[Pharmwaste] FW: [epa-tox] Endocrine Disruptor Methods Validation
Advisory Committee
Tenace, Laurie
Laurie.Tenace at dep.state.fl.us
Thu Mar 30 09:10:31 EST 2006
FYI
Laurie
-----Original Message-----
From: envsubset at epamail.epa.gov [mailto:envsubset at epamail.epa.gov]
Sent: Wednesday, March 29, 2006 12:24 PM
To: Federal Register TOXIC documents
Subject: [epa-tox] Endocrine Disruptor Methods Validation Advisory Committee
http://epa.gov/EPA-TOX/2006/March/Day-29/
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[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15724-15726]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-73]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2006-0233; FRL-7771-1]
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 18 through April 20,
2006, 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: Male and
Female Pubertals Assay Interlaboratory Studies, EDSP's Applied Approach
to Validation, Tier 1 Fish Screen Assay Validation Status, updates on
Tier 1 Aromatase Assay, and Tier 1 Steroidogenesis Cell Based H295R Assay.
DATES: The meeting will be held on Tuesday, April 18, 2006, from 12:30
p.m. to 6 p.m.; Wednesday, April 19, 2006, from 8:30 a.m. to 5:30 p.m.;
and Thursday, April 20, 2006, 8 a.m. to 1:30 p.m., eastern standard
time. Request to make public comments at the meeting must be received
by EPA on or before April 14, 2006.
To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATION CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.
ADDRESSES: The meeting will be held at the Capital Hilton Hotel and
Conference Center, 1001 16th St., NW., Washington, DC 20036; telephone
number: (202) 393-1000; e-mail: <A
HREF="http://www.hilton.com">http://www.hilton.com</A>.
Requests to make public comments at 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 or for
information on access or services for individuals with disabilities:
William Wooge, 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:wooge.william at epa.gov">
wooge.william 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, 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.
[[Page 15725]]
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 EPA-HQ-OPPT-2006-0233.
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.regulations.gov/">http://www.regulations.gov/</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 ``Advance
search,'' select ``Docket search,'' then key in the appropriate docket
ID number.
C. How Can I Request to Give Comments in Person at the Meeting?
You may submit a request to make public comments at 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 14, 2006. To ensure
proper receipt by EPA, it is imperative that you identify docket ID
number EPA-HQ-OPPT-2006-0233 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 make
public comments at 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.regulations.gov/">http://
www.regulations.gov/</A>, and follow the online instructions for
submitting materials. Once in the system, select ``Advance search,'' select
``Docket search,''and then key in docket ID number EPA-HQ-OPPT-2006-
0233. 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 make public comments at the meeting or
written 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 EPA-HQ-OPPT-2006-0233. 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
at 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 EPA-HQ-
OPPT-2006-0233. 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 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 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
[[Page 15726]]
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 Disruptors 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 <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.regulations.gov/">http://www.regulations.gov/</A>, and
follow the online
instructions for submitting materials.
III. Meeting Objectives for the April 18-20, 2006 Meeting
The objectives for the April 18 through April 20, 2006 meeting
(docket ID number EPA-HQ-OPPT-2006-0233) are to review and discuss:
Aromatase Assay Update (Tier 1), Steroidogenesis Cell Based H295R Assay
Update (Tier 1), Male and Female Pubertals Assay Interlaboratory
Studies, Fish Screen Assay Validation Status (Tier 1), and EPA's
Applied Approach to Validation.
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: March 21, 2006.
Clifford J. Gabriel,
Director, Office of Science Coordination and Policy.
[FR Doc. E6-4570 Filed 3-28-06; 8:45 am]
BILLING CODE 6560-50-S
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