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Development of a Strategic Roadmap

Word cloud representing key concepts identified in the February 2017 meeting

The “reinvention” of ICCVAM in 2013 (Birnbaum 2013) positioned the committee to become more collaborative and responsive to the needs of its stakeholders. Over the next few years, ICCVAM activities became more focused on agency needs, and efforts were made to conduct these activities in collaboration with stakeholders from academia, non-governmental organizations, and the regulated community.

The concept for a coordinated strategy and roadmap that fully incorporated more advanced non-animal capabilities was initially presented to the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) by Brian Berridge, GlaxoSmithKline, in 2015. Such a strategy would require establishing a national multisector framework for supporting and industrializing innovative non-animal technologies, and would benefit from public and private sector engagement. While acknowledging that a number of challenges existed, both SACATM and stakeholders expressed support for the roadmap effort. SACATM tasked ICCVAM with continuing the development of a strategy.

As a result, A Strategy for Implementing the Vision for Regulatory Toxicity Testing in the 21st Century was the main focus of the 2016 SACATM meeting. Discussions at this meeting centered on moving away from animal models for toxicity testing, impediments to adoption of new alternative methods, approaches to establishing public/private partnerships, and next steps toward developing a national strategy.

With the continued support of SACATM expressed at its 2016 meeting, ICCVAM entered into a year-long process to develop the roadmap. This process involved the participation of representatives from 16 federal agencies and multiple interagency workgroups, and included multiple opportunities for members of the stakeholder community to provide written and oral comments to the document.

During the first quarter of FY2017, ICCVAM drafted a mission and vision statement, which was released to a Roadmap Planning Group prior to a workshop held in February 2017. The Roadmap Planning Group consisted of ICCVAM members and other employees of ICCVAM agencies with interest and expertise in new approach methodologies. At the February 2017 meeting, the Roadmap Planning Group reviewed and commented on the mission and vision statements and began developing an outline for the roadmap.

The first opportunity for public comment on the development of the roadmap occurred at the March 2017 annual meeting of the Society of Toxicology during a National Toxicology Program-hosted session, “Developing a Strategic Roadmap to Establish New Approaches for Evaluating the Safety of Chemical and Medical Products in the United States.” Subsequent opportunities for public comment during the development of the roadmap occurred at the ICCVAM Public Forum (May 23 at the National Institutes of Health [NIH] in Bethesda, Maryland) and the National Toxicology Program Board of Scientific Counselors meeting (June 29 at the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina).

A draft of the roadmap was released for public comment on the NTP webpage on August 14; this draft was discussed at the 2017 SACATM meeting (September 18-19 at NIH in Bethesda, Maryland). Comments collected from SACATM and the public were considered and incorporated into a final draft that was reviewed by ICCVAM committee members.

Three Federal Register Notices that referenced the roadmap effort were published during this time period: 

  1. 82 FR 19071 - ICCVAM Notice of Public Meeting; Request for Public Input (25 April 2017)
  2. 82 FR 20484 - National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments (2 May 2017)
  3. 82 FR 37885 - SACATM; Announcement of Meeting; Request for Comments (14 August 2017)

A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States is the final product from this effort. Review of the final document by ICCVAM members occurred in December 2017, with publication on the National Toxicology Program’s website in January 2018.