Pesticide Petitions: Residues of Pesticide Chemicals in or on Various Commodities

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0023; FRL-9901-96]

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 November 25, 2013.

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.html.

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), (703) 305-7090, email address: BPPDFRNotices@epa.gov; or the Registration Division (RD) (7505P), (703) 305-7090, email address: RDFRNotices@epa.gov.; 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 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 Registerdate 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 food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.

New Tolerances

1. PP 2E8119. (EPA-HQ-OPP-2013-0949). 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 fungicide triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1 H-imidazole, in or on tomato at 1.5 parts per million (ppm); fruit, pome, group 11-10 at 0.5 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.5 ppm; and berry, low growing, subgroup, 13-07G at 2.0 ppm. The analytical method is suitable for analyzing crops for residues of triflumizole and its aniline containing metabolites at the proposed tolerance levels. The analytical method has been independently validated. Residue levels of triflumizole are converted to FA-1-1 by acidic and alkaline reflux, followed by distillation. Residues are then extracted and subjected to SPE purification. Detection and quantitation are conducted by gas chromatograph equipped with nitrogen phosphorus detector (GC-NPD), electron capture detector (ECD) or mass spectrometry detection (MSD). The enforcement methodology has been submitted to the Food and Drug Administration (FDA) for publication in the Pesticide Analytical Manual, Vol. II (PAM II). (RD)

2. PP 2E8138. (EPA-HQ-OPP-2013-0653). Bayer CropScience LP, P.O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide tebuconazole, in or on orange, whole fruit at 1 ppm; orange, juice at 0.15 ppm; and orange, oil at 400 ppm. An enforcement method for plant commodities has been validated on various commodities. It has undergone successful EPA validation and has been submitted for inclusion in PAM II. The animal method has also been approved as an adequate enforcement method. (RD)

3. PP 3F8156. (EPA-HQ-OPP-2013-0654). Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide flutriafol, [(±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1 H-1,2,4-triazole-1-ethanol], including its metabolites and degradates, in or on cattle, liver at 0.3 ppm; cattle, muscle at 0.01 ppm; goat, liver at 0.3 ppm; goat, muscle at 0.01 ppm; horse, liver at 0.3 ppm; horse, muscle at 0.01 ppm; milk at 0.01 ppm; sheep, liver at 0.3 ppm; and sheep, muscle at 0.01 ppm. Adequate enforcement analytical methods for determining flutriafol in/on appropriate raw agricultural commodities and processed commodities are available for the established and proposed tolerances. (RD)

4. PP 3F8174. (EPA-HQ-OPP-2013-0655). Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide flutriafol, [(±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1 H-1,2,4-triazole-1-ethanol], including its metabolites and degradates, in or on African tree nut at 0.015 ppm; almond, nutmeat at 0.6 ppm; almond, hulls at 15 ppm; Brazil nut at 0.015 ppm; bur oak at 0.015 ppm; horse, butternut at 0.015 ppm; cajon at 0.015 ppm; cashew at 0.015 ppm; castanha-do-maranhao at 0.015 ppm; cattle, liver at 1.0 ppm; cattle, meat byproducts, except liver at 0.10 ppm; cattle, muscle at 0.03 ppm; coconut at 0.015 ppm; coquito nut at 0.015 ppm; dika nut at 0.015 ppm; goat, liver at 1.0 ppm; goat, meat byproducts, except liver at 0.10 ppm; goat, muscle at 0.03 ppm; Guiana chestnut at 0.015 ppm; hazelnut at 0.015 ppm; heartnut at 0.015 ppm; hickory nut at 0.015 ppm; horse, liver at 1.0 ppm; horse, meat byproducts, except liver at 0.10 ppm; horse, muscle at 0.03 ppm; Japanese horse-chestnut at 0.015 ppm; macadamia nut at 0.015 ppm; milk at 0.02 ppm; mongongo nut at 0.015 ppm; monkey-pot at 0.015 ppm; pachira nutat 0.015 ppm; peanut, hay at 15 ppm; pecan at 0.015 ppm; sapucaia nut at 0.015 ppm; sheep, liver at 1.0 ppm; sheep, meat byproducts, except liver at 0.10 ppm; sheep, muscle at 0.03 ppm; strawberry at 1.5 ppm; tomato, paste at 1.5 ppm; triticale, grain at 0.10 ppm; vegetable, cucurbit, Group 9 at 0.20 ppm; vegetable, fruiting, Group 8-10 at 0.60 ppm; walnut, black at 0.015 ppm; walnut, English at 0.015 ppm; wheat, forage at 30 ppm; wheat, grain at 0.10 ppm; wheat, hay at 15 ppm; and wheat, straw at 9 ppm. Adequate enforcement analytical methods for determining flutriafol in/on appropriate raw agricultural commodities and processed commodities are available for the established and proposed tolerances. (RD)

5. PP 3F8180. (EPA-HQ-OPP-2013-0504). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide trifloxystrobin (benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl)phenyl] ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid), in or on pea, dry, seed at 0.06 ppm; pea, field, hay at 15 ppm; pea, field, vines at 4.0 ppm; chickpea, seed at 0.06 ppm; and lentil, seed at 0.06 ppm. A practical analytical methodology for detecting and measuring levels of trifloxystrobin in or on raw agricultural commodities has been submitted. The method is based on crop specific cleanup procedures and determination by GC-NPD. A newer analytical method is available employing identical solvent mixtures and solvent to matrix ratio (as the first method), deuterated internal standards, and liquid chromatography/mass spectrometry-mass spectrometry (LC/MS-MS) with an electrospray interface, operated in the positive ion mode. (RD)

6. PP 3F8192. (EPA-HQ-OPP-2013-0622). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on grass, forage at 15 ppm; grass, hay at 20 ppm; grass, seed screenings at 0.9 ppm; and grass, straw at 1.5 ppm. Adequate enforcement methodology (LC/MS-MS) methods for plant and livestock commodities are available to enforce the tolerance expression. (RD)

Amended Tolerances

1. PP 2E8119. (EPA-HQ-OPP-2013-0949). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to amend the existing tolerance in 40 CFR 180.476 for residues of the fungicide triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl)-1 H-imidazole, in or on vegetable, cucurbit, group 9 from 0.5 ppm to 0.8 ppm. IR-4 also proposed, upon approval of the tolerances in 1. under “New Tolerance”, to remove established tolerances for apple at 0.5 ppm; pear at 0.5 ppm; grape at 2.5 ppm; and strawberry at 2.0 ppm. The analytical method is suitable for analyzing crops for residues of triflumizole and its aniline containing metabolites at the proposed tolerance levels. The analytical method has been independently validated. Residue levels of triflumizole are converted to FA-1-1 by acidic and alkaline reflux, followed by distillation. Residues are then extracted and subjected to SPE purification. Detection and quantitation are conducted by GC-NPD, ECD or MSD. The enforcement methodology has been submitted to the FDA for publication in the PAM II. (RD)

2. PP 2F8090. (EPA-HQ-OPP-2013-0659). McLaughlin Gormley King Company, 8810 Tenth Avenue North, Minneapolis, MN 55427, requests to amend 40 CFR 180.545 to read: “(a)(1) A tolerance of 1.0 ppm is established for residues of the insecticide prallethrin, including its metabolites and degradates, in or on all raw agricultural commodities and processed food from use of prallethrin in food handling establishments where food and food products are held, processed, prepared and/or served, or as a wide-area mosquito adulticide. Compliance with the tolerance level specified is to be determined by measuring only prallethrin, (RS)-2-methyl-4-oxo-3-(2-propynyl) cyclopent-2-enyl(1RS)-cis,trans-chrysanthemate.” An LC/MS-MS analytical method was developed and validated for prallethrin in grass, alfalfa, and leaf lettuce. (RD)

3. PP 3F8156. (EPA-HQ-OPP-2013-0654). Cheminova A/S, c/o Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510, requests to amend the established tolerances in 40 CFR 180.629 for residues of the fungicide flutriafol, [(±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1 H-1,2,4-triazole-1-ethanol], including its metabolites and degradates, in or on corn, field, forage from 0.75 ppm to 5.0 ppm; corn, field, stover from 1.5 ppm to 15 ppm; corn, pop, stover from 1.5 ppm to 15 ppm; and cattle, meat byproducts at 0.07 ppm to cattle, meat byproducts, except liver at 0.03 ppm; goat, meat byproducts at 0.07 ppm to goat, meat byproducts, except liver at 0.03 ppm; horse, meat byproducts at 0.07 ppm to horse, meat byproducts, except liver at 0.03 ppm; and sheep, meat byproducts at 0.07 ppm to sheep, meat byproducts, except liver at 0.03 ppm. Adequate enforcement analytical methods for determining flutriafol in/on appropriate raw agricultural commodities and processed commodities are available for the established and proposed tolerances. (RD)

4. PP 3F8157. (EPA-HQ-OPP-2013-0656). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to amend the tolerances in 40 CFR 180.617 for residues of the fungicide metconazole, [5-[(4-chlorophenyl)methyl]-2,2-dimethyl-1-(1 H-1,2,4-triazol-1-ylmethyl)cyclopentanol] as the sum of its cis- and trans- isomers in or on corn, field, stover from 4.5 ppm to 30.0 ppm and corn, pop, stover from 4.5 ppm to 30.0 ppm. Independently validated analytical methods have been submitted for analyzing parent metconazole residues with appropriate sensitivity in the raw crop and processed commodities for field and sweet corn stover for which an increase in tolerance is being requested. (RD)

5. PP 3F8185. (EPA-HQ-OPP-2013-0622). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to amend the tolerances in 40 CFR 180.649 for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on barley, grain from 0.10 ppm to1.0 ppm; barley, straw from 0.10 ppm to15.0 ppm; barley, bran from 0.10 ppm to 1.53 ppm; wheat, grain from 0.10 ppm to 0.6 ppm; and wheat, straw from 0.10 ppm to 6.0 ppm, included under the existing tolerances for “Grain, cereal, group 15” and “Grain, cereal, forage, fodder and straw group 16”. In addition, BASF Corporation requests to amend the existing commodity definition, “Grain, cereal, forage, fodder and straw group 16” to “Grain, cereal, forage, fodder and straw, group 16, except barley, rice and wheat straw” as well as amend the commodity definition, “Grain, cereal, group 15” to “Grain, cereal, group 15, except barley and wheat.” Adequate enforcement methodology (LC/MS-MS) methods for plant and livestock commodities are available to enforce the tolerance expression. (RD)

6. PP 3F8192. (EPA-HQ-OPP-2013-0622). BASF Corporation, 26 DavisDrive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to amend the tolerances in 40 CFR 180.649 for residues of the herbicide saflufenacil, including its metabolites and degradates, in or on livestock commodities (cattle, goat, horse, sheep): fat from 0.01 ppm to 0.05 ppm; liver from 2.5 ppm to 45 ppm; and meat byproducts, except liver from 0.05 ppm to 0.5 ppm; hog, fat from 0.01 ppm to 0.05 ppm; hog, liver from 0.80 ppm to 45 ppm; and hog, meat byproducts, except liver from 0.02 ppm to 0.5 ppm. Adequate enforcement methodology (LC/MS-MS) methods for plant and livestock commodities are available to enforce the tolerance expression. (RD)

7. PP 3F8196. (EPA-HQ-OPP-2013-0673). K-I Chemical U.S.A., Inc. c/o Landis International, Inc., P.O. Box 5126 Valdosta, GA 31603-5126, requests to amend the tolerances in 40 CFR 180.659 for residues of the sum of the herbicide pyroxasulfone, [3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-yl]methyl] sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole] and its metabolite 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-carboxylic acid (M-3) calculated as the stoichiometric equivalent of pyroxasulfone, in or on corn, field, grain at 0.02 ppm; and pyroxasulfone [3-[[[5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-yl]methyl]sulfonyl]-4,5-dihydro-5,5-dimethylisoxazole] and its metabolites [5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic acid (M-1), 5-(difluoromethoxy)-1-methyl-3-(trifluoromethyl)-1H-pyrazol-4-carboxylic acid (M-3), and [5-(difluoromethoxy)-3-(trifluoromethyl)-1H-pyrazol-4-yl]methanesulfonic acid (M-25), calculated as the stoichiometric equivalent of pyroxasulfone in or on corn, field, forage at 0.09 ppm. EPA has approved an analytical enforcement methodology including LC/MS-MS to enforce the tolerance expression for pyroxasulfone. (RD)

8. PP 3F8197. (EPA-HQ-OPP-2013-0670). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to amend the tolerances in 40 CFR 180.464 for residues of the herbicide dimethenamid, in or on cottonseed, subgroup 20 at 0.01 ppm; cotton, gin byproducts at 1.5 ppm; and cotton, seed, refined oil at 0.02 ppm. Compliance with the plant commodity tolerances level is to be determined by measuring only the sum of residues of dimethenamid, 1 (R,S)-2-chloro- N -[(1-methyl-2-methoxy)ethyl]- N -(2,4-dimethylthien-3-yl)-acetamide, applied as either the 90:10 or 50:50 S:R isomers, in or on commodities. The enforcement analytical method uses extraction and clean up followed by quantification with capillary column gas chromatography using thermionic nitrogen specific detector. A gas spectrometry/MS (GS/MS) method for identification is also available. This method is not selective towards the dimethenamid isomer and is therefore valid for residues from both racemic dimethenamid and the enriched isomer dimethenamid-P. An LC/MS-MS method was developed as a residue generation method to fulfill residue chemistry investigations, and was used to develop the cotton residue data. Tolerances are proposed on a non-isomer specific basis. (RD)

New Tolerance Exemptions

1. PP 3F8148. (EPA-HQ-OPP-2013-0277). Amy Plato Roberts, Regulatory Consultant, Technology Sciences Group, Inc., 712 Fifth St., Suite A, Davis, CA 95616, on behalf of Agri-Neo, Inc., 3485 Ashby Saint-Laurent (Quebec), H4R 2K3, Canada, requests to establish an exemption from the requirement of a tolerance for residues of the biochemical tetraacetylethylenediamine (TAED) and its degradation product diacetylethylenediamine (DAED), in or on all food commodities. The petitioner believes no analytical method is needed because it is not required for a tolerance exemption. (BPPD)

2. PP 3F8172. (EPA-HQ-OPP-2013-0666). Novozymes BioAg, Inc., 13100 W. Lisbon Road, Suite 600, Brookfield, WI 53005, requests to establish an exemption from the requirement of a tolerance for residues of the microbial insecticide, Chromobacterium subtsugae strain SB3872, in or on all food commodities. The petitioner believes no analytical method is needed because, when used as directed, Chromobacterium subtsugae strain SB3872 will not result in residues that are of toxicological concern. (BPPD)

3. PP IN-10622. (EPA-HQ-OPP-2013-0590). Technology Sciences Group, Inc., 1150 18th St. NW., Suite 1000, Washington, DC 20036, requests to establish an exemption from the requirement of a tolerance for residues of coco alkyl dimethyl amines (CAS No. 61788-93-0), under 40 CFR 180.920, when used as a pesticide inert ingredient in pesticide formulations for use in or on growing crops. The petitioner believes no analytical method is needed because it is not required for the establishment of a tolerance exemption for inert ingredients. (RD)

List of Subjects

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

Dated: September 30, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-25267 Filed 10-24-13; 8:45 am]
BILLING CODE 6560-50-P
 
 
Comment Period Closed
ID: EPA-HQ-OPP-2013-0023-0006
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Date Posted: Oct 25, 2013
RIN: Not Assigned
CFR: 40 CFR Part 180
Federal Register Number: 2013-25267
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