National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of Plans for Future Evaluation of Di(2-ethylhexyl)phthalate; Request for Public Comments on this Chemical; and Solicitation for the Nomination of Scientists Qualified to Serve on an Expert Panel, 6024 [05-2125]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Notices]
[Page 6024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Announcement of Plans for Future 
Evaluation of Di(2-ethylhexyl)phthalate; Request for Public Comments on 
this Chemical; and Solicitation for the Nomination of Scientists 
Qualified to Serve on an Expert Panel

AGENCY: National Institute for Environmental Health Sciences (NIEHS); 
National Institutes of Health (NIH), Department of Health and Human 
Services (HHS).

ACTION: Notice of expert panel evaluation of the reproductive and 
developmental toxicities of di(2-ethylhexyl)phthalate.

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SUMMARY: The CERHR plans to convene an expert panel to evaluate the 
scientific evidence regarding the potential reproductive and/or 
developmental toxicity associated with exposure to di(2-
ethylhexyl)phthalate (DEHP). The expert panel will consist of 
approximately 8-12 scientists selected for their scientific expertise 
in various aspects of reproductive and developmental toxicology and 
other relevant areas of science. The CERHR invites the submission of 
public comments on DEHP and the nomination of scientists to serve on 
the expert panel for its evaluation (see SUPPLEMENTARY INFORMATION 
below). This meeting is tentatively scheduled for fall 2005, although 
the exact date and location are not yet established. As plans are 
finalized, they will be announced in the Federal Register and posted on 
the CERHR Web site (https://cerhr.niehs.nih.gov). CERHR expert panel 
meetings are open to the public with time scheduled for oral public 
comment.

DATES: Information and comments received by March 21, 2005, will be 
made available to the CERHR staff and the expert panel for 
consideration in the evaluation and posted on the CERHR Web site. 
Nominations of scientists received by March 21, 2005, will be 
considered for this panel and for inclusion in the CERHR Expert 
Registry.

ADDRESSES: Information and comments 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 
shelby@niehs.nih.gov (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, shelby@niehs.nih.gov.

SUPPLEMENTARY INFORMATION:

Background

    DEHP is a high production chemical used as a plasticizer of 
polyvinyl chloride in the manufacturer of a wide variety of consumer 
products, such as building products, car products, clothing, food 
packaging, children's products (but not in toys intended for mouthing) 
and in polyvinyl chloride medical devices. In 1999-2000, a NTP-CERHR 
expert panel evaluated DEHP and six other phthalates for reproductive 
and developmental toxicities. Since release of the NTP-CERHR expert 
panel report on DEHP in 2000, approximately 70 papers relevant to human 
exposure and reproductive and/or developmental toxicity of DEHP have 
been published. Because this is a chemical with wide human exposure and 
public and government interest, CERHR plans to convene an expert panel 
to conduct an updated evaluation of the potential reproductive and 
developmental toxicities of DEHP.

Request for Comments

    The CERHR invites the public and other interested parties to submit 
information and comments on DEHP 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 Scientist for the Expert Panel

    The CERHR invites nominations of qualified scientists to serve on 
the expert panel. 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 required to sign conflict of interest forms in 
accordance with Federal Advisory Committee Act Guidelines (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 the 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 developmental health effects associated with environmental 
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 
Web site (https://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 extent of the database on 
reproductive or 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 (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: January 27, 2005.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 05-2125 Filed 2-3-05; 8:45 am]
BILLING CODE 4140-01-P