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Proposed Rule

Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

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.

 

Table of Contents Back to Top

DATES: Back to Top

Comments must be received on or before May 4, 2012.

ADDRESSES: Back to Top

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.
  • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
  • 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 Facility'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.

Instructions: Direct your comments to the docket ID number and the pesticide petition number of interest as shown in the body of this document. EPA's policy is that all comments received will be included in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., 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 Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Back to Top

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 Antimicrobials Division (7510P), or Biopesticides and Pollution Prevention Division (7511P) or Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION: Back to Top

I. General Information Back to Top

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. Potentially affected entities may include, but are not limited to:

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

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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? Back to Top

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 174 or 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 1E7869. (EPA-HQ-OPP-2012-0048). Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27409, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide cyprodinil, 2-pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenyl-, in or on leafy petioles subgroup 04B at 30 parts per million (ppm). Syngenta Crop Protection, has developed and validated analytical methodology for enforcement purposes. This method Syngenta Crop Protection Method AG-631B, has passed an Agency petition method validation for several commodities and is currently the enforcement method for cyprodinil. Contact: Lisa Jones, (703) 308-9424, email address: jones.lisa@epa.gov.

2. PP 1E7870. (EPA-HQ-OPP-2012-0047). Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27409, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide fludioxonil, 4-(2, 2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile, in or on leafy petioles subgroup 04B at 14 ppm. Syngenta Crop Protection, has developed and validated the analytical method Syngenta Crop Protection Method AG-597B for enforcement purposes and has also passed an Agency petition method validation (PMV) for several commodities. It is currently the enforcement method for fludioxonil and has also been forwarded to the Food and Drug Administration (FDA) for inclusion into Pesticide Analytical Manual Volume II (PAM II). Contact: Lisa Jones, (703) 308-9424, email address: jones.lisa@epa.gov.

3. PP 1E7924. (EPA-HQ-OPP-2012-0038). Bayer CropScience, P.O. Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, requests to establish import tolerances in 40 CFR part 180 for residues of the insecticide spiromesifen, 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate and its enol metabolite; 4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one calculated as the parent compound equivalents, in or on imported tea, dried and the processed commodity instant tea at 50 ppm. Adequate analytical methodology using liquid chromatography/mass spectrometry (LC/MS/MS) detection is available for enforcement purposes. Contact: Jennifer Gaines, (703) 305-5967, email address: gaines.jennifer@epa.gov.

4. PP 1E7945. (EPA-HQ-OPP-2012-0041). Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish an import tolerance in 40 CFR part 180 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]pheny1]-3-methoxyacrylate, in or on ginseng extract (red ginseng extract and ginseng extract) at 0.5 ppm. An adequate analytical method, gas chromatography with nitrogen-phosphorus detection (GC/NPD) or in mobile phase by high performance liquid chromatography with ultra-violet detection (HPLC/UV) is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. Contact: Erin Malone, (703) 347-0253, email address: malone.erin@epa.gov.

5. PP 1E7951. (EPA-HQ-OPP-2011-1011). 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 herbicide S-ethyl dipropylthiocarbamate (EPTC), including its metabolites and degradates, determined by measuring only the sum of S-ethyl dipropylthiocarbamate, S-ethyl (2-hydroxypropyl) propylcarbamothioate, S-(2-hydroxyethyl)dipropylcarbamothioate, and S-ethyl (3-hydroxypropyl)propylcarbamothioate, calculated as the stoichiometric equivalent of S-ethyl dipropylthiocarbamate, in or on fruit, citrus, group 10-10 at 0.1 ppm; sunflower subgroup 20B at 0.08 ppm; and watermelon at 0.08 ppm. Adequate methods are available for the determination of EPTC and three hydroxy metabolites in crops, including watermelon. EPTC is analyzed by extraction of the macerated samples with toluene with subsequent quantification using GC/NPD. The three hydroxy metabolites are extracted from macerated samples with a mixture of acetone and water. The acetone is dispelled and the aqueous fraction is digested with acid. The hydrolyzed metabolites are then extracted with a mixture of hexane and ether, and the extract is purified through a solid phase extraction cartridge. The residues are then derivatized and quantified using a GC equipped with a mass-selective detector (MSD). Contact: Sidney Jackson, (703) 305-7610, email address: jackson.sidney@epa.gov.

6. PP 1E7957. (EPA-HQ-OPP-2012-0010). 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 herbicide quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, including its metabolites and degradates determined by measuring only quinclorac, in or on rhubarb at 0.4 ppm; and berry, low growing, except strawberry, subgroup 13-07H at 1.1 ppm. Adequate analytical methods, utilizing GC with electron capture detection (GC/ECD), are available to enforce the tolerance expression on plant (BASF Method A8902) and animal (BASF Method 268/1) commodities. Both methods have undergone successful Agency method validation trials, and have been submitted to the FDA for publication in PAM II as the tolerance enforcement methods. Contact: Sidney Jackson, (703) 305-7610, email address: jackson.sidney@epa.gov.

7. PP 1E7958. (EPA-HQ-OPP-2012-0107). 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 spirotetramat, cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate and its metabolites BYI 08330-enol cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, BYI 08330-ketohydroxy cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione, BYI 08330-enol-Glc cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and BYI 08330-mono-hydroxy cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, calculated as spirotetramat equivalents, in or on taro, leaves at 9 ppm; watercress at 1.5 ppm; pomegranate at 0.5 ppm; banana at 4 ppm; vegetable, bulb, group 3-07 at 0.6 ppm; berry, low growing, except strawberry, subgroup 13-07H at 0.3 ppm; bushberry, subgroup 13-07B at 3 ppm; artichoke, globe at 2 ppm; vegetable, fruiting, group 8-10 at 2.5 ppm; fruit, pome, group 11-10 at 0.7 ppm; fruit, citrus, group 10-10 at 0.6 ppm; pineapple at 0.3 ppm; pineapple, process residue at 0.36 ppm; coffee, green beans at 0.2 ppm; and coffee, roast beans at 0.32 ppm. Spirotetramat residues are quantified in raw agricultural commodities by HPLC/triple stage quadrupole mass spectrometry (HPLC/MS/MS) using the stable isotopically labeled analytes as internal standards. Contact: Laura Nollen, (703) 305-7390, email address: nollen.laura@epa.gov.

8. PP 1F7845. (EPA-HQ-OPP-2011-0458). Bayer CropScience, 2 T. W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, requests to establish a tolerance 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 artichoke, globe at 1.0 ppm. A practical analytical method for detecting and measuring levels of trifloxystrobin, in or on raw agricultural commodities is based on crop specific cleanup procedures and determination by GC/NPD. A newer analytical method is available by LC/MS/MS with electrospray interface, operated in the positive ion mode. Contact: Tawanda Maignan, (703) 308-8050, email address: maignan.tawanda@epa.gov.

9. PP 1F7954. (EPA-HQ-OPP-2012-0029). E. I. DuPont de Nemours and Company, DuPont Crop Protection, 1007 Market Street, Wilmington, DE 19898, requests to establish a tolerance in 40 CFR part 180 for residues of the chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-[(methylamino)-carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1 H-pyrazole-5-carboxamide, in or on oilseed, rapeseed, subgroup 20A at 2.0 ppm; oilseed, sunflower, subgroup 20B at 2.0 ppm; oilseed, cottonseed, subgroup 20C at 0.3 ppm; soybean, aspirated grain fractions at 300 ppm; vegetable, legume, group 6 at 2.0 ppm; vegetable, foliage of legume, group 7 at 30 ppm; and forage, vegetable, foliage of legume, group 7 at 90 ppm. An analytical residue method has been submitted to EPA which permits determination of trace residues of the parent compound on various food and feed commodities. Contact: Jennifer Urbanski, (703) 347-0156, email address: urbanski.jennifer@epa.gov.

Amended Tolerances

1. PP 1E7951. (EPA-HQ-OPP-2011-1011). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to amend the tolerances in 40 CFR 180.117 for residues of the herbicide S - ethyl dipropylthiocarbamate (EPTC), including its metabolites and degradates, determined by measuring only the sum of S-ethyl dipropylthiocarbamate, S-ethyl (2-hydroxypropyl) propylcarbamothioate, S-(2-hydroxyethyl)dipropylcarbamothioate, and S-ethyl (3-hydroxypropyl)propylcarbamothioate, calculated as the stoichiometric equivalent of S-ethyl dipropylthiocarbamate, by removing the following established tolerances: Fruit, citrus, group 10 at 0.1 ppm; safflower, seed at 0.08 ppm; and sunflower, seed at 0.08 ppm, as these commodities are included in updated crop groups or subgroups listed under “New Tolerances” for PP 1E7951. Contact: Sidney Jackson, (703) 305-7610, email address: jackson.sidney@epa.gov.

2. PP 1E7958. (EPA-HQ-OPP-2012-0107). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to amend 40 CFR 180.641 for residues of the insecticide spirotetramat, cis-3-(2,5-dimethlyphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate and its metabolites BYI 08330-enol cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, BYI 08330-ketohydroxy cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione, BYI 08330-enol-Glc cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and BYI 08330-mono-hydroxy cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, calculated as spirotetramat equivalents, by removing the established tolerances: Onion, bulb, subgroup 3A-07 at 0.30 ppm; fruit, citrus, group 10 at 0.60 ppm; fruit, pome, group 11 at 0.70 ppm; okra at 2.5 ppm; and vegetable, fruiting, group 8 at 2.5 ppm, as they will be superseded by inclusion in updated crop groups or subgroups listed under “New Tolerances”. Contact: Laura Nollen, (703) 305-7390, email address: nollen.laura@epa.gov.

New Tolerance Exemptions

1. PP 1E7912. (EPA-HQ-OPP-2012-0014). ICR, Inc., 1330 Dillon Heights Ave, Catonsville, MD on behalf of Triton Systems, Inc., 200 Turnpike Road, Chelmsford, MA 01824, requests to establish an exemption from the requirement of a tolerance for residues of 1,2-Ethanediamine, N1-(2-aminoethyl)-, polymer with 2,4-diisocyanato-1-methylbenzene, with number average molecular weight greater than 10,000 daltons, (CAS No. 35297-61-1) under 40 CFR 180.960 when used as a pesticide inert ingredient microencapsulation in pesticide formulations. The petitioner believes no analytical method is needed because this information is generally not required when all criteria for polymer exemption under 40 CFR 723.250 are met. Contact: Anthony Britten, (703) 308-8179, email address: britten.anthony@epa.gov.

2. PP 1E7938. (EPA-HQ-OPP-2012-0043). Honeywell International, Inc., 101 Columbia Road, Morristown, NJ 07962-1053, requests to establish an exemption from the requirement of a tolerance for residues of trans-1,3,3,3-tetrafluoroprop-1-ene, (CAS No. 29118-24-9) under 40 CFR 180.910, 180.930, and 180.940 when used as a pesticide inert ingredient propellant in pesticide formulations. The petitioner believes no analytical method is needed because this is a petition for exemption from the requirement of a tolerance. Contact: Lisa Austin, (703) 305-7894, email address: austin.lisa@epa.gov.

3. PP 1F7960. (EPA-HQ-OPP-2012-0152). Enerfab, Inc., 4955 Spring Grove Avenue, Cincinnati, OH 45232, requests to establish an exemption from the requirement of a tolerance for residues of the antimicrobial gaseous chlorine dioxide, on tomato. EPA Method 300, Ion Chromatography, was used for measuring chlorite and chlorate residues rinsed from surface of produce treated with chlorine dioxide gas. Contact: Jaclyn Carl, (703) 347-0213, email address: carl.jaclyn@epa.gov.

Amended Tolerance Exemption

PP 1F7857. (EPA-HQ-OPP-2012-0109). Syngenta Seeds, Inc., Field Crops NAFTA, P.O. Box 12257, 3054 E. Cornwallis Road, Research Triangle Park, NC 27709-2257, requests to amend an exemption from the requirement of a tolerance in 40 CFR 174.532 for residues of the plant-incorporated protectant (PIP), Bacillus thuringiensis eCry3.1Ab protein in corn, in or on the food and feed commodities of corn; corn, field; corn, sweet; and corn, pop. The petitioner believes no analytical method is needed because an exemption from the requirement of a tolerance is being sought. However, in response to an Agency request, the Petitioner has submitted an immunoassay method for determination of eCry3.1Ab protein in corn tissues. Contact: Mike Mendelsohn, (703) 308-8715, email address: mendelsohn.mike@epa.gov.

List of Subjects in 40 CFR Parts 174 and 180 Back to Top

Dated: March 16, 2012.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 2012-8095 Filed 4-3-12; 8:45 am]

BILLING CODE 6560-50-P

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