2013-31258. 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 January 29, 2014.

ADDRESSES:

Submit your comments, identified by 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:

Robert McNally, Biopesticides and Pollution Prevention Division (BPPD) (7511P), telephone number: [phone], email address: [e-mail]; or Lois Rossi, Registration Division (RD) (7505P), telephone number: [phone], email address: [e-mail]; Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. As part of the mailing address, include the contact person's name, division, and mail code.

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 division 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 petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on various food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

New Tolerance

1. PP 3E8201. (EPA-HQ-OPP-2013-0729). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the desiccant, defoliant, and herbicide paraquat dichloride, (1,1′-dimethyl-4,4′-bipyridinium-ion) derived from application of the dichloride salt (calculated as the cation) in or on tuberous and corm vegetables subgroup (Crop subgroup 1C) at 0.5 parts per million (ppm). An analytical method (spectrometric method) has been accepted and published in the Pesticide Analytical Manual (PAM Vol. II) for the enforcement of tolerances in plant commodities. (RD)

2. PP 3E8202. (EPA-HQ-OPP-2013-0712). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for the residues of the herbicide sulfentrazone, (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolite HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1 H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone, in or on apple at 0.15 ppm. There is a practical analytical method for detecting and measuring levels of sulfentrazone and its metabolites in or on food with a limit of quantitation that allows monitoring of food with residues at or above the levels set or proposed in the tolerances. The analytical enforcement method for sulfentrazone was used with minor modification that eliminated several clean-up and derivatization steps that was required for gas chromatography/mass spectrometry detection (GC/MSD), but not for liquid chromatograph/tandem mass spectrometry (LC/MS/MS). The analytical method for sulfentrazone involves separate analyses for parent and its metabolites. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/ECD. The metabolites samples were refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS. (RD)

3. PP 3E8203. (EPA-HQ-OPP-2013-0730). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for the combined residues of the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl] oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl- (2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11, 12,13,14,16a,16b-tetradecahydro-4,14-dimethyl- (2S,3aR,5aS,5bS,9S,13S,14R,16aS, 16bS); ND-J: (2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13-[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-3-yl(methyl)formamide in or on the following raw agricultural commodities: Coffee, green bean at 0.2 ppm; coffee, instant at 0.4 ppm; coffee, roasted bean at 0.4 ppm; cottonseed subgroup 20C at 0.04 ppm; caneberry subgroup 13-07A at 0.7 ppm; bushberry subgroup 13-07B, except lingonberry at 0.25 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.5 ppm; berry, low growing, subgroup 13-07G, except blueberry, lowbush, and cranberry at 1.0 ppm; fruit, pome group 11-10 at 0.2 ppm; vegetable, fruiting, group 8-10 at 0.4 ppm; fruit, citrus, group 10-10 at 0.3 ppm; fruit, stone, group 12-12 at 0.2 ppm; onion, bulb, subgroup 3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 2.0 ppm; and nuts, tree, group 14-12 at 0.1 ppm. Per the Federal Register of October 10, 2007 (72 FR 57492) (FRL-8149-9) supported by Data Package (DP) # 325387, August 9, 2008, EPA has determined adequate analytical methods are available for enforcement purposes for spinetoram in plant and animal matrices. For more details on the analytical methods and for specific GRMs, see EPA Memorandum—“Subject: Spinosad and Spinetoram; Human-Health Assessment Scoping Document in Support of Registration Review” dated August 9, 2011 (Decision # 446932). EPA conservatively concluded that for water, residues should be estimated using the total spinetoram residue method (EPA, DP # 331741, September 20, 2007). (RD)

4. PP 3E8204. (EPA-HQ-OPP-2013-0727). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide spinosad, a fermentation product of Saccharopolyspora spinosa, consisting of two related active ingredients: Spinosyn A (Factor A: CAS Registry No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS Registry No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw agricultural commodities: Coffee, green bean at 0.2 ppm; coffee, instant at 0.4 ppm; coffee, roasted bean at 0.4 ppm; cottonseed subgroup 20C at 0.02 ppm; caneberry subgroup 13-07A at 0.7 ppm; bushberry subgroup 13-07B, except lingonberry at 0.25 ppm; fruit, small, vine climbing, except fuzzy kiwifruit subgroup 13-07F at 0.5 ppm; berry, low growing, subgroup 13-07G, except blueberry, lowbush, and cranberry at 1.0 ppm; fruit, pome group 11-10 at 0.2 ppm; vegetable, fruiting, group 8-10 at 0.4 ppm; fruit, citrus, group 10-10 at 0.3 ppm; fruit, stone, group 12-12 at 0.2 ppm; onion, bulb, subgroup 3-07A at 0.1 ppm; onion, green, subgroup 3-07B at 2.0 ppm; and nuts, tree, group 14-12 at 0.1 ppm. EPA has determined adequate analytical methods are available for enforcement purposes for spinosad in plant and animal matrices. For more details on the analytical methods and for specific GRMs, see EPA Memorandum—“Subject: Spinosad and Spinetoram; Human-Health Assessment Scoping Document in Support of Registration Review,” dated August 9, 2011 (Decision # 446932). EPA conservatively concluded that for water, residues should be estimated using the total spinosad residue method (EPA, Decision # 316077, August 2, 2006). (RD)

5. PP 2F8053 (Revised) (EPA-HQ-OPP-2013-0008). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528 submitted revisions to their initial pesticide petition 2F8139 to establish tolerances in 40 CFR part 180 for residues of the herbicide saflufenacil, its metabolites, and degradates, in or on various commodities. Based on EPA's evaluation of the data supporting the original petition, BASF Corporation revised the petition by proposing tolerances for fish-freshwater finfish and fish-shellfish, crustacean; at 0.01 parts per million (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. (RD)

6. PP 3F8173. (EPA-HQ-OPP-2013-0445). ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide flazasulfuron, 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulfonyl) urea, in or on tree nuts (Crop group 14-12) at 0.01 ppm. A practical analytical method for flazasulfuron using LC-MS/MS is available for enforcement purposes. (RD)

Amended Tolerance

1. PP 3E8201. (EPA-HQ-OPP-2013-0729). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to remove the existing tolerance in 40 CFR 180.205(a) for residues of the desiccant, defoliant, and herbicide paraquat dichloride, (1,1′-dimethyl-4,4′-bipyridinium-ion) derived from application of the dichloride salt (calculated as the cation), in or on potato at 0.5 ppm, upon establishment of the proposed tolerance for the tuberous and corm vegetables subgroup (Crop subgroup 1C) at 0.5 ppm in paragraph 1. under “New Tolerance.” (RD)

2. PP 3E8203. (EPA-HQ-OPP-2013-0730). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, proposes based upon the establishment of tolerances in paragraph 3. under “New Tolerance” to remove established tolerances at 40 CFR 180.635 for the combined residues of the insecticide spinetoram, expressed as a combination of XDE-175-J: 1-H-as-indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-manno pyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-,(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-d] oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-a-L-manno pyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-9-ethyl-14-methyl-13-[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranoside; and NF-J: (2R,3S,6S)-6-([(2R,3aR,5aR,5bS,9S,13S, 4R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-alpha-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-3-yl(methyl)formamide, in or on the following raw agricultural commodities: Bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable, bulb, group 3, except green onion at 0.10 ppm; vegetable, fruiting group 8 at 0.4 ppm; and cotton, undelinted seed at 0.04 ppm. (RD)

3. PP 3E8204. (EPA-HQ-OPP-2013-0727). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, proposes based upon the establishment of tolerances in paragraph 4. under “New Tolerance” to remove established tolerances at 40 CFR 180.495 for residues of the insecticide spinosad, a fermentation product of Saccharopolyspora spinosa, consisting of two related active ingredients: Spinosyn A (Factor A: CAS Registry No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; CAS Registry No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α- L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on the raw agricultural commodities: Bushberry subgroup 13B at 0.25 ppm; caneberry subgroup 13A at 0.70 ppm; fruit, citrus, group 10 at 0.30 ppm; fruit, pome, group 11 at 0.20 ppm; fruit, stone, group 12 at 0.20 ppm; grape at 0.50 ppm; juneberry at 0.25 ppm; lingonberry at 0.25 ppm; nut tree, group 14 at 0.10 ppm; okra at 0.40 ppm; onion, green at 2.0 ppm; pistachio at 0.10 ppm; salal at 0.25 ppm; strawberry at 1.0 ppm; vegetable, bulb, group 3, except green onion at 0.10 ppm; vegetable, fruiting group 8 at 0.4 ppm; and cotton, undelinted seed at 0.02 ppm. (RD)

New Tolerance Exemption

1. PP 3F8176. (EPA-HQ-OPP-2013-0717). Anatis Bioprotection, Inc., 278, rang Saint-André, St-Jacques-le-Mineur, Quebec JOJ 1Z0, Canada (represented by Technology Sciences Group, Inc., 712 Fifth St., Suite A, Davis CA 95616), requests to establish an exemption from the requirement of a tolerance for residues of the microbial insecticide, Beauveria bassiana strain ANT-03, in or on all food commodities. The petitioner believes no analytical method is needed because their expectation is that, when used as proposed, Beauveria bassiana strain ANT-03 would not result in residues that are of toxicological concern. (BPPD)

2. PP IN-10604. (EPA-HQ-OPP-2013-0700). Gowan Company, LLC, P.O. Box 5569, Yuma, AZ 85366 requests to establish an exemption from the requirement of a tolerance for residues of ammonium acetate (CAS Registry No. 631-61-8), under 40 CFR 180.920, when used at not more than 15% of a pesticide formulation, as a preharvest inert ingredient in or on raw agricultural commodities. The petitioner believes no analytical method is needed because it is not required for the establishment of a tolerance exemption for inert ingredients. Based on the physical chemical characteristics of ammonium acetate, there is little likelihood of foliar residues remaining on treated crops. Ammonium acetate is highly soluble in water and undergoes rapid environmental degradation in soil and water, breaking down into acetate and ammonium. Acetate/acetic acid as such would not be expected to remain on foliage and or bioaccumulate or persist in humans. Therefore, analytical methods to assess residues of ammonium acetate are not required. (RD)

List of Subjects in 40 CFR Part 180

• Environmental protection
• Agricultural commodities
• Feed additives
• Food additives
• Pesticides and pests
• Reporting and recordkeeping requirements

Dated: December 20, 2013.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.