[Federal Register: July 10, 2002 (Volume 67, Number 132)]
[Notices]               
[Page 45720-45722]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jy02-63]                         

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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2002-0029; FRL-7186-7]

 
Endocrine Disruptor Methods Validation Subcommittee under the 
National Advisory Council for Environmental Policy and Technology; 
Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a meeting of the Endocrine Disruptor Methods 
Validation Subcommittee (EDMVS), a subcommittee under the National 
Advisory Council for Environmental Policy and Technology (NACEPT), a 
Federal Advisory Committee, on July 23-24, 2002. The EDMVS will provide 
technical advice on screening and testing methods for the Endocrine 
Disruptor Screening Program (EDSP). This meeting, as with all EDMVS 
meetings, is open to the public. Seating is on a first-come basis. 
Individuals requiring special accommodations at this meeting, including 
wheelchair access, should contact Jane Smith at the address listed 
under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to 
the meeting, so appropriate arrangements can be made.

DATES: The meeting will be held on July 23, 2002, from 9 a.m. to 5:45 
p.m. and July 24, from 8:30 a.m. to 12:30 p.m. (eastern daylight time).

ADDRESSES: The meeting will be held at RESOLVE, 1255 23rd St., NW., 
Suite 275, Washington, DC. The telephone number for RESOLVE is: (202) 
944-2300. The nearest Metro stop is Foggy Bottom.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Designated Federal 
Official, Office of Science Coordination and Policy (7201M), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 564-8476; fax number: 
(202) 564-8483; e-mail address: smith.jane-scott@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, potentially affect you if you produce, manufacture, use, 
consume, work with, or import pesticide chemical substances that may 
have an effect that is cumulative to an effect of a pesticide, or 
substances found in sources of drinking water. To determine whether you 
or your business may be affected by this notice you should carefully 
examine section 408(p) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (Public 
Law 104-170), 21 U.S.C. 346A(p), and amendments to The Safe Drinking 
Water Act (Public Law 104-182), 42 U.S.C. 300j-17. 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. 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 search for ``Endocrine 
Disruptor'' which will take you to the OSCP Endocrine Disruptor web 
site. You can also 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/.
    A list of the EDMVS members and meeting materials are available at: 
http://www.epa.gov/scipoly/oscpendo/edmvs.htm, and in the public 
Docket.
    2. In person. The Agency has established an official record for 
this meeting under docket ID number OPPT-2002-0029. The official record 
consists of the documents specifically referenced in this notice, any 
public comments received, and other information related to Endocrine 
Disruptor Method Validation, including any information claimed as 
Confidential Business Information (CBI). The public version of the 
official record is available for inspection in the TSCA Nonconfidential 
Information Center, North East Mall, Rm. B-607, Waterside Mall, 401 M 
St., SW., Washington, DC. The Center is

[[Page 45721]]

open from noon to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the Center is (202) 260-7099.

C. How Can I Request to Participate in this Meeting?

    In accordance with the Federal Advisory Committee Act (FACA), the 
public is encouraged to submit written comments on this meeting's 
topics. The EDMVS will have a brief period available during the meeting 
for public comment. It is the policy of the EDMVS to accept written 
public comments of any length, and to accommodate oral public comments 
whenever possible. The EDMVS expects that public statements presented 
at its meetings will be on the meeting topic and not be repetitive of 
previously submitted oral or written statements.
    You may submit a request to participate in the meeting by e-mail, 
telephone, fax, or in person. We would normally accept requests by 
mail, but in this time of delays in delivery of government mail due to 
health and security concerns, we cannot assure your request would 
arrive in a timely manner. Do not submit any information in your 
request that is considered CBI. Your request must be received by EPA on 
or before July 18, 2002. To ensure proper receipt by EPA, it is 
imperative that you identify docket ID number OPPT-2002-0029 in the 
subject line on the first page of your request.
    1. Electronically. You may submit your request electronically by e-
mail to Jane Smith at: smith.jane-scott@epa.gov or to the docket at: 
oppt.ncic@epa.gov. 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 ID number OPPT-2000-0029.
    2. By telephone or fax. Contact Jane Smith, by telephone at (202) 
564-8476 or by fax number at (202) 564-8483.
    3. In person or by courier. You may deliver a request to: OPPT 
Docket Control Office, North East Mall, Rm. B-607, Waterside Mall, 401 
M St., SW., Washington, DC. The Docket Office is open from noon to 4 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number of the Office is (202) 260-7099.

II. Background

A. History

    In 1996, through enactment of the Food Quality Protection Act, 
which amended the Federal Food, Drug, and Cosmetic Act, Congress 
directed EPA to develop a screening program, using appropriate 
validated test systems and other scientifically relevant information, 
to determine whether certain substances may have hormonal effects in 
humans. In 1996, EPA chartered a scientific advisory committee, the 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
under the authority of FACA to advise it on establishing a program to 
carry out Congress' directive. EDSTAC recommended a multi-step approach 
including a series of screens (Tier 1 Screens) and tests (Tier 2 Tests) 
for determining whether a chemical substance may have an effect similar 
to that produced by naturally occurring hormones. EPA adopted almost 
all of EDSTAC's recommendations in the Program that it developed, the 
Endocrine Disruptor Screening Program (EDSP), to carry out Congress' 
directive. EDSTAC also recognized that there currently are no validated 
test systems for determining whether a chemical may have an effect in 
humans that is similar to an effect produced by naturally occurring 
hormones. Consequently, EPA is in the process of developing and 
validating the screens and tests that EDSTAC recommended for inclusion 
in the EDSP. In carrying out this validation exercise, EPA is working 
closely with, and adhering to the principles of the Interagency 
Coordinating Committee for the Validation of Alternate Methods 
(ICCVAM). EPA also is working closely with the Organization for 
Economic Cooperation and Development's (OECD), Endocrine Testing and 
Assessment Task Force to validate and harmonize endocrine screening 
tests of international interest. To ensure that EPA has the best and 
most up-to-date advice available regarding the validation of the 
screens and tests in the EDSP, EPA recently chartered the Endocrine 
Disruptor Methods Validation Subcommittee (EDMVS) of the National 
Advisory Council for Environmental Policy and Technology (NACEPT). 
EDMVS provides independent advice and recommendations to the Agency 
through NACEPT, on scientific and technical issues related to 
validation of the EDSP Tier I screens and Tier II tests, including 
advice on ways to reduce animal use, refining procedures involving 
animals to make them less stressful, and replacing animals where 
scientifically appropriate. More information is available on the 
website: http://www.epa.gov/scipoly/oscpendo/edmvs.htm.

B. Previous Meeting

    The EDMVS has met four times since its establishment in September 
2001. The objectives of the October 2001 meeting (Docket OPPT-42212D) 
were for EPA to provide:
    1. An overview of EPA's Endocrine Disruptor Program.
    2. Background information on test protocol validation and 
approaches.
    3. For the EDMVS to develop a clear understanding of their scope, 
purpose, and operating procedures.
    4. For the EDMVS and the EDSP to determine the next steps.
    The objectives of the December 2001 meeting (Docket OPPT-42212E) 
were for the EDMVS to provide input and advice on:
    1. The EDMV'S mission statement and work plan.
    2. The in utero through lactation assay detailed review paper.
    3. The pubertal assay study design for the multi-dose and chemical 
array protocols.
    4. The mammalian 1-generation study design.
    The objectives of the March 2002 meeting (Docket OPPT-42212F) were 
for the EDMVS to provide input and advice on:
    1. EDSP's implementation process and practical aspects of 
validation; the in utero through lactation assay protocol.
    2. The fish reproduction assay detailed review paper.
    3. Special studies on fathead minnow assays, vitellogenin assay, 
and avian dosing protocol.
    4. The aromatase detailed review paper.
    5. A proposed standard suite of chemicals for testing in the Tier 1 
screening assay.
    6. EDSP presenting the current efforts related to evaluating the 
relevance of animal data to human health.
    7. EPA's approach to addressing low dose issues.
    The objectives of the June 2002 teleconference/meeting (docket ID 
number OPPT-2002-0029) was for the EDMVS to provide input and advice on 
the steroidogenesis detailed review paper.

III. Meeting Objectives for the July 2002 Meeting

    The draft objectives of the July 2002 meeting docket ID number 
OPPT-2002-0029 is for the EDMVS to provide input and advice on:
    1. The pubertals - special study: restricted feeding.
    2. The mammalian 2-generation PTU special study (Tier II).
    3. The amphibian metamorphosis detailed review paper (Tier I).
    4. The invertebrate detailed review paper (Tier II).

[[Page 45722]]

    5. For the EDSP to provide information on:
      Criteria for screens - review of EDSTAC recommendations.
      The ICCVAM-NICEATM expert panel meeting on in vitro ER/AR 
assays.
      An update on core chemicals selected by EDSP.
      General dose setting issues. (Tentative)

List of Subjects

    Environmental protection, Endocrine disruptor screening program, 
Endocrine disruptors.

    Dated: July 2, 2002.
  Sherell A. Sterling,
Acting Director, Office of Science Coordination and Policy.
[FR Doc. 02-17309 Filed 7-9-02; 8:45 am]
BILLING CODE 6560-50-S