This week, EPA Administrator Andrew Wheeler signed a directive instructing the agency to significantly reduce animal testing by 2035. The agency also awarded $4.25 million to four universities to advance the development of alternative test methods for chemical testing. This is yet another Trump Administration attack on scientific information, this time targeting the laboratory animal tests that show whether and how chemicals may harm people, wildlife, and ecosystems. Instead, the Trump EPA is pushing the use of non-animal alternative methods that are mostly still in development, and cannot capture the complexity of many chemical exposure risks like infertility and cancer.
Although non-animal alternative test methods are still in development, NRDC remains optimistic about the possibility of using them to help identify potential toxicity and adverse effects to humans, wildlife, and the environment. For example, NRDC has for years participated in the national conversation to help advance these methods for toxicity testing via comments, participation in expert panels/committees at the National Academies and EPA, and via engagement with other key stakeholders.
Nonetheless, NRDC scientists agree that the use of these tests—like any scientific or other toxicity information—can be harmful if used to explain away adverse effects (that is, incorrectly identifying a toxic chemical as harmless). In cases where this happens, harmful chemicals can get into our air, water, cosmetics and personal care products, household items, food and food packaging, etc. threatening the health of humans, pets and wildlife. Thus, if used to permit chemicals onto the market, the regulatory system must use the test information in a health-protective and precautionary manner. That is not the case with the Trump EPA, and it isn’t clear when EPA, the FDA or other regulatory agencies will adopt a simple health-protective approach, rather than favoring the chemical industry that it is supposed to regulate.
Instead of protecting animals, and people, the recent EPA announcement will fast-track chemicals onto the market with limited or flawed toxicity testing. Here’s why:
The last 15 years have witnessed the exponential growth of chemical evaluation methods that involve computational models, tests on cells and proteins, and engineered tissues (like a heart-on-a-chip).These advancements have largely been driven by a collaborative effort across Federal Agencies called Toxicology in the 21st Century, or Tox21. The good news is that thanks in part to this initiative, many of the acute toxicity tests—such as skin and eye corrosion and irritation tests—have been replaced by cellular tests or other alternative methods that do not involve whole animals. Many of these are already in widespread use, and are accepted by regulatory agencies including the EPA in the US and globally.
However, despite some impressive advances for acute toxicity testing, when it comes to chronic or systemic health effects, these methods still lack the ability to capture the biological processes that occur in whole living organisms. For complex disorders like infertility, autism, Parkinson’s disease, and even obesity—all of which can have environmental/chemical contributors—and for key windows of development (from conception to early adulthood) animal-based experimentation remains an essential component to keeping populations safe.
Humans and wildlife are constantly awash in a sea of chemicals. From the foods we eat to the products we use to the chemicals released into the environment, our bodies are constantly exposed to chemicals that have the potential to harm us, even before we are born. As of March 2019, EPA identified over 85,000 industrial chemicals (not including pesticides, food additives, and pharmaceuticals) that are or could be processed or manufactured in the United States. Despite being found in our bodies and in the bodies of diverse wildlife species from fish to polar bears, the vast majority of these industrial chemicals have never been fully tested for potential adverse effects on reproduction, fertility, brain and nervous system development, immune toxicity or even cancer. EPA’s announcement to limit or eliminate whole animal testing will make this problem worse by preventing the acquisition of important knowledge about the toxic chemicals that poison our homes, families, and environment.
In order for EPA to perform its congressionally mandated duty of protecting human health and the environment, regulators rely on a wide variety of tests, including ones using laboratory animals under strict oversight and rules to ensure the protection of test animals. These important tests provide reliable accurate information about the potential for chemicals to cause harm.
In 2007, the National Academies of Sciences suggested in their groundbreaking report, Toxicity Testing in the 21st Century, that several decades would be needed for scientists to develop the necessary biological understanding to completely replace animal tests in our chemical evaluations paradigm. Though scientists have made great strides in advancing our understanding of chemical behavior, there is still some distance left to travel.
While the EPA is warranted in taking steps to develop non-animal methods that provide information of equal or better quality—including funding additional research—it should not be setting artificial deadlines or prematurely eliminating funding or preventing the use of animal tests needed to inform and protect the public. In addition, it is imperative that the agency ensure and demonstrate that the replacement tests serve the public interest and not merely corporate ones (see the companion blog on this topic from my colleague, Dr. Kristi Pullen Fedinick). The state of our knowledge in 2035 is unknown to us all, but in the present, we all need an agency that uses every available information source at its disposal to protect people, wildlife, and our environment.