On Dec. 2, the U.S. Environmental Protection Agency (EPA) released the first update to its New Approach Methods (NAMs) Work Plan for reducing the use of animals in chemical testing through 2024.
“We are pleased to see that the plan confirms that the reduction and replacement of animal tests is a priority for the agency, since it is certainly a priority for the American people,” said Kristie Sullivan, MPH, vice president of research policy for the Physicians Committee.
The updated Work Plan retains key steps toward the EPA's reduction goals, including:
- Ensuring that the agency's regulatory framework is flexible enough to accommodate the use of NAMs
- Establishing metrics to track progress
- Increasing scientific confidence in NAMs by using them to support regulatory decisions
- Developing NAMs that fill critical information gaps
- Encouraging the development and evaluation of new methods by external organizations (important to save EPA resources)
- Reinforcing the importance of EPA staff training on NAMs
- Highlighting the role test waivers can play in avoiding the deaths of thousands of animals
- Engaging stakeholders to incorporate their knowledge and address their concerns
The work plan also increases the EPA’s efforts to reduce and replace testing on all vertebrates by expanding the first work plan’s focus beyond mammals, to include fish, amphibians, and birds. This is a huge step in protecting all animals from chemical tests and unsafe chemicals.
Protecting human health and the environment from tens of thousands of new and existing chemicals, as well as their complex mixtures, depends on the greater efficiency that NAMs provide. NAMs allow the EPA to more quickly identify and remediate risks to potentially exposed or susceptible subpopulations, including infants, children, pregnant women, workers, and the elderly, as well as fence-line communities adjacent to chemical emitters, which are disproportionately inhabited by people of color. Because many NAMs use human cells and tissues, they require no extrapolation from effects observed in animals to concerns for human health. Cells can even be used from a variety of people from different genetic, medical, or other backgrounds to reflect the potential diversity of responses individuals might experience from chemical exposures. NAMs don’t just benefit humans; they can also identify risks of pesticides to animals in the environment, including members of endangered species, without killing more animals in laboratory tests.
EPA efforts to reduce and replace animal testing have spanned several Administrations of both major political parties. Conducted at the EPA's request, the National Academy of Sciences' landmark 2007 review, Toxicity Testing in the 21st Century: A Vision and a Strategy, called for the transformation of toxicity testing from a system based on animal testing to one based on nonanimal, in vitro methods. In 2016, the Lautenberg Chemical Safety Act for the 21st Century (LCSA) codified the EPA's commitment to “reduce and replace […] the use of vertebrate animals in the testing of chemical substances,” mandating that it first consider NAMs that provide “information of equivalent or better scientific quality and relevance.” In the same year, the EPA's Office of Pesticide Programs (OPP) affirmed that NAMs “give us the opportunity to evaluate more pesticides across a broader range of potential effects in less time, using fewer animals and reducing costs.” Two years later, both OPP and the EPA's Office of Pollution Prevention and Toxics began accepting nonanimal approaches that predict skin sensitization in humans more accurately than do tests in mice.
While a growing number of internationally accepted test guidelines are already based on NAMs, the EPA continues to develop new NAMs to support regulatory decisions. At the EPA's request, the National Academy of Sciences is currently reviewing the variability and relevance of existing mammalian toxicity tests, because providing information of equivalent or better scientific quality and relevance requires the quality and relevance of these tests to be first understood. To screen existing chemicals for evaluation under the LCSA, the EPA's Public Information Curation and Synthesis approach integrates publicly available hazard and exposure information to determine the effort and resources needed to evaluate them. For the first tier of that evaluation, the EPA has developed high-throughput transcriptomics and image-based phenotypic profiling methods to estimate in vitro potency that can then be compared to human exposures or to existing in vivo data. The EPA also uses these methods to predict toxicity mechanisms that can be further tested with other NAMs.
No matter the administration, Physicians Committee scientists will continue to work with the EPA to ensure its rapid progress toward reducing—and eventually replacing—the use of animals in chemical testing with more relevant, reliable, and humane nonanimal approaches.