National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Availability of the Di-(2-Ethylhexyl)Phthalate (DEHP) Update Expert Panel Report; Request for Public Comment, 69567 [05-22693]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 220 (Wednesday, November 16, 2005)]
[Notices]
[Page 69567]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Toxicology Program (NTP); Center for the Evaluation of 
Risks to Human Reproduction (CERHR); Announcement of the Availability 
of the Di-(2-Ethylhexyl)Phthalate (DEHP) Update Expert Panel Report; 
Request for Public Comment

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

ACTION: Report availability and request for comment.

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SUMMARY: The CERHR announces the availability of the DEHP update expert 
panel report on November 21, 2005 from the CERHR Web site (https://
cerhr.niehs.nih.gov) or in print from the CERHR (see ADDRESSES below). 
The expert panel report is an updated evaluation of the reproductive 
and developmental toxicity of DEHP conducted by an 11-member expert 
panel composed of scientists from the Federal government, universities, 
and private organizations. The expert panel met in public on October 
10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to 
review and revise the draft expert panel report and reach conclusions 
regarding whether exposure to DEHP is a hazard to human development or 
reproduction. The expert panel also identified data gaps and research 
needs. The CERHR invites the submission of public comments on this 
expert panel report (see SUPPLEMENTARY INFORMATION below). The CERHR 
previously solicited public comment on the draft version of this expert 
panel report (70 FR 43870-43871, July 29, 2005).

DATES: The final DEHP update expert panel report will be available for 
public comment on November 21, 2005. Written public comments on this 
report should be received by January 4, 2006.

ADDRESSES: Comments on the expert panel report and any other 
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) 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.

SUPPLEMENTARY INFORMATION:

Background

    The NTP-CERHR convened an expert panel on October 10-12, 2005, to 
re-evaluate the reproductive and developmental toxicities of di(2-
ethylhexyl)phthalate (DEHP, CAS RN: 117-81-7). DEHP is a high 
production volume chemical used as a plasticizer in the manufacture of 
a wide variety of consumer products. It is found in many consumer 
products, such as building products, car products, clothing, food 
packaging, children's products (but not in toys intended for mouthing), 
and in some medical devices made of polyvinyl chloride. The public can 
be exposed to DEHP by ingesting food or drink that has been in contact 
with DEHP-containing plastics and through medical procedures that use 
DEHP-containing plastics.
    A previous CERHR expert panel evaluated DEHP in 1999-2000. However, 
since release of the earlier CERHR expert panel report on DEHP, 
approximately 150 papers relevant to human exposure and reproductive 
and/or developmental toxicity of DEHP have been published. The CERHR 
decided to update the evaluation of DEHP because of: (1) Widespread 
human exposure, (2) public and government interest in potential adverse 
health effects, and (3) the large number of relevant papers published 
since the earlier evaluation. Both the original and updated expert 
panel reports for DEHP are available on the CERHR Web site (https://
cerhr.niehs.nih.gov). This is the first time a CERHR expert panel was 
convened to update an evaluation conducted by an earlier expert panel.
    Following receipt of public comments on the DEHP update expert 
panel report, the CERHR staff will prepare an NTP-CERHR monograph on 
this chemical. NTP-CERHR monographs are divided into four major 
sections: (1) The NTP Brief which provides the NTP's interpretation of 
the potential for the chemical to cause adverse reproductive and/or 
developmental effects in exposed humans, (2) a roster of expert panel 
members, (3) the final expert panel report, and (4) any public comments 
received on that report. The NTP Brief is based on the expert panel 
report, public comments on that report, and any new information that 
became available after the expert panel meeting.

Request for Comments

    The CERHR invites written public comments on the DEHP update expert 
panel report. Written comments should be sent to Dr. Michael Shelby at 
the address provided above. 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). Any comments received will be posted 
on the CERHR Web site and be included in the NTP CERHR monograph on 
this chemical. All public comments will be considered by the NTP during 
preparation of the NTP Brief described above under ``Background.''

Background Information on the CERHR

    The NTP established CERHR in June 1998 [63 FR 68782, Dec. 14, 
1998]. 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 CERHR in 
public forums.
    CERHR invites the nomination of agents for evaluation or scientists 
for its expert registry. Information about CERHR and the nomination 
process can be obtained from its Web site (https://cerhr.niehs.nih.gov) 
or by contacting Dr. Shelby (see ADDRESSES 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 notice July 16, 2001 (66 FR 37047-
37048, July 16, 2001) and is available on the CERHR Web site under 
``About CERHR'' or in printed copy from the CERHR.

    Dated: November 3, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and the 
National Toxicology Program.
[FR Doc. 05-22693 Filed 11-15-05; 8:45 am]
BILLING CODE 4140-01-P