[Federal Register Volume 65, Number 196 (Tuesday, October 10, 2000)]
[Page 60206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25892]



Public Health Service

National Toxicology Program; National Institute of Environmental 
Health Sciences; Center for the Evaluation of Risks to Human 
Reproduction Announces the Availability of Seven Expert Panel Reports 
on Phthalate Esters and Solicits Public Comments on These Reports


    The National Toxicology Program (NTP) and the National Institute of 
Environmental Health Sciences have established the NTP Center for the 
Evaluation of Risks to Human Reproduction (CERHR; December 14, 1998 [63 
FR 68782]). The purpose of the Center is to provide timely and 
unbiased, scientifically sound evaluations of human and experimental 
evidence for adverse effects on reproduction, including development, 
caused by agents to which humans may be exposed. The goals of the 
individual assessments are to (1) interpret for and provide to the 
general public information about the strength of scientific evidence 
that a given exposure or exposure circumstance may pose a hazard to 
reproduction and the health and welfare of children: (2) provide 
regulatory agencies with objective and scientifically thorough 
assessments of the scientific evidence that adverse reproductive/
development health effects are associated with exposure to specific 
chemicals or classes of chemicals, including descriptions of any 
uncertainties that would diminish confidence in assessment of risks, 
and (3) identify knowledge gaps to help establish research and testing 

Phthalate Esters Reviewed

    This evaluation of seven phthalate esters was conducted over a one 
year period by a 16-member Expert Panel made up of scientists from 
government, universities, and industry (May 23, 2000 [65 FR 33343-
33345]). Public deliberations by the Panel were completed in July, 
2000. Since that time, the draft reports have been revised to 
incorporate the conclusions reached by the Panel in their July, 2000, 
meeting and have been reviewed for accuracy by the CERHR Core 
Committee, made up of representatives of NTP-participating agencies, 
NTP scientists, and members of the Phthalates Expert Panel. Phthalate 
esters are used as plasticizers in a wide range of polyvinyl chloride-
based consumer products. These phthalate esters were selected for the 
initial evaluation by the CERHR based on their high production volume, 
extent of human exposures, use in children's products, published 
evidence of reproductive or developmental toxicity, and public concern.
    The following phthalate esters were reviewed by CERHR (Chemical 
Abstract Service Registry Number):

butyl benzyl phthalate (85-68-7)
di(2-ethylhexyl) phthalate (117-81-7)
di-isodecyl phthalate (26761-40-0, 68515-49-1)
di-isononyl phthalate (28553-12-0, 68515-48-0)
di-n-butyl phthalate (84-74-2)
di-n-hexyl phthalate (84-75-3)
di-n-octyl phthalate (117-84-0)

Availability of Phthalate Reports

    Expert Panel reports on the above phthalate esters can be obtained 
from the CERHR website http://cerhr.niehs.nih.gov). Hard copies can be 
obtained by contacting: Ms. Harriet McCullom, Management Coordinator, 
CERHR, 1800 Diagonal Road, Suite 500, Alexandria, VA 22314-2808, 
Telephone: 703-838-9440, Facsimile: 703-684-2223.

Request for Public Comment on the Expert Panel Reports

    The Center invites public comment on the Expert Panel Reports 
listed above, including any recent relevant toxicology data and human 
exposure information. These reports are the product of the Expert Panel 
review of data available as of July 1, 2000. Public comments received 
on the Expert Panel Reports will be reviewed, summarized, and included 
in the NTP Center transmittal report prepared by the NTP staff. NTP 
will transmit the NTP Center report, the Expert Panel Report, the 
public comments received on the expert panel report, and any new 
information since completion of the expert panel report to the 
appropriate Federal and State Agencies, the public, and the scientific 
community. Further information on the Center's chemical review process 
can be obtained from the CERHR website (http://cerhr.niehs.nih.gov).
    Written comments received by December 11, 2000 will be considered. 
Please forward comments and chemical information to: Michael D. Shelby, 
Ph.D.; Director, CERHR, NIEHS/NTP B3-09; P.O. Box 12233; Research 
Triangle Park, NC 27709-2233; Telephone: 919-541-3455; Facsimile: 919-

    Dated: October 2, 2000.
Samuel H. Wilson,
Deputy Director, NIEHS.
[FR Doc. 00-25892 Filed 10-6-00; 8:45 am]