After more than a decade of pressure from environmental health advocates, the Food and Drug Administration is set to reconsider the health effects of a common and controversial industrial chemical often used in plastics.
At issue is BPA, or bisphenol A, a widely used compound that often serves as an additive in the production of polycarbonate, a hard type of plastic commonly used in consumer products, like reusable water bottles. The chemical has proved highly useful in making items sturdier, leading to its widespread use. But scientists and public health groups have worried for years that BPA, an endocrine disruptor that affects human hormones, poses risks for fetal development and to people, including infants and children. Other concerns include increased blood pressure, Type 2 diabetes and cardiovascular disease.
Despite those risks, U.S. regulators have repeatedly punted on a BPA crackdown even as their European counterparts have charged ahead. Advocates hope that is about to change.
“There is a sense of urgency on our part, and FDA should feel it, too, to make sure they reach a conclusion relatively quickly, because everyone is being exposed to too much of this BPA,” said Maricel Maffini, an independent consultant and scientist who focuses on chemicals and public health issues.
FDA’s reassessment stems from a petition submitted by the Environmental Defense Fund and multiple partners, including Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, the Endocrine Society, the Environmental Working Group and Healthy Babies Bright Futures. They were joined by Maffini and Linda Birnbaum, who formerly led the National Institute of Environmental Health Sciences.
The groups filed an initial petition in January calling on regulators to limit BPA in food packaging. They cited recent draft findings from the European Food Safety Authority that showed effects linked to BPA could occur at levels 100,000 times lower than previously acknowledged (Greenwire, Jan. 27).
But FDA said it would not accept the petition because the EFSA findings underpinning it had only been released in draft form, and the European agency was still accepting public comments on it. Three months later, after the European comment period closed, the environmental health groups refiled their petition with FDA. The new submission included supplemental information pulled from comments filed with European regulators. That included, among other research, a recent epidemiological study linking BPA exposure in utero to increased asthma in young girls as they grew. The first-of-its-kind human study closely mirrored previous results from studies involving mice. That additional information, the groups said, “reinforces our calls for an expedited review.”
In interviews, Maffini and Birnbaum expressed exasperation that FDA has not approached BPA with the same sense of urgency as European regulators.
“The Europeans have moved ahead, dramatically lowering their regulator limit, and what has FDA done? Almost nothing,” said Birnbaum. “So this is an effort to get some action.”
The petition specifically asks FDA to revoke all approval of BPA in metal can coatings and to strictly limit the allowed migration of BPA from polycarbonate plastic. It also asks FDA to remove the use of BPA in two adhesives approved for use in food containers.
Two trade organizations, the Plastics Industry Association and the American Chemistry Council, did not respond to a request for comment.
FDA says it does not comment on petitions that are under review and referred questions about BPA’s safety to the agency’s website.
“We are committed to ensuring the safety of the U.S. food supply and to the use of scientifically sound principles in developing our approach to this and other food safety issues,” FDA said in a statement.
The agency has consistently told the public that use of BPA in food packaging and containers is safe. FDA has acted only once to restrict the use of BPA in such containers — in 2012, when FDA banned use of the chemical in baby bottles and sippy cups. That move came only after industry members had voluntarily decided to stop using BPA in such products.
In the years since, FDA has continued to say that levels of BPA in foods are safe. The agency’s webpage offers guidance on the chemical stating: “The available information continues to support the safety of BPA for the currently approved uses in food containers and packaging.”
In accepting the petition, FDA has agreed to make a decision about whether or not to ban BPA in those products. Though the agency could ultimately say that current uses of BPA remain safe, that decision would be subject to litigation.
“You cannot challenge a statement [on a website], you cannot challenge something published in a peer-review journal,” Maffini said, contrasting statements and research with an actual finding from FDA that could be subject to a lawsuit. “This opens up an opportunity to have a real discussion, either through the scientific channels or through the courts.”
Lack of CLARITY
In an ironic twist, the new toxicological assessment from European regulators is based, in part, on data obtained through an American research effort helmed by FDA that the U.S. food safety agency has chosen to ignore.
Conceived more than a decade ago, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, known as CLARITY, was meant to be a compromise between FDA and environmental health advocates and academics. The advocates and academics were frustrated that FDA’s own scientists were not conducting research into BPA’s health effects at low doses, including on hormones and endocrine system disruption. But FDA argued that it could not accept independent academic studies showing such harms because they did not follow laboratory procedures designed to prevent drug makers from committing fraud.
The solution, proposed by the National Institute of Environmental Health Sciences, was CLARITY. Under the consortium, FDA was tasked with raising rats and mice and administering various doses of BPA to the animal test subjects in accordance with their preferred laboratory practices. FDA conducted its own research on the health effects, but also sent samples — sometimes including live rats, and sometimes just specific organs or tissue samples — to research grantees to conduct their own studies.
“You had, on the one hand, eight laboratories in academic institutions doing what they knew how to do best in their field of science,” Maffini recalled, “and FDA in their lab in Arkansas producing the animals, and feeding and breeding them in the way they like to do the experiments.”
The idea was that, because FDA had raised and fed the animals in accordance with its own procedures, the agency would ultimately accept any subsequent findings resulting from the CLARITY grantees and could use that research to help make decisions around BPA.
“The hypothesis of CLARITY was the question of: Do current regulatory studies ask the right questions, or are they missing key health effects?” Birnbaum, who helped set up the consortium, recollected. “And FDA agreed that it would publish, along with [the National Toxicology Program], an integrated analysis of all of the data.”
That is not what happened. Instead, FDA and the National Toxicology Program co-published a report in 2018 on BPA using only FDA’s CLARITY studies. The report, which did not include any research done by the participating academic institutions, found that BPA’s use in food containers was safe.
Then-Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff said in a statement at the time that the report “supports our determination that currently-authorized uses of BPA continue to be safe for consumers.”
“FDA basically pulled out of their agreement with NTP and the grantees,” Birnbaum recalled.
While FDA has yet to consider any of the CLARITY studies conducted by academic institutions, European regulators at EFSA cited quite a few of them in their proposal to limit BPA in food containers that could result in a migration of 0.5 nanogram per kilogram into food.
Those studies include research on how exposure to BPA affected learning and memory in rats.
EFSA also reviewed the study underpinning FDA and the National Toxicology Program’s co-published report that found BPA’s use in food containers was safe, but came to very different conclusions than its U.S. counterparts.
The European regulators highlighted three concerning effects of BPA exposure from that study: increased ovary weight, increased incidence of follicle cysts and an increase of a type of testicular cell that could be a precursor to tumors.
For those who want BPA to be regulated by FDA, the use of U.S. studies in shaping European decisions has left a sea of questions. They believe FDA should do as its peers across the Atlantic have and make decisions based on the science available in its own country. Birnbaum emphasized that point as she expressed hope that U.S. regulators would finally take action on BPA.
“It’s very frustrating that you have to go to other countries to have the data that we produced used,” she said.