[Federal Register Volume 70, Number 67 (Friday, April 8, 2005)]
[Notices]
[Pages 17995-17997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-7043]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2005-0012; FRL-7708-9]


Endocrine Disruptor Methods Validation Advisory Committee 
(EDMVAC); 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 Advisory Committe (EDMVAC) on April 26-28, 2005, in 
Washington, DC. This meeting, as with all EDMVAC meetings, is open to 
the public. Seating is on a first-come basis. The purpose of the 
meeting is to receive advice and input from the EDMVAC on: 
Steroidogenesis, Uterotrophic, Fish Screen Studies, and Amphibian 
Metamorphosis Assays.

DATES: The meeting will be held on Wednesday, April 26, 2005, from 
12:30 p.m. to 5:30 p.m.; Thursday, April 27, 2005, from 8:30 a.m. to 
5:30 p.m.; and Friday, April 28, 2005, from 8 a.m. to 12:15 p.m., 
eastern standard time.
    Request to participate in the meeting must be received by EPA on or 
before April 21, 2005. To ensure proper receipt by EPA, it is 
imperative that you identify docket identification (ID) number OPPT-
2005-0012 in the subject line on the first page of your request.
    Individuals requiring special accommodations at the meeting, 
including wheelchair access, should contact the person listed under FOR 
FURTHER INFORMATION CONTACT at least 5 business days prior to the 
meeting.

[[Page 17996]]


ADDRESSES: The meeting will be held at RESOLVE, 1255 23rd St., NW., 
Suite 275, Washington, DC 20037.
    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: Jane Smith, Designated Federal 
Official (DFO), Office of Science Coordination and Policy (7203M), 
Office of Prevention, Pesticides and Toxic Substances (OPPTS), 
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 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-2005-0012. 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 the 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 
EDMVAC members and information from previous EDMVS meetings are 
available electronically, from the EPA Internet Home Page at http://www.epa.gov/scipoly/oscpendo/.
    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 April 21, 2005. To ensure proper 
receipt by EPA, it is imperative that you identify docket ID number 
OPPT-2005-0012 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. The EDMVAC will have a period available during the meeting for 
public comment. It is the policy of the EDMVAC to accept written public 
comments of any length, and to accommodate oral public comments 
whenever possible. The EDMVAC 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 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-2005-0012. 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-2005-0012. 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 person listed under FOR FURTHER

[[Page 17997]]

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 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-
2005-0012. 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.
    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.
    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 chartered the Endocrine Disruptor Methods Validation 
Subcommmittee (EDMVS) of the National Advisory Council for 
Environmental Policy and Technology (NACEPT). The EDMVS convened nine 
meetings between October 2001 and December 2003. In 2003, NACEPT 
recommended EDMVS become an Agency level 1 FACA Committee due to the 
complexity of the recommendations. The EDMVAC was chartered in 2004. 
The EDMVAC provides independent advice and counsel to the Agency 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. 
EDMVAC and previous EDMVS meeting information and corresponding docket 
numbers are available electronically, from the EPA Internet Home Page 
at http://www.epa.gov/scipoly/oscpendo/. You may also go to the EPA 
Docket at http://www.epa.gov/edocket/, and follow the online 
instructions for submitting materials.

III. Meeting Objectives for the April 26-28, 2005 Meeting

    The objectives for the April 26-28, 2005 meeting (docket ID number 
OPPT-2005-0012) are to introduce the newly established EDMVAC 
Committee, review and discuss: Steroidogenesis (Tier 1 Assay), 
Uterotrophic (Tier 1 Assay, OECD), EPA Fish Screen Multi-Chemical 
Studies (Tier 1 Assay), OECD Fish Screen Phase 1B (Tier 1 Assay), 
Amphibian Metamorphosis Phase 1 Report and Phase 2 Draft Plan (Tier 1 
Assay, OECD).
    A list of the EDMVAC members and meeting materials are available at 
http://www.epa.gov/scipoly/oscpendo/ and in the public docket.

List of Subjects

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


    Dated: April 1, 2005.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. 05-7043 Filed 4-7-05; 8:45 am]
BILLING CODE 6560-50-S