04-13889. National Toxicology Program (NTP); National Institute of Environmental Health Sciences; The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) Expert Panel Report on the Developmental and Reproductive Toxicity of ...

Summary: Notice is hereby given of the availability on June 30, 2004, of the Expert Panel Report on the Developmental and Reproductive Toxicity of Acrylamide. This report includes the summaries and conclusions of the expert panel's evaluation of the scientific data for potential reproductive and/or developmental hazards associated with exposure to acrylamide. The CERHR held this expert panel meeting May 17-19, 2004. CERHR is seeking public comment on this report and additional information about recent, relevant toxicology or human exposure studies. The CERHR requests that all comments and other information be submitted to the CERHR at the address below by August 16, 2004.

Availability of Reports

This expert panel report will be available by June 30, 2004, on the CERHR Web site (http://cerhr.niehs.nih.gov) and in printed copy or compact disc by contacting the CERHR [P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709; telephone: [phone]; fax: [phone]; or e-mail: [e-mail]].

Request for Public Comments

The CERHR invites public comments on this expert panel report and input regarding any recent, relevant toxicology or human exposure studies. The CERHR requests that all comments and other information be submitted to the CERHR at the address above by August 16, 2004.

All public comments received by the date above will be reviewed and included in the final NTP-CERHR monograph on acrylamide to be prepared by NTP staff. The NTP-CERHR monograph will include the NTP brief, expert panel report, and all public comments received on the report. The brief will provide the NTP's interpretation of the potential for adverse reproductive and/or developmental effects to humans from exposure to acrylamide. The NTP-CERHR monograph will be sent to appropriate federal agencies and will be available to the public and the scientific community on the CERHR Web site, in hardcopy, or on compact disc.

Background

Acrylamide is used in the production of polyacrylamide, which is used in water treatment, pulp and paper production, mineral processing, and scientific research. Polyacrylamide is used in the synthesis of dyes, adhesives, contact lenses, soil conditioners, cosmetics and skin creams, food packaging materials, and permanent press fabrics. Acrylamide has been shown to induce neurotoxicity in highly exposed workers and in cases of acute poisoning. In animal studies, exposure to acrylamide has been shown to cause cancer and adverse effects on reproduction and fetal development. The CERHR selected acrylamide for expert panel evaluation because of (1) recent public concern for human exposures through its presence in some starchy foods cooked at high temperatures (e.g., French fries and potato chips) and (2) availability of data on human exposure, bioavailability, and reproductive toxicity.

A 14-member expert panel composed of scientists from the federal government, universities, and private companies conducted an evaluation of the reproductive and developmental toxicities of acrylamide [Federal Register Vol. 69, No. 34, pages 7977-7978, February 2004]. The panel did not evaluate potential cancer hazards associated with exposure to acrylamide. Public deliberations by the panel took place May 17-19, 2004, at the Holiday Inn Old Town Select in Alexandria, Virginia. Following the May meeting, the draft expert panel report was revised to incorporate the panel's conclusions and subsequently reviewed by Acrylamide Expert Panel, NTP scientists, and CERHR personnel.

Additional Information About CERHR

The NTP and the NIEHS established the NTP CERHR in June 1998 [Federal Register Vol. 63, No. 239, page 68782, December 1998]. The purpose of the CERHR 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. Further information on the CERHR's chemical review process, including how to nominate chemicals for evaluation and scientists for the expert registry, can be obtained from its Web site (http://cerhr.niehs.nih.gov) or by contacting the CERHR directly (see address above). The CERHR Web site also has information on various environmental exposures and their potential to affect fertility, pregnancy, and child development and links to other resources for public health information.

Dated: June 10, 2004.

Samuel H. Wilson,

Deputy Director, National Institute of Environmental Health Sciences.