Environmental Protection Agency (EPA).
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 applicability of the Up and Down Procedure Methodology in acute oral toxicity testing. 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.
The meeting will be held on December 12, 2001, from 8:30 a.m. to 5 p.m.
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 (703) 486-1111.
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-00750 in the subject line on the first page of your response.Start Further Info
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: (703) 305-5369; fax number: (703) 605-0656; e-mail address: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
SUPPLEMENTARY INFORMATION:Start Printed Page 57439
I. General Information
A. 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.
B. 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 mid November. In addition, the Agency may provide additional background documents as the materials become 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-00750. 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 (703) 305-5805.
C. 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-00750 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 SAP 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). 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 (703) 305-5805.
3. Electronically. You may submit your request electronically by e-mail to: email@example.com. 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-00750. You may also file a request online at many Federal Depository Libraries.
A. Purpose of the Meeting
The purpose of this meeting is to seek comments of the FIFRA SAP on the regulatory applicability of the Up and Down Procedure for acute oral toxicity testing. Acute oral toxicity testing constitutes the adverse health effects that occur within a short time of administration of a single dose of a chemical and provides information on its potential health and environmental hazards and risks. Acute oral toxicity is a basic requirement for registration and reregistration of pesticide active ingredients and products. An improved version of the Up and Down Procedure has been developed as an alternative method for use by member nations of the Organization for Economic Cooperation and Development to meet regulatory needs for acute toxicity. Accordingly, this method will replace the traditional acute oral toxicity test in EPA, Office of Prevention, Pesticides and Toxic Substances (OPPTS) test guideline 870.1100. The test procedure in this guideline is of value in minimizing the number of animals required to determine the acute oral toxicity testing of a chemical. In addition to the estimation of LD50 and confidence intervals, the test allows the observation of signs of toxicity. Moreover, use of guidance for humane endpoints should reduce the overall suffering of animals in this type of test. The Up and Down Procedure is to be used for acute oral toxicity testing.
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 Public Information and Records Integrity Branch at the address or telephone number listed in Unit I. of this document.Start List of Subjects
List of SubjectsEnd List of Subjects Start Signature
Dated: November 6, 2001.
Director, Office of Science Coordination and Policy.
[FR Doc. 01-28636 Filed 11-14-01; 8:45 am]
BILLING CODE 6560-50-S