Environmental Factor – July 2022: Advances in Non-Animal Methods Showcased in Public Forum


Federal agencies and their stakeholders discussed regulatory and research initiatives to reduce the use of animals in chemical safety testing at the May 26-27 public forum hosted by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

Nicole Kleinstreuer, Ph.D., is acting director of the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, which hosts the annual public forum. (Photo courtesy of Steve McCaw/NIEHS)

The committee is made up of federal agencies such as the NIEHS, the US Environmental Protection Agency, and the US Food and Drug Administration (FDA). Stakeholders include industry, academia and animal welfare groups.

The public forum has taken place every year since 2014. This year, for the first time, the meeting was scheduled over two days to cover the large number of ongoing activities within member agencies. The program included 15 presentations from eight of ICCVAM’s 17 member agencies, as well as updates on the ICCVAM board and international activities.

High stakeholder interest and engagement

The online meeting has generated widespread public interest, with more than 100 people watching the meeting every day. Five representatives from ICCVAM’s stakeholder groups made oral statements at the meeting.

The statements encouraged ICCVAM agencies to look beyond the obvious regulatory contexts to reduce animal use. While praising agencies’ efforts to reduce animal testing requirements and expand acceptance of non-animal testing, commentators stressed the need for agencies to clearly communicate which non-animal testing would be accepted. They also stated the need to develop approaches to validate new tests that do not require comparison with animal data, and to eliminate the use of animals for the production of antibodies and other reagents.

Remarks by Elizabeth Baker on behalf of the Physicians’ Committee for Responsible Medicine addressed the potential benefits of using human cell-based systems to predict the potential toxicity of new drugs. “There are good reasons to do this work centered on human health and scientific innovation,” she said. “It’s not just about saving animals, although that’s also very important.”

John Gordon Gordon is the agency’s lead representative to CPSC’s ICCVAM. He was recently elected to lead ICCVAM along with co-chair Anna Lowit, Ph.D., of the US Environmental Protection Agency. (Photo courtesy of John Gordon)

NIEHS scientist Nicole Kleinstreuer, Ph.D., who moderated the public statements session, thanked stakeholders for their constructive feedback. “Getting feedback from our public stakeholders is one of the most important aspects not only of this meeting, but also of our broader commitment to supporting public health and environmental protection with alternatives to experimentation. animal and human science,” she noted.

Agencies provide guidance and resources

Many of the day one presentations focused on regulators’ initiatives to reduce animal use requirements. John Gordon, Ph.D., described new guidelines from the U.S. Consumer Product Safety Commission (CPSC) on alternatives to animal use to meet the requirements of the Federal Hazardous Substances Act.

Gordon’s presentation generated several questions, including one on whether and how CPSC would measure the use of non-animal methods. “We will establish metrics so that we can track what methods are used and how often. We really want to follow that,” he replied.

Brandy Beverly Brandy Beverly, Ph.D., NIEHS Scientist, described the activities of the Cardiovascular Health Effects Innovation Program within the NIEHS Division of the National Toxicology Program. (Photo courtesy of Steve McCaw/NIEHS)

A number of questions and comments also followed a presentation by David Strauss, Ph.D., of the FDA Center for Drug Evaluation and Research. A viewer asked if an FDA initiative to promote the use of alternatives to animal testing would emphasize the use of human data to evaluate new methods. Strauss supported this approach saying, “If we’re talking about medical products for humans and predicting risk and efficacy in humans, then yes, harnessing human data is the way to go.”

Variety of research approaches

Presentations describing research activities illustrated the diversity of approaches used to replace animal experimentation. Tyler Goralski, Ph.D., described US military studies using organ chips to predict lung, liver, and kidney toxicity. A different approach to predicting toxicity was highlighted by Jueichuan Chang, Ph.D., who described how the FDA Center for Tobacco Products uses computational approaches to predict how e-cigarette ingredients might damage DNA.

Slides and video from the meeting will be available on the National Toxicology Program website.

(Catherine Sprankle is a communications specialist for Inotiv, the contractor behind NICETM.)


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