01-22760. FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a 1-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Food Quality Protection Act (FQPA) Scientific Advisory Panel (SAP) to review a set of issues being considered by the Agency pertaining to the regulatory applicability of the local lymph node assay. Seating at the meeting will be on a first-come basis. Individuals requiring special accommodations at this meeting, including wheelchair access, should contact Paul Lewis at the address listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting so that appropriate arrangements can be made.

DATES:

The meeting will be held on October 22, 2001, from 8:30 a.m. to 5 p.m.

ADDRESSES:

The meeting will be held at the Sheraton Crystal City Hotel, 1800 Jefferson Davis Highway, Arlington, VA 22202. The telephone number for the Sheraton Crystal City Hotel is [phone].

Requests to participate 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, your request must identify docket control number OPP-00740 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Paul Lewis, Designated Federal Official, Office of Science Coordination and Policy, (7202), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug and Cosmetic Act (FFDCA), FIFRA, and FQPA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Electronically. A meeting agenda and several background documents relevant to this meeting are now available. EPA's primary position paper and questions to the FIFRA SAP should be available as soon as possible, but no later than late September. In addition, the Agency may provide additional background documents as the materials becomes available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the FIFRA SAP Internet Home Page at http://www.epa.gov/​scipoly/​sap. To access this document on the Home Page select Federal Register notice announcing this meeting. You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an administrative record for this meeting under docket control number OPP-00740. The administrative record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other material information, including any information claimed as Confidential Business Information (CBI). This administrative record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. In addition, the Agency may provide additional background documents as the material becomes available. The public version of the administrative record, which includes printed, paper versions of any electronic comments that may be 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].

III. How Can I Request To Participate in this Meeting?

You may submit a request to participate in this meeting through the mail, in person, or electronically. Do not submit any information in your request that is considered CBI. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00740 in the subject line on the first page of your request. Interested persons are permitted to file written statements before the meeting. To the extent that time permits, and upon advance written request to the person listed under FOR FURTHER INFORMATION CONTACT, interested persons may be permitted by the Chair of the FIFRA Scientific Advisory Panel to present oral statements at the meeting. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment (e.g., overhead projector, 35 mm projector, chalkboard, etc.). There is no limit on the extent of written comments for consideration by the Panel, but oral statements before the Panel are limited to approximately 5 minutes. The Agency also urges the public to submit written comments in lieu of oral presentations. Persons wishing to make oral and/or written statements at the meeting should contact the person listed under FOR FURTHER INFORMATION CONTACT and submit 30 copies of their presentation and/or remarks to the Panel. The Agency encourages that written statements be submitted before the meeting to provide Panel Members the time necessary to consider and review the comments.

1. By mail. You may submit a request 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. 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 request electronically by e-mail to: [e-mail]. Do not submit any information electronically that you consider to be CBI. Use WordPerfect 6.1/8.0 or ASCII file format and avoid the use of special characters and any form of encryption. Be sure to identify by docket control number OPP-00740. You may also file a request online at many Federal Depository Libraries.

IV. Background

A. Purpose of the Meeting

The purpose of this meeting is to seek the SAP's comments on the regulatory applicability of the local lymph node assay (LLNA). The LLNA is a test method for assessing the allergic contact dermatitis (skin sensitization) potential of chemicals and compounds. The assay was found to be scientifically valid by an Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) external peer review as an alternative to traditional guinea pig tests (e.g., Buehler test and Guinea Pig Maximization test). It was also found to provide animal welfare advantages.

In 1996, the SAP gave approval to the incorporation of the LLNA in the Agency's harmonized OPPTS test guidelines (e.g., 870.200 Skin Sensitization) as a screening method. The Agency has now revised its harmonized OPPTS test guidelines to incorporate the LLNA for use as a stand alone method for assessing skin sensitization potential under the appropriate circumstances. These revisions and details of how the LLNA is proposed to fit into both EPA, Office of Pesticide Programs and EPA, Office of Pollution Prevention and Toxics evaluations of skin sensitization will be presented to the SAP for comment.

B. Panel Report

The Panel will prepare a report of its recommendations to the Agency in approximately 60 days. The report will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed in Unit I.

List of Subjects

• Environmental protection

Dated: August 31, 2001.

Vanessa Vu,

Director, Office of Science Coordination and Policy.