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Proposed Rule

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

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice of filing of pesticide petitions.

SUMMARY:

This notice 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 April 28, 2011.

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 on-line 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 on-line 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 e-mail. The regulations.gov website 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 e-mail comment directly to EPA without going through regulations.gov, your e-mail 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.

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FOR FURTHER INFORMATION CONTACT:

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

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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. 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 e-mail. 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.Start Printed Page 17375

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, proposing 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. EPA has determined that the pesticide petitions described in this notice 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. 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 notice, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available on-line 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 0E7794. (EPA-HQ-OPP-2011-0110). BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709, proposes to establish a tolerance in 40 CFR part 180 for residues of the herbicide imazapic, (±)-2-[4,5-dihydro-4-methyl-4-(1-methylethyl)-5-oxo-1-H-imidazol-2-yl]-5-methyl-3-pyridinecarboxylic acid, in or on soybean at 0.5 parts per million (ppm). The proposed analytical method for detecting residues of imazapic and the metabolites M715H001 (CL 263,284) and M715H002 (CL 189,215) in soybean seed and processed fractions is a liquid chromatography-tandem mass spectrometry (LC/MS/MS) method. Enforcement methods for analysis of residues of imazapic and metabolite M715H001 (CL 263,284) in animal commodities have been previously submitted. The analytical method for analysis in meat and meat byproducts is based on capillary electrophoreses with confirmation by LC/MS. The analytical method for analysis in milk and fat is based on determination by LC/MS with confirmation by LC/MS/MS. Contact: Mindy Ondish, (703) 605-0723, e-mail address: ondish.mindy@epa.gov.

2. PP 0E7797. (EPA-HQ-OPP-2011-0146). Bayer CropScience, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709, proposes to establish import tolerances in 40 CFR part 180 for residues of the fungicide propineb, [[[2-[(Dithiocarboxy)amino]-1-methyethyl] carbamodithioato(2-)-êS,êS']zinc], in or on apple, fruit at 2.5 ppm; apple, wet pomace at 2.5 ppm; pear, fruit at 2.5 ppm; citrus, fruit at 4.5 ppm; banana, fruit (bagged) at 1.2 ppm; banana, fruit (unbagged) at 8.0 ppm; vegetable, cucurbit, group 9 at 8.0 ppm; vegetables, fruiting, group 8 at 8.0 ppm; onion, dry bulb at 1.6 ppm; onion, green at 13 ppm; grape at 0.8 ppm; olive at 0.35 ppm; avocado; and fruit crops, including: Black sapote; canistel; mamey sapote; mango; papaya; sapodilla; and star apple at 5.0 ppm. Propineb is rapidly degraded by hydrolysis and photolysis to the main metabolite propylenethiourea (PTU), which is the toxicologically relevant metabolite. Various analytical methods have been used, but samples are now prepared and analyzed by high performance liquid chromatography (HPLC)-atmosphere pressure chemical ionization/MS/MS. The limits of quantitation LOQ) is 0.01 ppm for PTU. Contact: Tamue L. Gibson, (703) 305-9096, e-mail address: gibson.tamue@epa.gov.

3. PP 0E7820. (EPA-HQ-OPP-2011-0087). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, proposes to establish tolerances in 40 CFR part 180 for residues of the insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, persimmon and acerola at 0.45 ppm; and lychee, longan, Spanish lime, rambutan and pulasan at 3.5 ppm. Adequate analytical methodology using LC/MS/MS detection is available for enforcement purposes. Contact: Laura E. Nollen, (703) 305-7390, e-mail address: nollen.laura@epa.gov.

4. PPs0F7714 and F7715. (EPA-HQ-OPP-2011-0053). Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709, proposes to establish tolerances in 40 CFR part 180 for residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl)]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio metabolite, in or on raw or processed agricultural commodities rice, grain at 0.25 ppm; rice, hulls at 1.0 ppm; alfalfa, forage and alfalfa, hay at 0.02 ppm; and potato, tuber at 0.02 ppm. Bayer CropScience is also proposing use of the currently established tolerances for residues of prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl)]-1,2-dihydro-3H-1,2,4-triazole-3-thione and its desthio metabolite, in or on the raw agricultural commodity pea and bean, dried shelled, except soybean, subgroup 6C; soybean, forage; soybean, hay; and soybean, seed to support the use of prothioconazole as a seed treatment on these crops. Bayer CropScience is also proposing that the above proposed tolerances on rice, based on foliar data, also support the use of prothioconazole as a seed treatment on rice. The analytical method for determining residues of concern in plants extracts residues of prothioconazole and JAU6476-desthio and converts the prothioconazole to JAU6476-desthio and JAU6476-sulfonic acid. Following addition of internal standards the sample extracts are analyzed by LC/MS/MS. Radiovalidation and independent laboratory validation have shown that the method adequately quantifies prothioconazole residues in treated commodities. The validated LOQ for total prothioconazole-derived residues in rice grain was 0.02 ppm. The validated LOQs were 0.01 ppm for 1H-1,2,4-triazole and 0.05 ppm for the triazole conjugates for grain. The Start Printed Page 17376analytical method for analysis of large animal tissues includes extraction of the residues of concern, followed by addition of an internal standard to the extract. The extract is then hydrolyzed to release conjugates, partitioned and analyzed by LC/MS/MS as prothioconazole, JAU6476-desthio and JAU6476-4-hydroxy. The method for analysis of milk eliminated the initial extraction step in the tissue method. Contact: Tawanda Maignan, (703) 308-8050, e-mail address: maignan.tawanda@epa.gov.

5. PP 0F7812. (EPA-HQ-OPP-2011-0007). Nippon Soda Co., Ltd., c/o Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide acetamiprid, N 1-[(6-chloro-3-pyridyl)methyl]-N 2-cyano-N 1-methylacetamidine, including its metabolites and degradates, in or on food/feed handling establishments at 0.05 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 toxic residues. As a result a method was developed that involves extraction of acetamiprid from composite meals with a solvent followed by a decantation and filtration and finally analysis by a LC/MS/MS method. The LOQ and the limit of detection (LOD) for the method are calculated to be 0.05 ppm and 0.01 ppm for composite meals, respectively. The method was reliable for composite meal analyses with an overall average recovery of 93 ± 14%. Contact: Jennifer Urbanski, (703) 347-0156, e-mail address: urbanski.jennifer@epa.gov.

6. PP 0F7817. (EPA-HQ-OPP-2011-0144). E.I. duPont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898, proposes to establish a tolerance in 40 CFR part 180 for residues of the herbicide aminocyclopyrachlor, [6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylic acid] and aminocyclopyrachlor methyl ester [methyl 6-amino-5-chloro-2-cyclopropyl-4-pyrimidinecarboxylate], expressed as aminocyclopyrachlor, in or on grass forage at 65 ppm; grass hay at 125 ppm; fat (of cattle, goat, horse and sheep) at 0.07 ppm; meat (of cattle, goat, horse and sheep) at 0.02 ppm; meat byproducts—excluding liver (of cattle, goat, horse and sheep) at 0.4 ppm; liver (of cattle, goat, horse and sheep) at 0.06 ppm; and milk at 0.035 ppm. Adequate analytical methods for enforcement purposes are available to monitor residues of aminocyclopyrachlor in grass commodities, milk, meat and meat byproducts. The analytical methods for both grass commodities and ruminant commodities use an LC/MS/MS system operating with an electrospray interface (ESI) in positive ion mode with limits of quantitation (LOQ) of 0.01 ppm. Both methods have been successfully independently validated by outside laboratories. Aminocyclopyrachlor had also been tested through the Food and Drug Administration (FDA), Multi-residue Methodology. Contact: Mindy Ondish, (703) 605-0723, e-mail address: ondish.mindy@epa.gov.

7. PP 1F7822. (EPA-HQ-OPP-2011-0152). E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898, proposes to establish tolerances in 40 CFR part 180 for residues of the herbicide quizalofop-p-ethyl, (ethyl-2-[4-(6-chloroquinoxalin-2-yl oxy) phenoxy] propanoate), including its metabolites and degradates (DUPONTTM ASSURE® II), in or on corn, grain at 0.01 ppm; corn, forage at 0.01 ppm; and corn, stover at 0.03 ppm. The currently proposed aspirated grain fraction (AGF) tolerance of 1.0 ppm, based on sorghum AGF in PP 0E7802, will not be changed by corn AGF residues. An adequate analytical methodology (HPLC using either ultraviolet (UV) or fluorescence detection) is available for enforcement purposes in Volume II of the Food and Drug Administration Pesticide Analytical Method (PAM II, Method I). Contact: Mindy Ondish, (703) 605-0723, e-mail address: ondish.mindy@epa.gov.

Amended Tolerances

1. PP 0E7781. (EPA-HQ-OPP-2010-0980). BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709, proposes to amend the tolerances in 40 CFR 180.560 by amending the tolerance expression to establish combined residues of cloquintocet-mexyl (acetic acid, [(5-chloro-8-quinolinyl)oxy]-,1-methylhexylester) (CAS Reg. No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid) when used as an inert ingredient (safener) in pesticide formulations containing either the herbicide clodinafop-propargyl or pinoxaden in a 1:4 ratio of safener to active ingredient or in combination with the registered active ingredient dicamba, in or on wheat, grain at 0.10 ppm; wheat, forage at 0.2 ppm; wheat, hay at 0.50 ppm; and wheat, straw at 0.10 ppm. A practical analytical method for the determination of cloquintocet-mexyl and its major plant metabolite CGA-153433 in wheat raw agricultural commodities (RACs) published in the Federal Register of April 19, 2000 (65 FR 20972) (FRL-6554-3). Contact: Bethany Benbow, (703) 347-8072, e-mail address: benbow.bethany@epa.gov.

2. PP 0F7792. (EPA-HQ-OPP-2011-0120). Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709, proposes to amend the tolerances in 40 CFR part 180.474 for residues of the fungicide tebuconazole, alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethylethyl)-1 H -1,2,4-triazole-1-ethanol), in or on wheat, grain and oats, grain by increasing the tolerances from 0.05 ppm to 0.15 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 Pesticide Analytical Method Volume II (PAM II). The animal method has also been approved as an adequate enforcement method. Contact: Tracy Keigwin, (703) 305-6605, e-mail address: keigwin.tracy@epa.gov.

New Tolerance Exemptions

1. PP 0E7815. (EPA-HQ-OPP-2011-0093). Monsanto Company, 1300 I Street NW., Suite 450 East, Washington, DC 20005, proposes to establish an exemption from the requirement of a tolerance for residues of amides, C5-C9, N-3-[(dimethylamino)propyl] (CAS No. 1044764-00-2) and amides C6-C12, N-3-[(dimethylamino)propyl] (CAS No. 1044754-06-8) when used as a pesticide inert ingredient (surfactant) in pesticide formulations in 40 CFR part 180.910 pre- and post-harvest uses. The petitioner believes no analytical method is needed because they are not applicable or required for the establishment of a tolerance exemption for inert ingredients. Contact: Deirdre Sunderland, (703) 603-0851, e-mail address: sunderland.deirdre@epa.gov.

2. PP 0E7797. (EPA-HQ-OPP-2011-0146). Bayer CropScience, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709, proposes to establish an exemption from the requirement of a tolerance for residues of the fungicide propineb, [[[2-[(Dithiocarboxy)amino]-1-methyethyl] carbamodithioato(2-)-êS, êS']zinc], in or on apple, juice; citrus, juice; citrus, oil; citrus, dried pulp; tomato, puree; tomato, paste. The petitioner believes no analytical method is needed because no concentration was recovered by the maximum residue level (MRL) for these raw agricultural commodities. Also, the high performance liquid chromatography-atmosphere pressure chemical ionization/tandem mass spectrometry analytical method is available to EPA for the detection and measurement of the pesticide residues. Contact: Tamue Start Printed Page 17377L. Gibson, (703) 305-9096, e-mail address: gibson.tamue@epa.gov.

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List of Subjects

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Dated: March 15, 2011.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.

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[FR Doc. 2011-6887 Filed 3-28-11; 8:45 am]

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