Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before October 29, 2012.
Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) for the petition 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 online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
A contact person, with telephone number and email address, is listed at the end of each pesticide petition summary. You may also reach each contact person by mail at Biopesticides and Pollution Prevention Division (BPPD) (7511P) or Registration Division (RD) (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
- Crop production (NAICS code 111).
- Animal production (NAICS code 112).
- Food manufacturing (NAICS code 311).
- Pesticide manufacturing (NAICS code 32532).
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 email. 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), requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. 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. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. 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 document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available online 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 2E8039. (EPA-HQ-OPP-2012-0509). Syngenta Crop Protection, Inc, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide isopyrazam (SYN520453), in or on apple at 0.6 parts per million (ppm); and peanuts at 0.01 ppm. An adequate, validated method (GRM006.01B) is available for enforcement purposes for the determination of residues of isopyrazam, analyzed as the isomers SYN534968 and SYN534969, in crop samples. Final determination is by liquid chromatography-tandem mass spectrometry (LC-MS/MS). An analytical method suitable for the determination of residues of the metabolites CSCD459488 and CSCD459489 (syn and anti forms respectively) in crop samples using an external standardization procedure is also available. Final determination is by LC-MS/MS. Contact: Shaunta Hill, RD, (703) 347-8961, email address: firstname.lastname@example.org.
2. PP 2E8050. (EPA-HQ-OPP-2012-0586). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2 pyrimidinyl)amino]carbonylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, including its metabolites and degradates, in or on artichoke at 0.05 ppm; and caneberry subgroup 13-07 at 0.05 ppm. A practical analytical method, gas chromatography with a nitrogen-specific detector (GC-NSD), is available for enforcement purposes. The analytical method accounts for parent halosulfuron-methyl and for the halosulfuron-methyl rearrangement ester, sometimes referred to as “RRE” and “MON 5781.” This product results from the abstraction for the S02NHCO moiety between the rings, such that the two rings are then joined together only by an NH group. Contact: Sidney Jackson, RD, (703) 305-7610, email address: email@example.com.
3. PP 2E8051. (EPA-HQ-OPP-2012-0588). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part 180 for residues of the herbicide fenoxaprop-ethyl, [(±)-ethyl 2-[4- [(6-chloro-2-benzoxazolyl)oxy]phenoxy]propanoate] and its metabolites 2-[4-[(6:-chloro-2-benzoxazolyl) oxy]phenoxy] propanoic acid and 6-chloro-2,3-dihydrobenzoxazol-2-one, each expressed as the parent compound, in or on grass, hay at 0.15 ppm. Tolerances are being proposed in grass hay for the combined residues of fenoxaprop-ethyl and its metabolites fenoxaprop-acid and AE F05414. The analytical method involves reflux with acid to convert fenoxaprop-ethyl and fenoxaprop acid to AE F05414, derivatization followed by SPE clean-up. Quantitation is by GC/MS. Contact: Andrew Ertman, RD, (703) 308-9367, email address: firstname.lastname@example.org.
4. PP 2E8052. (EPA-HQ-OPP-2012-0590). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide prometryn, (2,4-bis(isopropylamino)-6-methylthio-s-triazine), in or on bean, snap, succulent at 0.05 ppm; bean, forage at 0.09 ppm; dill, leaves at 0.3 ppm; dill, dried leaves at 1.1 ppm; and dill, oil at 1.3 ppm. Syngenta has developed and validated a GC analytical method for enforcement purposes. The method determines residues of prometryn in/on plants using a microcoulometric sulfur detection system. This method has been submitted to the EPA and is in the Pesticide Analytical Manual (PAM). Contact: Laura Nollen, RD, (703) 305-7390, email address: email@example.com.
5. PP 2E8061. (EPA-HQ-OPP-2012-0589). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide sodium salt of fomesafen (fomesafen), 5-[2-chloro-4-(trifluoromethyl) phenoxy]-N-(methylsulfonyl)-2-nitrobenzamide, in or on cantaloupe; cucumber; pea, succulent; pumpkin; squash, summer; squash, winter; and watermelon at 0.025 ppm; and vegetable, soybean, succulent (edamame) at 0.05 ppm. An analytical method using chemical derivatization followed by GC with Nitrogen-Phosphorus detection (GC-NPD) has been developed and validated for residues of fomesafen in snap/dry beans, cotton seed and cotton gin byproducts, as well as for other crops. Contact: Laura Nollen, RD, (703) 305-7390, email address: firstname.lastname@example.org.
6. PP 2E8062. (EPA-HQ-OPP-2012-0628). Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide mancozeb, in or on tangerine at 10 ppm. The proposed tolerances are to support imports of mandarins, tangerines and clementines. There are international maximum residue levels (MRLs) for mancozeb on citrus, including an applicable CODEX MRL. Per the 2011 Final Rule (April 6, 2011 Federal Register, Volume 76, No. 66, page 18906, FRL 8864-1; Docket EPA-HQ-OPP-2005-0307), adequate enforcement methodology is available to enforce the tolerance expression. The PAM lists Methods I, II, III, IV and A for dithiocarbamate residues in/on plant commodities. Method III based on group degradation to CS2 is preferred. For ETU, methodology is based on the original method published by Olney and Yip (JAOAC 54: 165-169). Contact: Heather Garvie, RD, (703) 308-0034, email address: email@example.com.
7. PP 2E8070. (EPA-HQ-OPP-2012-0706). Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the molluscicide metaldehyde, in or on grass, forage at 1.5 ppm; grass, hay at 1.8 ppm; leaf petioles subgroup 4B at 0.80 ppm; peppermint, tops at 3.5 ppm; spearmint, tops at 3.5 ppm; peppermint, oil at 14 ppm; spearmint, oil at 14 ppm; caneberry subgroup 13-07A at 0.15 ppm; bushberry subgroup 13-07B at 0.15 ppm; berry, low growing, subgroup 13-07G at 6.25 ppm; taro, corn at 0.25 ppm; taro, leaves at 0.60 ppm; corn, field, grain at 0.05 ppm; corn, field, stover at 0.15 ppm; corn, field, forage at 0.25 ppm; corn, sweet, kernel plus cob with husks removed at 0.05 ppm; and soybean, seed at 0.05 ppm. A GC/MS analytical method has been developed for analyzing residues of metaldehyde in food crops including all of the crops identified above. Contact: Laura Nollen, RD, (703) 305-7390, email address: firstname.lastname@example.org.
8. PP 2F8008. (EPA-HQ-OPP-2010-0217). Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm; and pepper/eggplant subgroup 8-10B at 0.7 ppm. Adequate enforcement methodology (LC/MS/MS analysis) is available to enforce the tolerance expression. Contact: Marianne Lewis, RD, (703) 308-8043, email address: email@example.com.
9. PP 2F8019. (EPA-HQ-OPP-2012-0593). Makhteshim Agan of North America, Inc, 3120 Highwoods Blvd., Suite 100, Raleigh, NC 27604, requests to establish tolerances in 40 CFR part 180 for residues of the nemacide, fluensulfone equivalents (i.e.; the sum of thiazole sulfonic acid (TSA) and butene sulfonic acid (BSA) expressed as total fluensulfone equivalents), in or on fruiting vegetables at 0.6 ppm; and cucurbits at 1.0 ppm. Adequate analytical methods for determining fluensulfone in/on appropriate raw agricultural commodities and processed commodities have been developed and validated, including LC-MS/MS methods for use on tomato, pepper, melon, and cucumber. The analytical procedures have been successfully validated in terms of specificity, linearity, precision, accuracy and level of quantitation. The multiresidue methods (MRMs) study demonstrates that the FDA MRMs are not suitable for detection and enforcement of fluensulfone residues as sulfonic acid metabolites in non-fatty matrices. Contact: Jennifer Gaines, RD, (703) 305-5967, email address: firstname.lastname@example.org.
10. PP 2F8054. (EPA-HQ-OPP-2012-0624). Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85366, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide hexythiazox (trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carboxamide), in or on sorghum, grain at 3 ppm; sorghum, grain, forage at 5 ppm; and sorghum, grain, stover at 6 ppm. A practical analytical method, high performance liquid chromatography (HPLC) with an ultraviolet (UV) detector, which detects and measures residues of hexythiazox and its metabolites as a common moiety, is available for enforcement purposes with a limit of detection that allows monitoring of food with residues at or above the levels set in this tolerance. Contact: Olga Odiott, RD, (703) 308-9369, email address: email@example.com.
11. PP 2F8060. (EPA-HQ-OPP-2012-0626). Nippon Soda Co., Ltd. c/o Nisso America Inc., 88 Pine St., 14th Fl., New York, NY 10005, requests to establish tolerances in 40 CFR part 180 for residues of the insecticide acetamiprid, in or on citrus fruits, crop group 10 at 1.0 ppm; and citrus, dried pulp at 2.4 ppm. Based upon the metabolism of acetamiprid in plants and the toxicology of the parent and metabolites, quantification of the parent acetamiprid is sufficient to determine toxic residues. As a result, a method has been developed which involves extraction of acetamiprid from various matrices with solvents and analysis by LC/MS/MS methods. Contact: Jennifer Urbanski, RD, (703) 347-0156, email address: firstname.lastname@example.org.
12. PP 2F8071. (EPA-HQ-OPP-2012-0704). Syngenta Crop Protection, LLC, Regulatory Affairs, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide sedaxane as a seed treatment, in or on corn (grain, forage, stover) and popcorn (grain, stover, corn ears) at 0.01 ppm; sorghum (grain, forage, stover) at 0.01 ppm; pea and bean, dried, shelled, subgroup 6C (grain, forage, hay) at 0.01 ppm; and rapeseed, subgroup 20A (grain) at 0.01 ppm . Various crops were analyzed for sedaxane (parent only) using a procedure for analysis of sedaxane (SYN524464) that can distinguish between its trans and cis isomers (SYN508210 and SYN508211). Plant matrices using method GRM023.01A or modified method GRM023.01B are taken through an extraction procedure with final determination by HPLC with triple quadrupole mass spectrometric detection (LC-MS/MS). Contact: Heather Garvie, RD, (703) 308-0034, email address: email@example.com.
1. PP 2F8008. (EPA-HQ-OPP-2010-0217). Valent U.S.A. Corporation, P.O. Box, 8025 Walnut Creek, CA 94596, requests to amend the tolerance in 40 CFR 180.586 (a) by deleting the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the vegetable, fruiting group 8 at 0.2 ppm, upon approval of fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm under “New Tolerance” for PP 2F8008; and replacing the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruit, pome at 1.0 ppm with fruit, pome group (11-10) at 1.0 ppm due to the expansion of crop groups. Contact: Marianne Lewis, RD, (703) 308-8043, email address: firstname.lastname@example.org.
2. PP 2F8034. (EPA-HQ-OPP-2012-0520). Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, requests to amend the tolerance in 40 CFR 180.480 for residues of the fungicide fenbuconazole, alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1 H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1 H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, in or on pepper from 0.4 ppm to 1.0 ppm. Adequate analytical methods are available to enforce the tolerances of fenbuconazole residues in plant commodities. For pepper, samples from the residue trials were analyzed for fenbuconazole (RH-7592) and its lactone metabolites, RH-9129 and RH-9130, using Rohm & Haas analytical method Technical Report Number 34-90-47 or Technical Report Number 34-90-47R. The method had undergone an independent method validation and was also successfully accepted by EPA with minor modifications suggested by the Agency that included procedure for the standardization of the silica gel and Florisil column clean-up elution pattern (TR-34-90-47R). Contact: Erin Malone, RD, (703) 347-0253, email address: email@example.com.
New Tolerance Exemption
1. PP 2E7986. (EPA-HQ-OPP-2012-0615). Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish an exemption from the requirement of a tolerance for residues of polymers of one or more diglycidyl ethers of bisphenol A, resorcinol, glycerol, cyclohexanedimethanol, neopentyl glycol, and polyethylene glycol with one or more of the following: Polyoxypropylene diamine, polyoxypropylene triamine, n-aminoethylpiperazine, trimethyl-1,6-hexanediamine isophorone diamine, N,N-dimethyl-1,3-diaminopropane, nadic methyl anhydride, 1,2-cyclohexanedicarboxylic anhydride and 1,2,3,6-tetrahydrophthalic anhydride when used as an inert ingredient (carrier) in pesticide formulations under 40 CFR 180.960. Syngenta is submitting a petition to EPA under the FFDCA, as amended by the Food Quality Protection Act (FQPA), requesting an exemption from the requirement of a tolerance. This petition requests the elimination of the need to establish a maximum permissible level for residues of polymers of one or more diglycidyl ethers of bisphenol A, resorcinol, glycerol, cyclohexanedimethanol, neopentyl glycol, or polyethylene glycol with one or more of the following: polyoxypropylene diamine, polyoxypropylene triamine, n-aminoethylpiperazine, trimethyl-1,6-hexanediamine isophorone diamine, N,N-dimethyl-1,3-diaminopropane, nadic methyl anhydride, 1,2-cyclohexanedicarboxylic anhydride and 1,2,3,6-tetrahydrophthalic anhydride in or on all raw agricultural commodities. The petitioner believes no analytical method is needed because this information is generally not required when all criteria for polymer exemption per 40 CFR 723.250 are met. In addition, Syngenta is petitioning for an exemption from the requirement of a tolerance without any numerical limitations. Contact: Kerry Leifer, RD, (703) 308-8811, email address: firstname.lastname@example.org.
2. PP 2E8017. (EPA-HQ-OPP-2012-0558). Rhodia Inc., c/o SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192, requests to establish an exemption from the requirement of a tolerance for residues of cationic hydroxypropyl guar (CAS No. 71329-50-5), with a minimum number average molecular weight (in amu) of 500,000, under 40 CFR 180.920 when used as an inert ingredient in pesticide formulations. This tolerance exemption petition summarizes and relies upon available data for cationic hydroxypropyl guar and the structurally similar substance, guar gum. The cationic hydroxypropyl guar data presented in this tolerance exemption petition are on two products. One product had a molar substitution (MS) of 0.6 and a degree of substitution (DS) of 0.1 and the other product had a MS of 0.6 and a DS of 0.3. In addition, test results on cationic guars are included as supporting data. Rhodia is requesting that cationic hydroxypropyl guar be exempt from the requirement of a tolerance under 40 CFR 180.920. Therefore, Rhodia believes that an analytical method to determine residues in treated crops is not relevant. Contact: William Cutchin, RD, (703) 305-7990, email address: email@example.com.
3. PP 2F7978. (EPA-HQ-OPP-2012-0264). Becker Underwood, Inc., 801 Dayton Ave., P.O. Box 667, Ames, IA 50010, requests to establish an exemption from the requirement of a tolerance for residues of the elicitor of Induced Systemic Resistance, Bacillus pumilus strain BU F-33, in or on all food commodities. The petitioner believes no analytical method is needed because it is expected that, as proposed, use of Bacillus pumilus strain BU F-33 (i.e., seed treatment, in-furrow, and soil drench pesticide applications) would not result in residues that are of toxicological concern. Contact: Jeannine Kausch, BPPD, (703) 347-8920, email address: firstname.lastname@example.org.
Dated: September 21, 2012.
Daniel J. Rosenblatt,
Acting, Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-23968 Filed 9-27-12; 8:45 am]
BILLING CODE 6560-50-P