[Pharmwaste] Endocrine Disruptor Methods Validation Advisory
Committee
Tenace, Laurie
Laurie.Tenace at dep.state.fl.us
Tue Nov 8 13:36:22 EST 2005
Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection
2600 Blair Stone Road, MS 4555
Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace at dep.state.fl.us
view our mercury web pages at:
http://www.dep.state.fl.us/waste/categories/mercury/default.htm
-----Original Message-----
From: envsubset at epamail.epa.gov [mailto:envsubset at epamail.epa.gov]
Sent: Tuesday, November 08, 2005 11:46 AM
To: Federal Register TOXIC documents
Subject: [epa-tox] Endocrine Disruptor Methods Validation Advisory Committee
http://epa.gov/EPA-TOX/2005/November/Day-08/
=======================================================================
[Federal Register: November 8, 2005 (Volume 70, Number 215)]
[Notices]
[Page 67700-67702]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no05-33]
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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: <A
HREF="http://www.brownstonehotel.com">http://www.brownstonehotel.com</A>
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: <A
HREF="mailto:smith.jane-scott at epa.gov">smith.jane-scott at epa.gov</A>.
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 <A
HREF="http://www.epa.gov/fedrgstr/">http://www.epa.gov/fedrgstr/</A>. A
meeting agenda, a list of
EDMVAC members and information from previous EDMVS meetings are
available electronically, from the EPA Internet Home Page at <A
HREF="http://www.epa.gov/scipoly/oscpendo/">
http://www.epa.gov/scipoly/oscpendo/</A>.
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 <A
HREF="http://www.epa.gov/edocket/">http://www.epa.gov/edocket/</A> 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 docket <A
HREF="http://www.epa.gov/edocket/">http://
www.epa.gov/edocket/</A>, 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 <A
HREF="mailto:oppt.ncic at epa.gov">oppt.ncic at epa.gov</A>,
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 <A
HREF="http://www.epa.gov/scipoly/oscpendo/">http://www.epa.gov/scipoly/oscpen
do/</A> You may also go to the EPA
Docket at <A
HREF="http://www.epa.gov/edocket/">http://www.epa.gov/edocket/</A>, 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
<A
HREF="http://www.epa.gov/scipoly/oscpendo/">http://www.epa.gov/scipoly/oscpen
do/</A> 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
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