Environmental Protection Agency (EPA).
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.
Comments must be received on or before October 5, 2009.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 Start Printed Page 45849pesticide 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.
1. PP 8E7495. (EPA-HQ-OPP-2009-0552). Syngenta Crop Protection, P. O. Box 18300, Greensboro, NC 27409, proposes to establish an import 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 canola, seed at 0.01 parts per million (ppm). Syngenta has developed and validated analytical methodology for enforcement purposes. This method (Syngenta Crop Protection Method AG-597B) has passed an Agency petition method validation for several commodities, and is currently the enforcement method for fludioxonil. This method has also been forwarded to the Food and Drug Administration (FDA) for inclusion into the Pesticide Analytical Manual, Volume II (PAM II). An extensive database of method validation data using this method on various crop commodities is available. Contact: Lisa Jones, (703) 308-9424; email@example.com.
2. PP 8E7502. (EPA-HQ-OPP-2009-0551). Syngenta Crop Protection, P. O. Box 18300, Greensboro, NC 27409, proposes to establish an import tolerance in 40 CFR part 180 for residues of the fungicide cyprodinil, 2-Pyrimidinamine, 4-cyclopropyl-6-methyl-N-phenyl-, in or on canola, seed at 0.03 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. An extensive database of method validation data using this method on various crop commodities is available. Contact: Lisa Jones, (703) 308-9424; firstname.lastname@example.org.
3. PP 9E7542. (EPA-HQ-OPP-2009-0553). Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808, proposes to establish a tolerance in 40 CFR part 180 for residues of the fungicide flutolanil, (N-(3-(1-methylethoxy) phenyl) -2- (trifluoromethyl) benzamide) and its metabolite, M-4, desisopropylflutolanil (N-(3-hydroxyphenyl)-2-(trifluromethyl) benzamide), expressed as 2-trifluoromethyl benzoic acid and calculated as flutolanil, in or on cotton, seed and soybean, seed at 0.05 ppm. A previously submitted analytical method designated AU-95R-04, a gas chromatography, mass spectrometry detection method has been Start Printed Page 45850independently validated and is adequate for enforcement purposes for flutolanil residue detection in soybean and wheat raw agricultural commodities. A multi-residue method for flutolanil has been previously submitted. The method is for use only by experienced chemists who have demonstrated knowledge of the principals of trace organic analysis and have proven skills and abilities to run a complex residue analytical method obtaining accurate results at the part per billion level. Users of this method are expected to perform additional method validation prior to using the method for either monitoring or enforcement. The method can detect gross misuse. Contact: Lisa Jones, (703) 308-9424; email@example.com.
4. PP 9E7566. (EPA-HQ-OPP-2009-0623). Gowan Company, 370 South Main Street, Yuma, AZ 85364, proposes to establish a tolerance in 40 CFR part 180 for residues of the fungicide fenarimol, and its metabolites in or on cucurbits at 0.2 ppm. Analytical methodology used for cucurbit crops is a slight modification of the basic Pesticide Analytical Manual (PAM II) method for fenarimol (Method R039). Residues are extracted with methanol. Aqueous sodium chloride 5% is added and the extract is partitioned with dichloromethane. Residues are cleaned up on a Florisil column and detected by gas chromatography/electron capture detector (GC/ECD). Recoveries ranged from 84 - 97% in samples fortified with fenarimol at 0.02 ppm to 0.2 ppm. The limit of detection (LOD) is 0.01 ppm. Contact: Tamue L. Gibson, (703) 305-9095; firstname.lastname@example.org.
5. PP 8F7468. (EPA-HQ-OPP-2009-0622). 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 fungicide pyrimethanil, (4,6-dimethyl-N-phenyl-2-pyrimidinamine) in or on caneberries, subgroup 13-07A at 12 ppm and bushberries, subgroup 13-07B at 6 ppm. Pyrimethanil was extracted from apples by homogenization with acetone. An aliquot of the extract was diluted with a mixture of acetonitrile and water with subsequent residue determination by high performance liquid chromatography-mass spectrometry/mass spectrometry (HPLC-MS/MS). The method allows the detection and measurement of residues in or on agricultural commodities at or above the proposed tolerance level. Contact: Tamue L. Gibson, (703) 305-9095; email@example.com.
6. PP 9F7515. (EPA-HQ-OPP-2009-0611). 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 fungicide tebuconazole, in or on vegetables, fruiting, group at 1.4 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 the PAM II. The animal method has also been approved as an adequate enforcement method. Contact: Tracy Keigwin, (703) 305-6605; firstname.lastname@example.org.
7. PP 9F7543. (EPA-HQ-OPP-2009-0616). Elanco Animal Health via Technology Sciences Group Inc., 4061 North 156th Drive, Goodyear, AZ 85395, proposes to establish a tolerance in 40 CFR part 180 for residues of the insecticide spinosad, a fermentation product of Saccharopolyspora spinosa which consists of two related active ingredients:
Spinosyn A (Factor A: CAS No. 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione;
and Spinosyn D (Factor D; CAS No. 131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on milk at 5 ppm; milk, fat at 40 ppm; cattle, goat, and sheep, fat at 30 ppm; hog, meat and poultry, meat byproducts at 0.2 ppm; hog, meat byproducts at 0.6 ppm; poultry, fat at 1.5 ppm; and hog, fat at 2.0 ppm. The supporting assessment includes the Agency conclusion that spinosad is considered toxicologically identical to another pesticide, spinetoram. EPA has determined adequate analytical methods are available for enforcement purposes for spinosad in plant and animal matrices. Methods include an immunoassay particle-based method 97.05 and an high performance liquid chromatography/ultraviolet (HPLC/UV) method GRM 03.15 and a suite of specific crop methods: GRM 94.02 (cottonseed and related commodities), GRM 95.17 (leafy vegetables), GRM 96.09 (citrus), GRM 96.14 (tree nuts), GRM 95.04 (fruiting vegetables), GRM 94.02.S1 (cotton gin byproducts). GRM 94.02 has a successful independent lab validation and was submitted for inclusion in PAM II as Method I. EPA recently concluded that for water, residues should be estimated using total spinosad residue method (EPA, D316077, August 2, 2006). An updated Dow AgroSciences method GRM 06.13 for the determination of residues of spinosad and its metabolites in poultry tissues and eggs by liquid chromatography with tandem mass spectrometry supports this petition. Contact: Samantha Hulkower, (703) 603-0683; email@example.com.
8. PP 9F7563. (EPA-HQ-OPP-2009-0575). Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419-8300, proposes to establish a tolerance in 40 CFR part 180 for residues of the herbicide sodium salt of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on potato at 0.025 ppm; and tomato at 0.025 ppm. The analytical method used for analysis of the potato tubers, tomato fruit and related processed fractions was based upon methodology previously utilized for analysis of fomesafen in soybeans. Contact: Michael Walsh, (703) 308-2972; firstname.lastname@example.org.
9. PP 9F7565. (EPA-HQ-OPP-2009-0550). Devgen US, Inc., 413 McFarlan Road, Suite B, Kennett Square, PA 19348, proposes to establish a tolerance in 40 CFR part 180 for residues of the fungicide iprodione, in or on cucurbit crop group at 0.3 ppm; and fruiting vegetables, except cucurbits at 2.0 ppm. An adequate analytical method, gas liquid chromatography using an electron-capture detector, is available in the PAM II for enforcement purposes. Contact: Lisa Jones, (703) 308-9424; email@example.com.
New Tolerance Exemptions
1. PP 9E7575. (EPA-HQ-OPP-2009-0478). BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932, proposes to establish an exemption from the requirement of a tolerance for residues of carbonic acid, diethyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)] ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), ester with alpha-[[[[5-(carboxyamino)-1,3,3-trimethylcyclohexylmethyl]amino]carbonyl]-omega-methoxypoly(oxy-1,2-ethanediyl) (CAS No. 1147260-65-8) under 40 CFR 180.960 when used as an inert ingredient as a surfactant in pesticide formulations without limitation. The petitioner believes no analytical method is needed because this petition is a request for an exemption from the requirement of a tolerance. Contact: Start Printed Page 45851Elizabeth Fertich, (703) 347-8560; firstname.lastname@example.org.
2. PP 9E7581. (EPA-HQ-OPP-2009-0610). Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268, proposes to establish an exemption from the requirement of a tolerance for residues of the dibenzylidene sorbitol (DBS) (CAS No. 32647-67-9); IUPAC D-Glucitol, bis-O-(phenylmethylene) (CAS No. 32647-67-9) under 40 CFR 180.920 when used as an inert ingredient in a pesticide formulation. A limitation to herbicides only with a 3% formulation cap is proposed. The petitioner believes no analytical method is needed because this petition is a request for an exemption from the requirement of a tolerance. Contact: Elizabeth Fertich, (703) 347-8560; email@example.com.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: August 24, 2009.
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E9-21395 Filed 9-3-09; 8:45 am]
BILLING CODE 6560-50-S