E8-20519. Notice of Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the Agency’s receipt of several initial filing of pesticide petitions proposing the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities

DATES:

Comments must be received on or before October 6, 2008.

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 [phone].

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 [phone].

FOR FURTHER INFORMATION CONTACT:

A contact person is listed at the end of each pesticide petition summary and may be contacted by telephone or e-mail. The mailing address for each contact person listed is: 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. 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.

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 180 for residues of pesticide chemicals in or on various food commodities. 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. 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 8F7373. (EPA-HQ-OPP-2008-0126). Chemtura Corporation, 199 Benson Road, Middlebury, CT 06749, proposes to establish a tolerance for residues of the insecticide bifenazate, hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl) 1-methylethyl ester, in or on corn, grain at 0.02 part per million (ppm); corn, sweet, kernel plus cob with husks removed at 0.05 ppm; corn, forage at 25 ppm; corn, stover at 13 ppm; and aspirated grain fractions at 0.7 ppm. The analytical method was designed to convert all residues of D3598, a significant metabolite, to the parent compound (bifenazate) for analysis. The method utilizes reversed phase high performance liquid chromatography (HPLC) to separate the bifenazate from matrix derived interferences, and oxidative coulometric electrochemical detection for the identification and quantification of this analyte. The limit of quantitation (LOQ) for bifenazate in corn matrices and processed commodities was 0.01 ppm. The limit of detection (LOD) for the method is set at 0.005 ppm. The method has also been validated by liquid chromatography/mass spectrometry/mass spectroscopy (LC/MS/MS), and used for the confirmation of residues for corn raw agricultural commodities (RAC) and processed commodities. The analytical method for bifenazate and its major metabolite D3598, in animal tissues was designed using the same principles invoked in the plant method, with minor modifications. However, in animal tissue samples, a separate aliquot of the extract was used to determine residues of A1530, and its sulfate (combined) in milk and meat samples (as these metabolites appeared to be significant in the goat metabolism studies). The extract was subjected to acid hydrolysis to convert the sulfate conjugate to A1530, before it was quantified by LC/MS/MS. Another metabolite, D9569, was also monitored in milk by LC/MS/MS. Contact: Amer Al-Mudallal, [phone]; [e-mail].

2. PP 8F7395. (EPA-HQ-OPP-2008-0646). Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596 (as Agent for Sumitomo Chemical Company, Ltd.), proposes to establish a tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on almond, hull at 1.5 ppm; cotton, seed at 0.25 ppm; cotton, gin trash at 4.5 ppm; cotton, meal at 0.25 ppm; cotton, hull at 0.25 ppm; cotton, refined oil at 0.01 ppm; soybean, seed at 0.03 ppm; soybean, hull at 0.35 ppm; soybean, meal at 0.07 ppm; soybean, oil at 0.01 ppm; tomato, paste at 0.08 ppm; tomato, puree at 0.07 ppm; nut, tree, group 14 at 0.01 ppm; vegetable, cucurbit, group 9 at 0.05 ppm; and vegetable, fruiting, group 8 at 0.25 ppm; and clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine and its metabolite, N-(2-chlorothiazol-5-ylmethyl)-N’-methylguanidine (TMG), in or on vegetable, leafy, brassica, group 5 at 3.0 ppm; and vegetable, leafy, except brassica, group 4 at 3.5 ppm. Adequate enforcement methodology LC/MS/MS analysis is available to enforce the tolerance expression. Contact: Kable Davis, [phone]; [e-mail].

New Exemption from an Inert Tolerance

PP 8E7402. (EPA-HQ-OPP-2008-0652). Falcon Lab, LLC, 1103 Norbee Drive, Wilmington, DE 19803, proposes to establish an exemption from the requirement of a tolerance in 40 CFR 180.910 and 40 CFR 180.950 for residues of ammonium salts of higher fatty acids, [C₈-C₁₈ saturated and C₈-C₁₂ unsaturated, (CAS No. 84776-33-0)], when used as a pesticide inert ingredient in pesticide formulations in or on all food commodities. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, [phone]; [e-mail].

List of Subjects

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

Dated: August 27, 2008.

Donald R. Stubbs,

Acting Director, Registration Division, Office of Pesticide Programs.