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:

As mandated by the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996, EPA is implementing an Endocrine Disruptor Screening Program (EDSP). As part of the implementation of EDSP, the Endocrine Disruptor Methods Validation Subcommittee (EDMVS) under the National Advisory Council for Environmental Policy and Technology, a Federal Advisory Committee NACEPT, has been established. There will be a 3-day meeting of the EDMVS. EDMVS will provide technical advice on the Tier 1 screening and Tier 2 testing methods for its EDSP. The meeting 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 3-day meeting will be held on December 10, 2001, from 1 p.m. to 6 p.m., December 11, 2001, from 9 a.m. to 5 p.m., and December 12, 2001, from 9 a.m. to noon.

Requests to participate in the meeting must be received on or before December 6, 2001. The public comment period will be late on the afternoon of December 10, 2001.

ADDRESSES:

The meeting will be held at RESOLVE 1255 23rd St., NW., Suite 275, Washington, DC. The telephone number at RESOLVE is (202) 944-2300.

Requests to participate may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. listed under SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your request must identify docket control number OPPTS-42212E 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 (7203M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564-8476; fax number: (202) 564-8483; e-mail address: smith.jane-scott@epa.gov. (Please make note of these new phone/fax numbers).

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 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 (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 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. The draft meeting agenda is now available. In addition, the Agency may provide additional background documents as the material becomes available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/scipoly/oscpendo. To access this document, on the Home Page select “Endocrine Disruptor” which will take you to the OSCP Endocrine Disruptor Screening Program web site. You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an administrative record for this meeting under docket control number OPPTS-42212E. 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 Methods Validation, including any information claimed as Confidential Business Information (CBI). This administrative record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the administrative record, which includes printed, paper versions of any electronic comments that may be submitted during an applicable comment period, 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 (202) 260-7099.

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

You may submit a request to participate in this meeting through the mail, in person, or electronically. Do not submit any information in your request that is considered CBI. Your request must be received by EPA on or before December 6, 2001. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS-42212E in the subject line on the first page of your request.

1. By mail. You may submit a request to: Docket Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. U.S. EPA Confidential Business Information Center (CBIC), Room 6148, Mail Code 7407M, ATTN: NCIC, East Building, 1201 Constitution Ave., NW., Washington, DC 20004. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 564-8930 or 8940. You must call for escort or pick-up.

3. Electronically. You may submit your request electronically by e-mail to: oppt.ncic@epa.gov. 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 OPPTS-42212E. You may also file a request online at many Federal Depository Libraries.

IV. Meeting Topics

December 10, 11, and 12, 2001

• Review summary of previous meeting, (October 30-31, 2001) mission statement and workplan.
• Pubertal studies: Single dose study, multi-dose protocol, and array protocol.
• Mammalian one generation extension study.
• In utero through lactation protocol.

List of Subjects

• Environmental protection
• Endocrine Disruptor Screening Program
• Endocrine Disruptor