The recent directive by the Environmental Protection Agency (EPA) that it will reduce, and eventually eliminate, animal testing by 2035 is an important, welcome and overdue action. It is based on scientific and policy advancements that have been in the works for many years.
In 2007, the National Academy of Sciences, Engineering and Medicine (NASEM) issued the report Toxicity Testing in the 21st Century that recommended that EPA fundamentally change the way chemicals are tested.
The report concluded that the EPA should move toward a testing system that is more human relevant, cost effective and much less reliant on animal toxicology. EPA’s focus should be on evaluating biological processes that can lead to diseases.
To help make the vision of this report a reality, the federal government has invested in the underlying science. EPA launched a computational toxicology research program that includes high-throughput screening and robotics.
The EPA, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have created a program called “Tox21,” which applies 21st Century scientific tools to screen thousands of compounds for toxicity — without new animal tests.
In addition research universities (including my own) are also working hard to implement this vision. We do not yet have a full suite of non-animal tests ready to go, but these efforts demonstrate that we are serious about moving forward.
EPA’s decision correctly charts the arc of modern day regulatory toxicology while at the same time challenging the scientific community to do more. First, this move by the EPA is consistent with the concept of the three “Rs” of replacement, reduction and refinement, an idea about how to approach animal testing that was first proposed and adopted 60 years ago.
The three Rs underlie U.S. laws, regulations and policies that govern the use of animals in laboratories. One of these Rs, replacement, calls for the substitution of animal tests for non-animal methods when possible. The announcement by EPA is a bold step toward replacement, and in line with our scientific heritage.
Seeking to reduce and eventually eliminate vertebrate animal testing is also consistent with the actions that Congress taken. Congressional desire to move in this direction is evident in recent legislation.
In 2016, Congress passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act. This was the first overhaul to the nation’s major chemical laws in 40 years. It requires EPA to develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies that can replace vertebrate animals. This comprehensive overview, the first of its kind, was provided to Congress last year.
Congress has also exercised its appropriations authority to encourage EPA to incorporate the various recommendations of the NASEM report, provided additional resources to the agency for computational toxicology and required the agency to provide updates of progress made on the implementation of alternative methods. The requirements have been incrementally phased in over the past four or five years.
Further, legislation has been introduced in Congress by Reps. Lucille Roybal-Allard (D-Calif.) and Ken Calvert (R-Calif.) to actively encourage the use of non-animal models where feasible and applicable.
The HEARTS (The Humane and Existing Alternatives in Research and Testing Sciences) Act would require NIH grant applicants to more fully evaluate the use non-animal alternatives, and to carry out harm-benefit analyses of proposed animal research.
Incentives like these, along with continued investment in in-vitro and computational toxicology at federal agencies; universities, as well as private sector innovation, will help give the transition the institutional support that will be needed to meet the 2035 goal that EPA has proposed.
The bottom line is that EPA’s announcement is a logical and appropriate step in an evolution toward more human-relevant science that first began 60 years ago, was conceptualized for toxicity testing by the NASEM 12 years ago, and has been supported and encouraged by Congress through authorization and appropriations legislation over the last several years.
It is true that we do not have in place today all of the toxicity tests that we need, but over the next decade we must demonstrate the will, skill and determination to develop, validate and deploy them. EPA is challenging the scientific community to partner with it in developing better ways of protecting communities and public health. As a nation we must rise to the challenge.
Paul A. Locke is an environmental health scientist and attorney. He is also an associate professor at Johns Hopkins Bloomberg School of Public Health in the Department of Environmental Health and Engineering. The views expressed do not reflect the official policy or position of Johns Hopkins University or Johns Hopkins Bloomberg School of Public Health.