Hazardous chemicals are present in many products and materials that we use in our daily lives, from cookware or cleaning liquids to electronic devices; they are pretty much everywhere around us. While these chemicals may make our lives easier, they can also pose a significant risk to human health and the environment. To manage these risks, regulators in the USA have put in place a variety of standards aimed at reducing the use of hazardous chemicals and promoting safer alternatives.
Nevertheless, throughout the years many regulations have failed miserably, and in some cases, the use of hazardous chemicals has been replaced with regrettable substitutions that pose equal or even greater threats. In this article, we will explore the impact of governmental regulations on hazardous chemicals usage in the United States, discuss regrettable substitutions and their consequences, and provide insights into the future of U.S. administrative controls on hazardous chemicals.
History of HAPs Regulation in the USA
The history of chemical regulation in the USA dates back to the early 20th century, with the first major piece of legislation being the 1906 Pure Food and Drugs Act. This law aimed to protect consumers from adulterated and misbranded food and drugs and paved the way for future regulation of harmful substances. In the following years, various laws were enacted to address specific chemical hazards, such as the 1976 Toxic Substances Control Act (TSCA) which gave the nascent Environmental Protection Agency (EPA) the authority to regulate chemicals which were determined to pose a great risk to human health or the environment [1].
Despite the existence of these regulations, harmful chemicals continued to be widely used in the USA. In particular, when the TSCA grandfathered in tens of thousands of chemicals that were already on the market in 1976 without any safety testing this allowed a loophole to exist for most chemicals and their subsequent derivatives. Essentially, there was no public oversight or information on how these might affect human health in the United States. As a result, many of these chemicals remain in use today, despite growing concerns about their potential health and environmental impacts and awareness of such in other countries [2].
Despite this, there have been some achievements. For example, the 1970 Clean Air Act led to the phase-out of leaded gasoline, resulting in a significant reduction in lead exposure and improved public health in general. Additionally, the Montreal Protocol, an international agreement signed in 1987, successfully disengaged the use of ozone-depleting substances such as chlorofluorocarbons (CFCs) and halons, resulting in the partial recovery of the Earth's ozone layer.
Despite these accomplishments, the effectiveness of chemical regulation in the USA has been limited. A significant challenge is the difficulty of identifying and regulating hazardous chemicals, particularly as many remain in today’s markets without the awareness of regulators (traceability). What is more, many chemicals are used in complex mixtures, making it challenging to assess their risks in isolation or combination. The sheer number in use (over 85,000 registered with the EPA) makes it impossible to test and regulate all of them [3].
Another obstacle is the slow pace of regulatory action. The TSCA, for example, has been widely criticized for being ineffective due to the lengthy and complex process required to regulate chemicals. The TSCA reform act was passed on June 22, 2016, which aimed to strengthen chemical safety regulation by requiring safety reviews of chemicals already on the market, but the implementation of the law has been delayed due to tedious consent agreements [4].
Phenomenon of “Regrettable Substitutions”
One unintended consequence of current chemical regulation efforts are regrettable substitutions. This occurs when a dangerous chemical is replaced with another chemical that may have similar or even greater risks. For example, the use of bisphenol A (BPA) in plastics and other products has been linked to a range of health concerns, leading to its phase-out in some applications. However, BPA has been replaced with other chemicals, such as bisphenol S (BPS), which may be equally or even more harmful [5].
Regrettable substitutions appear for a variety of reasons, including:
- Lack of information about the risks of alternative chemicals
- Financial accessibility and technical considerations
- Failure to consider exposure and functional use (effectiveness).
The phenomenon of regrettable substitution highlights the need for greater attention to be paid to the potential risks of alternative chemicals. Regrettable substitutions are a common concern among policymakers, and they are a real-world manifestation of the tension that can exist between the desire to avoid risk and ambiguity, which is itself aversive. As we move forward, it will be vital to continue developing effective laws that protect human health and the environment, while also promoting innovation and economic growth.
Aftermath of Regrettable Substitutions
Regrettable substitutions can take place in a wide range of industries, from dry cleaning to electronic manufacturing, and can have worse and far-reaching consequences compared to the compound they are trying to replace. Even if the alternative chemical is known to be safer, it may not be used or handled properly. As an example, if a company switches to a chemical that is less toxic to humans but requires more energy to produce, the increased energy consumption could have negative environmental impacts as well.
The previous scenario underscores the need for careful consideration when substituting materials and chemicals, to ensure they are safe and environmentally sustainable. As Joseph Allen (Deputy Director at Harvard Education and Research Center for Occupational Safety & Health) mentioned: “Nobody wants to engage in a dangerous experiment to which none of us knowingly signed on” [6]. In this context, we will briefly discuss some historical examples of regrettable substitutions of HAPs and their impacts on human health and the environment.
3.1 Chlorofluorocarbons (CFCs) are a prime example of a regrettable substitution of a hazardous air pollutant. CFCs were once widely used as refrigerants, solvents, and propellants in aerosol cans, among other applications. However, it was discovered that when released into the atmosphere, CFCs can break down ozone molecules, leading to the depletion of the ozone layer.
As a result of these concerns, the international community came together to address the issue, culminating in the Montreal Protocol, an international treaty signed in 1987. The treaty called for a phase-out of CFCs and other ozone-depleting substances. In response, manufacturers began using hydrochlorofluorocarbons (HCFCs) as a substitute for CFCs, which were initially seen as a safer alternative.
However, it was later discovered that HCFCs are also greenhouse gases and contribute to climate change. As a result, the international community agreed to further phase out HCFCs, and they are now being replaced with presumed safer alternatives, such as hydrofluorocarbons (HFCs).
3.2 Bisphenol A (BPA) is a chemical that was commonly used in the production of polycarbonate plastics and epoxy resins. However, studies have shown that BPA is an endocrine disruptor, meaning it can interfere with the normal functioning of hormones in the body. Exposure to BPA has been linked to a range of health problems, including reproductive disorders, obesity, and cancer.
As a result of these concerns, many manufacturers began using bisphenol S (BPS) as a substitute for BPA. However, it has since been discovered that BPS may also have negative effects on human health and the environment. Like BPA, BPS is an endocrine disruptor and has been linked to reproductive disorders, developmental problems, and other health issues. In addition, BPS has been found in water sources and aquatic environments, indicating that it may be harmful to wildlife.
It's important to note that the safety of BPS is still a topic of debate among researchers and regulatory agencies. Some studies have suggested that BPS may be safer than BPA, while others have raised concerns about its potential hazards. In response to these concerns, some manufacturers are now using alternative materials that are considered safer than both BPA and BPS, such as polyethylene and polypropylene. Additionally, some countries have banned or restricted the use of BPA and other harmful chemicals in certain products, such as baby bottles and food containers.
3.3 Perchloroethylene (PERC) is a chemical solvent that has been widely used to dry clean fabrics, degrease metal parts, manufacture other chemicals, and in other industrial applications. However, it is a hazardous air pollutant and a carcinogen, meaning it can cause respiratory diseases, liver damage, and even cancer in humans.
In response to these concerns, some dry cleaners began using 1-bromopropane (1-BP) as a substitute for PERC. However, it has since been discovered that 1-BP is also a hazardous air pollutant and a potential human carcinogen. Exposure to 1-BP has been linked to neurological and respiratory problems, as well as cancer.
As a result, the use of 1-BP has been restricted or banned in some countries, including the European Union and the state of California in the United States. In some cases, alternative solvents or dry-cleaning methods that do not involve hazardous chemicals, such as liquid carbon dioxide or wet cleaning, are being used instead.
Insights on Potential Regulatory Contradiction (PFAS case)
One group of chemicals that have recently gained the attention of the public and regulatory agencies are the so-called "forever chemicals", or Per- and poly-fluoroalkyl substances (PFAS). They are man-made substances produced for consumer and industrial products, especially those with heat-, water-, and oil -properties. PFAS has been linked to a range of adverse health effects, including developmental delays, immune system dysfunction, and cancer. As a result, there is also growing concern about the widespread contamination of PFAS in the environment and human exposure [7].
The regulation of PFAS is a complex issue that involves a range of stakeholders, including the industry, the government, and the public. The biggest challenge of their regulation is the potential conflict between different regulatory frameworks, such as those governing the use of chemicals in consumer products versus those governing the release of chemicals into the environment. In the PFAS case, there is an increasing evidence base suggesting that these chemicals can persist in the environment for a long time and can travel great distances, which makes it difficult to control their release and exposure.
The regulatory contradiction involving PFAS comes along when manufacturers try to replace their particular PFA with another PFA, which technically is a novel alternative. However, this approach falls in the category of regrettable substitution that is preventing complex redesign or manufacturing of products but often has similar toxicological effects. In January 2022, The Organization for Economic Co-operation and Development (OECD) released a report about chemicals frequently used to substitute long-chain PFAS in food packaging made from paper and board. They found that most of these alternatives lack sufficient information on their safety and are not publicly known [8].
Typically, a chemical has to be proven dangerous before it gets taken off the market. This can be a lengthy process, lasting years or even decades, depending on each country's regulatory procedures. An investigation conducted by the European Environmental Bureau (EEB) in July 2022 revealed that the EU takes approximately 20 years to ban hazardous chemicals. One of the hold-ups in the EU's regulatory process, as identified by the EEB, is that the current regulations don't grant the European Chemicals Agency (ECHA) the authority to take swift precautionary measures [9].
Various stakeholders, particularly consumer health organizations, are increasingly advocating for a collective examination of chemicals like PFAS and the application of the precautionary principle before permitting structurally similar alternatives to enter the market. Essentially, this principle suggests that if the government lacks comprehensive data to determine the safety of a chemical within such groups, it should be treated as unsafe. Ideally, this precautionary approach would extend to each new chemical as well. By adopting this framework, regulators would prioritize safety and avoid unnecessary risks associated with insufficiently understood chemicals.
The first initiatives of the previous principle are appearing in recent years. As of August 2022, a cluster of five EU member countries crafted a proposal to collectively restrict or ban PFAS from all applications, without needing to examine each chemical and its specific use separately. Similarly, the US state of Washington is contemplating comparable regulations for PFAS, bisphenols, and phthalates. Washington's Safer Products Initiative evaluates specific sets of consumer products to identify safer alternatives for each case and then mandates the use of those alternatives [10].
In the case of PFAS, the debate is still open, having industry trade groups as the major opponents against the “class” approach to regulation. Although most governments are taking a step in the right direction when it comes to PFAS, ultimately it will not solve the problem. Despite these challenges, there are opportunities for promoting safer and more sustainable alternatives to hazardous chemicals, within the framework of green chemistry for example. Green chemistry is the design of chemical products and processes that are safer for human health and the environment. Green chemistry principles can be applied to the entire lifecycle of a chemical, from its design and manufacture to its use and disposal, to minimize its impact on human health and the environment.
Conclusion
The regulation of hazardous chemicals in the USA has been a complex and challenging process. While various laws have been enacted to protect human health and the environment, the effectiveness of these regulations has been limited. The existence of regrettable substitutions, where hazardous chemicals are replaced with equally or even more harmful alternatives, highlights the need for greater attention to the potential risks of alternative chemicals. Regulators need to evaluate the precautionary approach, collectively examining chemicals as groups and applying stricter standards to ensure safer and more sustainable alternatives.
One major hurdle in chemical regulation is the slow pace of action, resulting in delayed implementation and continued use of hazardous substances. To address this, policymakers should consider streamlining regulatory processes and conducting comprehensive safety assessments for chemicals already on the market. Additionally, increasing public awareness and support for safer alternatives can encourage manufacturers to prioritize the use of less hazardous substances.
Moving forward, the ongoing efforts to regulate hazardous chemicals, particularly PFAS, must be further bolstered by international collaboration and harmonization of regulations. The collective examination of chemicals as groups, as demonstrated by some EU member countries and Washington's Safer Products Initiative, shows promise in promoting more comprehensive and efficient regulation. Moreover, embracing green chemistry principles can better help the development and adoption of safer chemicals, promoting a more sustainable and healthier future for both human beings and the environment.
Ultimately, addressing the paradox of hazardous air pollutants regulations requires a multifaceted approach, involving cooperation between government agencies, industries, consumer health organizations, and the public. By working together and prioritizing safety over convenience, industries can navigate the complexities of chemical regulation and pave the way for a cleaner, healthier, and more sustainable future.
References
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[2] Wilson, Mike, and Michael Kirschner. “Chapter 31. Policy Developments in the United States Related to Chemicals and Electronic Waste.” Governance, Risk, and Compliance Handbook: Technology, Finance, Environmental, and International Guidance and Best Practices, by Anthony Tarantino, 1st ed., Wiley, 2008, pp. 425–438.
[3] Erickson, Britt E. “How Many Chemicals Are in Use Today?” Cen.Acs.Org, 2018, cen.acs.org/articles/95/i9/chemicals-use-today.html.
[4] Shea, Kerry E., and Michelle E. Smith. “New Amendments to TSCA Invigorate Chemical Regulatory Regime and Empower EPA: Energy & Environmental Law Blog: Davis Wright Tremaine.” Energy & Environmental Law Blog | Davis Wright Tremaine, 2016, www.dwt.com/blogs/energy--environmental-law-blog/2016/06/new-amendments-to-tsca-invigorate-chemical-regulat.
[5] Maertens, Alexandra, et al. “Avoiding Regrettable Substitutions: Green Toxicology for Sustainable Chemistry.” ACS Sustainable Chemistry & Engineering, vol. 9, no. 23, 2021, pp. 7749–7758, doi:10.1021/acssuschemeng.0c09435.
[6] Allen, Joseph. “Harmful Chemicals Removed from Products Often Replaced with Something as Bad or Worse.” Harvard T.H CHAN. School of Public Health, 25 Jan. 2017, www.hsph.harvard.edu/news/hsph-in-the-news/harmful-chemicals-removed-from-products-often-replaced-with-something-as-bad-or-worse/.
[7] Agency for Toxic Substances and Disease Registry. “What Are PFAS?” Centers for Disease Control and Prevention, 1 Nov. 2022, www.atsdr.cdc.gov/pfas/health-effects/overview.html.
[8] Organization for Economic Co-operation and Development. PFAS and Alternatives in Food Packaging (Paper and Paperboard): Hazard Profile, Jan. 2022, one.oecd.org/document/env/cbc/mono(2022)2/en/pdf. Accessed July 2023.
[9] Food Packaging Forum. EEB: At This Pace, the EU Will Take Centuries to Regulate Chemicals, 11 July 2022, www.foodpackagingforum.org/news/eeb-at-this-pace-the-eu-will-take-centuries-to-regulate-chemicals.
[10] Food Packaging Forum. Washington State Publishes PFAS Action Plan, 25 Nov. 2021, www.foodpackagingforum.org/news/washington-state-publishes-pfas-action-plan.
