ICCVAM Biennial Report 2020-2021

In 1997, ICCVAM published Validation and Regulatory Acceptance of Toxicological Test Methods, which recommended criteria and processes for validation and regulatory acceptance of toxicological testing methods that would be useful to federal agencies and the scientific community. Approaches to validating new methods have evolved considerably since the publication of this document. New concepts have emerged related to the development of NAMs and the evaluation of their utility for regulatory uses, such as the qualification of a NAM for a particular context of use (also known as fit-for-purpose). However, guidance is needed on specific processes to put these concepts into practice.

In 2021, ICCVAM established a Validation Workgroup to consider this issue. The workgroup, which has members from nine ICCVAM agencies, is applying the advances of the last 2 decades to a new document describing criteria and processes for validation and regulatory acceptance of toxicological testing methods. In addition to supporting development of flexible validation practices that consider context of use, the new document will address the need to align validation approaches in a manner that encourages international harmonization and incorporates best practices for quality and quality systems development. The document will draw upon recent well-established validation publications to ensure alignment of approaches.

As of December 2021, drafting of the new document was in progress, and it is envisioned that it will be made available for public comment sometime in 2022.