[Federal Register Volume 70, Number 215 (Tuesday, November 8, 2005)]
[Notices]
[Pages 67700-67702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22229]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2005-0054; FRL-7744-2]


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 Committee (EDMVAC) on November 30 through December 
2, 2005, in Raleigh, NC. 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: EPA's 
Applied Approach to Validation, OECD Uterotrophic Peer Review Report, 
Steroidogenesis Using the H295R Cell Line, Avian Studies, and an update 
on the Pubertal Assays.

DATES: The meeting will be held on Wednesday, November 30, 2005, from 8 
a.m. to 5 p.m.; Thursday, December 1, 2005, from 8:30 a.m. to 5 p.m.; 
and Friday, December 2, 2005, from 8:30 a.m. to noon, eastern standard 
time. Request to attend and/or make public comments in the meeting must 
be received by EPA on or before November 28, 2005.
    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.

ADDRESSES: The meeting will be held at the Holiday Inn Brownstone Hotel 
and Conference Center, 1707 Hillsborough St., Raleigh, NC 27605; 
telephone number: (919) 828-0811; e-mail:http://www.brownstonehotel.com
    Requests to attend and/or make public comments 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,

[[Page 67701]]

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-2005-0054. 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 Attend the Meeting or Submit Comments?

    You may submit a request to attend and/or make public comments 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 Novemer 28, 2005. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
ID number OPPT-2005-0054 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 attend 
and/or make public comments 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 dockethttp://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-2005-0054. 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 attend and/or make public comments in the 
meeting or comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPPT-2005-0054. 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 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-
2005-0054. 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 an

[[Page 67702]]

effect in humans that is similar to an effect produced by a naturally 
occurring estrogen, or such other endocrine effect as the Administrator 
may designate. 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 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 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 the 
Interagency Coordinating Committee for the Validation of Alternate 
Methods (ICCVAM) and other validation groups, as appropriate. 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 
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. 
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 November 30-December 2, 2005 Meeting

    The objectives for the November 30 through December 2, 2005 meeting 
(docket ID number OPPT-2005-0054) are to review and discuss: EPA's 
Applied Approach to Validation, Uterotrophic (Tier I Assay, OECD) Peer 
Review Report, Steriodgenesis (Tier I Assay) Using the H295R Cell Line, 
Avian 2-Generation (Tier II Assay, OECD) and receive an update on the 
Pubertal (Tier I) Assays.
    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: October 27, 2005.
Clifford Gabriel,
Director, Office of Science Coordination and Policy.

[FR Doc. 05-22229 Filed 11-7-05; 8:45 am]
BILLING CODE 6560-50-S