01-10206. National Toxicology Program (NTP); National Institute of Environmental Health Sciences; Center for the Evaluation of Risks to Human Reproduction (CERHR) Solicits Public Comments on Draft Guidelines for CERHR Expert Panel Members

Background

The NTP and the National Institute of Environmental Health Sciences established the NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) in 1998 to serve as an environmental health resource to the public and regulatory and health agencies. The CERHR provides scientifically based, uniform assessments of the potential for adverse effects on reproduction and development caused by agents to which humans may be exposed. The assessments are carried out through rigorous, independent evaluations of the scientific literature on these agents by panels of scientists. The products of these evaluations are Expert Panel Reports.

The Expert Panel Report provides a consensus scientific judgement of the potential human reproductive and developmental toxicity of the chemical agent or mixture. The goals of the evaluations are to:

(1) Evaluate the quality of the available scientific data and identify critical data needs so that research and testing priorities can be established;

(2) Interpret scientific studies for and provide information to the general public about the strength of evidence that a given exposure poses a hazard to reproduction and/or to the health and welfare of the developing child; and

(3) Provide regulatory agencies with objective and scientifically credible evaluations of reproductive/developmental health effects associated with exposure to specific chemicals or classes of chemicals, including descriptions of any uncertainties associated with the assessment of risks.

Availability of Draft Guidelines for CERHR Expert Panel Members

In order to maintain consistency among the expert panel reviews and to provide guidance about these reviews and preparation of Expert Panel Reports, the CERHR has prepared draft guidelines for the expert panels and CERHR staff. The Guidelines cover the three phases of the Expert Panel review process: pre-meeting preparation, Expert Panel Meeting, and completion of the Panel Report.

A copy of the Draft Guidelines for CERHR Expert Panel Members can be obtained electronically from the CERHR web site (http://cerhr.niehs.nih.gov). Hard copies can be obtained by contacting: Ms. Irma Velazquez, Special Assistant, CERHR, 111 T.W. Alexander Drive, PO Box 12233, MD EC-32, Research Triangle Park, NC 27709-2233; Telephone: [phone], Facsimile: 919-316-4511; E-mail: [e-mail].

Request for Public Comment on Draft Guidelines

Written Comments

CERHR invites written public comment on the Draft Guidelines through June 11, 2001. All comments should refer to the specific section of the guidelines being addressed. Persons submitting written comments should include the following information: name, address, affiliation, telephone, fax, e-mail, and sponsoring organization (if any). All comments received will be reviewed by NTP and CERHR staff and considered in making any revisions to the Draft Guidelines. Comments on the Draft Guidelines should be directed to: Michael D. Shelby, Director, CERHR, 111 T.W. Alexander Drive, PO Box 12233, MD EC-32, Research Triangle Park, NC 27709-2233; Telephone: [phone], Facsimile: 919-316-4511; E-mail: [e-mail].

Oral Comments

A May 25, 2001 meeting of the NTP Board of Scientific Counselors provides an additional opportunity for public comment on the Draft Guidelines. The NTP Board provides external scientific oversight to CERHR, and an item on the May 25 agenda is presentation and discussion of the Draft Guidelines. This meeting will be held at the National Institute of Environmental Health Sciences (111 T.W. Alexander Drive, Research Triangle Park, NC 27709). For planning purposes, persons wishing to make oral comments are asked to contact the NTP Executive Secretary by May 16; registration will however be accepted at the meeting as well. It is important to contact the Executive Secretary to register, obtain additional details about the meeting, including a draft agenda, and information for members of the public wishing to speak. This information can also be found on the NTP web site (http://ntp-server.niehs.nih.gov). Dr. Mary Wolfe, NTP Board Executive Secretary, 111 T.W. Alexander Drive, PO Box 12233, MD A3-07, Research Triangle Park, NC 27709-2233; Telephone: [phone], Facsimile: 919-541-0295; E-mail: [e-mail].

Additional Information About CERHR

Information about CERHR including its chemical nomination and review process, Expert Panel Registry, the recently completed Expert Panel Review on Phthalates, and upcoming reviews can be obtained from the CERHR web site (http://cerhr.niehs.nih.gov). The CERHR maintains an expert registry of scientists qualified to participate in its Expert Panel Reviews. If you are interested in being included in the registry, send a description of expertise and curriculum vitae to Dr. Shelby at the address above.

Dated: April 12, 2001.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Services.