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®: CRE Regulatory Action of the Week

Important EPA Science Advisory Panel On Test Method Performance Standards
EPA's FIFRA Science Advisory Panel will meet on October 28 and 29 to review EPA's proposed adoption of Performance Standards for determining the regulatory acceptability of three in vitro tests for dermal corrosivity. The Performance Standards were developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). This SAP review is very important because it is a test case for the Government's use of Performance Standards to determine whether any new tests are sufficiently accurate and reliable to use in a regulatory context. While Performance Standards for a particular test would apply regardless of whether the test was public, EPA and the other ICCVAM agencies intend to use them to determine the regulatory acceptability of proprietary test methods. Ensuring the accuracy and reliability of proprietary tests is a particular problem with regard to in vitro tests because many new in vitro tests are proprietary. Most federal agencies, including EPA, are members of ICCVAM. ICCVAM's statutory mission is ensuring the reliability, accuracy and reproducibility of new test methods before they are used for regulatory purposes, with an emphasis on reducing the use of test animals. ICCVAM recently published a document establishing guidelines for approving new tests. This document establishes specific criteria for various test accuracy and reliability issues, including inter-laboratory variability. With regard to Performance Standards, it states, "The purpose of performance standards is to communicate the basis on which a new proprietary (i.e., copyrighted, trademarked, registered) or nonproprietary test method was determined to have sufficient accuracy and reliability for a specific testing purpose." While this SAP will review these important issues in the context of three specific in vitro tests, its conclusions and EPA's final action will have Government-wide implications for many more tests.
  • Click for information on the October 28-29 FIFRA SAP.
  • Click for the new ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test methods.