National Toxicology Program

[Federal Register: March 5, 2002 (Vol. 67, No. 43)]
[Notices]
[Pages 9980 - 9981]

The NTP Center for the Evaluation of Risks to Human Reproduction (CERHR) 1. Announces a Future Evaluation of Ethylene Glycol (CASRN: 107-21-1) and Propylene Glycol (CASRN: 57-55-6), 2. Requests Public Input on These Chemicals, and 3. Solicits the Nomination of Individuals Qualified to Serve on an Expert Panel.

Evaluation of Ethylene Glycol and Propylene Glycol

The CERHR plans to hold an expert panel evaluation of ethylene glycol (CASRN:107-21-1) and propylene glycol (CASRN: 57-55-6). The exact date for this expert panel meeting is not yet set, but is tentatively planned for the fall of 2002. Additional details about the meeting, including the date and location, will be published in a future Federal Register notice.

The CERHR will convene an expert panel to evaluate the reproductive and developmental toxicity of ethylene glycol and propylene glycol. The expert panel will consist of approximately 12 scientists, selected for their scientific expertise in various aspects of reproductive and developmental toxicology and other relevant areas of science. The expert panel meeting will be open to the public with time scheduled for oral public comment.

Ethylene glycol is a high production volume chemical used chiefly in antifreeze for heating and cooling systems. There is widespread exposure to ethylene glycol due to its use as an automotive antifreeze and as a de-icer for aircraft. The toxicology database on ethylene glycol includes recent mechanistic data and occupational exposure information. Propylene gylcol, similar in structure to ethylene glycol, is used as an antifreeze, de-icing solution, and in various paints and coatings. Unlike ethylene glycol, propylene glycol is approved for use in various food additives, drugs, and cosmetics.

Request for Public Input

The CERHR invites input from the public and other interested parties on ethylene glycol and propylene glycol including toxicology information from completed and ongoing studies, information on planned studies, as well as information about current production levels, human exposure, use patterns, and environmental occurrence. Information and comments should be forwarded to the CERHR at P.O. Box 12233, MD EC-32, Research Triangle Park, NC 27709 (mail), (919) 541-3455 (phone), (919) 316-4511 (fax), or shelby@niehs.nih.gov (email). Information and comments received by May 6, 2002 will be made available to the CERHR staff and the expert panel for consideration in the evaluation.

The CERHR also invites nominations of qualified scientists to serve on the expert panel for the ethylene glycol / propylene glycol evaluation. Panelists are primarily drawn from the CERHR Expert Registry and / or the nomination of other scientists who meet the criteria for listing in that registry. Criteria for listing in the CERHR Expert Registry include: formal academic training and experience in a relevant scientific field, publications in peer-reviewed journals, membership in relevant professional societies, certification by an appropriate scientific Board or other entities, and participation in similar committee activities. All panel members serve as individual experts in their specific areas of expertise, not as representatives of their employer or other organization. Scientists on the expert panel will represent a wide range of expertise including developmental toxicology, reproductive toxicology, epidemiology, general toxicology, pharmacokinetics, exposure assessment, and biostatistics. Nominations received by May 6, 2002 will be considered for the Ethylene Glycol / Propylene Glycol Expert Panel and inclusion in the CERHR Expert Registry. Nominations should be forwarded to the CERHR at the address given above.

Additional Information about CERHR

The NTP and the NIEHS established the CERHR in June 1998 [Federal Register (Vol. 63, No. 239, p. 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. The CERHR also serves as a resource for information on various environmental exposures and their potential to affect pregnancy and child development. Its website (http://cerhr.niehs.nih.gov) 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.

The CERHR follows a formal, open process for the selection and review of chemicals nominated for evaluation of potential reproductive and / or developmental hazards. This process includes an evaluation of the chemical(s) by an external scientific panel that follows specific guidelines in conducting its assessment and provides multiple opportunities for public input. As a final step in the process, the CERHR publishes a NTP-CERHR report on each chemical that includes the expert panel report, public comments, and an NTP brief. A summary of the review process was recently published in the Federal Register (Vol. 66, No. 136, pp. 37047-37048, July 16, 2001). The process and guidelines are posted on the CERHR website and are available in hard copy by contacting the CERHR (address provided above). The CERHR welcomes the nomination of chemicals to be considered for future evaluation or qualified scientists for its expert registry. These nominations can be made through the CERHR website or by contacting the CERHR directly (see address above).

Dated: February 8, 2002

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