Posted on January 29, 2025 by Lynn L. Bergeson*
It has been almost nine years since Toxic Substances Control Act (TSCA) stakeholders celebrated President Obama’s enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). Because the road to amending TSCA was long (almost a decade), contentious, and complicated, stakeholders were perhaps more relieved that the process was finally over than inclined to focus on the fine print.
Many of us have been doing a lot of focusing on that fine print for years and a growing consensus seems to be emerging: TSCA needs tweaking. As euphoric as the chemical community, industrial and non-governmental organization (NGO) members alike, was in 2016, a real sense of foreboding has settled in as we look to a fourth Administration taking the reins of power, one that is almost certain to “undo” what the prior Administration set in place, which was to undo what the second Administration set in place, which, well you get the idea. It is perplexing why such a consequential law is so lacking clear congressional direction and specificity. The irony is not lost on practitioners versed in TSCA 1.0. The law was spectacularly grand in design but uniquely devoid of specifics as to how exactly the U.S. Environmental Protection Agency (EPA) was to implement the vision lawmakers outlined in TSCA but neglected to elaborate legislatively. For TSCA 1.0, it was written in 1976, so the grand ambitions of many legislative directives from that time had similar problems (make rivers and lakes “fishable and swimmable,” modernize the review of all pesticides in commerce within three years, for example).
Lautenberg (TSCA 2.0) was intended to address the universally acknowledged core deficiencies of TSCA 1.0. These include, among others, the absence of a clear legislative mandate requiring EPA to prioritize, evaluate, and regulate the then 62,000-plus existing chemicals in commerce in 1976, EPA’s limited ability to compel chemical testing, and the requirement that EPA demonstrate the “least burdensome” regulatory option to address an unreasonable chemical risk as required under TSCA Section 6(a). This last deficiency’s undoing was on full display in the often-cited 1991 Fifth Circuit decision in Corrosion Proof Fittings where EPA’s regulation of asbestos was remanded back to the Agency because the rule lacked substantial evidence. The blow was crushing and led to EPA’s feckless approach to regulating existing chemicals, further undermining the public’s confidence in TSCA’s ability to assure chemical safety. After all, if you can’t ban asbestos….
Three other factors contributed significantly to the perception (if not reality) that TSCA was ineffective: (1) the European Union’s adoption in 2006 of a bold new chemical management program titled the Registration, Evaluation, Authorisation and Restriction of Chemicals program, which contrasted sharply with TSCA’s approach to chemical regulation; (2) the accelerating emergence of state chemical initiatives quickly filling the void left by EPA and triggering concern with the resulting commercial incoherence caused by highly variable state one-off chemical control measures; and (3) the public’s increasingly demanding need for greater transparency about the compositional elements of consumer products, aided in large part by the effective advocacy of many new public health advocates and environmental non-governmental organizations (e-NGO). All these factors contributed to the cratering of public confidence in the federal government’s ability to regulate chemicals and the hastening calls for legislative action.
Many aspects of Lautenberg work well, but tweaking is needed. This is especially true in the new chemicals area. The General Accountability Office (GAO) would agree. It released this week a report “New Chemicals Program: EPA Needs a Systematic Process to Better Manage and Assess Performance.” The report echoes a 2023 report by the EPA Office of Inspector General, “The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions” (23-P-0026). GAO found that EPA’s New Chemicals Division “does not follow most key practices for managing and assessing the results of the New Chemicals Program.”
New chemicals are urgently needed to replace older, less sustainable chemistries. This is not an industrial chemical manufacturer’s rhetorical dream; it is a fact. The fact is implementation of Lautenberg is hurting new chemical innovation, driving new chemical commercialization offshore, and for most new chemicals that make it through the years-long new chemical gauntlet, they enter the market hobbled by unjustified regulatory limitations that make them commercially uncompetitive and contribute little to human health and safety. The current regulatory morass perversely favors continuation of older chemistries and chemical products rather than promotes market substitutes with preferable risk profiles.
At the root of this regulatory malpractice is the lack of definitional clarity around key legislative terms, including “reasonably foreseen,” “not likely,” and EPA’s stubborn conflation between hazard and risk. “Reasonably foreseen” does not mean every conceivable chemical use condition an imaginative EPA reviewer conjures up, however improbable. “Not likely” is amenable to as many diverse interpretations as there are individuals asked to opine on the term — again proving the axiomatic “you cannot prove a negative.” None of the three past Administrations implementing TSCA has provided a rationale for its interpretation or ensured consistent decision-making between and among reviewers, and Trump 2.0 can be expected to do likewise. The fate of the industrial chemical community’s commitment to innovation and sustainable chemistry should not be yo-yoed like this, as the adverse consequences are significant.
TSCA fees must be legislatively reauthorized no later than 2026. This fact provides a convenient opportunity to engage in some mid-course corrections that are desperately needed in the New Chemicals Program especially, as extensively outlined in my colleague’s congressional testimony on January 22, 2025. Chemical reform is in iterative process, and we have learned a lot since 2016. In this post-Chevron world, legislative definitional clarity is the best way to ensure new chemicals — especially those with improved risk profiles — have a rational, fair, timely, and predictable shot at commercialization.
*The views expressed in this blog are my own.