[Federal Register Volume 67, Number 220 (Thursday, November 14, 2002)]
[Notices]
[Pages 69002-69003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28910]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2002-0059; FRL-7277-4]
Endocrine Disruptor Methods Validation Subcommittee Under the
National Advisory Council for Environmental Policy and Technology;
Notice of Public Meeting
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing a 2-hour teleconference meeting of the
Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a
subcommittee under the National Advisory Council for Environmental
Policy and Technology (NACEPT), a Federal advisory committee. The EDMVS
will provide technical advice on a fish lifecycle assay detailed review
paper presented by the Endocrine Disruptor Screening Program (EDSP).
The upcoming teleconference meeting is open to the public.
DATES: The teleconference meeting will be held on Wednesday, December
4, 2002, from 10 a.m. to noon, eastern standard time.
ADDRESSES: The meeting will originate at RESOLVE, 1255 23\rd\ St., NW.,
Suite 275, Washington, DC.
To participate in the EDMVS teleconference meeting, or to request
special accommodations, including wheelchair access, one should contact
the Designated Federal Official (DFO) under FOR FURTHER INFORMATION
CONTACT at least 5 business days prior to the meeting.
FOR FURTHER INFORMATION CONTACT: Jane Smith, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8476; fax number: (202) 564-8483; e-mail address: [email protected].
SUPPLEMENTARY INFORMATION:
I. 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 chemical and other substances etc. 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 of 1996 (FQPA) (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 affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the DFO
under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPPT-2002-0059. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. 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 is 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 EPA Docket Center, is (202) 566-
0280.
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/, or through the EDSP Web site
for the EDMVS at http://www.epa.gov/scipoly/oscpendo/edmvs.htm.
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. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
C. How Can I Request to Participate in this Meeting?
You may submit a request to participate in the meeting to the DFO
listed under FOR FURTHER INFORMATION CONTACT. You can request special
accommodations by electronic mail, telephone, fax, or in person.
Seating is on a first-come basis. We would normally accept requests by
mail, but in this time of delays in delivery of Federal government mail
due to health and security concerns, we can not 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 November 27, 2002. To ensure proper receipt by EPA, it is
imperative that you identify docket ID number OPPT-2002-0059, in the
subject line on the first page of your request.
1. Electronically. You may submit your request by e-mail to [email protected]. Do not submit any information electronically that you
consider to be CBI. Use WordPerfect 6.1/8.0 or ASCII file format and
avoid the use of special characters and any form of encryption. To
ensure proper receipt by EPA, it is imperative that you identify docket
ID number OPPT-2002-0059, in the subject line on the first page of your
request.
2. By telephone or fax. Contact Jane Smith, the person listed under
FOR FURTHER INFORMATION CONTACT.
3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) to EPA East Building Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2002-0059. The DCO is open from 8 a.m. to 4 p.m., Monday through
Friday, 8 a.m. to noon and 2 p.m. to 4 p.m., 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
[[Page 69003]]
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 the Federal Advisory Committee Act (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 many of EDSTAC's
recommendations in the program that it developed, the EDSP, to carry
out Congress' directive.
EDSTAC also recognized that there currently are no validated
testing systems for determining whether a chemical may have an effect
in humans that is similar to an effect produced by naturally occurring
hormones. Consequently, 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) Endocine 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 recently chartered EDMVS of the NACEPT. EDMVS provides
independent advice and counsel to the Agency through NACEPT, 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.
EDMVS has met five times since its establishment in September 2001.
The objectives of the October 2001 meeting (docket control number
OPPTS-42212D) were for EPA to provide:
1. An overview of EPA's EDSP.
2. Background information on test protocol validation and
approaches.
3. For the EDMVS to develop a clear understanding of their scope,
purpose and operating procedures.
4. For the EDMVS and the EDSP to determine the next steps.
The objectives of the December 2001 meeting (docket control number
OPPTS-42212E) were for the EDMVS to provide input and advice on:
1. EDMVS's mission statement and work plan.
2. The in utero through lactation assay detailed review paper.
3. The pubertal assay study design for the multi-dose and chemical
array protocols.
4. The mammalian 1-generation study design.
The objectives of the March 2002 meeting (docket control number
OPPTS-42212F) were for the EDMS to provide input and advice on:
1. EDSP's implementation process and practical aspects of
validation.
2. The in utero through lactation assay protocol.
3. The fish reproduction assay detailed review paper.
4. Special studies on fathead minnow assays, vitellogenin assay,
and avian dosing protocol.
5. The steroidogenesis detailed review paper.
6. The aromatase detailed review paper.
7. A proposed standard suite of chemicals for testing in the Tier I
screening assay.
8. The current efforts related to evaluating the relevance of
animal data to human health.
9. EPA's approach to addressing low-dose issues.
The objective of the June 2002 teleconference meeting (docket ID
number OPPT-2002-0020) was for the EDMVS to provide input and advice on
the steroidogenesis detailed review paper.
The objectives of the July 2002 meeting (docket ID number OPPT
2002-0029) were:
1. To review criteria, recommended by EDSTAC and adopted by EDSP
for screens.
2. To receive an update on the NICEATM estrogen and androgen
receptor binding efforts.
3. To discuss and provide advice on general dose setting issues,
and to provide comments and advice on:
[sbull] A pubertals--special study--restricted feeding.
[sbull] A mammalian 2-generation--draft PTU special study.
[sbull] An amphibian metamorphosis detailed review paper.
[sbull] An invertebrate detailed review paper.
III. Meeting Objectives for the December 2002 Teleconference Meeting
The objective of the December 2002 teleconference meeting (docket
ID number OPPT-2002-0059) is for the EDMVS to provide input and advice
on the Tier II fish lifecycle assay detailed review paper.
A list of the EDMVS members and meeting materials are available on
our Web site (http://www.epa.gov/scipoly/oscpendo/edmvs.htm), and in
the EPA Docket.
List of Subjects
Environmental protection, Endocrine disruptors.
Dated: November 4, 2002.
Joseph Merenda,
Director, Office of Science Coordination and Policy, Office of
Prevention, Pesticides and Toxic Substances.
[FR Doc. 02-28910 Filed 11-13-02; 8:45 am]
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