Measuring U.S. Federal Agency Progress Toward Implementation of Alternative Methods in Toxicity Testing
The U.S. Government Accountability Office (GAO) recommended to Congress that federal agencies establish a workgroup through ICCVAM to propose metrics for assessing progress on the development and promotion of alternative methods. This document describes the recommendations of the ICCVAM Metrics Workgroup.
"Implementing the Strategic Roadmap: Incorporation of Alternatives and Associated Metrics" was a major theme of discussion at the 2022 meeting of the Scientific Advisory Committee on Alternative Toxicological Methods.
Adoption of Alternatives and Reduction of Animal Use
Federal agencies promote the use of alternative methods for biomedical research and testing to evaluate toxicity. Implementation of alternatives can:
- Replace animals with non-animal systems or one animal species with a phylogenetically lower one.
- Reduce the number of animals required to provide scientifically valid results.
- Refine procedures to decrease pain and distress.
ICCVAM was established to promote chemical hazard evaluation methods that protect human health and the environment while reducing animal use. ICCVAM’s 2018 strategic roadmap called for the identification of appropriate metrics for monitoring progress and measuring success in adopting alternatives.
In response to a request by Congress, the GAO investigated and reported on how federal agencies ensure that alternative methods are being considered and used. The GAO found that federal agencies actively promote the use of alternative methods in a variety of ways, including:
- Modifying regulations and policies.
- Incorporating new methods into guidances.
- Inspecting testing facilities.
- Providing training on the use of alternative methods.
- Developing new strategic plans to minimize the use of animals.
However, the GAO also found that federal agencies have not routinely developed or reported metrics that demonstrate how their efforts to encourage the use of alternative methods affect animal use.
The GAO report recommended that ICCVAM establish a workgroup to develop metrics that ICCVAM member agencies could use to assess progress made toward replacing, reducing, or refining animal use in testing. Furthermore, the report recommended that such metrics be incorporated into ICCVAM Biennial Progress Reports.
In response, ICCVAM established its Metrics Workgroup in early 2020. The workgroup included members from nine ICCVAM agencies. Its charge was to determine how agencies can best address the GAO report’s recommendations within the context of the ICCVAM Authorization Act. The workgroup developed the document linked above, which was published in March 2021.
Agency Activities to Measure Success
ICCVAM agencies are developing webpages to inform their stakeholders about progress on adoption of alternatives and reduction of animal use. Links to those pages are available below.
- Recent ICCVAM agency activities
- EPA New Approach Methods: Efforts to Reduce Use of Animals in Chemical Testing (U.S. Environmental Protection Agency)
- Adopting 21st Century Science Methodologies – Metrics (Office of Pesticide Programs, U.S. Environmental Protection Agency)
- Advancing Alternative Methods at FDA (U.S. Food and Drug Administration)
- Assessing Contaminant Hazards Without a Critter – Advancements in Alternatives to Animal Toxicity Testing (U.S. Geological Survey, U.S. Department of the Interior)
- USGS Ecosystems Mission Area: Animal Welfare Assurance (U.S. Geological Survey, U.S. Department of the Interior)
- Animal Welfare Information Center (National Agricultural Library, U.S. Department of Agriculture)
- Recommended Procedures Regarding the CPSC’s Policy on Animal Testing (U.S. Consumer Product Safety Commission)