chevron-down Created with Sketch Beta.


Winter 2024: Environmental Health & Safety

Regulating Chemicals: Learning from PFAS

Steve C Gold and Wendy Elizabeth Wagner


  • The catastrophic, widespread dissemination of toxic and persistent PFAS spotlights the inadequacies of our chemical regulatory program.
  • Despite recent amendments, chemical regulation under the Toxic Substances Control Act (TSCA) is fundamentally reactive, placing the obligation to investigate and assess chemical toxicity almost exclusively on EPA.
  • TSCA should be reimagined to flip the burden of proof, requiring chemical manufacturers proactively to document the usefulness and risks of their products rather than requiring EPA to justify reactive regulation.
Regulating Chemicals: Learning from PFAS

Jump to:

The story of per- and polyfluoroalkyl substances (PFAS) is a story of serendipitous discovery followed by explosive growth, culminating in an environmental and legal nightmare that is still unfolding. Beginning with a DuPont chemist’s inadvertent creation of polytetrafluorethylene in 1938, the PFAS chemistry has spawned at least 8,000 diverse chemical structures, and probably many more. Marina G. Evich et al., Per- and Polyfluoroalkyl Substances in the Environment, 375 Science 512, 513 (2022). And starting with a dogged attorney’s chance representation of a West Virginia cattle farmer, as detailed in Robert Bilott’s 2019 memoir, Exposure, the law of PFAS has come to include thousands of lawsuits, regulatory actions worldwide, and legislation in response to the global dispersion of toxic, bioaccumulative, and persistent compounds in this chemical class.

The unique properties of PFAS, especially their stability, slipperiness, and resistance to water and oil, made them extremely useful in many applications around the world. Since the 1940s, PFAS have been used in numerous industrial processes (notably the manufacture of nonstick fluoropolymers), included in aqueous film-forming foams used to fight fires, and incorporated into thousands of diverse consumer products including cookware, food containers, paints, and textiles used in carpeting, furniture, and clothing. Evich et al., supra, at 514. These varied uses provided numerous pathways for large environmental releases. For example, manufacturing processes released PFAS directly to air and water, disposal of solid waste caused PFAS to leach into groundwater, and firefighting foam contaminated soil, groundwater, and surface water. Id. at 512, 515–18. Today, the blood of virtually every American, and perhaps everyone on earth, contains PFAS. Id. at 518.

The health effects of PFAS contamination first attracted wide public notice years after Robert Bilott, an initially reluctant attorney representing cattle farmer Wilbur Earl Tennant, filed the first-known PFAS lawsuit. Bilott sued DuPont, alleging claims for property damage—sickened and dead cattle—as well as personal injury. But the initial complaint could not and did not specify the allegedly harmful chemical. Bilott identified perfluorooctanoic acid (PFOA) as the culprit only after obtaining favorable discovery rulings that enabled him to learn about PFOA’s existence and toxicity from DuPont’s own internal documents. Bilott, Exposure, at 33–34, 78. This case triggered another, a class action lawsuit seeking medical monitoring on behalf of persons whose drinking water had been contaminated by PFOA released from DuPont’s Washington Works. The class action settlement included an interim agreement for DuPont to fund a science panel and a massive epidemiologic study to assess the links between PFOA exposure and a number of diseases. The science panel found probable links between PFOA exposure and increased risk of six health conditions, including testicular and kidney cancer and pregnancy-related hypertension. Mark Nevitt & Robert V. Percival, Can Environmental Law Solve the “Forever Chemical” Problem?, 57 Wake Forest L. Rev. 239, 253–54 at n.86 (2022). As allowed by the medical monitoring settlement, class members suffering from the linked diseases filed personal injury claims. After several multimillion-dollar verdicts for plaintiffs, DuPont and the class members reached a $671 million settlement. See In re E.I. Du Pont De Nemours & Co. C-8 Personal Injury Litig., 2018 WL 4771524 (S.D. Ohio Oct. 3, 2018).

Soon, other PFAS began enjoying similar notoriety. In 2017, residents of the Cape Fear, North Carolina, area learned that their drinking water was contaminated with GenX, which DuPont used to replace PFOA, but which also proved toxic. Ashley Ahearn, A Regrettable Substitute: The Story of GenX, 127 Env’t Health Persp. (Supp.) 1 (2019). The notoriety and concerns over PFAS exposure have only grown. Recently, a team of U.S. Geological Survey researchers estimated, based on testing for some 80 PFAS in tap water samples across the country, that “at least one PFAS could be detected in about 45% of US drinking-water samples.” Kelly L. Smalling et al., Per- and Polyfluoroalkyl Substances (PFAS) in United States Tapwater, 178 Env’t Int’l 108033, at 1 (2023).

PFAS in Law: Where We Are Now

Scientists have reported that they “struggle to keep pace with manufacturing, use, and subsequent release” of PFAS, Evich et al., supra, at 513, and novel PFAS continue to be detected in environmental media, sometimes far from their source. If scientists struggle to keep pace, it is predictable that regulators will also struggle. In 1999, when Bilott filed suit, no federal or state regulation restricted the manufacture, use, or release of PFAS in any way. Since then, rolling waves of high-stakes regulatory activities have ever so slowly addressed PFAS. These have ranged from state legislation and regulations to a range of proposed and final federal regulations under existing statutory authorities, to federal legislation requiring additional regulatory steps.

Even when the U.S. Environmental Protection Agency (EPA) learned—partly from Bilott’s efforts—about PFAS, EPA first preferred to negotiate with the manufacturers rather than to swing a regulatory hammer. For example, in 2000, under EPA pressure, the 3M Company announced that it would stop making Scotchgard because of concerns about perfluorooctane sulfonate (PFOS); in 2006 EPA finally achieved an agreement with eight manufacturers to phase out PFOA, PFOS, and a handful of other long-chain PFAS over a 10-year period. See Steve C. Gold & Wendy E. Wagner, Filling Gaps in Science Exposes Gaps in Chemical Regulation, 368 Science 1066, 1066 (2020). More recently, EPA began to use its limited authority under the Toxic Substances Control Act (TSCA) to promulgate a series of regulations (Significant New Use Rules) that require EPA approval before a company can lawfully manufacture or import certain PFAS or articles containing them. However, these rules only target the re-introduction of “legacy” PFAS that have already been phased out or are not currently in commerce.

Of course, if a family of chemicals is used extensively in production processes, it will likely show up in waste streams as well, and PFAS are no exception. However, releases of PFAS into the environment remain unregulated. None of the PFAS, not even legacy compounds like PFOS and PFOA, are currently listed or proposed for listing as a hazardous air pollutant under section 112 of the Clean Air Act or as a toxic pollutant under section 307 of the Clean Water Act (CWA). EPA is working toward, but has not finalized, CWA effluent limit guidelines for PFAS; to date, few discharge permits under section 402 of the CWA have addressed PFAS effluents.

EPA has made more progress on disclosure requirements, after being directed to do so by Congress. The 2020 National Defense Authorization Act (NDAA), Pub. L. No. 116-92 (2019), required EPA to add some PFAS to the Toxic Release Inventory, the list of chemicals for which releases must be reported under the Emergency Planning and Community Right-to-Know Act. EPA met this obligation through a series of rulemakings that began in 2020 and now require annual reporting of releases of about 180 PFAS. EPA, Addition of Certain PFAS to the TRI by the National Defense Authorization Act. The 2020 NDAA also required EPA to impose reporting requirements on PFAS manufacturers by January 1, 2023. 15 U.S.C. § 2607(a)(7). But EPA missed that deadline, despite initially proposing a rule in 2021. See TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements, 87 Fed. Reg. 72,439 (Nov. 25, 2022) (soliciting further comment on the proposed rule’s effect on small businesses).

What about addressing PFAS contamination already in the environment from prior releases, particularly in drinking water supplies? Here EPA has lagged behind many states. EPA issued nonbinding Health Advisory Levels for PFOA and the closely related PFOS in 2016, but New Jersey in 2018 implemented the first mandatory PFAS drinking water standard. 50 N.J. Reg. 1939(a) (Sept. 4, 2018); see N.J. Admin. Code § 7:10-5.2(a)5 (2023). Today, 11 states have enforceable drinking water standards for at least one PFAS and 15 have health advisory levels. Lexis, Regulation of PFAS Chemicals in Drinking Water State Law Survey (Apr. 5, 2023). In March 2023, EPA proposed stringent Maximum Containment Levels (MCLs) that would impose binding, nationwide limits on the amounts of several PFAS in drinking water. These include the highly toxic, persistent, and bioaccumulative legacy compounds PFOA and PFAS, as well as the more recent substitute compound GenX, and a few others. The rules have not yet been finalized. PFAS National Primary Drinking Water Regulation Rulemaking, 88 Fed. Reg. 18,638 (Mar. 29, 2023).

Mandatory standards for concentrations of PFAS in environmental media prompt the question of how to remediate existing contamination. In 2022, EPA proposed adding PFOA and PFOS to the list of hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Designation of PFOA and PFOS as CERCLA Hazardous Substances, 87 Fed. Reg. 54,415 (Sept. 6, 2022). That proposed rule remains pending, as does a 2023 Advance Notice of Proposed Rulemaking addressing seven additional PFAS and precursors also under CERCLA. Addressing PFAS in the Environment, 88 Fed. Reg. 22,399 (Apr. 13, 2023). These proposed hazardous substance listings, if finalized, could bring to bear both Superfund and private money to remediate PFAS contamination.

But states and drinking water suppliers are not waiting. Instead, they have turned to tort liability, outpacing the regulatory system. In hundreds of cases consolidated in a multidistrict litigation, water utilities sued manufacturers of PFAS and PFAS-containing products, seeking compensation for the costs of remediating or replacing contaminated water supplies. In June 2023, as the first bellwether trial approached, some of the plaintiffs reached settlements with four PFAS manufacturers totaling at least $11 billion. Lisa Friedman & Vivian Giang, 3M Reaches $10.3 Billion Settlement in “Forever Chemicals” Suit, N.Y. Times, June 22, 2023, at B1. If the court approves those settlements, the total value of publicly reported settlements and judgments in PFAS litigation will exceed $13.5 billion, with much litigation still pending and, probably, to be filed.

Two facts stand out about PFAS litigation and regulation to date. First, the threat of massive tort liability and possible government enforcement action did not suffice to forestall rational corporate decisionmakers from manufacturing a dangerous chemical. Roy Shapira & Luigi Zingales, Is Pollution Value-Maximizing? The DuPont Case (2017). And second, even as the regulatory reaction ramifies, it remains just that—a reaction to exposures and risks now known to have been created in the past.

How TSCA Works to Regulate PFAS (or Not)

How could such a hazardous family of chemicals escape regulatory attention for decades? Unfortunately, PFAS did not slip through the cracks of an otherwise high-functioning regulatory program. Instead, the PFAS family of chemicals likely represents the norm rather than the exception.

An investigation into the origins of regulatory failure begins and ends with the chemical regulatory statute, TSCA. While there are other laws in the United States that regulate risky chemicals once they make it on the regulatory radar, TSCA is the only statute that endeavors to provide a mechanism to screen out dangerous chemicals before the hazards are released into commerce and the environment.

Unlike other 1970s-era environmental laws passed in the wake of publicly visible disasters, TSCA’s passage was motivated by more abstract logic: The United States needed a way to screen out the most toxic hazards before they became health and environmental disasters. These ho-hum origins may have left something of an enthusiasm gap between the environment-minded public and the directly affected chemical industry as TSCA wound through the legislative process. Researchers have documented the industry’s authorship of key provisions of TSCA designed both to raise the agency’s burden of proof and to provide numerous “attachment points” for challenges to EPA’s decisions. Lauren Richter et al., Producing Ignorance Through Regulatory Structure: The Case of Per- and Polyfluoroalkyl Substances (PFAS), 64 Socio. Persp. 631, 637–39 (2021). After the chemical industry successfully used these provisions to challenge EPA’s partial ban of asbestos in the 1980s, it became clear that TSCA imposed effectively insurmountable legal hurdles to EPA’s regulation of chemicals. Id. From 1976 to 2016, EPA managed to require testing of only 200 chemicals, GAO, Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks, GAO 05-458, at 18 (2005), and banned only five. Noah M. Sachs, Jumping the Pond: Transnational Law and the Future of Chemical Regulation, 62 Vand. L. Rev. 1817, 1830 (2009).

EPA’s failure to make meaningful progress in assessing and overseeing chemical safety generated calls for major amendments, which were finally passed in 2016 via the Lautenberg Chemical Safety Act’s reform of TSCA. While the amendments were hailed by some as a success, many of TSCA’s problematic evidentiary prerequisites remain in place, and many new attachment points are sprinkled throughout the statute. See Valerie J. Watnick, The Lautenberg Chemical Safety Act of 2016: Cancer, Industry Pressure, and a Proactive Approach, 43 Harv. Env’t L. Rev. 373 (2019).

At its base, even in its amended form, TSCA still operates more like a disclosure statute than a licensing statute with respect to screening chemicals. For a chemical produced after 2016 (considered “new”), the manufacturers must provide EPA with basic information about the chemical; EPA then has 90 days to determine whether the chemical “presents” or is “not likely to present an unreasonable risk” to health and the environment, without considering cost. 15 U.S.C. § 2604(a)(3). (Before 2016, EPA had a 90-day window to intervene on the manufacture of a new chemical, but EPA was not obliged to make a formal determination about the safety of each new chemical.) By contrast, manufacturers of “old” chemicals need only register their chemicals with EPA. 40 C.F.R. § 710.29; see generally New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation (Lynn L. Bergeson & Charles M. Auer eds., 2017). EPA can order the collection of additional information on any chemical (new or old) through various testing and reporting authorities, but EPA carries the burden of supporting these orders, which are sometimes challenged by industry. EPA also has the authority to impose further restrictions—like warnings or bans—on a chemical, although EPA bears an even heavier burden and must prove that the restrictions are justified by both risk and cost considerations. 15 U.S.C. § 2605(a), (c). As resources allow, EPA is also required to sort all chemicals sold in commerce into high and low priority categories and conduct risk evaluations on at least 20 high-priority chemicals under staggered statutory deadlines. Id. § 2605(b).

The 2016 amendments introduce new, important requirements on EPA to oversee the large inventory of chemicals, but TSCA still imposes numerous, substantial evidentiary burdens on EPA’s effort to meaningfully screen the 33,000 chemicals sold in commerce. For example, manufacturers are not required to conduct toxicity testing on their chemicals unless EPA issues an order requiring a specific test. Gold & Wagner, supra, at 1068. Manufacturers are not even required to provide a literature review synthesizing the existing research and data bearing on the toxicity of their chemicals; instead, they need only share information that exists in their own files. Id. They are also not expected to provide EPA with information on the social need for or the efficacy of their chemicals, particularly in relation to alternatives. Implicitly, TSCA assumes all chemicals to be equally efficacious and socially valuable unless EPA proves otherwise. Thus, despite the fact that TSCA itself recognizes that manufacturers enjoy superior information regarding both the social value and the potential risks of their chemical products, TSCA imposes almost no responsibility on them to provide this expertise to inform EPA’s assessments.

Given this statutory structure, it is not surprising that we still know very little about either the safety or social need for most chemicals in commerce. Even for “new” chemicals that must undergo at least some regulatory clearance, 67% of new chemicals submitted during the first three decades of TSCA were submitted with no toxicity data. U.S. Env’t Prot. Agency, Overview: Office of Pollution Prevention and Toxics Laws and Programs 8 (2008).

This legal design helps explain how PFOA and the larger PFAS class of chemicals escaped notice. PFOA and PFOS were produced long before TSCA was passed in 1976, so these chemicals were grandfathered into the statute. Other PFAS were first produced after 1976 and, unless exempted, went through TSCA’s pre-marketing disclosure required at that time. But because this pre-clearance system requires no testing or literature synthesis, EPA still learned effectively nothing about the safety of incoming chemicals from the manufacturers’ submissions. Gold & Wagner, supra.

For chemicals on the TSCA inventory, manufacturers have an obligation to report “substantial risk[s] of injury to health or the environment” of which they are aware. 15 U.S.C. § 2607(e). This obligation impacted DuPont, which had documented adverse effects of PFOA but had not shared the information with EPA. Shapira & Zingales, supra. Eventually DuPont agreed to pay a negotiated $16.5 million administrative penalty. Id. Yet as any lawyer knows—and PFOA demonstrates—“failure to disclose” violations are hard to detect, so the probability of being caught is very low. EPA brought its enforcement action against DuPont only after Bilott sent the files over to EPA.

It is striking that the dangers of PFOS and PFOA were first uncovered by manufacturers rather than by independent researchers. We might hope that academic or government scientists would discover the very worst risks of chemicals present in household products, emission streams, and the environment. Yet the existing legal landscape creates significant impediments to this back-end research and discovery of chemical risks. Wendy E. Wagner & Steve C. Gold, Legal Obstacles to Toxic Chemical Research, 375 Science 138 (2022).

Perhaps most problematic, TSCA (and EPA) have embraced a permissive approach to trade secret classification, allowing manufacturers to shield many chemicals from public view. Historically, manufacturers enjoyed substantial discretion in deciding whether virtually all of the documents they shared with EPA on each chemical were proprietary and confidential trade secrets, and they employed this right liberally, with no consequence for overclaiming. Id. The 2016 legislative overhaul to TSCA imposed greater regulatory oversight of trade secret claims, but as of 2021, the identity of one-fifth of the chemical inventory (8500+ chemicals) is still completely obscured by blanket “trade secret” claims. Even when a chemical’s identity is disclosed, other vital information—such as manufacturers’ names, locations of production or use, production quantities, commercial uses, and handling practices—is often classified by the manufacturers as trade secret protected. Id. The 2016 amendments allow manufacturers to designate much of this information as trade secrets without justifying the claim at all. See 15 U.S.C. § 2613(c)(2). In 2005, GAO reported that “95 percent of the TSCA premanufacture submitted to EPA contain some information that is claimed as confidential.” GAO, supra, at 5.

Even if a contaminant in an environmental sample is a publicly known chemical, researchers still face challenges in identifying it. TSCA does not require manufacturers to provide an analytical reference standard and yet, without a standard, researchers may be forced to rely on difficult and expensive nontargeted analyses to make inferences about a chemical’s structure. Moreover, without a reference standard, chemists cannot precisely quantify the concentration of whatever chemicals they find. Wagner & Gold, supra.

Both scientific knowledge and legal authority are needed to protect society from unreasonable chemical risks. Yet the law we have in place provides inadequate regulatory authority, while simultaneously interfering with independent scientific research on chemical hazards.

Reform—Now and Later

Based on the legal design of TSCA, there is no reason to think that PFAS will be the last set of contaminants to impose unexpected and catastrophic harms on health and the environment. On the horizon lie tens of thousands of unassessed chemicals that have found their ways into all aspects of American life, 8,500 of which have secret identities known only to the companies producing them and a small subset of EPA staff.

Given this grim diagnosis, what can be done? An effective solution requires amending TSCA again, this time in ways that place greater responsibility on industry to provide early warnings of their chemical hazards. Until that happens, EPA can use its existing regulatory authorities to encourage and reward manufacturers for researching and documenting the risks and social value of their chemicals.

A reformed TSCA would alter the current law’s presumption in favor of unrestricted innovation in the chemical industry. Rather, manufacturers and importers should be required to assess the risks of each chemical and also document each chemical’s value to society, including a comparison to alternative, safer products available for those same essential uses. Industry, and not EPA, should bear the burden of rigorously evaluating the risks of each of its chemicals to health and the environment, as well as each chemical’s utility, in comparison to alternative chemicals that can serve the same purpose. For new chemicals, this evaluation should be required prospectively as well as through ongoing monitoring. This would allow society to benefit from risky chemicals that meet essential needs but also to protect itself from chemicals not worth their dangers. This amendment could encourage green chemical companies to serve as vital informants, scrutinizing competitors’ chemicals and calling attention to manufacturers who have misstated or exaggerated a chemical’s safety or efficacy. An improved TSCA could produce an improved market of chemicals that offer the best balance of safety, necessity, and cost.

Flipping the burden of proof to industry will admittedly raise difficult questions. Issues about assigning priorities for study, how much evidence is needed, the independence of those who prepare and assess the information, and how to handle the many gray cases afflicted by residual uncertainties all will need to be resolved. In light of the record of the 2016 TSCA amendments, statutory reform will not come quickly. In the meantime, an intermediate step could involve instituting agency procurement policies that adopt these same types of requirements. Experience with these procurement policies can then be used to design more systematic requirements through legislation.

Recent innovations in tort liability might help further reinforce these suggested reformed regulatory requirements. In at least a few tort cases, industry has been required to finance investigations into the latent toxicity of their products as an injunctive-style form of relief, what Alexi Lahav calls the “knowledge remedy.” Alexandra D. Lahav, The Knowledge Remedy, 98 Tex. L. Rev. 1361 (2020). By imposing research responsibilities on manufacturers that do not conduct reasonable investigations into the potential hazards of presumptively dangerous chemicals to which plaintiff-victims are extensively exposed, tort law can serve to encourage chemical safety rather than reward ignorance, which is currently the case.

Finally, legal impediments to back-end research need to be eliminated. EPA can do much using its existing authorities. Going forward, manufacturers should be required to supply EPA with chemical standards for each chemical in the TSCA inventory. Trade secret protections need to be revisited to make it harder for safety-related data to hide behind protected chemical identities and to make it easier for researchers to find, identify, and trace chemicals’ transport, exposure pathways, fate, and toxicity. And the deplorable fragmentation of agency chemical records across agencies and states needs to be brought into the 21st century with a central electronic repository.

Small but vital steps now. A bold rethinking later. That is how we can finally fulfill the promise Congress made in 1976 and ensure that the PFAS past is not prologue.