[Federal Register: May 30, 2003 (Volume 68, Number 104)]
[Notices]
[Page 32482-32485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30my03-59]
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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2003-0011; FRL-7305-4]
Endocrine Disruptor Screening Program; Endocrine Disruptor
Methods Validation Subcommittee under the National Advisory Council for
Environmental Policy and Technology; Request for Nominations for
Membership
AGENCY: Environmental Protection Agency (EPA).
ACTIONS: Notice.
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SUMMARY: As mandated by the Federal Food, Drug, and Cosmetic Act
(FFDCA), amended by the Food Quality Protection Act (FQPA) of 1996, EPA
implemented an Endocrine Disruptor Screening Program (EDSP). As part of
the EDSP, the Endocrine Disruptor Methods Validation Subcommittee
(EDMVS) was established in 2001, is a Subcommittee under the National
Advisory Council for Environmental Policy and Technology (NACEPT). The
members of the EDMVS may serve up to three 2-year terms. This notice is
a request for nominations for new members of the EDMVS from interested
organizations. NACEPT is a chartered federal advisory committee subject
to the provisions of the Federal Advisory Committee Act (FACA). Through
NACEPT, the EDMVS provides technical advice and recommendations to EPA
regarding validation of the Tier I screening and Tier II testing
methods for the EDSP. Background information regarding the Agency's
EDSP and the EDMVS are discussed in Unit III. of the SUPPLEMENTARY
INFORMATION. This information is being provided to allow interested
persons and organizations to review the scope of activities when
nominating qualified individuals for membership on the EDMVS.
DATES: Nominations, identified by docket ID Number OPPT-2003-0011 must
be received on or before June 30, 2003.
ADDRESSES: Nominations for membership may be submitted electronically,
by fax, or through hand delivery/courier. Follow the detailed
instructions as provided in Unit II. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20406-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov. For technical information contact: Jane Smith, Designated Federal
Official (DFO) 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 (202)
564-8483; 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. You may be
interested in nominating members to the
[[Page 32483]]
subcommittee set forth in this notice if you are a member of an
environmental/public interest organization, a public health
organization, an animal welfare organization, academia, or Federal
agencies, state, local, or tribal governments. You also may be
interested in activities of EPA's EDSP if you produce, manufacture,
use, consume, work with, or import pesticides or other chemicals. To
determine whether you or your business may have an interest in this
notice you should carefully examine section 408(p) of the FFDCA, as
amended by the 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 affected by this action. If you have any questions regarding the
applicability of this action, consult the technical persons 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-2003-0011. This
official public docket consists of this Notice, public comments
regarding this Notice, 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 is available for public viewing at EPA's Docket Center,
Rm. B102 - Reading Room, EPA West, 1301 Constitution Ave., NW.,
Washington, DC. EPA's Docket Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. EPA's 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. 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
submit nominations and comments 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 edocket system, select ``search,'' then key
in the appropriate docket ID number (OPPT-2003-0011). 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.
You may access this Federal Register document electronically
through the EPA Internet under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/, or you may obtain electronic copies of
this document, and certain other related documents through the EDSP Web
site for the EDMVS at http://www.epa.gov/scipoly/oscpendo/edmvs.htm.
3. In person. The Agency has established an administrative record
for the EDMVS under docket ID number OPPT-2003-0011. The public version
of the administrative record, which includes printed, paper versions of
any electronic comments that may be submitted during an applicable
comment period, is available for inspection in the EPA Docket Center.
See I.B.1. for docket center information.
II. How Can I Nominate Potential Members to the Endocrine Disruptor
Methods Validation Subcommittee?
You may nominate technically qualified persons for membership to
the EDMVS electronically, by fax or in person/courier service. A
technically qualified nominee could come from industry, an
environmental/public interest organization, a public health
organization, an animal welfare organization, academia or Federal
agencies, State, local or tribal governments or any other group
knowledgeable in endocrine disruption, method validation or related
topics. Nominations for membership may be submitted by individuals or
on behalf of organizations, and must include a curriculum vitae of the
nominee detailing his or her specific area of relevant scientific
expertise. (Please exclude the following information from the
curriculum vitae: The nominee's social security number, birth date and
place, home address, and telephone number.) Technically qualified
persons may also nominate themselves. Current members whose terms are
about to expire may be renominated or self-nominate as their time and
interests allow. Current members being renominated will be evaluated in
the same manner as newly nominated candidates. Members of the EDMVS are
selected by EPA taking into consideration their relevant scientific
expertise and diversity of perspectives on mammalian, ecological, and
in vitro endocrine disruptor screening and testing methods and
procedures, toxicity test methods standardization and validation, and
chemical and pesticide regulatory processes. Members will be appointed
for 2 years. In appointing members, EPA will seek to achieve balanced
representation from among the following sectors: the agrichemical and
commodity chemical industries; environmental/public interest
organizations; public health organizations; animal welfare
organizations; Federal agencies; State, local and tribal governments;
academia; consumers, and the public.
Nominations must be received by EPA on or before June 30, 2003. To
ensure proper receipt by EPA, it is imperative that you identify docket
ID number OPPT-2003-0011 in the subject line on the first page of your
submission. Do not include the nominee's private information, such as,
social security number, birth date and place, home address, and
telephone number. You may submit your nomination electronically, by
fax, in person, or by courier. We normally would accept requests by
mail, but in this time of delays in delivery of Federal government mail
due to health and security concerns, we cannot assure your request
would arrive in a timely manner.
1. Electronically. You may submit your nomination electronically.
Do not submit any information electronically that you consider to be
CBI or information protected under the Privacy Act. 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 nomination. Go to EPA Dockets at, 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-2003-
0011. Please see Unit I.B.1.
ii. E-mail. Nominations may be sent by e-mail to the technical
contact listed under FOR FURTHER INFORMATION CONTACT, or directly to
the docket at oppt.ncic@epa.gov, Attention: Docket ID number OPPT-2003-
0011.
iii. Disk or CD ROM. You may submit nominations on a disk or CD ROM
by courier or package service, such as Federal Express, to: the OPPT
Document Control Office (DCO) in EPA East Building Room 6428, 1201
Constitution Ave., NW., Washington, DC, Attention: Docket ID number
OPPT-2003-0011. 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. These electronic
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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. Due to security measures, disks
and CD ROMs risk being destroyed when handled as Federal government
mail.
2. By fax. Send your nomination(s) to the technical contact
identified under FOR FURTHER INFORMATION CONTACT.
3. In person or by courier. Deliver your nomination to: OPPT
Document Control Office (DCO). See Unit II.1.iii. for Document Control
Office information.
III. Background
A. Action
EPA's ongoing implementation of EDSP is science-driven, and
supported by the recommendations and comments of knowledgeable
scientists and stakeholders. Information on the EDMVS meetings to date,
a list of the current members of the EDMVS, and other EPA EDSP-related
information are available at http://www.epa.gov/scipoly/oscpendo/edmvs.htm
.
The EDMVS held it's initial meeting in October 2001. All 26 members
started their membership with that meeting and 25 of the original
members remain with the subcommittee. In October 2003, 25 of the
current members will have served their initial 2-year term and may
reapply to the subcommittee or not, as time and responsibilities may
dictate.
The purpose of this Federal Register notice is to solicit
nominations for scientists who would be interested in serving on this
cutting edge subcommittee. You may nominate others and you may self-
nominate. Qualifications for subcommittee membership are discussed in
Unit II. of the SUPPLEMENTARY INFORMATION.
EPA hopes to announce its selection of members for the
subcommittee's third and fourth years by September 2003.
B. The Purpose of the Endocrine Disruptor Methods Validation
Subcommittee
1. Purpose and authority. The EDMVS was established in accordance
with the FACA (5 U.S.C. app. 2 section 9(c)). The EDMVS is a
subcommittee of EPA's NACEPT. The purpose of the EDMVS is to assist
NACEPT in providing advice and counsel to EPA on scientific issues
associated with the conduct of studies necessary for validation of Tier
I and Tier II assays for EPA's EDSP. The EDMVS explores issues
regarding: The development and choice of initial protocols;
prevalidation study designs; validation study designs; the integration
of prevalidation, and validation study results into EDSP Tier I and
Tier II methods documents suitable for external peer review. All EDMVS
recommendations are forwarded to the Agency through NACEPT. Taking into
consideration this advice and recommendations, EPA will manage and
conduct prevalidation and validation laboratory studies.
2. Objective and scope of the activity. The EDMVS and NACEPT
provide a forum for diverse groups of individuals representing a broad
range of interests to consult with and make recommendations to the
Agency on matters relating to the development, optimization, and
validation of endocrine disruptor screening and testing methods. The
subcommittee will analyze issues, review data and protocols, compile
information, make recommendations to the Agency through NACEPT, and
undertake other activities necessary to meet its responsibilities. The
complete Mission Statement is available at: http://www.epa.gov/scipoly/oscpendo/edmvs.htm
, press enter and page down to ``EDMVS Subcommittee
Mission Statement.''
3. Meetings. The EDMVS may hold up to six meetings a year. These
meetings generally are held in Washington, DC and usually last for 2-3
days. Meeting materials to be discussed are distributed to members
prior to the meetings. A regular employee of EPA acts as the DFO and
will be present or represented at all meetings. All EDMVS meetings are
called, announced, and held in accordance with FACA and NACEPT rules,
which require open meetings and an opportunity for interested persons
to file comments before or after meetings, or to make statements during
the public meetings to the extent time permits. The date, time,
location, and any public participation instructions for each meeting
are announced in the Federal Register at least 15 days before the
meeting date. Each meeting is conducted in accordance with an agenda.
Meeting information and the agenda are posted on the Agency's web site
as soon as available.
To date, the EDMVS has held six, meetings starting with a 2-day
meeting October 30-31, 2001. Other face-to-face meetings were held;
December 10-12, 2001; March 25-27, 2002; and July 23-24, 2002. There
have been two 2-hour teleconferences, each on a single topic. There are
face-to-face meetings planned for June 5-6, 2003 and August 19-21,
2003.
C. Establishment of the Endocrine Disruptor Screening Program
The complexity of the scientific and regulatory issues surrounding
the endocrine disruptor issue led EPA to seek broad expert advice and
counsel beyond the Agency. EPA held a public meeting in May of 1996
requesting advice on how to develop a scientifically defensible,
pragmatic approach to endocrine disruptor screening and testing. The
stakeholder feedback indicated that a broad based multi-sector
stakeholder committee should be established under the FACA. Following a
second public meeting and analysis of stakeholder interests (Keystone
Center Convening Report), the Agency chartered the Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC).
EDSTAC was charged with providing advice and recommendations to the
Agency regarding a strategy for testing chemical substances to
determine whether they may have an effect in humans similar to an
effect produced by naturally occurring hormones. EDSTAC consisted of 39
representatives from industry, environmental and public health advocacy
groups, state government, other Federal agencies, and academic
scientists. Over a 2-year period, EDSTAC held eight meetings. In its
final report (available at http://www.epa.gov/scipoly/oscpendo/history/exesum14.pdf
), EDSTAC provided 71 consensus recommendations regarding
an endocrine disruptor screening program.
EPA's EDSP was set forth in a notice published in the Federal
Register of August 11, 1998 (63 FR 42852) (FRL-6021-3), and described
in more detail in a proposed statement of policy published in the
Federal Register of December 28, 1998 (FR 67 79611) (FRL-7286-6). The
EDSP proposed statement of policy, was subsequently reviewed by a joint
panel of the FIFRA Scientific Advisory Panel (SAP) and the EPA Science
Advisory Board (SAB) in May 1999. The SAP/SAB issued a final report
that concluded that a tiered approach relying on a combination of in
vivo and in vitro screens for Tier I and a set of in vivo Tier II tests
was scientifically reasonable.
D. Implementation of EPA's Endocrine Disruptor Screening Program
EPA's ongoing implementation of EDSP is science-driven, and
supported by the recommendations and comments of EDSTAC, the SAP/SAB
Joint Panel, and the EDMVS. The Agency's Implementation is currently
proceeding on three fronts: Priority setting for
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chemicals to be screened and tested: Prevalidation and validation
studies on Tier I and Tier II assays; and developing policy and
procedures to require endocrine disruptor testing.
1. Priority setting. Priority setting is a separate activity from
the EDMVS. For the latest information on priority setting of chemicals
for testing see Federal Register of December 30, 2002, (67 FR 79611)
(FRL-7286-6) and docket ID number OPPT-2002-0066.
2. Validation process. As a charter member of the Interagency
Coordinating Committee on the Validation of Alternative Methods
(ICCVAM), EPA is following the interagency validation framework
outlined in the ICCVAM report ``Validation and Regulatory Acceptance of
Toxicological Test Methods'' for validating the EDSP screening and
testing methods. The National Institute of Environmental Health
Sciences (NIEHS) established ICCVAM as a standing committee of Federal
agencies to coordinate and facilitate interagency validation,
acceptance, and harmonization of toxicological test methods with an
emphasis on reducing animal use, refining procedures involving animals
to make them less stressful and replacing animals where scientifically
appropriate.
The ICCVAM validation process was designed as a flexible, adaptable
framework applicable to conventional and alternative methods, and to
meet the needs of diverse test sponsors, Federal agencies and
regulatory processes. EPA's EDSP is managing the validation process
with substantial involvement of ICCVAM personnel.
Although there is widespread interest in EPA's EDSP, the screening
and testing methods are being developed and validated with the specific
goal of developing test guidelines for EPA regulatory use. The test
guidelines will ultimately be used by chemical manufacturers, pesticide
registrants, and other entities to develop data for submission to EPA
in support of the Agency's statutorily mandated chemical risk
management programs.
In addition to EPA's domestic EDSP validation program, certain
screening assays and tests for international use are also being
developed by the Organization for Economic Cooperation and Development
(OECD) Test Guidelines Program. EPA is an active member of the OECD
Test Guidelines Program activities, as well as the latter's Endocrine
Disruptor Testing and Assessment Workgroup. EPA will rely upon the OECD
mechanism for validating those EDSP screens and tests of international
interest. The OECD, EPA, and ICCVAM have also mutually agreed to this
administrative arrangement to ensure that all appropriate validation
and peer review steps are achieved in both domestic and international
efforts.
3. Status of validation of the assays. The table below shows the
validation process steps that have been initiated on each of the
assays.
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Initial Protocol Prevalidation
Screens/Assays Literature Review Demonstration Studies Validation Studies
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Amphibian metamorphosis X X X
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AR binding X X X
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Aromatase X X X
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ER binding X X X X
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Fish reproductive X X X
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Hershberger X X X
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Pubertal female X X X
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Pubertal male X X X
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Steroidogenesis X X X
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Uterotrophic (Tier ?) X X X X
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Amphibian 2-generation X X
development and.................
reproduction test...............
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Avian 2-generation test X X X
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Fish life-cycle test X
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Mammalian 2-generation X X
test............................
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Mysid life-cycle test X X X
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4. Policy and procedures workgroup. The Agency has established a
workgroup composed of scientists, economists, lawyers, and policy
specialists from different EPA offices that is in the process of
developing policy and procedures related to requiring endocrine
disruptor testing.
List of Subjects
Environmental protection, Endocrine disruption, Endocrine disruptor
screening program.
Dated: May 21, 2003.
Stephen Johnson,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. 03-13432 Filed 5-29-03; 8:45 am]
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