Source: https://www.federalregister.gov/documents/2013/04/24/2013-09701/azoxystrobin-pesticide-tolerances
Timestamp: 2017-03-30 13:05:51
Document Index: 110258569

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', 'art2', '§\u2009180']

:: Azoxystrobin; Pesticide Tolerances
This regulation is effective April 24, 2013. Objections and requests for hearings must be received on or before June 24, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
78 FR 24094
24094-24100
EPA-HQ-OPP-2012-0282
FRL-9384-2
2013-09701
EPA-HQ-OPP-2012-0283
Azoxystrobin: Revised Human Health Risk Assessment for Use in...
Azoxystrobin: Occupational and Residential Exposure Assessment...
Azoxystrobin: Section 3 Petitions for the Establishment of...
Acute and Chronic Aggregate Dietary (Food and Drinking Water)...
Azoxystrobin: Human Health Risk Assessment for Use on Ginseng...
Notice of Filing for Petition 2F7984 from Syngenta Crop...
https://www.federalregister.gov/d/2013-09701
This regulation establishes tolerances for residues of azoxystrobin in or on multiple commodities discussed later in this document. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
The docket for these actions, identified by docket identification (ID) number EPA-HQ-OPP-2012-0282, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/​dockets.
Erin Malone, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0253; email address: Malone.Erin@epa.gov.
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2012-0282 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 24, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2012-0282, by one of the following methods:
In the Federal Register of April 4, 2012 (77 FR 20336) (FRL-9340-4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1E7945) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 180.507 be amended by establishing an import tolerance for residues of the fungicide azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-(2-Start Printed Page 24095cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate] in or on ginseng extract (red ginseng extract and ginseng extract) at 0.5 parts per million (ppm). That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket EPA-HQ-OPP-2012-0041, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Additionally, in the Federal Register of May 23, 2012 (77 FR 30484) (FRL-9347-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 2F7976 and PP 2F7984) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300. The petitions requested that 40 CFR 180.507 be amended by:
Establishing tolerances for residues of the fungicide azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate] and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], in or on oats, forage at 4 parts per million (ppm); oats, hay at 7 ppm; oats, straw at 3 ppm; oats, grain at 1 ppm; rye, forage at 4 ppm; rye, straw at 0.8 ppm; rye, grain at 0.07 ppm; poultry, meat at 0.01 ppm; poultry, liver at 0.2 ppm; poultry, fat at 0.01 ppm; egg at 0.1 ppm; cattle, liver at 0.5 ppm; cattle, kidney at 0.1 ppm; hog, liver at 0.2 ppm; hog, kidney at 0.03 ppm (PP 2F7976);
Amending established tolerances for barley, hay from 15 ppm to 7 ppm; barley, straw from 7 ppm to 8 ppm; barley, grain from 3 ppm to 2 ppm; wheat, forage from 25 ppm to 10 ppm; wheat, straw from 4 ppm to 6 ppm; wheat, hay from 15 ppm to 20 ppm; grain aspirated fractions from 420 ppm to 460 ppm; cattle, fat from 0.03 ppm to 0.3 ppm; hog, fat from 0.01 ppm to 0.1 ppm; hog, meat from 0.01 ppm to 0.02 ppm; (PP 2F7984).
The notices referenced summaries of the petitions prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the dockets EPA-HQ-OPP-2012-0282 and EPA-HQ-OPP-2012-0283, http://www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is establishing tolerances that vary from what the petitioner requested. The reason for these changes is explained in Unit IV.C.
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.* * *”
The toxicological profile for azoxystrobin has not changed since the final rule published in the Federal Register of July 13, 2012 (77 FR 41285) (FRL-9352-2). See that rule for a summary of the toxicological profile and references to supporting Agency documents that discuss specific information on the toxicity studies received and the nature of the adverse effects caused by azoxystrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL).
A summary of the toxicological endpoints for azoxystrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 13, 2012 (77 FR 41286) (FRL-9352-2).
Such effects were identified for azoxystrobin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in Start Printed Page 24096America (NHANES/WWEIA) conducted from 2003 to 2008. As to residue levels in food, the acute dietary exposure assessment of azoxystrobin is partially refined by using highest residue values for citrus fruits and assuming tolerance-level residues for all other existing and proposed commodities. One hundred percent of the crops were assumed treated with azoxystrobin and DEEM (Dietary Exposure Evaluation Model) version 7.81 default processing factors were used except where tolerances were established for processed commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for azoxystrobin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of azoxystrobin. 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), the highest estimated drinking water concentrations (EDWCs) of azoxystrobin for acute exposures are estimated to be 173 parts per billion (ppb) for surface water and 33 ppb for chronic exposures for non-cancer assessments. Based on the Screening Concentration in Groundwater, version 2.3, August 8, 2003 (SCI-GROW), the EDWC for ground water is 3.1 ppb for all exposures.
3. From non-dietary exposure. The term “residential exposure” is used in Start Printed Page 24097this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Azoxystrobin is currently registered for the following uses that could result in residential exposures: Outdoor residential (lawns, ornamentals, flower gardens, vegetables, fruit and nut trees, berries and vines) and recreational (golf courses, parks and athletic fields) sites. Additionally, azoxystrobin is registered for uses on indoor carpets/other surfaces, and in treated paints (preservative incorporation). EPA assessed residential exposure using the following assumptions:
Residential uses will result in short-term (1 to 30 days) handler exposure; residential handlers are assumed to be wearing short-sleeved shirts, short pants, shoes, and socks during the application; and because there was no dermal endpoint chosen for azoxystrobin, residential handler risk from exposure was assessed for the inhalation route only.
The Agency assumed that post-application exposure in residential settings is expected to be short-term in duration only. Residential post-application inhalation exposure in outdoor settings is considered negligible; however, residential post-application inhalation exposure in indoor settings has been assessed for adults and children.
Further information regarding EPA's standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/​pesticides/​trac/​science/​trac6a05.pdf.
EPA has not found azoxystrobin to share a common mechanism of toxicity with any other substances, and azoxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that azoxystrobin 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 Web site at http://www.epa.gov/​pesticides/​cumulative.
3. Conclusion. EPA has retained the FQPA SF, reduced to 3X, in assessing acute dietary risk. An additional safety factor is needed for acute risk assessment to account for the use of a LOAEL from the acute neurotoxicity study in rats in deriving the acute reference dose used for assessing acute dietary exposure for all populations including infants and children. To account for the use of a LOAEL from the acute neurotoxicity study in rats, the Agency believes that a 3X FQPA SF (as opposed to a 10X) will be adequate to extrapolate a NOAEL in assessing acute risk based on the following considerations:
The very high dose level needed to reach the acute oral lethal dose (LD)50 (>5,000 milligrams/kilogram (mg/kg)), and the overall low toxicity of azoxystrobin.
However, EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X for short-term, intermediate-term, and chronic risk assessment. This determination is based on the following considerations.
iv. There are no residual uncertainties in the azoxystrobin exposure database. While some refinements were incorporated into the dietary exposure calculations, EPA is confident that the aggregate risk from exposure to azoxystrobin in food, drinking water, and residential pathways will not be underestimated. The acute dietary (food) exposure assessment utilized conservative upper-bound inputs including 100% of the proposed and registered crops treated, and tolerance-level residues for all existing and proposed commodities, except citrus fruits where the highest field trial residue was used as a refinement. The chronic dietary exposure assessment was partially refined, and used tolerance-level residues for all commodities and PCT estimates when available (SLUA, 07/13/11). Although the acute and chronic assessments included minor refinements, the use of Start Printed Page 24098field trial and PCT estimates ensures that actual exposures/risks from residues in food will not be underestimated. The drinking water assessment utilized water concentration values generated by models and associated modeling parameters which are designed to produce conservative, health protective, high-end estimates of water concentrations which are not likely to be exceeded. The dietary (food and drinking water) exposure assessment does not underestimate the potential exposure for infants, children, or women of child-bearing age.
In addition, the residential exposure assessment is based on the updated 2012 Residential SOPs employing surrogate study data, including conservative exposure assumptions based on Day 0 dermal/oral contact to turf and surfaces treated at the maximum application rate. These data are reliable and are not expected to underestimate risks to adults or children. The Residential SOPs are based upon reasonable “worst-case” assumptions and are not expected to underestimate risk.
Adequate enforcement methodologies are available to enforce the tolerance expression and have been submitted to FDA for inclusion in the Pesticide Analytical Manual (PAM) Volume II: A gas chromatography method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the enforcement of tolerances for residues of azoxystrobin and its Z-isomer in crop commodities; and a GC/NPD method, RAM 255/01, for the enforcement of tolerances of azoxystrobin in livestock commodities.
The Codex has established MRLs for azoxystrobin in or on oats, grain at 0.5 ppm and barley, grain at 0.5 ppm. These MRLs are different than the tolerances established for azoxystrobin in the United States. The U.S. tolerance on oat grain (1.5 ppm) and barley grain (3 ppm) could not be harmonized since the Codex MRLs are lower. Setting the U.S. tolerance to be consistent with the Codex MRLs might lead to residues in excess of the tolerance, despite legal use of the pesticide in accordance with the registered label.
The tolerance levels requested by the petitioners are based on residue data submitted using lower application rates than are found on the registered label; therefore, EPA used the proportionality principle (JMPR Report 2011) to estimate residue values that reflect the higher application rates on the registered label. In doing this exercise, EPA determined that an adjustment to the wheat, grain tolerance was required to reflect the application rates for the pesticide.
The proposed tolerance on ginseng extract (red ginseng extract and ginseng Start Printed Page 24099extract) is not needed because the tolerance on ginseng will cover the expected residues in these processed commodities.
The tolerance expression in 40 CFR 180.507(a)(2) is incorrect and was revised.
Therefore, tolerances are established for residues of azoxystrobin, [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], in or on oat, forage at 5.0 ppm; oat, hay at 10.0 ppm; oat, straw at 3.0 ppm; oat, grain at 1.5 ppm; rye, forage at 7.0 ppm; rye, straw at 1.5 ppm; rye, grain at 0.2 ppm; barley, hay at 10.0 ppm; barley, straw 15.0 ppm; wheat, forage from at 15.0 ppm; wheat, straw at 10.0 ppm; wheat, hay at 30.0 ppm; and wheat, grain at 0.2 ppm. In conjunction with establishment of the wheat grain tolerance at 0.2 ppm, the existing tolerance on wheat bran needs to be deleted from 40 CFR 180.507(a)(1).
Also, EPA is establishing a tolerance for residues of azoxystrobin [methyl(E)-2-(2-(6-(2-cyanophenoxy) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate] and the Z-isomer of azoxystrobin, [methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate], in or on ginseng at 0.5 ppm. Although, as of the date of publication of this rule, there are no U.S. registrations for use of azoxystrobin on ginseng, this tolerance will allow for imports of treated ginseng meeting this tolerance level.
Start Amendment Part2. In § 180.507:End Amendment Part
Start Amendment Parta. Revise the entries for “Barley, hay”, “Barley, straw”, “Wheat, grain”, “Wheat, hay”, ands “Wheat, straw” in the table in paragraph (a)(1);End Amendment Part
Start Amendment Partb. Add alphabetically the entries for “Ginseng”, “Oats, forage”, “Oats, grain”, “Oats, hay”, “Oats, straw”, “Rye, forage”, “Rye, grain”, “Rye, straw” to the table in paragraph (a)(1);End Amendment Part
Start Amendment Partc. Remove the entry in the table in paragraph (a)(1) for “Wheat, bran”;End Amendment Part
Start Amendment Partd. Add footnote 1 to the table in paragraph (a)(1); andEnd Amendment Part
Start Amendment Parte. Revise the introductory text of paragraph (a)(2)End Amendment Part
CommodityParts per million * * * * *Barley, hay10.0Barley, straw15.0 * * * * *Ginseng 10.5 * * * * *Oats, forage5.0Oats, grain1.5Oats, hay10.0Oats, straw3.0 * * * * *Rye, forage7.0Rye, grain0.2Rye, straw1.5Start Printed Page 24100 * * * * *Wheat, grain0.2Wheat, hay30.0Wheat, straw10.01 There are no United States registrations for use of azoxystrobin on ginseng.
[FR Doc. 2013-09701 Filed 4-23-13; 8:45 am]