Submissions of Test Methods for Evaluation

ICCVAM welcomes submission of innovative test methods that may be acceptable for specific regulatory uses. Acceptability for regulatory use is generally demonstrated by completion of adequate validation studies to characterize the usefulness and limitations of a test method in accordance with ICCVAM test method submission guidelines.

To maximize the potential for effective implementation of new test methods or approaches, ICCVAM will only conduct evaluations and prepare recommendations on test method submissions proposed for regulatory uses that align with ICCVAM member agency needs and priorities. Test method developers are encouraged to consult with NICEATM and ICCVAM throughout the test method development, prevalidation, and validation process, as well as during submission preparation to ensure that:

• The test method aligns with the needs and priorities of one or more ICCVAM agencies, and there is at least one agency willing to sponsor the test method for evaluation.
• Validation studies conducted using the test method adequately characterize its usefulness and limitations for a particular regulatory application.
• The test method submission package contains data and information required by the sponsoring agencies to determine if a test method will meet their regulatory needs.

Test method submissions may be made by contacting ICCVAM. Guidance for preparing adequate submission packages is available in the ICCVAM Guidelines for the Nomination and Submission of New, Revised, and Alternative Test Methods (NIH Publication No. 03-4508 - September 2003). Additional guidance on method validation is available in the 2024 document, "Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies," available above.

NIEHS and other organizations offer funding for validation studies of new test methods: see our Funding Opportunities for Test Method Developers page for current opportunities.

Update of ICCVAM Document on Validation and Regulatory Acceptance

The ICCVAM Validation Workgroup was established in 2021 to update the 1997 ICCVAM report, “Validation and Regulatory Acceptance of Toxicological Test Methods.” The new document, available above, aligns with principles articulated in the 2018 ICCVAM publication, “A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States.” ICCVAM invited public comments from all stakeholders on the draft document, which was also discussed at the September 21-22 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods.

View Federal Register notice (August 10, 2023 - View as PDF)

Public Comments Received

• Errol Zeiger, Errol Zeiger Consulting (August 18, 2023)
• Anna van der Zalm and Amy Clippinger, People for the Ethical Treatment of Animals (August 24, 2023)
• Christian Strupp, Gowan Company (September 4, 2023)
• Jessica Ryman-Rasmussen, American Chemistry Council (September 5, 2023)
• Philippe Hubert, PEPPER: Public-Private Platform for the Pre-Validation of Endocrine Disruptors Characterization Methods (September 5, 2023)
• Amanda Ulrey and Hans Raabe, Institute for In Vitro Sciences (September 5, 2023)
• Environmental Defense Fund (September 5, 2023)
• Adela Ben-Yakar, vivoVerse (September 5, 2023)
• Elizabeth Baker and Susan Howe, Physicians Committee for Responsible Medicine (September 5, 2023)
• Laura Alvarez, Cruelty Free International (September 5, 2023)

Past Nominations and Submissions