Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities,

[Federal Register: February 6, 2008 (Volume 73, Number 25)]

[Notices]

[Page 6964-6967]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr06fe08-54]

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0046; FRL-8350-9]

Notice of Filing of Pesticide Petitions for Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the 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 March 7, 2008.

ADDRESSES: Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest, 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'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 identification (ID) number and the pesticide petition number of interest. 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 in regulations.gov. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. 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. Publicly available docket materials are available electronically 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: The person listed at the end of the pesticide petition summary of interest.

SUPPLEMENTARY INFORMATION:

  1. General Information

    1. 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.

    2. 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.

      [[Page 6965]]

      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.

  2. Docket ID Numbers

    When submitting comments, please use the docket ID number and the pesticide petition number of interest, as shown in the table.

    PP Number

    Docket ID Number

    PP 7E7258

    EPA-HQ-OPP-2008-0049

    PP 7E7286

    EPA-HQ-OPP-2008-0049

    PP 7E7268

    EPA-HQ-OPP-2007-1199

    PP 7E7287

    EPA-HQ-OPP-2007-1159

    PP 7E7298

    EPA-HQ-OPP-2006-0875

    PP 7E7300

    EPA-HQ-OPP-2007-1202

    PP 7F7289

    EPA-HQ-OPP-2008-0066

    PP 7F7304

    EPA-HQ-OPP-2008-0065

    PP 7E7239

    EPA-HQ-OPP-2008-0039

    PP 7E7241

    EPA-HQ-OPP-2008-0040

    PP 7E7309

    EPA-HQ-OPP-2008-0044

    PP 7E7261

    EPA-HQ-OPP-2008-0043

    PP 7E7303

    EPA-HQ-OPP-2008-0060

    PP 7F7179

    EPA-HQ-OPP-2008-0041

  3. What Action is the Agency Taking?

    EPA is printing notice of the filing of pesticide petitions received 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 notice contain data or information regarding the elements set forth 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 rules on these pesticide petitions.

    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions included in 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.

    1. New Tolerances

      1. PP 7E7258 and 7E7286. (EPA-HQ-OPP-2008-0049). Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390, proposes to establish a tolerance for residues of triflumizole, [1-[1-((4-chloro-2-(trifluoromethyl) phenyl)imino)-2propoxyethyl]-1H-imidazole] in or on food commodities for PP 7E7258: Leafy greens except spinach (subgroup 4A) and cilantro, leaves at 35 parts per million (ppm); swiss chard at 18 ppm; pineapple at 4.0 ppm; papaya; sapote black; canistel; sapote, mamey; mango; sapodilla and star apple at 2.5 ppm; hop, dried cones at 50.0 ppm; and for PP 7E7286: Brassica, head and stem, subgroup 5A at 5.0 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, electron capture detector or mass spectrometry detection. The limit of quantitation of the method has been determined in the range of 0.01 ppm to 0.05 ppm for the combined residues of triflumizole and FA- 1-1. The enforcement methodology has been submitted to the Food and Drug Administration for publication in the Pesticide Analytical Manual (PAM II) Vol. II. Contact: Sidney Jackson, telephone number: (703) 305- 7610; e-mail address: jackson.sidney@epa.gov.

      2. PP 7E7268. (EPA-HQ-OPP-2007-1199). Valent USA Corporation, 1600 Riviera Avenue, Walnut Creek, CA 94596-8025, proposes to establish a tolerance for residues of the uniconazole, [(E)-(+)-(S)-1-(4- chlorophenyl)-4,4-dimethyl-2-(1,2,4-triazol-1-yl)-pent-1-ene-3-ol] in or on food commodity vegetables, fruiting, group 8 at 0.01 ppm. An adequate analytical enforcement method is available for the determination of residues of uniconazole in plants. The analytical method has been validated by an independent laboratory. Contact: Shaja R. Brothers, telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.

      3. PP 7E7287. (EPA-HQ-OPP-2007-1159). Interregional Research Project 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for residues of gamma-cyhalothrin ((S)-[alpha]- cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoripropenyl)- 2,2-dimethylcyclopropanecarboxylate) in or on food commodities pistachio at 0.05 ppm and okra at 0.2 ppm. An adequate analytical method is available for enforcement purposes. In the Federal Register of April 8, 2004 (69 FR 18480) (FRL-7353-4), the ICI method 81 for lamda-cyhalothrin has been validated by EPA. Given the enantiomeric relation of gamma-cyhalothrin to lambda-cyhalothrin and the fact that the method does not provide chiral resolution, the method is also applicable to gamma-cyhalothrin. Contact: Susan Stanton, telephone number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

      4. PP 7E7298. (EPA-HQ-OPP-2006-0875). Interregional Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, North Brunswick, NJ 08902-3390, proposes to establish a tolerance for residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate in or on food commodities caneberry subgroup 13-07A at 12 ppm and olives at 5 ppm. Adequate analytical methodology is available to detect and quantify fenpropathrin at residue levels in numerous matrices. The methods use solvent extraction and partition and/or column chromatography clean-up steps, followed by separation and quantitation using capillary gas liquid chromatography (GLC) with FID. The extraction efficiency has been validated using radiocarbon samples from the plant and animal metabolism studies. The enforcement methods have been validated at independent laboratories and by EPA. The limit of quantification (LOQ) for fenpropathrin in raw agricultural commodity samples is usually 0.01 ppm. Contact: Sidney Jackson, telephone number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.

      5. PP 7E7300. (EPA-HQ-OPP-2007-1202). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 05840, proposes to establish a tolerance for

        [[Page 6966]]

        residues of propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites determined as 2,4,-dichlorobenzoic acid and expressed as parent compound in or on food commodities beet, garden, roots at 0.6 ppm; parsley, leaves at 13 ppm; parsley, dried leaves at 60 ppm; coriander, fresh at 13 ppm; vegetable, leaves of root and tuber, group 2 at 8.0 ppm; pineapple (post harvest) at 0.9 ppm; and turnip, roots at 0.2 ppm. Analytical methods AG-626 and AG-454A were developed for the determination of residues of propiconazole and its metabolites containing the DCBA moiety. Analytical method AG-626 has been accepted and published by EPA as the tolerance enforcement method for crops. The limit of quantitation (LOQ) for the method is 0.05 ppm. Contact: Shaja R. Brothers, telephone number: (703) 308-3194; e-mail address: brothers.shaja@epa.gov.

      6. PP 7F7289. (EPA-HQ-OPP-2008-0066). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a tolerance for residues of the herbicide fluazifop-p-butyl in or on food commodities dry beans at 25 ppm; dry beans at 25 ppm; peanuts at 1.5 ppm; soybean at 2.5 ppm; soybean meal at 2.5 ppm; and soybean refined oil at 0.01 ppm. The analytical method utilized in the studies supporting this action is based upon the Pesticide Analytical Method (PAM) Vol. II, Method II for the enforcement of tolerances for fluazifop-p-butyl residues of concern for oily and non-oily crops. Using this method, residues of fluazifop-p-butyl or fluazifop, and any ester or acid conjugates are extracted from crop samples using a mixture of acetonitrile and dilute acid. Residues are then hydrolyzed using hydrochloric acid to fluazifop and further cleaned up via solvent partitioning, and absorption chromatography. Once sufficiently cleaned up, the samples are subsequently derivatized to form the methyl ester derivative of fluazifop prior mass-selective detection using gas chromatography/mass spectrometry (GC/MS). It should be noted that this analytical method does not distinguish the optical isomers of fluazifop-butyl or fluazifop but instead, hydrolyzes these residues to a common moiety (fluazifop acid) and as such, the detected residues are reported as ``fluazifop'' residues. Contact: James M. Stone, telephone number: (703) 305-7391; e-mail address: stone.james@epa.gov.

      7. PP 7F7304. (EPA-HQ-OPP-2008-0065). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the herbicide propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H- 1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl] benzoate and its metabolite, methyl 2-[[[(4,5-dihydro-3-(2-hydroxypropoxy)-4-methyl-5- oxo-1H-1,2,4-triazol-1-yl)carbonyl]amino]sulfonyl]benzoate (MKH-6561) in or on food commodities grass forage at 20 ppm, and grass hay at 25 ppm. The proposed tolerance expression is MKH-6561 and Pr-2-OH MKH- 6561. An analytical method was developed to measure these two analytes in plant matrices. The method was validated in grass tissues and the analysis by high performance liquid chromatography-electrospray ionization/tandem mass spectrometry (LC/MS/MS). In animal matrices, the proposed tolerance expression is MKH-6561. The proposed tolerance expression is MKH-6561. An analytical method was developed to measure this analyte in animal tissues and milk. The method was validated in animal tissues and milk. MKH-6561 was extracted from the tissues with 0.05 M NH4OH using accelerated solvent extraction. Trifluoroacetic acid (0.5 mL) and an isotopically labeled internal standard were added to the extract which was then centrifuged at 2,000 rpm for 10 minutes. Approximately half of the sample was loaded onto a C-18 SPE cartridge. The C-18 SPE cartridge was washed with aqueous trifluoroacetic acid (0.1%) and aqueous acetic acid (0.1%). A three to one mixture of acetonitrile and aqueous acetic acid (0.1%) was used to elute the analytes from the C-18 SPE cartridge. Water and acetic acid were added to the sample which was analyzed by LC/MS/MS. Milk samples were analyzed by amending an aliquot of milk with trifluororacetic acid (0.5 mL) and isotopically labeled internal standard. The sample was purified by C-18 SPE as described above. The resultant sample was analyzed by LC/MS/MS. Contact: James M. Stone, telephone number: (703) 305-7391; e- mail address: stone.james@epa.gov.

    2. Amendment to Existing Tolerance

      PP 7F7304. (EPA-HQ-OPP-2008-0065). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, proposes to amend the tolerances in 40 CFR 180.600 by increasing the established tolerances for residues of the herbicide propoxycarbazone, methyl 2-[[[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1- yl)carbonyl]amino]sulfonyl]benzoate (Pr-2-OH MKH-6561) in or on the food commodities cattle, goat, horse, sheep meat from 0.05 ppm to 0.1 ppm; meat byproducts from 0.3 ppm to 1.0 ppm; and milk from 0.03 ppm to 0.05 ppm. The analytical method is described (see Unit III. A. 7). Contact: James M. Stone, telephone number: (703) 305-7391; e-mail address: stone.james@epa.gov.

    3. New Exemption from Tolerances

      1. PP 7E7239. (EPA-HQ-OPP-2008-0039). Whitmire Micro-Gen c/o Landis International, Inc., P.O. Box 5126, Valdosta, GA 31603-5136, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.930 for residues of acetone, when used as an inert ingredient in a pesticide product when used in accordance with good agricultural practice as a solvent or co-solvent in pesticide formulations applied to animals. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-8825; e- mail address: samek.karen@epa.gov.

      2. PP 7E7241. (EPA-HQ-OPP-2008-0040). Whitmire Micro-Gen c/o Landis International, Inc., P.O. Box 5126, Valdosta, GA 31603-5136, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.910 for residues of potassium benzoate, when used as an inert ingredient in a pesticide product when used in accordance with good agricultural practice as a preservative in pesticide products applied to growing crops or to raw agricultural commodities after harvest. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-8825; e- mail address: samek.karen@epa.gov.

      3. PP 7E7309. (EPA-HQ-OPP-2008-0044). Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27409, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.910 for residues of 1,2-benzisothiazolin-3-one (BIT) as an inert ingredient in post-harvest applications at a maximum of 0.1% in an end-use product formulation. In September 2005, EPA published a Reregistration Eligibility Decision (RED) for BIT. This extensive document provides an overview of the available information for BIT. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-

        [[Page 6967]]

        8825; e-mail address: samek.karen@epa.gov.

      4. PP 7E7261. (EPA-HQ-OPP-2008-0043). Monsanto Company, 1300 ``I'' St., NW. Suite 450 East, Washington, DC 20005, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance for residues of sodium sulfite in or on any food or feed commodity when used as an inert ingredient in a pesticide product with the following limitations: Not to exceed 0.8% by weight in the formulated product. For use only in formulated products containing the active ingredient glyphosate and applied only to growing crops. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-8825; e-mail address: samek.karen@epa.gov.

      5. PP 7E7303. (EPA-HQ-OPP-2008-0060). LANXESS Corporation, 111 RIDC Park West Dr., Pittsburgh, PA 15275, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.910 for residues of methanol, (phenylmethoxy)- (CAS Reg. No. 14548-60-8) applied to growing crops and raw agricultural commodities after harvest at no more than 0.25% of the total pesticide formulation when used as either an in-can preservative or as a colorant in seed coatings. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-8825; e-mail address: samek.karen@epa.gov.

    4. Amendment to Existing Exemption from a Tolerance

      PP 7F7179. (EPA-HQ-OPP-2008-0041). ETI H2O, 1725 Gillespie Way, El Cajon, CA 92020, proposes to amend the existing exemption from the requirement of a tolerance in 40 CFR 180.940(a) for residues of sodium lauryl sulfate, (CAS Reg. No. 151-21-3) as a component of food contact sanitizing solutions applied to all food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at a maximum level in the end-use concentration of 350 ppm. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, telephone number: (703) 347-8825; e-mail address: samek.karen@epa.gov.

      List of Subjects

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

      Dated: January 30, 2008. Lois Rossi, Director, Registration Division, Office of Pesticide Programs.

      [FR Doc. E8-2172 Filed 2-5-08; 8:45 am]

      BILLING CODE 6560-50-S

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