[Federal Register Volume 68, Number 75 (Friday, April 18, 2003)]
[Notices]
[Pages 19215-19216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9545]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Toxicology Program

    The National Toxicology Program (NTP) Center for the Evaluation of 
Risks to Human Reproduction (CERHR) Announces the Future Evaluations of 
Fluoxetine Hydrochloride (Prozac[reg]; SarafenTM, CAS RN 
54910-89-3) and Acrylamide (CAS RN 79-06-1), Requests Public Comments 
on These Chemicals, and Solicits the Nominations of Scientists 
Qualified to Serve on Expert Panels Evaluating Fluoxetine Hydrochloride 
and Acrylamide.
    Summary: The CERHR plans to conduct an expert panel evaluation of 
fluoxetine hydrochloride and a separate expert panel evaluation of 
acrylamide. The exact dates for these expert panel meetings are not yet 
set, but the meetings are tentatively planned for 2003 and early 2004. 
Fluoxetine hydrochloride will be evaluated first. Additional details 
about the meetings, including the dates and locations, will be 
published in future Federal Register notices and posted on the NTP Web 
site (http://ntp-server.niehs.nih.gov).
    The CERHR will convene expert panels to evaluate the reproductive 
and developmental toxicities of fluoxetine hydrochloride and 
acrylamide. For each of these meetings, the expert panel will consist 
of approximately 12 scientists, selected for their scientific expertise 
in various aspects of reproductive and developmental toxicology and 
other relevant areas of science. The expert panel meetings will be open 
to the public with time scheduled for oral public comment.

Evaluation of Fluoxetine Hydrochloride

    Fluoxetine hydrochloride (Prozac[reg]; SarafemTM; CAS RN 
54910-89-3), an antidepressant, is a widely prescribed drug in the 
United States. The CERHR selected fluoxetine hydrochloride for 
evaluation because of (1) numerous reproductive and developmental 
studies in laboratory animals and humans, (2) human exposure 
information, and (3) changing prescription patterns. Fluoxetine 
hydrochloride, under the name SarafemTM, is now being

[[Page 19216]]

prescribed to treat premenstrual dysphoric disorder (PMDD), potentially 
increasing the number of exposures for women of childbearing age. 
Further, FDA recently approved SarafemTM for use in 7-17-
year-olds thereby increasing exposures of children. CERHR anticipates 
holding the expert panel evaluation in late 2003.

Evaluation of Acrylamide

    Acrylamide (CAS RN 79-06-1) is used in the production of 
polyacrylamide, which is used in water treatment, pulp and paper 
production, and mineral processing. It is used in the synthesis of 
dyes, adhesives, contact lenses, soil conditioners, and permanent press 
fabrics and in molecular biology procedures such as electrophoresis. 
Acrylamide is a neurotoxicant and in animal studies has been shown to 
be a carcinogen, germ cell mutagen, and reproductive toxicant. The 
CERHR selected acrylamide for expert panel evaluation because of recent 
public concern for human exposures through its presence in starchy 
foods treated at high temperatures, e.g., french fries and potato 
chips. In addition, recent data are available on occupational exposure, 
bioavailability, and reproductive toxicity. It is anticipated that the 
expert panel evaluation on acrylamide will occur in 2004.

Request for Public Input

    The CERHR invites input from the public and other interested 
parties on fluoxetine hydrochloride and acrylamide, 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. Information 
and comments should be forwarded to the CERHR at P.O. Box 12233, MD EC-
32, Research Triangle Park, NC 27709 (mail), (919) 541-3455 (phone), 
(919) 316-4511 (fax), or [email protected] (e-mail). Information and 
comments received by July 17, 2003 will be made available to the CERHR 
staff and the expert panel for consideration in the evaluation and 
posted on the CERHR Web site.
    The CERHR also invites nominations of qualified scientists to serve 
on the expert panel for the fluoxetine hydrochloride evaluation and the 
acrylamide evaluation. 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 that include: formal academic 
training and experience in a relevant scientific field, publications in 
peer-reviewed journals, membership in relevant professional societies, 
certification by an appropriate scientific board or other entities, and 
participation in similar committee activities. All panel members serve 
as individual experts in their specific areas of expertise 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 developmental toxicology, reproductive toxicology, 
epidemiology, general toxicology, pharmacokinetics, exposure 
assessment, and biostatistics. Nominations received by July 17, 2003 
will be considered for the fluoxetine hydrochloride and acrylamide 
panels and for inclusion in the CERHR Expert Registry. Nominations 
should be forwarded to the CERHR at the address given above.

Background Information About the CERHR

    The NTP established the NTP CERHR in June 1998 (Federal Register, 
December 14, 1998 (Volume 63, Number 239, page 68782)). The 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.
    Information about CERHR and its process for nominating agents for 
review or scientists for its expert registry can be obtained from its 
Home page (http://cerhr.niehs.nih.gov) or by contacting Dr. Shelby 
(contact information provided above). The CERHR selects chemicals for 
evaluation based upon several factors, including production volume, 
extent of human exposure, public concern, and published evidence of 
reproductive or developmental toxicity.
    CERHR follows a formal, multi-step process for review and 
evaluation of selected chemicals. The formal evaluation process was 
published in the Federal Register notice 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: April 9, 2003.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-9545 Filed 4-17-03; 8:45 am]
BILLING CODE 4140-01-P