. territories and possessions for defense purposes, spills of PCBs and when PCB equipment has reached the end of its natural life span. VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65659 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules C. Paperwork Reduction Act (PRA) This regulatory action does not contain any information collection requirements that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U. S. C. 3501 et seq. D. Unfunded Mandates Reform Act (UMRA) Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104± 4, EPA has determined that this action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local or tribal governments, in the aggregate, or on the private sector in any one year. The UMRA requirements in sections 202, 204, and 205 do not apply to this rule, because this action does not contain any `` Federal mandates'' or impose any `` enforceable duty'' as defined by UMRA on StateTribal, or local governments or on the private sector. The requirements in section 203 do not apply because this rule does not contain any regulatory requirements that might significantly or uniquely affect small governments. E. Executive Order 13132 Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' are defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. '' This proposed rule does not have federalism implications, because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA­ approved facilities on the mainland of the United States. Thus, the requirements of section 6 of the Executive Order do not apply to this rule. F. Executive Order 13084 Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments `` to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities. '' This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose substantial direct compliance costs on such communities. It interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA­ approved facilities on the mainland of the United States. Accordingly, the requirements of section 3( b) of Executive Order 13084 do not apply to this rule. G. Executive Order 12898 Pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations (59 FR 7629, February 16, 1994), the Agency has considered environmental justice related issues with regard to the potential impacts of this action on the environmental and health conditions in low­ income and minority communities. EPA finds that the amendments in this proposed rule will reduce the risk to human health and the environment from exposure to PCBs, particularly in low­ income and minority communities. This proposed rule would allow PCB waste found in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA­ approved facilities on the mainland of the United States. H. Executive Order 13045 Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not apply to this rule, because it is not `` economically significant'' as defined under Executive Order 12866, and does not involve decisions on environmental health risks or safety risks that may disproportionately affect children. This proposed regulation would allow PCB waste in U. S. territories and possessions located outside of the customs territory of the U. S. to be disposed of in EPA­ approved facilities on the mainland of the United States. Therefore, the disposal of PCB waste will occur where children are either not present or not permitted, and the disposal activity will pose no special risks to children. Also, the rule will prevent exposure of children in U. S. territories and possessions to PCBs that might result from improper storage or disposal of PCB waste. I. National Technology Transfer and Advancement Act (NTTAA) This regulatory action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104± 113, section 12( d) (15 U. S. C. 272 note). J. Executive Order 12630 EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the `` Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the Executive Order. K. Executive Order 12778 In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2 65660 Federal Register / Vol. 65, No. 212 / Wednesday, November 1, 2000 / Proposed Rules List of Subjects in 40 CFR Part 761 Environmental protection, Hazardous substances, Labeling, Polychlorinated Biphenyls (PCBs), Recordkeeping and reporting requirements. Dated: October 24, 2000. Carol M. Browner, Administrator. Therefore, 40 CFR chapter I, part 761 is proposed to be amended as follows: PART 761Ð[ AMENDED] 1. The authority citation for part 761 will continue to read as follows: Authority: 15 U. S. C. 2605, 2607, 2611, 2614, and 2616. 2. Section 761.99 is amended by adding paragraph (c) to read as follows: §761.99 Other transboundary shipments. * * * * * (c) PCB waste transported from any State to any other State for disposal, regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCB waste or the PCBs from which the waste was derived were present in the United States on January 1, 1979, and have remained within the United States since that date. [FR Doc 00± 27971 Filed 10± 26± 00; 4: 34 p. m.] BILLING CODE 6560± 50± S VerDate 11< MAY> 2000 13: 47 Oct 31, 2000 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 E:\ FR\ FM\ 01NOP2. SGM pfrm03 PsN: 01NOP2

epa

2024-06-07T20:31:45.648546

regulations

EPA-HQ-OPPT-2002-0013-0009

Proposed Rule

Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U.S. Territories Outside the Customs Territory of the United States; Final Rule

Friday, March 30, 2001 Part II Environmental Protection Agency 40 CFR Part 761 Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U. S. Territories Outside the Customs Territory of the United States; Final Rule VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17468 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 761 [OPPTS– 66020A; FRL– 6764– 9] Polychlorinated Biphenyls (PCB's); Return of PCB Waste from U. S. Territories Outside the Customs Territory of the United States AGENCY: Environmental Protection Agency (EPA). ACTION: Final Rule. SUMMARY: EPA is amending its rules in order to clarify that PCB waste in U. S. territories and possessions outside the customs territory of the United States may be moved to the customs territory of the United States for proper disposal. This rule interprets the prohibition on the manufacture of PCBs at Section 6( e) of the Toxic Substances Control Act (TSCA) to allow the movement of most PCB waste among any States of the United States for the purpose of disposal because such movement is not considered `` import'' for purposes of the definition of `` manufacture'' as that term is used in TSCA section 6( e)( 3). This interpretation will allow U. S. territories and possessions which fall outside of the definition of `` customs territory of the United States'' to dispose of their PCB waste in the mainland of the United States where facilities are available that can properly dispose of PCB waste. Thus, this rule would ensure that a safe and viable mechanism exists for the protection of health and the environment for those citizens in areas of the United States where facilities are not available for the proper management and disposal of PCB waste. Because disposal of these wastes may occur only at approved facilities, no unreasonable risks to health or the environment on the mainland United States should be created by this rule. DATES: This rule shall become effective April 30, 2001. This rule shall be promulgated for purposes of judicial review at 1 p. m. eastern standard time on April 13, 2001 (see 40 CFR 23.5, 59 FR 7271). FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics (7408), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: 202– 554– 1404; e­ mail address: TSCA­ Hotline@ epa. gov. For technical information contact: Peggy Reynolds, OPPT/ NPCD, 7404, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202– 260– 3965; fax number: 202– 260– 1724; e­ mail address: reynolds. peggy@ epa. gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are in a U. S. territory or possession outside of the customs territory of the United States, and you manufacture, process, distribute in commerce, use, or dispose of PCBs. Examples of such territories and possessions are Guam, American Samoa, the Commonwealth of the Northern Mariana Islands (CNMI), and the U. S. Virgin Islands. Potentially affected entities may include, but are not limited to: Types of entities NAICS codes Examples of potentially affected entities Crude Petroleum and Natural Gas Extraction 211111 Facilities that own electrical equipment containing PCBs Electric Power Generation; Transmission and Distribution 2211 Facilities that own electrical equipment containing PCBs Food Manufacturing 311 Facilities that own electrical equipment containing PCBs Petroleum and Coal Products Manufacturing 324 Facilities that own electrical equipment containing PCBs Chemical Manufacturing 325 Facilities that own electrical equipment containing PCBs Primary Metal Manufacturing 331 Facilities that own electrical equipment containing PCBs Waste Treatment and Disposal 5622 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Materials Recovery Facilities 56292 Facilities that own electrical equipment containing PCBs. Entities that process and distribute PCB waste Public Administration 92 Agencies that own electrical equipment containing PCBs This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR part 761. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed in the FOR FURTHER INFORMATION CONTACT section. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? 1. Electronically. You may obtain electronic copies of this document and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov. To access this document, on the Home Page select `` Laws and Regulations'' `` Regulations and Proposed Rules, '' and then look up the entry for this document under the Federal Register— Environmental Documents. You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. Information about the Office of Prevention, Pesticides and Toxic Substances (OPPTS) and OPPTS related programs is available from http:// www. epa. gov/ internet/ oppts/. If you want additional information about EPA's PCB regulations at 40 CFR part 761, go to http:// www. epa. gov/ pcb. 2. In person. The Agency has established an official record for this action under docket control number OPPTS– 66020A. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information (CBI). This official VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17469 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, Northeast Mall, Rm. B– 607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from 12 noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260– 7099. II. Background A. What Action is the Agency Taking? EPA is amending the disposal regulations at 40 CFR 761.99 to allow certain PCB waste located anywhere in the United States, including the territories and possessions of the United States that are not inside the customs territory of the United States (hereafter `` territories and possessions''), to be moved to any area within the United States for disposal. For purposes of the ban on manufacturing PCBs under TSCA section 6( e)( 3), this rule clarifies that such movement is not considered `` import. '' B. What is the Agency's Authority for Taking this Action? EPA is taking this action to clarify its interpretation of the TSCA provisions relating to the manufacture of PCBs as an exercise of the Agency's inherent authority to issue regulations interpreting the statutes it administers. As a result, the Agency has not made a formal finding of `` no unreasonable risk'' for this regulation as would be required for a regulation that is issued under section 6( e) of TSCA. This regulation codifies EPA's interpretation of an undefined term, `` import, '' in the definition of `` manufacture'' under section 3( 7) of TSCA, for purposes of section 6( e)( 3) of TSCA. EPA's definition of the term `` import'' for all other purposes under TSCA is not affected. C. Why is the Agency Taking This Action? Under section 6( e) of the Toxic Substances Control Act (TSCA), 15 U. S. C. 2605( e), and implementing regulations at 40 CFR part 761, the manufacture, processing, and distribution in commerce of PCBs are banned unless EPA issues a regulatory exemption to the ban. The ban on manufacture of PCBs was designed to prevent the creation or introduction to the United States of new PCBs, and it has been largely successful. Use of PCBs is banned except in a totally enclosed manner or as authorized by rule based on a finding that the use will not pose an unreasonable risk to human health or the environment. Disposal of PCBs is strictly controlled to minimize release to the environment. By enacting TSCA section 6( e), Congress established a presumption that PCBs pose an unreasonable risk of injury to health and the environment. See, Central and Southwest Services, et al. v. EPA, 220 F. 3d 683, 688 (5th Cir. 2000). Before the statutory ban was enacted in 1976, PCBs were widely used in industrial applications, particularly as insulating fluids in electrical equipment. Utilities and other industries lawfully manufactured, sold, and used items such as PCB electrical equipment and hydraulic or heat transfer equipment. After TSCA's general bans on manufacture, processing, distribution in commerce, and use of such items went into effect, EPA authorized the continued use of much of this equipment subject to conditions that protect against an unreasonable risk to health or the environment from the PCBs in the equipment. As these items reach the end of their useful lives, the owners are responsible for disposing of them following the stringent requirements of 40 CFR part 761. Any PCBs that are released from the equipment also must be disposed of following these requirements. PCBs and PCB waste in the territories and possessions pose an especially great environmental threat. The territories and possessions have no permitted commercial PCB disposal facilities, so PCB waste is accumulated in long­ term storage. Many of the territories and possessions are subject to frequent typhoons and earthquakes, which can severely damage storage areas and other buildings. PCBs and PCB waste in storage in these areas, therefore, may present a significantly greater risk to human health and the environment than PCBs stored in the mainland United States (Ref. 8). Because most of the population of the territories and possessions tend to be made up of minority or low­ income communities, these risks present important environmental justice concerns. EPA has a strong commitment to ensuring the protection of these communities by mitigating their risk of exposure to PCBs to the greatest extent possible under the law. For the reasons mentioned above and as discussed more fully in the preamble to the proposed rule (65 FR 65656– 65658), EPA proposed to amend its regulations to allow the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14). This movement would be allowed regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs or the PCB waste were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and have remained within the United States since then. EPA does not consider these movements to be imports subject to the ban on manufacturing under TSCA sections 3( 7) and 6( e)( 3). III. Summary of the Final Action In this action EPA is finalizing the rule as proposed. A. What Comments Supported the Proposed Rule? The Agency received 13 sets of comments from individuals in the environmental services and other U. S. industry, the U. S. Congress, and the Department of Defense, as well as representatives of some of the U. S. territories, and an environmental group. With one exception, all of the comments were in favor of the proposed action for the reasons that were cited in the preamble to the proposed rule (65 FR 65656– 65658). In addition, many of the comments provide examples of situations in the U. S. territories which exist as a result of the previous interpretation of the statute. (The following discussions include a parenthetical reference to the docket number that was assigned by EPA to the comment.) Several comments cited the burden that PCB waste cleanup activities create for inhabitants of U. S. territories that are not located within the customs territory of the United States. One commenter (C1– 007) stated that millions of dollars are spent annually by the U. S. armed forces to clean up and remediate formerly used military dump sites which existed during World War II. PCBs and other contaminants (e. g., mustard gas and trichloroethylene (TCE)) that were buried on Guam are evident in the drinking water which comes from the island's sole source aquifer. In addition, efforts are currently underway to clean up PCBs from an old military power plant located in the village of Mong Mong, Guam, that have migrated into the Agana Swamp and adjacent farmed areas, which serve as a source of catfish, fruit and vegetables VerDate 11< MAY> 2000 17: 05 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm11 PsN: 30MRR2 17470 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations that have been consumed by the village for many years. In describing the lack of disposal options that are available to inhabitants of Guam, the commenter cited unfair restrictions that allowed the U. S. Government to transport PCBs to Guam, but limits their return to the U. S. mainland for proper disposal. In another set of comments (C1– 009), the commenter related how PCB capacitors were sold to the U. S. military in Texas and were brought to the village of Tanapag in the Commonwealth of the Northern Mariana Islands, where the capacitors were abandoned about 40 years ago. Contaminated soil cleanup continues today. Efforts by the U. S. Army Corps of Engineers to dispose of PCBs onsite have resulted in the collection of contaminated soil in a single location within the village where the soil is exposed to rain and wind. According to the commenter, village residents have excess body loads of PCBs that have been verified by the Agency for Toxic Substances and Disease Registry (ATSDR), and EPA is currently conducting an evaluation of the degree of contamination of ground water and food sources used by the village. This commenter mentioned several difficulties that are associated with PCB contamination in U. S. territories. Specific difficulties include: a growing population and limited land which make it impossible to designate a location for hazardous waste disposal; there are no alternatives when the single source for water is contaminated; severe tropical storms, earthquakes or volcanic events, which are characteristic of the islands, increase the likelihood of the spread of PCB contamination; and subsistence economies are at risk by contamination and replacement sources of food may be unavailable or unaffordable. Although this commenter (C1– 009) recognizes that the shipment of waste to the U. S. mainland is not without risk, he stated that leaving the waste in place is inconsistent with national goals of protecting human populations and the environment from exposure to PCBs. A similar concern was repeated in another set of comments (C1– 003) which stated that natural events can easily spread PCBs throughout the local environments to the detriment of ecosystems on which human, animal and plant life depend. Another commenter (C1– 013) pointed out that U. S. territories rely on tourism for income, and as such, it is important to protect their ecosystems and natural resources. Since U. S. territories have sensitive ecosystems, limited natural resources and no TSCA facilities for proper treatment and disposal of PCB wastes, the commenter stated these areas face increased risk of costly, longterm PCB environmental and human health issues in the future. Another set of comments (C1– 006) expressed support for the rule because there are no viable disposal options in the territories and the rule will require disposal to be conducted in strict compliance with the TSCA PCB regulations. This commenter believes it would be more protective to destroy wastes than to store the waste in areas of frequent hurricanes and earthquakes. Along those lines, another commenter (C1– 007) believes it is in the interest of the island of Guam to ensure PCBs brought to Guam from the United States are returned to the United States for proper disposal. Still another commenter (C1– 009) applauded EPA's efforts to correct the illogical distinction which currently exists and cited the disparity in EPA's 1984 policy which allowed U. S. manufactured PCBs to be returned to the United States as long as that waste remained under the control of the U. S. Government, but that same waste when found in U. S. territories could not be returned to the mainland for disposal. In this commenter's opinion, populations and environments located in U. S. territories were being treated with less care than those populations and environments that are outside the United States. One commenter (C1– 010) stated that the proposed rule properly recognizes that TSCA specifically defines territories or possessions of the United States, such as Guam, as `` States'' and reiterates that the term `` United States'' means all of the States (see Sec. 3( 13) and 3( 14)). Another commenter (C1– 001) stated the previous interpretation prohibited U. S. territories from shipping PCB waste to approved disposal sites in compliance with applicable regulations and that the earlier interpretation has had an adverse effect on health and environment. These (C1– 001, C1– 003, C1– 006, C1– 007, C1– 009, C1– 010, C1– 013) and other comments (C1– 002, C1– 008, C1– 011) all support promulgating the rule as proposed. B. What Comments Opposed the Proposed Rule? 1. Legal authority. In comments submitted during the comment period (C1– 012) and in a follow­ up letter (C1– 014), a commenter argued that the rule violates TSCA section 6( e)( 3), which bans the manufacture of PCBs unless EPA issues a regulatory exemption to the ban (C1– 012). TSCA section 3( 7) defines the term `` manufacture'' to include `` import into the customs territory of the United States. '' The commenter cited the decision in Sierra Club v. EPA, 118 F. 3d 1324 (9th Cir. 1997), which held that, in banning manufacture of PCBs after January 1, 1979, Congress had also banned all import of PCBs after that date, because `` manufacture'' is defined to include import. The commenter viewed this rule as authorizing PCB waste to be imported into the customs territory of the United States, in violation of TSCA and the decision of the U. S. Court of Appeals for the Ninth Circuit. First, the commenter argued that EPA may not ignore the statutory definition of `` manufacture, '' which includes `` import into the customs territory of the United States. '' This rule does not attempt to avoid the definition of `` manufacture. '' Instead, it clarifies what EPA will consider to be an `` import'' of PCBs into the customs territory of the United States for the purposes of that definition. While TSCA defines the term `` manufacture, '' it does not define the term `` import. '' The commenter believes that the phrase `` into the customs territory of the United States'' defines the word `` import, '' rather than modifies it. EPA disagrees with this interpretation. In this rule, EPA interprets the movement of certain PCB waste from areas within the United States but outside the customs territory of the United States to disposal facilities inside the customs territory of the United States not to be an `` import'' for purposes of TSCA section 6( e). EPA believes that `` import'' in this context applies to the initial introduction of particular PCBs into the United States (and the jurisdiction of TSCA), not the movement across the border of the customs territory of previously manufactured PCBs that have never left the regulatory jurisdiction of TSCA. For example, under TSCA, Guam is part of the United States, but it is outside the customs territory of the United States. Under this rule, it would not be an `` import'' of PCBs to transport PCB waste that was present in Guam on January 1, 1979, and has remained in Guam since that date, to an area inside the customs territory of the United States for disposal. Since this transport would not be an `` import, '' it would not be an act of `` manufacture'' which is banned under TSCA section 6( e)( 3) and the Sierra Club decision. The definition of `` manufacture'' therefore is not a bar to the amendments in this rule. Second, the commenter believed EPA ignored the definition of `` manufacture, '' which includes `` import into the customs territory of the United States [emphasis added] '' when it read sections 3( 13) and 3( 14) of TSCA as defining the `` United States'' to encompass territories and possessions of VerDate 11< MAY> 2000 17: 05 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm11 PsN: 30MRR2 17471 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations the United States outside the customs territory of the United States. EPA disagrees with this comment. Under TSCA section 3( 14), the term `` United States'' means `` all of the States. '' Under TSCA section 3( 13), `` State'' means `` any State of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the Canal Zone, American Samoa, the Northern Mariana Islands, or any other territory or possession of the United States. '' Thus, the requirements of TSCA apply to PCBs in areas inside the customs territory of the United States (the 50 States, the District of Columbia, and Puerto Rico) as well as to areas outside the customs territory of the United States (the remaining territories and possessions). Persons who manage PCBs in areas outside the customs territory of the United States must manage and dispose of them in compliance with all of the regulations at 40 CFR part 761, yet they often lack adequate local storage and disposal facilities. As the commenter points out, in banning manufacture of PCBs, TSCA bans the import of PCBs into the customs territory. However, in this rule, EPA interprets the movement of certain PCB waste from areas within the United States (and therefore subject to TSCA) but outside the customs territory of the United States, to disposal facilities inside the customs territory of the United States not to be an `` import'' for purposes of the definition of `` manufacture'' as it applies to TSCA section 6( e) as long as the PCBs in the waste were present in the United States as the result of legal manufacture (i. e., manufacture prior to January 1, 1979) and have remained in the United States since that time. In doing so, EPA is not attempting to avoid that portion of the definition of `` manufacture'' that prohibits `` import into the customs territory of the United States. '' Third, the commenter argues that EPA cannot support this rule by reference to a long­ standing policy that treats transboundary movement of certain PCB waste controlled by the U. S. Government as neither import nor export. In the preamble to the proposed rule, EPA compared the interpretation of the term `` import'' proposed at § 761.99( c) to its view of the terms `` import'' and `` export'' under that prior policy. The policy provides that PCBs purchased or procured in the United States by the Federal government, taken overseas for use in U. S. Government facilities, and that have remained under the control and jurisdiction of the U. S. Government, may be subsequently returned to the United States for disposal in an approved facility without violating TSCA's bans on import and export of PCBs. EPA did not refer to this policy as the basis for the proposed revisions to § 761.99( c). This rule is based on EPA's interpretation of the undefined statutory term `` import'' for purposes of the definition of `` manufacture'' as used in TSCA section 6( e)( 3). Rather, EPA referred to that policy, as well as the other provisions of 40 CFR § 761.99, to illustrate the point that not every movement of PCBs across the border of the customs territory constitutes an `` import'' per se for purposes of TSCA section 6( e)( 3). Finally, the commenter pointed out that EPA did not propose to amend its regulatory definition of `` manufacture. '' That term is defined in 40 CFR 761.3 to mean `` to produce, manufacture, or import into the customs territory of the United States [emphasis added]. '' The commenter pointed out that, under this definition, it is not unlawful to import PCBs from a foreign country into a territory or possession outside the customs territory of the United States. For example, PCB waste could still lawfully move from Japan to Guam. The commenter suggested EPA amend this definition by deleting the words `` customs territory of. '' This would bar import of PCBs into any territory or possession of the United States, and would effectuate EPA's stated goal that `` the prohibitions and restrictions of PCBs under TSCA section 6( e) and its implementing regulations protect not only U. S. citizens in the 50 States, but U. S. citizens in all the territories and possessions of the United States, '' (65 FR 65656). Moreover, the commenter opined that this change would prevent the territories and possessions from becoming a conduit of PCB waste from foreign countries to disposal facilities on the U. S. mainland. This rule does not allow the territories and possessions to become a conduit to disposal facilities in the U. S. mainland for PCB waste generated in foreign countries. This rule allows PCBs that have been in the United States since January 1, 1979, including PCB waste in areas outside the customs territory of the United States, to be moved to the U. S. mainland for disposal. The rule does not apply to PCBs that arrived in the United States after that. The commenter is correct that, under the current definition of `` manufacture, '' it is not unlawful for foreign PCBs to enter territories and possessions outside the customs territory of the United States. However, the rule does not allow PCBs in the U. S. territories and possessions that entered those areas after January 1, 1979, to be transported to the U. S. mainland for disposal. The territories and possessions therefore cannot become a conduit of PCB waste from foreign countries to disposal facilities on the U. S. mainland. EPA has not adopted the commenter's suggestion to amend the regulatory definition of `` manufacture. '' First, the regulatory definition of `` manufacture'' at 40 CFR 761.3 mirrors the statutory definition in TSCA section 3( 7). Because the statutory definition would remain intact, amending the regulatory definition would not have the effect the commenter anticipates. In addition, the result the commenter seeks by the amendment is outside the scope of the proposed rule. The rule as proposed would not have prevented foreign PCBs from entering areas of the United States that are outside the customs territory, and was not intended to. 2. Risks posed by transportation of PCB waste. A commenter expressed concern about the risks to health and the environment of transporting PCB waste from the territories and possessions to the U. S. mainland for disposal (C1– 012 and C1– 014). The commenter cited U. S. Department of Transportation (DOT) data on highway incidents involving PCBs and other hazardous materials that resulted in death, injury, or property damage. The commenter also pointed out the risk of accidents during transoceanic shipments of PCB waste. The commenter suggested that disposal technology be transported to the waste, rather than transporting the waste to the disposal site. (See EPA's response to this comment in Unit III. B. 3. below.) PCBs (both liquid and solid) are subject to DOT regulations that apply to transport of hazardous materials. The Hazardous Materials Regulations (HMR), 49 CFR parts 171 through 180, apply to materials, or groups or classes of materials, that the Secretary of Transportation has determined may pose an unreasonable risk to health and safety or property when transported in commerce in a particular amount and form. The HMR are issued for the safe transportation of these materials in interstate, intrastate, and foreign commerce by aircraft, railcars, vessels, and any motor vehicles. The HMR address hazard communication, packaging requirements, operational rules, and training. These rules already apply to transoceanic shipment of PCBs between areas inside the customs territory but not in the mainland United States and disposal facilities on the mainland. EPA's intent for this rule is to put citizens in the territories and possessions in the same regulatory position as citizens in Hawaii or Puerto VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17472 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations Rico with respect to disposal of PCBs. To the extent the commenter has concerns about the adequacy of those other rules, such concerns are outside the scope of this rulemaking. As the commenter points out, incidents involving transportation of PCBs and other hazardous materials do occur. Therefore, transporters of PCBs must be familiar with the HMR as they apply to PCBs, and are legally obligated to comply with those provisions as applicable. Compliance with the HMR is the best way to prevent transportation incidents to the greatest extent practicable. Additional information, including information on enforcement and training, is available at http:// hazmat. dot. gov/. The commenter was particularly concerned about a tanker spill of PCBs and the effect such a spill would have in biologically rich coastal waters, or near areas of high human population, croplands, water supplies, critical wildlife habitat, ports, or fisheries. Although a comprehensive inventory of the PCB waste in the territories and possessions is not available, information developed by EPA Region IX did not identify any appreciable quantities of liquid PCB waste that would be likely to be disposed of in U. S. mainland facilities. The PCB waste Region IX identified is made up of approximately 10,000 cubic yards of soil, 13 transformers (one estimated to contain up to 310 gallons of liquid PCBs), one 55– gallon drum of personal protective equipment, 800 fluorescent lamp ballasts packed in four 55– gallon drums, and 41 drums of sludge and soil from leaking transformers (Ref. 8). Therefore, EPA believes it is unlikely that any territory or possession would ever generate enough liquid PCB waste to fill a tanker ship bound for the mainland United States. As noted above, transporters of PCBs must be familiar with the HMR as they apply to PCBs, and are legally obligated to comply with those provisions as applicable. 3. Risks posed by disposal of PCB waste. The commenter also opposed the proposed rule on the ground that facilities that treat and dispose of PCBs have records of spills, environmental violations, and imposed penalties, and pose risks to health and the environment that are `` not negligible'' (C1– 012 and C1– 014). The commenter also noted that dioxin­ like products of incomplete combustion can form from unburned PCBs released during incineration. These products of incomplete combustion can become widely dispersed in the environment and can bioaccumulate in the food chain. The commenter pointed out that innovative, alternative technologies are available as alternatives to incineration. The commenter suggested that these innovative, alternative technologies be used to treat the waste on­ site in the territories and possessions, rather than sending the waste to the mainland United States for incineration. PCB waste covered by this rule must be managed in accordance with the disposal regulations at 40 CFR part 761, which were promulgated under TSCA's no unreasonable risk standard. These regulations allow disposal of PCB waste in TSCA­ approved incinerators (see § 761.70). As part of its approval process for PCB incinerators, EPA conducts a technical assessment of the facility's technology and procedures to ensure that operation of the facility will not present an unreasonable risk of injury to health or the environment. EPA's technical assessment establishes limits on the PCB concentration of the waste the facility may dispose of, and on the waste feedrate per hour, based on a demonstration test. The operating conditions of the approval are set so that they do not exceed the values established in the technical assessment. The approval also requires the facility to meet the regulatory standards set out in 40 CFR part 761, subpart D as to destruction and removal efficiency and PCB concentration of the facility's waste products. However, thermal destruction is not the only disposal option available under EPA's regulations. Depending on the form of the waste and its PCB concentration, other disposal options include TSCA­ approved landfills (see § 761.75), decontamination (§ 761.79), and disposal in certain landfills permitted in accordance with the Resource Conservation and Recovery Act (RCRA) (see § 761.61( a) and § 761.62( a) and (b)). In addition, the PCB regulations allow EPA Regional Administrators to grant risk­ based approvals for alternative disposal and decontamination methods under § 761.60( e), § 761.61( c), § 761.62( c), and § 761.79( h). In 1994, the last year for which data have been compiled, 842,584,000 kilograms of PCB waste were disposed of in the United States using all technologies available at that time (Ref. 22). EPA supports the commenter's suggestion that generators and disposers of PCB waste now located in the territories and possessions examine innovative, alternative disposal technologies. Some of these technologies are commercially available and may offer further risk reductions over mainland disposal in an incinerator or TSCA landfill. EPA recently released a report reviewing several of these alternative technologies, `` Potential Applicability of Assembled Chemical Weapons Assessment Technologies to RCRA Waste Streams and Contaminated Media, '' August 2000. This report is available from EPA's web site at www. epa. gov/ tio or at www. clu­ in. org., or from EPA's National Service Center for Environmental Publications, (800) 490– 9198. Information about these innovative, alternative technologies, including mobile technologies that can be taken to the locations where PCB wastes are stored, is also available to local government officials and members of the public through Regional PCB Coordinators. Anyone intending to dispose of PCBs using an alternative technology must confirm that it is consistent with EPA's regulations, and that a TSCA PCB disposal approval has been issued that is specific to the waste and technology that will be used. EPA acknowledges that, because PCBs are toxic, there are risks associated with managing them that cannot be completely prevented. Accidents can occur during storage and disposal, as can lapses in compliance. This is true of conventional disposal technologies as well as of innovative, alternative technologies. EPA's PCB regulations and facility­ specific approvals provide regulatory and enforcement structures for reducing the risks inherent in managing and disposing of PCBs. Moreover, it is long­ standing EPA policy that the benefits of permanently removing PCBs from the environment through proper disposal outweigh the risks of the disposal processes themselves (see EPA's Import for Disposal Rule, 61 FR 11096, 11098 (March 18, 1996) (FRL– 5354– 8)). These benefits may be greater with regard to the territories and possessions, where facilities for proper management and disposal are more limited than on the U. S. mainland, and the risks of release to the environment are greater. As noted above, EPA's intent for this rule is to put citizens in the territories and possessions in the same regulatory position as citizens in Hawaii or Puerto Rico with respect to disposal of PCBs. To the extent the commenter has concerns about the adequacy of the PCB disposal regulations, such concerns are outside the scope of this rulemaking. 4. Environmental justice concerns. A commenter questioned EPA's conclusion in the preamble to the proposal that this rule presents no environmental justice concerns, and that it will reduce risks to health and the environment from PCBs (C1– 012 and C1– 014). The commenter believed VerDate 11< MAY> 2000 17: 05 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm11 PsN: 30MRR2 17473 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations EPA had disregarded the environmental risks that low­ income and minority communities in the territories may face due to transportation of PCB wastes. The commenter also believed EPA's conclusion ignored increased exposure to PCBs and attendant health risks that will be borne by low­ income and minority communities surrounding the treatment and disposal facilities in the United States where the wastes will be sent. Pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Communities (59 FR 7629, February 16, 1994), the Agency has considered environmental justice related issues with regard to the potential impacts of this action on the environmental and health conditions in low­ income and minority communities. EPA finds that the amendments in this final rule will reduce the risk to human health and the environment from exposure to PCBs in low­ income and minority communities in the U. S. territories and possessions located outside of the customs territory of the United States because it will allow PCB waste found there to be disposed of in EPA­ approved facilities on the mainland of the United States. Executive Order 12898 directs Federal agencies to identify and address `` disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minority populations and lowincome populations in the United States and its territories and possessions. . .'' EPA's judgment at the time of the proposed rule was that the rule would benefit low­ income and minority populations in the territories and possessions because it would allow PCB waste to be removed from those areas for permanent disposal. Comments from the territories and possessions support that judgment. The Resident Representative to the United States from the Commonwealth of the Northern Mariana Islands supported the proposed rule (C1– 009). The commenter noted the risks to residents of the village of Tanapag from soil contaminated by abandoned PCB capacitors. As discussed in Unit III. A., members of the village community have been verified by the ATSDR to have excess body loads of PCBs. EPA is currently evaluating the degree of contamination of ground water and food sources used by the village. An attempted remediation of the contaminated soil using thermal desorption has not been completed, and contaminated soils are stockpiled within the village, exposed to sun and rain. The commenter also noted the difficulty of managing hazardous waste on a small tropical island with limited land resources, a single source of drinking water, and frequent tropical storms, earthquakes, and volcanos. The commenter further observed that economic factors for the islands are problematic. The island may be exposed to a variety of toxic wastes due to global commerce, requiring a multitude of disposal technologies, but for a small quantity of each type of waste. Thus, economies of scale in establishing and operating disposal facilities are lacking. Furthermore, the subsistence economies on which some island people rely are put at risk by contamination, and replacement sources of food may be unavailable or unaffordable. The commenter concluded, `` Shipment of PCB wastes from the U. S. territories to the U. S. customs territory is not without risk; but the alternative of leaving the wastes where they are has proven to have results inconsistent with the goals of our national policy of protecting the environment and human populations from exposure to PCBs. '' EPA has issued an Order under RCRA to the Army Corps of Engineers to clean up the Tanapag Village contamination. The Chairperson of the Committee on Natural Resources of the Senate of Guam also wrote in favor of the proposed rule (C1– 007). The senator pointed out that Guam is a small island, prone to natural disasters such as typhoons and earthquakes. The senator also noted that the island's growing population and limited land area will make it difficult if not impossible to designate any part of the island for hazardous waste disposal. The population of Guam is becoming more concerned about the health and environmental effects PCBs may have on the people and the island. A current case on Guam involves PCBs that leaked into the largest wetland on Guam from a Navy power plant. The Navy is currently assessing the effect PCBs may have on the aquatic life in the wetland, such as catfish, and the fruits and vegetables that have been farmed in the area and consumed by island residents for many years. A number of residents in the local village are concerned that adverse health effects such as cancer may have occurred because of living next to the power plant or consuming food that was produced in the area. The senator concluded: To insure the health and welfare of our island residents, it is in the interest of the island to insure that toxins such as PCBs that have been brought into Guam from U. S. destinations be returned for proper disposal. The U. S. territories, such as Guam, should not be unfairly burdened by restrictions that allowed for the transportation of such a toxin from the United States to Guam, but limits the return to the U. S. mainland from Guam for proper disposal. Our islands and our limited land resources and extenuating environmental conditions should be given fair consideration in addressing USEPA's proposed rule for proper disposal facilities in the U. S. mainland. The Administrator of the Guam Environmental Protection Agency commented that PCBs from several cleanups are in indefinite storage on Guam (C1– 008). These storage areas are subject to damage by frequent typhoons and earthquakes. PCBs that are released can present an exposure risk to Guam residents through consumption of contaminated fish, which is a subsistence food for Guam residents. Even a small amount seeping into the groundwater could eliminate Guam's sole aquifer as a source of drinking water. The commenter stated that the proposed rule would remove a tremendous burden on Guam and ensure that a safe and viable mechanism existed for the protection of health and the environment for residents on Guam where disposal facilities are not available. A Member of Congress from Guam supported the proposed rule, commenting that it would help to eliminate the threat to the health and welfare of Guam and other U. S. territories communities from PCB waste (C1– 002). A Member of Congress from American Samoa commented that the proposed rule was a common sense solution to the problem of storage of PCBs in the territories, noting that hurricanes, typhoons, and earthquakes in the territories can spread PCBs throughout the local environments on which humans, animals, and plant life depend (C1– 003). Finally, a long­ term resident of Guam who is also an environmental professional engaged in environmental consulting services on Guam and in the Commonwealth of the Northern Mariana Islands supported the proposed rule and commented that EPA's prior policy of prohibiting PCBs in the territories and possessions from being shipped to an EPA­ approved disposal site was not protective of health and the environment (C1– 001). EPA believes that the interpretation in this final rule will result in reduced risk to health and the environment from exposure to PCBs in low­ income and minority communities in the U. S. territories and possessions. This rule will allow most PCB waste found in those territories and possessions to be disposed of in EPA­ approved facilities on the mainland of the United States. VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17474 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations While the rule could result in some short­ term risk from transportation of the waste, EPA believes that that risk is outweighed by the elimination of the health and environmental concerns in the U. S. territories and possessions over the long term that would be posed by continued storage of the waste. The commenter also asserted that the rule would adversely affect low­ income and minority populations who live near the disposal facilities in the United States where the waste would be disposed of by incineration (C1– 012). As part of its approval process for PCB incinerators, EPA conducts a technical assessment of the facility's technology and procedures to ensure that operation of the facility will not present an unreasonable risk of injury to health or the environment. EPA's technical assessment establishes limits on the PCB concentration of the waste the facility may dispose of, and on the waste feedrate per hour, based on a demonstration test. The operating conditions of the approval are set so that they do not exceed the values established in the technical assessment. The approval also requires the facility to meet the regulatory standards set out in 40 CFR part 761, subpart D as to destruction and removal efficiency and PCB concentration of the facility's waste products. EPA conducts a similar analysis when permitting other types of PCB disposal facilities, as well, and determines that activities at the facility will not pose an unreasonable risk of injury to health or the environment. Additionally, the approval process for PCB disposal facilities is subject to E. O. 12898. Therefore, EPA is also required to consider the potential impacts of that action on the environmental and health conditions in low­ income and minority communities whenever a permit is approved. Therefore, as long as PCB waste from the U. S. territories and possessions is disposed of in accordance with a facility's approval, disposal of the waste will not produce risks greater than those calculated at the time the PCB disposal approval was issued, which EPA determined will not pose an unreasonable risk to the surrounding community. Disposal facilities permitted under TSCA must renew their permits periodically. The permit renewal process is open to public participation. Issues on siting of facilities, including environmental justice issues, can be raised as part of that process, and will be considered by EPA. As noted above, EPA's intent for this rule is to put citizens in the territories and possessions in the same regulatory position as citizens in Hawaii or Puerto Rico with respect to disposal of PCBs. To the extent the commenter has concerns about the adequacy of EPA's approval of specific PCB disposal facilities under TSCA, such concerns are outside the scope of this rulemaking, and can be addressed in the renewal process for those facilitlies' permits. 5. Non­ cancer health effects of PCBs. A commenter questioned the basis for the statement in the preamble to the proposed rule that `` PCBs cause significant ecological and human health effects, including cancer, neurotoxicity, reproductive and developmental toxicity, immune system suppression, liver damage, skin irritation, and endocrine disruption'' (C1– 011) (see 65 FR 65655, November 1, 2000)( FRL– 6750– 6). The commenter noted that the only reference for the statement was a report by EPA's Office of Research and Development, `` PCB Cancer DoseResponse Assessment and Application to Environmental Mixtures'' (Ref. 1). The commenter pointed out that that report addressed the carcinogenicity of PCBs, not their non­ cancer or ecological effects, and that EPA's Office of Research and Development is in the process of reassessing the non­ cancer effects of PCBs. The commenter referred to a literature review it has conducted on non­ cancer effects of PCBs, which was submitted for the Agency's consideration as part of EPA's reassessment of the effects of dioxin and related compounds (including co­ planar PCBs) (see 65 FR 59186, October 4, 2000) (FRL– 6880– 9). The literature review concludes that, except for certain oculodermal effects, PCBs do not contribute to adverse health effects in humans. EPA appreciates the commenter's contribution to the ongoing efforts elsewhere in the Agency to assess the health effects of PCBs. However, the preamble statement the commenter questions was included for background only, as this rule is not based on an assessment of the risks of PCBs. This rule clarifies EPA's interpretation of the TSCA provisions relating to the manufacture of PCBs as an exercise of the Agency's inherent authority to issue regulations interpreting the statutes it administers. As a result, the Agency has not made a formal finding of `` no unreasonable risk'' for this regulation as would be required for a regulation that is issued under section 6( e) of TSCA. This regulation codifies EPA's interpretation of an undefined term, `` import, '' in the definition of `` manufacture'' under section 3( 7) of TSCA, for purposes of section 6( e)( 3) of TSCA. All PCB wastes affected by this rule are subject to the current regulations at 40 CFR part 761, which were promulgated based on the standard of no unreasonable risk. C. What Other Comments Were Received on the Proposed Rule? The Agency also received comments that raised additional issues. 1. Broaden the scope of the rule. EPA received a request (C1– 004) to broaden the scope of the proposed rule to include both domestic­ and foreignmanufactured PCBs that have remained under the control of the U. S. Government. The Agency was also asked to consider submitted comments (C1– 005) as a petition for an exemption from the TSCA prohibitions to allow the import for disposal of U. S. manufactured PCBs that are located within the Western Hemisphere. (An exemption petition requires Agency action in the form of a separate rulemaking.) EPA cannot act favorably on either of these requests since they clearly fall outside of the scope of the proposed rule. The proposal was issued as an interpretive rule rather than a TSCA section 6( e) action; therefore, a formal finding of `` no unreasonable risk'' is not necessary. The legal basis for the proposed interpretive rule was that PCBs which were legally present anywhere in the United States when the ban took effect in 1979 should not be considered `` imported'' when they are moved to another place in the United States, regardless of whether the PCBs leave or enter the customs territory of the United States. EPA believes that `` import'' in this context applies to the initial introduction of particular PCBs into the United States (and the jurisdiction of TSCA), not to the movement across the border of the customs territory of previously manufactured PCBs that have never left the regulatory jurisdiction of TSCA. Therefore, foreign­ manufactured PCBs and U. S.­ manufactured PCBs that have been exported do not fit within the narrowly crafted interpretation of the proposed rule. An exemption remains a viable alternative for seeking Agency approval to import for disposal either foreign­ made PCBs or domestic­ made PCBs that have been exported from the United States. The appropriate means of obtaining a response from the Agency on those requests is to submit an exemption petition pursuant to section 6( e)( 3) of TSCA, following the procedures at 40 CFR 750.10. Exemptions may be granted for a period not to exceed 1 year, but only after the petitioner has demonstrated that the two statutory requirements have been met (i. e., there will be no unreasonable risk VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17475 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations of injury associated with the requested activity, and that good­ faith efforts have been made to find a substitute for the PCBs). Neither set of comments provided the level of detailed information that is necessary for the Administrator to act on a request for an exemption from the TSCA prohibitions. 2. Treatment of post­ January 1, 1979 wastes. EPA also received two inquiries regarding the applicability of the interpretive rule to post– 1979 PCB wastes. One set of comments (C1– 008) raised a concern that the proposed rule would not allow PCB wastes which arrived in U. S. territories after January 1, 1979, to be disposed of on the U. S. mainland. Another commenter (C1– 011) expressed a similar opinion and indicated there may be difficulty in demonstrating that PCBs were present in a U. S. territory or possession prior to January 1, 1979. The suggested solution was to allow importation for disposal of PCBs present in a territory or possession on the `` effective date of the proposed rule. '' These commenters apparently misunderstood the proposed rule. As discussed in the preamble to the proposed rule, in order to qualify for this regulation, the PCBs in the waste in question must have been present in the United States prior to 1979, not present in the territory or possession where they are now prior to that date (65 FR 65657). So long as the PCBs were lawfully manufactured in or imported into the United States prior to 1979, and never left the United States, the date on which they entered the territory or possession in question is irrelevant. Wastes that are covered by this rule may be sent to the U. S. mainland for disposal in accordance with the PCB disposal regulations. Any other PCB waste may not be imported to the U. S. mainland for disposal, unless an exemption under section 6( e)( 3) of TSCA has been obtained. Similarly, foreign PCB waste in a U. S. territory or possession may be exported to another country for disposal only when the TSCA exemption requirements, and all requirements of any relevant international agreement, have been satisfied. With respect to changing the date on which PCBs must have been in the United States in order to qualify for this regulation, EPA does not agree that using the date of the proposed rule would be appropriate. Part of the basis for this interpretive rule is that PCBs that are present in the United States when the ban on manufacturing went into effect and have remained in the United States since then should be managed in the same manner regardless of whether they are now present in a territory or possession, rather than within the customs territory of the United States. Therefore, using a threshold date other than January 1, 1979, would not be supported by the rationale for the proposed rule. D. What Does this Final Rule Do? As noted above, the territories and possessions are subject to all of TSCA's requirements. EPA is charged with implementing section 6( e) to protect the health and environment of all U. S. citizens, including the residents of the territories and possessions. To interpret the statute as prohibiting the movement of PCB waste from the territories and possessions to disposal facilities in the U. S. mainland puts the residents of the territories and possessions at a serious disadvantage compared to residents of areas that fall within the definition of the customs territory. Because there are no EPA­ approved commercial PCB storage or disposal facilities outside the customs territory, and because of the unique environmental conditions in the territories and possessions, the U. S. citizens of these areas are subject to a higher likelihood of exposure to PCBs, and thus potential for a higher risk of injury. EPA has determined that its previous interpretation of the definition of `` manufacture'' is not mandated by the language of TSCA, results in inequitable treatment among different areas within the United States, does not adequately protect health and the environment throughout the United States, and therefore is not in the public interest. EPA believes that use of the term `` import '' in the definition of `` manufacture'' was not intended to include the movement of PCB waste that has never been outside the United States or outside the regulatory control of TSCA (after enactment) from one area of the United States (the territories and possessions) to another area of the United States (the mainland) for disposal. There is an obvious distinction between that type of movement and the introduction of a chemical substance into the customs territory of the United States from a foreign country. This latter category results in the introduction of a substance in the United States that was not there before, and is much more analogous to the manufacture of a new chemical substance in the United States. Therefore, EPA is interpreting the movement of certain PCB waste from the territories and possessions into the customs territory of the United States for disposal not to be a `` manufacture'' subject to the ban set forth in TSCA section 6( e). This interpretive rule allows the movement of PCB waste for disposal among any States of the United States, as defined in TSCA sections 3( 13) and 3( 14), regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCBs in the waste were present in the United States on January 1, 1979, when the ban on manufacturing took effect, and has remained within the United States since that time. This rule will allow PCB waste that was present in the territories and possessions at the time TSCA's ban on manufacturing took effect, and that remained within the territories and possessions since that date, to be stored and disposed of in any facility in the United States that meets the requirements of 40 CFR part 761, subpart D. It also allows PCBs that were present in the territories and possessions at the time TSCA's bans took effect, but were not designated as waste until after that date, to be stored and disposed of in any subpart D facility in the United States, as long as the PCBs and PCB waste had remained in the United States. Finally, this interpretive rule allows PCBs or PCB wastes that were transferred from an area in the United States that is outside the territories and possessions, but that was moved to a territory or possession after January 1, 1979, and that has never left the United States, to be stored and disposed of in any subpart D facility in the United States. EPA does not consider movement of any of these wastes to the customs territory of the United States to be `` manufacture'' as that term is defined in TSCA and therefore does not consider it subject to the ban on manufacturing under TSCA section 6( e). This final rule applies to PCB waste in the territories and possessions provided that the PCBs in the waste are there as the result of conduct that was legal at the time it occurred (for example, PCB materials that were brought to the territories before TSCA's ban on distribution in commerce became effective), and have been subject to regulation under TSCA since that time. This would include PCB equipment that was lawfully in use in one of the States, that was transferred to a territory or possession for continued lawful use, and that reached the end of its useful life and became subject to disposal while in the territory or possession. This final rule does not allow disposal in the United States of PCBs transported to the territories and possessions from foreign countries after the effective date of the ban on manufacture in TSCA section 6( e)( 3). The purpose of this rule VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17476 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations is to ensure that all U. S. PCB waste can be disposed of in compliance with the requirements of TSCA section 6( e) and its implementing regulations. This final rule does not allow the territories and possessions to become a conduit to the United States for PCB waste generated in other countries. Finally, EPA has not made a formal finding of `` no unreasonable risk'' for this regulation. This regulation is not being promulgated under TSCA section 6( e), but rather as an exercise of EPA's inherent authority to interpret the statutes it administers. VIII. References and Documents in the Record As indicated in Unit I. B. 2., the official record for this rulemaking has been established under docket control number OPPTS– 66020A, the public version of which is available for inspection as specified in Unit I. B. 2. The following is a listing of the documents that have already been placed in the official record for this rulemaking: A. Federal Register Notices 1. U. S. Environmental Protection Agency (USEPA). 44 FR 31514, May 31, 1979, `` Polychlorinated Biphenyls (PCBs); Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions: Final Rule. '' 2. USEPA. 45 FR 29115, May 1, 1980, `` Polychlorinated Biphenyls (PCBs); Expiration of the Open Border Policy for PCB Disposal: Notice. '' OPTS 62008. 3. USEPA. 59 FR 62788, December 6, 1994, `` Disposal of Polychorinated Biphenyls: Proposed Rule. '' OPPTS– 66009A. 4. USEPA. 61 FR 11096, March 18, 1996, `` Disposal of Polychlorinated Biphenyls; Import for Disposal: Final Rule. '' OPPTS– 66009B. 5. USEPA. 63 FR 35384, June 29, 1998, `` Disposal of Polychlorinated Biphenyls (PCBs): Final Rule. '' OPPTS– 66009C. B. Reference Documents 1. USEPA, Office of Research and Development (ORD). PCBs Cancer DoseResponse Assessment and Application to Environmental Mixtures. EPA600P– 96001F (September 1996): 75pp. OPPTS– 66009C. 2. USEPA, Office of Air Quality Planning and Standards (OAQPS). Deposition of Air Pollutants to the Great Waters, First Report to Congress. EPA– 453R– 93– 055 (May 1994): 136pp. OPPTS– 66009B. 3. USEPA, OAQPS. Identification of Sources Contributing to the Contamination of the Great Waters by Toxic Compounds. EPA– 453R– 94– 087 (March 17, 1993): 145pp. OPPTS– 66009B. 4. USEPA, OAQPS. Relative Atmospheric Loadings of Toxic Contaminants and Nitrogen to the Great Waters. EPA– 453R– 94– 086 (March 15, 1993): 142pp. OPPTS– 66009B. 5. USEPA. Chapter 2.2, Exposure and Effects of Airborne Contamination for the Great Waters Program Report. EPA– 453R– 94– 085 (December 22, 1992): 201pp. OPPTS– 66009B. 6. USEPA, Office of Prevention, Pesticides, and Toxic Substances (OPPTS). Commercially Permitted PCB Disposal Companies (April 2000): 3pp. 7. USEPA, Office of Pollution Prevention and Toxics (OPPT). Excerpt from the PCB Waste Handler Database; Facility Information for U. S. Territories and Possessions (September 27, 2000): 12pp. 8. USEPA, Region IX. Memo from Lily Lee, Guam Program Manager, to Enrique Manzanilla, Director, Cross Media Division, Re: Summary of PCB Waste Quantities and Concentrations in the U. S. Territories (July 19, 2000): 5pp. 9. Unitek Environmental­ Guam. Letter from LeRoy Moore, President, to John Malone [sic], Director, National Program Chemicals Division, Re: PCB Shipments from Guam and Possessions of the United States for Disposal in the Mainland United States (May 11, 2000): 2pp. 10. USEPA, OPPT. Note from Peter Gimlin to the File, Re: Unitek Environmental­ Guam (UEG) Meeting (September 27, 2000): 1p. 11. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol M. Browner, Administrator, EPA, Re: Disposal of Polychlorinated Biphenyls (PCBs) from Guam and the Other U. S. Territories (April 12, 2000): 2pp. 12. USEPA, Region IX. Letter from Felicia Marcus, Regional Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of Polychlorinated Biphenyl Waste (February 4, 2000): 2pp. 13. USEPA, OPPT. Memo from John W. Melone, Director, Chemical Management Division, to George Abel, Chief, Pesticides and Toxic Substances Branch, USEPA Region X, Re: Transit of PCB Waste Generated in the United States Through a Foreign Country (January 19, 1995): 2pp. 14. USEPA, OPPT. Letter from John W. Melone, Director, Chemical Management Division, to Arthur J. Brown, National Science Foundation, Re: Request to Return PCBs in Antarctica to the United States for Disposal (March 11, 1994): 3pp. 15. USEPA, OCM and OE. Letter from Michael F. Wood, Director, Compliance Division, and Michael J. Walker, Enforcement Counsel for the Toxics Litigation Division, to Marion P. Herrington, General Electric Company, Re: Transfer of PCB Waste Generated in A U. S. Territory to An Approved Disposal Facility in the Continental United States (August 14, 1992): 2pp. 16. USEPA, Office of Toxic Substances (OTS). Letter from Don R. Clay, Director to Colonel Joseph T. Cuccaro, Defense Logistics Agency, Re: USEPA Position on DOD Owned PCB Fluid Located Abroad and Returned to the U. S. for Disposal (February 7, 1984): 3pp. 17. United Nations Environment Programme (UNEP). Inventory of World­ wide PCB Destruction Capacity, First Issue (December 1998): 85pp. 18. U. S. Congress. Congressional Record from the House of Representatives, H8598, Guam's Environmental Problems (October 2, 2000): 1p. 19. U. S. Congress. Letter from Robert A. Underwood, House of Representatives, to Carol Browner, Administrator, EPA, Re: Inability of Guam to Import PCBs into the U. S. Mainland for Proper Disposal (December 10, 1999): 2 pp. 20. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Disposal of PCB Waste in Guam (June 14, 2000): 2 pp. 21. USEPA, OPPTS. Letter from Susan H. Wayland, Acting Assistant Administrator, to Robert A. Underwood, U. S. House of Representatives, Re: Meeting on PCB Waste in Guam (September 29, 2000): 2 pp. 22. USEPA, OPPT. PCB Disposal and Storage Statistics, 1990– 1994 (May 10, 1996): 11 pp. IX. Regulatory Assessment Requirements A. Executive Order 12866 Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this action is not a `` significant regulatory action'' subject to review by OMB, because this action is not likely to result in a rule that meets any of the criteria for a `` significant regulatory action'' provided in section 3( f) of the Executive Order. This final rule simply clarifies EPA's interpretation of the TSCA section 6( e) provisions relating to the manufacture of PCBs. B. Regulatory Flexibility Act (RFA) Pursuant to section 605( b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U. S. C. 601 et seq., the Agency hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is that this action is not expected to result in any direct adverse impact for small entities. This rule interprets the prohibition on the `` manufacture of PCBs'' in a manner which affords U. S. citizens (including small entities) residing in U. S. territories and possessions located outside the `` customs territory of the United States'' an opportunity to dispose of PCB waste when facilities that require EPA approval to manage PCB waste are not readily available. This rule is being promulgated in the public interest to ensure equitable treatment among different areas within the United States and adequate protection of health and the environment throughout the United VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17477 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations States. This rule provides a mechanism for the disposal of PCB waste resulting from natural disasters (e. g., tropical storms, cyclones, typhoons and hurricanes), former use of U. S. territories and possessions for defense purposes, spills of PCBs and the expiration of PCB equipment that has reached the end of its natural life span. C. Paperwork Reduction Act (PRA) This regulatory action does not contain any information collection requirements that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U. S. C. 3501 et seq. D. Unfunded Mandates Reform Act (UMRA) Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104– 4, EPA has determined that this action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local or tribal governments, in the aggregate, or on the private sector in any one year. The UMRA requirements in sections 202, 204, and 205 do not apply to this rule, because this action does not contain any `` Federal mandates'' or impose any `` enforceable duty'' as defined by UMRA on State, Tribal, or local governments or on the private sector. The requirements in section 203 do not apply because this rule does not contain any regulatory requirements that might significantly or uniquely affect small governments. E. Executive Order 13132 Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. '' `` Policies that have federalism implications'' are defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. '' This final rule does not have federalism implications, because it will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the United States to be disposed of in EPA­ approved facilities on the mainland of the United States. Thus, the requirements of section 6 of the Executive Order do not apply to this rule. F. Executive Order 13084 and 13175 Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments `` to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities. '' This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose substantial direct compliance costs on such communities. It interprets the TSCA prohibition on the manufacture of PCBs in a manner which allows PCB waste in U. S. territories and possessions located outside of the customs territory of the United States to be disposed of in EPA­ approved facilities on the mainland of the United States. Accordingly, the requirements of section 3( b) of Executive Order 13084 do not apply to this rule. On November 6, 2000, the President issued Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249). Executive Order 13175 took effect on January 6, 2001, and revokes Executive Order 13084 as of that date. EPA developed this rule, however, during the period when Executive Order 13084 was in effect; thus, EPA addressed tribal considerations under Executive Order 13084. G. Executive Order 12898 Pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low­ Income Populations (59 FR 7629, February 16, 1994), the Agency has considered environmental justice related issues with regard to the potential impacts of this action on the environmental and health conditions in low­ income and minority communities. EPA finds that the interpretation in this final rule will reduce the risk to human health and the environment from exposure to PCBs in low­ income and minority communities in the territories and possessions. This rule allows PCB waste found in U. S. territories and possessions located outside of the customs territory of the United States to be disposed of in EPAapproved facilities on the mainland of the United States. H. Executive Order 13045 Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not apply to this rule, because it is not `` economically significant'' as defined under Executive Order 12866, and does not involve decisions on environmental health risks or safety risks that may disproportionately affect children. This regulation would allow PCB waste in U. S. territories and possessions located outside of the customs territory of the United States to be disposed of in EPA­ approved facilities on the mainland of the United States. Therefore, the disposal of PCB waste will occur where children are either not present or not permitted, and the disposal activity will pose no special risks to children. Also, the rule will prevent exposure of children in U. S. territories and possessions to PCBs that might result from improper storage or disposal of PCB waste. I. National Technology Transfer and Advancement Act (NTTAA) This regulatory action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104– 113, section 12( d) (15 U. S. C. 272 note). J. Executive Order 12630 EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with VerDate 11< MAY> 2000 11: 23 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2 17478 Federal Register / Vol. 66, No. 62 / Friday, March 30, 2001 / Rules and Regulations Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the `` Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the Executive Order. K. Executive Order 12778 In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996). X. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2). List of Subjects in 40 CFR Part 761 Environmental protection, Hazardous substances, Labeling, Polychlorinated Biphenyls (PCBs), Recordkeeping and reporting requirements Dated: March 20, 2001. Christine T. Whitman, Administrator. Therefore, 40 CFR chapter I, part 761 is amended as follows: PART 761—[ AMENDED] 1. The authority citation for part 761 will continue to read as follows: Authority: 15 U. S. C. 2605, 2607, 2611, 2614, and 2616. 2. Section 761.99 is amended by adding paragraph (c) to read as follows: § 761.99 Other transboundary shipments. * * * * * (c) PCB waste transported from any State to any other State for disposal, regardless of whether the waste enters or leaves the customs territory of the United States, provided that the PCB waste or the PCBs from which the waste was derived were present in the United States on January 1, 1979, and have remained within the United States since that date. [FR Doc. 01– 7920 Filed 3– 29– 01; 8: 45 a. m.] BILLING CODE 6560– 50– S VerDate 11< MAY> 2000 18: 56 Mar 29, 2001 Jkt 194001 PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 E:\ FR\ FM\ 30MRR2. SGM pfrm08 PsN: 30MRR2

epa

2024-06-07T20:31:45.663067

regulations

EPA-HQ-OPPT-2002-0014-0001

Notice

TSCA Section 8(d) Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies; Request for Comment on Renewal of Information Collection Activities

epa

2024-06-07T20:31:45.680032

regulations

EPA-HQ-OPPT-2002-0014-0004

Supporting & Related Material

PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503. 1. Agency/ Subagency originating request EPA, Office of Prevention, Pesticides & Toxic Substances 2. OMB control number b. G None a. 2 0 7 0 ­ 0 0 0 4 __ __ __ __ 3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. O Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. O Regular b. G Emergency ­ Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes G No For b­ f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. O Three years from approval date b. G Other Specify: / /___ 7. Title Health and Safety Data Reporting; Submission of Lists and Copies of Health and Safety Studies 8. Agency form number( s) ( If applicable) EPA ICR # 0575.09 9. Keywords Environmental Protection; Hazardous Substances; Reporting and Recordkeeping Requirements 10. Abstract This rule requires the submission of health and safety studies on specified chemicals by manufacturers and processors. The chemicals subject to the rule have been recommended for study by the Interagency Testing Committee or were otherwise selected by EPA. EPA will then use the studies to assess health and environmental effects of the chemicals and the need for testing under TSCA section 4. 11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for­ profit e. Federal Government c. Not­ for­ profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 569 b. Total annual responses 495 1. Percentage of these responses collected electronically 0 % c. Total hours requested 2,344 d. Current OMB inventory 4,542 e. Difference ­ 2,198 f. Explanation of difference 1. Program Change 2. Adjustment ­ 2,198 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. G Recordkeeping b. G Third party disclosure c. O Reporting 1. O On occasion 2. G Weekly 3. G Monthly 4. G Quarterly 5. G Semi­ annually 6. G Annually 7. G Biannually 8. G Other ( describe) 17. Statistical methods Does this information collection employ statistical methods? G Yes O No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Angela F. Hofmann, Director, Regulatory Coordination Staff Phone: 202­ 564­ 0258 OMB 83­ I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with 5 CFR 1320.9. NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions. The following is a summary of the topics, regarding the proposed collection of information, that the certification covers: ( a) It is necessary for the proper performance of agency functions; ( b) It avoids unnecessary duplication; ( c) It reduces burden on small entities; ( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; ( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; ( f) It indicates the retention periods for recordkeeping requirements; ( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number; ( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions); ( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology. If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Official Angela F. Hofmann, Director Regulatory Coordination Staff ( OPPTS) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83­ I 10/ 95

epa

2024-06-07T20:31:45.682915

regulations

EPA-HQ-OPPT-2002-0014-0005

Notice

Agency Information Collection Activities; Submission of EPA ICR No. 0575.09 (OMB No. 2070?0004) to OMB for Review and Approval; Comment Request

78447 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov/ edocket. Title: Information Collection Request for Clean Water Act Section 404 State­ Assumed Programs ( OMB Control No. 2040 0168, EPA ICR Number 0220.09). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Section 404( g) of the Clean Water Act authorizes States ( and Tribes) to assume the section 404 permit program. States/ Tribes must demonstrate that they meet the statutory and regulatory requirements ( 40 CFR part 233) for an approvable program. Specified information and documents must be submitted by the State/ Tribe to EPA to request assumption. Once the required information and documents are submitted and EPA has a complete assumption request package, the statutory time clock for EPA's decision to either approve or deny the State/ Tribe's assumption request starts. The information contained in the assumption request is made available to the other involved Federal agencies ( Corps of Engineers, Fish and Wildlife Service, and National Marine Fisheries Service) and to the general public for review and comment. States/ Tribes must be able to issue permits that comply with the 404( b)( 1) Guidelines, the environmental review criteria. States/ Tribes and the reviewing Federal agencies must be able to review proposed projects to evaluate, avoid, minimize and compensate for anticipated impacts. EPA's assumption regulations establish recommended elements that should be included in the State/ Tribe's permit application, so that sufficient information is available to make a thorough analysis of anticipated impacts. These minimum information requirements are based on the information that must be submitted when applying for a section 404 permit from the Corps of Engineers. EPA is responsible for oversight of assumed programs to ensure that State/ Tribal programs are in compliance with applicable requirements and that State/ Tribal permit decisions adequately consider, avoid, minimize and compensate for anticipated impacts. States/ Tribes must evaluate their programs annually and submit the results in a report to EPA. EPA's assumption regulations establish minimum requirements for the annual report. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: This collection of information is separated into three pieces. The annual public reporting and recordkeeping burden for this collection of information is estimated to average 520 hours to request program assumption, 5 hours to complete a permit application, and 80 hours to prepare the annual report. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: States/ Tribes, permit applicants. Estimated Number of Respondents: 20,006. Frequency of Response: one time to request assumption; one time when requesting a permit; annually for the annual permit. Estimated Total Annual Hour Burden: 101,360. Estimated Total Annual Cost: $ 37,200 includes $ 0 annualized capital or O& M costs. Changes in the Estimates: There is a change of an additional 693 hours from the currently approved hours in the OMB Inventory of Approved ICR Burdens; this is a math correction/ adjustment. Dated: December 17, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32388 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P ENVIRONMENTAL PROTECTION AGENCY [ OPPT 2002 0014; FRL 7427 6] Agency Information Collection Activities; Submission of EPA ICR No. 0575.09 ( OMB No. 2070 0004) to OMB for Review and Approval; Comment Request AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice. SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies [ EPA ICR No. 0575.09; OMB Control No. 2070 0004]. The ICR, which is abstracted below, describes the nature of the information collection and its estimated cost and burden. On May 21, 2002 ( 67 FR 35806), EPA sought comments on this ICR pursuant to 5 CFR 1320.8( d). EPA received no comments. DATES: Additional comments may be submitted on or before January 23, 2003. ADDRESSES: Follow the detailed instructions in the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Barbara Cunningham, Acting Director, Environmental Assistance Division, Office of Pollution Prevention and Toxics, Environmental Protection VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1 78448 Federal Register / Vol. 67, No. 247 / Tuesday, December 24, 2002 / Notices Agency, Mailcode: 7408, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202 554 1404; e­ mail address: TSCA Hotline@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. EPA has established a public docket for this ICR under Docket ID No. OPPT 2002 0014, which is available for public viewing at the OPPT Docket in the EPA Docket Center, EPA West Building Basement Room B102, 1301 Constitution Ave., NW., Washington, DC. The Center is open from 8 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by e­ mail to oppt. ncic@ epa. gov, or by mail to: Document Control Office ( DCO), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, Mailcode: 7407M, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No. OPPT 2002 0014, and ( 2) Mail a copy of your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. Title: Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies ( EPA ICR No. 0575.09; OMB Control No. 2070 0004). This is a request to renew an existing approved collection that is scheduled to expire on January 31, 2003. Under the PRA regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Section 8( d) of the Toxic Substances Control Act ( TSCA) and 40 CFR part 716 require manufacturers and processors of chemicals to submit lists and copies of health and safety studies relating to the health and/ or environmental effects of certain chemical substances and mixtures. In order to comply with the reporting requirements of section 8( d), respondents must search their records to identify any health and safety studies in their possession, copy and process relevant studies, list studies that are currently in progress, and submit this information to EPA. EPA uses this information to construct a complete picture of the known effects of the chemicals in question, leading to determinations by EPA of whether additional testing of the chemicals is required. The information enables EPA to base its testing decisions on the most complete information available and to avoid demands for testing that may be duplicative. EPA will use information obtained via this collection to support its investigation of the risks posed by chemicals and, in particular, to support its decisions on whether to require industry to test chemicals under section 4 of TSCA. Responses to the collection of information are mandatory ( see 40 CFR part 716). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting burden for this collection of information is estimated to be about 4 hours per response. Burden means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purposes of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Manufacturers, processors, importers, or distributers in commerce of chemical substances or mixtures. Frequency of Collection: On occasion. Estimated No. of Respondents: 569. Estimated Total Annual Burden on Respondents: 2,344 hours. Estimated Total Annual Costs: $ 203,512. Changes in Burden Estimates: There is a decrease of 2,198 hours ( from 4,542 hours to 2,344 hours) in the total estimated respondent burden compared with that identified in the information collection request most recently approved by OMB. This adjustment results from an updated analysis of the historical reporting patterns and the number of chemicals listed on the section 8( d) reporting rule. Specifically, because no new chemicals were added to the rule during the previous ICR reporting period, the number of chemicals added during the 1993 through 1996 period were averaged over eight­ years ( 1993 through 2000) to provide an estimate of expected reporting over the coming three­ year period of this ICR renewal. Unit burden estimates have not changed. Dated: December 17, 2002. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 02 32389 Filed 12 23 02; 8: 45 am] BILLING CODE 6560 50 P VerDate 0ct< 31> 2002 19: 49 Dec 23, 2002 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 24DEN1. SGM 24DEN1

epa

2024-06-07T20:31:45.687636

regulations

EPA-HQ-OPPT-2002-0015-0001

Notice

Certain New Chemicals; Receipt and Status Information

epa

2024-06-07T20:31:45.692326

regulations

EPA-HQ-OPPT-2002-0016-0001

Notice

National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances; Notice of public meeting

epa

2024-06-07T20:31:45.693341

regulations

EPA-HQ-OPPT-2002-0017-0001

Notice

National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Subtances; Second List of Priority Chemicals for Guideline Development

epa

2024-06-07T20:31:45.694324

regulations

EPA-HQ-OPPT-2002-0018-0001

Notice

Access to Confidential Business Information by C-Technologies.net LLC and INADEV Corporation

epa

2024-06-07T20:31:45.695470

regulations

EPA-HQ-OPPT-2002-0020-0001

Notice

Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology; Notice of Public Meeting

epa

2024-06-07T20:31:45.696927

regulations

EPA-HQ-OPPT-2002-0021-0001

Notice

Certain New Chemicals; Receipt and Status Information

epa

2024-06-07T20:31:45.700141

regulations

EPA-HQ-OPPT-2002-0024-0001

Notice

Lead-Based Paint Activities in Target Housing and Child-Occupied Facilities; State of Colorado Authorization of Lead-Based Paint Activities Program

epa

2024-06-07T20:31:45.701503

regulations