[Federal Register: May 15, 2003, Volume 68, Number 94]
[Notices]
[Pages 26325-26326]

The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) Expert Panel Report on the Developmental and Reproductive Toxicity of Ethylene Glycol and the CERHR Expert Panel Report on the Developmental and Reproductive Toxicity of Propylene Glycol: Notice of Availability and Request for Public Comments

Summary

Notice is hereby given of the availability of the Expert Panel Report on the Developmental and Reproductive Toxicity of Ethylene Glycol and the Expert Panel Report on the Developmental and Reproductive Toxicity of Propylene Glycol. These reports include 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 ethylene glycol and to propylene glycol. The CERHR held this expert panel meeting in February 2003. CERHR is seeking public comment on these reports and additional information about recent, relevant toxicology or human exposure studies.

Availability of Reports

These expert panel reports are available electronically on the CERHR web site (http://cerhr.niehs.nih.gov) and in printed copy by contacting the CERHR [P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709; telephone: (919) 541-3455; fax: (919) 316-4511; or email: shelby@niehs.nih.gov].

Request for Public Comments

The CERHR invites public comments on these expert panel reports 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 July 14, 2003.

All public comments received by the date above will be reviewed and included in the final NTP-CERHR monograph on ethylene glycol or propylene glycol 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 ethylene glycol or propylene glycol. The NTP will transmit the NTP-CERHR monograph to the appropriate federal and state agencies, the public, and the scientific community.

Background

A 9-member expert panel composed of scientists from state and federal governments, universities, and private companies conducted an evaluation of the reproductive and developmental toxicities of ethylene glycol and propylene glycol [Federal Register Vol. 67 No. 236, pp. 72965-72967, December 9, 2002]. Public deliberations by the panel took place February 11-13, 2003 at the Holiday Inn Old Town Select in Alexandria, Virginia. Following the February meeting, the draft expert panel report for each chemical was revised to incorporate the panel's conclusions and subsequently reviewed by the Ethylene Glycol and Propylene Glycol Expert Panel, NTP scientists, and CERHR personnel.

Ethylene glycol is a high production volume chemical used as a chemical intermediate in the production of polyester compounds. There is widespread public exposure to ethylene glycol due to its use in heating and cooling systems (e.g., automotive antifreeze and as a de-icer for aircraft). Propylene glycol is used commercially as an intermediate in the manufacture of unsaturated polyester resins and in the production of plasticizers. Similar in structure to ethylene glycol, public exposure is through its FDA-approved use in food, tobacco, pharmaceutical products, and cosmetics, its use in various paints and coatings, and as an antifreeze and de-icing solution.

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 also serves as a resource for information on various environmental exposures and their potential to affect pregnancy and child development. The web site has information about common concerns related to fertility, pregnancy and the health of unborn children and links to other resources for information about public health.

Dated: May 7, 2003

Samuel H. Wilson, M.D.
Deputy Director, National Institute of Environmental Heatlh Sciences

[Billing Code 4140-01-P]