[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Notices]
[Pages 74534-74536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21040]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Availability of the Draft Expert 
Panel Report on Bisphenol A and Request for Public Comment on the Draft 
Report; Announcement of the Bisphenol A Expert Panel Meeting

AGENCY: National Institute of Environmental Health Sciences (NIEHS); 
National Institutes of Health (NIH).

ACTION: Announcement of a meeting and request public comment.

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SUMMARY: The CERHR announces the availability of the draft expert panel 
report for bisphenol A on December 15, 2006, from the CERHR Web site 
(http://cerhr.niehs.nih.gov) or in printed text from CERHR (see FOR 
FURTHER INFORMATION CONTACT below). The CERHR invites the submission of 
public comments on sections 1-4 of the draft expert panel report (see 
SUPPLEMENTARY INFORMATION below). The expert panel will meet on March 
5-7, 2007, at the Radisson Hotel Old Town in Alexandria, Virginia to 
review and revise the draft expert panel report and reach conclusions 
regarding whether exposure to bisphenol A is a hazard to human 
development or reproduction. The expert panel will also identify data 
gaps and research needs. CERHR expert panel meetings are open to the 
public with time scheduled for oral public comment. Attendance is 
limited only by the available meeting room space. Following the expert 
panel meeting and completion of the expert panel report, the CERHR will 
post the final report on its Web site and solicit public comment on it 
through a Federal Register notice.

DATES: The expert panel meeting for bisphenol A will be held on March 
5-7, 2007. Sections 1-4 of the draft expert panel report will be 
available for public comment on December 15, 2006. Written public 
comments on the draft report must be received by February 2, 2007. Time 
is set-aside at the expert panel meeting on March 5, 2007 for oral 
public comments. Individuals wishing to make oral public comments are 
asked to contact Dr. Michael D. Shelby,

[[Page 74535]]

CERHR Director, by February 26, 2007, and if possible, send a copy of 
the statement or talking points at that time. Persons needing special 
assistance, such as sign language interpretation or other reasonable 
accommodation in order to attend, should contact 919-541-2475 (voice), 
919-541-4644 TTY (text telephone), through the Federal TTY Relay System 
at 800-877-8339, or by e-mail to [email protected]. Requests 
should be made at least seven business days in advance of the event.

ADDRESSES: The expert panel meeting on bisphenol A will be held at the 
Radisson Hotel Old Town 901 N. Fairfax Street Alexandria, Virginia 
22314-1501 (telephone: 703-683-6000, facsimile: 703-683-7597). Comments 
on the draft expert panel report should be sent to Dr. Michael D. 
Shelby, CERHR Director, NIEHS, P.O. Box 12233, MD EC-32, Research 
Triangle Park, NC 27709 (mail), (919) 316-4511 (fax), or 
[email protected] (e-mail). Courier address: CERHR, 79 T.W. 
Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 
27709.

FOR FURTHER INFORMATION CONTACT: Dr. Michael D. Shelby, CERHR Director, 
919-541-3455, [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical 
used in the production of epoxy resins, polyester resins, polysulfone 
resins, polyacrylate resins, polycarbonate plastics, and flame 
retardants. Polycarbonate plastics are used in food and drink 
packaging; resins are used as lacquers to coat metal products such as 
food cans, bottle tops, and water supply pipes. Some polymers used in 
dental sealants and tooth coatings contain bisphenol A. Exposure to the 
general population can occur through direct contact to bisphenol A or 
by exposure to food or drink that has been in contact with a material 
containing bisphenol A. CERHR selected this chemical for evaluation 
because of (1) high production volume, (2) widespread human exposure, 
(3) evidence of reproductive toxicity in laboratory animal studies, and 
(4) public concern.
    At the meeting, the expert panel will review and revise the draft 
expert panel report and reach conclusions regarding whether exposure to 
bisphenol A is a hazard to human reproduction or development. Each 
draft expert panel report has the following sections:

1.0 Chemistry, Use, and Human Exposure.
2.0 General Toxicological and Biological Effects.
3.0 Developmental Toxicity Data.
4.0 Reproductive Toxicity Data.
5.0 Summary, Conclusions, and Critical Data Needs (to be prepared at 
expert panel meeting).

Request for Comments

    The CERHR invites written public comments on sections 1-4 of the 
draft expert panel report on bisphenol A. Any comments received will be 
posted on the CERHR website prior to the meeting and distributed to the 
expert panel and CERHR staff for their consideration in revising the 
draft report and/or preparing for the expert panel meeting. Persons 
submitting written comments are asked to include their name and contact 
information (affiliation, mailing address, telephone and facsimile 
numbers, e-mail, and sponsoring organization, if any) and send them to 
Dr. Shelby (see ADDRESSES above) for receipt by February 2, 2007.
    Time is set-aside on March 5, 2007, for the presentation of oral 
public comments at the expert panel meeting. Seven minutes will be 
available for each speaker (one speaker per organization). When 
registering to comment orally, please provide your name, affiliation, 
mailing address, telephone and facsimile numbers, email and sponsoring 
organization (if any). If possible, send a copy of the statement or 
talking points to Dr. Shelby by February 2. This statement will be 
provided to the expert panel to assist them in identifying issues for 
discussion and will be noted in the meeting record. Registration for 
presentation of oral comments will also be available at the meeting on 
March 5, 2007, from 7:30-8:30 a.m. Persons registering at the meeting 
are asked to bring 20 copies of their statement or talking points for 
distribution to the expert panel and for the record.

Preliminary Agenda

    The meeting begins each day at 8:30 a.m. On March 5 and 6, it is 
anticipated that a lunch break will occur from noon-1 p.m. and the 
meeting will adjourn at 5-6 p.m. The meeting is expected to adjourn by 
noon on March 7; however, adjournment may occur earlier or later 
depending upon the time needed by the expert panel to complete its 
work. Anticipated agenda topics for each day are listed below.

March 5, 2007

     Opening remarks.
     Oral public comments (7 minutes per speaker; one 
representative per group).
     Review of sections 1-4 of the draft expert panel report on 
bisphenol A.
     Discussion of Section 5.0 Summary, Conclusions, and 
Critical Data Needs.

March 6, 2007

     Discussion of Section 5.0 Summary, Conclusions, and 
Critical Data Needs.
     Preparation of draft summaries and conclusion statements.

March 7, 2007

     Presentation, discussion of, and agreement on summaries, 
conclusions, and data needs.
     Closing comments.

Expert Panel Roster

    The CERHR expert panel is composed of independent scientists 
selected for their scientific expertise in reproductive and/or 
developmental toxicology and other areas of science relevant for these 
evaluations.

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Robert E. Chapin, PhD (Chair)..........  Pfizer Inc., Groton, CT.
Jane Adams, PhD........................  University of Massachusetts,
                                          Boston, MA.
Kim Boekelheide, MD, PhD...............  Brown University, Providence,
                                          RI.
Michael A. Gallo, PhD..................  University of Medicine &
                                          Dentistry NJ, Piscataway, NJ.
Leon Earl Gray, Jr, PhD................  U.S. Environmental Protection
                                          Agency, Research Triangle
                                          Park, NC.
Simon William Hayward, PhD.............  Vanderbilt University Medical
                                          Center, Nashville, TN.
Peter S.J. Lees, PhD...................  The Johns Hopkins University,
                                          Baltimore, MD.
Barry S. McIntyre, PhD.................  Schering-Plough Research
                                          Institute, Summit, NJ.
Michael John McPhaul, MD...............  The University of Texas,
                                          Dallas, Texas.
Kenneth Portier, PhD...................  American Cancer Society,
                                          Atlanta, GA.
Teresa Schnorr, PhD....................  Centers for Disease Control,
                                          National Institute for
                                          Occupational Safety & Health,
                                          Cincinnati, OH.
Sherry G. Selevan, PhD.................  Retired, U.S. Public Health
                                          Service, Silver Spring, MD.
John G. Vandenbergh, PhD...............  North Carolina State
                                          University, Raleigh, NC.
Kendall B. Wallace, PhD................  University of Minnesota,
                                          Duluth, MN.

[[Page 74536]]

 
Susan R. Woskie, PhD...................  University of Massachusetts
                                          Lowell, Lowell, MA.
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Background Information on the CERHR

    The NTP established CERHR in June 1998 [Federal Register, December 
14, 1998 (Volume 63, Number 239, page 68782)]. CERHR is a publicly 
accessible resource for information about adverse reproductive and/or 
developmental health effects associated with exposure to environmental 
and/or occupational exposures. Expert panels conduct scientific 
evaluations of agents selected by the CERHR in public forums.
    CERHR invites the nomination of agents for review or scientists for 
its expert registry. Information about CERHR and the nomination process 
can be obtained from its homepage (http://cerhr.niehs.nih.gov) or by 
contacting Dr. Shelby (see FOR FURTHER INFORMATION CONTACT above). 
CERHR selects chemicals for evaluation based upon several factors 
including production volume, potential for human exposure from use and 
occurrence in the environment, extent of public concern, and extent of 
data from reproductive and developmental toxicity studies.
    CERHR follows a formal, multi-step process for review and 
evaluation of selected chemicals. The formal evaluation process was 
published in the Federal Register on July 16, 2001 (Volume 66, Number 
136, pages 37047-37048) and is available on the CERHR Web site under 
``About CERHR'' or in printed copy from CERHR.

    Dated: November 27, 2006.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences 
and National Toxicology Program.
[FR Doc. E6-21040 Filed 12-11-06; 8:45 am]
BILLING CODE 4140-01-P