January 18, 2024: The U.S. Environmental Protection Agency (EPA) recently reversed its decision to implement to phase out the use of mammals in chemical safety testing by 2035.
This move, announced in 2019, aimed to accelerate the adoption of non-animal testing models such as computer programs and “organs on a chip.” The decision to abandon the 2035 deadline has sparked debates among scientists, environmental advocates, and former EPA officials.
The animal testing debate
Former EPA Administrator Andrew Wheeler, who initially set the deadline, expressed concerns that this move will stall the development of alternative methods. Wheeler fears that this reversal represents a step toward maintaining the status quo and taking the “easy way out.”
Those who welcome the EPA decision for the removal of deadline say that ending animal experimentation without any adequate alternative methodology is concerning. In vitro/petri dish testing is incomplete and do not give a whole picture of the effects and impact on a full-blown human with a complex body structure. Solely relying on cell-based assessments for determining chemical safety is unsafe, they say.
Some scientists say that the intricacies of some biological processes are not fully understood, making it challenging to develop accurate alternative methods that can predict all potential effects of chemicals. Animal testing has historically provided insights into complex biological responses that may be difficult to replicate in vitro or in silico.
As with any major shift in scientific approaches, there is a possibility of unforeseen consequences. The full impact of relying solely on alternative methods may not be apparent until they are widely implemented, and there could be unexpected challenges or limitations that emerge over time. These include the transition cost both in terms of resources and manpower.
Additionally some big companies have proprietary computation testing models, which they are not obliged to share or divulge and may lead to unauthorised and ungoverned activities.
The European Union and its various regulatory agencies have been actively working toward reducing and eventually phasing out animal testing for chemicals. The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation, REACH, adopted in 2007, aims to ensure the safe use of chemicals while minimizing animal testing. The European Chemicals Agency (ECHA) plays a crucial role in implementing REACH. ECHA has established the REACH-IT platform, which allows companies to submit information and data on chemical substances without the need for new animal testing.
Focus on scientific advancements
The EPA attributes the decision to the need to focus on scientific advancements rather than arbitrary dates. Chris Frey, the agency’s assistant administrator for R&D, emphasizes the importance of advancing methods that do not involve animal testing while acknowledging the need for a science-driven approach.
The initial push for phasing out animal testing was prompted by a 2016 amendment to the federal Toxic Substances Control Act, which required the EPA to move away from animal experiments without specifying a strict deadline. Wheeler’s 2019 pledge included stopping mammal studies by 2035, with an interim goal of a 30% reduction by 2025.
Critics accused Wheeler of catering to the chemical industry, which views animal testing as time-consuming and expensive.
Both the 2025 and 2035 deadlines have now been abandoned. The White Coat Waste Project, an advocacy group against taxpayer-funded animal experiments, brought attention to this change in plans based on internal EPA documents.
Despite the removal of the deadlines, the EPA states that its commitment to exploring alternatives to animal experiments remains unchanged. The agency aims to fully phase out animal testing, although the timeline for such a transition remains uncertain.
The debate continues among scientists, environmental advocates, and policymakers about the feasibility of phasing out animal testing for chemicals and the adequacy of current alternative models.