Source: https://www.federalregister.gov/documents/2008/09/05/E8-20515/pyraflufen-ethyl-time-limited-pesticide-tolerances
Timestamp: 2018-02-21 19:27:12
Document Index: 34585617

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 178', 'art 2']

Federal Register :: Pyraflufen-ethyl; Time-Limited Pesticide Tolerances
Pyraflufen-ethyl; Time-Limited Pesticide Tolerances
This regulation is effective September 5, 2008. Objections and requests for hearings must be received on or before November 4, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
51738-51743 (6 pages)
EPA-HQ-OPP-2007-0366
FRL-8377-6
https://www.federalregister.gov/d/E8-20515 https://www.federalregister.gov/d/E8-20515
This regulation establishes permanent tolerances for residues of pyraflufen-ethyl in or on grass, forage, group 17; and grass, hay, group 17; establishes time-limited tolerances for milk; cattle, meat byproducts; goat, meat byproducts; horse, meat byproducts and sheep, meat byproducts, and revises the existing tolerances for soybean, forage; soybean, hay; wheat, forage and wheat, hay. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). The time-limited tolerances expire on October 15, 2012.
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0366. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Public Docket, in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
Joanne I. Miller, Registration Division (7505P), 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@epa.gov.
In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Start Printed Page 51739Office's pilot e-CFR site at http://www.gpoaccess.gov/​ecfr.
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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2007-0366 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 November 4, 2008
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2007-0366, by one of the following methods:
Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg., 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be amended by establishing tolerances for residues of the herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate; and its acid metabolite, E-1, 2-chloro-5-4-chloro-5-difluoromethoxy-(1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the parent in or on food commodities: Soybeans, forage at 0.05 parts per million (ppm); soybean, hay at 0.10 ppm; grass, forage, crop group 17 at 1.0 ppm; and grass, hay, crop group 17 at 1.2 ppm.
In the Federal Register of June 13, 2008 (73 FR 33814) (FRL-8367-3), EPA issued a second notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 7F7190) by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be amended by establishing new tolerances for residues of the herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the parent, in or on food commodities grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm; milk at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm, and by revising existing tolerances for residues of the herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the parent, in or on food commodities soybean, seed to 0.05 ppm; soybean, hay to 0.10 ppm; wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm.These notices referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the notices of filing. Tolerances for milk at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm expire on October 15, 2012. A time limitation been imposed because of the requirement for a cattle feeding study conducted to determine residues of the E-9 metabolite in milk and cattle tissues.
Consistent with the factors specified in FFDCA 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 for the petitioned-for tolerances for residues of pyraflufen-ethyl and its metabolite expressed in terms of the parent on grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm; milk at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm, and by revising existing tolerances for soybean, forage to 0.05 ppm; soybean, hay to 0.10 ppm; wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows.
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. Specific information on the studies received and the nature of the toxic effects caused by Start Printed Page 51740pyraflufen-ethyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies.
Pyraflufen-ethyl has low to moderate toxicity from acute exposure and it is not a dermal sensitizer. The liver, kidney, and possibly the hematopoietic system are the target organs for pyraflufen-ethyl in the rat and/or the mouse. There is no evidence of increased sensitivity to the young in developmental and reproductive studies with pyraflufen-ethyl. Pyraflufen-ethyl was not shown to be mutagenic in a battery of tests. Pyraflufen-ethyl was classified as “Likely to be carcinogenic to humans” based on male mouse hepatocellular adenomas, carcinomas and/or hepatoblastomas (combined) observed in the mouse carcinogenicity study.
Specific information on the studies received and the nature of the toxic effects caused by pyraflufen-ethyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Pyraflufen-ethyl: Human Health Risk Assessment for Pyraflufen-ethyl: Proposed New Use on Pasture and Rangeland Grasses (PP 7F7190) and Amendment to Allow Early Season Postemergence Broadcast Uses to Corn (excluding sweet corn), Soybeans and Wheat at page 13 in docket ID number EPA-HQ-OPP-2007-0366.
For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs/safety factors) are used in conjunction with the POD to take into account 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. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the Level of Concern (LOC).
A summary of the toxicological endpoints for pyraflufen-ethyl used for human risk assessment can be found at http://www.regulations.gov in document Pyraflufen-ethyl: Human Health Risk Assessment for Pyraflufen-ethyl: Proposed New Use on Pasture and Rangeland Grasses (PP#7F7190) and Amendment to Allow Early Season Postemergence Broadcast Uses to Corn (excluding sweet corn), Soybeans and Wheat at page 13 in docket ID number EPA-HQ-OPP-2007-0366. Also, a summary of the toxicological endpoints for pyraflufen-ethyl used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 30, 2003 (68 FR 23046) (FRL-7300-9).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pyraflufen-ethyl, EPA considered exposure from the petitioned-for tolerances as well as all existing pyraflufen-ethyl tolerances in 40 CFR 180.585. EPA assessed dietary exposures from pyraflufen-ethyl in food as follows:
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, the following assumptions were made for the chronic exposure assessments: 100 percent crop treated (PCT) and tolerance-level residues for pyraflufen-ethyl on all treated crops except corn, cottonseed, potato, soybean and wheat for which one half of the combined Levels of Quantification (LOQs) for the parent and the metabolite were used since all field trial data were less than the LOQ.
iii. Cancer. For the cancer dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, the following assumptions were made for the chronic exposure assessments: 100 percent crop treated (PCT) and tolerance-level residues for pyraflufen-ethyl on all treated crops except corn, cottonseed, potato, soybean and wheat for which one-half of the combined LOQs for the parent and the metabolite were used since all field trial data were less than the LOQ.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for pyraflufen-ethyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pyraflufen-ethyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/​oppefed1/​models/​water/​index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of pyraflufen-ethyl for acute exposures are estimated to be 1,247 parts per trillion (ppt) for surface water and 1.8 ppt for ground water. Chronic exposures for cancer assessments are estimated to be 281 ppt for surface water and 1.8 ppt for ground water
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 281 ppt was used to assess the contribution to drinking water.
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Pyraflufen-ethyl is currently registered on the following residential non-dietary sites that could result in residential exposures: airports, nurseries, ornamental turf, golf courses, roadsides, railroads, non-crop land, and uncultivated agricultural areas. The risk assessment was conducted using the following residential exposure assumptions: adults and children may be exposed to residues of pyraflufen-ethyl through short-term post-application contact with treated areas which may include residential/recreational areas.
EPA has not found pyraflufen-ethyl to share a common mechanism of toxicity with any other substances, and pyraflufen-ethyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pyraflufen-ethyl does not have 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 EPA's website at http://www.epa.gov/​pesticides/​cumulative.
ii. There is no indication that pyraflufen-ethyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that pyraflufen-ethyl results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% of the crop treated and a conservative estimate of residues in food. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pyraflufen-ethyl in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pyraflufen-ethyl.
1. Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, pyraflufen-ethyl 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 chronic exposure to pyraflufen-ethyl from food and water will utilize less than 1% of the cPAD for all population groups. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pyraflufen-ethyl is not expected.
3. Short-term risk. Pyraflufen-ethyl is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pyraflufen-ethyl.
Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term risk aggregate assessment was not performed for adults because no handler exposure is expected and post-application inhalation exposure is expected to be negligible (and there are no dermal endpoints of concern). A short-term aggregate risk assessment was performed for infants and children because there is a potential for oral post-application exposure resulting from contact with treated areas which may include residential/recreational areas. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water. Short term aggregate risk is based on children's incidental oral exposure (from residential post-application treatment) and dietary exposure (food and drinking water). The anticipated exposure level for children, 1-2 years (the highest exposed population) is below EPA's level of concern, with a Margin of Exposure (MOE) greater than 60,000.
4. Intermediate-term risk.
Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).
Pyraflufen-ethyl is not registered for any use patterns that would result in intermediate-term residential exposure. No residential handler exposure is expected and post-application inhalation exposure is expected to be negligible. Post-application exposure to infants and children over the intermediate term duration (1 to 6) months is not likely based on the use pattern. Therefore, the intermediate-Start Printed Page 51742term aggregate risk is the sum of the risk from exposure to pyraflufen-ethyl through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.
5. Aggregate cancer risk for U.S. population. The aggregate cancer risk assessment for the general population takes into account exposure estimates form dietary consumption of pyraflufen-ethyl from food, residential, and drink water sources. Exposures from residential uses are based on the lifetime average daily dose and assume an exposure period of 5 days per year and 50 years of exposure in a lifetime (70 years). Average food plus water source dietary exposure was used. Estimated cancer risk for the U.S. population includes infants and children. The aggregate cancer risk estimate for pyraflufen-ethyl is 2.9 x 10-6. This risk estimate is based, in part, on the conservative assumption that 100% of all crops for which pyraflufen-ethyl is registered or proposed for registration are treated. Additional refinement using Percent Crop Treated estimates would result in a lower estimate of cancer risk.
EPA generally considers cancer risks in the range of 1 in 1 million (1 x 10-6) or less to be negligible. The precision which can be assumed for cancer risk estimates is best described by rounding to the nearest integral order of magnitude on the log scale; for example, risks falling between 3.16 x 10-7 and 3.16 x 10-6 are expressed as risks in the range of 1 x 10-6. Considering the precision with which cancer hazard can be estimated, the conservativeness of low-dose linear extrapolation, and the rounding procedure described above, cancer risk should generally not be assumed to exceed the benchmark LOC of the range of 1 x 10-6 until the calculated risk exceeds approximately 3 x 10-6. Since the calculated cancer risk for pyraflufen-ethyl does not exceed this level, estimated cancer risk is considered to be negligible.
Adequate enforcement methodology (Gas Chromatography and Mass Spectrometry (GC/MS)) 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.
There are currently no established Codex, Canadian or Mexican maximum residue limits, for residues of pyraflufen-ethyl in/on grass, milk, meat byproducts, soybean and wheat.
Therefore, permanent tolerances are established for residues of pyraflufen-ethyl and its metabolite expressed in terms of the parent on grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm. Time-limited tolerances are established for milk at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm. Existing tolerances are revised for soybean, forage to 0.05 ppm; soybean, hay to 0.10 ppm; wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm.
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2. Section 180.585 is amended by revising paragraph (a) to read as follows:
(a) General. Tolerances are established for residues of the herbicide, pyraflufen-ethyl, ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate, and its acid metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid, expressed in terms of the parent in or on the following food commodities:
Cattle, meat byproducts 0.02 10/15/12
Corn, field, forage 0.01 None
Corn, field, grain 0.01 None
Corn, field, stover 0.01 None
Cotton, gin byproducts 1.5 None
Cotton, undelinted seed 0.04 None
Goat, meat byproducts 0.02 10/15/12
Grass, forage, group 17 1.0 None
Grass, hay, group 17 1.4 None
Horse, meat byproducts 0.02 10/15/12
Milk 0.02 10/15/12
Potato 0.02 None
Sheep, meat byproducts 0.02 10/15/12
Soybean, forage 0.05 None
Soybean, hay 0.10 None
Soybean, seed 0.01 None
Wheat, forage 0.02 None
Wheat, grain 0.01 None
Wheat, hay 0.01 None
Wheat, straw 0.01 None
[FR Doc. E8-20515 Filed 9-4-08; 8:45 am]