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MU's Frederick vom Saal wants FDA to ban BPA, endocrine disruptors

Photo by Nick Michael

COLUMBIA (Columbia Missourian) — For the past 20 years, much of MU biology professor Frederick vom Saal’s research, thoughts and time have converged into one point: trying to get endocrine disruptors — chemicals that interfere with the hormone system and can cause obesity, infertility and cancer — out of daily use.

He's accomplished the laboratory part, which resulted in dozens of scientific papers outlining the negative effects of bisphenol-A, an endocrine disruptor found in plastics.

Endocrine disruptors are everywhere in the environment: in plastics, food cans, clothing fabrics, furniture and household and beauty products.

Now he's doing the communicator's part, trying to convince U.S. authorities to regulate the chemicals.

In mid-September, vom Saal was among 20 scientists who met in a closed session in St. Louis to discuss why, in the face of what they see as mountainous evidence, U.S. regulatory agencies such as the Food and Drug Administration don't ban endocrine-disrupting chemicals.

Vom Saal's work, and that of other scientists, has so far persuaded 11 states, Canada, China and the European Union to enact legislation prohibiting or restricting endocrine disruptors. Now he’s making further attempts to crack a tougher nut: the U.S. regulatory system.

That's why Vom Saal, 67, spent most of the first week of October away from his beloved laboratory mice. Instead, he knuckled down at the computer in his office in Lefevre Hall, surrounded by figurine mice and a drawing of a wide-eyed rodent. He had a paper to write.

Seen as a three-act play, vom Saal’s pursuit is near the end of its second act — influencing federal regulation on endocrine disruptors.

Getting to Act 3 might be up to the public.

"As a scientist I feel I have an obligation to identify when, in fact, science and government policy are not consistent with each other," vom Saal says. "And that’s what I'm doing."

"We need to get together and talk"

Vom Saal's quest to get endocrine-disrupting chemicals out of daily use began with a 1990 phone call from Theo Colborn.

He was preparing to leave for New York when Colborn, then leading the toxics division of the World Wildlife Fund, called because she had just read vom Saal's paper on the physiological changes of animals exposed to low doses of estrogenic hormones. At the same time, Colborn was studying how chemicals in the environment altered the physiology of animals.

But somehow, their studies were describing the same effects.

"Are you aware of this?" Holborn asked.

"No," vom Saal said.

"We need to get together and talk," she said.

They met in New York, and Colborn provided vom Saal with a 2-foot stack of research papers on the chemicals in wildlife, posing the hypothesis that the chemicals might be acting like hormones even in very small doses — smaller than anyone would have thought.

Vom Saal took a few weeks to read the papers, then got back to Colborn. "My God, this is astounding," he recalls telling her. "I think you are onto something really important."

They called a meeting of scientists from different fields: physiologists, wildlife biologists and epidemiologists. The specialists talked over a weekend in Racine, Wis., and concluded that endocrine-disrupting chemicals interfere with hormonal signals, altering the physiology of animals.

A few years later, Colborn wrote a book called "Our Stolen Future" in which she included the conclusions of the Wisconsin meeting.

Now, two decades after the scientists met, the bibliography on endocrine disrupting chemicals has increased by thousands of papers and so has the list of chemicals identified as endocrine disruptors.

"It happened in the first experiment"

One disruptor, in particular, bisphenol-A, or BPA, has stirred public interest.

Vom Saal has become nationally recognized as a leader opposing the chemical, which is used to manufacture plastics and plastic linings — in water bottles, baby bottles, food cans, soda cans, dental sealants and cash register receipts, among others.

In 1976, BPA was included in a list of more than 60,000 chemicals deemed safe by the Toxic Substances Control Act.

In the mid-1990s, vom Saal and his research partners, Wade Welshons, an associate professor of veterinary biomedical sciences, and Susan Nagel, an assistant professor of obstetrics and gynecology, did an experiment to test whether proteins act as barriers to keep natural estrogens from entering cells and thus having effects on organisms. They wanted to see which chemicals can get around those protective proteins at extremely low doses and act like hormones in the body.

They tried it with BPA at a dose 25,000 times lower than toxicologists had studied before.

"And good grief, it happened in the first experiment," Welshons recalls.

The group repeated the experiment several times and got the same results: BPA was an endocrine-disrupting chemical, acting like estrogen at very low doses to enlarge the prostates and lower sperm counts in laboratory mice. In 1997, they published their findings.

A few months later, when the MU professors were preparing the publication of a second article on BPA, they received a visit from someone at Dow Chemical Co., one of the leading BPA manufacturers.

Vom Saal has repeatedly described that visit in media interviews over the years: The Dow Chemical representative allegedly asked the scientists not to publish their paper unless approved by the Chemical Manufacturers Association, offering MU instead a research budget for a new study.

Vom Saal and Welshons refused and reported the visit as inappropriate and potentially illegal in a letter to the FDA, the MU chancellor and the media. Dow Chemical's spokesman has repeatedly explained that the incident was just an "enormous misunderstanding."

Hundreds of studies have since linked BPA to obesity, diabetes, breast and prostate cancer, ADHD and abnormal development of genitals, but the chemical industry has fought back with studies that showed that BPA had no negative effects or that there wasn’t enough exposure to unleash those effects.

Vom Saal was interviewed and quoted by news media including The New York Times and PBS’ "Frontline."

But BPA was still on the market and still deemed safe by the U.S. government.

"The regulatory community is locked in traditional mid-20th century"

In 2008, a National Toxicology Program report expressed "some concern" regarding BPA’s negative effects.

But then, in the same year, the FDA said the chemical was completely safe — a conclusion later rejected by scientists on the FDA's review board.

In January 2010, the FDA released a new statement, saying that BPA is of "some concern" for infants and children. Then, in September, vom Saal’s team got a $1 million grant from the National Institute of Environmental Health Sciences for further research.

Meanwhile, states have been passing legislation to ban BPA in feeding products for children, such as baby bottles and sipping cups, with California becoming the 11th state to do so at the beginning of October. Similar legislation was adopted by the European Commission, and last year Canada became the first country to declare BPA as a toxic substance altogether.

All of these slow, steady steps built up to a case for regulations and then suddenly collapsed before the most powerful authority in the field: the FDA.

"We’ve gotten to a point where there’s a huge amount of understanding within the scientific community," vom Saal says. "However, the regulatory community is locked in traditional mid-20th century, 1940s to 1960s' science and is saying, ‘We don’t know how to evaluate these new studies, so we’re going to continue to call all these chemicals safe.'"

Asked why the FDA doesn't ban endocrine-disrupting chemicals, a spokeswoman said the FDA is considering the potential for harmful effects on the endocrine system caused by very low exposures to some substances.

“FDA considers the available high quality scientific information from all sources (e.g. published literature, FDA research, manufacturer’s studies), as well as the structure of the molecule and what is known about similar substances,” spokeswoman Morgan Liscinsky wrote in an email.

"He is work, that is what he does"

Why are endocrine disruptors important to understand? Because they interfere with that magical process in which a single cell becomes an organism. Depending on the hormonal signals the cell receives in different stages of cellular division, it can become a nerve cell, a skin cell, a muscle cell, a fat cell or a bone cell.

Wanting to understand this process was what got vom Saal started.

"I have always been fascinated with how is it that we develop the way we are and what are the causes of the differences between people," he says. "How do you start off with twins and have those twins become more and more different throughout life?"

Those were the types of questions vom Saal encountered as an undergraduate student at New York University in the 1960s. The biology classes he took then got him interested in development. Right after graduation, he enrolled in the Peace Corps and left his hometown of New York for Africa. He taught biology in a secondary school in Somalia until a military coup started in 1969 and Americans were expelled from the country. He ended his service in Kenya.

The malnourished children he saw in Africa triggered his interest in early nutrition and development factors that affect the way people end up functioning later in life.

After Africa, he flew to Paris, where he spent another two years teaching biology. Upon his return to the U.S., he enrolled at Rutgers University in New Jersey, where he received his master’s and doctoral degrees. Since then he has been researching and teaching the ways hormones influence development.

Vom Saal came to MU in 1979, where he is a curators’ professor of biology and teaches reproductive endocrinology. He lives in Columbia with his wife, Kathi. They have a daughter, Jillian.

"He is work, that is what he does," says Annette Hormann, a doctoral candidate who works with vom Saal. As a mentor, he focuses on his students’ successes. He picks up whether they understand a particular issue, and if they don't, he explains it using metaphors — whether it’s science or the ups and downs of pursuing a Ph.D., which he compares to a couple of magnets of the same pole, rejecting one another.

Vom Saal’s work is driven by curiosity but also by a wish shared among scientists: that their work might make people healthier.

"That’s a huge part of it," he says.

He sees modern science as concentrating too much on treating diseases instead of getting to the root of what causes the disease and stopping it before it manifests.

Can the gradual removal of chemicals from the environment and people’s everyday lives lead to a world with fewer diseases? To an extent, vom Saal believes it’s possible. Then there are people’s lifestyle choices.

"I’m certainly aware that what we’re doing isn’t 100 percent of the answer," he says. "But it clearly is a contributor to arriving at an answer of what is going on that Americans are becoming horrifyingly obese and at an alarmingly rapid rate. And, you know, we think we’ve got some of the answers to that."

"It's called a paradigm shift"

This is not the first case of a long path to regulation.

Dioxins, toxic byproducts of various industrial processes, have avoided regulation for more than two decades, despite about 5,000 papers highlighting their negative effects.

With endocrine disruptors, the problem is that decision-makers in chemical risk assessment were trained in toxicology before the concept of endocrine disruption was coined 20 years ago, vom Saal says. He compares this to a patient with an endocrine problem seeing a foot doctor instead of an endocrinologist.

Risk assessors are usually trained in evaluating chemicals that cause DNA mutations and not in evaluating the way hormones modify gene activity without mutating the genes. "It’s an entirely different field of science," vom Saal says.

And the foot doctor doesn’t allow endocrinologists to examine the patient.

In March 2011, eight scientific societies representing about 40,000 researchers and clinicians published a common letter, asking the FDA and the Environmental Protection Agency to include them in the risk assessment process for endocrine disruptors.

"One of the problems they have is they look at some of the science and don't know how to interpret it because it's not done using the traditional toxicology testing paradigm," Patricia Hunt, a professor in the Washington State University School of Molecular Biosciences, said according to the university's website. "We need geneticists, we need developmental and reproductive biologists, and we need the clinical people on board to actually help interpret and evaluate some of the science."

The Society of Toxicology, which is currently involved in risk assessment for chemicals, replied in a letter published in the Washington Post, with a message that vom Saal summed up as: "We’re the experts, leave us alone."

It’s not an atypical response whenever new scientific revelations emerge.

"It’s called a paradigm shift," vom Saal says, "(Causing) extreme pain that people within a field experience when their beloved beliefs, their cherished assumptions about how the world works are challenged."

A "revolving door"

Some of the scientists who attended the St. Louis conference in September began collaborating on a common paper that would summarize discussions and conclusions and propose new regulations on endocrine disruptors, a paper that could speed up their unfolding scientific revolution.

One of the things that needs to change, vom Saal says, is the heart of the regulatory system. Its structure and its members are not organized to recognize new scientific discoveries.

"We need to move beyond attacking one chemical at a time through specific legislation," vom Saal says. "We’re trying to move so that the process of assessing risk of all chemicals is changed because there are a hundred thousand chemicals in commerce. You can’t rely on (state) legislation independently regulating each of them. That’s just not going to work.

"We need a regulatory system that is set up to accurately assess risk associated with chemicals and a regulatory system that works for the public and not for the few corporations that manufacture the chemicals."

Vom Saal says regulatory structures in many countries incorporate a "revolving door," which brings people in and out along with influence from the industry. When members of the FDA assess chemical risks in this country, they usually rely entirely on studies delivered by the chemical industry itself.

In the documentary "Tapped," which examines the bottled water industry, there is a sequence from a U.S. Senate hearing on BPA in 2008. Massachusetts Sen. John Kerry asks FDA official Norris Alderson to describe what kind of studies the FDA bases its decision when it is telling the public that BPA is safe.

"Did you ask for studies from independent sources?" the senator asked.

"We don’t normally ask for independent sources," Alderson answered.

"Then you don’t protect the American people," Kerry responded.

"Running off into the sunset"

Roughly 2 billion pounds of BPA are sold every year in the U.S. for about a dollar a pound to be used in plastic products. Profits by BPA producers and customers who go on to use it in manufacturing add up to a $10 billion-a-year industry, according to Welshons’ calculations.

"Ten billion dollars a year is about $25 million a day or a million dollars an hour," Welshons says, doing the math. "So it means that for every hour that regulation of BPA is delayed, the industry is making a million dollars."

The biggest BPA producers in the United States are SABIC Innovative Plastics, Dow Chemical, Bayer MaterialScience, Momentive and Sunoco Chemicals, according to Nexant Inc., a consulting company based in San Francisco.

Welshons has a theory for why roughly all industry-funded studies found no harmful effects or exposure to BPA. There’s no high-up, conspiratorial authority. Instead, "it’s hundreds of middle managers who are making these decisions within the company. They ask for information and some lab will say, 'We have found low-dose effects of BPA.' And another (lab) may say, 'Oh, we’ve done that, we can’t find a thing.' Where are they going to give the money?"

"It’s a bunch of choices — a very diffuse thing like the protection of the public versus something very specific, protection of corporate income stream — and what choices are they going to make?" Welshons says. "If they’re loyal employees, of course, they’re going to make the wrong choice."

Vom Saal says chemical companies "have no incentive to care. It’s not going to cost them any money. They’re going to bail out and take their millions and go running off into the sunset before the end of their world occurs."

Public pressure could lead to regulation changes

And who is there to save the world in vom Saal’s intricate chemical drama?

In short, the U.S. public and risk assessors in other countries.

Vom Saal and his colleagues plan to publish a paper with conclusions from the St. Louis conference and then take pieces of it to distribute in Congress and to the regulatory agencies. But also, most critically, they plan to take it to the public through the news media.

Parts of the paper will be sent abroad, where vom Saal thinks they are more likely to have an impact on regulatory systems. Canada and the European Union have already introduced legislation on BPA. Changes in other countries can put pressure on the U.S. to follow.

The European Union passed legislation that requires, starting in December 2010, testing and classifying chemicals before they can be put into products.

"We have no law like that in the United States," vom Saal says. "We are literally like a Third World country in terms of our chemical regulatory system, compared to the Europeans. And with this Congress, there’s no hope of getting a European-style approach."

He continues: "I mean, most people think that the chemicals in the plastic you’re using or in the clothes you’re wearing or in the fabrics on the couch you’re sitting on — that they’ve been tested for whether they’re harmful or not. And the answer is no, they haven't. There’s no law that requires that. And that’s crazy.”

Vom Saal and his colleagues hope to convince the American public of the need to regulate endocrine disrupting chemicals. Public pressure could persuade Congress to make changes.

Public pressure could also influence corporations "in the middle," Welshons says, referring to the manufacturers that buy BPA to use in baby bottles or cans. Welshons thinks that if the public stops buying those products, manufacturers will change what they put into them immediately.

In the past few years, after Canada took the lead in banning BPA, Walmart promised to stop selling products containing the chemical. Playtex launched a line of BPA-free baby bottles. Nalgene, a brand of reusable water bottles, announced it would stop making bottles that contained BPA. In Columbia, Clover’s Natural Market got rid of BPA water bottles and baby products.

A scientist's responsibility

To Welshons, vom Saal is a guy with "pathetic math skills, fantastic animal development skills." It's an interesting description, vom Saal says after he stops laughing, especially because he used to teach statistics. The two scientists have known each other for 25 years and have learned to have fun together, sometimes by making fun of each other.

Outside the office, vom Saal sometimes plays guitar in his folk band and flies his airplane.

Welshons, who is married with children to Susan Nagel, thinks that what sets him and vom Saal apart as a research team is that they have a set of scientific controls and an openness to accept results that contradict their hypotheses.

And then there’s the work outside the laboratory — talking to the media, going to conferences, testifying at hearings in the Senate — to which vom Saal has dedicated big chunks of his time. He refers to Albert Einstein when he talks about a scientist’s responsibility to get out in the world and support his findings if they involve world safety or public health issues.

"As I said, paradigm shifts are painful and never quick. But they’re inevitable," vom Saal says. "The regulatory system cannot ignore the reality of science, particularly when you have literally tens of thousands of scientists saying to them, ‘You can’t keep doing this.' They cannot keep doing that and get away with it forever."

It would take new laws and the changing of the chemical regulatory system. It would take the public understanding what changes are needed and providing legislators in Congress with a mandate to do that. It would maybe take different people from the ones who are now in the regulatory structures.

"So am I optimistic that in the long run there will be a change? Yes, it’s inevitable," vom Saal says. "And the longer it takes for that to happen, the more people will be harmed by these chemicals. That’s the sad part."

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