Manipulating Uncertainty in the Clash of Corporate and Public Health Interests: A Case Study on Bisphenol A (BPA)
At the intersection of public health and corporate culture, uncertainty are pervasive and regulation is controversial. Many divergent interests clash at this nexus, resulting in tensions, which allows uncertainty to flourish: whereas corporations seek to maximize profits, public institutions aim to maximize public health while simultaneously satisfying their constituents and interest groups, and consumers primarily attempt to minimize costs. Chemicals, which can potentially damage public health yet are used in private sector production illustrate the clash of public and private interests, and the role of medical uncertainty in policy determinations. Historically, several government agencies have overlapped in terms of assessment and consequent regulation of chemicals with potentially harmful effects on humans. Bisphenol A, commonly known as BPA, is a telling case study of the resulting public health and medical challenges resulting from these clashing intentions and complex dynamics. The existing framework for studying and regulating BPA is prone to a lack of structured analysis due to the intrinsic uncertainty of scientific studies, coupled with the aforementioned clashing interests of those doing this research. Government bodies like the NTP, in charge of researching effects of various chemicals, are in fact not those that create the laws, and those in the legislative branch like the FDA are biased by their funding by the very industries who would be harmed by regulations on chemicals like BPA. When it comes to regulating corporations, in this case the chemical and manufacturing industries that use BPA in their products, there is a clash between corporate interests and public health. As a result, organizations that are beholden to industries due to their funding structures only regulate corporations when harm is scientifically certain, which is infrequent, thus prioritizing corporate profits over medical risks to and public health of consumers.
A mass produced chemical originally meant for use as a hormone substitute—synthetic estrogen—, BPA is today primarily used in polycarbonate plastics and epoxy resins. First synthesized by Russian chemist Aleksandr Dianin in 1891, chemists in the United States as well as in Switzerland began to create the first epoxy resins using BPA in the 1950s, leading to its mass production. Epoxy resins are used directly and indirectly in nearly every industry, though its main uses are as a protective coating on metal equipment and as lining for the interior of food cans. In 1957, BPA was discovered to turn into a very hard plastic called a polycarbonate when polymerized, a material nearly as strong as steel and as durable as glass. In the shift from BPA’s use as a hormone to its use in commercial and industrial practices, evaluations of BPA shifted to be based on its toxicity rather than its efficiency as a medical hormone. This very transition meant that the exposure to Bisphenol A and therefore to synthetic estrogen is a constant part of everyday life. In 1958, the FDA began to tighten regulations on food packaging and the definition of food additives. The Delaney clause stated that “the Secretary of the Food and Drug Administration shall not approve for use in food any chemical additive found to induce cancer in man, or, after tests, found to induce cancer in animals.” This law also would have the US Food and Drug Administration take charge of regulating chemicals in food by having them approve or disapprove of chemicals affecting food in the process of its preparation, packaging and subsequently affecting the consumer. Due to the fact that BPA seeps from polycarbonates and epoxy resins into the food packaged within, the FDA listed BPA as a chemical food additive. However, it was considered to be a low toxicity chemical and its presence in only very minimal levels made it so permissible for use in food packaging. The FDA considered not to be harmful and its effects as a carcinogen were not heavily tested until much later, however, there are no long term exposure studies that have been able to conclusively link BPA exposure to cancer.
In 1976, the passing of the Toxic Substances Control Act shifted responsibility for informing consumers about product contents’ toxicity from the manufacturer to several, overlapping government agencies and their designated independent laboratories, increasing the uncertainty. This shift coupled with the lack of clearly outlined oversight guidelines lengthened and complicated the process of banning toxic chemicals due to the current governmental regulation structure. In 1977, as mass production of BPA expanded, the National Cancer Institute began the first carcinogenesis evaluation of BPA. The experiment was done on rats and mice with results indicating no statistically significant evidence that BPA was carcinogenic under these bioassay conditions. The entire Bioassay was investigated when the private laboratories running the research was called into question. It was discovered that Litton Biotechnics, the lab that ran the study on BPA as a carcinogen had substandard practices, calling their results into question. Following these findings, the carcinogenesis of Bisphenol A was still not reevaluated. Today, the “safe” levels of BPA were set by the Environmental Protection Agency using the data from this questionable study, calling the so-called safe levels into question.
Studies on the detrimental effects of BPA have been shrouded in uncertainty. In the 1980s, the estrogenicity of bisphenol A was revisited as people grew more and more interested in the environmental role of hormones. In 1993, Dr. David Feldman of Stanford University discovered that BPA, an estrogenic molecule, was leaching from the polycarbonate plastic wares that were used in his lab. He called attention to BPA as an endocrine disruptors: chemicals that interfere with the proper production, processing, transmission and overall functioning of an individual’s endocrine system. In 1992, Fredrick vom Saal began to study the detrimental effects of BPA on mice and rats, with his findings being a watershed moment illustrating the significant damage caused by low level exposure to endocrine disruptors, the very same low concentrations that had so far been dismissed as not harmful by the EPA. Dr. Vom Saal found a link between BPA and reproductive system problems in both male and female rats as well as in rhesus monkeys. Specifically, he discovered enlarged prostates and lower sperm count and elevated obesity rates. According to Vom Saal’s studies, these effects were permanent, increasingly so in fetuses who, once exposed, have non-reversible damage to their organ development. As a result, 1996 Congress passed the Food Quality Protection Act, which contained two amendments that established EPA screenings and testings for endocrine disruptors. This Act required that the EPA screen over 80,000 endocrine disrupting chemicals, which was done by way of a panel of industry specialists, many of whom had ties to Big Tobacco. These ties called their judgements and assessments into question, increasing the uncertainty in the field. In 1998, Frederica Perera of the Mailman School of Public Health at Columbia University began investigating the short and long-term effects of environmental chemicals on children. As a result of the studies being done in-vivo, it was difficult to differentiate between direct effects caused by BPA and those caused by confounding variables in the mothers’ lives. This challenge illustrates the primary problem with testing for endocrine disruptors such as BPA, the omnipresence of BPA in products consumed, as well as the ample in vivo confounding variables and unreported daily practices results in uncertainty of findings and allows these to be more easily dismissed by corporations and the government agencies influenced by them if the findings are unfavorable or threaten their profits.
In order to decrease the uncertainty surrounding endocrine disruptor standards, in 2000, the EPA requested that the NIH’s National Toxicology Program (NTP) review the research done on low level concentration endocrine disruptors including BPA. The resulting report did not, however, diminish confusion, as it stated that its results were inconclusive. In 2001, the NTP published the Report of the Endocrine Disruptors Low Dose Peer Review, which cited findings some of which showed that BPA did have statistically significant detrimental effects at low doses, while other cited studies illustrated the contrary. The studies that showed that BPA was not harmful were, not surprisingly, funded largely by players in the chemicals industry. The NTP concluded that, although the reports’ results were inconclusive, the current testing standards and protocols used to establish the toxicity of low level endocrine disruptors needed to be reassessed and potentially altered.
Throughout history, the chemical industry has sought to minimize the economic impact of legislation intended to protect the public’s health from exposure to toxins, often emphasizing the uncertainty of studies suggesting these chemicals’ harm. In 1981, the Chemical Manufacturers Association (CMA), a group representing the interests of the chemical industry, published the “Report of the Chemical Regulations Advisory Committee to the CMA Executive Committee,” listing the potential economic impact of the OSHA and EPA regulations, specifically those proposed by the Toxic Substances Control Act, on the industry. Released prior to Congressional oversight hearings to decide whether the Act would pass, the report was intended to pressure Congress into blocking the creation of any further amendments or regulations that would harm chemical industry profits. This report included “The Advisory Panel Report of August 1981,” wherein the panel’s technical director states: “Epoxy resins: The panel will ask OSHA to remove bisphenol-A diglycidol from its list of candidates for scientific review as carcinogens.” This statement clearly illustrated the attempts to limit regulations on the use of bisphenol-A, specifically seeking to prevent OSHA from further investigating BPA’s effects, a testament to the fears that further study would prove that BPA truly was a carcinogen. The report further demonstrated the codependent relationship between the CMA and the EPA, wherein the CMA can use its EPA funding as leverage. This economic link between the EPA and huge chemical industry players such as the CMA means that lack of EPA cooperation with the chemical industry’s interests could result in loss of parts of its funding. This leverage explains why regulations on low level toxins and endocrine disruptors are slow and few. This type of relationship between industry and government agencies in charge of Public Health harms the consumer, who agencies like the EPA are supposed to protect.
Another indication of corrupt and harmful relations between the chemical industry and those regulating it comes to light after the suggestions by the NTP that the processes being used to establish safety thresholds were flawed (in 2000, double check). In a 93 page letter, the head of BPA for the American Chemistry Council (ACC) claimed that the NTP’s BPA panel’s findings on the harms of BPA were flawed and the push for BPA regulation was therefore baseless. Soon after sending this letter, the American Plastics Council (APC) proceeded to hire an independent laboratory, the Harvard Center for Risk Analysis to review the research on the potential harms of BPA exposure. Ironically, the Harvard Center for Risk Analysis was funded by the American Chemistry Council, the Dow Chemical Company, General Electric, Phillip Morris, the Society of the Plastics Industry, and the Business Roundtable, all of which had vested interests in lack of BPA regulations. Ultimately, the Harvard Center for Risk Analysis report found fault in the studies that found that low doses of BPA were harmful. Once this report was published, Dr. vom Saal as well as a researcher at the Harvard Center composed their own criticism of the review. Their criticism stated that of the 115 studies carried out worldwide between 1997 and 2015 on doses of BPA far below the accepted safety threshold, findings listed harmful effects ranging from lower sperm count to behavioral and cognitive changes to weakened immune system to altered fetal development. 90% of these 115 studies concluded that these low BPA doses resulted in physical changes, whereas the 11 studies that were industry-funded found no detrimental effects of bisphenol A. This discrepancy in these studies’ results and the fact that funding sources correlated with positive or negative results became a focus of federal government investigations in 2006. Following these allegations of corruption and questions regarding the accuracy of BPA research, several government agencies—the NIH/DHHS, US-EPA, and Commonweal—co-sponsored a meeting called “Bisphenol A: An Examination of the Relevance of Ecological, In vitro and Laboratory Animal Studies for Assessing Risks to Human Health.” Five panels of scientists, including Dr. vom Saal, were convened in Chapel Hill to discuss the effects of low levels of BPA on the human body. The conference conclusions were used to produce a document entitled the Chapel Hill Consensus Statement, which states that:
“BPA at concentrations found in the human body is associated with organizational changes in the prostate, breast, testis, mammary glands, body size, brain structure and chemistry, and behavior of laboratory animals.”
This significant statement rattled the entire industry as its government agency-backing lended it authority and a seemingly unbiased nature, and it thus catalyzed ample BPA litigation and legislation in the U.S. and internationally.
In another attempt to eliminate the uncertainty around BPA exposure effects, the NIH’s NTP published the “Finalized Report on Bisphenol A” in 2008, which provided the program’s latest findings on BPA’s effect on human development and reproduction. This report’s methodology consisted of reviewing all peer-reviewed and public experimental results in order to minimize bias in the findings. The report concluded that on the NTP’s five level scale of concern, BPA lies around the midpoint and should thus be treated with “some concern.” The NTP’s associate director John Bucher put out a statement regarding these findings, stating that:
“There remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects, but we have concluded that the possibility that BPA may affect human development cannot be dismissed.”
The significant potential harms of BPA exposure that should be treated with “some concern” illustrate that there is evidence that illustrates that there are significant risks associated with BPA exposure, although the evidence is not conclusive. As a result, the NTP seemed to iterate the need for preventative measures to minimize the uncertain risks associated with BPA. Once published, this report was passed from the NTP to the FDA—the body in charge of regulating harmful chemicals. Later in 2008, the FDA came out with their own report: “Draft Assessment of Bisphenol A for Use in Food Contact Applications.” This document stood by existing BPA safety levels, stating that:
“The data reviewed on highlighted endpoints, such as the prostate gland and developmental neural and behavioral toxicity, were insufficient to provide a basis to alter the no observed adverse effect level (NOAEL) used to calculate the margins of safety. FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”
According to this report, the NOAEL threshold, the safe level of BPA exposure that vom Saal was criticizing, was sufficient; a seeming contradiction to the NTP’s call for caution. The FDA report highlighted several sources of uncertainty that were ignored in the NTP’s statement, including the neglect of the crucial role of environmental confounders that prevent low-dose endocrine disrupting chemicals effects from being isolated. Ultimately, this statement justified a lack of BPA regulation by the FDA and provided an excuse to avoid a concerted effort for legislation of the chemical. The controversy over confounders and inconclusive evidence set back efforts for litigation and legislation, which ultimately benefited the involved chemical and manufacturing industries’ interests and helped minimize their costs relating to the production of goods that included BPA. This report also served as evidence in court cases based on the NTP’s 2008 report, wherein plaintiffs claimed that corporations including plastic bottle manufacturers—Sigg and Nalgene—, baby bottle manufacturers—Avent America, Playtex, Evenflo Co., and Gerber Novartis—, and baby formula manufacturers—Mead Johnson—knew about the harms of BPA and ignored them.
Ultimately, these lawsuits were brought together into one large MultiDistrict Litigation, following which the National Resource Defense Council (NRDC) filed their own lawsuit against the FDA, in 2010. This NRDC lawsuit asked the courts to force the FDA to respond to a previously filed petition that asked the FDA to enforce a ban on BPA use in food related packaging. In 2012, the court ordered the FDA to respond to the petition, at which point the FDA decided not to implement a BPA ban. In January 2010, the FDA released an updated report on BPA entitled “Update on Bisphenol A for Use in Food Contact Applications,” which states:
“At this interim stage, FDA shares the perspective of the National Toxicology Program that recent studies provide reason for some concern about the potential effects of BPA on the brain, behavior, and prostate gland of fetuses, infants and children. FDA also recognizes substantial uncertainties with respect to the overall interpretation of these studies and their potential implications for human health effects of BPA exposure. Given these uncertainties, it is important that no harmful changes be made in food packaging or consumption, whether by industry or consumers, that could jeopardize either food safety or reduce access to and intake of food needed to provide good nutrition, particularly for infants.”
In their report, the FDA focuses on the lack of undeniable proof of BPA’s harms and calls for a prolonged the research period and thus a delay of the implementation of BPA regulations. In this excerpt, the FDA places the emphasis on consumption and accessibility above preventative measures for public safety and health, arguing that the greater harm would be to over-regulate the industry and thus damage the economy and lower consumption. Though masked by a claim regarding the importance of nutrition, the fear for industry underlies this statement. This seemed to differentiate the NTP from the FDA: the NTP advised regulation when harm was possible, albeit uncertain, whereas the FDA only implemented regulations if harm was certain. Though both agencies acknowledged the need for more research, the apparent lack of urgency associated with preventative measures is significant. However, the FDA seems to admit the likely dangers of BPA more clearly in this updated report, proclaiming that:
“[The] FDA will encourage manufacturers to voluntarily submit a food contact notification for their currently marketed uses of BPA-containing materials.”
By recommending to corporations that a warning be placed on BPA-containing materials, allowed industries to continue to profit from the more than likely damaging use of BPA without any legal ramifications or requirement to warn the public of the presence of the potentially harmful additive. In 2012, the FDA ultimately chose to ban BPA in baby bottles, a regulation which seemed to ignore the prevalence of BPA in most food packaging. This small, seemingly symbolic act put off the need for universal elimination of BPA from food packaging, which undermines the impact of the regulation, as many infants and other members of the public would continue to ingest BPA in other forms and by way of other products.
The different treatments of scientific uncertainty, which greatly impact public health, by various agencies is fundamentally due to these organizations’ funding compositions, which results in diverging interests that are reflected in both their reports and in their actions or lack thereof. While the EPA is primarily funded directly by the US government, it is as such not beholden to the industries they are regulating, but is rather meant to represent the interests of and therefore protect the consumer and more broadly the health of the public. This is reflected by their more precautionary approach, which emphasizes public health above industry profits. On the other hand, the FDA can collect fees from the very manufacturers whose products they regulate, under the 1992 Prescription Drug User Fee Act (PFUDA). The fact that corporations with a vested interest in a given verdict are funding the approval and regulation process heavily influences the FDA, a seeming conflict of interest. Another part of the PDUFA stipulates that in order to be allowed to continue collecting large fees from industry, the FDA is required meet benchmarks for speed and efficiency in the regulatory process. This emphasis on efficiency impedes thorough evaluations by the FDA, as meticulousness, which requires time, will ultimately result in lost funding. Rather than looking out for the public’s interests above all else, the FDA therefore balances corporate interests, which often directly clash with the public’s health. The lack of regulation of BPA seems to be one such instance.
CONCLUSION ON UNCERTAINTY? Question of when to regulate industry: prove harm or prevent harm, given high chance of it?? Use of scientific uncertainty to justify lack of action, allow corporate interests to take precedence over public health and medical risks. Link to same dynamic between physicians and pharmaceutical companies…