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Questions for the Panel

I. Performance Standards

The Agency plans to adopt the Performance Standards developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) as a means of communicating the basis by which each of three validated in vitro test methods, Corrositex®, EPISKIN™/EpiDerm™, and Transcutaneous Electrical Resistance (TER), are deemed acceptable for providing dermal corrosivity data. Performance Standards consist of descriptions of (1) essential test method components, which are the essential 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 similar test method; and (3) comparable accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum set of Reference Chemicals.

II. Quality Control

The Agency is proposing quality control measures that should be considered when evaluating the reliability of test kits for regulatory purposes. Please address the following specific issues.


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