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ICCVAM Biennial Report 2020-2021

Biennial Progress Report 2020-2021 Interagency Coordinating Committee on the Validation of Alternative Methods

National Academies Panel on Variability and Relevance of Mammalian Toxicity Tests

ICCVAM members from NIEHS and NIST are serving on a committee convened by the National Academies of Sciences, Engineering, and Medicine for the consensus study, “Variability and Relevance of Current Laboratory Mammalian Toxicity Tests and Expectations for New Approach Methods (NAMs) for use in Human Health Risk Assessment.” This study was undertaken by the National Academies in response to a request from EPA. It will review the variability and relevance of existing mammalian toxicity tests, specifically in the context of human health risk assessment. The review will support the establishment of data-driven and science-based expectations for NAMs based on the variability and relevance of the traditional toxicity testing models.

The committee was established in 2021 and has held two public meetings. The first of these on September 23 included discussions with EPA staff regarding the statement of task, reasons for the committee’s study, and description of the types of committee recommendations that would be most useful, as well as a brief public comment period. A workshop on December 9 featured expert presentations addressing several questions relevant to the study:

  • How are traditional toxicity studies used in informing chemical safety decisions?
  • What do we know about the variability and concordance of traditional mammalian toxicity studies?
  • What are the needs and expectations of different stakeholders?

Proceedings from this workshop will be published in 2022. The committee will hold additional public meetings in 2022 and expects to issue a report with recommendations late in the year.