Scientists and animal welfare advocates want an upcoming EPA strategy on ways to reduce the use of animals in chemical safety tests to state specifically what is expected of both regulators and companies.
The Environmental Protection Agency will release its long-awaited strategic plan to promote alternative methods for animal testing the week of March 5, Louis Scarano, who manages the development of the strategy, said Feb. 28 at an American Chemistry Council conference in Washington.
The amended Toxic Substances Control Act requires the EPA by June 22 to develop a strategy to reduce or replace vertebrate animal tests and use more data from non-animal tests to predict the health and environmental effects of chemical exposures.
The chemical industry and animal welfare advocates are looking for specific and technical language in the plan that would detail methods and criteria, how the EPA will implement the non-animal approaches in chemical assessments, and what information regulators need from the alternative tests to aid regulatory decisions. The guidelines should also be flexible enough to accommodate new approaches in the future, they said.
Detailed Plans and Criteria
Catherine Willett, director of regulatory toxicology, risk assessment and alternatives at the Humane Society of the United States, said she is looking for a well-articulated, descriptive strategy for how the EPA will identify testing methods that don’t involve animals, determine the information needed to make decisions, and successfully implement new approaches.
The agency presented a basic outline of the strategy in November.
But the chemicals industry needs very specific guidance on what criteria federal agencies will use to determine if new testing methods are acceptable, Craig Rowlands, senior scientist at Underwriters Laboratories, told Bloomberg Environment.
Animal Data a Benchmark
Historical chemical bioassays—which involve testing on a living organism—could serve as a benchmark for how accurate the new, alternative tests need to be in predicting chemical safety, Rowlands said.
Allowing the industry to access that data could help determine if new approaches will deliver equivalent scientific information to what an animal bioassay offers.
Sue Marty, toxicology science director at the Dow Chemical Co., told Bloomberg Environment the EPA needs to develop a framework “where alternative models can be applied in a manner such that they are ‘fit for their intended purpose.’”
The agency could work with laboratories and other groups with alternative test experience to support decisions to shape the strategy, she said.
The elements of an evaluation to prioritize chemicals, for example, could be different than those for a final hazard decision, she said.
The strategy should also clearly state that developing non-animal tests is an iterative process, and that the plan will continually be updated to reflect new technologies, Willett said. The EPA is required to provide a report to Congress every five years on progress in implementing the plan.
The agency’s list of acceptable new methods and strategies should clearly state that companies are also free to use evolving approaches not on the list, Kristie Sullivan, vice president of research policy with the Physicians Committee for Responsible Medicine, told Bloomberg Environment. The list is a starting point, and should allow the effort to keep evolving, she said.
The agency’s Office of Pollution Prevention and Toxics—which evaluates new and existing chemicals—needs to leverage already-available methods in addition to new strategies to determine what works or can be changed, Sullivan said.