The Debate over BPAJun-18-2012
Sonya Lunder, MPH and senior analyst, Environmental Working Group (pro-ban) vs. Dr. Mitchell Cheeseman, Managing Director, Environment and Life Sciences, Steptoe & Johnson LLP (anti-ban)
Recently, the FDA 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 lack of sufficient data provided by NRDC led the FDA to deny the petition, but the debate is long from over. 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.
How is BPA different from any other chemical used in food packaging or for food safety? In other words, why is BPA at the top of activist ban lists?
Lunder: In the laboratory BPA exposure to juvenile animals causes permanent changes to the reproductive system as well as altering activity and behavior. Human studies are scarcer but suggest similar effects to the developing brain and reproductive system. BPA tops our concern list because it causes more serious adverse effects and at lower concentrations than nearly every other chemical we've tested. This is particularly concerning given that Americans have daily exposure to BPA from dozens of consumer products (studies show it in about 90% of the population). All replacements to BPA in food packaging should be carefully screened for toxicity, but don't let industry tell you that this is a good reason for further delay.
Cheeseman: BPA really began to be highlighted when the Center for Disease Control began to publicize the results from their National Health and Nutrition Examination Survey that reported BPA in the urine of 93% of subjects tested. Unfortunately the NHANES results did not distinguish between the active and inactive forms of BPA. We now know that BPA is almost completely inactivated in the first pass metabolism in humans. The likelihood that BPA was inactivated in firstpass metabolism was a cornerstone of the safety assessment performed in 2008 by FDA and in those assessments performed by other regulatory scientists around the world. Since then, NIEHS funded research has consumed over 40 million dollars of stimulus funds to confirm the original conclusion by FDA reviewers that BPA is effectively inactivated by humans and that BPA is safe for food contact uses. However, the sheer volume of research and the fact that "positive" results are far more likely to reach publication both in scientific journals and in the press has made BPA a poster child for reinvention of chemical regulation in the U.S. and around the world. Because of that and the media coverage, the general public is largely unaware that dozens of formal risk assessments performed by chemical regulators around the world have all found that BPA is safe for its current uses in food packaging. My view is that BPA was simply in the wrong place at the wrong time.
In February 2012, France banned BPA from all food contact materials. How could this ban affect U.S. imports/exports? Might other EU countries follow suit?
Lunder: Various countries have been contemplating BPA restrictions or bans for several years (countries that have banned BPA in baby bottles include Canada, Denmark, France, Malaysia, South Africa, and China). The Canadian government has been working with infant formula producers on BPA-free packaging (chiefly negotiating with U.S.-based formula companies). A 2010 law in Vermont banned BPA in formula packaging. These efforts prompted a rapid effort to repackage baby formula in BPA-free containers (powders, and liquids in tetrapaks or BPA-free metal cans) with the State of Vermont reporting sufficient supplies of BPA-free formula available by October 2011. We believe that similar efforts are warranted and possible for other types of canned foods.
Cheeseman: Actually, the French complete "ban" was never made final. That result was in part because of the adverse comments filed by the European Commission and several member states in opposition to the proposed ban. It is worth noting that the French "ban" was not supported by either the scientific review completed by the French risk assessors or by an European Food Safety Authority (EFSA) scientific opinion. In fact, as recently as December 2011, the EFSA updated its safety assessment and confirmed the safety of all current food contact uses of BPA. France and several other nations have "banned" BPA in baby bottles but all after adverse press had forced removal of such products from the market. In nearly every case bans were enacted at odds with authoritative scientific opinions. If French legislators successfully reintroduce their proposal to ban all uses of BPA, it will likely have some effect on canned foods entering France from all other nations including the U.S. However, I would expect the bigger economic effect to be on the French food industry and public itself as grocery store shelves are emptied of canned foods because no completely suitable replacements for epoxy coatings exist. Given the opposition to the French proposed ban in Europe, it is unclear whether and to what extent other countries may try and follow suit.
Where does the debate go from here? Will there be more deliberation, more research? Is there a chance the FDA will reconsider their decision?
Lunder: While we were disappointed (but not surprised) by FDA's announcement in March refusing to regulate BPA in food contact material, we are hopeful in manufacturers who have responded to consumer demand for safer foods and food contact materials (baby bottles, water bottles). Ultimately, the public will not be protected until BPA and other toxic chemicals are removed from food - they should not be allowed as food additives or in packaging materials.
Cheeseman: I can tell you that the FDA scientists performing the reviews can't worry about where the debate goes. They must stay focused, as they have been for five years, on objectively reviewing all the available science as it comes out. Once they begin worrying about the "debate" we will start to get politically motivated decisions as have been made elsewhere rather than scientifically based decisions from FDA. When that happens, public health protection will be the real loser. FDA and NIEHS do have several million dollars more research planned and that research will likely take between three to four years to be completed and fully reported. As far as FDA's decision is concerned, I am completely confident that FDA will do whatever is warranted by the science as they have for the past five years on BPA. I am equally confident that, given the depth of the research already completed, it is unlikely that the vast amount of data supporting the safety of BPA will be overturned.
Posted by Ken at 12:00 AM
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