[Federal Register Volume 62, Number 49 (Thursday, March 13, 1997)]
[Notices]
[Pages 11901-11902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service


National Institute of Environmental Health Sciences; Validation 
and Regulatory Acceptance of Toxicological Test Methods: A Report of 
the ad hoc Interagency Coordinating Committee on the Validation of 
Alternative Methods, Now Available

    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.

Background

    The National Institutes of Health Revitalization Act of 1993 (Pub. 
L. 103-43, Section 1301) directed the National Institute of 
Environmental Health Sciences of the National Institutes of Health 
(NIEHS/NIH) to ``(a) establish criteria for the validation and 
regulatory acceptance of alternative testing methods, and (b) recommend 
a process through which scientifically validated alternative methods 
can be accepted for regulatory use'' (Appendix F).
    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:

Consumer Product Safety Commission
Department of Agriculture
    Agriculture Research Service
    Animal and Plant Health Inspection Service
Department of Defense
Department of Energy
Department of Health and Human Services
    Agency for Toxic Substances and Disease Registry
    Food and Drug Administration
    National Institute for Occupational Safety and Health/CDC
    National Institute of Health
    National Cancer Institute
    National Institute of Environmental Health Sciences
    National Library of Medicine
    Office of Laboratory Animal Research
Department of the Interior
Department of Labor
    Occupational Safety and Health Administration
Department of Transportation
    Research and Special Programs Administration
Environmental Protection Agency

    The Committee met initially in September 1994, and then monthly or 
bimonthly until completion of the report in October 1996. The Committee 
interpreted its charge as the development of general criteria and 
processes for the validation and regulatory acceptance of new and 
revised toxicological test methods.
    The specific goals of this Report are to:
     Communicate the criteria and procedures that Federal 
agencies should employ in considering new and revised test methods,
     Encourage the development of new and revised test methods 
that will provide for improved assessment of the potential toxicity of 
agents to human health and other organisms in the environment,
     Provide effective guidance for scientists for the 
validation and evaluation of new and revised test methods,
     Contribute to the increased likelihood of regulatory 
acceptance of scientifically valid new and revised test methods,
     Encourage the use of validated and accepted new and 
revised test methods,
     Encourage, when scientifically feasible, the reduction and 
refinement of animal use in testing and the replacement of animal 
methods with non-animal methods or of animal species with 
phylogenetically lower species.
    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,

[[Page 11902]]

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, academe, 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. Commends 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.

 Summary of the Report

    The report totals 105 pages, and consists of four chapters. Chapter 
one is an introduction that provides a general overview of the need for 
toxicological test methods, how they are used, and the driving forces 
for the development and validation of new methods. Chapter two 
discusses the concept of validation and the criteria that should be met 
for a new or revised test method to be considered for regulatory risk 
assessment purposes. Chapter three discusses the criteria that should 
be used in considering the acceptability of a test method proposed for 
regulatory use. It also discusses the processes involved in achieving 
regulatory acceptance of a test method. A series of recommendations for 
developing a consistent and efficient process for evaluating new 
methods for regulatory acceptance is provided. Recommendations address 
development and validation, regulatory review of new methods, intra- 
and interagency coordination and harmonization, communication, and 
international harmonization. Chapter four discusses an implementation 
plan to facilitate the review and consideration of new test methods 
proposed for regulatory acceptance.
    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 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.

Obtaining the Report

    Retrieval instructions and the anticipated date for availability on 
the internet can be found at the NTP website: <http://ntp-
server.niehs.nih.gov>. 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 to: (919) 541-0295.
    For further information about the Report, please contact one of the 
ICCVAM co-chairs--Dr. William Stokes at NIEHS, PO Box 12233, Research 
Triangle Park, NC 27709, telephone 919-541-7997, FAX (919) 541-0947, or 
internet email at [email protected] or Dr. Richard Hill at EPA, Mail 
Code 7101, 401 M Street, SW, Washington, DC 20460, telephone (202) 260-
2897, FAX (202) 260-1847, or internet email at 
[email protected].

    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