Chemical Compliance: Is TSCA Reform in Our Future?
It’s been almost nine years since Toxic Substances Control Act (TSCA) stakeholders celebrated President Obama’s enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) on June 22, 2016. Because the road to amending TSCA was long (almost a decade), contentious and complicated, stakeholders may have been more relieved that the process was finally over than interested in the fine print.
Given the passage of nearly a decade, there’s a growing consensus that TSCA’s fine print needs tweaking. If the past is prologue, this fourth administration now taking the reins of power is expected 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’s perplexing why such a consequential law is so lacking clear congressional direction and specificity. The irony is not lost on TSCA stakeholders. The original law was grand in design but 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. TSCA 1.0, enacted in 1976, and the grand ambitions of many legislative directives from that era had similar problems (make rivers and lakes “fishable and swimmable,” modernize the review of all pesticides in commerce within three years, for example).
Background
Lautenberg (TSCA 2.0) was intended to address the universally acknowledged core deficiencies of TSCA 1.0. These include the absence of a clear legislative mandate requiring the EPA to prioritize, evaluate and regulate the then 62,000-plus existing chemicals, address the EPA’s limited ability to compel chemical testing and eliminate the requirement that the EPA demonstrate the “least burdensome” regulatory option to address an unreasonable chemical risk as required under TSCA Section 6(a).
Other factors contributed to the perception that TSCA was ineffective: the European Union’s adoption in 2006 of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) program; the accelerating emergence of state chemical initiatives and triggering concern with the resulting commercial incoherence caused by variable state one-off chemical measures; and the public’s increasing demand for greater transparency about the compositional elements of consumer products. 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 recently released a report entitled “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 the 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 needed to replace older, less sustainable chemistries. 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 the 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 the 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.
Fees Reauthorization
TSCA fees must be legislatively reauthorized no later than Sept. 30, 2026. This offers a convenient opportunity to engage in some mid-course corrections that are needed in the New Chemicals Program especially. Chemical reform is an iterative process, and we have learned a lot since 2016. In this post-Chevron world, legislative definitional clarity is the best way to ensure that new chemicals -- especially those with improved risk profiles — have a rational, fair, timely and predictable shot at commercialization.
Lynn L. Bergeson, Compliance Advisor columnist
LYNN L. BERGESON is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.
