[Federal Register Volume 65, Number 188 (Wednesday, September 27, 2000)]
[Notices]
[Pages 58097-58099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences, NIH; 
National Toxicology Program; Peer Review Meeting on Low-Dose Issues for 
Endocrine Disruptors; Update on Meeting Scope; Meeting Agenda; and 
Registration Information

Summary

    The National Toxicology Program (NTP) is organizing a Peer Review 
to evaluate dose-response relationships for endocrine disrupting 
chemicals. In particular, the panel will 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. If the

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review panel concludes that the current data on low-dose effects are 
inconclusive, it will be asked to describe specific research that would 
resolve the ambiguities. The Peer Review will take place October 10-12, 
2000 at the Sheraton Imperial Hotel and Convention Center, Research 
Triangle Park, NC. This meeting is open to the public.
    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. A second 
Federal Register notice was published April 17, 2000 (Volume 65, Number 
74, pages 20478-20479] that broadened the scope of the research studies 
and data to be considered for inclusion in this peer review. This 
notice supplements the earlier ones and provides an agenda, 
registration information, and updated details about the Peer Review.

Endocrine Disruptor Peer Review

A. Background and Scope

    The goals of this peer review are to review the scientific evidence 
related to the low-dose effects of endocrine disruptors and to consider 
their implications for the development, validation, and interpretation 
of test protocols for reproductive and developmental toxicity. The 
intent is to examine data from major selected studies (excluding 
studies on dioxin and dioxin-like compounds) supporting the presence or 
absence of low-dose effects and to evaluate the likelihood and 
significance of these and/or other potential low-dose effects for 
humans. A main topic to be addressed is defining the shape of the dose-
response curves for endocrine-active substances in the low-dose region. 
The analysis and evaluation will be accomplished during this three-day 
scientific peer review that includes plenary sessions and several 
subpanel meetings. This peer review is open to the public.
    The EPA has established an official record for this action under 
docket control number OPPTS-42208A. The official record consists of the 
selected and background studies being considered in this peer review, 
any public comments received, and other information related to this 
action. The public version of the official record 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.

B. Tentative Agenda

Tuesday, October 10, 2000
8:30-8:45 am
    Scope of Review
8:45-9:00 am
    Charge to Panel
9:00-10:15 am
    Body of Knowledge Presentation and Discussion--Dr. Frederick S. vom 
Saal, University of Missouri
10:15-10:45 am
    Break
10:45 am-Noon
    Body of Knowledge Presentation and Discussion--Dr. John Ashby, 
Zeneca, Central Toxicology Laboratory, United Kingdom
Noon-1:00 pm
     Lunch
1:00-2:15 pm
    Body of Knowledge Presentation and Discussion--Dr. K. Barry 
Delclos, National Center for Toxicological Research
2:15-3:30 pm
    Body of Knowledge Presentation and Discussion--Dr. John C. 
O'Connor, DuPont Haskell Laboratory
3:30-3:45 pm
    Break
3:45-4:30 pm
    Summary of Other Bodies of Knowledge Studies
4:30-5:00 pm
    Report from the Statistics and Dose-Response Modeling
    Subpanel--Statistical Evaluations
5:00-5:20 pm
    Report from the Statistics and Dose-Response Modeling
    Subpanel--Mechanism-Based Dose-Response Modeling
5:20-6:15 pm
    Dinner
6:15-8:00 pm
    Public Comments
8:00-9:00 pm
    Subpanels: Initial Meeting
Wednesday, October 11, 2000
8:30-5:00 pm
    Subpanel Meetings
    Bisphenol A
    Other Environmental Estrogens and Estradiol
    Androgens and Anti-Androgens
    Biological Factors (i.e. confounders: diet, strain, etc.) and Study 
Design
10:00-10:30 am
    Break
Noon-1:00 pm
    Lunch
2:30-3:00 pm
    Break
Thursday, October 12, 2000
8:30-10:00 am
    Subpanel Meetings
10:00-10:30 am
    Break
10:30 am-Noon
    Presentation and Discussion of Subpanel Reports
Noon-1:00 pm
    Lunch
1:00-2:30 pm
    Presentation and Discussion of Subpanel Reports
2:30-3:00 pm
    Break
3:00-5:00 pm
    Presentation and Discussion of Subpanel Reports

C. Peer Review Evaluation and Analysis

    The NTP is establishing a scientific panel with broad expertise 
including endocrinology, reproductive and development biology/
toxicology, statistics, modeling, receptor biology, and molecular 
biology to conduct the evaluation and analysis for this peer review. 
The Panel will be divided into five subpanels: (1) Bisphenol A, (2) 
Other Environmental Estrogens and Estradiol, (3) Androgens and Anti-
Androgens, (4) Biological Factors (i.e. confounders: diet, strain, 
etc.) and Study Design, and (5) Statistics and Dose-Response Modeling. 
At the peer review, members of the Statistics and Dose-Response 
Modeling Subpanel will be available to interact with the other 
subpanels. A list of the Panel members and their subpanel assignments 
is available on-line through the NTP web site (http://ntp-server.niehs.nih.gov, What's New), from the EPA docket (see above), or 
by contacting the NTP Liaison and Scientific Review Office (contact 
information given below).
    Studies for inclusion in this peer review are catalogued as either 
Selected Studies or Background Information. A list of the studies 
included in each group is found on the NTP web site (see above), from 
the EPA docket (see above), or by contacting the NTP Liaison and 
Scientific Review Office (see below). Copies of most studies are 
available from the EPA docket. As more information is received, the 
lists will be updated and studies will be added to the docket. Raw data 
for the Selected Studies will be available from the EPA docket no 
earlier than October 3rd. Individuals wanting to obtain a copy of 
particular datasets should bring two rewritable CDs to the EPA docket 
so the data can be transferred. The datasets will be available in ASCII 
format as well as SAS transport files.
    The Panel will have available to them copies of both the Selected 
Studies and Background Information. Prior to the peer review, the 
Statistics and Dose-

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Response Modeling Subpanel will reevaluate selective laboratory data 
and analyze dose-response relationships from identified studies and 
make that information available to the other subpanels for inclusion in 
their evaluations. Analyses by the Panel will focus on the 
interpretation of the Selected Studies showing or refuting effects at 
low doses for endocrine disruptors on reproductive and developmental 
endpoints. In addition, at the meeting invited researchers will make 
oral presentations to the Panel during the plenary sessions (see 
tentative agenda) and will be available for in-depth discussions during 
subpanel meetings. The individual subpanels will review all evidence, 
including relevant pharmacokinetic and mechanistic information that may 
have a bearing on the low-dose issue. In addition, they will consider 
the consistency in the data (within and across studies), the strength 
and specificity of the evidence for low-dose effects, the evidence for 
defining the shape of the dose-response curves in the low-dose regions, 
and the biologic plausibility of the reported effect(s). The subpanels 
will identify research gaps and as possible, suggest ways to address 
those gaps.
    All subpanels will prepare reports of their conclusions, including 
areas of consensus and disagreement and identify research needs that 
would help resolve ambiguities. Following the meeting, the NTP will 
receive the final reports from the individual subpanels and will 
synthesize this information into its own report. The NTP will solicit 
public comments on the NTP report, synthesize those comments, and 
incorporate them into its final transmission to the EPA and other 
Federal agencies. The NTP will also publish the report in a scientific 
journal. This report will be posted on the NTP web site (see above) and 
made available to the panel members and the public; requests for 
hardcopies can be made to the NTP Liaison and Scientific Review Office 
(see below).

D. Public Comments

    The Public is invited to attend the Peer Review with the number of 
observers limited only by the space available. A formal public comment 
period is scheduled for October 10 (see tentative agenda) for 
interested persons or groups to present their views and comments to the 
Panel (please limit speakers to one per group). The Public is invited 
to present oral comments at the meeting or to submit written comments 
by October 6, 2000 for distribution to the Panel at the meeting. Oral 
presentations will be limited to five to seven minutes per speaker 
depending upon the number of speakers. Individuals presenting oral 
comments are asked to provide 40 copies of their statement at 
registration for distribution to the Panel. For planning purposes, 
persons wishing to give oral comments are asked to check the box 
provided on the Registration Form (information provided below) or 
contact the NTP Liaison and Scientific Review Office (see below), 
although requests for oral presentations will also be accepted on-site 
(subject to availability of time). Persons registering for oral 
comments or submitting written remarks are asked to include their 
contact information (name, address, affiliation, telephone, fax, and e-
mail). Written comments should be sent to the NTP Liaison and 
Scientific Review Office.
    In addition to the plenary sessions, the Public is invited to 
attend the individual subpanel meetings. When registering, the Public 
is asked to indicate their first and second subpanel choices on the 
registration form. Attendance in these meetings will be limited by the 
available space and the NTP will make every effort to honor specific 
requests.

E. Meeting Registration

    The Peer Review is open to the public, limited only by the space 
available. The registration fee is $90 per registrant. In order to plan 
appropriately, advance registration is requested by September 29, 2000, 
although on-site registration will be available (subject to space 
availability). Registration Forms can be obtained through the Internet 
at the NTP web site (http://ntp-server.niehs.nih.gov, What's New?) or 
by contacting the NTP Liaison and Scientific Review Office, NIEHS, P.O. 
12233, MD A3-01, Research Triangle Park, NC, telephone: 919-541-0530; 
fax: 919-541-0295; and e-mail: [email protected].

    Dated: September 13, 2000.
Kenneth Olden,
Director, NIEHS/NTP.
[FR Doc. 00-24731 Filed 9-26-00; 8:45 am]
BILLING CODE 4140-01-P