02-17309. 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.

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), a Federal Advisory Committee, on July 23-24, 2002. The EDMVS will provide technical advice on screening and testing methods for the Endocrine Disruptor Screening Program (EDSP). This meeting, as with all EDMVS meetings, is open to the public. Seating is on a first-come basis. Individuals requiring special accommodations at this 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.

DATES:

The meeting will be held on July 23, 2002, from 9 a.m. to 5:45 p.m. and July 24, from 8:30 a.m. to 12:30 p.m. (eastern daylight time).

ADDRESSES:

The meeting will be held at RESOLVE, 1255 23rd St., NW., Suite 275, Washington, DC. The telephone number for RESOLVE is: [phone]. The nearest Metro stop is Foggy Bottom.

FOR FURTHER INFORMATION CONTACT:

Jane Smith, Designated Federal Official, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, potentially affect you if you produce, manufacture, use, consume, work with, or import pesticide chemical substances that may have an effect that is cumulative to an effect of a pesticide, or substances found in sources of drinking water. To determine whether you or your business may be affected by 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 (Public Law 104-170), 21 U.S.C. 346A(p), and amendments to The Safe Drinking Water Act (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 person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. To access this document, on the Home Page search for “Endocrine Disruptor” which will take you to the OSCP Endocrine Disruptor web site. You can also look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/​fedrgstr/​.

A list of the EDMVS members and meeting materials are available at: http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm,, and in the public Docket.

2. In person. The Agency has established an official record for this meeting under docket ID number OPPT-2002-0029. The official record consists of the documents specifically referenced in this notice, any public comments received, and other information related to Endocrine Disruptor Method Validation, including any information claimed as Confidential Business Information (CBI). The public version of the official record is available for inspection in the TSCA Nonconfidential Information Center, North East Mall, Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Center is [phone].

C. How Can I Request to Participate in this Meeting?

In accordance with the Federal Advisory Committee Act (FACA), the public is encouraged to submit written comments on this meeting's topics. 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 meetings will be on the meeting topic and not be repetitive of previously submitted oral or written statements.

You may submit a request to participate in the meeting by e-mail, telephone, fax, or in person. We would normally accept requests by mail, but in this time of delays in delivery of government mail due to health and security concerns, we 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 July 18, 2002. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2002-0029 in the subject line on the first page of your request.

1. Electronically. You may submit your request electronically by e-mail to Jane Smith at: [e-mail] or to the docket at: [e-mail]. 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. Be sure to identify by docket ID number OPPT-2000-0029.

2. By telephone or fax. Contact Jane Smith, by telephone at [phone] or by fax number at [phone].

3. In person or by courier. You may deliver a request to: OPPT Docket Control Office, North East Mall, Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Docket Office is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Office is [phone].

II. Background

A. History

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 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 1 Screens) and tests (Tier 2 Tests) for determining whether a chemical substance may have an effect 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. 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 the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) of the National Advisory Council for Environmental Policy and Technology (NACEPT). EDMVS provides independent advice and recommendations 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 ways to reduce animal use, refining procedures involving animals to make them less stressful, and replacing animals where scientifically appropriate. More information is available on the website: http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm.

B. Previous Meeting

The EDMVS has met four times since its establishment in September 2001. The objectives of the October 2001 meeting (Docket 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. For the EDMVS and the EDSP to determine the next steps.

The objectives of the December 2001 meeting (Docket OPPT-42212E) were for the EDMVS to provide input and advice on:

1. The EDMV'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 OPPT-42212F) were for the EDMVS to provide input and advice on:

1. EDSP's implementation process and practical aspects of validation; the in utero through lactation assay protocol.

2. The fish reproduction assay detailed review paper.

3. Special studies on fathead minnow assays, vitellogenin assay, and avian dosing protocol.

4. The aromatase detailed review paper.

5. A proposed standard suite of chemicals for testing in the Tier 1 screening assay.

6. EDSP presenting the current efforts related to evaluating the relevance of animal data to human health.

7. EPA's approach to addressing low dose issues.

The objectives of the June 2002 teleconference/meeting (docket ID number OPPT-2002-0029) was for the EDMVS to provide input and advice on the steroidogenesis detailed review paper.

III. Meeting Objectives for the July 2002 Meeting

The draft objectives of the July 2002 meeting docket ID number OPPT-2002-0029 is for the EDMVS to provide input and advice on:

1. The pubertals - special study: restricted feeding.

2. The mammalian 2-generation PTU special study (Tier II).

3. The amphibian metamorphosis detailed review paper (Tier I).

4. The invertebrate detailed review paper (Tier II).

5. For the EDSP to provide information on:

• Criteria for screens - review of EDSTAC recommendations.
• The ICCVAM-NICEATM expert panel meeting on in vitro ER/AR assays.
• An update on core chemicals selected by EDSP.
• General dose setting issues. (Tentative)

List of Subjects

• Environmental protection
• Endocrine disruptor screening program
• Endocrine disruptors

Dated: July 2, 2002.

 Sherell A. Sterling,

Acting Director, Office of Science Coordination and Policy.