Why the FDA and the EPA aren't set up to protect us from contaminants in the food we eat.
In July 2017, The New York Times ran a story titled The Chemicals in Your Mac and Cheese. Researchers, the article explained, had found plasticizers—known as phthalates—in the popular kids’ food. Fewer than two weeks later, the Times reported that traces of the herbicide glyphosate, the main ingredient in Roundup, had been found in Ben & Jerry’s ice cream. Several people asked me: Should we be worried?
My answer: Yes, we should, but not just because researchers found plasticizers (which are chemicals that make plastics more durable) in our mac and cheese or herbicide in our ice cream. We should be worried because these kinds of environmental chemical contaminants are literally everywhere, in nearly all our foods.
We know they exist in these two foods because researchers specifically looked for them. Roughly 9,000 environmental chemicals on the market end up in our foods, including food additives, colorings, flavorings, pesticides, and food-packaging chemicals. Even though they are ever-present in our environment and our bodies, many are never thoroughly tested for safety—and some are never tested at all.
In dozens of interviews with scientists and researchers, I have identified major roadblocks to the fair and impartial regulation of environmental chemicals that we are all in direct contact with on a daily basis, especially those in our food.
The two main agencies responsible for regulating all the environmental chemicals in our food are the Food and Drug Administration (FDA), which oversees all food and food ingredients on the market—except meat, poultry, and certain processed egg products, which are overseen by the US Department of Agriculture—and the Environmental Protection Agency (EPA), which regulates pesticides, herbicides, insecticides, and fungicides used in food production. But the laws governing the agencies have myriad problems, as do the agencies themselves.
Let’s take a look at a few of the most egregious flaws in the system.
Food manufacturers are responsible for their own safety testing (and you can imagine how that turns out)
One of the fundamental flaws in the design of the regulatory system is that the manufacturers of the pesticides, emulsifiers, and plasticizers that are added to our food supply, food products, and food packaging provide their own data conducted by scientists that they hire to perform safety testing on their products.
In the case of pesticides, an EPA spokesperson told me that this practice is intended to save taxpayers money on expensive research and scientific studies. “Congress placed this obligation on the pesticide registrant rather than requiring taxpayers [to] fund data development,” the representative told me.
Most people would assume that governmental agencies are doing independent testing to ensure the safety of our foods and other products in contact with our foods. But that is simply not the case. Although the EPA and FDA sometimes do review the internal findings, no independent body or group of scientists tries to replicate them.
“The…only entity testing the safety of the components is the company—and they have no incentive to show that their products are dangerous,” says Bruce Blumberg, a professor at the University of California, Irvine, who studies endocrine-disrupting chemicals. “It is a conflict of interest, and they are not protecting public health—that is the bottom line.”
Some of the chemicals tested at high doses actually show effects at very low doses
When we eat that mac and cheese, that Ben & Jerry’s ice cream, and probably hundreds of other foods, the FDA and EPA say that since we are only being exposed to “trace” amounts of phthalates or glyphosate, for example, these chemicals are harmless. This strikes many people as common sense—people often say, “If I’m only getting a little bit, it can’t hurt, right?”
But this thinking, by both regulators and eaters, is fundamentally flawed based on discoveries in the study of endocrine-disrupting chemicals (EDCs), which can act on the endocrine system by mimicking or blocking the action of natural hormones. (The endocrine system is a chemical messenger system consisting of hormones and glands that are central to nearly all our biological functions, from brain and sexual development to our metabolic systems.)
When it comes to EDCs, an abundance of scientific findings show that they are biologically active in extremely small amounts and, in fact, small amounts can have a major effect on cells and the body while larger doses may have no effect all. (Hormone receptors are down-regulated by hormones, which means that high doses can cause a complete down-regulation, or desensitization.)
A basic tenet of endocrinology is that the endocrine system is exquisitely sensitive to tiny amounts of hormones or hormone-like substances—whether they are hormones we produce inside our bodies or those we are exposed to in drugs or the environment. Yet manufacturers base most of their testing on toxicology, a field that often abides by the outdated edict that “the dose makes the poison,” or the idea that it is not the substance itself but rather the amount that matters.
Indeed, pharmacology (the study of how drugs work) and drug development are based on the understanding that all drugs have vastly different dose ranges, and the physiologic effects of each drug do not always depend on the dosage. That is, a tiny amount of a drug can have a powerful effect on our bodies. Think of the birth control pill: It can contain as little as twenty micrograms of estrogen yet prevent a woman from ovulating. (One microgram is one thousand times less than a milligram, the usual measure for vitamins.) Because many of the chemicals we are exposed to through our food supply are at low levels, acute or immediate effects are often not the problem; rather, long-term effects and effects passed down over generations are the main concerns.
According to a 2015 statement from the Endocrine Society, scientists and researchers have found “strong mechanistic, experimental, animal, and epidemiological evidence for endocrine disruption” and its role in obesity and diabetes, problems with female and male reproduction, hormone-sensitive cancers in women, prostate cancer, and impairment to thyroid function, neurodevelopment, and neuroendocrine systems.
Our food supply represents one of the biggest sources of EDC contamination, in the form of pesticides, herbicides, fungicides, and the chemicals in food packaging. But the regulatory agencies have been slow to adapt to any of these findings. “They do not test chemicals at the concentrations that people are being exposed to—period,” says R. Thomas Zoeller, a biology professor and researcher at the University of Massachusetts, Amherst. They test chemicals in much higher concentrations, which, as mentioned above, simply don’t have the same effects as tiny dosages.
When I contacted the EPA for comment on the concern that very low doses of these chemicals can have an impact on human health (note that this is called “nonmonotonic dose response”) a spokesperson replied with this statement: "EPA continues to research a nonmonotonic dose response (NMDR) and ‘Low Dose’ issues. The agency is currently working with the National Academy of Sciences to better understand ‘Low Dose’ issues."
Maricel Maffini, a scientist and independent consultant who has authored several prominent papers about the problems at the FDA, says the agency’s internal problems stem from a generational divide among its scientists. “Many of their scientists are old-school, many of their scientists have told us to our faces that endocrine disruptors are not a thing, that low-dose effects are not a thing ... they forgot—even though some of them are pharmacologists, and so they are very familiar with the concept—[that] you have to find the sweet spot for the drug to work. But they don’t apply the same science when it comes to food additives,” she says.
All the researchers I interviewed agreed that current evaluations conducted by regulatory agencies are faulty for another reason: The agencies are not considering "sensitive endpoints," or systems of the body that are affected by small amounts of hormones, such as the thyroid, reproductive, or neuroendocrine systems. Nor are they considering fetal development in the womb, especially brain and sexual development. Instead they tend to look at more crude effects on an organ—by, say, removing the thyroid and weighing it, but not looking at all the other systems of the body that the thyroid effects, like the brain.
Zoeller has been studying the effects of endocrine-disrupting chemicals on the thyroid for decades. He has looked at polychlorinated biphenyls (PCBs) and dioxins that are prevalent in our food supply and has shown that, because these chemicals are structurally similar to thyroid hormones, they are having profound effects on the thyroid—especially in the womb. The effects include lowered IQ, impaired brain development, issues linked to attention deficit/hyperactivity disorder (ADHD) and autism, and visual and perceptual disturbances.
When I contacted the FDA to ask if the agency considers low-dose exposures and sensitive endpoints, press officer Megan McSeveney said that the key determination in a safety assessment of a substance in our food is “probable intake and the level at which adverse effects are observed in toxicological studies.”
Yet the parameters of toxicological studies—and the idea that ”the dose makes the poison,” as mentioned above—run counter to findings from independent scientists in the field of endocrine disruption. “For toxins, the more you’re exposed to, the greater the effect. [But] that is not true of hormones,” Frederick vom Saal, a University of Missouri professor of biological sciences who studies BPA, recently told Vox. “Hormones aren’t toxins; they’re regulatory molecules that operate at a trillionth of a gram level.”
There are nearly 1,000 chemicals that have never been tested at all
The other piece of legislation that essentially allows manufacturers to greenlight their own chemicals for use in our foods is what’s known as “generally recognized as safe,” or GRAS. This designation represents one of the biggest hurdles for adequate protection of the public’s health.
The provision was originally intended to give common food ingredients added to foods—such as salt, sugar, and vinegar—an exemption from testing and scrutiny before manufacturers could put them in our foods. But what actually happens is that chemical manufacturers use GRAS as a way to fast-track products to market without review for safety by the FDA.
Due to a severe backlog in decision-making on new substances coming to the market, the agency made the GRAS system officially voluntary in 1997, only reviewing the data if the company submits it, and only offering a non-binding opinion about the substance. That means the FDA’s position is that the manufacturer is responsible for ensuring the safety of its product.
And chemical manufacturers can even choose whether the agency reviews a new substance at all; if a manufacturer does submit a notification to the agency and is asked a lot of questions about the data, the manufacturer can simply withdraw the notification and use the substance. “Many times, the FDA has plenty of questions about the safety of the substance, in which case, the company can ask the agency to stop reviewing the GRAS notice. They then withdraw it from the system and continue to market it or start marketing it without resolving those problems,” Maffini says. “And in some cases the problems are really big and serious safety concerns.” According to Maffini’s research, approximately 1,000 chemicals on the market today have never been reviewed by the FDA at all.
Even the FDA’s former deputy commissioner for food, Michael Taylor, acknowledges how little the FDA knows about the majority of chemicals added to our foods. “We simply don’t have the information to vouch for the safety of many of these chemicals,” he told The Washington Post in 2014.
When I asked the FDA more recently what it was doing to change its practices and better protect the public, this was the response I received from McSeveney:
Companies are responsible for ensuring that ingredients added to food are safe and comply with the law. [...] There is no requirement under the FD&C Act for companies to notify the FDA of a GRAS conclusion. However, we continue to encourage companies to notify us about food ingredients they have independently concluded as GRAS so that we have the opportunity to discuss with them any questions we may have about the basis for these conclusions.
Maffini’s review of GRAS notifications revealed other troubling facts about the scientists the industry hires to perform research on its chemicals. She identified ten people who served on 27 or more scientific review panels. One person, now in his late 80s, served on almost 45 percent of the panels that Maffini and her colleagues analyzed.
Maffini says that after these scientists approve one chemical for the industry, the manufacturers tap them repeatedly. “So…you have this small group of people being constantly called to be part of the panels, and they are working on scientific concepts from the 1960s and 70s,” Maffini says. According to research conducted by the Center for Public Integrity, some of these same scientists served as consultants for tobacco companies during the 1980s and 1990s.
The labs that do rigorous testing can’t afford the bureaucratic requirements that would qualify them for governmental consideration
Of course, many independent, academic scientists are attuned to the latest science and do not have industry connections. But the agencies do not consider their findings when making decisions about the safety of environmental chemicals because academic labs do not follow a protocol known as “good laboratory practices,” or GLP.
The concept of GLP goes back to the mid-70s when the government investigated Industrial Bio-Test Laboratories, which operated the largest toxicology-testing facility in the United States during the 1950s, 60s, and 70s. Its clients included many of the major manufacturers, among them DuPont, Dow, and Monsanto. In 1977, a government investigation revealed extensive fraud in its practices that affected scientific findings about products widely used in the home or in agriculture, including Roundup, that herbicide in your Ben & Jerry’s, and PCBs, those now-banned chemicals that persist in the environment and remain pervasive in our food.
The fraud in this lab was so extensive that some manufacturers were citing studies conducted on animals that did not even exist, the researchers were substituting new animals for those that had died during testing, and they were not even feeding animals the test substances. As a result, the government mandated that when industry uses its own laboratories to conduct studies of its products, it has to abide by a set of standards, known as good laboratory practices.
However, these guidelines are prohibitively expensive for smaller academic labs to follow, even though this is where most cutting-edge science is taking place. Academic labs like those of Blumberg and Zoeller simply cannot afford or don’t have the staff to adhere to GLP. The trouble is that GLP does not address scientific principles or the design of a study. “All that GLP means is that the animals existed, that the data was collected, and that you know who was there when it was done…it does not mean that it was conducted with good scientific principles in mind; it just means you did record keeping,” says Laura Vandenberg, a scientist who studies endocrine disruption at UMass Amherst’s School of Public Health. “We don’t get that much money on our grants to do it, and our universities are not set up with animal facilities that can record every time someone enters the animal facility or leaves and what they are doing at that time—so my work cannot be GLP compliant. Which means that the FDA and EPA can’t look at it.”
Scientists at the FDA and EPA are pressured to support agency positions
When the FDA or the EPA do conduct their own research, several independent scientists told me that the agencies’ scientists are pressured to come up with findings that support their employer’s current stance on particular additives. Vom Saal has found that regulators and scientists within the FDA are pressured to support its position that BPA does not pose health risks—despite the fact that there are more than 1,000 studies in animals, the vast majority of which show harm.
Zoeller told me that he saw pressures within the agency while working at the FDA, from 2010 to 2013, as well. “The FDA is conflicted. The regulatory arm at FDA has an agenda that the data don’t always fit into, and instead of following the data, they follow their agenda,” he says. In the case of BPA, the regulators at the FDA are employed by the same agency that is conducting the science, and “that creates the potential for very significant conflict of interest,” he says. Ultimately, Zoeller says of his experience at the FDA, “I never saw any evidence that they are motivated by public health protection.”
Zoeller also took note of what he called the turnstile effect. By this, he meant the revolving door between people who leave the regulatory agencies to work for industry and vice versa. One of the most widely reported examples is Michael Taylor, who stepped down in June 2016 as deputy commissioner for food at the FDA; before joining the FDA he had been the vice president for public policy at Monsanto.
When asked about these conflict of interest issues at the FDA, McSeveney replied with a link to information about “FDA employment and ethics.” She did not reply to further requests for more detail.
In 2017, President Donald Trump nominated a well-known friend of industry, Scott Pruitt, to head the EPA. Within his first month at the agency, Pruitt denied the petition to ban the common pesticide chlorpyrifos, which laces our food supply. It has been shown to cause brain damage and reduced IQs in children, and is linked to lung cancer and Parkinson’s disease in adults. Documents received through a Freedom of Information Act request revealed that Pruitt met with the CEO of Dow Chemical, maker of the pesticide, just before he rejected the ban. Pruitt resigned in July amid an array of ethics scandals.
Because of all this, we have no idea what we’re consuming
Since so many chemicals pollute our larger environment, not just our foods, even if you avoid all packaged and processed foods (a near impossibility), you're still exposed to these chemicals in our environment every day.
This brings up another major issue: consent. Vandenberg put it this way: “There is no consent in typical environmental exposures; when you eat food out of a can, you might be consenting to eating the green beans—but you’re not even thinking or imagining that you are being exposed to a dozen other chemicals, the can lining, the can, and the preservatives and all that other stuff.”
And because the regulatory agencies are not testing final products for environmental chemicals, even they don’t know what’s in them, never mind requiring that they be labeled.
What are the benefits of these chemicals versus their risks? Food manufacturers would argue that food additives and chemical-laden packaging extend shelf life, keep food production costs down, and enhance flavors; chemical manufacturers would argue that their various pesticides and herbicides protect crops and help farmers. But at what cost?
“When you allow a system to develop where every baby born in this country has literally well over 100 manufactured chemicals in their body—most of which have never been tested,” Zoeller says, “You have to ask, what does that say about our society?”
Adapted from FORMERLY KNOWN AS FOOD: How the Industrial Food System Is Changing Our Minds, Bodies, and Culture by Kristin Lawless. Copyright © 2018 by the author and reprinted by permission of St. Martin’s Press.