2010-6344. 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 filings 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 April 23, 2010.

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, 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 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 a typical 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 0E7684. (EPA-HQ-OPP-2009-0682). The Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201W, Princeton, NJ 08540, proposes to establish 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 parent compound equivalents, in or on pea, dry, seed at 0.15 parts per million (ppm); spearmint, tops at 25 ppm; and peppermint, tops at 25 ppm. Adequate analytical methodology using liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) detection is available for enforcement purposes. Contact: Andrew Ertman, [phone]; e-mail address: [e-mail].

2. PP 9E7564. (EPA-HQ-OPP-2010-0136). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to establish tolerances in 40 CFR part 180 for residues of the fungicide spiroxamine, (8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-dioxaspiro[4,5]decane-2-methanamine) and its metabolites containing the N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane moiety, calculated as parent equivalent, in or on artichoke at 0.7 ppm; asparagus at 0.05 ppm; and vegetable, fruiting, group 8 at 1.2 ppm. Analytical methods to determine the total residues of spiroxamine (sum of spiroxamine and all metabolites containing the aminodiol moiety [N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane]) using gas chromatography (GC) have been submitted to the EPA. In addition, a new validated method employing high performance liquid chromatography/MS/MS (HPLC-MS/MS) with a limit of quantitation (LOQ) of 0.05 ppm for total residues of spiroxamine is being submitted. The extraction and hydrolysis procedures of the two methods are, and the LC/MS/MS substitutes a cation exchange cartridge cleanup, compared to the liquid/liquid partition, polystyrenedivinylbenzene column cleanup and trimethylsilylation derivatization. Contact: Tamue Gibson, [phone]; e-mail address: [e-mail].

3. PP 9F7602. (EPA-HQ-OPP-2009-0682). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to establish a tolerance 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 vegetable, leafy petiole, crop subgroup 4B at 6.0 ppm. Adequate analytical methodology using LC/MS/MS detection is available for enforcement purposes. Contact: Jennifer Gaines, [phone]; e-mail address: [e-mail].

4. PP 9F7644. (EPA-HQ-OPP-2009-0988). Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 20052, proposes to establish a tolerance in 40 CFR part 180 for residues of the herbicide glyphosate, N-(phosphonomethyl) glycine, in or on corn, sweet, forage at 9 ppm. Adequate enforcement methods are available for analysis of residues of glyphosate and its metabolite AMPA in or on plant and livestock commodities. These methods include: Gas liquid chromatography (GLC) — Method I in PAM II, 0.05 ppm LOD; HPLC with fluorometric detection, 0.0005 ppm LOD; and GC/MS in crops validated by EPA's Analytical Chemistry Laboratory (ACL). Thus, adequate analytical methods are available for residue data collection and enforcement of the proposed tolerances for glyphosate. Contact: Erik Kraft, [phone]; e-mail address: [e-mail].

5. PP 9F7657. (EPA-HQ-OPP-2010-0041). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish tolerances in 40 CFR part 180 for residues of the insecticide thiamethoxam, 3-[(2-chloro-5-thiazolyl)methyl] tetrahydro-5-methyl-N-nitro-4 H-1,3,5-oxadiazin-4-imine and its metabolite, N-(2-chloro-thiazol-5-ylmethyl)-N'-methyl-N'-nitro-guanidine, in or on peanut at 0.05 ppm and peanut, hay at 0.25 ppm. Syngenta Crop Protection, Inc., has submitted practical analytical methodology for detecting and measuring levels of thiamethoxam in or on raw agricultural commodities. This method is based on crop specific cleanup procedures and determination by liquid chromatography with either ultra-violet (UV) or MS detections. The limit of detection (LOD) for each analyte of this method is 1.25 nanogram (ng) injected for samples analyzed by UV and 0.25 ng injected for samples analyzed by MS, and the limit of quantification (LOQ) is 0.005 ppm for milk and juices, and 0.01 ppm for all other substrates. Contact: Julie Chao, [phone]; e-mail address: [e-mail].

6. PP 9F7673. (EPA-HQ-OPP-2010-0051). Veto-Pharma SA, c/o Arysta LifeScience America, 1450 Broadway, 7th Floor, New York, NY 10018, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide amitraz, in or on honey at 1 ppm. There are two adequate methods listed in FDA's Pesticide Analytical Manual (PAM Vol. II) for purposes of data collection and enforcement of tolerances for residues of amitraz and its metabolites containing the 2,4-DMA moiety. Methods I (designed for animal tissues and milk) and II (designed for plant commodities) are both gas liquid chromatography (GLC) methods with electron capture detection (ECD), and convert residues of amitraz to 2,4-DMA by acid and base hydrolysis, respectively. The LOD are 0.01 ppm for milk and 0.05 ppm for plant and other animal commodities. Amitraz, and its metabolites containing the 2,4-DMA moiety have been tested using the Food and Drug Administration's (FDA's) Multi-residue Method Protocol D; the metabolite BTS-27919 was the only compound which could be analyzed by this protocol. Contact: Julie Chao, [phone]; e-mail address: [e-mail].

Amended Tolerance

PP 9F7644. (EPA-HQ-OPP-2009-0988). Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 20052, proposes to amend the tolerances in 40 CFR 180.364 for residues of the herbicide glyphosate, N-(phosphonomethyl) glycine, in or on corn, sweet, kernels plus cob with husk be removed at 3 ppm; and correction of the glyphosate tolerance in the commodity poultry, meat from 4 ppm to 0.1 ppm. Adequate enforcement methods are available for analysis of residues of glyphosate and its metabolite AMPA in or on plant and livestock commodities. These methods include: GLC - Method I in PAM II, 0.05 ppm LOD; HPLC with fluorometric detection, 0.0005 ppm LOD; and GC/MS in crops validated by EPA's Analytical Chemistry Laboratory (ACL). Thus, adequate analytical methods are available for residue data collection and enforcement of the proposed tolerances for glyphosate. Contact: Erik Kraft, [phone]; e-mail address: [e-mail].

New Tolerance Exemptions

1. PP 9E7621. (EPA-HQ-OPP-2010-0138). Lamberti USA Inc., 161 Washington St., Conshohocken, PA 19428, proposes to establish an exemption from the requirement of a tolerance in 40 CFR 180.910 for residues of alkyl polyglucoside esters (AGEs) group, formed by D-Glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(C₈-C₂₀ linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-97-7); D-Glucopyranose, oligomeric, 6-(hydrogen sulfobutanedioate), 1-(C₈-C₂₀ linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-92-2); D-Glucopyranose, oligomeric, Propanoic acid, 2-hydroxy-, 1-(C₈-C₂₀ linear and branched alkyl) ethers (CAS No. 1079993-94-4); and in 40 CFR 180.920 for residues of alkyl polyglucoside esters (AGEs) group, formed by D-Glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(C₈-C₂₀ linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-97-7); D-Glucopyranose, oligomeric, 6-(hydrogen sulfobutanedioate), 1-(C₈-C₂₀ linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-92-2); D-Glucopyranose, oligomeric, Propanoic acid, 2-hydroxy-, 1-(C₈-C₂₀ linear and branched alkyl) ethers (CAS No. 1079993-94-4) in or on all raw agricultural commodities when used as a pesticide inert ingredient in pesticide formulations. The petitioner believes no analytical method is needed because requirements for an analytical method are not applicable to a request to establish an exemption from the requirement of a tolerance. Contact: Lisa Austin, [phone]; e-mail address: [e-mail].

2. PP 9E7671. (EPA-HQ-OPP-2010-0181). AMVAC Chemical Corporation, 4695 MacArthur Court, Suite 1250, Newport Beach, CA 90660, proposes to establish an exemption from the requirement of a tolerance for residues of n-Octyl Alcohol (CAS No. 111-87-5) and n-Decyl Alcohol (CAS No. 112-30-1) in or on potatoes when used as a pesticide inert ingredient in pesticide formulations applied to raw agricultural commodities after harvest. The petitioner believes no analytical method is needed because requirements for an analytical method are not applicable to a request to establish an exemption from the requirement of a tolerance. Contact: Alganesh Debesai, [phone]; e-mail address: [e-mail].

Amended Tolerance Exemption

PP 0E7683. (EPA-HQ-OPP-2009-0130). Joint Inerts Task Force, Cluster Support Team 15, EPA Company No. 84947, c/o CropLife America, 1156 15th St., Suite 400, Washington, DC 20005, proposes to amend an exemption from the requirement of a tolerance in 40 CFR 180.920 for residues of N,N,N',N,”-Tetrakis-(2-hydroxypropyl) ethylenediamine (NTHE) (CAS No. 102-60-3) to include the exemption from the requirement of a tolerance for 40 CFR 180.910 and 40 CFR 180.930 when used as a pesticide inert ingredient in pesticide formulations, including: N,N,N',N,”-Tetrakis-(2-hydroxypropyl) ethylenediamine N,N,N',N,”-Tetrakis-(2-hydroxypropyl) ethylenediamine with a maximum concentration of 20% by weight in pesticide formulations. The petitioner believes no analytical method is needed because requirements for an analytical method are not applicable to a request to establish an exemption from the requirement of a tolerance. Contact: Lisa Austin, [phone]; e-mail address: [e-mail].

List of Subjects

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

Dated: March 11, 2010.

Lois Rossi,

Director, Registration Division, Office of Pesticide Programs.