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Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Notices]
[Page 17995-17997]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08ap05-54]
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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: 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, 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.regulations.gov/ 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 oppt.ncic@epa.gov, 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.regulations.gov/., 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