[Federal Register Volume 64, Number 55 (Tuesday, March 23, 1999)]
[Notices]
[Pages 14006-14007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service


National Institute of Environmental Health Sciences (NIEHS); The 
Murine Local Lymph Node Assay: A Test Method for Assessing the Allergic 
Contact Dermatitis Potential of Chemicals/Compounds, Report Now 
Available

SUMMARY: The report entitled ``The Murine Local Lymph Node Assay: A 
Test Method for Assessing the Allergic Contact Dermatitis Potential of 
Chemicals/Compounds,'' NIH Publication 99-4494, is now available and 
may be obtained as described in this notice. The report describes the 
results of an independent peer review evaluation of the validation 
status of the Local Lymph Node Assay (LLNA) that was conducted on 
September 17, 1998 (Federal Register 63 FR 37405-6, July 10, 1998). The 
(LLNA) was proposed as an alternative toxicological test method for 
assessing the allergic contact dermatitis (contact hypersensitivity) 
potential of chemicals and products. The review was coordinated by the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency 
Center for the Evaluation of Alternative Toxicological Methods 
(NICEATM). The review was sponsored by the National Institute of 
Environmental Health Sciences and the NTP.

Background

    Pub. L. 103-43 directed the NEIHS to develop and validate 
alternative methods that can reduce or eliminate the use of animals in 
acute or chronic toxicity testing, establish criteria for the 
validation and regulatory acceptance of alternative testing methods, 
and recommend a process through which scientifically validated 
alternative methods can be accepted for regulatory use. Criteria and 
processes for validation and regulatory acceptance were developed in 
conjunction with 14 other Federal agencies and programs with broad 
input from the public. These are described in the document ``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, March 1997, which is 
available on the internet at http://ntp-server.niehs.nih.gov.htdocs/
ICCVAM/iccvam.html. ICCVAM was subsequently establihsed in a 
collaborative effort by NIEHS and 13 other Federal regulatory and 
research agencies and programs. The Committee's functions include the 
coordination of interagency reviews of toxicological test methods and 
communication with stakeholders throughout the process of test method 
development and validation. The following Federal regulatory and 
research agencies and organizations are participating in this effort:

Consumer Product Safety Commission
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 Institutes of Health
    National Cancer Institute
    National Institute of Environmental Health Sciences
    National Library of Medicine
Department of the Interior
Department of Labor
    Occupational Safety and Health Administration
Department of Transportation
    Research and Special Programs Administration
Environmental Protection Agency

    The LLNA was proposed to ICCVAM for consideration as a stand-alone 
test to identify chemicals that have a potential to cause allergic 
contact dermatitis. The ICCVAM determined that there was sufficient 
information available to merit an independent scientific peer review 
evaluation of the LLNA test method. Peer review is an essential 
prerequisite

[[Page 14007]]

for consideration of a method for regulatory acceptance. The peer 
review panel was charged with developing a scientific consensus on the 
usefulness and limitations of the test method. The peer review panel 
concluded that the LLNA is a valid alternative to currently accepted 
guinea pig test methods for the assessment of allergic contact 
dermatitis when the test method is conducted in accordance with peer 
review panel recommendations. The panel also concluded that the LLNA 
offers animal welfare advantages compared to conventional guinea pig 
methods in that it involves less pain and distress, and fewer animals 
may be required. The peer review panel's report has been forwarded to 
Federal agencies for their determination of the regulatory 
acceptability and applicability of the test method according to their 
statutory mandates.

Summary of the Report

    The report contains 212 pages and includes the results of the 
independent peer review evaluation and supporting documentation, 
including the original test method submission, supporting data 
evaluations conducted by NICEATM, and a proposed protocol that 
incorporates the recommendations of the peer review panel.

Obtaining the Report

    To receive a copy of the report, please contact NICEATM at PO Box 
12233, MD EC-17, Research Triangle Park, NC 27709 (mail), 919-541-3398 
(phone), 919-541-0947 (fax), or [email protected] (email). The 
report is also available on the ICCVAM/NICEATM website at http://
iccvam.niehs.nih.gov/llnarep.htm.

    Dated: March 11, 1999.
Samuel H. Wilson,
Deputy Director, National Institutes of Environmental Health Sciences.
[FR Doc. 99-6953 Filed 3-22-99; 8:45 am]
BILLING CODE 4140-01-M