02-26578. Availability of the Report on FQPA Tolerance Reassessment Progress and Risk Management Decision (TRED) for Metolachlor

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of the report on the Food Quality Protection Act (FQPA) tolerance reassessment progress and Risk Management Decision (TRED) for metolachlor for public comment. EPA has reassessed the 81 tolerances, or legal limits, established for residues of metolachlor in/on raw agricultural commodities (RACs). These tolerances are now considered safe under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the FQPA of 1996.

DATES:

Comments, identified by docket ID number OPP-2002-0223, must be received on or before November 22, 2002.

ADDRESSES:

Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0223 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Anne Overstreet, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general, but will be of interest to a wide range of stakeholders, including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the use of pesticides. The Agency has not attempted to describe all the persons or entities who may be interested in or affected by this action. If you have questions in this regard, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register— Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

You can obtain copies of the TRED and related documents discussed in this notice on EPA's website at http://www.epa.gov/​pesticides/​reregistration/​status.htm.

Available documents include the TRED, supporting technical documents, and Federal Register notices. Information on pesticide reregistration and tolerance reassessment, including the purpose and status of Agency programs to complete Reregistration Eligibility Decisions (REDs), Interim REDs, and Tolerance Reassessment Decisions (TREDs), is available at http://www.epa.gov/​pesticides/​tolerance. General information is available on the Office of Pesticide Programs' Home Page, http://www.epa.gov/​pesticides.

2. In person. The Agency has established an official record for this action under docket ID number OPP-2002-0223. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0223 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0/9.0 or ASCII file format. All comments in electronic form must be identified by docket ID number OPP-2002-0223. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under For Further Information Contact.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burdens or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the notice or collection activity.

7. Make sure to submit your comments by the deadline in this document.

8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has assessed the risks associated with current and proposed food uses of metolachlor, reassessed 81 existing tolerances, and reached a tolerance reassessment and risk management decision. The Agency is issuing the resulting report on FQPA Tolerance Reassessment Progress and Risk Management Decision for metolachlor, known as a TRED, as well as a summary, overview, and technical support documents.

EPA must review tolerances and tolerance exemptions that were in effect when FQPA was enacted in August 1996, to ensure that these existing pesticide residue limits for food and feed commodities meet the safety standard established by the new law. Tolerances are considered reassessed once the safety finding has been made or a revocation occurs. In total, 81 tolerances have been reassessed and are now considered safe under section 408(q) of FFDCA.

The Agency has determined that there are no dietary (food or drinking water) or aggregate risks of concern for metolachlor, so mitigation of these risks is not necessary. EPA is able to make the FQPA safety finding for all current and proposed uses of metolachlor.

EPA must consider the cumulative effects of pesticides that have common mechanisms of toxicity, and may issue final tolerance reassessment decisions for these pesticides only after their cumulative risks have been considered. The Agency has examined this common mechanism potential for metolachlor and has concluded that only some of the pesticides that comprise the class of chloroacetanilides should be designated as a “Common Mechanism Group” based on the development of nasal turbinate tumors. Because only acetochlor, alachlor, and butachlor should be grouped based on a common mechanism of toxicity for nasal turbinate tumors, a cumulative assessment is not necessary to determine whether tolerances established for residues of metolachlor in/on RACs are reassessed as safe.

EPA works extensively with affected parties to reach the tolerance reassessment decisions presented in TREDs. The Agency therefore is issuing the metolachlor TRED as a final decision. However, the docket remains open, and if the Agency receives any comments within the next 30 days which significantly affect the Agency's decision, EPA will publish an amendment to the TRED in the Federal Register. In the absence of substantive comments, the tolerance reassessment decisions reflected in this TRED will be considered final.

List of Subjects

• Environmental protection
• Pesticides and pests
• Metolachlor

Dated: October 2, 2002.

 Lois Ann Rossi,

Director, Special Review and Reregistration Division, Office of Pesticide Programs.