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ICCVAM Biennial Report 2014-2015

ICCVAM Biennial Report 2014-2015

ICCVAM Contributions to OECD Activities

ICCVAM member agencies participate in the development and national review of guidelines for the testing of chemicals issued by the Organisation for Economic Co-operation and Development (OECD). OECD test guidelines represent internationally agreed-upon testing methods that can be used by government, industry, and independent laboratories in the 34 OECD member countries to determine the safety of chemicals and chemical preparations.

The U.S. National Coordinator for the OECD Test Guidelines Programme, an ex officio member of ICCVAM, solicits and collates U.S. comments on draft test guidelines and other documents of the Test Guidelines Programme. The National Coordinator represents the United States at the annual meeting of the National Coordinators of the Test Guidelines Programme and in other test guideline development activities. During 2014-2015, first Christine Olinger and then Wanda Hall, both of the U.S. Environmental Protection Agency (EPA), served as U.S. National Coordinator.

Judy Strickland, Ph.D., senior toxicologist on the ILS NICEATM support contract, attended a November 2014 meeting of the OECD expert group tasked with drafting the “Guidance Document on the Reporting of Integrated Approaches to Testing and Assessment.” Strickland submitted for inclusion in the draft guidance document a case study of the ICCVAM integrated decision strategy that uses machine-learning approaches to predict skin sensitization. The draft guidance document and case studies are under review by the OECD Task Force on Hazard Assessment.

ICCVAM co-chairs Anna Lowit, Ph.D., of EPA and Abby Jacobs, Ph.D., of the U.S. Food and Drug Administration (FDA) along with ICCVAM member Suzanne Fitzpatrick, Ph.D., of FDA attended the November 2015 OECD-sponsored workshop Framework for the Development and Use of Integrated Approaches to Testing and Assessment in Arlington, Virginia. The workshop’s objectives were to discuss how the adverse outcome pathway (AOP)/mode-of-action concept could be used to develop and refine integrated approaches for testing and assessment, and define the degree of confidence needed to apply these to specific regulatory contexts. A report from the workshop was published by OECD in July 2015.

NICEATM Director Warren Casey, Ph.D., and ICCVAM member Patience Browne, Ph.D., EPA, attended a December 2015 meeting of the OECD Validation Management Group-Non-animal in Budapest, Hungary. This international group focuses on evaluation of new methods for identifying endocrine disruptors. Casey led a discussion on selection of reference chemicals for evaluating these new methods, and Browne gave two presentations, one focused on evaluating estrogenic activity of environmental chemical metabolites, and one on the status of a pathway-based validation approach. The group also discussed current proposals for the use of high throughput methods for identifying endocrine disruptors.