Environmental Protection Agency (EPA).
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.
Comments must be received on or before July 14, 2008.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2008-0046 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 EPA-HQ-OPP-2008-0046 the assigned docket 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 Start Printed Page 33815Business 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
The person listed at the end of the pesticide petition summary of interest.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 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.
II. 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|
III. 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 Start Printed Page 33816pesticide 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. PP 7E7206. (EPA-HQ-OPP-2008-0042). Bayer Crop Science, 2 T. W. Alexander Dr., Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the inert safener cyprosulfamide (parent) in or on food commodities field corn grain at 0.01 parts per million (ppm); sweet corn kernels at 0.01 ppm; sweet corn (k+cwhr) at 0.01 ppm; pop corn grain at 0.01 ppm; and parent cyprosulfamide and its metabolites AE 0001789-sulfonamide-alanine, AE 0001789-sulfonamide-lactate, and AE 0001789-N-cyclopropyl-4-sulfamoylbenzamide in or on food commodities field corn forage at 0.15 ppm; sweet corn forage at 0.40 ppm; field corn stover at 0.60 ppm; sweet corn stover at 0.60 ppm; and popcorn stover at 0.60 ppm. For the following animal tissues parent cyprosulfamide is proposed based on the tissue to feed ratio from the feeding study, applied to a new diet calculated from the proposed tolerances from the residue studies in or on food commodities milk at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, fat at 0.01 ppm; cattle, liver at 0.02 ppm; cattle, kidney at 0.05 ppm; goat, meat at 0.01 ppm; goat, fat at 0.01 ppm; goat, liver at 0.02 ppm; goat, kidney at 0.05 ppm; hog, meat at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.02 ppm; hog, kidney at 0.05 ppm; horse, meat at 0.01 ppm; horse, fat at 0.01 ppm; horse, liver at 0.02 ppm; horse, kidney at 0.05 ppm; sheep, meat at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, liver at 0.02 ppm; sheep, kidney at 0.05 ppm. An adequate liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) analytical method is available for AE 0001789 to enforce the tolerances. The residues of cyprosulfamide and its metabolites AE 0001789-cyclopropylsulfamoylbenzamide (M02, AE 0852999), AE 0001789-sulfonamide-alanine (M11, AE 2300003), and AE 0001789-sulfonamide-lactate (M10, AE 2300002) are quantitated by high performance liquid chromatography/triple stage quadruple mass spectrometry (HPLC/MS/MS) (Method UB-008-P06-01). The individual analyte residues are reported in AE 0001789 molar equivalents and summed to give a total cyprosulfamide residue. The limit of quantitation (LOQ) is 0.01 ppm for each analyte in all matrices. Contact: Karen Samek, (703) 347-8825, firstname.lastname@example.org.
2. PP 8E7350. (EPA-HQ-OPP-2008-0458). Interregional Research Project No. 4, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540, proposes to establish a tolerance for residues of the fungicide fenamidone, 4H-imidazol-4-one, 3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-, (S)-, in or on food commodities: Vegetables, root, except sugarbeet, subgroup 1B, except radish at 0.2 ppm; turnip, leaves at 55 ppm; coriander, leaves at 60 ppm; okra at 3.5 ppm; and a tolerance with regional registration for grape at 1.0 ppm. Residues are quantified by high performance liquid chromatography (HPLC) with LC/MS/MS. The method LOQ are 0.02 ppm or lower for fenamidone, and its metabolites, RPA 412636, RPA 412708, and RPA 410193 in test raw agricultural commodities and processed fractions. Contact: Susan Stanton, (703) 305-5218, email@example.com.
3. and 4. PP 0F1234 and 6F7098. (EPA-HQ-OPP-2008-0405). BASF Corporation, 26 Davis Dr., Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, and its 3, 5-dinitrobenzyl alcohol metabolite (CL 202347)] in or on food commodities crayfish at 0.05 ppm; cotton gin byproducts at 3.0 ppm; and rice processing fractions at 0.1 ppm. The analytical method in plants is aqueous organic solvent extraction, column clean up, and quantitation by gas chromatography (GC). The method has a LOQ of 0.05 ppm for pendimethalin and the alcohol metabolite. Contact: James Tompkins, (703) 305-5697, firstname.lastname@example.org.
5. PP 6F7105. (EPA-HQ-OPP-2007-0214). BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709, proposes to establish a tolerance for residues of the fungicide pyraclostrobin, carbamic acid, [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl]methoxy-, methyl ester and its metabolite methyl-N-[[[1-(4-chlorophenyl) pyrazol-3-yl]oxy]o-tolyl] carbamate (BF 500-3); expressed as parent in or on the food commodities borage at 0.45 ppm; castor oil plant at 0.45 ppm; Chinese tallowtree at 0.45 ppm; crambe at 0.45 ppm; cuphea at 0.45 ppm; echium at 0.45 ppm; euphorbia at 0.45 ppm; evening primrose at 0.45 ppm; flax seed at 0.45 ppm; gold of pleasure at 0.45 ppm; hare's ear mustard at 0.45 ppm; jojoba at 0.45 ppm; lesquerella at 0.45 ppm; lunaria at 0.45 ppm; meadowfoam at 0.45 ppm; niger seed at 0.45 ppm; milkweed at 0.45 ppm; mustard seed at 0.45 ppm; oil radish at 0.45 ppm; poppy seed at 0.45 ppm; rapeseed at 0.45 ppm; rose hip at 0.45 ppm; safflower at 0.45 ppm; sesame at 0.45 ppm; stokes aster at 0.45 ppm; sunflower at 0.45 ppm; sweet rocket at 0.45 ppm; tallowwood at 0.45 ppm; tea oil plant at 0.45 ppm; and vernonia at 0.45 ppm. In plants, the method of analysis is aqueous organic solvent extraction, column clean up and quantitation by LC/MS/MS. In animals, the method of analysis involves base hydrolysis, organic extraction, column clean up and quantitation by LC/MS/MS or derivatization (methylation) followed by quantitation by gas chromatography/mass spectrometry (GC/MS). Contact: John Bazuin, (703) 305-7381, email@example.com.
6. PP 7F7190. (EPA-HQ-OPP-2007-0366). Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808, proposes to establish a tolerance for residues of the herbicide pyraflufen-ethyl [ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate] and its acid metabolite, E-1 [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid], expressed in terms of the parent, in or on food commodities grass, forage, group 17 at 1.0 ppm; grass, hay, group 17 at 1.4 ppm; milk at 0.02 ppm; cattle, meat byproducts at 0.02 ppm; goat, meat byproducts at 0.02 ppm; horse, meat byproducts at 0.02 ppm; and sheep, meat byproducts at 0.02 ppm. Aqueous organic solvent extraction, column clean up, and quantitation by gas chromatography is used to measure and evaluate the chemical residues. Contact: James M. Stone, (703) 305-7391, firstname.lastname@example.org.
7. PP 8F7322. (EPA-HQ-OPP-2008-0352). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, proposes to establish a tolerance for residues of the herbicide combined residues of BAS 800 H (N'-[2-chloro-4-fluoro-5-(3-methyl-2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)benzoyl]-N-isopropyl-N-methylsulfamide) plus metabolite M800H11 (N-[2-chloro-5-(2,6-dioxo-4-(trifluoromethyl)-3,6-dihydro-1(2H)-pyrimidinyl)-4-fluorobenzoyl]-N'-isopropylsulfamide) and plus metabolite M800H35 (N-[4-chloro-2-fluor-5-([(isopropylamino)sulfonyl]amino carbonyl)phenyl]urea) in or on food Start Printed Page 33817commodities legume vegetables (group 06), citrus fruits (group 10), pome fruits (group 11), stone fruits (group 12), tree nuts (group 14), pistachio, cereal grains (group 15), undelinted cotton seed, cotton gin by products, and grape at 0.03 ppm; foliage of legume vegetables (group 07), forage, fodder and straw of cereal grains (group 16), and sorghum stover at 0.1 ppm; almond hulls at 0.2 ppm; and sunflower seed at 0.7 ppm. Independently validated analytical methods have been submitted for analyzing residues of parent BAS 800 H plus metabolites M800H11 and M800H35 with appropriate sensitivity in all the crop and processed commodities for legume vegetables (group 06), foliage of legume vegetables (group 07), citrus fruits (group 10), pome fruits (group 11), stone fruits (group 12), tree nuts (group14), cereal grains (group 15), pistachio, forage, fodder, and straw of cereal grains (group 16), cotton, sunflower and grape and in animal liver and kidney matrices which tolerances are being requested. Contact: Kathryn Montague, (703) 305-1243, email@example.com.
8. PP 8F7334. (EPA-HQ-OPP-2008-0386). Gowan Company, 370 South Main St., Yuma, AZ 85364, proposes to establish a tolerance for residues of the herbicide triallate in or on food commodity Bermuda grass hay at 0.2 ppm. Residues of triallate and its metabolite TCPSA in Bermuda grass forage, hay, straw and seed screenings were quantitated using a GC/MS analytical method. The LOQ was 0.02 ppm for triallate and 0.05 ppm for TCPSA. Contact: Vickie Walters, (703) 305-5704, firstname.lastname@example.org.
9. PP 8F7342. (EPA-HQ-OPP-2007-00461). Syngenta Crop Protection, Inc., 410 Swing Rd., P.O. Box 18300, Greensboro, NC 27419, proposes to establish a tolerance for residues of the fungicide mandipropamid, benzeneacetamide, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy) phenyl]ethyl-alpha-(2-propynyloxy)] in or on food commodity hops at 50 ppm. Analytical method RAM 415-01 was developed for determination of mandipropamid residues in crops. This method involves extraction of mandipropamid residues from crop samples by homogenization with acetonitrile:water (80:20 v/v). Extracts are centrifuged and aliquots diluted with water prior to being cleaned up using polymeric solid-phase extraction cartridges. Residues of mandipropamid are quantified using high performance liquid chromatography with LC-MS/MS. This method has been successfully validated at an independent facility and therefore is suitable for use as the enforcement method for the determination of residues of mandipropamid in crops. Contact: Rosemary Kearns, (703) 305-5611, email@example.com.
Amendment to Existing Tolerance
1. PP 7F7190. (EPA-HQ-OPP-2007-0366). Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808, proposes to amend the tolerances in 40 CFR 180.585 by revising existing tolerances for residues of the herbicide pyraflufen-ethyl [ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetate] and its acid metabolite, E-1 [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-fluorophenoxyacetic acid], expressed in terms of the parent, in or on food commodities soybeans, seed to 0.05 ppm; soybeans, hay to 0.1 ppm; wheat, forage to 0.02 ppm; and wheat, hay to 0.01 ppm. Aqueous organic solvent extraction, column clean up, and quantitation by gas chromatography is used to measure and evaluate the chemical residues. Contact: James M. Stone, (703) 305-7391, firstname.lastname@example.org.
2. PP 7F7306. (EPA-HQ-OPP-2008-0384). Monsanto Company (a member of the Acetochlor Registration Partnership, ARP), 1300 I Street NW, Suite 450 East, Washington DC 20005, proposes to amend the tolerances in 40 CFR 180.470 for residues of the herbicide acetochlor (2-chloro-2'-methyl-6'-ethyl-N-ethoxymethylacetanilide) and its metabolites containing either the 2-ethyl-6-methylaniline (EMA) or the 2-(1-hydroxyethyl)-6-methyl-aniline (HEMA) moiety, to be expressed as acetochlor equivalents, in or on the food commodities when present therein as a result of the application of acetochlor to soil or growing crops: corn, field, forage at 4.5 ppm and corn, field, stover at 3.0 ppm. An adequate enforcement method for residues of acetochlor in crops has been approved. Acetochlor and its metabolites are hydrolyzed to either EMA or HEMA, which are determined by high performance liquid chromatography-oxidative coulometric electrochemical detector (HPLC-OCED) and expressed as acetochlor equivalents. Contact: Vickie Walters, (703) 305-5704, email@example.com.
3. PP 7F7307. (EPA-HQ-OPP-2008-0385). E. I. du Pont de Nemours and Company, DuPont Crop Protection, Laurel Run Plaza, P.O. Box 80038, Wilmington, DE 19880-0038, proposes to amend the tolerances in 40 CFR 180.364 by establishing tolerances for the combined residues of the herbicide glyphosate [N-(phosphonomethyl)glycine] and its metabolite N-acetylglyphosate [N-acetyl-N-(phosphonomethyl)glycine] resulting from the application of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine salt of glyphosate, the ammonium salt of glyphosate, and the potassium salt of glyphosate to OptimumTM GATTM field corn, in or on the food commodities: Field corn, grain; field corn, forage; field corn, stover; and field corn, aspirated grain fractions at levels already established for glyphosate alone. An analytical method was developed, and validated, for the determination of glyphosate and degradate residues in transgenic crop and crop fraction matrices. The analytes examined included glyphosate and N-acetylglyphosate since N-acetylglyphosate is a metabolite associated with transgenic crops containing the glyphosate N-acetyltransferase (gat) enzyme. The method target LOQ in each matrix examined was 0.050 mg/kg (ppm). The method was validated at 0.050 milligrams/kilograms (mg/kg) and 0.50 mg/kg or higher fortification level using a LC/MS/MS system operating with an electrospray interface (ESI) in positive ion mode detection. An analytical method was developed, and validated, for the determination of N-acetylglyphosate, glyphosate, AMPA, and N-acetyl AMPA in animal matrices including milk, eggs, muscle, kidney, liver, and fat. The method target LOQ in glyphosate equivalents for each analyte was 0.025 mg/kg in egg, milk, and muscle matrices and 0.050 mg/kg in kidney, liver, and fat matrices. The method was validated at the respective LOQ and 10xLOQ level for each matrix using a LC/MS/MS system operating with an electrospray interface (ESI) in positive or negative ion mode detection. Contact: Vickie Walters, (703) 305-5704, firstname.lastname@example.org.
New Exemption from Tolerance
1. PP 6E7093. (EPA-HQ-OPP-2008-0105). Huntsman Corporation, 8600 Gosling Rd., The Woodlands, TX 77381, proposes to amend 40 CFR 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.910, 40 CFR 180.920, and 40 CFR 180.930 for residues of morpholine 4-C6-12 Acyl derivatives (CAS Reg. No. 887947-29-7) when used as a pesticide inert ingredient as a solvent in pesticide formulations applied to growing food crops, post harvest applications, and to animals. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Start Printed Page 33818Samek, (703) 347-8825, email@example.com.
2. PP 7E7206. (EPA-HQ-OPP-2008-0042). Bayer Crop Science, 2 T. W. Alexander Dr., Research Triangle Park, NC 27709, proposes to establish an exemption from the requirement of a tolerance for residues of the inert safener cyprosulfamide (parent) in or on food commodities sorghum grain and plants grown from cyprosulfamide treated seeds. Because this petition is a request for an exemption from the requirement of a tolerance, no analytical method is required. Contact: Karen Samek, (703) 347-8825, firstname.lastname@example.org.
3. PP 8E7329. (EPA-HQ-OPP-2008-0407). SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, proposes to amend 40 CFR part 180 by establishing an exemption from the requirement of a tolerance under 40 CFR 180.920 for residues of ammonium chloride (CAS Reg. No. 12125-02-9) when used as a pesticide inert ingredient as a carrier/nutrient in pesticide formulations applied pre-harvest to 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, (703) 347-8825, 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: June 5, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E8-13344 Filed 6-12-08; 8:45 am]
BILLING CODE 6560-50-S