National Toxicology Program

[Federal Register: April 17, 2000 (Volume 65, Number 74)]
[Notices]
[Pages 20478-20479]

National Institute of Environmental Health Sciences, NIH; National Toxicology Program

Peer Review Meeting on Low-Dose Issues for Endocrine Disruptors; Scope of Information Considered for Review Broadened, Deadline for Receipt of Information Extended, and Date for Meeting Delayed

Summary

The National Toxicology Program (NTP) is organizing a Peer Review to evaluate whether chemicals can cause hormone-related effects at doses lower than those typically used in the standard toxicological dose-setting paradigm. The U.S. Environmental Protection Agency (EPA) Endocrine Disruptor Screening Program will use the results from this peer review to assist in determining how to identify and characterize potential low-dose effects that may arise during endocrine disruptor screening, testing, and hazard assessment.

On January 6, 2000 the NTP published a Federal Register notice [Volume 65, Number 4, pages 784-787] outlining plans for the Peer Review meeting and soliciting public input into the process. This notice broadens the request for research studies and data to be considered and extends previously announced deadlines for receipt of research information for use in this peer review.

Broader Request for Research Studies to be considered for the Peer Review

On January 6, 2000, the NTP published a Federal Register notice [Volume 65, Number 4, pages 784-787] providing details about a Peer Review meeting to evaluate scientific data on the potential low-dose effects associated with exposure to endocrine disruptors. In that notice, the NTP solicited comments on the planned scope and process of the proposed peer review, nominations of studies for inclusion in this review, as well as nominations of individuals for the Peer Review panel. The notice also detailed the criteria for selection of studies for review.

The NTP Selection/Organizing Committee will review the nominated studies and designate them as either critical to resolution of the low-dose issue or background information. The January 6^th notice stipulated that studies nominated for consideration in this peer review should have been published or accepted for publication by April 1, 2000. The NTP is now broadening the scope of studies to be considered for this peer review to include relevant data from unpublished studies. Submission of unpublished studies should include an abstract of the study describing the hypothesis being tested, experimental design [model system (cell line, species, strain, number per group, etc.), dosing regimen, duration of treatment and follow-up], endpoints evaluated, and results (if available).

If an unpublished study is nominated for consideration, the NTP will contact the principal investigator for an update of the study's status and to obtain additional information about the study. If selected by the NTP Selection/Organizing Committee, the studies will be distributed to the Peer Review Panel for its review and evaluation. The NTP may need access to raw data for subsequent independent analysis by the Panel. As with published studies and studies accepted for publication but not yet published, all information given to the Peer Review Panel will simultaneously be made available to the public. Therefore, studies, which are unpublished by the date of their distribution to the Panel, will require approval from the author (and publisher if accepted for publication) in order to be included in the Peer Review. A list of the studies included in the Peer Review will be posted on the NTP web page (http://ntp.niehs.nih.gov/ntp) and available from NTP Liaison and Scientific Review Office (NIEHS/NTP, P.O. Box 12233, Research Triangle Park, NC 27709; t: 919-541-0530; f: 919-541-0295).

Deadline Extended

The revised deadline for nomination of studies for consideration in the Peer Review is May 22, 2000.

Peer Review Meeting Delayed

The NTP anticipates that the Peer Review Meeting will occur in mid-October 2000 in the Raleigh-Durham, North Carolina area and not July 2000 as noted in the January 6^th Federal Register announcement. Planning for the Peer Review Meeting is ongoing and the date and location will be announced in the Federal Register in the near future.

Solicitation of Public Comment

Comments about the scope and process for the Peer Review are welcome. The deadline for submission of comments, identified by docket control number OPPTS-42208A, is extended from February 22, 2000 to May 22, 2000.

Guidelines for Submission of Public Comment

The EPA will manage the record-keeping aspects of the Peer Review as part of the Endocrine Disruptor Screening Program. General information about the U.S. EPA Endocrine Disruptor Screening Program is available from the Internet at http://www.epa.gov/scipoly/oscpendo/index.htm or by contacting Mr. James Kariya (contact information provided below).

The EPA has established an official record for this action under docket control number OPPTS-42208A. The official record consists of the document specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action. This official 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 official record does not include any information claimed as confidential business information (CBI). The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Room B-607, Waterside Mall, 401 M. Street, SW, Washington, DC. The Center is open from noon to 4 PM., Monday through Friday, excluding legal holidays. The telephone number of the Center is (202) 260-7099.

Comments can be submitted through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that the docket control number OPPTS-42208A is identified in the subject line on the first page of the comments.

1. By mail: Submit comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460.

2. In person or by courier: Deliver comments to: OPPT Document Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M St. SW, Washington, DC. 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 (202) 260-7093.

3. Electronically: Submit comments electronically by e-mail to: "oppt.ncic@epa.gov," or mail the computer disk to the Document Control Office (address identified above). Do not submit any information that is considered to be CBI. Electronic comments may be submitted in WordPerfect 6.1/8.0 or as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS-42208A. Electronic comments may also be filed online at many Federal Depository Libraries.

Do not submit any information that you consider is CBI. If you believe that relevant information will be overlooked because of this restriction, please consult James P. Kariya, Office of Science Coordination and Policy (7203), Office of Prevention, Pesticides, and Toxic Substances, U.S. EPA, 1200 Pennsylvania Avenue NW, Washington, DC 20460; t: 202-260-2916; email: kariya.jim@epa.gov.

Dated: April 6, 2000

Kenneth Olden, Ph.D.
Director
National Toxicology Program

[Billing Code 4140-01-P]