02-28910. 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:

EPA is announcing a 2-hour teleconference 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. The EDMVS will provide technical advice on a fish lifecycle assay detailed review paper presented by the Endocrine Disruptor Screening Program (EDSP). The upcoming teleconference meeting is open to the public.

DATES:

The teleconference meeting will be held on Wednesday, December 4, 2002, from 10 a.m. to noon, eastern standard time.

ADDRESSES:

The meeting will originate at RESOLVE, 1255 23^rd St., NW., Suite 275, Washington, DC.

To participate in the EDMVS teleconference meeting, or to request special accommodations, including wheelchair access, one should contact the Designated Federal Official (DFO) under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting.

FOR FURTHER INFORMATION CONTACT:

Jane Smith, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Does this Action 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 chemical and other substances etc. 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 of 1996 (FQPA) (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 to a particular entity, consult the DFO under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPPT-2002-0059. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. 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 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 [phone] and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​, or through the EDSP Web site for the EDMVS at http://www.epa.gov/​scipoly/​oscpendo/​edmvs.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to submit 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. 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. Once in the system, select “search,” then key in the appropriate docket ID number.

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

You may submit a request to participate in the meeting to the DFO listed under FOR FURTHER INFORMATION CONTACT. You can request special accommodations by electronic mail, telephone, fax, or in person. Seating is on a first-come basis. We would normally accept requests by mail, but in this time of delays in delivery of Federal government mail due to health and security concerns, we can not 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 November 27, 2002. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2002-0059, in the subject line on the first page of your request.

1. Electronically. You may submit your request by e-mail to [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. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2002-0059, in the subject line on the first page of your request.

2. By telephone or fax. Contact Jane Smith, the person listed under FOR FURTHER INFORMATION CONTACT.

3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office (DCO) to EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT-2002-0059. The DCO is open from 8 a.m. to 4 p.m., Monday through Friday, 8 a.m. to noon and 2 p.m. to 4 p.m., excluding legal holidays. The telephone number for the DCO is [phone].

II. Background

In 1996, through enactment of FQPA, which amended the FFDCA, 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 similar to that produced by naturally occurring hormones. EPA adopted many of EDSTAC's recommendations in the program that it developed, the EDSP, to carry out Congress' directive.

EDSTAC also recognized that there currently are no validated testing 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) Endocine 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 recently chartered EDMVS of the 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.

EDMVS has met five times since its establishment in September 2001.

The objectives of the October 2001 meeting (docket control number OPPTS-42212D) were for EPA to provide:

1. An overview of EPA's EDSP.

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 control number OPPTS-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 1-generation study design.

The objectives of the March 2002 meeting (docket control number OPPTS-42212F) were for the EDMS to provide input and advice on:

1. EDSP'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 on 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 assay.

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 criteria, recommended by EDSTAC and adopted by EDSP for screens.

2. To receive an update on 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:

•   A pubertals—special study—restricted feeding.
•   A mammalian 2-generation—draft PTU special study.
•   An amphibian metamorphosis detailed review paper.
•   An invertebrate detailed review paper.

III. Meeting Objectives for the December 2002 Teleconference Meeting

The objective of the December 2002 teleconference meeting (docket ID number OPPT-2002-0059) is for the EDMVS to provide input and advice on the Tier II fish lifecycle assay detailed review paper.

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 EPA Docket.

List of Subjects

• Environmental protection
• Endocrine disruptors

Dated: November 4, 2002.

Joseph Merenda,

Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances.