Environmental Factor

Environmental Factor

Your Online Source for NIEHS News

October 2017

Speeding the adoption of alternative safety tests

Scientists from the National Toxicology Program (NTP) and other government offices received positive public feedback on a plan to replace animal use for safety testing.

About 40 participants attended the Sept. 18-19 meeting of the  Scientific Advisory Committee on Alternative Toxicological Methods (SACATM; see sidebar), held at the National Institutes of Health in Bethesda, Maryland. Participants provided feedback on a strategic roadmap for new approaches to evaluating the safety of chemicals and medical products. This was the last in a series of meetings to gather public input on the plan, due to be published in December.

Wei Xu and Lawrence Milchak SACATM members Wei Xu, Ph.D., left, from the University of Wisconsin at Madison, and Lawrence Milchak, Ph.D., right, from 3M Corporation, relaxed during a meeting break. (Photo courtesy of Catherine Sprankle)

While offering a number of specific suggestions to consider as the roadmap is finalized, committee members praised both the roadmap document itself and the work that has already been done toward achieving its goals. “The tremendous amount of work that’s already gone into this is great,” said SACATM member ClarLynda Williams-Devane, Ph.D., from North Carolina Central University.

The draft roadmap lays out three strategies to achieve the goal of replacing animal tests.

  • Encourage adoption and use of new methods.
  • Establish confidence in new methods.
  • Connect developers of new methods with those who will ultimately use them.

Encourage adoption and use

Lowit Speaking “It’s a complicated thing, but leaders … someone has to take the first step and hope that the people follow suit,” said Lowit, referring to adoption of new testing methods. (Photo courtesy of Catherine Sprankle)

Anna Lowit, Ph.D., from the U.S. Environmental Protection Agency (EPA), noted that regulators and industries must work together internationally to identify methods that can meet regulatory needs. Lowit is co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), which SACATM advises.

Feedback from participants emphasized the need for regulatory agencies to communicate clearly about which testing approaches meet their needs. For example, agencies could promote success stories and provide incentives to use new approaches.

Commenting on behalf of Physicians Committee for Responsible Medicine, Kristie Sullivan praised EPA for committing to use new testing approaches and to determine which approaches are acceptable.

Establish confidence

Participants agreed that sharing data and information are important factors in building confidence in new methods. SACATM member Kelly Coleman, Ph.D., from medical device manufacturer Medtronic, cited a 2015 workshop on acute toxicity testing as an example of information sharing.

“That meeting brought together a lot of different stakeholders, industry people, government people, getting together and telling each other what kinds of acute systemic tox tests they use,” he said.

Abby Jacobs and Linda Birnbaum NIEHS and NTP Director Linda Birnbaum, Ph.D., right, thanked ICCVAM Co-chair Abby Jacobs, Ph.D., who recently retired from the U.S. Food and Drug Administration, for her many years of service to the group. (Photo courtesy of Catherine Sprankle)

Coleman added that key elements for success of such workshops included setting goals with timelines and publicizing results. The 2015 workshop was organized by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).

Connect developers with end-users

Grants to small businesses were discussed as one example of how developers of new test methods could connect with the industries and regulators that will use those methods and the data they produce.

Daniel Shaughnessy, Ph.D., from the Division of Extramural Research and Training described current NIEHS funding opportunities for small businesses that develop tests with the potential to replace animal use.

He emphasized that administrating each of these grants involves a steering committee with members from regulatory agencies. “We try to, early on, get involvement from the agencies that may be using these tests to increase the likelihood that they’ll be accepted as alternative models,” he explained.

Materials and video recordings from the SACATM meeting are available on the NTP website.

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


Deputy Director Nicole Kleinstreuer NICEATM Deputy Director Nicole Kleinstreuer, Ph.D., who also serves on ICCVAM, described work to implement the roadmap goal for acute systemic toxicity testing. (Photo courtesy of Catherine Sprankle)
Warren Casey and Tae Sung Kim Tae Sung Kim, Ph.D., right, from the Korean Center for Validation of Alternative Methods, observed the meeting and met with collaborators. NICEATM Director Warren Casey, Ph.D., left, serves on ICCVAM. (Photo courtesy of Catherine Sprankle)
group meeting and discussion During a time of informal discussions, SACATM member Catherine Willett, Ph.D., center, from the Humane Society of the United States, spoke with ICCVAM members, from left, Kleinstreuer, Casey, Moiz Mumtaz, Ph.D., from the Agency for Toxic Substances and Disease Registry, and Lowit. (Photo courtesy of Catherine Sprankle)
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