[Federal Register Volume 66, Number 136 (Monday, July 16, 2001)]
[Notices]
[Pages 37047-37048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17749]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


Draft Methanol Expert Panel Report and Meeting

    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 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 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 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 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; [email protected]).

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 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, 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:

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 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 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

[[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 
EC-32, Research Triangle Park, NC 27709, Phone: (919) 541-3455; Fax 
(919) 316-4511; [email protected]]. 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; [email protected].]

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

     Chemical Nominations.

Open nomination process includes interested individuals, NTP 
ExecutiveCommittee, Federal Agencies, NTP Staff, Labor Unions, Industry

     CERHR Multi-agency Core Committee.

--Nominations reviewed quarterly by Core Committee made up of NTP 
agency representatives
--Highest priority chemicals identified based on production volume, 
evidence of reproductive or developmental toxicity, human exposure, 
public concern
--Center staff prepares dossiers on priority chemicals for review by 
Core Committee
--Core Committee recommends candidate chemicals to be considered for 
evaluation
--Candidate chemicals approved by Associate Director, NTP

     First Solicitation of Public Comment.

--Notice of candidate chemicals and request for public comment 
published in Federal Register, NTP Newsletter and listserver, and CERHR 
web site
--Center staff compiles public comments for review by the Core 
Committee

     CERHR Core Committee Review.

--Reviews dossiers and material submitted in public comments
--Recommends list of prioritized chemicals to Associate Director, NTP, 
for final selection

     Second Solicitation of Public Comment.

--Federal Register notice announces selected chemical(s) and solicits 
public comment, new data, information on exposure, and nominations of 
individuals qualified to serve on the Expert Panel

     Third Solicitation of Public Comment.

--Federal Register notice announces availability of sections 1-4 of the 
Draft Expert Panel Report, requests public comments, and announces the 
Expert Panel Meeting

     Expert Panel Meeting.

--The Panel meets in public session to discuss their review of the 
literature and to prepare the final panel report
--The meeting includes time for presentation of public comments

     Final Solicitation of Public Comment.

--Federal Register notice announces availability of Expert Panel Report 
and requests public comment

     NTP Center Report Transmitted.

--NTP staff prepares an NTP Center Report on the chemical(s). This 
report integrates background information on the chemical evaluated, the 
findings in the Expert Panel Report, a discussion of any recent 
relevant study findings, public comments, and an executive summary that 
includes conclusions intended for a readership of non-scientists
--The Center Report is distributed to Federal and state agencies, 
interested stakeholders, and the public

    Dated: July 2, 2001.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 01-17749 Filed 7-13-01; 8:45 am]
BILLING CODE 4140-01-P