[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27797-27799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-32]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2003-0016; FRL-7304-9]
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 of public meeting.
-----------------------------------------------------------------------
SUMMARY: There will be a meeting of the Endocrine Disruptor Methods
Validation Subcommittee (EDMVS), a Subcommittee under the National
Advisory Council for Environmental Policy and Technology (NACEPT), on
June 5-6, 2003. This meeting, as with all EDMVS meetings, is open to
the public. Seating is on a first-come basis.
DATES: The meeting will be held on Thursday, June 5, 2003, from 9 a.m.
to 5 p.m., and Friday, June 6, 2003, from 8:30 a.m. to 3 p.m. eastern
daylight time. The telephone number at RESOLVE is (202) 944-2300.
Individuals requiring special accommodations at the meeting,
including wheelchair access, should contact Jane Smith at the address
listed under FOR FURTHER INFORMATION CONTACT at least 5 business days
prior to the meeting, so appropriate arrangements can be made.
ADDRESSES: The meeting will be held at RESOLVE, 1255 23rd St., NW.,
Suite 275, Washington, DC.
Requests and comments may be submitted electronically, by
telephone, fax, or through hand delivery/courier. Follow the detailed
instructions as provided in Unit I.C. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jane Smith, Designated Federal
Official for the EDMVS, Exposure Assessment Coordination and Policy
Division (7203M), Office of Science Coordination and Policy,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8476; fax
number: (202) 564-8483; or e-mail address: smith.jane-scott@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Notice 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-2003-0016. 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 EPA Docket Center, is (202) 566-0282.
2. Electronic access. A meeting agenda, a list of EDMVS members and
information from previous meetings are available electronically, from
the EPA Internet Home Page at http://www.epa.gov/scipoly/oscpendo/edmvs.htm.
You may also go directly to the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic docket and comment system, EPA Dockets. You may use
EPA Dockets at http://www.epa.gov/edocket to view public comments,
access the index
[[Page 27798]]
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 docket ID number
OPPT-2003-0016. 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.I.
C. How Can I Request to Participate in the Meeting?
You may submit a request to participate in the meeting through
electronic mail, telephone, fax, or in person. EPA would normally
accept requests by mail, but in this time of delays in delivery of
government mail due to health and security concerns, EPA 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 May 27, 2003. To ensure proper receipt
by EPA, it is imperative that you identify docket ID number OPPT-2003-
0016 in the subject line on the first page of your request.
1. Electronically. You may submit your request to participate
electronically. 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.
i. EPA Docket. You may use EPA's electronic public docket to submit
a request to participate in this meeting. Go to EPA Dockets at http://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-2003-0016.
ii. E-mail. Request to participate may be sent by e-mail to the
person listed in FOR FURTHER INFORMATION CONTACT, or directly to the
docket at oppt.ncic@epa.gov, Attention: Docket ID Number OPPT-2003-
0016.
2. Telephone or fax. Send your request to participate to the
individual identified in FOR FURTHER INFORMATION CONTACT.
D. How and to Whom Do I Submit Comments?
In accordance with the Federal Advisory Committee Act (FACA), the
public is encouraged to submit written comments on the topic of this
meeting. The EDMVS will have a brief period available during the
meeting for public comment. It is the policy of the EDMVS to accept
written public comments of any length, and to accommodate oral public
comments whenever possible. The EDMVS 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.
You may submit comments electronically or through hand delivery/
courier. To ensure proper receipt by EPA, identify the appropriate
docket ID number in the subject line on the first page of your comment.
EPA is not required to consider these late comments. If you wish to
submit CBI or information that is otherwise protected by statute,
please follow the instructions in Unit I.E. Do not use EPA Dockets or
e-mail to submit CBI or information protected by statute.
1. Electronically. If you submit an electronic comment 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 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 comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPPT-2003-0016. 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 comment.
ii. E-mail. Comments may be sent by e-mail to oppt.ncic@epa.gov,
Attention: Docket ID Number OPPT-2003-0016. 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 comment 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 comment 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
courier or package service, such as Federal Express to the address
identified in Unit I.D.2. These electronic submissions will be accepted
in WordPerfect or ASCII file format. Avoid the use of special
characters and any form of encryption.
2. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2003-0016. 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.
E. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.
II. Background
In 1996, through enactment of the Food Quality Protection Act,
which
[[Page 27799]]
amended the Federal Food, Drug, and Cosmetic Act, 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 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 in humans 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.
EDSTAC also recognized that there currently are no validated test
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) 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 formed the Endocrine Disruptor Methods Validation
Subcommittee (EDMVS) of the National Advisory Council for Environmental
Policy and Technology (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.
The EDMVS has held six meetings since its establishment in
September 2001.
The objectives of the first meeting, which was held in October
2001, (docket control number OPPT-42212D) were for EPA to provide:
1. An overview of EPA's Endocrine Disruptor Program.
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. The EDMVS and the EDSP to determine the next steps.
The objectives of the December 2001 meeting (docket control number
OPPT-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 one-generation study design.
The objectives of the March 2002 meeting (docket control number
42212F) were for the EDMVS to provide input and advice on:
1. EPA'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, the 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 assays.
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 the screening criteria, recommended by EDSTAC and
adopted by EDSP for screens.
2. To receive an update of 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 pubertal--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.
The objective of the December 2002 teleconference meeting (docket
ID number OPPT-2002-0059) was for the EDMVS to provide input and advice
on the Tier II fish life cycle assay detailed review paper.
III. Meeting Objectives for the June 5-6, 2003 Meeting
The objectives of the June 5-6, 2003 (docket ID number OPPT-2003-
0016) are for EDMVS to provide input and advice on:
1. The Tier II Mammalian 2-generation special study on the one-
generation extension results.
2. The Tier I steroidogenesis (sliced testes) study results.
3. To provide the status of the Tier I study results of the
aromatase placental tissue study.
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
public docket.
List of Subjects
Environmental protection, Endocrine system, Endocrine disruptors,
Endocrine disruptor screening program.
Dated: May 9, 2003.
Joseph Merenda,
Director, Office of Science Coordination and Policy, Office of
Prevention, Pesticides and Toxic Substances.
[FR Doc. 03-12484 Filed 5-20-03; 8:45 am]
BILLING CODE 6560-50-S