[Federal Register Volume 70, Number 244 (Wednesday, December 21, 2005)]
[Notices]
[Pages 75827-75828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Plans for Future Expert Panel 
Evaluations of Bisphenol A and Hydroxyurea; Request for Comments and 
Nominations of Scientists Qualified To Serve on These Expert Panels

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

ACTION: Request for comments, nominations of scientific experts.

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SUMMARY: The CERHR plans to convene two expert panels to evaluate the 
scientific evidence regarding the potential reproductive and 
developmental toxicities of bisphenol A and hydroxyurea. Each expert 
panel will consist of approximately 12 scientists, selected for their 
expertise in various aspects of reproductive and developmental 
toxicology and other relevant areas of science. The CERHR invites the 
submission of public comments on these chemicals and the nomination of 
scientists to serve on the expert panels for their evaluation (see 
SUPPLEMENTARY INFORMATION below). These meetings are tentatively 
scheduled for late 2006, although the exact dates and locations have 
not yet been established. As plans are finalized, they will be 
announced in the Federal Register and posted on the NTP Web site 
(http://ntp-server.niehs.nih.gov). CERHR expert panel meetings are open 
to the public with time scheduled for oral public comment.

DATES: Comments received by February 6, 2006 will be made available to 
the CERHR staff and the expert panels and posted on the CERHR Web site. 
Nominations of scientists received by February 6, 2006 will be 
considered for these panels and for inclusion in the CERHR Expert 
Registry.

ADDRESSES: Correspondence 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) 541-3455 (telephone), (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.

SUPPLEMENTARY INFORMATION:

Evaluation of Bisphenol A

    Bisphenol A (CAS RN: 80-05-7) 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; the 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 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.

[[Page 75828]]

Evaluation of Hydroxyurea

    Hydroxyurea (CAS RN: 127-07-1) is used in the treatment of cancer, 
sickle cell disease, and thalassemia. It is the only treatment for 
sickle cell disease used in children aside from blood transfusion. 
Hydroxyurea may be used in the treatment of children and adults with 
sickle cell disease for an extended period of time or for repeated 
cycles of therapy. Treatment with hydroxyurea may be associated with 
cytotoxic and myelosuppressive effects and hydroxyurea is mutagenic. 
This drug is used to treat sickle cell disease only if there is an 
indication of significant disease complications. CERHR selected this 
chemical for evaluation because of (1) increasing use in the treatment 
of sickle cell disease in children and adults, (2) knowledge that it 
inhibits DNA synthesis and is cytotoxic, and (3) published evidence of 
reproductive and developmental toxicity in rodents and humans.

Request for Comments

    CERHR invites the public and other interested parties to submit 
information and comments on bisphenol A and hydroxyurea including 
toxicology information from completed and ongoing studies, information 
on planned studies, and information about current production levels, 
human exposure, use patterns, and environmental occurrence.

Request for the Nomination of Scientists for Expert Panels

    CERHR invites nominations of qualified scientists to serve on the 
individual expert panels for (1) bisphenol A and (2) hydroxyurea. 
Panelists are primarily drawn from the CERHR Expert Registry and/or the 
nomination of other scientists who meet the criteria for listing in 
that registry which include: formal academic training and experience in 
a relevant scientific field, publications in peer-reviewed journals, 
membership in relevant professional societies, and certification by an 
appropriate scientific board or other entities. Expert panel members 
are subject to applicable guidelines for conflict of interest in 
accordance with Federal Advisory Committee Act (5 U.S.C. Appendix 2).
    All panel members serve as individual experts and not as 
representatives of their employers or other organizations. Scientists 
on the expert panel will be selected to represent a wide range of 
expertise including, but not limited to, developmental toxicology, 
reproductive toxicology, epidemiology, general toxicology, 
pharmacokinetics, exposure assessment, and biostatistics. Nominations 
should include contact information and a current curriculum vitae (if 
possible) and be forwarded to the CERHR at the address given above.

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 
developmental health effects associated with environmental and/or 
occupational exposures. Expert panels conduct scientific evaluations of 
environmental chemicals, drugs, physical agents, or mixtures selected 
by CERHR in public forums.
    CERHR invites the nomination of substances for expert panel 
evaluation 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 ADDRESSES 
above). CERHR selects substances 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 the CERHR.

    Dated: December 13, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and the 
National Toxicology Program.
[FR Doc. E5-7617 Filed 12-20-05; 8:45 am]
BILLING CODE 4140-01-P