05-13563. Endocrine Disruptor Methods Validation Advisory Committee (EDMVAC); Notice of Public Meeting

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

There will be a meeting, via teleconference, of the Endocrine Disruptor Methods Validation Advisory Committe (EDMVAC) on August 2, 2005, in Washington, DC. This meeting, as with all EDMVAC meetings, is open to the public. Due to limited phone lines, we encourage all local participants to join us at RESOLVE. Seating will be on a first-come basis. The purpose of the meeting is to receive advice and input from the EDMVAC on the 15-Day Intact Adult Male Assay.

DATES:

The teleconference meeting will be held on Tuesday, August 2, 2005, from noon to 2 p.m. eastern daylight time.

Requests to participate in the meeting must be received by EPA on or before July 25, 2005. To ensure proper receipt by EPA, it is imperative that you identify docket identification (ID) number OPPT-2005-0037 in the subject line on the first page of your request.

Individuals requiring special accommodations at the meeting, including wheelchair access, should contact the person listed under FOR FURTHER INFORMATION CONTACT at least 5 business days prior to the meeting.

ADDRESSES:

The teleconference meeting will originate at RESOLVE, 1255 23rd St., NW., Suite 275, Washington, DC 20037.

Requests to participate in the meeting may be submitted by e-mail, telephone, fax, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

Comments may be submitted electronically, by fax, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Jane Smith, Designated Federal Official (DFO), Office of Science Coordination and Policy (7203M), Office of Prevention, Pesticides and Toxic Substances (OPPTS), 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. General Information

A. 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 chemicals and other 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-2005-0037. 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 [phone], and the telephone number for the OPPT Docket, which is located in the 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/​. A meeting agenda, a list of EDMVAC members and information from previous EDMVS and EDMVAC meetings are available electronically, from the EPA Internet Home Page at http://www.epa.gov/​scipoly/​oscpendo/​.

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. Once in the system, select “search,” then key in the appropriate docket ID number.

C. How Can I Request to Participate in the Meeting or Submit Comments?

You may submit a request to participate in the meeting through e-mail, telephone, fax, or hand delivery/courier. 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 25, 2005. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPPT-2005-0037 in the subject line on the first page of your request.

In accordance with the Federal Advisory Committee Act (FACA), the public is encouraged to submit written comments on the topic of this meeting. The EDMVAC will have a period available during the meeting for public comment. It is the policy of the EDMVAC to accept written public comments of any length, and to accommodate oral public comments whenever possible. The EDMVAC 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.

1. Electronically. If you submit an electronic request to participate in the meeting or comments 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 request or 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 request or comment and allows EPA to contact you in case EPA cannot read your request or comment due to technical difficulties or needs further information on the substance of your request or comment. EPA's policy is that EPA will not edit your request or comment, and any identifying or contact information provided in the body of a request or comment will be included as part of the request or comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your request or comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your request or comment.

i. EPA Docket. You may use EPA's electronic public docket 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-2005-0037. 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 request.

ii. E-mail. Requests to participate in the meeting or comments may be sent by e-mail to [e-mail], Attention: Docket ID Number OPPT-2005-0037. 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 request 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 automatically captured by EPA's e-mail system are included as part of the request 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 hand delivery, courier, or package service, such as Federal Express, to the person listed under FOR FURTHER INFORMATION CONTACT. These electronic 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. Disks and CD ROMs risk being destroyed when handled as Federal Government mail.

2. Telephone or fax. Telephone or fax your request to participate in the meeting to the person listed under FOR FURTHER INFORMATION CONTACT.

3. 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-2005-0037. 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 [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 or such other endocrine effects. 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.

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 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 chartered the Endocrine Disruptor Methods Validation Subcommmittee (EDMVS) of the National Advisory Council for Environmental Policy and Technology (NACEPT). The EDMVS convened nine meetings between October 2001 and December 2003. In 2003, NACEPT recommended EDMVS become an Agency level 1 FACA Committee due to the complexity of the recommendations. The EDMVAC was chartered in 2004. The EDMVAC provides independent advice and counsel to the Agency on scientific and technical issues related to validation of the EDSP Tier 1 screens and Tier 2 tests, including advice on methods for reducing animal use, refining procedures involving animals to make them less stressful, and replacing animals where scientifically appropriate. EDMVAC and previous EDMVS meeting information and corresponding docket numbers are available electronically, from the EPA Internet Home Page at http://www.epa.gov/​scipoly/​oscpendo/​. You may also go to the EPA Docket at http://www.epa.gov/​edocket/​, and follow the online instructions for submitting materials.

III. Meeting Objective for the August 2, 2005 Teleconference Meeting

The objective for the August 2, 2005 teleconference meeting (docket ID number OPPT-2005-0037) is to discuss the 15-Day Intact Adult Male Assay.

A list of the EDMVAC members and meeting materials are available at http://www.epa.gov/​scipoly/​oscpendo/​ and in the public docket.

List of Subjects

• Environmental protection
• Endocrine disruptors
• Hazardous substances
• Health
• Safety

Dated: June 30, 2005.

Clifford Gabriel,

Director, Office of Science Coordination and Policy.