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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.
Widespread exposure
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.
Mixtures of chemicals
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
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.”
“In the case of BPA, it is clear that the toxicity is a problem"
(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.
Related: Europe’s revolutionary BPA proposal puts more scrutiny on US regulatory inaction
“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.
Regulating chemicals as classes, not individually
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.”
Green chemistry
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.”
Related: Get BPA out of food packaging, US health professionals tell feds
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)
What does PFAS stand for?
PFAS stands for per-and polyfluoroalkyl substances, which contain a strong carbon-fluorine bond that allows them to accumulate over time in the environment and in the bodies of animals and people, posing health risks. PFAS chemicals might also be thought of as “everywhere chemicals,” since they’ve become so common in the products we use every day.
Where does PFAS contamination come from?
Chemical plants and other industrial facilities, along with landfills and treatment plants, are among the common sources of PFAS contamination. (Credit: Wikimedia Commons)
Manufacturing processes and waste storage and treatment sites release PFAS into the air, soil, and water. The Environmental Working Group (EWG) has identified 41,828 industrial and municipal sites in the U.S. that are known or suspected of using PFAS. Among the industrial facilities the group pointed to are petroleum stations and terminals, chemical manufacturers, commercial printers, plastics and resin manufacturing sites, paint and coating manufacturers, semiconductor manufacturers, makers of metal products and electrical components, and electroplating and polishing.
EWG recently released an additional report based on EPA data that found PFAS may be discharged by more than 1,500 U.S. textile mills. Landfills and waste disposal facilities, along with sewage and waste treatment plants, are other common sources of contamination.
In addition, military bases and airports are major contributors to PFAS contamination, mostly from training and testing exercises using firefighting foam. EWG mapped 385 U.S. military installations with PFAS contamination and several hundred more that are suspected to be contaminated. Many nearby communities also suffer groundwater and drinking water contamination as a result of their proximity to these facilities.
What’s the difference between PFAS, PFOS, PFOA, PTFE, and GenX?
There are estimated to be more than 9,000 PFAS chemicals. Some of the most common include Perfluorooctane Sulfonate (PFOS) and Perfluorooctanoic Acid (PFOA), also known as C8. These chemicals were once widely used in substances like fabric and leather coatings, household cleaning products, firefighting foams, and stain-resistant carpeting. Although manufacturers have phased out their use in Canada and the U.S. over the past two decades, they remain ubiquitous in the environment—and in our bodies. Dupont developed GenX as a replacement for PFOA in 2009, but subsequent studies of GenX have also raised health concerns.
Polytetrafluoroethylene (PTFE), along with C8/PFOA, were used to produce Teflon, the non-stick chemical coating manufactured for decades by Dupont and now Chemours, which Dupont spun off in 2015.
What are the dangers of PFAS?
PFAS exposure begins before birth and the chemicals build up in our bodies over time. (Credit: Silvio Lucchini/flickr)
PFAS are in the blood of nearly all Americans, and testing of umbilical cord blood and breast milk indicates that exposure begins before birth. Some PFAS bioaccumulate—build up—which means even low exposures are cause for concern over time as our bodies accumulate more and more of them. PFAS bioaccumulation also occurs in non-human organisms, including fish and other human food sources, which eventually end up in people. That’s another reason protecting the environment from PFAS contamination—and monitoring PFAS levels—is so important.
PFAS are endocrine disrupting chemicals, meaning they interfere with our hormone systems. When an external chemical interferes with our hormone systems, it can lead to changes in our bodies and brains capable of causing disease and, in some cases, even death.
Research links PFAS to health problems including kidney and testicular cancer, liver and thyroid problems, reproductive problems, pregnancy-induced high blood pressure, low birthweight, and increased risk of birth defects, among others. PFAS has also been linked to changes in cholesterol levels and in the timing of puberty. Evidence of PFAS impacts on immune function is another growing concern, and studies have found some PFAS may lower vaccine effectiveness.
PFAS contamination also has an environmental justice dimension, as low-income communities and communities of color are often more likely to be located near sites of PFAS contamination, increasing their health risks.
Why is PFAS getting so much attention now?
For decades, a chemical plant in North Carolina dumped PFAS-contaminated waste into the Cape Fear River, a source of drinking water. PFAS is linked to serious health conditions, including cancer. (Credit: Rich Brents/Unsplash)
Although there is evidence that makers of PFAS were aware of their adverse health effects as far back as the 1950s, the general public was largely uninformed. The companies kept health research from employees and the public for decades, as EWG chronicles in this timeline. We know much more about the health impacts of PFAS today.
In 1998, the company 3M, maker of the Scotchgard water- and stain-repellent material, alerted the EPA that PFOS builds up in blood and had been detected in blood samples of people across the United States who weren’t exposed on the job. Data received from 3M eventually prompted greater EPA scrutiny of PFAS.
While almost everyone has PFAS in their bodies today, those living or working near PFAS manufacturing, industry, or disposal sites face heightened risk of health problems.
- Some 80,000 local residents of Parkersburg, West Virginia, settled a lawsuit against Dupont, which was found to be knowingly contaminating ground and river water with PFAS chemicals for decades, despite evidence that the chemicals were toxic to humans and animals. A subsequent study found a likely link between PFOA/C8, and several serious health conditions, including cancer.
- For more than three decades, a chemical manufacturing plant outside of Fayetteville, North Carolina owned by Dupont and later Chemours dumped PFAS-contaminated waste into the Cape Fear River. Not until 2017 did the public learn they were consuming water contaminated with a newer PFAS, GenX, and other lesser-known PFAS compounds.
- In the 1960s, the Wolverine Worldwide Tannery in Rockford, Michigan contaminated land, groundwater, and the Rogue River—once Rockford’s drinking water source—with PFAS-laden leather manufacturing waste. The EPA is now considering whether to designate the former tannery and its old dump as federal Superfund sites.
- The group Physicians for Social Responsibility recently reported that oil and gas companies used PFAS and substances that could degrade into PFAS at more than 1,200 fracking wells across six states—Arkansas, Louisiana, Oklahoma, New Mexico, Texas, and Wyoming—between 2012 and 2020.
Where do you find PFAS?
PFAS have been used around the world since the 1950s in a wide variety of consumer goods. Today, they can be found in products like firefighting foam, non-stick cookware, cosmetics, and materials that protect against grease, oil, and water, such as stain-resistant carpeting and fabrics, food packaging, and water-repellent clothing. So whether we’re camping, hiking, hunting, fishing, cooking, putting on makeup, enjoying a takeout meal, or playing with our kids on the living room floor, PFAS have infiltrated everyday life.
PFAS testing
Researchers are finding PFAS in a wide variety of consumer goods — including products in which PFAS are not intentionally added.
A testing collaboration between EHN.org and wellness site Mamavation has found evidence of the chemicals in clothing, food, and makeup. See additional testing at Mamavation's Product Investigation page, including bamboo flooring, period underwear, and parchment paper.
PFAS in food
Takeout containers, pizza boxes, microwave popcorn bags, and non-stick cookware are all ways that food can become contaminated with PFAS. (Credit: Jordan Nix/Unsplash)
Food packaging, like takeout containers and wrappers, pizza boxes, french fry containers, hamburger wrappers, and microwave popcorn bags are all common means of PFAS food contamination. Even supposedly environmentally-friendly compostable bowls sometimes contain PFAS. The Food and Drug Administration has not restricted use of PFAS in food packaging, leaving it up to states and the public to protect consumers.
Non-stick cookware is another way that PFAS can enter our food and air. Although PFOA has been phased out in the U.S, non-stick cookware still contains alternatives that may be harmful to health. Labels claiming PFOA-free don't necessarily mean cookware is safe. PFAS-free is the safest choice.
PFAS in cosmetics
Makeup and personal care products like dental floss may contain PFAS even if none are listed among the ingredients. (Credit: Carlos Martinez/Unsplash)
A growing body of research is turning up evidence that personal care products like cosmetics—even supposedly “green” cosmetics—contain PFAS. A recent peer-reviewed study found high levels of organic fluorine, an indicator of PFAS, in more than half of 231 makeup and personal care samples, including lipstick, eyeliner, mascara, foundation, concealer, lip balm, blush, and nail polish. It’s also been found in some types of dental floss designed to glide more easily between teeth.
Some makeup manufacturers intentionally add PFAS to make cosmetics last longer and spread easily. In other cases, PFAS is introduced into cosmetics through cross-contamination, such as machinery used in manufacturing or plastic packaging that contains PFAS. Cosmetic maker CoverGirl was recently hit with a lawsuit alleging PFAS were found in makeup products the company labels as “sustainable.”
PFAS in clothing and home goods
New research suggests people may absorb PFAS through their skin from stain-resistant carpeting and water- and stain-repellent textiles. (Credit: Picsea/Unsplash)
Testing by EHN and other organizations has found indicators of PFAS in everything from athletic and yoga clothes to period underwear to stain- and water-repellent clothing. PFAS indicators have also been detected in popular kitchen linens and bedding and stain-resistant carpeting and upholstery. PFAS from textiles can build up in household dust, and emerging evidence suggests that we could absorb some compounds through our skin. Treated jackets and other items can also contaminate water supplies, as PFAS run off them in the wash.
PFAS in firefighting foams
Firefighting foams used on military bases, airports, and burn sites are a big source of PFAS contamination. (Credit: Wikimedia Commons)
According to the Green Science Policy Institute, the majority of known PFAS-contaminated sites in the U.S. are related to the use of firefighting foam. These sites include military sites, airports, fire-training areas, and past burn sites.
PFAS in landfills and wastewater
Landfill waste washes PFAS into soil and waterways. (Credit: Alexander Schimmeck/Unsplash)
Discarded products such as clothing, carpet, bedding, and food packaging can release PFAS into landfills, where rainwater moves it (along with other chemicals), creating a concentrated toxic waste that infiltrates soil and nearby water sources like rivers and lakes. Typical landfill waste treatment systems do not remove PFAS.
PFAS from products we use everyday get washed down the drain and flow to wastewater treatment plants. Most wastewater plants aren’t advanced enough to remove PFAS, so the chemicals remain in treated water and biosolids (recycled sewage) that are sometimes used in agriculture. This can end up contaminating agricultural lands, and PFAS then return to our kitchen table via fruits, vegetables, and meat.
PFAS in drinking water
PFAS has been detected in drinking water systems across the U.S. (Credit: Bluewater Sweden/Unsplash)
PFAS contamination in the water supply is widespread. Research by EWG has found PFAS contamination in drinking water systems across all 50 states and two U.S. territories, Guam and Puerto Rico. But the full extent of the problem remains unknown.
Bottled water constitutes another emerging PFAS risk. A 2021 study led by Johns Hopkins researchers found 39 out of 100 bottled waters tested contained PFAS. The Food and Drug Administration has not set PFAS limits for bottled water.
Are PFAS alternatives safer?
An international group of scientists has called for a phase-out of PFAS according to how essential the chemicals are. In short, things like cosmetics and most other personal care products that can be made without PFAS should be. In other cases, there may be safer substitutes available, such as for waterproof jackets and equipment.
Right now, though, the most common substitutes for PFAS are other PFAS chemicals. So-called short-chain PFAS have been developed as supposedly safer alternatives to the older long-chain PFAS. That’s what happened in the 1990s, when 3M struck a deal with the EPA to phase out PFOS in Scotchgard products. The company replaced it with an alternative that lingers in people’s bodies for significantly less time, decreasing human exposure. The EPA subsequently created a voluntary stewardship program for PFOA that encouraged companies to phase out its use and develop safer alternatives.
Researchers from around the world have expressed concerns, however, that more study is needed to determine whether current PFAS alternatives are truly safe. Even if they leave the human body sooner, they still build up in the environment, which could continue to create serious pollution problems over time.
What are governments doing to protect people from PFAS?
Even now, there are no federal standards limiting PFAS discharges. In 2021, the EPA issued a “PFAS roadmap” with a timeline for setting drinking water and wastewater treatment standards, health assessment protocols, and hazardous substance designations for several PFAS chemicals, including PFOA and PFOS.
Congress is currently considering comprehensive PFAS legislation. The U.S. House of Representatives passed the PFAS Action Act of 2021 and advanced it to the Senate. A separate House bill, The Clean Water Standards for PFAS Act, would require water discharge limits on PFAS from chemical manufacturers, paint, paper, plastics, electrical components, textiles, leather tanning, metal finishing and electroplating companies.
Growing concerns about the health and environmental impacts of PFAS is prompting action at the state level as well. A recent analysis found that at least 32 U.S. states are considering more than 210 bills that would ban or restrict PFAS, including in personal care products, clothing, and food packaging.
Europe is moving faster. The European Union is considering a ban on thousands of PFAS chemicals except when their use is deemed essential. If successful, a final agreement could come by 2025.
What can you do to avoid PFAS?
Using stainless steel, cast iron, glass, or ceramic cookware instead of non-stick pots and pans is one way to avoid PFAS exposure. (Credit: Justus Menke/Unsplash)
Completely avoiding PFAS is almost impossible, and the cost of cleanup is enormous. But there are things you can do to reduce your risk and advocate for change.
- Avoid water and stain-repellent carpeting and household textiles, such as curtains, furniture upholstery, bedding, table cloths, and napkins.
- Limit use and purchase of “waterproof,” “water-resistant,” and “stain-resistant” clothing and other products, and “anti-fog” eyeglass sprays and wipes
- Avoid food packaged in greaseproof bags or containers. As an alternative, use your own glass containers for takeout and leftovers. Encourage restaurants to ditch food containers and packaging containing PFAS. Skip microwave popcorn from PFAS-treated bags.
- Be aware that not all compostable packaging is PFAS-free: choose BPI-certified packaging to be sure, and ask about it at restaurants that use compostable containers.
- Cook with stainless steel, cast iron, glass, or ceramic cookware instead of non-stick options.
- Read personal care product and cosmetic labeling carefully and avoid those with “perfluor-,” “polyfluor-,” “PTFE,” or Teflon on the label.
- Find out if your water source has been tested for PFAS. If it contains PFAS, or if it hasn’t been tested, a water filter might be a good purchase. However, be aware that not all water filters are equally effective; a 2020 Duke University study found that reverse osmosis filters and two-stage filters performed best at eliminating PFAS.
- If you drink bottled water, try to purchase water labeled “purified,” rather than spring water.
And, of course, stay in touch with EHN. We will continue to report on PFAS. Our ongoing testing and coverage of PFAS contamination in food packaging and common consumer goods, coupled with reporting on policy and regulation, seeks to hold companies, political leaders, and agency officials accountable for protecting the public.
We also have a rich archive of PFAS coverage from U.S. and international news organizations. Enter “PFAS” in our search tool in the upper right-hand corner of our homepage to find all of it.
Banner photo credit: engin akyurt/Unsplash
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.
Related: Get BPA out of food packaging, US health professionals tell feds
“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?
Different approaches to testing BPA impacts
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.
Related: BPA use in doubt as Europe proposes vastly more protective health limits
“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.
“Clarity” on BPA elusive in U.S.
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.
BPA alternatives excluded
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.
Related: BPA replacement linked to increased cardiovascular disease
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.
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A near-ubiquitous ingredient in plastic products, BPA is increasingly replaced by cousin chemicals — such as Bisphenol F (BPF) or BPS — due to mounting health concerns. However, scientists are now uncovering that these replacement chemicals may be as harmful as BPA.
The study tapped into data from the National Health and Nutrition Examination Survey between 2013 and 2016 conducted by the Centers for Disease Control and Prevention (CDC). After examining more than 1,200 participants with available bisphenol and cardiovascular disease data, the scientists derived a significant association between urinary BPS and an increased risk of cardiovascular disease, especially in people aged 50–80 years. Specifically, the researchers found a positive correlation between urinary BPS and coronary heart disease risk.
“Although BPA, BPS, and BPF share similar chemical properties, BPS and BPF are not safe alternatives for BPA,” the study authors concluded in the paper.
Laura Vandenberg, an endocrinologist at University of Massachusetts, Amherst who was not involved in this study, told EHN that the finding in this study is “pretty consistent” with previous scientific evidence. “It's not surprising that chemicals that are structurally similar to BPA are going to have similar effects on human populations,” said Vandenberg, who spent almost the last two decades studying endocrine disruptors, including BPA and its replacements.
Replacements for BPA
A key ingredient in polycarbonate, a hard, clear plastic, and epoxy resins, which act as a protective lining in food and beverage packaging, BPA can be found in all corners of our lives — shatterproof windows, eyeglasses, water bottles, metal food cans, water pipes, and medical supplies, to name a few.
Although BPA does not stick around in our body, it is still a great health concern “because we're constantly being exposed to it,” Vandenberg said. By mimicking estrogens, BPA molecules can forestall estrogen receptors, triggering a plethora of molecular pathways down to adverse health outcomes. Previous studies have linked BPA to heart diseases, obesity, diabetes, hypertension, brain and reproductive system damages, and children's behavior problems.
By design, most replacement bisphenols bear similar chemical structures as BPA to achieve parallel characteristics in products. While a BPA molecule looks similar to a batman symbol, the molecules of replacement bisphenols “look like the batman symbol with antenna,” said Vandenberg. Therefore, scientists are also finding comparable biological effects from these BPA replacements on our bodies.
“The bisphenols we've looked at have similar effects on the hearts,” Glen Pyle, a biomedical professor at University of Guelph in Canada who was not involved in the study, told EHN. Pyle’s team investigates the molecular cardiology of BPA and its replacements in animal models. His research demonstrated that, with subtle mechanistic differences, both BPS and BPA can depress the ability of the heart to contract by disrupting the calcium flow inside the cell, sabotaging the heart’s force.
BPA and bisphenol regulation
Despite sweeping concerns, the U.S. Food and Drug Administration still considers BPA “safe at the current levels occurring in foods.” As a result, BPA and its analogous replacements are still free-floating in the U.S., except for baby bottles, sippy cups, and infant formula packaging.
Meanwhile, European regulators recently recommended slashing the recommended daily dose of BPA by 100,000, which would ensure the chemical cannot be used in any food contact products. A group of U.S. health professionals recently petitioned the FDA to revisit BPA’s safety in light of the European findings and recommendations.
“The FDA really has ignored a lot of data on BPA,” said Vandenberg. “I think that it's time for that to change.” In addition to BPA, scientists are also racing to keep tabs on the health impact of BPA replacements, as they continue to emerge. “The metaphor of ‘Whack a Mole’ is really a very common one,” said Vandenberg. “It is frustrating.”
As for the BPA-free labels on products, Pyle said they mean “not much” for the consumers as they often contain BPA-replacements. “I think one of the simplest things we can do [to avoid bisphenols] is to reduce our use of plastics when it's not necessary,” he said.
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