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Notice

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

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Information about this document as published in the Federal Register.

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AGENCY:

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

ACTION:

Meeting announcement and request for comment.

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 shelby@niehs.nih.gov (e-mail). Courier address: CERHR, 79 T.W. Alexander Drive, Building 4401, Room 103, Research Triangle Park, NC 27709.

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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 Start Printed Page 43871panel 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.

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Dated: July 22, 2005.

David A. Schwartz,

Director, National Institute of Environmental Health Sciences and the National Toxicology Program.

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[FR Doc. 05-15080 Filed 7-28-05; 8:45 am]

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