Research in animal models suggests the simple 'energy in, energy out' model doesn't tell the whole story. Common chemicals could be contributing to the obesity epidemic.
Research in animal models suggests the simple 'energy in, energy out' model doesn't tell the whole story. Common chemicals could be contributing to the obesity epidemic.
What could connect such disquieting and disparate health concerns as early onset puberty, female depression, and fatty liver disease? Endocrine disrupting chemicals.
CAMBRIDGE, Mass.—In the basement workshop of Rockler Woodworking and Hardware, instructor Palo Coleman is wrapping up a class on epoxy resin art, a popular craft for creating sparkly jewelry or charcuterie boards and “river” tables, with vibrant glass-like features that seemingly flow through the wood surfaces.
As Coleman’s students—a woodworking hobbyist, and a retired builder and his doctor daughter—gather around a workbench, he tears pieces of 400 grit sandpaper and demonstrates how to sand and stain the elm and cherry coasters they crafted and adorned the week prior with electric blue, red, and copper epoxy resins. The students had mixed two substances—a resin and a curing agent—added pigments, and poured the concoction into grooves. The chemicals reacted to form the solid plastic now glittering on the coasters’ surface.
While beautiful, these resin materials are loaded with a dangerous hormone-disrupting, and likely carcinogenic, chemical called bisphenol-A diglycidyl ether, or BADGE. BADGE is similar to bisphenol A (BPA), an endocrine disruptor that can hijack the body's hormone functions at tiny concentrations. BPA is linked to multiple health problems including cancer, diabetes, reproductive impacts, and behavioral problems, and is especially harmful to unborn and young children whose hormone systems are still in development.
BADGE is far less studied than BPA, but its chemical structure concerns researchers because it includes reactive compounds known to cause cancer and other serious diseases. It is broadly used beyond artisan woodworking, such as in glues, boat repair and refinishing, in powdered coatings in automotive and other metal finishing, and in can linings. Zero workplace exposure limits on BADGE leave the door open for potentially harmful worker exposures, and sketchy, or even false, advertising about the safety of woodworking and art supplies. Researchers worry that the failure to adequately test and regulate BADGE leaves scores of workers, artisans, and individuals at risk.
“Joe woodworker, who knows nothing about chemistry, is being given products that are endocrine disruptors of massive significance, potential carcinogens, and told to go play with them,” Terrence Collins, Teresa Heinz Professor of Green Chemistry at Carnegie Mellon University, told EHN.
BADGE is the most widely used epoxy resin.
Wooden coasters embellished with epoxy resin art.
BADGE is the most widely used epoxy resin, with an annual U.S. production of several million tons. EHN’s review of epoxy resin kits sold online and in stores found just nine of 16 brands provided material safety data sheets (MSDS). Out of these, all but one, which blacked out its chemical ingredients, reported their resins contained BADGE at concentrations as high as 70% to 100%. Many resins also contain nonylphenol, another endocrine disruptor.
Collins began investigating BADGE a decade ago after learning that BPA was used in epoxy resins. Reviewing BADGE’s chemical structure, he thought “this compound is too dangerous to be used,” he said.
BADGE is a BPA molecule with two reactive chemical groups stuck to it that link to other bisphenol molecules to yield a viscous epoxy polymer. Mixing it with an acid, or heating it, in the presence of a solvent, sets a reaction in motion that ends in a chain of alternating BADGE and bisphenol molecules (BPA, BPS, or PBF) that form a tough plastic.
It has a so-called “double alkylation structure,” which means it can crosslink with DNA and potentially result in cancer, said Collins. In 1989, the International Agency for Research on Cancer (IARC) found limited evidence for the carcinogenicity of BADGE. Two of five mice studies reviewed by the IARC found increases in epidermal, kidney, and lymphoreticular/haematopoietic tumors following skin application of BADGE. The other studies saw no increase or were “inadequate for evaluation.” IARC also noted that glycidaldehyde, a metabolite of BADGE, is carcinogenic to experimental animals and classified as possibly carcinogenic to humans.
BADGE “really should be treated as a potential carcinogen,” Frederick vom Saal, BPA expert and distinguished professor emeritus of biological sciences at the University of Missouri, told EHN. “It’s not rocket science, that’s just applying the chemistry to the biology.”
BADGE has been identified as an endocrine disruptor in animal studies, and shown to promote the differentiation of fat cells in humans. A recent review of research to date—noting little information available at human-relevant levels—concluded that BADGE is a potential endocrine disruptor.
BADGE differs from BPA in that its reactive chemical groups make it an unstable compound that can break down into byproducts that aren’t well known or studied.
It’s like “BPA’s insidious alter ego,” Patricia Hunt, Meyer distinguished professor in the School of Molecular Biosciences at Washington State University, told EHN. “It disappears, or turns into something else, and we don't know what the metabolites are.”
BADGE’s half-life in the body isn’t known, but evidence suggests it can linger for a long time in the blood, said Collins, and if it's traveling around in the body, it can make its way into cells where it does its damage.
One of the few studies on human exposure found widespread prevalence of BADGE, Bisphenol F diglycidyl ether, and five BADGE metabolites in blood and fat samples collected from New York City residents. The same study also measured BPA levels and found that they positively correlated with BADGE and its metabolites.
“If there’s BADGE, there’s BPA,” said vom Saal, confirming these findings on co-exposure. Resin can linings for food are still predominantly made with BADGE, he said, and they all release BPA at varying amounts.
Despite these warning signs, there are no regulations for workplace exposure to BADGE, and the Food and Drug Administration continues to allow both BADGE and BPA use in can linings, arguing that exposure levels are low and that the chemical clears the body rapidly when ingested. An FDA spokesperson pointed EHN to its policy on approving food contact materials and said the agency “ is not aware of any new information that has raised concern about the safety of BADGE under its intended use.”
The Consumer Product Safety Commission, which has the authority to develop standards for art materials, declined to comment on whether the agency was addressing BADGE in epoxy resins, but directed EHN to a guide on health hazards in art supplies.
When BPA is breathed in or absorbed through the skin, however, Hunt said her research shows it gets into the blood and lingers. And that’s how woodworkers would be exposed—through skin contact when mixing and pouring the resin materials, or by breathing in dust when sanding the cured plastics.
“As you sand … you're probably getting a nice coating on your body, some of which is making its way into your body” even if you’re using a vacuum system on the wood dust, said Hunt.
Fully cured resins in theory would not release BADGE when sanded, at least in the short-term, but “very few reactions are ever 100 percent complete,” said Collins. That residual BADGE could become airborne on dust during finishing.
“In woodworking, the assumption is that everything's carcinogenic."
Rockler Woodworking epoxy aisle.
Coleman, a vegan with closely-cropped grey hair and pale blue eyes, is knowledgeable about woodworking’s chemical hazards, although he did not know that the resin mixes contained a potential carcinogen and endocrine disruptor.
“In woodworking, the assumption is that everything's carcinogenic,” he told EHN. “That's why it's just best to use best practices whenever working with any chemical.”
Best practices for Coleman, who has taught at Rockler for five years, means mixing resins outside in open air when possible, not mixing large portions at once, wearing personal protection equipment, and waiting at least a week for the materials to cure before he sands.
In class he donned purple nitrile gloves and safety glasses when handling the resins, and showcased Rockler’s HEPA air filtration system on its routers, sanders, and saws.
“I train people how to use epoxy and how creative it is,” said Coleman. “When they leave, it's on them to do the things that keep them safe that they've learned in the class.”
Other woodworkers may or may not be aware of woodworking hazards. Steve Minnehan, a 35-year-old woodworker perusing the epoxy resin aisle at Rockler, questioned whether epoxies were any more dangerous than other chemicals he’s exposed to. “I know it’s incredibly harmful. I mean, this has a cancer warning,” he said, waving his hand at a product on the shelf. “It’s the nature of the work.”
Michaels craft store resin aisle. A few products warn of potential cancer and reproductive harms.
Blick Art sells the Art Resin brand, one of a handful that market their products as BPA-free. ArtResin is 80% to 90% BADGE.
What of the occasional hobbyist? The Internet is a free-for-all of DIY art resin videos, and most don’t talk about safety.
“They never tell you on YouTube that [uncured] epoxy will harden in your lungs, because it hasn't cured yet. All these people who sand it the next day, if they're not wearing hazmat suits, it's really dangerous,” said Coleman, pointing to a wood piece with a deep vein of resin that had yet to cure from the week before because it hadn’t been mixed properly. As an experienced woodworker, Coleman can tell when resin is completely cured, but that may not be the case for people doing projects at home.
Worsening matters, the majority of epoxy resin kits sold in stores and online—in bottles up to half a gallon in size—are poorly labeled. A few products, like those sold at the craft store Michaels, warn of potential cancer and reproductive harms, per California law. Many others simply say that the kits contain chemicals that may be harmful if misused and to read the cautions—which can only be found online.
Others provide outright misleading information. Blick Art Materials sells a brand called ArtResin, with 80% to 90% BADGE and a label that says BPA free, while only warning of skin irritation and allergic reactions. Online, the product is marketed as non-toxic.
Asked whether the company was aware of the health hazards of BADGE, a spokesperson told EHN, “Our formula is so pure everything reacts during the chemical reaction, and that makes it very safe for home use.” She directed EHN to a blog about BPA on its website where it claims that testing shows its fully-cured products contain only trace amounts of BPA that “are so infinitesimally low that we are able to say our epoxy resin is BPA-free.”
Brands sold on Amazon are particularly egregious. Unicone Art advertisements say, “With low odor and no fumes, our resin epoxy is non-toxic, making it 100% safe for you to work with for your casting, mold making and glazing projects.” It blacks out the chemical ingredients in its MSDS. Ecopoxy markets its FlowCast kit, labeled with a green leaf, as “thinner, clearer and more eco-friendly,” because it contains biorenewable content. Its kit is 40% to 60% BADGE. Some brands, like HXDZFX and Janchun have no websites other than their Amazon pages full of sparkly resin art supplies, which do not provide detailed safety information.A spokesperson for the American Coatings Association, Danielle Chalom, told EHN that the association was “unfamiliar” with the research on BADGE and therefore unable to comment.
Meanwhile, back at Rockler, students discuss their home project ideas with Coleman. One is planning to build an L-shaped raised bed with an ensconced bench, and he may dabble with resin art to create some Christmas presents.
The doctor, who runs a nonprofit on children’s allergy issues, tells EHN she is concerned about the resin materials though she doesn’t know much about what’s in them. “I’m learning about them, as I work with them,” she told EHN.
As Coleman tidies the workbench, he talks about the time he researched urethanes and discovered just how little was known about potential health impacts.
“A lot of the safety issues won’t show up for a long time, [until] after you’ve messed up your body,” he said.
Banner photo: Palo Coleman shows his class how to use a router for cutting grooves in the resin-decorated wooden coasters they created. The black hose sucks the wood/resin dust, capturing via the workshop's HEPA air filtration system.
All photos taken by Meg Wilcox for Environmental Health News.
Everyday levels of a pregnant woman’s exposure to mixtures of endocrine-disrupting chemicals like bisphenol A (BPA), phthalates, and per- and polyfluoroalkyl substances (PFAS), put their child at an increased risk of delayed language development, according to new research.
Because hormones regulate much of human development, endocrine-disrupting chemicals—which disrupt hormone activity—can create developmental problems. In the study, published today in Science, researchers determined that more than half of the pregnant women studied were exposed to endocrine-disrupting chemicals at a level that raises concerns about their child’s development.
“It’s very disconcerting,” Barbara Demeneix, a professor at the National Museum of Natural History in Paris and an author on the study, told EHN.
Demeneix and her collaborators used data from more than 2,000 pregnant women from Sweden to identify a mixture of endocrine-disrupting chemicals that was associated with a subsequent delay in the child’s language development. They then exposed tadpoles, zebrafish, and brain organoids—small brain “prototypes” made of human stem cells—to the same mixture of chemicals that had been measured in those mothers’ blood. In all three organisms, they saw similar results: a disruption of the regulation of genes responsible for language development in children.
They concluded that 54% of the women had enough exposure to put their child at risk of a developmental delay. While that doesn’t mean that 54% of babies born will develop more slowly, it does show that more than half the women in the study had concerning levels of endocrine-disrupting chemicals in their blood.
The research, said Demeneix and Joëlle Rüegg, a professor of toxicology at Uppsala University and an author on the study, highlights the importance of studying mixtures of chemicals rather than individually, since that’s how exposure happens in everyday life. “When we do this mixture approach, it’s much more concerning than if we looked at single chemicals,” said Rüegg.
Because these chemicals are so widespread, and different countries regulate them differently, Demeneix and Rüegg said it would be difficult for a pregnant woman to limit her exposure meaningfully. Rather, they encourage more systemic action, including classification of chemicals. In some countries, endocrine-disrupting chemicals are tested and regulated individually, which makes it difficult for all PFAS, for example, to be banned or regulated.
Regulating endocrine-disrupting chemicals as classes, said Demeneix, would be a step in the right direction.
“It’s a personal choice to control your food, to control your environment,” Demeneix told EHN. “It’s a regulator’s problem, a policy-maker’s problem, to make sure we are all protected.”
Banner photo: Dakota Corbin/Unsplash
After careful evaluation of the latest science, European officials have proposed lowering the safe daily dose of bisphenol-A, or BPA, by a factor of 100,000.
The same agency had already dropped their recommended exposure limit in 2015, down 12-fold from where they set it in 2006. “It's almost like the limbo stick: How low can we go?” Cheryl Rosenfeld, a biologist at the University of Missouri, told EHN.
Whether it’s lead, phthalates, per- and polyfluoroalkyl substances (PFAS), or BPA, nearly every time scientists assess chemicals, they lower the thresholds for safety. Doses that were previously thought innocuous, we find, turn out harmful. Why does that happen? And why does it seem to be happening yet again with BPA?
The answer: science is not static. Scientific advances constantly improve our ability to identify harmful effects, as well as help us to know where to look. “We haven’t just gotten better at measuring the pollutants in our bodies and in the environment, we’ve also gotten so much better at being able to measure their impact on people,” Laura Vandenberg, a professor at University of Massachusetts Amherst School of Public Health & Health Sciences, told EHN.
“Looking at groups of toxic chemicals decade by decade by decade, we recognize that less and less and less of these chemicals are safe for human exposure,” said Vandenberg.
For example, as blood lead levels declined in children over the decades—in response to more and more stringent regulations on the uses of lead—scientists continued to find detrimental impacts at lower and lower levels. They continued to ratchet down the limit of what they deemed safe before ultimately realizing that there was no safe level of lead exposure for children. But it wasn’t that kids in the 1970s were any less vulnerable to lead.
With the latest scientific opinion from the European Food Safety Authority, a similar storyline appears to be playing out for BPA, the plastic additive commonly used in everything from food can linings to cash register receipts. Again, it’s not that kids in the 1990s were any less vulnerable to BPA. “There’s really no safe dose for this chemical,” Pat Hunt, geneticist at Washington State University in Pullman, Wash., told EHN. Her research, and the research of others, consistently links very low doses of BPA to a host of health problems, including cancer, diabetes, reproductive impacts, and behavioral problems.
“But the way our regulatory system works, we are not erring on the side of caution,” said Hunt. “So, the more data we get, the more we have to keep dropping down and dropping down—which can’t inspire confidence on the part of the general public.”
(Credit: Cheryl Rosenfeld)
EFSA’s recommendation only applies to food and beverage contact materials, which are likely the greatest route of BPA exposure. Once finalized, it will inform decisions taken by European Union risk managers in the European Commission, European Parliament and member states—including the amount of BPA they allow in certain products.
Experts predict that the proposed daily dose all but ensures that BPA would need to be eliminated from these products. They also suggest that it will spur action in the U.S. If the proposed limit is upheld, that new safe level of BPA for Europe would fall to more than a million times lower than what U.S. regulators currently say is safe.
Two factors generally drive drops over time in accepted levels of a chemical in products: changes in the estimated exposure, or dose, and changes in our understanding of the toxicity. It could be that exposures in people have increased to exceed the safe dose, or that more information is available about the toxicity of the chemical, Maricel V. Maffini, a consultant to the Environmental Defense Fund, told EHN.
“In the case of BPA, it is clear that the toxicity is a problem,” said Maffini, who, along with other health researchers, last month petitioned the FDA to re-examine BPA’s safety in light of the European draft changes.
Many scientific assumptions have changed over time, noted Vandenberg. She highlighted our evolved understanding about exposures in study animals compared to humans—a critical comparison when translating findings from lab research into public health policy. It had been a long-held belief that a large animal—say, a human—can tolerate more exposure than a smaller animal. But, in fact, the smaller you are, oftentimes the faster you metabolize chemicals, Vandenberg explained. “You actually have to give mice a bigger dose in order to see the same level that's circulating in their bodies,” she said. “And EFSA finally appreciated that when they did their analyses of the studies to determine what's a safe dose.”
Our understanding of the myriad ways a chemical can wreak havoc on our biology is also constantly changing. For example, scientists have gained more knowledge over the last two decades in how BPA interferes with the normal function of hormones in the body—even in tiny amounts. Experts suggest a major shift came in the 1990s, with mounting recognition of endocrine disruption and its impacts on our health. BPA is just one of many chemicals with this hormone-mimicking potential. Notably, its chemical cousins—bisphenol-S, or BPS, and bisphenol-F, or BPF—can do the same.
The European proposal would only affect BPA and not these related chemicals, which are also already widely used in commerce. Thomas Zoeller, an emeritus professor of biology at the University of Massachusetts Amherst, points out that industry had voluntarily eliminated BPA from sippy cups and baby bottles before the U.S. FDA banned such uses in 2012. “Industry saw this coming,” Zoeller told EHN. “They were already replacing BPA with BPS and BPF.”
He fears the same scenario may be happening with EFSA’s decision. “Products are being protected, not people,” said Zoeller. Does that mean we have to go through the same long-term ratchetting down of what is considered a “safe level” for each replacement?
The regrettable substitution problem has triggered a growing push for the regulation of chemicals as classes, rather than individually. Vandenberg is among the champions of this movement. “Here we have a decision on BPA, but nothing on BPS. And that's unacceptable,” said Vandenberg.
The same goes for several other toxic chemicals that are following this same pattern of dropping limits and regrettable substitutions. “Do we really need to study all 1,000 or 5,000 PFAS chemicals?” said Vandenberg. “We’re creating problems, they’re going to have to be cleaned up at some point. And the longer we wait, the bigger the problem gets.”
Of course, conducting a risk assessment based on a group of chemicals naturally increases the chance that an exposure limit for any individual chemical would need to be lowered. The challenges mount. But there is a way off this toxic treadmill: ideally, starting “at the beginning before a chemical goes into commerce and determine whether it has any adverse effects,” said Hunt. “Let’s decide if we should even let this stuff loose.”
More than a thousand new chemicals are introduced onto the market each year. Most come into our homes having never been tested for potential harm. “That has to change,” said Zoeller. “Before a chemical gets into the public domain, there should be an earnest attempt to ensure its safety. If those chemicals had been tested for their ability to interfere with hormone action, then we could have engineered those chemicals to be without those properties.”
The process Zoeller referred to often goes by the term green chemistry. Vandenberg suggested it is a “good place to start.”
“We can’t let the perfect be the enemy of the good,” she said. “So, finding less hazardous chemicals is the place to start instead of insisting that everything has no hazard. But we always need to be moving toward innovative chemicals that have the features that we want them to have without the adverse health effects.”
Another part of the solution: maybe we don’t need chemicals for everything. “I do think we need to have a little bit of a societal reckoning: are we creating chemicals to solve problems that are not really problems? Do I need to be able to eat a pastrami sandwich with mustard on my sofa?” said Vandenberg, referring to a commercial for furniture that could be hosed down thanks to its chemical treatment. “That is a solution to a problem that did not exist.”
Zoeller shared one promising effort in his home city of Indianapolis, where local elementary schools have long been serving student lunches in plastic dishes. “Some of the plastics are reusable, so they put them in industrial dishwashers. You couldn’t create a worse situation,” said Zoeller.
A local pediatrician, Manasa Mantravadi, had the idea to replace those potential hormone-disrupting dishes with stainless steel versions. The new dishes were designed to be the same size and shape as the plastic dishes used by the schools—and can fit in the same dishwashers. “So, there are ways of doing this,” said Zoeller. “We just need to be smart about it.”
Other experts anticipate that the EFSA move will promote yet more positive change: “We need a revolution in food packaging, and I think this is going to push it,” said Hunt.
EFSA is accepting public comments on the draft proposal until February 22.
Banner photo: From left—Dr. Carlos Sonnenschein, Dr. Ana Soto, and Dr. Silva Krause looking at mammary glands of a BPA experiment. (Credit: Ana Soto, Tufts University)
If a scientific opinion recently proposed by European officials is upheld, the recommended daily dose of bisphenol-A, or BPA, in Europe will be more than a million-fold lower than what U.S. regulators say is safe.
And the change in accepted exposure would all but ensure the chemical cannot be used in any food contact products.
“There's nothing different about the physiology of an American compared to a European,” Laura Vandenberg, a professor at University of Massachusetts Amherst School of Public Health & Health Sciences, told EHN. “So, if it's hazardous in Europe, it's hazardous for us.”
A significant gap already existed between the European Union and the U.S. in what regulators considered a safe dose of the plastic additive commonly used in everything from can linings to plastic water bottles. The draft opinion, released in December by the European Food Safety Authority, or EFSA, is “just moving it all the way to the left,” said Vandenberg. She added that their conclusion is “very solidly backed up by science,” and, in fact, has been now for at least a decade.
“And it’s really different compared to the FDA [U.S. Food and Drug Administration],” she said.
BPA is an endocrine disruptor, meaning it alters the proper functioning of our hormones, and is linked to a host of health problems, including cancer, diabetes, obesity, reproductive, nervous and immune system impacts, and behavioral problems. Scientists like Vandenberg have published studies on such health effects for decades.
So, that begs the question: How can two major regulatory bodies look at the science and come to such vastly different conclusions? Where is the disconnect?
BPA testing in the lab of Cheryl Rosenfeld, a University of Missouri researcher. (Credit: Cheryl Rosenfeld)
Historically, the U.S. FDA has leaned almost exclusively on so-called “guideline” studies in determining what amount of exposure to traditional toxics—whether that’s lead or PFAS (perfluoroalkyl and polyfluoroalkyl substances) or BPA—is safe for people. These studies are typically done by government scientists and follow a prescription for everything from the type of animal to use to how long the animal is exposed. There is also a standard set of endpoints such as the weight of the organs.
This prescription was based on assumptions made decades ago about how toxic chemicals affect the body. Not all of these assumptions have stood the test of time, including the idea that a chemical’s toxicity is always proportional to the dose of exposure. In fact, research finds that sometimes a relatively high dose of some hormone-mimicking chemicals can prove innocuous for a given endpoint while a far lower dose wreaks havoc on the body.
Academic scientists tend to take a different, more investigative approach. They might look at changes in specific regions of the brain, or for alterations in behavior. All told, academics have published thousands of peer-reviewed studies, many of which have found negative health effects of BPA¾even at very low doses.
In their assessment of BPA, EFSA went beyond guideline studies and considered evidence from academics, including many epidemiological studies and other laboratory-based studies that didn’t follow the standardized formula. Edward Bray, a spokesperson for the agency, noted that the key study driving their decision was published in 2016 by a team of academic scientists in China. That data linked BPA exposure in lab mice to an increase in the number of a type of immune cell, which can lead to the development of allergic lung inflammation.
“We need to acknowledge that if another agency has looked at these data and is drawing a conclusion that's intended to protect public health, then we're the ones who are behind,” said Vandenberg. “We're the ones who aren't being protective enough in the U.S.”
Many U.S. health professionals want to change that: last month, a group of scientists, doctors, and environmental and health organizations petitioned the FDA to review the safety of BPA and to remove or restrict approvals for the chemical in light of the European recommendations.
Maricel V. Maffini, a consultant to the Environmental Defense Fund, was among the signees of the petition. The agency is obligated to respond to the petition within 180 days, she told EHN. If they deny the petition, “they have to explain themselves,” said Maffini.
The ripple effects of EFSA’s move could be great. Many U.S. manufacturers produce products to be sold worldwide. If they want to keep the European market, and the proposal goes through, they will need to meet the new, more stringent limits. Experts also believe that this move could lead to tighter regulations in the U.S. “I think this is going to put enormous pressure on the FDA. It’s about time,” Pat Hunt, a geneticist at Washington State University in Pullman, Wash., told EHN. In an emailed statement to EHN, the FDA said that their “regulatory decisions remain grounded in the robust evaluation of the totality of the available science on the use of food additives, including substances used in food packaging.” The agency noted that they had yet to complete their review of EFSA’s draft proposal.
Jennifer Garfinkel, director of product communications for the American Chemistry Council, which represents chemical manufacturers, told EHN that they, too, are currently analyzing the draft.
“BPA is one of the most widely studied chemicals used today,” she added in an emailed statement. “In 2018, the [FDA] published its findings from the Clarity Core Study, the largest study ever conducted on BPA. This study along with many others confirmed that BPA is safe at the very low levels to which consumers are exposed.”
Importantly, the study that Garfinkel referenced was part of a larger collaboration on the health effects of BPA: the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, or Clarity. The unprecedented multimillion-dollar project was the subject of a four-part series published in November 2019 by EHN that found the FDA stacked the deck against such findings from independent scientists studying BPA – as well as many compounds used in "BPA-free" products.
Clarity aimed to synthesize a traditional regulatory study from the government and investigational studies from academics. The “core study” was the government’s contribution. Meanwhile, the studies published by academics showed health consequences—such as mammary gland cancer, kidney damage, increased body weight, and altered gene expression in the brain—after exposures to exceptionally low doses BPA. And when Vandenberg and her colleagues, all not involved in Clarity, took a close look at the government’s core study results, they identified 41 endpoints with statistically significant effects, too. A final 122-page “compendium of published findings” was released by the government in October, which summarized and collated all of the government and academic findings. It did not attempt to integrate or interpret those findings.
However, when the draft of the Clarity Core Study was published in 2018, the FDA released a statement highlighting the agency’s interpretations: they wrote that the study supported their ongoing stance that “currently authorized uses of BPA continue to be safe for consumers.” The statement made no mention of significant findings of effects at low doses of BPA in both the Core Study and in the peer-reviewed studies from academic collaborators that had been published by that time.
Among the hazard endpoints identified by EFSA is actually one from the Clarity Core Report. Still, most of the information they used came from academic studies, noted Maffini. “They used everything they could get their hands on,” she said. “So, the spectrum of information was very different from what the FDA usually looks at.”
Bray confirmed that EFSA considered all the Clarity studies, including the academic contributions, in coming to their conclusion. Also, while EFSA’s mandate was to look solely at BPA, Bray added that, moving forward, the agency did recommend the collection of data on the use of BPS—a BPA alternative that has been linked to similar health impacts—in plastic food contact material, as well as its presence in and migration into food.
The European rule would only apply to food and beverage contact materials, and not the other uses of BPA such as in-store receipts and dental sealants. It also would not apply to a growing list of replacements, such as bisphenol-S (BPS). Many such chemical cousins are now regularly used in popular products labeled as BPA-free.
“The rest of them are just as bad, some are even worse,” said Hunt. “This is insidious business.”
EFSA is accepting public comments on the draft proposal until February 22. Once finalized, the assessment will inform decisions taken by EU risk managers in the European Commission, European Parliament and member states.
Banner photo credit: Guillaume Périgois/Unsplash