[Federal Register Volume 66, Number 221 (Thursday, November 15, 2001)]
[Notices]
[Pages 57438-57440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28636]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00750; FRL-6811-1]


FIFRA Scientific Advisory Panel; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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 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.

DATES: The meeting will be held on December 12, 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 (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.

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: [email protected].

SUPPLEMENTARY INFORMATION:

[[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 protected]. 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.

II. Background

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.

List of Subjects

    Environmental protection.


[[Page 57440]]


    Dated: November 6, 2001.
Vanessa Vu,
Director, Office of Science Coordination and Policy.
[FR Doc. 01-28636 Filed 11-14-01; 8:45 am]
BILLING CODE 6560-50-S