[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]
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