Endocrinologist Heather Patisaul: EPA & FDA Complicit w/ Industry in Poisoning American Public

HEATHER PATISAUL

“It is now becoming evident that the effects of EDC exposure are not necessarily limited to the exposed individual. Many of these compounds are now recognized to have transgenerational effects and in some cases the effects within subsequent generations are more profound than those seen in the first generation.”—Heather B. Patisaul and Heather B. Adewale, “Long-term effects of environmental endocrine disruptors on reproductive physiology and behavior,” Frontiers in Behavioral Neuroscience

It’s going to take Heather Patisaul’s kind of unfettered courage by Americans nationwide to snap EPA and FDA out of their comfort zone with industry and rein-in endocrine-disrupting chemicals (EDCs) poisoning the country. Patisaul, a neuroendocrinologist, accuses the EPA and FDA of cherry picking data, among other irregularities. She is one of the most respected voices on the hazards of EDCs, particularly with regard to understanding “sex-specific mechanisms by which chemical exposures affect brain development and behavior.”

Heather Patisaul is currently Associate Dean for Research at North Carolina State University’s College of Sciences as well as a professor of biology at NCSU.

In 2016, Patisaul chaired Gordon Research Council’s conference on EDCs, and in 2020, chaired the Endocrine Society’s advocacy and outreach committee.

Patisaul is author with Scott M. Belcher of the book, Endocrine Disruptors, Brain, and Behavior. She is also one of the authors of the Endocrine Society’s 2020 EDC Guide. Patisaul has published more than 100 scientific papers.

Heather Patisaul’s academic base in North Carolina, and before that at Georgia’s Emory University (PhD) and the University of Florida (BS, zoology), has required some serious protection from the sun. As one fair-skin blonde to another, Patisaul told me she relies on a mineral (as opposed to chemical) sunscreen, which blocks UV rays. So it’s just nanoparticles entering the skin that you have to worry about, she joked. Our conversation follows.

Suzan Mazur: Does the US government essentially leave it up to industry to police itself regarding harmful chemicals, endocrine-disrupting and otherwise?

Heather Patisaul: Essentially, yes.

Suzan Mazur: Since the Food and Drug Administration (FDA) has no mandate to test for or to label America’s food regarding toxic chemicals or endocrine-disrupting chemicals (EDCs), and the Environmental Protection Agency (EPA) has not been testing and labeling products contaminated with EDCs either—can we assume that Americans are being poisoned because of government failure to regulate?

Heather Patisaul: Yes.

Suzan Mazur: Would you explain the EPA’s high-throughput approach to identifying EDCs in lieu of animal testing?

Heather Patisaul: Toxicology testing for regulatory purposes was originally whole animal testing. And there are still statutes and laws that require animal data so whole animal testing remains super important. As an endocrinologist I find these tests particularly valuable because in the endocrine system one organ influences another organ.

The ovary is a classic example. The ovary makes hormones like estrogens, which then circulate through the body, traveling to the uterus, mammary glands, and to lots of other organs. However, there’s been a push to move away from animal testing for ethical and other reasons. High-throughput testing strategies [relying on data] are being devised that are meant to be faster, safer, easier, and avoid using whole animals. But it’s a bit of a Wild West and not all of them work well.

That’s how the EPA has been spending its time on EDCs. It’s trying to develop some of these assays with a pretty high failure rate. Meanwhile, we’re not seeing EPA in any hurry to use the mountain of data already available in the literature to regulate EDCs.

Suzan Mazur: A lot of the data EPA would be using in its high-throughput approach would be coming from industry that created the chemicals. Is that right?

Heather Patisaul: That’s my worry. A lot of the assay development and a lot of the information and data is coming from industry. We call that “grey data.” Because the EPA can see it, but a scientist like me and the public—we can’t see it. We don’t know how it’s being evaluated. That’s true for some whole animal work as well.

From some of the data that’s come out through the Freedom of Information Act and other means, it’s clear that industry is really good at saying nothing is toxic. If you believe that, then industry has never produced a toxic chemical. Since we know that’s completely false, we have a big problem, where our regulatory system is heavily reliant on industry data and there is an obvious financial conflict of interest.

Suzan Mazur: What are the differences between the US & EU approaches to dealing with the EDC catastrophe?

Heather Patisaul: The biggest difference is that Europe—its program is called REACH—takes what’s called a hazard-based approach. That means: I have a chemical, chemical X and I’m going to test it for toxicity.

Suzan Mazur: Europe is testing animals?

Heather Patisaul: Yes, Europe is mostly doing animal testing but it is also pushing to develop non-animal tests. That’s good, we want a whole variety of tests. So for Europe, if a chemical turns out to be hazardous enough, the regulatory process starts.

In the US it’s different. Determining if a chemical is endocrine-disrupting or has a toxic effect is step 1. That’s called identifying the hazard. Step 2 is where EPA tries to determine what the public’s exposure is. OK, chemical X is toxic—how much are people exposed to chemical X? Step 3 is risk assessment. EPA says, OK chemical X is toxic, but public exposure to chemical X is low—so we’re not going to regulate it. The problem with that is, as soon as EPA makes that determination, the exposure level changes and it usually goes up and up quickly.

We’ve seen that with flame retardants. And we’ve definitely seen that with perfluorinated chemicals where exposure is so dynamic. We’re going to be stuck with those for literally centuries because they’re so persistent.

You may have low exposure to a chemical and then its use goes up. And two years later, there is really high public exposure to that chemical. That’s how in the US we can end up with higher exposures than in other countries to some chemicals—and really toxic chemicals that are still on the market.

Suzan Mazur: Is the EPA privy to Europe’s testing information that the EU relies on to label its products?

Heather Patisaul: Some information is shared. What’s different is how the information is used. For example, a lot of chemicals in personal care products not legal in the EU because they’re identified as hazardous are in products used all over the United States, since the US takes a risk-assessment approach. That is, regulators like EPA and FDA decide the public’s exposure is too low for there to be a problem and so the public can just be “micro-dosed” constantly with all this toxic stuff. That’s why we have chemicals in our environment that are banned in other countries.

Suzan Mazur: Are you aware of any major National Science Foundation or National Academy of Sciences publicly accessible webinars in recent years on the EDC issue?

Heather Patisaul: No.

Suzan Mazur: It’s interesting that NAS recently hosted a major In Vitro Gametogenesis (IVG) symposium online, where a lawyer for the FDA predicted we’d see IVG within one or two US presidential cycles. Part of the discussion had to do IVG enabling same sex couples to have a family in light of a recent experiment by Japanese scientists resulting in the birth of mouse pups from two mouse fathers.

It’s very odd that the NAS would be hosting such an IVG conference with lawyers from the FDA participating, yet a preventive EDC conference does not merit a similar public meeting.

Heather Patisaul: The FDA is an interesting case. The Food and Drug parts of the agency operate in completely different functional universes. The Food side is entirely dependent and reliant on industry self-policing. The FDA has done virtually nothing on regulating not just EDCs but any toxic chemicals in our food. I would say the Food side of FDA is one of the biggest problems we have in the US. It’s all industry-voluntary-based.

I think it was in 2018 or somewhere around then that the FDA said: If you don’t see the effect of toxicity in both sexes, it’s not biologically relevant. Which is absurd.

Suzan Mazur: Why aren’t scientists in the EDC field and regulatory agencies taking into consideration that there’s been a paradigm shift in evolutionary science to include viruses and microbes, which are the bulk of the biosphere? Thus, the harmful effects of EDCs are, indeed, systemic, since we live within a microbe/virus sphere.

For example, a recent paper in the journal Cell Host & Microbe discusses how the human hydrogel known more commonly as mucus lubricates the eyes, oral cavity, lungs, stomach, intestines, as well as the female urogenital tract—and that the microbes the mucus lining harbors are particularly sensitive to chemical signals, which can change bacterial physiology leading to inflammation and other maladies. Would you comment?

Heather Patisaul: You’ve got me thinking. The struggle is that the US is not even regulating overtly toxic chemicals that cause people to become infertile, obese, get cancer, or even to die. We can’t even get FDA and EPA to budge on that. Something more complex, which you’re addressing—that wouldn’t hit any regulatory agency’s radar as adverse. There are probably some academic scientists working in that field, but there’s not going to be a lot of movement until we get some action regarding these overtly toxic chemicals the government just can’t seem to regulate. Industry has a stranglehold on our regulatory system.

Suzan Mazur: What are your thoughts about the recent EDC evidence-based policy actions paper by Duh-Leong, Kassotis, Vandenberg et al.?

They make the point that there is no safe EDC level, no safe benchmark dose because of the non-linear and non-monotonic properties of EDCs, with exposure effects that are often latent. It’s an intensely informative and damning paper, in which the authors also propose solutions. The problem is so huge—something’s got to give.

Heather Patisaul: Yes, something’s got to give. I have not yet read their recent Nature paper but I am familiar with their work on EDCs. Laura Vandenberg has been in this discussion for a long time and knows the ins and outs of the EDC field like the back of her hand.

It all comes down to money. Industry makes these hysterical leaps when regulations are imposed even though there are long lead times for implementation: Controlling pollution is a job killer. Economic catastrophe could ensue. Our food supply will collapse. Etc. Meanwhile, it’s okay for industry to keep poisoning us.

Suzan Mazur: There seems to be no money for preventive focus, the EPA’s Endocrine Disruption Screening Program budget for 2023 is $7.6 million. Meanwhile, one district alone in Manhattan is spending a half million dollars on changing three public school bathrooms.

Heather Patisaul: As a society, the US likes to fix things when they’re broken. We don’t do prevention very well. Sadly, the culture in the US prefers dehumanizing and blaming the victims rather than addressing the problem. The culture is not proactive.

Whether it’s climate or health. Whether it’s cancer alley in Louisiana, where you’ve got an unbelievably high rate of cancer and death—the people who live there are blamed rather than the chemical plants that surround them. Whether it’s infertility being seen as a failing of the individual. Obesity, where tons of these chemicals are obesogenic—individuals are again blamed and shamed.

Suzan Mazur: Are you at all optimistic? TV injury lawsuits must be creating public awareness and putting some pressure on industry and government regulators.

Heather Patisaul: I am optimistic about the current attention to curbing plastics. Most of the toxic chemicals negatively impacting life are from the petrochemical industry. However, companies like Chevron are now burning plastic to make fuels, which are in some cases the most toxic fuels anyone has ever seen—and they’re calling that recycling. And EPA thinks that’s fine.

There needs to be an overhaul of chemical policy in the US. There is no political will to do so, and scientific panels, such as WHO, are being infiltrated by industry representatives planted as scientific experts. It’s terrible to say but much of the system is rigged. These so-called experts have a financial interest in preserving the status quo and they are on these panels for a reason.

Suzan Mazur: Right. As science and technology historian/critic David F. Noble has advised: There’s been a pas de deux between US scientists and industry going back to post World War II. The public is kept out through peer review. And a private company putting money into university research—a university that is also publicly funded—has pre-publication review. The private company can censor what it wants.

Heather Patisaul: Industry has created its own journals and editorial boards and its own societies with aims and goals that sound scientifically independent but are not.

Ethics reform would help a lot as would transparency and financial conflict of interest disclosure. We don’t have enough of that at the moment. It will take substantial political will on the part of America’s poisoned public to effect EDC regulatory discipline