Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
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.
Table of Contents
- I. General Information
- A. Does this action apply to me?
- B. What should I consider as I prepare my comments for EPA?
- II. What action is the Agency taking?
- New Tolerances
- Amended Tolerance
- New Tolerance Exemptions
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 Web site 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.
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.
Supplementary 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 ofthis 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 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 174 or 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 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.
New Tolerances ↑
1. PP 1E7890.(EPA-HQ-OPP-2011-0758). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W., Princeton, NJ 08540, requests to establish tolerances in 40 CFR part 180 for residues of the herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide), in or on rhubarb at 0.2 parts per million (ppm); turnip, roots at 0.2 ppm; turnip, tops at 0.7 ppm; and sunflower subgroup 20B at 0.2 ppm; “Tolerances with regional registrations” in or on wheat, forage at 0.45 ppm (Pacific Northwest only); wheat, hay at 0.20 ppm (Pacific Northwest only); wheat, grain at 0.20 ppm (Pacific Northwest only); wheat, straw at 1.4 ppm (Pacific Northwest only); and cowpea, succulent at 0.15 ppm (Tennessee only). There is a practical analytical method for detecting and measuring levels of sulfentrazone and its metabolites in or on food with a limit of quantitation that allows monitoring of food with residues at or above the levels set or proposed in the tolerances. The analytical enforcement method for sulfentrazone was used with minor modification that eliminated several clean-up and derivatization steps that was required for gas chromatography with mass selective detection (GC/MSD) but not for liquid chromatography with tandem mass spectrometric detection (LC/MS/MS). The analytical method for sulfentrazone involves separate analyses for parent and its metabolites. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/electron capture detector (ECD). The metabolites samples were refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS. Contact: Laura Nollen, (703) 305-7390, e-mail address: firstname.lastname@example.org.
2. PP 1F7872.(EPA-HQ-OPP-2011-0743). Agriphar S.A., c/o Ceres International, LLC., 1087 Heartsease Drive, West Chester, PA 19382, requests to establish tolerances in 40 CFR part 180 for residues of the fungicide dodine (dodecylguanidine acetate), in or on stone fruits (Group 12) at 5 parts per million (ppm); tree nuts (Group 14, except almond hulls) at 0.3 ppm; and almond hulls at 12 ppm. An adequate enforcement method using GC/mass spectrometry detection (MSD), Method 45137, is available for determining dodine residues in or on plant commodities. Concerning tree crops, a method using LC/MS/MS; METH1595.02, after the samples were extracted with methanol, wassubmitted. Adequate data collection method validation, independent laboratory validation (ILV), and radio-validation data for the method has been submitted. Since there is no reasonable expectation of finding residues of dodine in livestock or poultry, no analytical method for animal tissues is required. Contact: Tamue L. Gibson, (703) 305-9096, e-mail address: email@example.com.
3. PP 1F7887.(EPA-HQ-OPP-2011-0741). Cytec Industries, Inc., 5 Garret Mountain Plaza, Woodland Park, NJ 07424, requests to establish tolerances in 40 CFR part 180 for residues of phosphine, in or on asparagus; cherimoya; dates, fresh; figs, fresh; globe artichokes; pawpaws; pineapple, water chestnuts and watercress, and for all fresh fruit and vegetable crop groups (including berry and small fruit; citrus fruit; pome fruit; stone fruit; herbs and spices;Brassica leafy vegetables; leafy vegetables; bulb vegetables; cucurbits; fruiting vegetables except cucurbits; legume vegetables, except soybeans; foliage of legume vegetables; root and tuber group; and root and tuber leaves group) at 0.01 ppm. The PAM Vol. II lists, under aluminum phosphide, a colorimetric method level of detection (LOD = 0.01) and a gas liquid chromatography (GLC) method with a flame photometric detection (LOD = 0.001 ppm) as Method A and B, respectively, for the enforcement of tolerances. The residue of concern is phosphine. It is noted that Method A, remains a lettered method because of variable recoveries observed in an Agency method try-out. However, the method has been determined to be acceptable for enforcement because phosphine is highly reactive, and finite residues are not expected. Data submitted in support of the established tolerances were collected by one of these two methods. Because phosphine is an inorganic compound, recovery of residues using FDA Multiresidue Protocols is not expected, and the requirement for such data has been waived by the Agency. Contact: Gene Benbow, (703) 347-0235, e-mail address: firstname.lastname@example.org.
4. PP 1F7897.(EPA-HQ-OPP-2009-0677). Arysta LifeScience, North America, LLC., 15401 Weston Parkway, Suite 150, Cary, NC 27513, requests to establish a tolerance in 40 CFR part 180 for residues of the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl] (5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, and its Z- isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-pyrimydinyl]oxy]phenyl] (5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-methyloxime, in or on rice, grain at 6.0 ppm. Adequate analytical methodology is available for enforcement purposes. The method comprises microwave solvent extraction followed by a solid phase extraction clean-up and quantification by high performance liquid chromatography with tandem mass spectrometric detection (HPLC/MS/MS). The individual detector responses for measured E- and Z-isomers is summed to give total residue. Contact: Heather A. Garvie, (703) 308-0034, e-mail address: email@example.com.
Amended Tolerance ↑
PP 1E7890.(EPA-HQ-OPP-2011-0758). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W., Princeton, NJ 08540, requests to amend the current tolerances in 40 CFR 180.498 for residues of the herbicide sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide), in or on bean, lima, succulent at 0.15 ppm by removing the tolerance from the table in Section (a)(2) and adding the tolerance to Section (c)Tolerances with regional registrations. Upon approval of the aforementioned tolerance under “New Tolerances”, the petition additionally proposes to remove the established tolerance in or on the raw agricultural commodity sunflower, seed at 0.2 ppm. Contact: Laura Nollen, (703) 305-7390, e-mail address: firstname.lastname@example.org.
New Tolerance Exemptions ↑
1. PP 1E7903.(EPA-HQ-OPP-2011-0736). ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish an exemption from the requirement of a tolerance for residues of D-mannose (CAS No. 3458-28-4) under 40 CFR 180.920 when used as an inert ingredient (sequestrant) in pesticide formulations applied pre-harvest to all raw agricultural commodities. The petitioner believes no analytical method is needed because this information is not required for the establishment of a tolerance exemption. Contact: Mark Dow, (703) 305-5533, e-mail address: email@example.com.
2. PP 1E7909.(EPA-HQ-OPP-2011-0732). Momentive Performance Materials, 22 Corporate Woods Blvd., Albany, NY 12211, requests to establish an exemption from the requirement of a tolerance for residues of 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and ethenylbenzene (CAS No. 25036-16-2) under 40 CFR 180.960 when used as a pesticide inert ingredient as a sticker in pesticide formulations without limitation. The petitioner believes no analytical method is needed because this information is not required for the establishment of a tolerance exemption. Contact: Elizabeth Fertich, (703) 347-8560, e-mail address: firstname.lastname@example.org.
List of subjects ↑
Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements.Dated: September 28, 2011. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs.