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ICCVAM Biennial Report 2018-2019

ICCVAM Biennial Report 2018-2019
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Strategic Plans

In January 2018, ICCVAM published the Strategic Roadmap. Publication of this document was accompanied or followed by the development of strategic plans by four ICCVAM member agencies to replace or reduce animal use. These plans will support assessments of chemical safety testing needs and opportunities for new technology development.
Publication of Strategic Roadmap

In January 2018, ICCVAM published "A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States." It describes a framework for safety testing that will provide more human-relevant toxicology data while reducing the use of animals. ICCVAM coordinated the development of this document during 2017 with participation from the 16 ICCVAM member agencies and multiple interagency workgroups, as well as input from a broad range of stakeholder groups. The Strategic Roadmap describes a new framework that will enable development, establish confidence in, and ensure use of new approaches to toxicity testing that improve human health relevance and reduce or eliminate the need for testing in animals. To facilitate access to the roadmap by ICCVAM’s international partners, the roadmap was translated into five languages in 2018. Progress towards the roadmap goals during 2018 and 2019 focused on replacing or reducing animal use for acute toxicity endpoints. Relevant activities are described throughout this document.

Development of a Strategic Roadmap to Promote the Use of NAMs in Rapid Chemical Assessment

DoD is developing a roadmap to promote the use of NAMs in rapid chemical hazard assessment. DoD scientists recognized the unique challenges in assessing chemical safety for diverse occupational exposure scenarios and a chemical space not well-represented outside of military interests. To address these specific concerns, DoD leadership felt that a more tailored approach was needed to fulfill the goal of reducing animal use for chemical safety testing in concert with the ICCVAM Strategic Roadmap. The DoD-specific roadmap will help laboratories across DoD to better define their chemical assessment needs and collaborate on development or refinement of appropriate non-animal approaches for testing.

Drafting of the DoD roadmap began with the “Joint DoD Technical Interchange and Roadmap Development Meeting to Promote the Use of New Approach Methodologies in Rapid Chemical Hazard Assessment.” This workshop was comprised of DoD stakeholders and experts from federal and academic agencies and designed to help provide direction for future development.

While work is being led by the Army Corps of Engineers, this has been a tri-services effort with input received from all three branches of the military. Roadmap development is ongoing, with publication planned for mid-2021 following a federal stakeholder commenting period.

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Strategic Plan for the Toxic Substances Control Act

In June 2018, EPA published its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. The document describes how EPA will promote development and implementation of methods and strategies that reduce, refine, or replace vertebrate animal testing to provide chemical safety information required under the Toxic Substances Control Act (TSCA). The core components of the plan are (1) identifying, developing, and integrating NAMs for TSCA decisions; (2) building confidence that the NAMs are scientific, reliable, and relevant for TSCA decisions; and (3) implementing the reliable and relevant NAMs for TSCA decisions.

The 2018 Strategic Plan established a TSCA NAM Team to take advantage of experts/resources within the Agency to implement the plan. EPA’s long-term goal is to move towards making TSCA decisions with NAMs to reduce and eventually eliminate vertebrate animal testing for TSCA.

A 2016 update of TSCA required EPA to develop “a list, which the Administrator shall update on a regular basis, of particular alternative test methods or strategies the Administrator has identified that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing.” EPA issued the original list required under TSCA in June 2018 with the Strategic Plan, and issued an update of the list in December 2019.

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New Strategic Plan for Tox21

Over the last 10 years, the U.S. federal Tox21 consortium has developed and evaluated in vitro HTS methods for hazard identification and mechanistic insight. Tox21 has generated data on thousands of pharmaceuticals and data-poor chemicals, characterized the limits and applications of in vitro methods, and enabled incorporation of HTS data into regulatory decisions. To more broadly address challenges in the field of toxicology, Tox21 released a new strategic and operational plan (Thomas et al. 2018) that expands the focus of its research activities. This plan proposed that Tox21 expand its portfolio of alternative test systems, address technical limitations of in vitro test systems, curate legacy in vivo toxicity testing data, establishing scientific confidence in in vitro test systems, and refine alternative methods for characterizing pharmacokinetics and in vitro assay disposition. The new Tox21 strategic and operational plan addresses key challenges to advance toxicology testing and will benefit both the organizations involved and the toxicology community.

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Implementation of the FDA Predictive Toxicology Roadmap

In December 2017, FDA published its Predictive Toxicology Roadmap for integrating predictive toxicology methods into safety and risk assessments. The Predictive Toxicology Roadmap presents a framework for new or enhanced FDA engagement in the science of toxicology that includes six elements:

  1. An organizing committee to help identify areas where research is needed and reduce duplication of efforts.
  2. Training in use of new test methods.
  3. Communication among the agency, sponsors, and test method developers.
  4. Fostering collaborations across sectors and disciplines nationally and internationally.
  5. Research to identify data gaps and promote promising technologies.
  6. Oversight to track progress.

FDA held a public hearing on September 12, 2018, to solicit comments on the roadmap. A public workshop on September 18, 2019, highlighted work done by FDA to support and implement the roadmap.

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