Oral Comments Can Be Presented at the Expert Panel Meeting

Time is set aside on October 15 for presentation of oral public comments at
[[Page 37048]]
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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 3164511; 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, email 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 (7:308:30 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.

PostMeeting 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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 316 4511; shelby@niehs.nih.gov.] Additional Information About CERHR

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 the Center Director, Dr. Shelby (contact information provided above). The Center 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. The Center establishes an expert panel to review the scientific evidence on the chemical(s) under review, to receive public comments, and to prepare a report on the chemical(s). This draft Expert Panel Report is made publicly available for comment on the CERHR web site and upon request from CERHR, and an Expert Panel Meeting is held to discuss and evaluate the draft report. Following the Expert Panel Meeting and completion of the Expert Panel Report, public comment is solicited again.

After this public comment period ends, the NTP staff prepares a NTP Center Report on the evaluated chemical(s) that integrates background information on the chemical(s), findings of the expert panel, and a discussion of any additional, recent studies. The NTP Center Report includes all public comments received on the Expert Panel Report. The final NTP Center Report is made publicly available and distributed to interested stakeholders and to appropriate regulatory and research agencies. The formal evaluation process is outlined below.
CERHR Review Process

Dated: July 2, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0117749 Filed 71301; 8:45 am] BILLING CODE 414001P

SUMMARY:

Center for Evaluation of Risks to Human Reproduction—; Methanol Expert Panel report; comment request; and meeting,

DOCUMENT BODY 2:

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 ReportPublic 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 1517, 2001The meeting is open to the public and will be held at the Radisson Hotel in 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 scientificallybased, 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: 67561) 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 byproduct 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 Draft 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 14 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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax: (919)3164511; shelby@niehs.nih.gov). Request for Written Comments on Draft Methanol Expert Panel Report

The CERHR invites written public comments on Sections 14 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 reviewing 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, email, 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:
Methanol Expert Panel (Name and Affiliation)
Eula Bingham, Ph.D. (Chair), University of Cincinnati, Cincinnati, Ohio Stanley Barone, Ph.D. US EPA, Research Triangle Park, NC
David Bellinger, Ph.D., Children's Hospital, Boston, MA
Gary Burin, Ph.D., Technology Sciences Group, Washington, DC Robert Chapin, Ph.D., DuPont Pharmaceuticals, Newark, DE
J. Michael Davis, Ph.D., US EPA, Research Triangle Park, NC David Dorman, DVM, Ph.D., CIIT Centers for Health Research, Research Triangle Park, NC
John R. Glowa, Ph.D., LSU Medical Center, Shreveport, LA
Deborah K. Hansen, Ph.D., National Center for Toxicological Research, Jefferson, AR
H.B. (Skip) Matthews, Ph.D., Consultant, Durham, NC
Mark Miller, M.D., MPH Cal EPA, Oakland, CA
Kathleen M. Nauss, Ph.D., Consultant, Sudbury, MA
John M. Rogers, Ph.D., US EPA, Research Triangle Park, NC

Public Meeting of the Methanol Expert Panel

This meeting is open to the public and attendance is limited only by the availability of space. Theis meeting will take place from October 1517, 2001 in the Washington Ballroom of the Radisson Hotel Old Town Alexandria, 901 N. Fairfax Street, Alexandria, Virginia, telephone (703) 6836000, fax (703) 6837597.

Preliminary Meeting Agenda

The meeting begins each day at 8:30 a.m. It is anticipated that a lunch break will occur from 121 p.m. daily and that adjournment will be between 5 and 6 p.m. each day.
October 15, 2001 (8:30 a.m.)
Opening commentsPublic Comment comment session

Oral Comments Can Be Presented at the Expert Panel Meeting

Time is set aside on October 15 for presentation of oral public comments at
[[Page 37048]]
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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 3164511; 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, email 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 (7:308:30 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.

PostMeeting 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 EC32, Research Triangle Park, NC 27709, Phone: (919) 5413455; Fax (919) 316 4511; shelby@niehs.nih.gov.] Additional Information About CERHR

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 the Center Director, Dr. Shelby (contact information provided above). The Center 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. The Center establishes an expert panel to review the scientific evidence on the chemical(s) under review, to receive public comments, and to prepare a report on the chemical(s). This draft Expert Panel Report is made publicly available for comment on the CERHR web site and upon request from CERHR, and an Expert Panel Meeting is held to discuss and evaluate the draft report. Following the Expert Panel Meeting and completion of the Expert Panel Report, public comment is solicited again.

After this public comment period ends, the NTP staff prepares a NTP Center Report on the evaluated chemical(s) that integrates background information on the chemical(s), findings of the expert panel, and a discussion of any additional, recent studies. The NTP Center Report includes all public comments received on the Expert Panel Report. The final NTP Center Report is made publicly available and distributed to interested stakeholders and to appropriate regulatory and research agencies. The formal evaluation process is outlined below.
CERHR Review Process

Dated: July 2, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences. [FR Doc. 0117749 Filed 71301; 8:45 am] BILLING CODE 414001P