[Federal Register Volume 69, Number 104 (Friday, May 28, 2004)]
[Notices]
[Pages 30693-30694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12126]


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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) [email protected].

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