Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Notice of Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
Environmental Protection Agency (EPA).
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 January 18, 2013.
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:
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 Registration Division (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:
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 Registerdate 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 2E7980. (EPA-HQ-OPP-2012-0454). Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419-8300, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide fenpropidin, 1-[3-[4-(1,1-dimethylethyl) phenyl]-2-methyl-propyl] piperidine in or on banana, unbagged fruit at 9 parts per million (ppm) and banana, pulp from unbagged fruit at 0.4 ppm using the Organization for Economic Cooperation and Development/Maximum residue level (OECD/MRL) calculator. An adequate, validated method is available for enforcement purposes (method REM 164.09). Final determination is carried out with triple quadrupole mass spectrometric detection liquid chromatography-mass spectrometry ((LC-MS/MS), Applied Biosystems API 3,000 detector). Contact: Tamue L. Gibson, (703) 305-9096, email address: firstname.lastname@example.org.
2. PP 2E8011. (EPA-HQ-OPP-2012-0858). Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC, 27419, requests to establish a tolerance 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) (CAS Reg. No. 153719-23-4) and its metabolite [N-(2-chloro-thiazol-5-yl)methyl]-N′-methyl-N′-nitro-guanidine, in or on tea at 20 ppm. Syngenta Crop Protection, LLC, 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 LC with either ultraviolet (UV) or mass spectrometry (MS) detections. Contact: Jennifer Urbanski, (703) 347-0156, email address: email@example.com.
3. PP 1F7826. (EPA-HQ-OPP-2012-0815). State of Florida, Department of Citrus, 605 East Main Street, P.O. Box 9010, Bartow, FL 33831-9010, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide 5-chloro-3-methyl-4-nitro-1 H-pyrazole (CMNP) and its metabolite (5-chloro-4-nitro-1 H-pyrazol-3-yl)-methanol (CHNP), in or on oranges at 0.80 ppm and its processed commodities: Orange, juice at 0.025 ppm; orange, oil at 0.070 ppm; and orange, dried pulp (also referred to as dried pomace) at 1.80 ppm. In all plant matrices, the residue of concern, parent CMNP and CHNP/CHNP glucoside, can be determined using high performance liquid chromatography/tandem mass spectrometry (HPLC/MS-MS) following sample extraction, hydrolysis (to convert CHNP-glucoside to its aglycone, CHNP) and solid-phase clean up. Contact: Tony Kish, (703) 308-9443, email address: firstname.lastname@example.org.
4. PP 2F8044. (EPA-HQ-OPP-2012-0876). Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide prothioconazole, 2-[2-(1-chlorocyclopropyl)-3-(2-chlorophenyl-2-hydroxypropyl]-1,2-dihydro-3 H-1,2,4-triazole-3-thione and its desthio metabolite, in or on bushberry crop subgroup 13-07B at 2.0 ppm; low growing berry crop subgroup 13-07H (except strawberry) at 0.15 ppm; and cucurbit vegetables crop group 9 at 0.3 ppm. The analytical method for determining residues of concern in plants extracts residues of prothioconazole and JAU6476-desthio and converts the prothioconazole to JAU6476-desthio and JAU6476-sulfonic acid. Following the addition of internal standards, the sample extracts are analyzed by LC/MS/MS. The analytical method for analysis of large animal tissues includes extraction of the residues of concern, followed by addition of an internal standard to the extract. The extract is then hydrolyzed to release conjugates, partitioned and analyzed by LC/MS/MS as prothioconazole, JAU6476-desthio and JAU6476-4-hydroxy. The method for analysis of milk eliminated the initial extraction step in the tissue method. Contact: Rosemary Kearns, (703) 305-5611, email address: email@example.com.
5. PP 2F8053. (EPA-HQ-OPP-2012-0638). BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide fluxapyroxad, (BAS 700 F); 1 H-Pyrazole-4-carboxamide,3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-, its metabolites, and degradates, in or on almond at 0.05 ppm; almond, hulls at 4.0 ppm; berry, low growing, subgroup 13-07G at 4.0 ppm; bushberry, subgroup 13-07B at 6.0 ppm; caneberry, subgroup 13-07A at 6.0 ppm; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 2.0 ppm; grapes at 2.0 ppm; grapes, raisin at 5.7 ppm; pecans at 0.05 ppm; rice, bran at 8.5 ppm; rice, grain at 5.0 ppm; rice, hullsat 15.0 ppm; rice, straw at 20.0 ppm; strawberry at 4.0 ppm; sugarcane, cane at 3.0 ppm; vegetable, Brassica leafy, group 5 at 3.0 ppm; vegetable, bulb, group 3-07 at 0.8 ppm; vegetable, cucurbit, group 9 at 0.4 ppm; vegetable, leafy, except Brassica, group 4 at 15.0 ppm; vegetable, root, except sugar beet, subgroup 1B at 0.7 ppm. Independently validated analytical methods have been submitted for analyzing residues of parent BAS 700 F (fluxapyroxad) plus metabolites M700F008, M700F048 and M700F002 with appropriate sensitivity in all the crop and processed commodities for root and tuber vegetables, subgroups 1A,1C, D, sugar beet tops, legume vegetables including soybean, group 6, foliage of legume vegetables, group 7, fruiting vegetables, group 8, pome fruits, group 11, stone fruits, group 12, cereal grains, group 15, forage, fodder and straw of cereal grains, group 16, cotton, canola, rapeseed, sunflower, and peanut, and in animal meat, fat, liver and kidney matrices, poultry meat, fat, liver and skin, milk, cream and eggs for which tolerances have been established. Contact: Olga Odiott, (703) 308-9369, email address: firstname.lastname@example.org.
6. PP 2F8067. (EPA-HQ-OPP-2012-0841). Monsanto Company, 1300 I St., NW., Suite 450 East, Washington, DC 20052, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide dicamba, (3,6-dichloro-o-anisic and its metabolites 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH dicamba) and 3,6-dichloro-2-hydroxybenzoic acid (DCSA), in or on cotton, undelinted seed at 3 ppm and cotton, gin byproducts at 70 ppm. Adequate enforcement methods are available for the analysis of residues of dicamba and its relevant metabolites in or on plant and livestock commodities. Pesticide Analytical Manual (PAM) Vol. II, lists appropriate analytical methods, based on GC with electron capture detection (GC/ECD), that are sufficient to provide for the enforcement of proposed dicamba tolerances in cottonseed and cotton gin by-products. Contact: Michael Walsh, (703) 308-2972, email address: email@example.com.
7. PP 2F8076. (EPA-HQ-OPP-2012-0796). Chemtura Corporation, 199 Benson Rd, Middlebury, CT 06749, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide ipconazole (2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-ylmethyl)cyclopentanol) from the treatment of seed prior to planting in or on legume vegetables, succulent or dried, crop group 6 at 0.01 ppm. Analytical methods have been developed, validated (including radiovalidation), and independently validated for the determination of ipconazole, triazolylalanine, triazolylacetic acid and triazolylpyruvate in wheat forage, hay, straw, and grain and in corn forage, cobs and straw using LC-MS/MS. Contact: Dominic Schuler, (703) 347-0260, email address: firstname.lastname@example.org.
8. PP 2F8113. (EPA-HQ-OPP-2012-0885). Syngenta Crop Protection, LLC, 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 sedaxane, N-[2-[1,1′-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-methyl-1 H-pyrazole-4-carboxamide, as the sum of its cis- and trans- isomers, as a seed treatment in or on potato at 0.02 ppm and potato, wet peel at 0.06 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 high performance liquid chromatography (HPLC) with triple quadrupole MS detection (LC-MS/MS). Contact: Heather Garvie, (703) 308-0034, email address: email@example.com.
1. PP 2F7992. (EPA-HQ-OPP-2012-0575). Syngenta Crop Protection, LLC, Regulatory Affairs, P.O. Box 18300, Greensboro, NC 27419-8300, requests to amend the tolerances in § 180.475 for residues of the fungicide difenoconazole, 1 [2-[2-chloro-4-(4-chlorophenoxy)]phenyl-4-methyl-1,3-dioxolan-2-ylmethyl]-1H-1,2,4,-triazole), in or on vegetables, tuberous and corm, subgroup 1C from 0.01 ppm to 4.0 ppm; and by removing the established tolerance in or on the raw agricultural commodity potatoes, processed waste at 0.04 ppm. Syngenta Crop Protection, Inc., has submitted a practical analytical method (AG-575B) for detecting and measuring levels of difenoconazole in or on food with a limit of quantitation (LOQ) that allows monitoring of food with residues at or above the levels set in the proposed tolerances. Residues are qualified by LC/MS/MS; and has submitted a practical analytical method (AG-544A) for detecting and measuring levels of difenoconazole in or on cattle tissues and milk and poultry tissues and eggs, with a LOQ that allows monitoring of food with residues at or above the levels set in the proposed tolerances. Contact: Rosemary Kearns, (703) 305-5611, email address: firstname.lastname@example.org.
2. PP 2F8076. (EPA-HQ-OPP-2012-0796). Chemtura Corporation, 199 Benson Rd, Middlebury, CT 06749, requests to amend the tolerance in § 180.646 for residues of the fungicide ipconazole, (2-[(4-chlorophenyl)methyl]-5-(1-methylethyl)-1-(1H-1,2,4-triazole-1-ylmethyl)cyclopentanol) by deleting the tolerance for pea and bean, dried shelled, except soybean, subgroup 6C at 0.01 ppm, upon approval of legume vegetables (succulent or dried), crop group 6 at 0.01 ppm under “New Tolerance” for PP 2F8076. Contact: Dominic Schuler, (703) 347-0260, email address: email@example.com.
3. PP 2F8085. (EPA-HQ-OPP-2012-0843). Dow AgroSciences, LLC, 9330 Zionsville Road, Indianapolis, IN 46268, requests to amend the tolerances in § 180.560 for the combined residues of cloquintocet-mexyl (acetic acid, [(5-chloro-8-quniolinyl)oxy]-, 1-methylhexyl ester) (CAS No. 99607-70-2) and its acid metabolite (5-chloro-8-quinlinoxyacetic acid), when used as an inert ingredient (safener) in pesticide formulations containing the new active ingredient halauxifen-methyl (XDE-729 methyl), in or on barley, grain at 0.1 ppm; barley, hay at 0.1 ppm; barley, straw at 0.1 ppm; wheat, forage at 0.2 ppm; wheat, grain at 0.1ppm; wheat, hay at 0.5 ppm; and wheat, straw at 0.1 ppm. Specifically, this pesticide petition proposes to amend the tolerance expression by adding a reference to the new herbicide active ingredient halauxifen-methyl (XDE-729 methyl). Tolerances are already established for use of cloquintocet-mexyl in conjunction with other herbicides. This petition will not change the established tolerance levels. Adequate enforcement methodology is available to enforce the tolerance expression in theFederal Registerof June 29, 2011 (76 FR 38035) (FRL-8877-2). There are two enforcement methods available. The HPLC with Ultraviolet Detection (HPLC/UV) method REM 138.01 is for the determination of cloquintocet-mexyl (parent) and the HPLC/UV Method REM 138.10 allows determination of its acid metabolite (also known as CGA-153433). Contact: Mindy Ondish, (703) 605-0723, email address: firstname.lastname@example.org.
New Tolerance Exemptions
1. PP 2E8027. (EPA-HQ-OPP-2012-0777). Honeywell International, Inc., 101 Columbia Road, Morristown, NJ 07962-1053, requests to establish anexemption from the requirement of a tolerance for residues of trans-1-chloro-3,3,3-trifluoropropene (CAS No. 102687-65-0) under §§ 180.910, 180.930, and 180.940 when used as a pesticide inert ingredient (propellant) in pesticide formulations. No analytical method is included as this is a petition for exemption from the requirements of a tolerance. Contact: Lisa Austin, (703) 305-7894, email address: email@example.com.
2. PP 2E8082. (EPA-HQ-OPP-2012-0789). Sekisui Specialty Chemicals, 1501 West, LBJ Freeway, Dallas, TX 75234, requests to establish an exemption from the requirement of a tolerance for residues of 2-pyrrolidone, 1-ethenyl-, polymer with ethenol (CAS No. 26008-54-8) under § 180.960 when used as a pesticide inert ingredient in pesticide formulations for a packaging film for unit dose packaging of pesticides and pool sanitizers. The petitioner believes no analytical method is needed because it is not required for the establishment of a tolerance exemption for inert ingredients. Contact: David Lieu, (703) 305-0079, email address: firstname.lastname@example.org.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: December 11, 2012.
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2012-30450 Filed 12-18-12; 8:45 am]
BILLING CODE 6560-50-P
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Comment Period Closed
Jan 18 2013, at 11:59 PM ET
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Date Posted: Dec 19, 2012
CFR: 40 CFR Part 180
Federal Register Number: 2012-30450
1. fenpropidin - by syngenta pp2e7980 - 0.4 ppm should be 0.00000000000000000 ppm. i do not believe organization for economic develoipment should be making...
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