[Federal Register Volume 68, Number 146 (Wednesday, July 30, 2003)]
[Notices]
[Pages 44763-44766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19359]


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ENVIRONMENTAL PROTECTION AGENCY

[OPPT-2003-0027; FRL-7320-3]


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.

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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 
August 18-20, 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 Monday, August 18, 2003, from 1:30 
p.m. to 5:45 p.m.; Tuesday, August 19, 2003, from 7:45 a.m. to 2:30 
p.m.; and Wednesday, August 20, 2003, from 8 a.m. to 2:45 p.m. mountain 
daylight time.
    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 The Table Mountain Inn, 1310 
Washington, Ave., Golden, CO 80401.
    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: [email protected].

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

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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-2003-0027. 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 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-2003-0027. 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 August 12, 2003. To ensure proper 
receipt by EPA, it is imperative that you identify docket ID number 
OPPT-2003-0027 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-2003-0027.
    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 [email protected], Attention: Docket ID Number OPPT-2003-
0027.
    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-2003-0027. 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 [email protected], 
Attention: Docket ID Number OPPT-2003-0027. 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

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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-2003-0027. 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 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 seven 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 National Interagency Center for the 
Evaluation of Alternate Toxicological Methods (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.

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    [sbull] A mammalian 2-generation draft propylthiouracil (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.
    The objectives of the June 5-6, 2003 (docket ID number OPPT-2003-
0016) were 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. The Tier I pre-optimization, substrate characterization for 
aromatase placental tissue study.

III. Objectives of the August 18-20, 2003 Meeting

    The objectives of the August 18-20 meeting (docket ID number OPPT-
2003-0027) are to:
    1. Review and discuss the status/results of the prevalidation work 
on:
    [sbull] The fish screening assay, specifically: The survey of 
vitellogenin methods in fathead minnow, zebrafish and medaka; the 
comparative evaluation of the fathead minnow assays; and the fish 
screen (non-spawning) assay.
    [sbull] The steroidogenesis assay optimized protocol.
    2. Provide input and advice on the:
    [sbull] EDSP's validation plans for the fish screening assay and 
steroidogenesis assay.
    [sbull] Strain/species white paper.
    [sbull] Chemicals used in EDSP's prevalidation and validation.
    [sbull] Avian detailed review paper.
    [sbull] Issues related to the pubertal assays.
    3. Receive an update on the amphibian workshop conducted recently.
    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: July 23, 2003.
Kathryn R. Mahaffey,
Acting Director, Office of Science Coordination and Policy, Office of 
Prevention, Pesticides and Toxic Substances.

[FR Doc. 03-19359 Filed 7-29-03; 8:45 am]
BILLING CODE 6560-50-S