Proposed Tolerance Actions: Metolachlor, S-Metolachlor, Bifenazate, Buprofezin, and 2,4-D

Federal Register: June 26, 2009 (Volume 74, Number 122)

Proposed Rules

Page 30487-30493

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr26jn09-15

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180

EPA-HQ-OPP-2009-0239; FRL-8411-5

Metolachlor, S-Metolachlor, Bifenazate, Buprofezin, and 2,4-D;

Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to modify, establish and revoke certain tolerances for the herbicides metolachlor and S-metolachlor and correct the tolerance guava (from guave) on bifenazate and buprofezin and 2,4-D on cranberry. The regulatory actions proposed in this document are in follow-up to the Agency's reregistration program under the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA), and tolerance reassessment program under the Federal Food, Drug, and Cosmetic Act

(FFDCA), section 408(q).

DATES: Comments must be received on or before August 25, 2009.

ADDRESSES: Submit your comments, identified by docket identification

(ID) number EPA-HQ-OPP-2009-0239, 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 docket ID number EPA-HQ-OPP- 2009-0239. 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.,

Page 30488

Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and

Reregistration Division (7508P), Office of Pesticide Programs,

Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail address: smith.jane-scott@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.A. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER

      INFORMATION CONTACT.

   2. 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.

2. Background

   1. What Action is the Agency Taking?

   EPA is proposing to modify, revoke, and establish specific tolerances for residues of the herbicides metolachlor, S-metolachlor, bifenazate, buprofezin, and 2,4-D in or on commodities listed in the regulatory text.

   EPA is proposing these tolerance actions to implement the tolerance recommendations made during the reregistration and tolerance reassessment processes (including follow-up on canceled or additional uses of pesticides). As part of these processes, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of ``reasonable certainty of no harm'' is discussed in detail in each Reregistration

   Eligibility Decision (RED) and Report of the Food Quality Protection

   Act (FQPA) Tolerance Reassessment Progress and Risk Management Decision

   (TRED) for the active ingredient. REDs and TREDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy.

   Printed copies of many REDs and TREDs may be obtained from EPA's

   National Service Center for Environmental Publications (EPA/NSCEP),

   P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490- 9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/ ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800- 553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies of REDs and TREDs are available on the Internet at http:// www.epa.gov/pesticides/reregistration/status.htm and in the public docket, at http://www.regulations.gov.

   The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA recommends the raising of a tolerance when data show that: 1. Lawful use (sometimes through a label change) may result in a higher residue level on the commodity. 2. The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance.

   In REDs, Chapter IV on ``Risk management, Reregistration, and Tolerance reassessment'' typically describes the regulatory position, FQPA assessment, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. In TREDs, the Agency discusses its evaluation of the dietary risk associated with the active ingredient and whether it can determine that there is a reasonable certainty (with appropriate mitigation) that no harm to any population subgroup will result from aggregate exposure.

   EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.

   Explanations for proposed modifications in tolerances can be found in the RED and TRED document and in more detail in the Residue

   Chemistry Chapter document which supports the RED and TRED. Copies of the Residue Chemistry Chapter documents are found in the Administrative

   Record and EPA's

   Page 30489

   electronic copies are available through EPA's electronic public docket and comment system, regulations.gov at http://www.regulations.gov. You may search for docket ID number EPA-HQ-OPP-2009-0239, EPA-HQ-OPP-2002- 0223, EPA-HQ-OPP-2007-0445, EPA-HQ-OPP-2007-0674, EPA-HQ-OPP-2007-0097, and EPA-HQ-OPP-2007-1170, then click on that docket ID number to view its contents.

   EPA has determined that the aggregate exposures and risks are not of concern for the above-mentioned pesticide active ingredients based upon the data identified in the RED or TRED which lists the submitted studies that the Agency found acceptable.

   EPA has found that the tolerances that are proposed in this document to be modified, are safe; i.e., that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residues, in accordance with FFDCA section 408(b)(2)(C). (Note that changes to tolerance nomenclature do not constitute modifications of tolerances). These findings are discussed in detail in each RED or TRED. The references are available for inspection as described in this document under

   SUPPLEMENTARY INFORMATION.

   In the Federal Register notices published August 8, 2007 (72 FR 44439) (FRL-8138-8) and May 21, 2008 (73 FR 29456) (FRL-8362-1), EPA proposed to revoke, modify, and establish specific tolerances for residues of the herbicides metolachlor and S-metolachlor as well as tolerances for other pesticide chemicals. These proposals provided a 60-day comment period which invited public comment for consideration and for support of tolerance retention under FFDCA standards. These proposed actions were finalized on September 10, 2008 (73 FR 52607)

   (FRL-8379-3) and September 17, 2008 (73 FR 53732) (FRL-8375-2). The

   Agency received comments to the proposal published August 8, 2007 on S- metolachlor in which we indicated we would respond in the future. This action responds to those comments and addresses other tolerance actions associated with metolachlor, S-metolachlor, bifenazate and buprofezin.

   The proposal published May 21, 2008 provides related information on metolachlor and S-metolachlor. 1. Metolachlor/S-metolachlor. The Agency received comments from

   Syngenta (EPA-HQ-2007-0445-0013) in response to the Federal Register proposal published August 8, 2007 (73 FR 53732) as follows:

   (i) Revocation of tolerance in stone fruit-Use of S-Metolachlor in stone fruit is an important tool for Canadian fruit producers and therefore, it would be beneficial to maintain U.S. tolerances to avoid any trade irritant issues for these crops being exported from

   Canada to the U.S. Canada currently has a tolerance of 0.1 ppm for

   S-metolachlor in apples, apricots, cherries, peaches/nectarines, pears and plums.

   (ii) Increase in tolerance for Crop Group 6A from 0.3 ppm to 0.5 ppm-Canada currently has a tolerance of 0.3 ppm for S-metolachlor in peas and snap beans. An increase in the U.S. tolerance could result in a trade irritant for these crops exported from the U.S. to

   Canada.

   (iii) Decrease in tolerance for Crop Group 6C from 0.3 ppm to 0.1 ppm-Canada currently has a tolerance of 0.3 ppm for S- metolachlor in dry beans. A decrease in the U.S. tolerance could result in a trade irritant for these crops exported from Canada to the U.S.

   (iv) Increase in tolerance for egg and meat from 0.02 pm to 0.04 ppm-Canada currently has a tolerance of 0.02 ppm for S-metolachlor in eggs, meat of cattle, goats, hogs, poultry and sheep. An increase in the U.S. tolerance could result in a trade irritant for these animal products exported from the U.S. to Canada.

   (v) Increase tolerance in animal liver from 0.05 ppm to 0.1 ppm-

   Canada currently has a tolerance of 0.05 ppm for S-metolachlor in liver of cattle and poultry. An increase in the U.S. tolerance could result in a trade irritant for these animal products exported from the U.S. to Canada.

   The Agency responded to Syngenta's first comment (i) on September 17, 2008 (73 FR 53732). In response to the remaining comments (ii)-(v), the Agency has re-evaluated new and existing data for the legume crop group 6, and existing data for cattle meat, fat and liver, poultry meat, fat and egg for both metolachlor and S-metolachlor which, in general, the Agency agrees with the comments. The maximum S-metolachlor residue field trial data in/on legume vegetables support the harmonization of the corresponding legume vegetable crop group 6 tolerances with the Canadian MRLs at 0.3 ppm for existing S-metolachor tolerances and the establishment of a tolerance of 0.3 ppm in/on pea and bean, succulent shelled, subgroup 6B where maximum residues were 0.14 ppm. Extrapolating the residue data from the ruminant feeding study to a 1x feeding level for cattle, goats, horses, and sheep the maximum combined residues of concern for metolachlor and S-metolachlor would be 0.01 ppm in meat and fat and 0.03 ppm in liver; and considering the harmonization of tolerances with Canadian MRLs under the North American Free Trade Agreement (NAFTA), the Agency determined that the tolerances should be decreased for cattle, goat, horse, and sheep liver to 0.05 ppm and meat and fat to 0.02 ppm. Based on feeding studies in hens dosed up to 3.9x the maximum theoretical dietary burden, metolachlor and S-metolachlor residues of concern were not detected (