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Notice

National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Availability of the Draft Expert Panel Report on Bisphenol A and Request for Public Comment on the Draft Report; Announcement of the Bisphenol A Expert Panel Meeting

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

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

ACTION:

Announcement of a meeting and request public comment.

SUMMARY:

The CERHR announces the availability of the draft expert panel report for bisphenol A on December 15, 2006, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from CERHR (see FOR FURTHER INFORMATION CONTACT 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 March 5-7, 2007, at the Radisson Hotel Old Town in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A 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 final report on its Web site and solicit public comment on it through a Federal Register notice.

DATES:

The expert panel meeting for bisphenol A will be held on March 5-7, 2007. Sections 1-4 of the draft expert panel report will be available for public comment on December 15, 2006. Written public comments on the draft report must be received by February 2, 2007. Time is set-aside at the expert panel meeting on March 5, 2007 for oral public comments. Individuals wishing to make oral public comments are asked to contact Dr. Michael D. Shelby, Start Printed Page 74535CERHR Director, by February 26, 2007, and if possible, send a copy of the statement or talking points at that time. Persons needing special assistance, such as sign language interpretation or other reasonable accommodation in order to attend, should contact 919-541-2475 (voice), 919-541-4644 TTY (text telephone), through the Federal TTY Relay System at 800-877-8339, or by e-mail to niehsoeeo@niehs.nih.gov. Requests should be made at least seven business days in advance of the event.

ADDRESSES:

The expert panel meeting on bisphenol A will be held at the Radisson Hotel Old Town 901 N. Fairfax Street Alexandria, Virginia 22314-1501 (telephone: 703-683-6000, facsimile: 703-683-7597). Comments on the draft expert panel report 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.

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FOR FURTHER INFORMATION CONTACT:

Dr. Michael D. Shelby, CERHR Director, 919-541-3455, shelby@niehs.nih.gov.

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SUPPLEMENTARY INFORMATION:

Background

Bisphenol A (CAS RN: 80-5-07) is a high production volume chemical used in the production of epoxy resins, polyester resins, polysulfone resins, polyacrylate resins, polycarbonate plastics, and flame retardants. Polycarbonate plastics are used in food and drink packaging; resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants and tooth coatings contain bisphenol A. Exposure to the general population can occur through direct contact to bisphenol A or by exposure to food or drink that has been in contact with a material containing bisphenol A. CERHR selected this chemical for evaluation because of (1) high production volume, (2) widespread human exposure, (3) evidence of reproductive toxicity in laboratory animal studies, and (4) public concern.

At the meeting, the expert panel will review and revise the draft expert panel report and reach conclusions regarding whether exposure to bisphenol A is a hazard to human reproduction or development. Each draft 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 bisphenol A. Any comments received will be posted on the CERHR website prior to the meeting and distributed to the expert panel and CERHR staff for their consideration in revising the draft report and/or 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 February 2, 2007.

Time is set-aside on March 5, 2007, 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, send a copy of the statement or talking points to Dr. Shelby by February 2. 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 March 5, 2007, from 7:30-8:30 a.m. 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 a.m. On March 5 and 6, 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 March 7; 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.

March 5, 2007

  • 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 bisphenol A.
  • Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs.

March 6, 2007

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

March 7, 2007

  • 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 these evaluations.

Robert E. Chapin, PhD (Chair)Pfizer Inc., Groton, CT.
Jane Adams, PhDUniversity of Massachusetts, Boston, MA.
Kim Boekelheide, MD, PhDBrown University, Providence, RI.
Michael A. Gallo, PhDUniversity of Medicine & Dentistry NJ, Piscataway, NJ.
Leon Earl Gray, Jr, PhDU.S. Environmental Protection Agency, Research Triangle Park, NC.
Simon William Hayward, PhDVanderbilt University Medical Center, Nashville, TN.
Peter S.J. Lees, PhDThe Johns Hopkins University, Baltimore, MD.
Barry S. McIntyre, PhDSchering-Plough Research Institute, Summit, NJ.
Michael John McPhaul, MDThe University of Texas, Dallas, Texas.
Kenneth Portier, PhDAmerican Cancer Society, Atlanta, GA.
Teresa Schnorr, PhDCenters for Disease Control, National Institute for Occupational Safety & Health, Cincinnati, OH.
Sherry G. Selevan, PhDRetired, U.S. Public Health Service, Silver Spring, MD.
John G. Vandenbergh, PhDNorth Carolina State University, Raleigh, NC.
Kendall B. Wallace, PhDUniversity of Minnesota, Duluth, MN.
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Susan R. Woskie, PhDUniversity of Massachusetts Lowell, Lowell, MA.

Background Information on the CERHR

The NTP established CERHR in June 1998 [Federal Register, December 14, 1998 (Volume 63, Number 239, page 68782)]. 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.

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 FOR FURTHER INFORMATION CONTACT 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 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 CERHR.

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Dated: November 27, 2006.

Samuel H. Wilson,

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

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[FR Doc. E6-21040 Filed 12-11-06; 8:45 am]

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