[Federal Register Volume 68, Number 225 (Friday, November 21, 2003)]
[Notices]
[Pages 65706-65708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29186]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2003-0064; FRL-7334-5]


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), on 
December 10-12, 2003. The purpose of this meeting is to: Receive advice 
and input from the EDMVS on: The Pubertals assay and Aromatase assay 
prevalidation results; receive the introductory presentation on Adult 
Intact Male assay; and receive updates on: The Androgen Receptor 
Binding assay, efforts to finalize reference chemicals, and the 
Organization for Economic Cooperation and Development (OECD) Fish 
Drafting Group.

DATES: The meeting will be held on Wednesday, December 10, 2003, from 1 
p.m. to 4:45 p.m.; Thursday, December 11, 2003, from 8:30 a.m. to 5 
p.m.; and Friday, December 12, 2003, from 8:30 a.m. to Noon, eastern 
standard time.
    Requests to participate in the meeting must be received by EPA on 
or before December 5, 2003. To ensure proper receipt by EPA, it is 
imperative that you identify docket ID number OPPT-2003-0064 in the 
subject line on the first page of your request.
    Individuals requiring special accommodations at the meeting, 
including wheelchair access, should contact the technical person listed 
under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to 
the meeting.

ADDRESSES: The meeting will be held at RESOLVE, 1255 23\rd\ St., NW., 
Suite 275, Washington, DC.
    Requests to participate in the meeting may be submitted by e-mail, 
telephone, fax, or through hand delivery/courier. Follow the detailed 
instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.
    Comments may be submitted electronically, by fax, or through hand 
delivery/courier. Follow the detailed instructions as provided in Unit 
I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact: 
Barbara Cunningham, Director, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Jane Smith, Designated Federal 
Official (DFO), Exposure Assessment Coordination and Policy Division 
(7203M), Office of Science Coordination and Policy, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8476; fax number: (202) 564-8482; e-
mail address: [email protected].

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, be of interest if you produce, manufacture, use, consume, work 
with, or import pesticide chemicals and other substances. 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 
(FQPA) of 1996 (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 
interested in this action. If you have any questions regarding this 
action, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPPT-2003-0064. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
related information. 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 are 
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) 566-0282.
    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/. A meeting agenda, a list of 
EDMVS members, and information from previous meetings are available 
electronically, from the EPA Internet Home Page 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. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.

C. How Can I Request to Participate in the Meeting or Submit Comments?

    You may submit a request to participate in the meeting through e-
mail, telephone, fax, or hand delivery/courier. 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 December 5, 2003. To ensure proper 
receipt by EPA, it is imperative that you identify docket ID number 
OPPT-2003-0064 in the subject line on the first page of your request.
    In accordance with the Federal Advisory Committee Act (FACA), the 
public is encouraged to submit written comments on the topic of this 
meeting.

[[Page 65707]]

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 meeting will be on the meeting topic and not be repetitive of 
previously submitted oral or written statements.
    1. Electronically. If you submit an electronic request to 
participate in the meeting or comments as prescribed in this unit, EPA 
recommends that you include your name, mailing address, and an e-mail 
address or other contact information in the body of your request or 
comment. Also include this contact information on the outside of any 
disk or CD ROM you submit, and in any cover letter accompanying the 
disk or CD ROM. This ensures that you can be identified as the 
submitter of the request or comment and allows EPA to contact you in 
case EPA cannot read your request or comment due to technical 
difficulties or needs further information on the substance of your 
request or comment. EPA's policy is that EPA will not edit your request 
or comment, and any identifying or contact information provided in the 
body of a request or comment will be included as part of the request or 
comment that is placed in the official public docket, and made 
available in EPA's electronic public docket. If EPA cannot read your 
request or comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your request or 
comment.
    i. EPA Docket. You may use EPA's electronic public docket to submit 
a request to participate in the meeting or to submit comments. Go to 
EPA Dockets at http://www.epa.gov/edocket/, and follow the online 
instructions for submitting materials. Once in the system, select 
``search,'' and then key in docket ID number OPPT-2003-0064. The system 
is an ``anonymous access'' system, which means EPA will not know your 
identity, e-mail address, or other contact information unless you 
provide it in the body of your request.
    ii. E-mail. Requests to participate in the meeting or comments may 
be sent by e-mail to [email protected], Attention: Docket ID Number 
OPPT-2003-0064. In contrast to EPA's electronic public docket, EPA's e-
mail system is not an ``anonymous access'' system. If you send an e-
mail request directly to the docket without going through EPA's 
electronic public docket, EPA's e-mail system automatically captures 
your e-mail address. E-mail addresses that are automatically captured 
by EPA's e-mail system are included as part of the request that is 
placed in the official public docket, and made available in EPA's 
electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM by 
hand delivery, courier, or package service, such as Federal Express, to 
the technical person listed under FOR FURTHER INFORMATION CONTACT. 
These electronic submissions will be accepted in WordPerfect or ASCII 
file format. Avoid the use of special characters and any form of 
encryption. Do not submit any disk or CD ROM through the mail. Disks 
and CD ROMs risk being destroyed when handled as Federal Government 
mail.
    2. Telephone or fax. Telephone or fax your request to participate 
in the meeting to the technical person listed under FOR FURTHER 
INFORMATION CONTACT.
    3. By hand delivery or courier. Deliver your comments to: OPPT 
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201 
Constitution Ave., Washington, DC. Attention: Docket ID Number OPPT-
2003-0064. The DCO is open from 8 a.m. to 4 p.m., Monday through 
Friday, 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 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 OECD's Endocrine 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 established the EDMVS under NACEPT. EDMVS provides 
independent advice and counsel to the Agency through NACEPT, on 
scientific and technical issues related to validation of the EDSP Tier 
1 screens and Tier 2 tests, including advice on methods for reducing 
animal use, refining procedures involving animals to make them less 
stressful, and replacing animals where scientifically appropriate.
    The EDMVS has held eight meetings since its establishment in 
September 2001.
October 2001
    The objectives of the first meeting, which was held in October 
2001, (docket control number OPPTS-42212D) were for EPA to provide:
    1. An overview of the 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. The EDMVS and the EDSP to determine the next steps.
December 2001
    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.
March 2002
    The objectives of the March 2002 meeting (docket control number 
OPPTS-42212F) were for the EDMVS to provide input and advice on:
    1. EPA's implementation process and practical aspects of 
validation.
    2. The In Utero Through Lactation Assay Protocol.
    3. The Fish Reproduction assay detailed review paper.

[[Page 65708]]

    4. Special studies, the 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 1 
Screening assays.
    8. The current efforts related to evaluating the relevance of 
animal data to human health.
    9. EPA's approach to addressing low-dose issues.
June 2002
    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.
July 2002
    The objectives of the July 2002 meeting (docket ID number OPPT-
2002-0029) were:
    1. To review the screening criteria, recommended by EDSTAC and 
adopted by EDSP for screens.
    2. To receive an update of 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 pubertal (special study)--restricted feeding.
    [sbull] A mammalian 2-generation (draft)--Propylthiouracil (PTU) 
special study.
    [sbull] An amphibian metamorphosis detailed review paper.
    [sbull] An invertebrate detailed review paper.
December 2002
    The objective of the December 2002 teleconference meeting (docket 
ID number OPPT-2002-0059) was for the EDMVS to provide input and advice 
on the Tier 2 Fish Life Cycle assay detailed review paper.
June 2003
    The objectives of the June 5-6, 2003 meeting (docket ID number 
OPPT-2003-0016) were for the EDMVS to provide input and advice on:
    1. The Tier II Mammalian 2-Generation Special Study and the 1-
generation extension results.
    2. The Tier I Steroidogenesis (Sliced Testes) Study results and 
validation plan.
    3. The Tier I Pre-Optimization, substrate characterization for 
Aromatase Placental Microsomes Study results.
August 2003
    The objectives of the August 18-20, 2003 meeting (docket ID number 
OPPT-2003-0027) were:
    1. Review and discuss the status/results of the prevalidation work 
on:
    [sbull] The Fish Screening assay, specifically: The survey of 
vitellogenin methods in Fathead Minnow, Zebrafish, and Medaka; the 
comparative evaluation of the Fathead Minnow assays; and the Fish 
Screen (Non-Spawning) assay.
    [sbull] The Steroidogenesis Assay Optimized Protocol.
    2. Provide input and advice on the:
    [sbull] EDSP's validation plans for the Fish Screening assay and 
Steroidogenesis assay.
    [sbull] Strain/species white paper.
    [sbull] Chemicals used in EDSP's prevalidation and validation.
    [sbull] Avian detailed review paper.
    [sbull] Issues related to the Pubertal assays.
    3. Receive an update on the amphibian workshop conducted recently.

III. Meeting Objectives for the December 2003 Meeting

    The objectives for the December 10-12, 2003 meeting (docket ID 
number OPPT-2003-0064) are for EDMVS to provide input and advice on:
    1. Discuss the Pubertals assay and Aromatase assay prevalidation 
results and recommend next steps.
    2. Receive introductory presentation on Adult Intact Male assay.
    3. Receive updates on:
    [sbull] Androgen Receptor Binding assay.
    [sbull] Efforts to finalize reference chemicals.
    [sbull] OECD Fish Drafting Group.
    [sbull] Activities regarding In Vitro Fish assays.
    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 
public docket.

List of Subjects

    Environmental protection, Endocrine disruptors, Hazardous 
substances, Health, Safety.


    Dated: November 14, 2003.
Joseph J. Merenda, Jr.,
Director, Office of Science Coordination and Policy.
[FR Doc. 03-29186 Filed 11-20-03; 8:45 am]
BILLING CODE 6560-50-S