02-30960. The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR): Availability of Draft Expert Panel Reports on Ethylene Glycol and Propylene Glycol, Request for Public Comment, and Expert Panel ...

Summary: The NTP CERHR announces:

1. The availability of the draft expert panel reports on ethylene glycol and propylene glycol and solicits written public comments on the reports January 23, 2003.

2. An expert panel meeting on February 11-13, 2003, at the Holiday Inn Old Town Select, Alexandria, Virginia and invites the public to present oral comments at this meeting.

Questions about the draft expert panel reports, submission of public comments, and the expert panel meeting should be directed to Dr. Michael Shelby, CERHR director (contact information below).

Draft Expert Panel Reports on Ethylene Glycol and Propylene Glycol Available

The CERHR announces the availability of draft expert panel reports on ethylene glycol (CASRN 107-21-1) and propylene glycol (CASRN 57-55-6). Most ethylene glycol is used as a chemical intermediate in the production of polyester compounds. There is widespread public exposure to ethylene glycol due to its use as automotive antifreeze and as a de-icer for aircraft. The toxicology database on ethylene glycol includes recent mechanistic data and occupational exposure information. Propylene glycol, similar in structure to ethylene glycol, is used as an antifreeze and de-icing solution and in various paints and coatings. Propylene glycol is approved for use in foods, drugs, and cosmetics.

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 written at expert panel meeting)

Sections 1-4 will be available to the public by December 4, 2003, and can be obtained electronically on the CERHR web site (http://cerhr.niehs.nih.gov) or in hard copy by contacting Dr. Michael Shelby, Director CERHR (NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, telephone: [phone]; facsimile: [phone]; [e-mail]).

Request for Written Comments on Draft Expert Panel Reports

The CERHR invites written public comments on sections 1-4 of the draft expert panel reports on ethylene glycol and propylene glycol. Comments can be submitted in hard copy or electronic format and must be received by the CERHR by January 23, 2003. These comments will be distributed to the expert panel and CERHR staff for consideration in revising the draft reports and in preparing for the expert panel meeting. They will be posted on the CERHR website prior to the expert panel meeting. These 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).

Expert Panel Meeting Planned

The CERHR will hold an expert panel meeting February 11-13, 2002, at the Holiday Inn Old Town Select, 480 King Street, Alexandria, VA 22314 (telephone: [phone], facsimile: 684-6508). The CERHR will ask the expert panel to review the scientific evidence regarding the potential reproductive and/or developmental toxicity associated with exposure to ethylene glycol and to propylene glycol. The expert panel will review and revise the draft expert panel reports and reach conclusions regarding whether exposure to ethylene glycol or propylene glycol is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs.

This meeting is open to the public and attendance is limited only by the available meeting room space. The meeting will begin at 8:30 a.m. each day. On February 11 and 12 it is anticipated that a lunch break will occur from noon-1 p.m. and that the meeting will adjourn 5-6 p.m. The meeting is expected to adjourn by noon on February 13; 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. Following the expert panel meeting and completion of the expert panel reports, the CERHR will post the reports on its website and solicit public comment through a Federal Register notice.

Preliminary Meeting Agenda

February 11, 2003

Opening remarks (8:30 a.m.).

Oral public comments (7 min per speaker; one representative per group, see below).

Review of sections 1-4 of the draft expert panel reports on ethylene glycol and propylene glycol.

Discussion of section 5.0 summary, conclusions, and critical data needs.

February 12, 2002

Discussion of section 5.0 summary, conclusions, and critical data needs (8:30 a.m.).

Preparation of draft summaries and conclusion statements.

February 13, 2003

Presentation, discussion of, and agreement on summaries and conclusions (8:30 a.m.).

Closing comments.

Oral Public Comments Welcome at Expert Panel Meeting

Time is set-aside on February 11, 2003, for the presentation of oral public comments at the expert panel meeting. To facilitate planning, those persons wishing to make oral public comments are asked to contact Dr. Shelby by January 31, 2003 (contact information provided above). 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, e-mail and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to Dr. Shelby by February 3, 2003. This information 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 February 11, 2003 (7:30-8:30 a.m.). Those persons registering at the meeting are asked to bring 20 copies of their statement or talking points.

In lieu of making an oral presentation at the meeting, the public is invited to submit a written statement to CERHR by February 3, 2003. This statement will be distributed to CERHR staff and the expert panel, noted in the meeting record, and posted on the CERHR website.

Ethylene Glycol and Propylene Expert Panel

The CERHR will convene an expert panel of independent scientists whose members were selected for their scientific expertise in reproductive and/or developmental toxicology and other areas of science relevant for this review.

Expert Panel Members and Affiliation

Elaine Faustman, PhD, DABT Chair)—University of Washington, Seattle, WA

Cynthia F. Bearer, MD, PhD—Rainbow Babies & Children's Hospital, Cleveland, OH

John M. DeSesso, PhD—Mitretek Systems, Falls Church, VA

Bruce A. Fowler, PhD— Agency for Toxic Substances Diseases Registry, Atlanta, GA

Gary L. Ginsberg, PhD—Connecticut Department of Public Health, Hartford, CT

Deborah K. Hansen, PhD—National Center for Toxicological Research, Jefferson, AR

Cynthia J. Hines, MS—National Institute for Occupational Safety and Health, Cincinnati, OH

Ronald N. Hines, PhD—Medical College of Wisconsin, Milwaukee, WI

Ken Portier, PhD—University of Florida, Gainesville, FL

Karl K. Rozman, PhD—University of Kansas Medical Center, Kansas City, KS

John A. Thomas, PhD—University of Texas, San Antonio, TX

Background Information About the CERHR

The NTP established the NTP CERHR in June 1998 (63 FR 68782, December 14, 1998). 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 (contact information provided above). The CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and published evidence of reproductive or developmental toxicity.

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 37047-48) and is available on the CERHR website under “About CERHR” or in printed copy from the CERHR.

Dated: November 18, 2002.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.