DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

National Toxicology Program (NTP), National Institute of Environmental Health Sciences (NIEHS), Center for the Evaluation of Risks to Human Reproduction (CERHR), announces:

(1) Availability of the Draft Methanol Expert Panel Report - Public comments are solicited on the draft report and the deadline for written comments is September 7, 2001.

(2) Methanol Expert Panel Meeting scheduled for October 15-17, 2001 - The meeting is open to the public and will be held at the Radisson Hotel Old Town Alexandria in Alexandria, Virginia.

BACKGROUND

The NTP and the NIEHS established the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) [Federal Register (FR), December 14, 1998 (Volume 63, Number 239, page 68782)] in June 1998. The purpose of the Center is to provide scientifically-based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposed. Expert panels conduct scientific evaluations of agents selected by the Center in public forums. The agent currently under evaluation is methanol. Additional details about CERHR and the formal review process are provided below (see Additional Information about CERHR).

Methanol (CASRN: 67-56-1) is a commercially important, high production volume chemical (10.54 billion pounds, US production, 1993), with high potential for occupational, consumer, and environmental exposure. Methanol is used in chemical syntheses and as an industrial solvent. It is found in a variety of consumer products such as paints, antifreeze, cleaning solutions, and adhesives and is a by-product of sewage treatment, fermentation, and paper production. Methanol is used in racing car fuels, and there is the potential for the expanded use of methanol as a vehicle fuel or fuel additive. There is a large toxicity database on reproductive and developmental effects of methanol, including a recently completed study in primates.

DRAFT METHANOL EXPERT PANEL REPORT AVAILABLE

The Draft Methanol Expert Panel Report is composed of 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

Sections 1-4 will be available to the public by July 9. Copies can be obtained electronically on the CERHR web site (http://cerhr.niehs.nih.gov) or in hard copy by contacting Dr. Michael Shelby, CERHR Director (NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, Phone: (919) 541-3455; Fax: (919)316-4511; shelby@niehs.nih.gov).

Request for Written Comments on Draft Methanol Expert Panel Report

The CERHR invites written public comments on Sections 1-4 of the Draft Methanol Expert Panel Report. Comments can be submitted in hard copy or electronic format and must be received by the Center by September 7, 2001. These comments will be distributed to CERHR staff and the Methanol Expert Panel for consideration in revising the draft report and in preparing for the Methanol Expert Panel Meeting (see below). 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, phone, fax, e-mail, and sponsoring organization, if any).

EXPERT PANEL WILL REVIEW METHANOL

An expert panel (the Panel) of 13 independent scientists selected for their scientific expertise in reproductive and developmental toxicology and other relevant areas of science are conducting this review. The roster of experts follows:

PUBLIC MEETING OF THE METHANOL EXPERT PANEL

This meeting is open to the public and attendance is limited only by the availability of space. The meeting will take place from October 15-17, 2001 in the Washington Ballroom of the Radisson Hotel Old Town Alexandria, 901 N. Fairfax Street, Alexandria, Virginia, telephone (703) 683-6000, fax (703) 683-7597.

Preliminary Meeting Agenda

The meeting begins each day at 8:30 a.m. It is anticipated that a lunch break will occur from 12-1 p.m. daily and that adjournment will be between 5 and 6 p.m. each day.

October 15, 2001 (8:30 a.m.)

Opening comments

Public comment session

• The Panel will receive comments from the public (up to seven minutes per speaker; details are given below).

Review of Sections 1-4 of the Draft Methanol Expert Panel Report

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

October 16, 2001 (8:30 a.m.)

Discussion of Section 5.0 Summary, Conclusions, and Critical Data Needs

Preparation of draft summaries and conclusion statements

October 17, 2001 (8:30 a.m.)

Presentation and discussion of and agreement on summaries and conclusions

Closing comments

Oral Comments Can Be Presented at the Expert Panel Meeting

Time is set aside on October 15 for presentation of oral public comments at the Methanol Expert Panel Meeting. To facilitate planning of this meeting, those persons wishing to make oral public comments are asked to contact the CERHR Director by October 10 [Dr. Michael Shelby, NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, Phone: (919) 541-3455; Fax (919) 316-4511; shelby@niehs.nih.gov ]. Seven minutes will be available for each speaker (one speaker per organization). When registering to comment orally, please provide your name, affiliation, mailing address, phone, fax, e-mail and sponsoring organization (if any). If possible, also send a copy of the statement or talking points to CERHR by October 10. This information will be provided to the Expert Panel and will assist the Panel in identifying issues for discussion. Registration for presentation of oral comments will also be available at the meeting on October 15 (7:30 - 8:30 a.m.). Those 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 October 10. This statement will be distributed to CERHR staff and the Methanol Expert Panel and noted in the meeting record.

Post-Meeting Public Comments

Following the Methanol Expert Panel Meeting and completion of the Expert Panel Report, public comment will be solicited. This solicitation will be announced in a future Federal Register notice.

For other questions about the Draft Methanol Report or the Methanol Expert Panel Meeting, contact Dr. Michael Shelby [CERHR, NIEHS, 79 T.W. Alexander Drive, Building 4401, Room 103, P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709, Phone: (919) 541-3455; Fax (919) 316-4511; shelby@niehs.nih.gov].