01-26621. National Toxicology Program; Availability of Expert Panel Reports 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 Expert Panel Reports on 1-Bromopropane and 2-Bromopropane—Public comments are solicited on these draft reports and the deadline for written comments is November 23, 2001.

(2) Bromopropane Expert Panel Meeting scheduled for December 5-7, 2001—The meeting is open to the public and will be held at the Hilton Washington-Dulles Airport Hotel, Herndon, VA.

Background

The NTP and the NIEHS established the NTP CERHR [Federal Register, 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. Additional details about CERHR are provided below (see Additional Information about CERHR evaluations).

The agents currently under evaluation are 1-bromopropane (CASRN: 106-94-5) and 2-bromopropane (CASRN: 75-26-3). 1-Bromopropane is used as a cleaning solvent; as a solvent vehicle in spray adhesives; as a solvent for fats, waxes, or resins; and as an intermediate in the synthesis of other compounds. 2-Bromopropane is used in the synthesis of pharmaceuticals, dyes, and other compounds and is present as a contaminant in 1-bromopropane. Bromopropanes are being considered as replacement chemicals for ozone-depleting chemicals such as hydrochlorofluorocarbons and chlorinated solvents. The scientific database on these chemicals includes studies on neurotoxicity, reproductive toxicity, and occupational exposures. 2-Bromopropane is reported to be a reproductive toxicant in humans.

Draft Expert Panel Reports on 1-Bromopropane and 2-Bromopropane Available

The 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 October 10, 2001. Copies 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, Phone: [phone]; Fax: [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 1-bromopropane and 2-bromopropane. Comments can be submitted in hard copy or electronic format and must be received by the Center by November 23, 2001. These comments will be distributed to CERHR staff and the Bromopropane Expert Panel for consideration in revising the draft report and in preparing for the Bromopropane 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 1-Bromopropane and 2-Bromopropane

An expert panel (the Panel) of 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:

Bromopropane Expert Panel (Name and Affiliation)

Kim Boekelheide, MD, PhD [Chair] Brown University, Providence, RI

Cynthia F. Bearer, MD, PhD Case Western Reserve, Cleveland, OH

Sally Perreault Darney, PhD U.S. EPA, Research Triangle Park, NC

George P. Daston, PhD Procter & Gamble Co., Cincinnati, OH

Raymond M. David, PhD Eastman Kodak Company, Rochester, NY

Ulrike Luderer, MD, PhD University of California-Irvine, Irvine, CA

Andrew F. Olshan, PhD University of North Carolina, Chapel Hill, NC

Wayne T. Sanderson, PhD, CIH NIOSH, Cincinnati, OH

Calvin C. Willhite, PhD DTSC, State of California, Berkeley, CA

Susan Woskie, PhD University of Massachusetts-Lowell, Lowell, MA

Public Meeting of the Bromopropane Expert Panel

This meeting is open to the public and attendance is limited only by the availability of space. The meeting will take place on December 5-7, 2001, in the Solarium of the Hilton Washington-Dulles Airport Hotel, 13869 Park Center Road, Herndon, VA 20171, Phone [phone], Fax [phone].

Preliminary Meeting Agenda

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

December 5, 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 Expert Panel Report on 1-Bromopropane and 2-Bromopropane

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

December 6, 2001 (8:30 a.m.)

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

Preparation of draft summaries and conclusion statements

December 7, 2001 (8:30 a.m.)

Presentation, discussion of, and agreement on summaries and conclusions

Closing comments

Oral Public Comments Can Be Presented at the Expert Panel Meeting

Time is set aside on December 5 for the presentation of oral public comments at the Bromopropane 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 November 26 [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: [phone]; Fax [phone]; [e-mail]]. 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 November 26. This information will be provided to the expert panel, to assist the panel 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 December 5 (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 November 26. This statement will be distributed to CERHR staff and the Bromopropane Expert Panel and noted in the meeting record.

Post-Meeting Public Comments

Following the Bromopropane 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 Report on 1-Bromopropane and 2-Bromopropane or the Bromopropane Expert Panel Meeting, contact the CERHR Director [contact information provided above].

Additional Information About CERHR Evaluations

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 (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.

CERHR follows a formal, multi-step process for review and evaluation of selected chemicals. The formal evaluation process is outlined in the Federal Register notice July 16, 2001 (Volume 66, Number 136, pages 37047-37048) and on the CERHR web site under “About CERHR”. Briefly, the Center establishes an expert panel to review and evaluate the scientific evidence on the selected chemical(s), to receive public comments, and to prepare a report on the chemical(s). This draft expert panel report is made publicly available for comment, both through 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, health, and research agencies.

Dated: October 3, 2001.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.