Progress toward replacing use of animals for safety testing of drugs and chemicals in the United States will be guided by a strategic roadmap developed by 16 federal government agencies. The roadmap was published Jan. 30 by the National Toxicology Program (NTP).
The "Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States" was developed during 2017 by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
“This document improves on similar past efforts in some very important ways,” noted Warren Casey, Ph.D. Casey directs the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), which supports ICCVAM.
“For one thing, the roadmap represents a statement by federal agencies of how they envision new approaches to toxicological testing being adopted, as opposed to this perspective being provided by an external group,” he continued. “If progress in this area is going to happen, the agencies need to take the lead, and that is exactly what they are doing with the publication of the roadmap.”
Elements that will help the roadmap achieve its goals include a focus on human health, understanding customer needs, and transparent, publicly tracked implementation plans, according to Casey.
Collaboration and confidence will encourage use
Many accepted methods for chemical safety testing rely on laboratory animals. It has been demonstrated that nonanimal 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. Such technologies include high-throughput screening, organs-on-a-chip (see related story), and computational models. The document describes three strategic goals required for progress.
- Connect new test method developers with end users.
- Promote flexible approaches for establishing confidence in new methods.
- Ensure that new methods will be used by federal agencies and regulated industries once validated.
To achieve these goals, the roadmap describes activities that should be undertaken by regulatory agencies, test method developers, regulated industries, funding agencies, and other stakeholders.
Implementation already underway
Activities are already underway to address the roadmap goals (see sidebar). Presentations at the September 2017 Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting described implementation of the roadmap for skin sensitization and acute systemic toxicity testing. Reviews of U.S. agency information requirements and decision contexts for these areas, as well as for skin and eye irritation, are being prepared for publication later this year.
Engaging a diverse group of stakeholders will be essential to achieve the roadmap goals. To continue this process, ICCVAM is sponsoring a session on the roadmap at the Society of Toxicology meeting in March. Other public presentations on the roadmap will take place at an April meeting on high-throughput screening sponsored by the Society of Environmental Toxicology and Chemistry, and at the annual ICCVAM Public Forum on May 24.
(Catherine Sprankle, NICEATM Communications Specialist, works for ILS, the contractor supporting NICEATM.)