Public Health

[Federal Register: October 10, 2000 (Volume 65, Number 196)]
[Page 60206]

Federal Register Notices



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 priorities.


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 ( Hard copies can be obtained by contacting:

Ms. Harriet McCollum
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 (

Written comments received by December 11, 2000 will be considered.  Please forward comments and chemical information to:

Michael D. Shelby, Ph.D.
Director, CERHR
P.O. Box 12233
Research Triangle Park, NC
Telephone 919-541-3455
Facsimile 919-541-4634

Dated: October 10, 2000

Samuel H. Wilson, M.D.
Deputy Director, NIEHS

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