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.
This page was last updated May 9, 2007
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