Endocrine Society petitions FDA to lower limit on bisphenol A
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The Endocrine Society has teamed up with other organizations to ask the FDA to strengthen its limits on bisphenol A in adhesives and coatings after new findings showed a lower level of exposure to the chemical can cause health risks.
Bisphenol A (BPA) is an endocrine-disrupting chemical used to make polycarbonate and other plastics. Multiple studies have shown BPA can act like estrogen, with effects during pregnancy and with adverse developmental implications for children. The FDA’s current limit on BPA is 50 µg/kg of body weight, but findings from a draft opinion published by the European Food Safety Authority (EFSA) show that exposure to BPA at a level 5,000 times lower can cause harmful effects.
“EFSA is acknowledging that there’s immune challenges, so there’s a greater risk of asthma and lung inflammation,” Heather B. Patisaul, PhD, BPA expert for the Endocrine Society and professor of biological sciences and associate dean of research for the College of Sciences at North Carolina State University, told Healio. “I’ve shown in my own work and in the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) studies we did in conjunction with the FDA with their own animals that you consistently get changes in the brain, particularly in the hypothalamus, which is controlling behavior, mood and social behavior. Other studies have shown effects on reproductive development in both males and females.”
The Endocrine Society’s petition, which was also filed by the Environmental Defense Fund, Breast Cancer Prevention Partners, Clean Water Action/Clean Water Fund, Consumer Reports, Environmental Working Group, Healthy Babies Bright Futures, independent consultant Maricel Maffini, PhD, and Linda Birnbaum, PhD, former director of the National Institute of Environmental Health Sciences and National Toxicology Program, calls for the FDA to lower its limit on BPA in food contact articles to 0.5 ng/kg of food. Healio spoke with Patisaul about why the Endocrine Society and other organizations are lobbying for the FDA to change its BPA regulations, the findings in EFSA’s draft opinion and some of the health risks surrounding BPA.
Healio: What are the types of products that commonly contain BPA and how does even a tiny amount of BPA cause health risks?
Patisaul: BPA makes plastics hard and shatter-resistant. It can also make the plastics more clear. For a long time, it was in polycarbonate bottles, although now you can buy a polycarbonate water bottle that says BPA-free on the outside. It’s used for eyeglass lenses, a lot of food-containing materials and the epoxy lining on the inside of cans. It can be in thermal printer ink, it can be in plastic piping, all kinds of stuff.
The reason it causes harm at really low doses is it primarily interferes with estrogen signaling. We know that estrogen can have profound effects on the body at really low levels, picomolar-type levels, particularly during development. The real concern is that a developing fetus, either male or female, should not be exposed to these estrogenic chemicals. If they are exposed, even at low doses, you can get really big effects. The placenta has mechanisms for keeping a mother’s estrogen away from the baby, but not necessarily for chemicals that can mitigate or interfere with it.
Healio: The EFSA draft opinion stated the amount of BPA exposure needed to cause harmful effects is lower than previously believed. What evidence did EFSA find to support this statement, and what are some of the risks detailed in the draft opinion?
Patisaul: What’s unique about EFSA is they pull and systematically review all of the literature on a chemical that’s available. They’ll pull it from all different sources, and they’ll use data that’s generated by the companies themselves. They’ll go through all of those papers, evaluate the quality of the information and integrate the high-quality information. What they’re doing is looking for the most sensitive endpoint because they want to regulate on the endpoint that is affected at the lowest dose. Every time they find a more sensitive endpoint, they change the benchmark for what is “safe.” That’s what’s really new in this report — those immune-sensitive endpoints that people haven’t looked at for a decade.
EFSA looks at a mix of studies, so they have human studies where you can only make associations, they have animal studies and then they also have cell-based assays. What was so compelling was EFSA had evidence for immune effects in all three of those areas. What they’re seeing is BPA causes changes to the number of T-helper cells in the immune system that makes the lung more vulnerable to allergic inflammation.
Healio: Are there limits that the FDA currently has on BPA use in food packaging and other products?
Patisaul: The FDA does not take the same approach as EFSA. When the FDA evaluates a chemical, they set a bar for what kind of literature they’re going to look at. That bar is almost impossible to get over, and ultimately excludes nearly all published literature. They’ll typically take one or two industry studies or only their own and say, “There’s nothing. We don’t have any problems, we’re good.”
The frustration of the Endocrine Society and a lot of scientists is the FDA is not using all the available data. From our perspective, they’re cherry-picking the data, and the criteria they set for the data that they’ll accept is inappropriately restrictive. If you put EFSA and FDA BPA assessments side by side, you can see the difference. EFSA is compiling the available data, and the FDA dismisses nearly all the same studies as uninformative.
In the US, the safe level is set at 50 µg/kg of body weight. EFSA just went to 0.04 ng — over 100,000-fold lower. The FDA was expected to reconsider the US limit once the CLARITY-BPA studies were done, and those are mentioned in the EFSA report, but the FDA will not even consider any of the data that was produced by CLARITY-BPA grantees to revise their numbers because there are effects and the FDA doesn’t want to acknowledge that there are any effects.
This petition says to the FDA that its review process is flawed. The process is not protective of public health, here’s a regulatory agency that took a very rigorous, scientifically driven approach and they’ve concluded that this stuff is not safe for people. So why are we still putting people’s health at risk in the U.S.?
Healio: What do the organizations petitioning the FDA plan to do to raise awareness?
Patisaul: Educate lawmakers and the public, so even if the FDA keeps their numbers at an unsafe level, there’s a big demand for products that don’t contain BPA. There are more products that are BPA-free now because the industry has responded to consumer demand for safer stuff. Educating policymakers, not just about BPA, specifically, but also how the FDA is not taking food safety seriously is also critical. There are certainly robust, rigorous and transparent ways to evaluate data and come to a science-driven decision. We need physicians to push, scientists to push, parents to push and demand that the FDA do its job.
For more information:
Heather B. Patisaul, PhD, can be reached at hbpatisa@ncsu.edu.
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