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Annual Report for Fiscal Year 2018

Annual Report for Fiscal Year 2018
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https://ntp.niehs.nih.gov/go/860653

Roadmap to Guide Progress Toward Replacing Animal Use

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which includes representatives of 16 federal government agencies, published the "Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States" on January 30, 2018. The roadmap will guide the replacement of animal use in safety testing of drugs and chemicals in the United States.

Many accepted methods for chemical safety testing rely on laboratory animals. It has been demonstrated that non-animal testing approaches based on toxicity pathways could better predict effects in humans. However, acceptance of such approaches to date has been limited by a lack of communication and coordination among regulatory agencies, test method developers, and regulated industries.

The roadmap was developed to guide the application of new technologies to toxicity testing of chemicals and medical products. The roadmap describes three strategic goals required for progress.

  1. Connect new test method developers with end users.
  2. Promote flexible approaches for establishing confidence in new methods.
  3. Ensure that new methods will be used by federal agencies and regulated industries once validated.

The roadmap describes activities to achieve these goals that should be undertaken by regulatory agencies, test method developers, regulated industries, funding agencies, and other stakeholders.

The roadmap has been translated into Spanish Chinese, Japanese, Korean, and Portuguese. These are available on the NICEATM website.

At its September 5–6, 2018 meeting, members of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) and other experts discussed these actions outlined in the roadmap and advised U.S. government scientists on issues that should be addressed to replace animal use for safety testing. This panel of experts was drawn from industry, academia, and animal welfare organizations and meets annually to advise ICCVAM, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the NIEHS director on activities related to ICCVAM’s mission.

Strategic roadmap

The roadmap provides a conceptual framework for development, evaluation, and use of new approach methodologies. (Photo courtesy of NTP.)