BPA is Back: But Was it Ever Gone?

BPA is back in the news and up for debate again in Washington. Here is a debate you don’t want to miss. You’ll see both sides of the coin, and learn why and where BPA is often found in our everyday lives.

July 25, 2014

BPA is back in the news and up for debate again in Washington. SupermarketGuru wanted to share with you a debate you don’t want to miss from Food Nutrition and Science on the topic. You’ll see both sides of the coin, and learn why and where BPA is often found in our everyday lives.

Previously, the FDA had rejected a petition to ban the chemical bisphenol-A (BPA) in food and beverage containers, angering and frustrating environmental activist groups like the National Resources Defense Council (NRDC). The NRDC filed their petition against BPA in 2008, referencing the health effects linked to the chemical, including asthma and diabetes, and possible hormonal changes during pregnancy that could lead to disorders like autism and attention deficit hyperactivity disorder (ADHD). 

The FDA ultimately denied the petition, but the debate is long from over, and many companies voluntarily removed BPA from their packaging. We talked to Sonya Lunder, senior analyst for the Environmental Working Group (EWG) and Dr. Mitchell Cheeseman, Managing Director of Environment and Life Sciences at Steptoe & Johnson LLP about what the debate actually means for manufacturers – and consumers.

Why is BPA used in food packaging and why is it considered such a key tool in consumer protection? Are there any less controversial alternatives that can provide the same benefits?

Lunder: The most problematic known use of BPA is as a lining in metal cans. It serves a useful purpose to protect food from contacting the metal, however there are substitutes, which are much less likely to be as toxic as BPA. Eden Foods uses a different type of epoxy as a can lining (manufactured by Ball Corporation) for its canned beans. General Mills recently replaced BPA as a lining for its Muir Glen brand of organic canned tomatoes, using a different type of can lining. Several other boutique brands have made the switch away from BPA as well. These replacements may have marginal increases in cost but would undoubtedly benefit from the economy of scale if they were adopted throughout the food industry.

Cheeseman: BPA-based epoxies have far better properties overall than any other currently available coating materials. It is important to understand the food safety function of a coating in the packaging system. The coating system protects the can material during production and storage of the food. Many foods can be chemically harsh to packaging materials especially if they must be processed at high temperatures to ensure the safety of the packaged food product. Without this protection, packaging can fail resulting in microbial or chemical contamination of food. The wide spread use of BPA based epoxies is one reason that U.S. consumers have not seen a food poisoning incident from the failure of a food can in nearly forty years.

Although some coating materials exist for niche uses, there currently are not any authorized alternatives for the thousands of different epoxy formulations now in use, non-controversial or otherwise, that have the same capabilities as BPA epoxies. I think it is impossible to say whether alternatives under development now will be more or less controversial given that the current controversy is not based on the best science. One thing that is certain; given the millions of dollars spent demonstrating the safety of BPA epoxy coatings, we will know less about the safety of those alternatives. Fortunately for us, FDA reviewers are hard at work to ensure we know enough to determine they are safe for use.          

How effective are the FDA’s scientific methods for determining chemical safety in foods? How accurate are the studies examining BPA’s toxicity?

Lunder: We have serious concerns with FDA's 2008 risk assessment, which proclaimed BPA to be safe for use in food packaging. The agency relied on two studies as the basis for its evaluation, both of which were funded by industry (of note, one of these studies was widely criticized by BPA experts for its fatal design flaws; the other study was not made available to the public and was not published in a peer-reviewed journal). Additionally, FDA disregarded the findings of the National Toxicology Program’s evaluation of the chemical’s risk to human health along with dozens of studies published in peer-reviewed literature linking extremely low levels of BPA exposure to a number of adverse health effects, including breast and prostate cancer, early puberty, infertility, obesity, and behavioral problems. FDA's Science Advisory Board and the Department of Health and Human Services shared concerns of FDA’s assessment. FDA's advisory board demanded FDA go back to the drawing board, and federal agencies launched a multimillion-dollar research effort to collect more information about BPA's low dose toxicity.

In the case of BPA, dozens of toxicity tests find serious and often permanent toxicity to laboratory animals at exposure levels FDA had deemed "safe." EWG has testified that FDA and other federal agencies must update methods for assessing toxicity risks for hormone disruptors to incorporate information from more sensitive but non-traditional toxicity tests. When it comes to endocrine disruptors, such as BPA, there truly is no “safe” dose, and conventional testing methods may not be sufficient to accurately show their effects.

Cheeseman: FDA’s approaches to determining the safety of chemicals used in food contact material are as effective or more effective than any other scientifically sound approach currently used. It is important to understand that FDA’s approach to safety assessment is the internationally accepted approach to safety assessment and is not substantially different than that used by other regulators around the world. FDA’s approach is also completely comparable to that used by international bodies such as the World Health Organization. FDA, like these other regulatory bodies has recommended testing approaches. However, FDA’s system is maximally flexible as well, allowing the Agency to require a variety of testing to ensure safety under its premarket approval system. This approach allows FDA to require whatever testing is most appropriate for safety and does not prevent FDA from accepting or requiring the most modern approaches to toxicity testing.

From the vast array of literature that the Agency has reviewed, FDA has used the best studies available on BPA to assess the safety of the use of the chemical in the production of food contact materials. In choosing the best data to rely on, FDA has not paid attention to the source of the data but the quality and relevance of the science. FDA has used eight criteria in determining the suitability of each of the available studies on BPA. These criteria are drawn from recommendations of regulators in the U.S. and from international standard setting bodies. The overall purpose of these criteria is to gauge the utility of each study to assess any impact of consumption of the chemical on human health. Much of the published research on BPA purports to show “effects” related to BPA using methods that are not validated regarding whether they have any predictive relationship to human health effects. In addition, many of these “positive” studies have issues with their design that limit their utility in assessing oral consumption of BPA. Such studies may be called “positive” in an experimental sense by the authors but when considered in the larger context of all of the available data most of these studies are not useful regarding a quantitative risk assessment.   

Lunder: Three government scientists from The National Institute of Health’s National Institute of Environmental Health Sciences (NIEHS) reviewed FDA's updated safety assessment in 2009 and again disputed its findings. In particular, each pointed out the absurdity of FDA's approach in setting a safe level that is so much greater than the concentrations that show toxic effects in more than a hundred other studies. Let me also point out that Dr. Cheeseman headed FDA's center for Food Safety and Applied Nutrition during the agency’s 2008 review period. 

Cheeseman: As with all scientific assessments, the only way to reach the correct decision is to have the facts right and to weigh all the evidence objectively. For example, it is important to know that six government scientists reviewed FDA’s updated safety assessment not just three. Three independent government scientists generally supported FDA’s assessment and three government scientists disputed some parts of it. These reviews and FDA’s response are matters of public record, and I urge interested individuals to consider all of them. Just to set the facts straight, I was the Deputy Director of the Office of Food Additive Safety during development of FDA’s 2008 assessment. As such, I was one member among nearly twenty on FDA’s BPA task force making the assessment, and I had far less opportunity to influence it than some would suggest. The Task Force and its chair developed the assessment jointly. In 2008, the BPA Task Force was chaired by FDA’s Associate Commissioner for Science.                

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