Environmental Protection Agency Administrator Andrew Wheeler has signed a directive to reduce funding and requests for animal testing.
The directive sets a target of reducing mammal study requests and funding 30% by 2025 and would eliminate all mammal study requests and funding by 2035.
“We are also awarding $4.25 million to advance the research and development of alternative test methods for evaluating the safety of chemicals that will minimize and hopefully eliminate the need for animal testing,” Wheeler said.
Any mammal studies requested after 2035 will require administrator approval on a case-by-case basis. In accordance with the memo, the EPA also will hold an annual conference on “new approach methods” (NAMs), which typically reduce or eliminate animal tests, beginning in 2019.
Among the alternative testing methods that Wheeler mentioned were computer modeling programs and in vitro tests, based on human cells and tissues.
The agency’s directive also applies to its office of chemical safety and pollution prevention and its research and development office.
While the EPA doesn’t conduct animal testing itself, pesticide companies seeking to register their products under the Federal Insecticide, Fungicide, and Rodenticide Act are often required to conduct significant animal tests when they submit data to the agency.
“Because they are designed to have biological activity, internationally pesticides are tested heavily to ensure safety,” said Anna Lowit, a senior science adviser in the EPA’s Office of Pesticide Programs.
Lowit said most countries require the same kinds of tests, such as for acute lethality, cancer, effects on the developing organism during pregnancy, and effects on reproduction.
By comparison, in the drug sector, new products eventually move on to humans in clinical trials, “but in the pesticide arena we don’t go to clinical trials so everything is done on animals,” said Lowit. “More lab animals are used on pesticide testing than any other sector because of that reason.”
Some consumer advocacy groups have questioned whether nonanimal testing methods are as accurate as mammal-based tests.
“Without non-human primate research, we lose our ability to learn better ways to prevent negative pregnancy outcomes, including miscarriage, stillbirth and premature birth,” wrote Nancy Haigwood, a scientist and director of the Oregon National Primate Research Center.
In a 2016 white paper, Haigwood said primate research, mostly on monkeys, has been directly responsible for helping scientists uncover information to make human organ transplants easier and more accessible.
Other scientists have also pointed out that because in vitro and nonanimal procedures are generally used in combination with live animal testing, they complement animal research, rather than replace it.
Equivalent or Better
Speaking before reporters at a ceremonial signing of the new directive, Wheeler said scientific advancements make it possible for NAMs to produce the same, or better, data on the potential biological effects to humans.
“Sometimes the information that we learn from rats is not directly applicable to humans,” he said.
Wheeler pointed out that not only will transitioning to computer-based testing save more animals, but it could also potentially allow scientists to evaluate more chemicals for broader range of biological effects more quickly.
“For decades, there has been a misguided reliance on cruel and scientifically flawed animal tests, and the EPA’s decision marks the beginning of the end of them,” said Amy Clippinger, director of PETA’s regulatory testing department.
Going forward she said PETA’s scientists will be collaborating with regulatory agencies and companies, “to help them switch to efficient and effective, nonanimal testing approaches and finally replace toxicity tests on all animals,” she said.
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