Follow the money, not the bunny: EPA Administrator follows PETA’s lead

Former coal-lobbyist (possible climate change denialist) EPA Administrator sides with PETA and changes test standards for potentially harmful chemicals that can affect humans, other animals, and the environment

In a sign of the times (and likely, not a good one for public health, the environment, and the future) Tuesday’s news carried pictures of the nation’s chief of Environmental Protection, Andrew Wheeler, sitting with the leaders of groups opposed to animal research. The occasion was Wheeler’s announcement that chemical safety tests would be driven not by science or evidence, but rather a political dictate. As reported in The Hill: “The Trump administration on Tuesday said it will adopt a plan to eliminate all animal testing requirements at the Environmental Protection Agency (EPA) by 2035.”

Wheeler also announced that by 2025 the EPA would “reduce all requests for, and funding of, studies with live mammals by 30 percent.”

Experts in toxicology and chemical health hazards responded swiftly. “Trump Administration Guts Collection of Data on Toxic Chemicals” was the title of a press release from the National Resources Defense Council (NRDC). It included the following comments from Jennifer Sass, who serves on the Healthy People and Thriving Communities program at the NRDC.

“EPA is eliminating tools that lay the groundwork for protecting the public from dangers like chlorpyrifos, formaldehyde and PFAS. Phasing out foundational scientific testing methods can make it much harder to identify toxic chemicals—and protect human health.

“Once again, the Trump administration appears to be working on behalf of the chemical industry and not the public. Congress should bar the agency from blindfolding itself.”

According to the Intercept, in earlier reporting this summer:

“Only a small handful of the more than 40,000 chemicals now in use have been regulated. An overhaul of the 40-year-old Toxic Substances Control Act law in 2016 was supposed to finally fix that….In the nearly 3 years since passage of TSCA reform, EPA has not once used these new authorities and seems to be avoiding them at all costs,” Democratic Senators Cory Booker, Tom Udall, Ed Markey, Jeff Merkley, and Sheldon Whitehouse wrote to EPA administrator Wheeler on June 20.”

As reported by Jeff Tolefson in Nature, Laura Vandenberg, an environmental health scientist at the University of Massachusetts Amherst, made clear that:

Scientists can and do use advanced screening tools to study the potential impacts of chemicals at the cellular and biochemical level, Vandenberg says. But in order to regulate a chemical the agency must show that there are adverse effects in living organisms, she says. “There is no adverse effect in a Petri dish.”

And just because researchers don’t see negative effects of chemicals on cells in the lab don’t mean they aren’t there, Vandenberg adds. “We are going to get caught in a position where we won’t really be able to regulate chemicals in the US.” (emphasis added)

Scientists had also raised alarms earlier this year. In July, in The Intercept Sharon Lerner reported in depth on an internal memo that Wheeler sent to staff announcing his intention to “cut its funding for experiments on mammals in half by 2025.” The article includes many cautionary comments. For example:

“…many scientists who study chemicals caution that research on cells outside a living organism, known as “in vitro toxicology,” cannot completely replace mammal experiments yet. “If you take the engine out of a car and study one piston at a time, it may not tell you what the car is going to do when you assemble it,” said Thomas Zoeller, a biologist at the University of Massachusetts Amherst who studies the health effects of man-made chemicals like polychlorinated biphenyls.

Zoeller’s own research revealed that, within mice, it’s not the actual PCB that causes harm but another chemical that the body creates by processing the original compound — a discovery that wouldn’t have been possible without exposing live mice to the chemical. “The parent compound gets into the animal and is metabolized in some tissues, including the brain. The body essentially bioactivates the parent compound,” Zoeller explained.

“If you exclusively depend on in vitro toxicology or mathematical modeling, you’re going to miss all the different interactions that happen in a physiological system — whether in rat, mouse, human, or a fetus. You simply cannot replicate that,” said Zoeller. “EPA is well aware that these cells don’t replicate human metabolism. So when it comes to bioactivation, they’re going to miss all that — and they know that.”

And that, some scientists fear, is exactly the reason the EPA is moving toward eliminating tests on animals. “If you require that, to regulate, you need to show an adverse effect for a chemical, and you can’t see an adverse effect in cells, then it’s to your benefit to only do testing in cells,” said Laura Vandenberg, a professor at UMass Amherst’s School of Public Health, who studies how exposures to chemicals during the development affects health later in life. “Laws, policy, and regulations require animal evidence.” (emphasis added)

Why does the EPA exist?

Concern about the EPA’s policies and decisions are raised, in short, because the EPA is the federal agency founded and charged with protecting public health. Their website description reads: “EPA works to ensure that: Americans have clean air, land and water; National efforts to reduce environmental risks are based on the best available scientific information; Federal laws protecting human health and the environment are administered and enforced fairly, effectively and as Congress intended; Environmental stewardship is integral to U.S. policies concerning natural resources, human health, economic growth, energy, transportation, agriculture, industry, and international trade, and these factors are similarly considered in establishing environmental policy; All parts of society–communities, individuals, businesses, and state, local and tribal governments–have access to accurate information sufficient to effectively participate in managing human health and environmental risks; Contaminated lands and toxic sites are cleaned up by potentially responsible parties and revitalized; and Chemicals in the marketplace are reviewed for safety.” (emphasis added)

Given this mission, it is clear that the EPA’s decisions must rely on the best available scientific information in order to protect public health and regulate chemical safety. Chemical safety tests can (and have) served as a bar for corporations and industries that profit from the sale of chemical products. Pesticides are an example. But pharmaceutical drugs and devices are another. The US has a long, strong history of public, federal agencies charged with regulating the chemicals, drugs, and devices that companies produce and market. The reason the US has these agencies, and the reason that they are federally funded, acknowledges that corporations and those seeking to profit from chemicals, drugs, and devices may not be positioned to ensure the health and safety of those consuming, using, or being affected by the downstream consequences (read more about FDA history here, EPA here).

Why 2025, why 2035? 

Wheeler’s announcement and associated media coverage emphasized specific dates for ending animal testing. What is the significance of the milestone dates set by Wheeler? Did he choose those dates after consulting with the best toxicologists in the world? Did he speak with those who study the problem, run experiments, produce evidence, subject the data to critical peer-review, assess the probabilities of fatalities, environmental destruction, then eliminated any potential new scenarios not obvious now, and unequivocally concluded that in 36 years there will be zero need for animal tests?

Not according to the news reports and Wheeler’s comments.

Rather, in Wheeler’s view, as reported by NPR:

“‘I really do think that with the lead time that we have in this — 16 years before we completely eliminate animal testing — that we have enough time to come up with alternatives.”  Further, “He notes that he wrote an op-ed for his college newspaper on the need to reduce animal testing back in 1987. (here) ‘I didn’t think we were that far away from banning animal testing then,’ Wheeler says. ‘Part of why I’m doing this today is because it’s been 30 years and we haven’t made enough progress.’”

If that’s not illogical, we don’t know what is. Part of the problem with setting an arbitrary deadline stems from the issue that it is impossible to predict future toxicants as well as the manner in which they may affect growth, reproduction, health or any number of a vast parameter space under which toxicological assessments are subsumed. Moreover, even in vitro and computational models rely on living animal data to inform validity, efficacy and monitoring. By extension it is virtually impossible to discount the need for animal research in the future. These simple facts are something that most anti-animal research groups conveniently ignore. Ironically, the fathers of the 3Rs (a widely referenced 1957 framework for considering nonhuman animal use in research and testing) describes the concept of absolute replacement as:

“Desirable as replacement is, it would be a mistake to put all our humanitarian eggs in this basket alone. The progress of replacement is gradual, nor is it ever likely to absorb the whole of experimental biology.”

This clearly is contrary to the position of anti-animal research groups, and even Wheeler, who are arguing for the elimination of toxicity testing using animals.

As well, it seems anyone who has expertise in working with and studying animals should condemn a policy that could harm the protection of pets, wild animals, and the environment. Wheeler also told NPR that his motivations for this policy stem again not from evidence, but from his family’s feelings on the topic of animal-based research. “My older sister is a zoologist, my younger sister is a veterinarian, so I come from this family that cares deeply about animals and the protection of animals.” As reported in the Intercept, one also has to wonder if Wheeler’s intentions genuinely reflect an interest in animals or animal well-being, given his financial investment in the Lucky Buns burger restaurant this year (https://twitter.com/LuckyBunsDC/status/1083827061507178497).

Why did a former coal-lobbyist decide to team up with PETA?

At first blush, it would seem odd that someone whose career has included defense of coal mining (link), apparent climate-change denialism (here, here, here), and repeal of the Obama Clean Power Plan (CPP) aimed at fighting climate change (here, here) would appear at a press conference surrounded by the leadership of most of the major anti-animal research groups in the US. It seems like groups concerned with animal lives should also care about the environment in which they live.

But here’s the thing:

First, attacks on federal agencies charged with regulation are a feature, not a bug, of the Trump administration. Reducing regulation, reducing costs, and increasing corporate profits all stand to be facilitated by reducing the standards of proof that a new chemical, product, or device is actually safe for the people who will use or be affected by it. What that means is that Wheeler’s position is absolutely consistent with this administration’s agenda. If the US lowers the bar for chemical safety tests it will benefit industry, not the US public. And while the decision will reduce the use of animals in testing, it also stands to negatively affect other animals who are affected by chemicals in the environment.

Second, Wheeler’s announcement is consistent with other attacks on federal agencies that use nonhuman animal studies and tests in their work aimed at protecting public health. Remember, for example, the FDA’s attack on adolescent nicotine research (read more here). Research aimed at determining the health effects of non-tobacco nicotine ended in 2018 to much public acclaim. Yet here we are, in 2019, with headlines like “A Sixth Person Has Now Died From the Mysterious Lung Illness Linked to Vaping” and new diagnoses like vape-related respiratory illness. In the past several years, campaigns against animal research and testing conducted by federal agencies charged with protecting public health have included campaigns that involve the VA, FDA, and NIH (summary here).

Third, Wheeler’s announcement is consistent with recent compromises of federal agencies–agencies whose research represents a very small, but vital, fraction of all animal research and testing in the US. Actions like Wheeler’s likely have a very small impact on nonhuman animal use. In fact, if one were concerned about the bunnies (or dogs, or cats, or monkeys, or mice, or fish) one might naturally be concerned about all of them and consider the trade-offs and balances in decisions. That plays many ways. For example, one might be concerned about the use of animals in research and testing by public agencies and institutions, but also in private industries that include pharmaceutical, chemical, and other companies. In addition, one might be concerned about the impact that decisions have on other animals who are affected by things like environmental chemical contaminants (see cautionary story on Lake Apopka).

But what Wheeler’s decisions and theatrics demonstrate is pandering to industry, not saving animals. Industry may not be negatively affected (in the short term) by constraining or eliminating animal testing. But they are positively affected at their bottom line by reducing regulatory requirements and tests that may show their products are unsafe or could result in long-term harm– to humans, other animals, and the environment. Reducing standards will result in less corporate liability, lower safety guards for products, and potentially more profit, but those motives are not the same as concern for animal welfare.

And so we might ask those concerned with animal protection – how do you balance concern for the animals and concern for science that can give us real answers about the short- and long-term effects of the chemicals used in our shared world? There are no easy answers, but it is clear that decisions made now will have effects that last well beyond the current administration and extend beyond the US. And at the same time, we might ask those concerned with human health and global environmental impacts to not only deeply consider these decisions, their import, and the long-term consequences, but also raise their voices together.

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