[Federal Register Volume 67, Number 220 (Thursday, November 14, 2002)]
[Notices]
[Pages 69002-69003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28910]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2002-0059; FRL-7277-4]


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: EPA is announcing a 2-hour teleconference 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. The EDMVS 
will provide technical advice on a fish lifecycle assay detailed review 
paper presented by the Endocrine Disruptor Screening Program (EDSP). 
The upcoming teleconference meeting is open to the public.

DATES: The teleconference meeting will be held on Wednesday, December 
4, 2002, from 10 a.m. to noon, eastern standard time.

ADDRESSES: The meeting will originate at RESOLVE, 1255 23\rd\ St., NW., 
Suite 275, Washington, DC.
     To participate in the EDMVS teleconference meeting, or to request 
special accommodations, including wheelchair access, one should contact 
the Designated Federal Official (DFO) under FOR FURTHER INFORMATION 
CONTACT at least 5 business days prior to the meeting.

FOR FURTHER INFORMATION CONTACT: Jane Smith, DFO, Office of Science 
Coordination and Policy (7201M), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8476; fax number: (202) 564-8483; e-mail address: [email protected].

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 if you produce, manufacture, use, consume, work 
with, or import pesticide chemical and other substances etc. To 
determine whether you or your business may have an interest in 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 (FQPA) (Public Law 104-170), 21 U.S.C. 346A (p) 
and amendments to the Safe Drinking Water Act (SDWA) (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 DFO 
under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2002-0059. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the EPA Docket Center, Rm. 
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, 
DC. The EPA Docket Center is open from 8:30 a.m. to 4:30 p.m., Monday 
through Friday, excluding legal holidays. The EPA Docket Center Reading 
Room telephone number is (202) 566-1744 and the telephone number for 
the OPPT Docket, which is located in EPA Docket Center, is (202) 566-
0280.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/, or through the EDSP Web site 
for the EDMVS at http://www.epa.gov/scipoly/oscpendo/edmvs.htm.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

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

     You may submit a request to participate in the meeting to the DFO 
listed under FOR FURTHER INFORMATION CONTACT. You can request special 
accommodations by electronic mail, telephone, fax, or in person. 
Seating is on a first-come basis. We would normally accept requests by 
mail, but in this time of delays in delivery of Federal government mail 
due to health and security concerns, we can not 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 November 27, 2002. To ensure proper receipt by EPA, it is 
imperative that you identify docket ID number OPPT-2002-0059, in the 
subject line on the first page of your request.
    1. Electronically. You may submit your request 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. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
ID number OPPT-2002-0059, in the subject line on the first page of your 
request.
    2. By telephone or fax. Contact Jane Smith, the person listed under 
FOR FURTHER INFORMATION CONTACT.
    3. By hand delivery or courier. Deliver your comments to: OPPT 
Document Control Office (DCO) to EPA East Building Rm. 6428, 1201 
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number 
OPPT-2002-0059. The DCO is open from 8 a.m. to 4 p.m., Monday through 
Friday, 8 a.m. to noon and 2 p.m. to 4 p.m., excluding legal holidays. 
The telephone number for the DCO is (202) 564-8930.

II. Background

    In 1996, through enactment of FQPA, which amended the FFDCA, 
Congress directed EPA to develop a screening program, using appropriate 
validated

[[Page 69003]]

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 the Federal Advisory Committee Act (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 I Screens) and tests (Tier II Tests) for determining whether a 
chemical substance may have an effect similar to that produced by 
naturally occurring hormones. EPA adopted many of EDSTAC's 
recommendations in the program that it developed, the EDSP, to carry 
out Congress' directive.
    EDSTAC also recognized that there currently are no validated 
testing 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) Endocine Testing and 
Assessment Task Force to validate and harmonize endocrine screening 
tests of international interest.
    Finally, 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 EDMVS of the NACEPT. EDMVS provides 
independent advice and counsel 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 methods for reducing 
animal use, refining procedures involving animals to make them less 
stressful, and replacing animals where scientifically appropriate.
    EDMVS has met five times since its establishment in September 2001.
    The objectives of the October 2001 meeting (docket control number 
OPPTS-42212D) were for EPA to provide:
    1. An overview of EPA's EDSP.
    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 control number 
OPPTS-42212E) were for the EDMVS to provide input and advice on:
    1. EDMVS'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 control number 
OPPTS-42212F) were for the EDMS to provide input and advice on:
    1. EDSP's implementation process and practical aspects of 
validation.
    2. The in utero through lactation assay protocol.
    3. The fish reproduction assay detailed review paper.
    4. Special studies on fathead minnow assays, vitellogenin assay, 
and avian dosing protocol.
    5. The steroidogenesis detailed review paper.
    6. The aromatase detailed review paper.
    7. A proposed standard suite of chemicals for testing in the Tier I 
screening assay.
    8. The current efforts related to evaluating the relevance of 
animal data to human health.
    9. EPA's approach to addressing low-dose issues.
    The objective of the June 2002 teleconference meeting (docket ID 
number OPPT-2002-0020) was for the EDMVS to provide input and advice on 
the steroidogenesis detailed review paper.
    The objectives of the July 2002 meeting (docket ID number OPPT 
2002-0029) were:
    1. To review criteria, recommended by EDSTAC and adopted by EDSP 
for screens.
    2. To receive an update on the NICEATM estrogen and androgen 
receptor binding efforts.
    3. To discuss and provide advice on general dose setting issues, 
and to provide comments and advice on:
    [sbull] A pubertals--special study--restricted feeding.
    [sbull] A mammalian 2-generation--draft PTU special study.
    [sbull] An amphibian metamorphosis detailed review paper.
    [sbull] An invertebrate detailed review paper.

III. Meeting Objectives for the December 2002 Teleconference Meeting

    The objective of the December 2002 teleconference meeting (docket 
ID number OPPT-2002-0059) is for the EDMVS to provide input and advice 
on the Tier II fish lifecycle assay detailed review paper.
    A list of the EDMVS members and meeting materials are available on 
our Web site (http://www.epa.gov/scipoly/oscpendo/edmvs.htm), and in 
the EPA Docket.

List of Subjects

    Environmental protection, Endocrine disruptors.

    Dated: November 4, 2002.
Joseph Merenda,
Director, Office of Science Coordination and Policy, Office of 
Prevention, Pesticides and Toxic Substances.
[FR Doc. 02-28910 Filed 11-13-02; 8:45 am]
BILLING CODE 6560-50-S