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ICCVAM Biennial Report 2016-2017

Biennial Progress Report 2016-2017 Interagency Coordinating Committee on the Validation of Alternative Methods

Development of the U.S. Strategic Roadmap

During 2017, ICCVAM coordinated the development of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States.

The roadmap describes a new framework for the safety testing of drugs and chemicals, which aims to provide more human relevant toxicology data while reducing the use of animals. The successful development and implementation of these new approaches will require coordinated efforts that address three strategic goals:

  • Connecting end-users with developers of new approach methodologies
  • Fostering the use of efficient, flexible, and robust practices to establish confidence in new methods
  • Encouraging the adoption and use of new methods and approaches by federal agencies and regulated industries

The roadmap was first proposed to the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) in 2015. SACATM expressed support for the development of the roadmap as an ICCVAM activity at its 2016 meeting. A meeting of ICCVAM members and other federal employees in February 2017 established an outline for the roadmap. Opportunities for public comment during development of the roadmap occurred during the annual meeting of the Society of Toxicology in March; the ICCVAM Public Forum in May; the NTP Board of Scientific Counselors meeting in June; and the SACATM meeting in September.

The final roadmap document was published in January 2018 and is available on the NTP website.

Activities are already underway to address the roadmap goals, some of which are described elsewhere in this document. Presentations at the September 2017 SACATM meeting described implementation of the roadmap for acute systemic toxicity, eye and skin irritation, and skin sensitization testing. Reviews of U.S. agency information requirements for all of these areas are being prepared and are planned for publication in 2018.

Cover of ICCVAM Strategic Roadmap Document (Jan 2018)

U.S. Strategic Roadmap

The U.S. Strategic Roadmap was developed with participation from all ICCVAM member agencies and multiple interagency workgroups, with input from a broad range of stakeholder groups.