The publication Validation and Regulatory Acceptance of Toxicological Test Methods: A Report of the Ad Hoc Interagency Coordinating Committee on the Validation of Alternative Methods, NIH Publication 97-3981 is now available and may be obtained as described in this notice.
In response to these mandates, NIEHS established an ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) (the Committee) in 1994 to develop a report recommending criteria and processes for validation and regulatory acceptance of toxicological testing methods that would be useful to Federal agencies and the scientific community. The following Federal regulatory and research agencies and organizations participated in this effort:
The specific goals of this report are to:
In developing the initial draft report, the Committee considered information obtained from the following sources: (1) A questionnaire completed by each agency on their criteria and processes for test method validation and acceptance, (2) public comments submitted in response to a Federal Register notice published December 7, 1994, requesting interested individuals and organizations to provide information for consideration by the Committee (appendix G), (3) presentations from various government scientists, (4) review of pertinent available literature, and (5) comments and suggestions from Federal agencies.
An NTP Workshop on Validation and Regulatory Acceptance of Alternative Test Methods was held on December 11-12, 1995, at the Crystal Gateway Mariott Hotel, Arlington, Virginia. The purpose of the workshop was to review the criteria and processes set forth in the draft report and accept comments and recommendations from workshop registrants and invited panelists, including representatives from industry, academia, public interest groups, and the international community. Written comments were also submitted in response to the Federal Register notice announcing availability of the draft report for public comment.
The draft report was also presented to participants at the Organization for Economic Cooperation and Development (OECD) Workshop on Harmonization of Validation Criteria for Alternative Test Methods held in Stockholm, Sweden, on January 22-24, 1996. Comments and recommendations generated by scientists from the 26 OECD member countries were considered by the Committee. The Committee prepared a revised draft report that was distributed to participating agencies for comment and concurrence prior to publication of the final report.
A standing interagency committee will be established to coordinate the development, validation, acceptance, and national/international harmonization of toxicological test methods. The committee will be designated as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and will replace the ad hoc ICCVAM. The ICCVAM will seek to promote sound toxicological test methods that (1) enhance agencies' ability to assess risks and make decisions and (2) reduce animal use, refine procedures involving animals to make them less stressful, and replace animals in toxicological tests, where scientifically feasible and practical. The [ad hoc ICCVAM] Committee anticipates that this effort will help to better evaluate risks to human and animal health and the environment, reduce costs necessary to establish the safety of agents in commerce, and facilitate international trade.
To receive a copy of the report, please contact the NTP Liaison and Scientific Review Office, NIEHS, PO Box 12233, MD A3-01, Research Triangle Park, NC 27709, or by fax: (919) 541-0295.
For further information about the report, please contact one of the
ICCVAM co-chairs:
Dr. William Stokes
NIEHS
PO Box 12233
Research Triangle Park, NC 27709
phone: (919) 541-7997
fax: (919) 541-0947
e-mail: stokes@niehs.nih.gov
-or-
Dr. Richard Hill
EPA
Mail Code 7101
401 M Street, SW
Washington, DC 20460
phone: (202) 260-2897
fax: (202) 260-1847
or e-mail at hill.richard@epamail.epa.gov.
Dated: March 5, 1997
Kenneth Olden,
Director, National Institute of Environmental Health
Sciences.
[FR Doc. 97-6288 Filed 3-12-97; 8:45 am]
BILLING CODE 4140-01-M
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