[Federal Register: May 28, 2004 (Volume 69, Number 104)]
[Notices]
[Page 30693-30694]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my04-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
National Toxicology Program (NTP); National Institute of
Environmental Health Sciences (NIEHS); National Institutes of Health;
Notice of Availability of Recommended Performance Standards for In
Vitro Test Methods for Skin Corrosion
SUMMARY: The NTP Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM) announces the availability of
recommended performance standards for in vitro test methods for skin
corrosion. The Interagency Coordinating Committee on the Validation of
Alternative Methods (ICCVAM) developed the performance standards to
communicate the basis by which a validated and accepted proprietary
(i.e., copyrighted, trademarked, or registered) or non-proprietary test
method has been determined to have sufficient accuracy and reliability
for a specific testing purpose. Performance standards should assist
other test developers in the validation of test methods that are
similar in structure and function and facilitate acceptance of test
methods that adhere to applicable performance standards.
Availability of the Recommended Performance Standards
The recommended performance standards are available electronically
in PDF format on the ICCVAM/NICEATM Web site at http://iccvam.niehs.nih.gov
or in printed form by contacting Dr. William
Stokes, NICEATM Director, NIEHS, P.O. Box 12233, MD EC-17, Research
Triangle Park, NC, 27709, (phone) 919-541-3398, (fax) 919-541-0947, (e-
mail) iccvam@niehs.nih.gov.
SUPPLEMENTARY INFORMATION: ICCVAM previously reviewed and recommended
four in vitro test methods for assessing the dermal corrosivity
potential of chemicals: Corrositex[reg], EPISKIN
TM, EpiDerm TM (EPI-200), and the rat skin
transcutaneous electrical resistance (TER) Assay (NIEHS 1999 and NIEHS
2002). Because three of these methods were proprietary, ICCVAM was
asked by the U.S. Environmental Protection Agency (EPA) to develop and
recommend performance standards that could be used to evaluate the
acceptability of similar test methods that are based on similar
scientific principles and that measure or predict the same biological
or toxic effect.
ICCVAM in collaboration with the NICEATM announced the availability
and sought public comment on proposed performance standards for these
three types of test methods in July 2003 (Federal Register, Vol. 68,
No. 126, pp. 39104-39105). Comments on the proposed standards were also
obtained from the Scientific Advisory Committee on Alternative
Toxicological Methods (SACATM) in August 2003 (NTP 2003) and the EPA
Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory
Panel in October 2003 (EPA 2003). Following consideration of public and
advisory committee comments, ICCVAM revised and approved recommended
performance standards for the three types of in vitro corrosivity test
methods.
This document will be forwarded, along with the final ICCVAM
recommendations on the four test methods mentioned above, to Federal
agencies for their consideration in accordance with the ICCVAM
Authorization Act of 2000 (Pub. L. 106-545).
Background Information on ICCVAM and NICEATM
ICCVAM is an interagency committee composed of representatives from
fifteen Federal regulatory and research agencies that use, generate, or
disseminate toxicological information. ICCVAM promotes the development,
[[Page 30694]]
validation, regulatory acceptance, and national and international
harmonization of toxicological test methods that more accurately assess
the safety or hazards of chemicals and products and test methods that
refine, reduce and replace animal use. The ICCVAM Authorization Act of
2000 (available at http://iccvam.niehs.nih.gov/about/PL106545.htm)
established ICCVAM as a permanent interagency committee of the NIEHS
under the NICEATM. NICEATM administers the ICCVAM and provides
scientific support for ICCVAM and ICCVAM-related activities. NICEATM
and ICCVAM work collaboratively to evaluate new and improved test
methods applicable to the needs of Federal agencies. Additional
information about ICCVAM and NICEATM can be found at the following Web
site: http://iccvam.niehs.nih.gov.
References
NIEHS. 1999. Corrositex[reg]: An In Vitro Test Method
for Assessing Dermal Corrosivity Potential of Chemicals. NIH
Publication No. 99-4495. Available at http://iccvam.niehs.nih.gov/methods/corrode.htm
.
NIEHS. 2002. ICCVAM Evaluation of EPISKIN TM, EpiDerm
TM (EPI-200), and the Rat Skin Transcutaneous Electrical
Resistance (TER) Assay: In Vitro Test Methods for Assessing Dermal
Corrosivity Potential of Chemicals. NIH Publication No. 02-4502.
Available at http://iccvam.niehs.nih.gov/methods/epiderm.htm.
NTP. 2003. Summary Minutes of the August 12-13, 2003 Scientific
Advisory Committee on Alternative Toxicological Methods (SACATM).
Available at http://iccvam.niehs.nih.gov/about/sacatm/minutes/min_120803.pdf
.
EPA. 2003. Minutes of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) Scientific Advisory Panel Meeting ``Ensuring
Data Quality for In Vitro Tests Used as Alternatives to Animal Studies
for Regulatory Purposes: A Consultation (October 28-29, 2003 in
Arlington, VA). Available at http://www.epa.gov/oscpmont/sap/2003/october/revisedmeetingminutes.pdf
.
Dated: May 20, 2004.
Samuel H. Wilson,
Deputy Director, National Institute of Environmental Health Sciences.
[FR Doc. 04-12126 Filed 5-27-04; 8:45 am]
BILLING CODE 4140-01-P