2013-04594. Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of filing of petitions and request for comment.

SUMMARY:

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

DATES:

Comments must be received on or before March 29, 2013.

ADDRESSES:

Submit your comments, identified by the docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/​dockets/​contacts.htm.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

A contact person, with telephone number and email address, is listed at the end of each pesticide petition summary. You may also reach each contact person by mail at Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

If you have any questions regarding the applicability of this action to a particular entity, consult the person listed at the end of the pesticide petition summary of interest.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one complete version of the comment that includes 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. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.

II. What action is the Agency taking?

EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), (21 U.S.C. 346a), requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed 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 pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available online at http://www.regulations.gov.

As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)), EPA is publishing notice of the petitions so that the public has an opportunity to comment on the requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition's summary referenced in this unit.

New Tolerance

1. PP 2E8126. (EPA-HQ-OPP-2012-0980). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide, mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide, in or on basil, fresh at 30 parts per million (ppm); basil, dried at 200 ppm; ginseng at 0.3 ppm; bean, succulent at 0.90 ppm; cowpea, forage at 15 ppm; vegetable, fruiting, group 8-10 at 1.0 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit at 2.0 ppm; onion, bulb, subgroup 3-07A at 0.1 ppm; and onion, green, subgroup 3-07B at 7.0 ppm. Analytical method RAM 415-01 was developed for determination of mandipropamid residues in crops. This method involves extraction of mandipropamid residues from crop samples by homogenization with acetonitrile: water (80:20 v/v). Extracts are centrifuged and aliquots diluted with water prior to being cleaned-up using polymeric solid-phase extraction cartridges. Residues of mandipropamid are quantified using high performance liquid chromatography with triple quadruple mass spectrometric detection (HPLC-MS/MS). Contact: Laura Nollen, [phone], email address: [e-mail].

2. PP 2E8136. (EPA-HQ-OPP-2013-0056). Interregional Research Project Number 4 (IR-4), requests to establish tolerances in 40 CFR part 180 for residues of the herbicide, clomazone, including its metabolites and degradates, determined by measuring only clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, in or on Brassica, head and stem, subgroup 5A at 0.10 ppm; rhubarb at 0.30 ppm; pea, southern, succulent, seed at 0.05 ppm; pea, southern, dry seed at 0.05 ppm; and pea, southern, hay at 0.05 ppm. There is a practical analytical method for detecting and measuring levels of clomazone in or on raw agricultural commodities with a limit of detection that allows monitoring of food for residues at or above the levels proposed in this tolerance. Samples are analyzed using an analytical method consisting of an acid reflux, a C₁₈ solid phase extraction (SPE), a Florisil SPE clean-up followed by gas chromatography (GC)-mass selective detection (MSD). Contact: Sidney Jackson, [phone], email address: [e-mail].

3. PP 3E8147. (EPA-HQ-OPP-2012-0626). Interregional Research Project Number 4 (IR-4), requests to establish tolerances in 40 CFR part 180 for residues of the insecticide, acetamiprid, (1 E)-N-[(6-chloro-3-pyridinyl)methyl]-N′-cyano-N-methylethanimidamide, including its metabolites and degradates, in or on corn, sweet, kernel plus cob with husks removed at 0.01 ppm; corn, sweet, forage at 15 ppm; and corn, sweet, stover at 30 ppm. Based upon the metabolism of acetamiprid in plants and the toxicology of the parent and metabolites, quantification of the parent acetamiprid is sufficient to determine residues of concern for enforcement purposes. As a result a method was developed that involves extraction of acetamiprid from crop matrices with a solvent followed by a decantation and filtration and finally analysis by a Liquid Chromotagraphy with tandem Mass Spectrometry (LC/MS/MS) method. Contact: Andrew Ertman, [phone], email address: [e-mail].

4. PP 2F8088. (EPA-HQ-OPP-2013-0038). ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish tolerances in 40 CFR part 180 for the combined residues of the insecticide, flonicamid, N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide, and its metabolites, TFNA (4-trifluoromethyl nicotinic acid), TFNA-AM (4-trifluoromethylnicotinamide), and TFNG, N-(4-trifluoro methylnicotinoyl)glycine, calculated as the stoichiometric equivalent of flonicamid, in or on tree, nuts, crop group 14-12 at 0.09 ppm; almond at 0.09 ppm; pecan at 0.04 ppm; and almond, hulls at 10.0 ppm. The residue analytical method for the majority of crops includes an initial extraction with acetonitrile/deionized water, followed by a liquid-liquid partition with ethyl acetate. The residue method for wheat straw is similar, except that a C₁₈ solid phase extraction (SPE) is added prior to the liquid-liquid partition. The final sample solution is quantitated using LC equipped with a reverse phase column and triple quadruple mass spectrometer (MS/MS). Contact: Carmen Rodia, [phone], email address: [e-mail].

5. PP 2F8130. (EPA-HQ-OPP-2012-0576). Arysta LifeScience North America, LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide fluoxastrobin, (1 E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its Z isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on wheat, grain at 0.15 ppm. Adequate analytical methodology is available for enforcement purposes. The method comprises microwave solvent extraction followed by a solid phase extraction clean up and quantification by HPLC/MS/MS. The individual detector responses for measured E- and Z-isomers is summed to give total residue. Contact: Heather Garvie, [phone], email address: [e-mail].

6. PP 2F8133. (EPA-HQ-OPP-2013-0071). BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6- dinitrobenzenamine, and its 3,5-dinitrobenzyl alcohol metabolite (CL202347), in or on almond, hulls at 6.0 ppm. In plants, the practical method for detecting and measuring levels of pendimethalin is aqueous organic solvent extraction, column clean up, and quantitation by GC. Contact: Erik Kraft, [phone], email address: [e-mail].

7. PP 2F8135. (EPA-HQ-OPP-2013-0051). Syngenta Crop Protection LLC., P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1 H-1,2,4-triazole and its metabolites determined as 2,4,-dichlorobenzoic acid and expressed as parent compound, in or on rapeseed, subgroup 20A at 0.3 ppm. The metabolism data in plants and animals suggest that analytical methods to detect either the phenyl or the triazole ring would be appropriate for the measurement of residues. However, because of the natural occurrence of compounds that interfere with the measurement of triazoles, methods designed to detect this moiety have been proven unreliable and unacceptable. Conversely, conversion of phenyl moiety to 2,4-dichlorobenzoic acid (DCBA) has proven to be satisfactory for all agricultural products analyzed to date. Analytical methods AG-626 and AG-454A were developed for the determination of residues of propiconazole and its metabolites containing the DCBA moiety. Analytical method AG-626 has been accepted and published by EPA as the tolerance enforcement method for crops. Contact: Erin Malone, [phone], email address: [e-mail].

8. PP 2F8139. (EPA-HQ-OPP-2013-0008). BASF Corporation, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide, saflufenacil, in or on crayfish at 0.01 ppm. Compliance with the tolerance levels is to be determined by measuring only saflufenacil, 2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2 H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide, in or on the commodities. Adequate enforcement methodology (LC/MS/MS) methods D0603/02 (plants) and L0073/01 (livestock) is available to enforce the tolerance expression. Contact: Bethany Benbow, [phone], email address: [e-mail].

Amended Tolerance

1. PP 2E8126. (EPA-HQ-OPP-2012-0980). Interregional Research Project Number 4 (IR-4), requests to amend the tolerances in 40 CFR 180.637 for residues of the fungicide, mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-alpha-(2-propynyloxy)-benzeneacetamide, by removing the previously established tolerances in or on grape at 1.4 ppm; onion, dry bulb at 0.05 ppm; onion, green at 4 ppm; okra at 1.0 ppm; and vegetable, fruiting, group 8 at 1.0 ppm, upon establishment of the tolerances listed under “New Tolerance” for PP 2E8126, elsewhere in this document. Contact: Laura Nollen, [phone], email address: [e-mail].

2. PP 2E8136. (EPA-HQ-OPP-2013-0056). Interregional Research Project Number 4 (IR-4), requests to amend the tolerance in 40 CFR 180.425 for residues of the herbicide, clomazone, including its metabolites and degradates, determined by measuring only clomazone, 2-[(2-chlorophenyl)methyl]-4,4-dimethyl-3-isoxazolidinone, by removing the previously established tolerance on cabbage at 0.10 ppm, upon approval of the petitioned-for tolerance on brassica, stem and head subgroup 5A listed under “New Tolerance” for PP 2E8136, elsewhere in this document. Contact: Sidney Jackson, [phone], email address: [e-mail].

3. PP 3E8147. (EPA-HQ-OPP-2012-0626). Interregional Research Project Number 4 (IR-4), requests to amend the tolerances in 40 CFR 180.578 for residues of the insecticide acetamiprid, (1 E)-N-[(6-chloro-3-pyridinyl)methyl]- N′-cyano-N-methylethanimidamide, including its metabolites and degradates, by increasing the existing tolerances in meat, meat byproducts, and milk. Tolerances for cattle, goat, horse, and sheep meat are proposed at 0.30 ppm; cattle, goat, horse, and sheep fat at 0.20 ppm; cattle, goat, horse, and sheep meat byproducts at 0.70 ppm; and milk at 0.30 ppm. Based upon the metabolism of acetamiprid in plants and the toxicology of the parent and metabolites, quantification of the parent acetamiprid is sufficient to determine residues of concern for enforcement purposes. As a result, a method was developed that involves extraction of acetamiprid from crop matrices with a solvent followed by a decantation and filtration and finally analysis by a LC/MS/MS method. Contact: Andrew Ertman, [phone], email address: [e-mail].

4. PP 2F8130. (EPA-HQ-OPP-2012-0576). Arysta LifeScience North America, LLC, requests to revise the tolerances in 40 CFR 180.609 for residues of the fungicide, fluoxastrobin, (1 E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its Z isomer, (1 Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinyl]oxy]phenyl](5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its phenoxy-hydroxypyrimidine, 6-(2-chlorophenoxy)-5-fluoro-4-pyrimidinol, increasing the milk tolerance from 0.02 ppm to 0.03 ppm; and milk, fat from 0.50 ppm to 0.75 ppm. Adequate analytical methodology is available for enforcement purposes. The method comprises microwave solvent extraction followed by a solid phase extraction clean up and quantification by HPLC/MS/MS detection. The individual detector responses for measured E- and Z-isomers is summed to give total residue. Contact: Heather Garvie, [phone], email address: [e-mail].

New Tolerance Exemption

PP 2E8049. (EPA-HQ-OPP-2012-0585). Pennzoil-Quaker State Company, 700 Milam Street, Houston, TX 77002 c/o Wagner Regulatory Associates, 7217 Lancaster Pike, Suite A, Hockessin, DE 19707, requests to establish an exemption from the requirement of a tolerance for residues of Distillates (Fishcher-Tropsch), heavy, C₁₈-C₅₀, branched, cyclic and linear (CAS Reg. No. 848301-69-9) under 40 CFR 180.910 when used as a pesticide inert ingredient in pesticide formulations as a solvent, diluent and dust suppressant without limitations in pesticide formulations. The petitioner believes no analytical method is needed because it is not required for the establishment of a tolerance exemption for inert ingredients. Contact: Mark Dow, [phone], email address: [e-mail].

Amended Tolerance Exemption

1. PP 2E8080. (EPA-HQ-OPP-2013-0098). Toxcel, LLC, 7140 Heritage Village Plaza, Gainesville, VA 20156 on behalf of Penn A Kem, LLC, 3324 Chelsea Avenue, Memphis, TN 38108, requests to amend an exemption from the requirement of a tolerance in 40 CFR 180.1263 for residues of tetrahydrofurfuryl alcohol (THFA), (CAS Reg. No. 97-99-4), when used as a pesticide inert ingredient in the form of a solvent/co-solvent in pesticide formulations, by allowing one pre-boot herbicide application to all small cereal grains, and by extending use on canola to early bolting stage, and use on soybeans up to bloom stage. The petitioner believes no analytical method is needed because it is not required for the amendment of a tolerance exemption for inert ingredients. Contact: Janet Whitehurst, [phone], email address: [e-mail].

2. PP IN-10541. (EPA-HQ-OPP-2013-0093). Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington DE 19808 c/o Wagner Regulatory Associates, 7217 Lancaster Pike, Suite A, Hockessin, DE 19707, requests to amend an exemption from the requirement of a tolerance in 40 CFR 180.1130 for residues of N-(n-octyl)-2-pyrrolidone, (CAS Reg. No. 2687-94-7), when used as a pesticide inert ingredient to include use in pesticide formulations containing the pyraflufen ethyl active ingredient. The petitioner believes no analytical method is needed because it is not required for the amendment of a tolerance exemption for inert ingredients. Contact: David Lieu, [phone], email address: [e-mail].

List of Subjects in 40 CFR Part 180

• Environmental protection
• Agricultural commodities
• Feed

Dated: February 20, 2013.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.