02-5736. Endocrine Disruptor Method 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 March 25th - 27th, 2002. The EDMVS will provide technical advice on screening and testing methods for the Endocrine Disruptor Screening Program (EDSP). The upcoming 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 March 25, 2002, from 1 p.m. to 5:45 p.m., March 26 from, 9 a.m. to 4:15 p.m., and March 27 from, 9 a.m. to 12:15 p.m.

Requests to participate in the meeting must be received on or before March 20, 2002.

ADDRESSES:

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

Requests to participate in the meeting may be submitted by electronic mail, telephone, or in person. Please follow the detailed instructions for each method as provided in Unit III. under SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your request must identify docket control number OPPT-42212F in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

Jane Smith, Designated Federal Official, Office of Science Coordination and Policy, Mail Code 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. 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 pesticides chemicals, substances that may have an effect cumulative to an effect of a pesticide, or substances found in sources of drinking water. 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 (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.

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

1. Electronically. A list of EDMVS members and information from previous meetings is available electronically, from the EPA Internet Home Page at http://www.epa.gov/​scipoly/​oscpendo. To access this document, on the EPA Home Page search for “Endocrine,” which will take you to the EDSP web site. You can also go directly to the Federal Register listing at http://www.epa.gov/​fedrgstr/​.

2. In person. The Agency has established an administrative record for this meeting under docket control number OPPT-42212F. The administrative record consists of the documents specifically referenced in this notice, any public comments received during an applicable comment period, and other information related to Endocrine Disruptor Method Validation, including any information claimed as Confidential Business Information (CBI). The public version of the administrative 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 form noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Center is [phone].

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

You may submit a request to participate in the meeting by electronic mail, telephone, by 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 March 20, 2002. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPT-42212F, in the subject line on the first page of your request.

1. Electronically. You may submit your request electronically 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. Be sure to identify by docket control number OPPT-42212F. You may also file a request online at many Federal Depository Libraries.

2. In person or by courier. You may deliver a request to: OPPT Docket Control Office, North East Mall, Rm B-607, Waterside Mall, 401M 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].

3. Fax. You may fax your request to: Jane Smith, Designated Federal Official, list under FOR FURTHER INFORMATION CONTACT.

IV. Background

In 1996, through enactment of the Food Quality Protection Act, 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 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 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 the EDMVS of the NACEPT. The 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 met twice since its establishment in September 2001. The objectives of the October 2001 meeting (docket control number 42212D) were for EPA to provide:

• An overview of EPA's Endocrine Disruptor Program.
• Background information on test protocol validation and approaches.
• For the EDMVS to develop a clear understanding of their scope, purpose and operating procedures.
• For the EDMVS and the EDSP to determine the next steps.

The objectives of the December 2001 meeting (docket control number 42212E) were for the EDMVS to provide input and advice on:

• The EDMVS's mission statement and work plan.
• The in utero through lactation assay detailed review paper.
• The pubertal assay study design for the multi-dose and chemical array protocols.
• The mammalian one-generation study design.

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.

V. Meeting Objectives for the March 2002 Meeting

The objectives of the March meeting are for the EDMVS to provide input and advice on:

• EDSP's implementation process and practical aspects of validation.
• The in utero through lactation assay protocol.
• The fish reproduction assay detailed review paper.
• Special studies on fathead minnow assays, vitellogenin assay, and avian dosing protocol.
• The aromatase detailed review paper.
• A proposed standard suite of chemicals for testing in the Tier 1 screening assay.

Time for public comment has been reserved on March 25th and 26th just prior to meeting adjournment for the day.

List of Subjects

• Environmental protection
• Endocrine disruptor screening program
• Endocrine disruptors

Dated: March 4, 2002.

 Andy Privee,

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