As Congress weighs TSCA changes, US chemical regulation hangs in the balance

Washington, DC—Nearly a decade after the US Congress overhauled the Toxic Substances Control Act (TSCA), the nation’s primary chemical safety law is once again at a crossroads. Most everyone agrees that some change is needed—and draft bills to update the 1976 law again have been released in the House and Senate—but which parts of it should change, and to what extent, are the focus of considerable debate.

Industry leaders say the chemical review process has become slow and unpredictable, threatening innovation and investment, while public health advocates say the US Environmental Protection Agency is not doing enough to protect people and the environment from harmful chemicals. Meanwhile, the EPA is struggling to meet deadlines under the statute while courts are increasingly asked to interpret the law to determine how TSCA should be implemented.

EPA officials and outside experts say the current system is being stretched by overlapping statutory deadlines, litigation risk, and conflicting data on how chemicals are used in real-world conditions. The result is a regulatory program that is simultaneously expanding in scope and increasingly constrained in practice.

At the GlobalChem conference hosted by the American Chemistry Council (ACC) in February, industry leaders, EPA officials, and consultants called for greater predictability in US chemical regulation and signaled support for reenvisioning the EPA’s authority through incremental changes to the law.

Separately, Wendy Wagner, the Richard Dale Endowed Chair in Law at the University of Texas School of Law and a scholar with the Center for Progressive Reform, says the EPA is “stuck” implementing a statute that hinders meaningful regulation, with industry litigation compounding the challenge. For her, the answer is a fundamental reset of the 50-year-old law.

The path forward is narrow: Congress weighs targeted changes

Nearly a decade after Congress overhauled TSCA with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, lawmakers in the Republican-controlled House and Senate are considering changes that are much more limited. They are drafting legislation to reauthorize TSCA’s user-fee program, which funds much of the EPA’s chemical regulation efforts, before it expires in September. Alongside that funding measure, lawmakers are considering targeted revisions they say could address implementation challenges that have plagued the EPA ever since the law was first updated in 2016.

Byron Brown, chief counsel for the House Energy and Commerce Committee’s Environment Subcommittee, has been helping House Republicans craft a discussion draft of a bill to revise TSCA (PDF). “There’s no appetite among our members to reopen TSCA entirely,” Brown said at GlobalChem. Brown, who formerly represented the ACC as its assistant general counsel, said the discussion draft reflects “a lot of new ideas about how to get innovative products and chemicals [more quickly] to market.”

Industry groups argue that when chemical approvals take years, production often shifts overseas—sometimes to countries with weaker environmental oversight. “Delays don’t make the US safer,” said Chris Jahn, CEO of the ACC. “They just move production to countries with less rigorous oversight.”

Those concerns have also resonated with some lawmakers. Brown said members of his committee increasingly view chemical regulation as part of a broader economic and national security landscape. “We’re in this race against China for [artificial intelligence] dominance and economic competitiveness,” he said. “TSCA fits in with that.”

Industry leaders say, however, that they don’t want weaker TSCA safety standards. Instead, many argue that even small tweaks to the statutory language could help both regulators and companies understand how the law should operate. “Industry does not like uncertainty,” Brown said. “When they’re making investment decisions, they want to know what the rules of the road are.”

Some ideas for updating TSCA that are being considered by lawmakers, Brown continued, focus on clarifying how the EPA should evaluate conditions of use for chemicals and identifying data needs earlier in the chemical review process. Others address potential overlap between the EPA and other regulators, particularly the Occupational Safety and Health Administration.

“We have two agencies regulating the same chemical molecule at the same part of the manufacturing process in two different ways,” said Stephanie Daigle, vice president of global government affairs and trade compliance at the chemical maker Celanese. Differences in personal protective equipment requirements, monitoring approaches, or reporting obligations can create unnecessary complexity, she added. “We need one set of requirements.”

Legal experts expressed similar views at GlobalChem, saying better coordination among agencies could help reduce unnecessary duplication while preserving strong protections for workers and the public.

In general, Brown said, the committee’s discussion draft attempts to address inconsistencies in the law through “small” statutory clarifications.

The effort reflects concerns among some lawmakers and industry groups about the pace and predictability of chemical reviews, Brown said. Even so, the political path forward is narrow, he said. Republicans hold a slim House majority, and any legislative changes are likely to require some bipartisan support. Brown said both parties broadly agree that fee reauthorization is necessary, along with some procedural improvements and transparency provisions, but that’s about it.

On a ‘hamster wheel’: EPA’s implementation challenges

While Congress debates potential legislative changes, the EPA must continue implementing the statute as written—a task agency officials admit they’re struggling with.

Douglas Troutman, assistant administrator for the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), said the agency has reorganized parts of its chemicals program and expanded staffing to help manage the workload.

Last year, OCSPP brought over more than 180 employees from other parts of the EPA. The agency also created the Risk Assessment Support Division to provide modeling and scientific support for chemical evaluations. But maintaining experienced leadership has been difficult through administration changes. “I lost every deputy across every division last year,” Elissa Reaves, director of the EPA’s Office of Chemical Safety and Pollution Prevention, said at GlobalChem. “The struggle with gaps in our leadership is real.”

On the positive side, addressing the chemicals program’s aging information technology system, in part through a $17 million appropriation from Congress in 2025, has been a “game changer,” according to Shari Barash, director of the EPA’s New Chemicals Division. The agency has also introduced a new group focused on cheminformatics, or computer science–driven methods for analyzing chemical compounds, and has begun a process to migrate its chemical data systems to a cloud-based platform by 2028.

The EPA is struggling to keep pace with its statutory workload, balancing reviews of new chemicals with risk evaluations for existing ones. TSCA, under the 2016 amendments, requires the agency’s existing chemicals division to select and maintain a roster of at least 20 high-priority existing chemicals undergoing risk evaluation at any given time. The agency completed its first 10 risk evaluations in 2020 and has issued additional—and in some cases revised—evaluations in the years since, though output has varied.

But the challenge is not simply the number of reviews, Reaves continued. Under the statute, each determination that a chemical presents an unreasonable risk triggers additional deadlines for developing regulations, compounding the agency’s workload.

“EPA is on the TSCA hamster wheel,” Reaves said. The agency must propose risk-management rules within 1 year after completing an evaluation and finalize them the following year, while also reviewing new chemicals entering the market and responding to thousands of public comments. “It’s an immense workload,” she said. “For my team moving forward, the question for us now is deciding where our resources matter most.”

Wagner says the issue is even bigger than EPA officials are letting on.

“I think EPA is stuck. I’m sure there are little adjustments they could be making, but I think it’s going to be hard for them to do much better.” The problem, she says, is that the agency has up to 90,000 chemical substances to oversee. “And for every single step that EPA does to regulate them, the burden is on them to generate all the information.”

Data gaps are complicating chemical reviews

That burden represents one of the most persistent challenges in the agency’s implementation of TSCA: the availability, or lack thereof, of data about how chemicals are used and how people are exposed to them, including incomplete submissions from companies seeking new chemical reviews.

“A robust, complete submission really helps us avoid those overly conservative assumptions that [submitters] are concerned with,” Barash said, explaining that when information is missing, agency reviewers often rely on modeling or conservative assumptions about exposure levels. But the EPA is “trying to pivot toward using monitoring data and real-world information wherever we can,” Reaves said. “If a chemical is never going to reach water, why are we doing a water assessment?”

Industry representatives say that shift cannot come soon enough. Companies argue that when their data are insufficient—or not incorporated—risk evaluations can drift toward hazard-based assessments rather than the risk-based approach they say was envisioned when Congress overhauled TSCA in 2016.

Kari Mavian, global director of regulatory advocacy and policy at Dow, said the EPA doesn’t always use company-provided data even when it is submitted. In one case, she said, the EPA assumed workers were exposed to a chemical 8 h a day, every day, even though company data indicated exposures lasted about 20 min once every 2–6 weeks.

Those kinds of differences illustrate a broader philosophical debate about how risk should be evaluated. Industry groups argue that regulators should focus on realistic exposure scenarios rather than modeling theoretical worst-case conditions, which they say is what happens when the EPA doesn’t have appropriate, real-world data from submitters. Mavian said industry “has a role to play to take fear out of the public’s mind,” and should be providing real-world data about how chemicals are used and what protections are in place to mitigate risk.

But obtaining that information is not always simple. Celanese’s Daigle said companies further down the supply chain often hold key information about how chemicals are ultimately used. “TSCA regulates the whole supply chain,” she said. “If everyone isn’t at the table early in the process, you end up with surprises later.”

For lawmakers considering legislative changes to TSCA, those disputes underscore the importance of improving communication between regulators and companies earlier in the review process. Brown said the House committee’s proposal “would force earlier collaboration” to identify information gaps before statutory deadlines begin.

But simply requiring the EPA to procure more information from manufacturers earlier in the process doesn’t do enough to put the onus on industry, according to Wagner. “You’ve got to flip the burdens,” she tells C&EN. “The burden is on EPA at every single turn, in spectacular ways that the public doesn’t fully appreciate. The burden has to be on industry, not on EPA.”

Still, she says, “there’s little hope for TSCA, short of a total reset.”

Considering a ‘total reset’

Nongovernmental organizations (NGOs) such as the Environmental Defense Fund argue that TSCA needs a reset that goes beyond procedural fixes and instead reorients the law toward a more preventive, health-protective framework. In addition to placing greater responsibility on industry to generate safety data, that approach would expand the EPA’s authority to require testing and act on potential risks, and it would ensure that chemicals are demonstrated to be safe—particularly for vulnerable populations—before they enter or as they remain on the market. Advocates also call for greater transparency in chemical data and stronger incentives to develop safer alternatives, instead of the current approach, which allows chemicals to persist in commerce unless there’s clear evidence of harm.

Wagner notes that the 2016 Lautenberg Act was passed with the support of Republicans and Democrats as well as NGOs. But in practice, the amendments didn’t help, Wagner says. They just “added a bunch of words . . . for industry to litigate.” Even after 10 years, she says, “we’re not seeing a lot of concrete regulation that isn’t being litigated.”

The solution Wagner proposes is for the EPA to define the best, safest chemical for a particular use, against which it would benchmark any new chemicals, and industry would have to prove a new chemical can beat those standards. She says that change would drive competition and innovation and provide industry with predictability. She acknowledges it’s not realistic to reset TSCA quickly. But the way the current statute is written, she says, makes it impossible for the EPA to reasonably regulate chemicals in a way that protects the public.

Courts, in the meantime, must sort out how the statute should be interpreted.

Courts are shaping the future of TSCA

While lawmakers debate legislative changes and the EPA makes process changes that “solve for predictability,” according to Troutman, courts are increasingly shaping how TSCA will be implemented. Several EPA risk-management rules already face lawsuits, raising the possibility that judges—not regulators—could ultimately determine how key provisions of the statute are applied.

“The courts are very much the playing field for TSCA right now,” Karyn Schmidt, a principal at the law firm Squire Patton Boggs, said at GlobalChem. And the legal environment has shifted significantly, she added, following the US Supreme Court’s 2024 decision in Loper Bright Enterprises v. Raimondo, which eliminated Chevron deference, meaning courts no longer defer to agency interpretations of ambiguous statutes. That shift could make judicial decisions more influential in shaping how TSCA is applied. “We’re now living in a new world,” Schmidt said.

Some legal observers say court rulings could eventually bring greater clarity to the statute by resolving disputes that have repeatedly surfaced in regulatory proceedings.

Current litigation is raising up to 30 different issues, ranging from substantive interpretations of the statute to procedural details, Wagner notes. These cases include challenges to the EPA’s framework for conditions of use and to its risk evaluation scope in petitions for review of existing chemical determinations; litigation over risk-management rules such as the EPA’s 2024 trichloroethylene prohibition rule, now under consolidated review in the US Court of Appeals for the Third Circuit, where multiple petitions—including labor and industry challenges—have been combined into a single proceeding; and disputes over how the agency defines and supports “unreasonable risk” determinations in cases such as the carbon tetrachloride risk-management rule challenge pending in the US Court of Appeals for the Eighth Circuit.

Both Wagner and Brown have highlighted the prevalence of litigation in the TSCA sphere and its negative impacts on the EPA.

Because “there’s a lot of wiggle room in how EPA interprets certain provisions [of TSCA] . . . EPA has a tendency to do analysis paralysis because they know they are going to get litigated,” Brown said at GlobalChem.

A focus on innovation

As courts weigh in on key legal questions and Congress debates possible statutory changes, the EPA’s Troutman said the agency’s renewed focus on unreasonable risk and “common-sense protections” will help it stop being a “gatekeeper to innovation . . . and allow businesses to thrive.”

At the same time, the agency faces significant pressure to meet court-ordered deadlines for evaluating existing chemicals. “We’re under [a] consent decree for another 10 risk evaluations this year,” Reaves said. “We are laser-focused on meeting that deadline.”

“The problem is not simply meeting a date on the calendar,” Troutman said. “The problem is meeting that date with a scientifically defensible and legally durable record.”

Meanwhile, Congress faces the ever-approaching September deadline to reauthorize TSCA’s user fee program, along with other legislative priorities, and the midterm elections. When you add in the tensions between Republicans and Democrats in Congress, broad changes to TSCA may not be politically feasible in the near term. But there is a general appreciation among all sides that something—even if it’s not clear what—needs to be done.

Regardless of the eventual scope of changes to the law, failing to renew the program’s funding this year could create serious challenges for US chemical regulation, Brown warned. “If we don’t take advantage of this opportunity with reauthorization of fees, it’s going to have a cascading set of challenges that are going to be hard to recover from.”