Is It Safe?: BPA and the Struggle to Define the Safety of Chemicals
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Seller: IJP Bookstore. Other Sellers. The Time commitment. Free customs procedures. In the s, regulation was more welcome politically, but some government agencies still favored industry interests after decades of lobbying and Congress pressures. Historically, FDA was meant to protect Americans from adulterated and contaminated foods as well as assuring pharmaceutical safety.
- Applying Utilitarianism and Deontology in Managing Bisphenol-A Risks in the United States;
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But FDA became caught between its dependence on traditional risk assessment methods and its closeness to industry. FDA retained considerable discretion to interpret scientific research to support its regulatory cases. Nonetheless, in the s and s, fissures have opened up inside FDA, resulting in confused positions that reveal much about its organizational thought processes. While some retailers voluntarily removed products containing BPA from their shelves, FDA cited the lack of validity of low-dose studies that rely on questionable scientific methodologies that may not be reliable enough for regulatory toxicity testing.
This finding undercuts attempts by federal legislators to intervene more vigorously. It is not a coincidence that the Obama Administration entered power in Like other government agencies, political appointees oversee FDA, altering with each Administration. Thus, politically contentious regulatory decisions may change according to the values of each Administration.
The agency requested that an independent science advisory board review BPA findings yet again and make recommendations. The controversies over BPA research continue on. A review of more than studies on BPA found that even extremely small doses of BPA can be toxic and that low doses of BPA are linked to higher rates of obesity, diabetes, thyroid disease, breast cancer, prostate cancer, and other illnesses Vandenberg et al. The study authors conclude that "fundamental changes in chemical testing and safety determination are needed to protect human health" ibid. Yet, in February , FDA scientists concluded that low-level exposure to BPA is safe, and that low-dose studies did not show adverse effects Delclos et al.
Researchers from another government study organized by the National Institutes of Health charge that FDA did not use the most up-to-date quality control methods in use among university researchers, nor did it incorporate new scientific findings about how chemicals affect human bodies through endocrine disruption Blake Academic researchers and advocacy groups criticize the FDA of being too accommodating to the scientific standards of industry scientists, whose real aim is to institute a standard of proof for risk that is unattainable — a tactic that the tobacco industry used to fight regulation.
In these highly adversarial circumstances, scientific evidence will remain contested, and it seems unlikely that a decisive ban on BPA is forthcoming unless government strongly favors a precautionary stance. In the absence of federal regulation, and with a patchwork of a few states restricting BPA through bans or labeling laws, what can be done? In response to consumer concerns, NGO campaigns, and imminent regulation in the late s, manufacturers quickly introduced new product lines, marketing them as containing BPA-free materials.
These campaigns provided information to consumers about BPA risks and urged them to boycott products known to feature BPA. Some consumers began using stainless steel bottles and glass bottles as alternatives to plastic bottles. SIGG, a stainless steel bottle manufacturer, had claimed that its products were BPA-free, only for independent laboratory testing to discover that the bottle lining contained trace amounts of BPA.
A widespread consumer backlash against SIGG was the result. In , the Canadian government imposed a ban on certain uses of BPA in consumer products. Even before the law came into effect, many consumer product manufacturers and retailers removed BPA products from their offerings in Canada.
Nalgene Outdoors Products, based in Rochester, exemplifies this response to market pressures and regulatory risks. However, our customers indicated they preferred BPA-free alternatives, and we acted in response to those concerns" Austen , p. As this action suggests, product manufacturers began investigating BPA substitutes in response to retailers pulling BPA products from their shelves. BPS can now be found in products made from recycled paper, like pizza boxes and food buckets. BPA-substitutes also come from outside of the bisphenol family. In , the Eastman Chemical Company began working on a new heat-resistant plastic called Tritan, which it released in Many product manufacturers quickly began using Tritan instead of BPA-containing polycarbonate to make infant products, water bottles, and food containers.
To buttress its claims to safety, Eastman released third-party test results showing that Tritan monomers do not bind to oestrogen or androgen receptors, and is therefore free of estrogenic activity Eastman Chemical Because the major US chemicals policy, the Toxic Substances Control Act TSCA , has allowed new chemicals to enter the market without being tested for safety, BPA substitutes have been offered to consumers with no or little public research available on the real or potential risks of such substances. As BPA has emerged as a chemical of concern over the past 15 years, many actors in the chemical industry, government, and civil society in the US have wrestled with the difficult dilemmas that using possibly harmful chemicals in products can pose.
In deciding what to do, these actors have most often taken three major ethical stances. First, actors can employ deontological reasoning. Deontological theories determine moral action according to intention, or whether an action is done for the right reasons.
Deontologists assert that people have a duty to do the right thing no matter the consequences. For example, the precautionary principle is sometimes invoked as a deontological base for environmental laws Kysar According to deontologists, societies should prioritize human and environmental welfare ahead of economic profit as a universal norm of justice.
Protecting human well-being is a fundamental societal value. If there is a possibility of serious, irreparable injury to human health occurring, even if scientific proof remains uncertain, then societies should intervene to prevent that harm. Second, actors can rely on consequentialist ethics to guide their choices. This ethics holds that the consequences of an action will determine whether it is morally permissible or not.
However, John Stuart Mill proposed balancing utilitarianism with a set of fundamental rights that defend individual liberties, namely the right to protection from harm, free speech, free association, and self-determination Mill Over the last century, utilitarian calculus has come to dominate decision-making in government and business organizations. Thus a chemical industry consultant suggests: "The really prudent step is to make the best scientific evaluations of the risk from the product as compared to the risks and loss of benefits associated with removing it from the market before any actions are taken" Entine , pp.
Finally, actors can choose to ostensibly sidestep ethical questions and instead engage in technical arguments over how to interpret the scientific evidence. Companies, regulators, and legislators frequently portray science as an arbiter of objective, factual truth.
By doing so, they remove social and political values from debates over chemical risks, and emphasize issues of methodological rigor, data quality, and expert credibility as the fundamental ones Kinchy If other actors attempt to raise concerns about the underlying priorities of chemical manufacturing, or about the observation that chemical exposures are widespread, they are attacked as lacking in scientific rigor and biased. We will now consider several key actor groups and summarize their potential reasoning. Our approach is to consider the practices and statements of these actors as they respond to the BPA situation.
Business executives must ponder whether their company should eliminate BPA or continue using it.
Bibliography on critical approaches to toxics and toxicity
At this time, they have access to incomplete, uncertain information about BPA risks, so they must necessarily be speculative. Because of their organizational culture, managers are likely to use utilitarian reasoning to evaluate the costs and benefits to their company in taking a particular course of action. This analysis can vary between managers as well as different types of companies. A firm manufacturing BPA stands to lose billions of dollars worth of sales over a few decades, since the substance has one of the highest production volumes worldwide. The firm could switch to producing substitutes for BPA to replace this lost market.
Moreover, once alternative ingredients are found, new testing must be done to ensure those substances are safe, and new supply chain partners must be cultivated and vetted. The company could undertake all of these activities only to lose its market-share to competitors who are not taking similar action. To oppose any change, managers could point to the existence of weak scientific evidence that shows low-level exposure to their product causes future adverse health effects.
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From their perspective, hypothetical harm is not enough to warrant real financial risk. From this view, it would be morally permissible for a company to wait for clearer scientific evidence, new regulations, or sizeable consumer demand for safer alternatives. In contrast, a retailer or a consumer product manufacturer might face a more complicated calculus.
There is no need to worry about possible BPA risks, since the chemical has already been on the market for decades, and any latent health consequences would have appeared by now if they were going to. Many firms appear to require stronger government positions on BPA before they are willing to intervene. The consensus repeatedly stated among regulatory agencies in Australia, Canada, Europe, Germany, Japan, New Zealand and the United States is that current levels of exposure to BPA through food and beverage packaging do not pose a health risk to the general population.
The downstream company could also decide to apply utilitarian reasoning in the same way that a BPA manufacturer might.