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A new federal report is seeking to reduce animal toxicity testing by advocating for the development and use of new technologies that could replace animals.

The report, A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States, was developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which facilitates the development of toxicological testing methods that replace, reduce or refine the use of animals.

Warren Casey, PhD, director of the National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods, said that the aim of the report is to offer a strategic roadmap for the safety testing of drugs and chemicals and aims to provide more human relevant toxicology data while ultimately reducing the use of animals in testing.

“The biggest thing that has come out of this roadmap effort is the need to really understand which tests are being required by agencies and how is the data being used,” Casey said in an interview with R&D Magazine. “In order for any success, give the people what they need. If we don’t start there with every single project we are not going to succeed .”

The three strategic goals outlined in the report include—connecting new test-method developers with end users, promoting flexible approaches for establishing confidence in new methods, and encouraging the adoption of new methods by federal agencies and regulated industries once validated, including high-throughput screening, tissue chips and computational models for toxicity testing of chemicals and medical products.

According to Casey, one of the hurdles to getting a full understanding of animal testing is there are not solid metrics to base the success of any initiatives on.

“One of the areas we really need to improve on is metrics,” Casey said. “How do you prove that you are actually doing anything? When we start a project we need to establish metrics because there is certainly a concern that if we don’t do it, Congress will make us do it.”

Casey explained that calculating the number of methods currently being used for testing is not a good metric, nor is just adding the total number of animals used.  In fact, it is nearly impossible to use the number of animals involved in testing as a metric in the U.S. because in accordance to the Animal Welfare Act rats, mice and birds are technically not classified as animals and not offered the same protections under the law as other species.

While the report does not propose legislation, Casey said one thing Congress could take on that would be helpful to achieve the goals of his organization is to eliminate outdated and cumbersome legislation that makes it difficult for new toxicology testing methods to emerge.

The report recommends developing mechanisms to improve the communication between end users and researchers, including hosting workshops or webinar series aimed at identifying agency and industry priorities.

The report also encourages the establishment of grant review criteria tailored to the development of alternative testing methods.

“Funding development of NAMs (new approach methodologies) should begin as early in the research and development process as possible,” the report states. “However, most current grant review processes are tailored to reward research involving animal models.

“To better support NAM development, processes for influencing the distribution of funding to NAMs by the federal government should be explored.”

Another recommendation is to identify and collect sources of high-quality human toxicological exposure, create centralized data access points that are publicly available, and actively solicit the submission and collation of parallel data from animal studies and alternative methods.

The report was completed over a three-year period as a partnership between 16 federal agencies and published on Jan 30 by the National Toxicology Program—a federal interagency program headquartered at the National Institute of Environmental Health Sciences in North Carolina.

ICCVAM was initially formed in the early 1990s and formalized in 2000 with the ICCVAM Authorization Act of 2000.

“We are really trying to make this a cross government activity,” Casey said. “Having all those people and making sure they were all onboard took a lot of work.”

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