Opinion: Is it time to amend the Toxic Substances Control Act . . . again?

Some 9 years after TSCA was updated, it’s clear it isn’t working—in part because some prior amendments left too much room for interpretation.

We are fast approaching the ninth anniversary of the enactment of the 2016 Lautenberg amendments to the Toxic Substances Control Act, or TSCA, the federal law that governs chemicals in commerce. And with each passing year, we have further confirmation from frustrated industry stakeholders that TSCA as amended is broken.

The 2016 revisions were spearheaded by the chemical industry and received overwhelming bipartisan support. Numerous provisions were overhauled, including section 6 on existing chemicals: it now mandates that the US Environmental Protection Agency prioritize and evaluate chemicals in commerce anticipated to present risks to human health or the environment, and if necessary, promulgate regulations to eliminate any unreasonable risk.

Amending TSCA was no easy feat. It took years of steadfast negotiation to cross the finish line. After all, TSCA had not been substantively amended since its original passage in 1976. Yet, after nearly 9 years, it is abundantly clear that TSCA isn’t working. Why? One answer is that some amendments were drafted in a manner that left too much room for interpretation. And key terms, such as “unreasonable risk,” were left undefined. The result has been implementation whiplash with each change in administration.

Take for example the following (truncated) sentence, added in 2016: “The Administrator shall conduct risk evaluations [. . .] to determine whether a chemical substance presents unreasonable risk [. . .] under the conditions of use.” During the first Donald J. Trump administration, this provision was interpreted as requiring the EPA to determine whether each condition of use (COU) being evaluated presents unreasonable risk. Under the risk evaluations for 10 chemicals completed by the Trump administration, the EPA determined that most of the COUs for each chemical presented unreasonable risk and that the remainder did not present unreasonable risk. But the Trump EPA ran out of time before it was able to draft risk management rules to address unreasonable risk.

Enter Joe Biden’s administration, under which the EPA now interpreted this same provision of TSCA as mandating what it called a whole chemical approach to risk evaluations, in which the EPA would make a single unreasonable risk determination on the chemical, not on any particular COU. COUs were still evaluated in order to assess whether each one “contributed” (a term EPA never defined) to unreasonable risk for the whole chemical. Even if only a single COU was deemed to contribute to unreasonable risk, the EPA would conclude that the whole chemical presented unreasonable risk. Of course, under these criteria, the chances were vanishingly small that any chemical subject to an EPA risk evaluation would be deemed not to present unreasonable risk. By adopting a whole chemical approach, the EPA effectively eviscerated the new preemption provision of TSCA that no unreasonable risk determination would preempt states from then regulating those same COUs.

To add another layer of (mis)interpretation, during a recent oral argument before a three-judge panel of the US Court of Appeals for the District of Columbia Circuit, Judge Harry T. Edwards appeared to interpret this TSCA provision as requiring the EPA to consider conditions of use only in the risk management phase, after the EPA had determined whether or not the chemical as a whole presented unreasonable risk. But how would the EPA determine whether the chemical presents unreasonable risk if the agency didn’t look at how the chemical is used and under what conditions?

The three-judge panel was acutely aware of the 2024 Supreme Court decision in Loper Bright Enterprises v. Raimondo that it is the province of judges—not agencies—to decipher the best reading of a statute. Although Loper Bright could put a stop to the freewheeling statutory interpretation by successive administrations, industry litigants may not like how a court ultimately interprets a TSCA provision, which appears to be the road the DC Circuit is heading down.

The 2016 TSCA amendments also dramatically reshaped how the EPA reviews new chemicals before they are allowed to enter the marketplace. Without fully appreciating the impacts of the changes to section 5 of TSCA, which governs new chemicals, Congress required the EPA to make an affirmative determination as to the safety of chemicals it reviews before they are allowed to go on the market. That is a far cry from the EPA’s pre-2016 review of new chemicals, in which nearly all chemicals were statutorily free to enter the marketplace after the 90-day review period.

For any company that has sought the EPA’s approval for a new chemical, you know first-hand the wait is frustratingly long—often many months and sometimes years before you are allowed to market your new chemical, and almost always with restrictions.

All of this frustration brings us back to the question: Is it time to amend TSCA again? For many industry stakeholders, the answer is most assuredly yes. And the window of opportunity is now because the EPA’s authority to collect fees from chemical companies to support TSCA implementation runs out in less than 2 years unless Congress reauthorizes it.

Nearly 9 years is long enough for Congress to assess how well its TSCA amendments have been working. There is ample evidence of TSCA’s persistent maladies to necessitate thoughtful and targeted efforts to reform the act. Fortunately, efforts are underway—especially in the Senate—to craft creative approaches to expedite new chemical reviews without jettisoning the EPA’s requirement to make “affirmative” determinations. Industry is also keen to be part of the solution, which is why the TSCA Improvement Coalition, an informal group of chemical companies focused on fixing TSCA, was formed. The coalition is concentrating on sections 5 and 6, as well as on other provisions, all with the intent of assisting the EPA with its daunting task of implementing TSCA.

*Reprinted from Chemical & Engineering News, copyright © 2025 by the American Chemical Society. This article was first published on May 5.