[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Notices]
[Pages 32482-32485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13432]


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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: [email protected].
    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: [email protected].

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

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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 [email protected], 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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