[Federal Register Volume 70, Number 145 (Friday, July 29, 2005)]
[Notices]
[Pages 43870-43871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15080]


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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 Di(2-
ethylhexyl)-phthalate Expert Panel Meeting and Availability of the 
Draft Expert Panel Report on Di(2-ethylhexyl)-phthalate; Request for 
Public Comment

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

ACTION: Meeting announcement and request for comment.

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SUMMARY: The CERHR announces the availability of the draft expert panel 
report for di(2-ethylhexyl)-phthalate (DEHP) on August 15, 2005, from 
the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from 
the CERHR (see ADDRESSES 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 October 
10-12, 2005, at the Holiday Inn Old Town Select in 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 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 report on its Web site and solicit public comment on it 
through a Federal Register notice.

DATES: The expert panel meeting for DEHP will be held on October 10-12, 
2005. Sections 1-4 of the draft expert panel report will be available 
for public comment on August 15, 2005. Written public comments on the 
draft report should be received by September 28, 2005. Individuals 
wishing to make oral public comments at the expert panel meeting are 
asked to contact Dr. Michael D. Shelby, CERHR Director, by September 
28, 2005, and if possible, also send a copy of the statement or talking 
points at that time. Persons needing special assistance in order to 
attend are asked to contact Dr. Shelby at least 7 business days prior 
to the meeting.

ADDRESSES: The expert panel meeting for DEHP will be held at the 
Holiday Inn Old Town Select Alexandria, Virginia (telephone: 703-549-
6080, facsimile: 703-684-6508). Comments on the draft expert panel 
report and other correspondence should be addressed to Dr. Michael D. 
Shelby, CERHR Director, NIEHS, PO Box 12233, MD EC-32, Research 
Triangle Park, NC 27709 (mail), (919) 541-3455 (phone), (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:

Background

    Di(2-ethylhexyl)-phthalate (CAS RN: 117-81-7) is a high production 
volume 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

[[Page 43871]]

panel to conduct an updated evaluation of the potential reproductive 
and developmental toxicities of DEHP.
    At the expert panel meeting, the expert panel will review and 
revise the draft expert panel report and reach conclusions regarding 
whether exposure to DEHP is a hazard to human reproduction or 
development. Each 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 DEHP. Any comments received will be posted 
on the CERHR Web site prior to the meeting and distributed to the 
expert panel and CERHR staff for their consideration in revising the 
draft report and 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 September 28, 2005.
    Time is set-aside on October 10, 2005, 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, also send a copy of the statement 
or talking points to Dr. Shelby by September 28, 2005. 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 October 10, 2005, from 7:30-8:30 AM. Those 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 AM. On October 10 and 11, 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 October 12; 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.

October 10, 2005

     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 
di (2-ethylhexyl)-phthalate
     Discussion of Section 5.0 Summary, Conclusions, and 
Critical Data Needs

October 11, 2005

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

October 12, 2005

     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 this 
review.

Robert J. Kavlock, Ph.D., (Chair)--U.S. Environmental Protection Agency 
Research Triangle Park, NC
Dana Boyd Barr, Ph.D.--Centers for Disease Control & Prevention, 
Atlanta, GA
Kim Boekelheide, MD, Ph.D.--Brown University, Providence, RI
William J. Breslin, Ph.D.--Eli Lilly and Company, Greenfield, IN
Patrick N. Breysse, Ph.D.--The Johns Hopkins University, Baltimore, MD
Robert E. Chapin, Ph.D.--Pfizer Global Research & Development Groton, 
CT
Kevin Gaido, Ph.D.--CIIT Centers for Health Research, Research Triangle 
Park, NC
Ernest. Hodgson, Ph.D.--North Carolina State University, Raleigh, NC
Michele Marcus, Ph.D.--Emory University, Atlanta, GA
Katherine M. Shea, MD, MPH--Consultant, Chapel Hill, NC
Paige L. Williams, Ph.D.--Harvard School of Public Health, Boston, MA

Background Information on 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.
    The 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 ADDRESSES above). The CERHR selects 
chemicals for evaluation based upon several factors including 
production volume, potential for human exposure from use and occurrence 
in the environment, extent 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: July 22, 2005.
David A. Schwartz,
Director, National Institute of Environmental Health Sciences and the 
National Toxicology Program.
[FR Doc. 05-15080 Filed 7-28-05; 8:45 am]
BILLING CODE 4140-01-P