Gaining acceptance of new test methods, such as faster, more accurate ways for predicting toxicity, involves a change in thoughts and approaches. A workshop Nov. 20-21, sponsored by the National Academies of Sciences, Engineering, and Medicine (NASEM), explored the paradigm shift required for successful adoption of advanced test methods.
John Bucher, Ph.D., NIEHS associate director of the National Toxicology Program (NTP), served on the planning committee, as did several NIEHS grantees. “We wanted to look at how other groups had faced paradigm shifts,” Bucher explained. “How did they build confidence in new methods, what steps did they take.”
Build trust, share evidence
For the event, Understanding Pathways to a Paradigm Shift in Toxicity Testing and Decision Making, organizers selected specific case studies to be presented. The planning team invited experts in test methods, regulation, and the social sciences. Participants agreed that adoption of new methods requires building trust and sharing evidence among stakeholders, including regulators, industry, public interest groups, academia, and members of the public.
“It is extremely difficult to move new science into regulatory science,” said Lynn Goldman, M.D., dean of the George Washington University Milken Institute School of Public Health, and formerly of the U.S. Environmental Protection Agency (EPA). Goldman discussed the EPA Endocrine Disruptor Screening Program and its path to adopting new screening methods.
Anna Lowit, Ph.D., from EPA, shared her experience with developing and adopting alternative toxicity text methods. She chairs the federal Interagency Coordinating Committee on the Validation of Alternative Methods. Lowit underscored the importance of working across different sectors to build public confidence. “Expediting the use of 21st century science is not just about reducing our animal use, it’s fundamentally about making better public health decisions,” she said.
Steps toward a paradigm shift
Melissa Perry, Sc.D., from George Washington University, is co-chair of the NASEM standing committee on Emerging Science for Environmental Health Decisions, which sponsored the workshop. In closing remarks, she called the discussions profound and thought-provoking. Perry summarized challenges posed by the paradigm shift, as follows.
- Epistemological — What makes a good test, what are the questions the test is trying to answer, and honesty about what scientists know and do not know.
- Technical — Moving from using 20th century methods to 21st century methods, including addressing mixtures and performing functional assays.
- Societal — Fulfilling the mandate to protect public health, address social inequalities, meet legal and regulatory requirements, and work within the framework of federal regulatory agencies.
Such a shift requires a collective activity, Bucher said later, reflecting on the meeting. He described a need for convergence of the test creators, the regulators, and, especially, members of the public. “You have safety paradigm that you’ve used for 50 years,” he explained. “People want to know why you are changing it, and what does that mean about the old ways of doing things.”
Presentations will be posted to the workshop website, linked above, and the committee will publish a report on the proceedings in the coming months.