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  Federal Register Notice 3/20/00


[Federal Register: March 20, 2000 (Volume 65, Number 54)]
[Notices]
[Pages 14497-14498]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

National Toxicology Program; National Institute of Environmental Health Sciences; Center for the Evaluation of Risks to Human Reproduction solicits comments on eleven chemicals being considered for further evaluation by the Center; solicits nominations of other chemicals for future consideration; and describes the Center’s evaluation process.

Background

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 (63 FR 68782, No 239). 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 poses a hazard to reproduction and the health and welfare of children: (2) provide regulatory agencies with objective and scientifically credible assessments of reproductive/development health effects associated with exposure to specific chemicals or classes of chemicals, including descriptions of any uncertainties associated with the assessment of risks, and (3) identify knowledge gaps to help establish research and testing priorities.

Chemicals Recommended for Further Consideration

The CERHR Core Committee, made up of representatives of NTP-participating agencies, reviewed chemical nominations for further study and recommended the following eleven chemicals for further consideration. Dossiers will be prepared on these chemicals reviewing information on their use, production volume, and general, reproductive, and developmental toxicity. Selection of candidate chemicals will be based upon production volume, extent of human exposures, public concern about chemical hazard, published evidence of reproductive or developmental toxicity, and evaluation of any additional information submitted by the public in response to this announcement. The chemicals to be considered for Expert Panel evaluation in the year 2000 are listed below with their Chemical Abstracts Service registry numbers (where available).

1-Bromopropane (106-94-5)
2-Bromopropane (75-26-3)
Dimethyl Methyl Phosphonate (DMMP) (756-79-6)
Ethylene glycol (107-21-1)
Glycol ethers (not available)
Glyphosate (1071-83-6)
Methanol (67-56-1)
Nicotine (54-11-5)
Phenol (108-95-2)
Thimerosal (54-64-8)
Toluene (108-88-3)

Request for Public Comment on Candidate Chemicals

The Center invites public comment on the candidate chemicals listed above, including toxicology information from completed or ongoing studies, and information on planned studies, as well as current production data, human exposure information, use patterns, and environmental occurrence. Written comments received by May 4, 2000 will be considered in the review. Please forward comments and chemical information to: Dr. John Moore, CERHR, 1800 Diagonal Road, Suite 500, Alexandria, VA 22314-2808, Phone: (703) 838-9440.

Request for Nominations for Future Reviews

Nominations of chemicals for future evaluations are also encouraged. Any individual or organization may nominate. Nominations should include the chemical name, Chemical Abstract Service registry number (if known), reason for the nomination, and references or articles on the chemical, when possible. The nominator's name, address, telephone number and e-mail address should be included with the nomination. Nominations can be made through the Center's web site or by mail to Dr. John Moore at the address listed above.

Review Process

The Center's review process is outlined below:

  • Chemical Nominations
    • open nomination process includes interested individuals, NTP Executive
    • Committee, Federal Agencies, NTP Staff, Labor Unions, Industry
  • CERHR multi-agency Core Committee
    • nominations reviewed quarterly by Core Committee made up of NTP
    • Agency representatives.
    • highest priority chemicals identified based on production volume, evidence of reproductive or developmental toxicity, human exposure, public concern.
    • candidate chemicals transmitted to Associate Director, NTP
    • Center staff prepares dossiers on candidate chemicals
  • First Solicitation of Public Comment
    • Notice of candidate chemicals and request for public comment published in Federal Register, NTP Newsletter and listserver, and CERHR website
    • public comments are compiled by Center staff for review by the Core Committee
  • CERHR Core Committee Review
    • reviews dossiers and material submitted in public comments
    • recommends list of prioritized chemicals to Associate Director, NTP, for final selection.
  • Second Solicitation of Public Comment
    • Federal Register notice announces selected chemical(s) and solicits public comment, new data, information on exposure, and nominations of individuals qualified to serve on the Expert Panel.
  • Expert Panel Meeting
    • the Panel meets in public session to discuss their review of the literature and to prepare the Panel report.
    • meeting includes time for presentation of public comments.
  • Final Solicitation of Public Comment
    • Federal Register notice announces availability of Expert Panel report and requests public comment.
  • Expert Panel Report is submitted for publication in Environmental Health Perspectives, monograph section
  • NTP Center Report Transmitted and Published
    • NTP staff prepares an NTP Center Report on the chemical(s) evaluated (intended for a readership of non-scientists). This report integrates background information on the chemical evaluated, the findings in the Expert Panel Report, a summary of the public comments, and a discussion of any recent relevant study findings.
    • the Center Report is distributed to Federal and state agencies, interested stakeholders, and the public, and is published in EHP, monthly section.

    Further information about the NTP Center for the Evaluation of Risks to Human Reproduction can be obtained through the Center's web site: http://cerhr.niehs.nih.gov or by contacting:

    Michael D. Shelby, Ph.D.
    Director, CERHR
    NIEHS / NTP B3-09
    P.O. Box 12233
    Research Triangle Park, NC 27709
    telephone 919-541-3455
    facismile 919-541-4634
    or John A. Moore, D.V.M., D.A.B.T.
    Principal Investigator, CERHR
    1800 Diagonal Road Suite 500
    Alexandria, VA 22314

    703-838-9440
    703-684-2223


    Dated: March 10, 2000
    ____________________________
    Kenneth Olden, P.D.
    Director, NIEHS.

 


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