ID#

1812

Location:

Exhibit Hall

Time of Presentation:

March 24, 1:30 PM

Category (Subcategory):

Regulatory/Policy, (In Vitro/Alternative Animal Models)

The ICCVAM/NICEATM Process for Developing Test Method Performance Standards
W.S. Stokes¹, L.M. Schechtman², A. Rispin³, R.N. Hill³, K. Hamernik³,
B.C. Blackard⁴, R.R. Tice⁴
1. NICEATM, NIEHS, RTP, NC
2. FDA, NCTR, Rockville, MD
3. U.S. EPA, Washington, DC
4. ILS Inc., RTP, NC

Test methods proposed for regulatory testing should routinely undergo validation studies to assess their reliability and relevance for specific applications. Regulatory agencies can then determine if the test method is sufficiently accurate and reliable to be accepted for a proposed specific use. The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) has established a process for developing and using performance standards (PS) to evaluate the acceptability of proposed test methods that are based on similar scientific principles and that measure or predict the same biological or toxic effect as an accepted test method. ICCVAM defined the three critical components of PS as: (1) essential test method components, i.e. the requisite structural, functional, and procedural elements of a validated test method that should be included in the protocol of a proposed mechanistically and functionally similar test method; (2) a minimum list of reference chemicals, which is used to assess the accuracy and reliability of the analogous test method; and (3) comparable accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum list of reference chemicals. The ICCVAM also established a process for developing and recommending PS during future test method evaluations. NICEATM and an ICCVAM working group will develop proposed test method specific PS, which will be made available for public comment. An independent peer review panel will review the proposed PS for completeness and appropriateness as a part of the panel's evaluation of the proposed test method. ICCVAM will then finalize and forward recommended PS together with test method recommendations to Federal agencies and make these available to the public. The availability of PS is expected to facilitate the development and validation of improved test methods that are similar to previously accepted methods. ILS staff supported by NIEHS contract NO1-ES-35504.