For decades, manufacturers of pharmaceuticals, cosmetics, pesticides and other commercial chemicals have tested their products on rodents or other vertebrate animals to comply with government safety testing regulations. This long-standing practice is now slowly starting to change. The Environmental Protection Agency recently announced that it intends to phase out all mammalian animal testing requirements by 2035. The Food and Drug Administration has also been actively exploring non-animal alternatives to safety testing.
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Reasons Behind the Shift
The paradigm shift away from animal testing is being propelled by the convergence of ethical, economic, and scientific pressures. Animal rights proponents have long opposed animal testing, and this ethical campaign is strengthening with growing antipathy to animal tests by young consumers and scientists.
Economics provides a second rationale for considering alternatives to animal testing, as housing, feeding, and exposing animals under carefully controlled conditions is increasingly expensive.
Most importantly is the role that science is playing in pushing for non-animal alternatives. It has been known for years that animal tests do not always accurately predict human safety. Reliance on animal tests therefore can produce false negative or false positive results that can have significant adverse consequences for human safety.
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What is aiding in the shift away from animal testing
A variety of new safety testing approaches, collectively called new approach methodologies (NAMs)*, have recently been developed. A NAM is any non-animal technology, methodology, or approach that can be used to provide information on chemical hazard and risk assessment. These include a variety of human cell in vitro systems, artificial organoids, “lab on a chip” technology, other high throughput screening methods, and computational or in silico tools in which machine intelligence conducts the analysis virtually.
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But Outdated Laws and Government Regulations are Standing in the Way
Over the past decades of mandated animal testing, agencies such as the EPA and FDA have embedded animal testing requirements into their regulations, which have the force of law. Unless these existing regulations are resolved, regulators cannot mandate or even approve non-animal testing for product safety, and manufacturers will not have confidence that their non-animal testing will stand up to regulatory or judicial scrutiny.
This is another manifestation of the so-called “pacing problem” where outdated legal requirements impede new scientific developments.
Regulatory agencies may be able to use regulatory gymnastics to circumvent some of these existing legal barriers to reliance on non-animal testing. For example, the EPA recently enacted a waiver program to exempt some pesticides from mandated testing in birds. While such efforts may reduce some unnecessary animal testing, a more comprehensive solution is needed.
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What is Needed
Agencies such as the FDA and EPA should act with anticipation now to start revising their own regulations to eliminate the mandatory use of animal tests in safety testing. Foresight today can prevent delay and inefficiency tomorrow.
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*The adoption of NAMs to replace animal tests got a big boost from the 2016 amendments to the Toxic Substances Control Act (TSCA), known as the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The act requires the EPA to eliminate vertebrate animal testing to “the extent practicable” when regulating new and existing chemicals under the TSCA statute.
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Author Gary E. Marchant is Regents’ Professor and faculty director of the Center for Law, Science & Innovation at the Sandra Day O’Connor College of Law at Arizona State University.
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