Development of a Strategic Roadmap

Word cloud representing key concepts identified in the February 2017 meeting: new approaches, collaboration, innovation, partnerships, relevance, best science

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
  • The regulated community

The idea of a coordinated strategy and roadmap that fully incorporated more advanced non-animal testing capabilities was originally 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 multi-sector framework for supporting innovative non-animal technologies. It would be beneficial for public and private sector engagement.

While acknowledging that a number of challenges existed, both SACATM and stakeholders expressed support for this roadmap effort. SACATM tasked ICCVAM to continue 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 focused on:

  • Moving away from animal models for toxicity testing
  • Potential hurdles to the adoption of new alternative methods
  • Approaches to establishing public/private partnerships
  • 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. Through the entire process there were many opportunities for members of the stakeholder community to provide written and oral comments to the document.

During late 2016, ICCVAM drafted and released a mission and vision statement 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 meeting, the Roadmap Planning Group reviewed and commented on the mission and vision statements. They then began developing an outline for the roadmap.

The first opportunity for public comment on the development of the roadmap occurred at the annual meeting of the Society of Toxicology in March 2017 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." Additional 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 NTP 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 website 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 reviewed by ICCVAM committee members.

Three Federal Register Notices referencing the roadmap effort were published during this time:

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