02-26577. Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and Tolerance Reassessment Decision (TRED) for Hexazinone

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

This notice announces the availability of EPA's tolerance reassessment decision and related documents for hexazinone including the Hexazinone Overview, Hexazinone Summary, Hexazinone Decision Document (TRED), and supporting risk assessment documents. EPA has reassessed the 25 tolerances, or legal limits, for residues of hexazinone in or on raw agricultural commodities. These tolerances are now considered safe under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) of 1996.

DATES:

Comments on the tolerance reassessment decision for hexazinone, must be received by EPA on or before November 22, 2002. In the absence of substantive comments, the tolerance reassessment decision will be considered final. Comments on the human health and ecological effects risk assessments for hexazinone, must be received by EPA 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 the SUPPLEMENTARY INFORMATION section. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP-2002-0188 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Dirk V. Helder, Special Review and Reregistration Division (7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone 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 persons 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. 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/​reregistration. 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-2002-0188. 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-2002-0188 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 Hwy., 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 in this unit. 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-2002-0188. 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 burden 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 notice.

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 reassessed the risks associated with current food uses of the pesticide hexazinone, reassessed 25 existing tolerances, and reached a tolerance reassessment and risk management decision. The Agency is issuing for comment the resulting report on FQPA tolerance reassessment progress, including the Hexazinone Overview, Hexazinone Summary, Hexazinone Decision Document (TRED), and supporting risk assessment 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. EPA has reviewed and made the requisite safety finding for the tolerances and exemptions included in this notice. EPA completed the hexazinone Reregistration Eligibility Decision (RED) prior to the 1996 enactment of the FQPA; therefore, while no reregistration decision is required at present, risks from non-occupational exposure to hexazinone through food, drinking water, and residential uses must be reassessed. There are no residential uses of hexazinone. The Agency has reassessed the 25 tolerances for hexazinone and determined that residues in food and drinking water are not expected to pose risk concerns. Because existing data were inadequate to calculate residue estimates for pasture and rangeland grass and grass hay, EPA constructed the maximum theoretical dietary burden (MTDB) of hexazinone to livestock using protective assumptions for the contributions of other hexazinone treated feed items. Thus, tolerances for meats and milk can be reassessed. Additional field trial data for grass forage and grass hay, as well as rotational crop studies for corn and wheat are required. Because of the relatively low volume of use on pasture and rangeland, data from these confirmatory studies are not expected to significantly change current dietary risk estimates. Some tolerances may be revised once additional data has been submitted to and reviewed by the Agency. The current tolerance expression for hexazinone in 40 CFR 180.396 is for “combined residues of the herbicide hexazinone (3-cyclohexyl-6-(dimethylamino)-1-methyl-1,3,5-triazine-2,4(1H,3H)-dione) and its metabolites, calculated as hexazinone.” The tolerance expression should be modified to include specific metabolites A, B, C, D, and E, identified by the appropriate chemical name. Final tolerances are being proposed as part of this Tolerance Reassessment Decision (TRED). In addition, occupational and ecological risk management decisions were made as part of the 1994 hexazinone RED.

EPA works with affected parties to reach the tolerance reassessment decisions. The Agency therefore is issuing the hexazinone decision as a final decision with a public comment period. All comments received during the public comment period will be considered by the Agency. If any comment significantly affects the Agency's decision, EPA will publish an amendment to the decision in the Federal Register. In the absence of substantive comments, the tolerance reassessment decisions reflected here will be considered final.

List of Subjects

• Environmental protection
• Chemicals
• Pesticides and pests

Dated: October 4, 2002.

 Betty Shackleford,

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