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Environmental Factor

Environmental Factor

Your Online Source for NIEHS News

October 2018

Regulators play key roles in replacing animals in tox testing

To help reduce animal use in toxicity testing, regulators should clarify what information they need and which new approaches they accept.

At the annual meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM), industry representatives requested that regulators clearly describe both information needs and their willingness to accept data from new approach methodologies (NAMs) to fulfill those needs.

Experts from academia, industry, and animal welfare organizations participated in the Sept. 5-6 meeting. They discussed the need for high-quality reference data from past animal tests to evaluate the performance of new methods. They also considered issues involved in sharing and using those data.

NIEHS and National Toxicology Program (NTP) Director Linda Birnbaum, Ph.D., thanked attendees for the productive meeting. She expressed optimism for overcoming the difficulty of many of the issues discussed. “There’s always a way around, and it’s a challenge to figure out how we can make it happen,” she said.

Birnbaum and Berridge share knowledge throughout the meeting Birnbaum and NTP Associate Director Brian Berridge, D.V.M., Ph.D., were active in discussions throughout the meeting. (Photo courtesy of Steve McCaw)

Finding opportunities

Attendees at the meeting, which was held at NIEHS, discussed actions needed to advance goals outlined in the recently published Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States. One of the goals discussed in depth at the meeting was how to encourage regulators and regulated industry to use new methods.

Anna Lowit, Ph.D., from the U.S. Environmental Protection Agency (EPA), described activities in this area, highlighting international (see sidebar) efforts to provide training on using new methods. Lowit co-chairs the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which SACATM advises.

Lowit listens during the meeting Lowit and Emily Reinke, Ph.D., from the U.S. Department of Defense, co-chair ICCVAM. (Photo courtesy of Steve McCaw)

One focus of discussion following her presentation was the role of specific new approaches. “If a NAM is not replacing [an animal test] but is adding new and valuable insight and providing decision-enabling data, the introduction is welcomed,” noted SACATM member Hisham Hamadeh, Ph.D., from the pharmaceutical company Amgen. Resistance to adopting the new method will increase, “if the NAM is replacing something that is already in existence, and not enabling clear decisions,” he added.

SACATM chair Pamela Spencer, Ph.D., from ANGUS Chemical Company, noted that opportunities to use nonanimal tests might be found in areas that are not subject to regulation. “We shouldn’t just think of NAMs as a replacement for how we’re making regulatory decisions, but NAMs for how we’re building safety into product launch and design,” she said.

SACATM chair Spencer speaks during the meeting SACATM chair Spencer brings experience from both large and small chemical companies to her work on the committee. (Photo courtesy of Steve McCaw)

Connections lead to collaborations

Casey addresses the participants Casey reviewed the Strategic Roadmap and described the participants and relationships involved in ICCVAM, its history, and SACATM. (Photo courtesy of Steve McCaw)

Participants frequently stressed the importance of communication and collaboration among different sectors and regions. It was clear during breaks, when the approximately 60 attendees held animated discussions with each other, that the SACATM meeting provided an opportunity to initiate such collaborations.

Warren Casey, Ph.D., director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), credited SACATM members and their input for the progress that ICCVAM has made in recent years. “This really is an all-star cast of people knowledgeable in the field of alternatives.”

Slides, meeting minutes, and other materials from the SACATM meeting are available on the NTP website.

(Catherine Sprankle is a communications specialist for ILS, the contractor supporting NICEATM.)

Members Charest and Williams-Devane responded to a presentation Ad hoc SACATM member Joseph Charest, Ph.D., right, from The Charles Stark Draper Laboratory, listened while fellow member ClarLynda Williams-Devane, Ph.D., from North Carolina Central University, responded to a presentation.
Chandrasekara participates in the meeting Charu Chandrasekara, Ph.D., represented the Canadian Centre for the Validation of Alternative Methods.
Hamadeh shared his experience during the meeting SACATM member Hamadeh drew on his experience in drug development in his comments on the use of animal models for safety testing.
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