[Federal Register Volume 63, Number 207 (Tuesday, October 27, 1998)]
[Notices]
[Pages 57303-57304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28713]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
Background
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.
Agenda
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]
BILLING CODE 4140-01-M