[Federal Register Volume 68, Number 94 (Thursday, May 15, 2003)]
[Notices]
[Pages 26325-26326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


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 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

[[Page 26326]]

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: 
[email protected]].

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,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 03-12101 Filed 5-14-03; 8:45 am]
BILLING CODE 4140-01-P