[Federal Register Volume 63, Number 207 (Tuesday, October 27, 1998)]
[Pages 57303-57304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28713]



Public Health Service

National Toxicology Program; National Institute of Environmental 
Health Sciences (NIEHS); National Institute of Health (NIH) Notice of 
Meeting to Review the Corrositex Assay as an Alternative 
Test Method for Assessing the Skin Corrosivity Potential of Chemicals; 
Request for Comments

SUMMARY: Pursuant to Public Law 103-43, notice is hereby given of a 
public meeting sponsored by the NIEHS and the National Toxicology 
Program (NTP), and coordinated by the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) and the NTP 
Interagency Center for the Evaluation of Alternative Toxicology Methods 
(NICEATM). The agenda topic is the scientific peer review of the 
Corrositex assay, which is proposed as an in vitro 
alternative toxicological test method for assessing the skin 
corrosivity potential of chemicals and products. The meeting will be 
held on January 21, 1999, at the Natcher Center, National Institute of 
Health, 45 Center Drive, Bethesda, MD, 20892. The meeting will take 
place from 8:30 a.m. to 5:30 p.m. and is open to the public.


    Public Law 103-43 directed the NIEHS 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 13 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 htm. Additional information on ICCVAM and NICEATM can be 
found through the ICCVAM/NICEATM web site http://iccvam.niehs.nih.gov.
    An Interagency Coordinating Committee on the Validation of 
Alternative Methods (ICCVAM) was

[[Page 57304]]

subsequently established 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 Corrositex assay was proposed to ICCVAM for 
consideration as a test to identify the potential of chemicals to cause 
skin corrosion. An ICCVAM Corrosivity Working Group composed of Federal 
employees determined that there was sufficient information available to 
merit an independent scientific peer review of the Corrositex 
assay test method. Peer review has been determined to be an essential 
prerequisite for consideration of a method for regulatory acceptance. 
The peer review panel will be charged with developing a scientific 
consensus on the usefulness of the test method to generate information 
for human hazard identification purposes. Following evaluation at this 
peer review meeting, the proposed test method and results of the peer 
review will be forwarded by ICCVAM to Federal agencies for 
consideration. Federal agencies will determine the regulatory 
acceptability of a method according to their mandates.


    There will be a brief orientation on ICCVAM and the ICCVAM review 
process, followed by peer review of the proposed Corrositex 
test method and supporting information. The peer review panel will 
discuss the usefulness of the Corrositex assay as an 
alternative to test methods currently accepted by government regulatory 
authorities for the assessment of skin corrosivity potential of 
chemicals and products. Copies of the Corrositex Test 
Method Protocol and supporting documentation may be obtained from 
NICEATM, MD EC-17, P.O. Box 12233, Research Triangle Park, NC, 27709 
(919-541-3398), FAX (919-541-0947), e-mail: [email protected] The 
Corrositex test method documents and copies of written 
public comments can also be viewed at the Consumer Products Safety 
Commission, Reading Room, 4330 East West Highway, Bethesda, MD 20814 on 
Monday through Friday from 8 am. to 5 pm.

Public Comment

    NICEATM invites the submission of written comments on the proposed 
Corrositex test method, and other available information 
regarding the usefulness of the Corrositex assay, including 
information about completed, ongoing, or planned studies. Written 
comments and additional information should be sent by mail, fax, or e-
mail to NICEATM at the address listed above by December 10, 1998. 
Written comments will be made available to the peer review panel 
members, ICCVAM agency representatives and experts, and will be made 
available for attendees at the meeting. Members of the public who wish 
to present oral statements at the meeting should also contact NICEATM 
as soon as possible, but no later than January 10, 1999. Speakers will 
be assigned on a first-come, first-serve basis and will be limited to a 
maximum of five minutes in presentation length. Written comments 
accompanying the oral statement should be submitted in advance so that 
copies can be made and distributed to the peer panel members.
    NICEATM will furnish an agenda and a roster of peer review panel 
members just prior to the meeting. Summary minutes and a final report 
of the Corrositex assay peer review meeting will be 
available subsequent to the meeting upon request to the Center. Persons 
needing special assistance, such as sign language interpretation or 
other special accommodations should contact NICEATM as described above.

    Dated: October 20, 1998.
Kenneth Olden,
Director, National Toxicology Program.
[FR Doc. 98-28713 Filed 10-26-98; 8:45 am]