EPA’s New Chemicals Program Eyed as Effort Builds to Change Law

The primary US law overseeing commercial chemicals is at a pivotal moment as lawmakers weigh potential changes and a federal court examines key regulations recently issued under the statute.

Congress’ probe into the 2016 Toxic Substances Control Act (TSCA) amendments began with a hearing last month by the House Energy and Commerce Environment subcommittee. The panel plans more sessions on the law, according to a Republican committee spokesman.

The law’s mandated review by 2026 of fees the Environmental Protection Agency charges chemical manufacturers offers a chance to see if technical corrections would help better achieve TSCA’s goals, said former congressional staffers who negotiated the 2016 update. Changes could also address complaints about EPA’s implementation of TSCA for new chemicals.

The EPA’s “broken” new chemicals program must be fixed, because US producers are suffering from delayed decisions about whether they can make or import new chemicals, said Chris Jahn, president and CEO of the American Chemistry Council (ACC), which represents producers.

But efforts to revise the statute aim to return to the past when EPA wasn’t required to ensure the safety of new chemicals before they could be made and get into people and the environment, said Maria Doa, who directed EPA’s chemical control division before and after Congress overhauled TSCA.

As lawmakers proceed, the US Court of Appeals for the Ninth Circuit is considering challenges to a 2024 EPA rule revising procedures to decide whether new chemicals that have never been made in or imported into the US can be.

Court reviews of chemical regulations come after the Supreme Court’s Loper Bright ruling ended deference to federal agencies’ interpretations of laws. Judges are likely to examine Congress’ reasons for amending TSCA and note issues lawmakers didn’t emphasize, said Dimitrios Karakitsos, who served as Republican senior counsel for the Senate Environment and Public Works Committee when lawmakers negotiated amended TSCA.

Concerns over the safety of “existing chemicals,” which have been made and used for decades without EPA’s review, and balancing states’ rights to regulate chemicals to protect their residents with the needs of interstate commerce were among the top reasons Congress revised TSCA—not new chemicals, he said.

Congressional Intent

Congress changed the new chemicals requirements to ensure the EPA reviewed their safety promptly, said Karakitsos and Michal Freedhoff, who represented Sen. Edward Markey (D-Mass.) during amended TSCA negotiations.

Yet, “new chemicals is the prime example of where Congress did not get what it intended,” nor what EPA officials offering technical assistance said the revisions would achieve, said Karakitsos, now a partner with Holland & Knight LLP.

Changes to new chemical provisions were intended to prevent backsliding, telling future administrations the “EPA can’t just do nothing,” he said.

Under the original law, if EPA staff did nothing for the 90 days the law allowed for new chemical application reviews, the company could automatically make or import it.

The EPA could negotiate controls if it had information showing a chemical might be risky, said Doa, now senior director of chemicals policy at the Environmental Defense Fund. But if the agency didn’t have sufficient information, 90 days could pass, the applicant could produce the chemical, and other companies could make or import it for uses the agency hadn’t considered or controlled for, she said.

Amended TSCA requires the EPA to make any of several decisions about a new chemical’s risks; reaffirms the 90-day review deadline while letting production begin sooner if excessive risks are unlikely; and directs the agency to refund manufacturers’ fees if the review isn’t finished in 90 days.

Commercial Impacts

The EPA hasn’t issued any refunds for delayed reviews since 2016, the agency said by email. Companies often voluntarily “stop the clock” to get information or revise their applications to secure approval.

The result: an EPA decision for a new chemical for electric vehicle batteries has been pending for almost five years, Jahn told lawmakers last month.

Another one for semiconductors is among nearly 60% of 431 chemicals under EPA’s review for a year or more, he said in a mid-February interview.

These delays affect manufacturers that want new chemicals to give televisions, automotive touch screens, and medical equipment new capabilities, said Lawrence Culleen, an Arnold & Porter Kaye Scholer LLP partner who counsels companies manufacturing goods.

Interactions between chemicals and electricity can produce more vivid colors, enhance finger computer connections, or help diagnose a patient, he said.

Without the EPA’s approval, new chemicals can’t be made or imported, so manufacturers purchase finished products produced overseas, Jahn said. “This is the opposite approach of what we should be doing.”

“We could see improvements—in relatively short order—to the TSCA new chemicals review process,” if the administration and congressional leaders fixed TSCA, Jahn said.

EPA Administrator Lee Zeldin is committed to streamlining regulatory and permitting processes across the agency, an agency spokesperson said by email. That includes robust chemical reviews to unleash innovation and growth while protecting human health and the environment, the agency said.

Money, Staff

Beginning with the first Trump administration, the EPA launched successful initiatives to speed reviews of new chemicals certain industry sectors need, said Freedhoff, the EPA’s top chemical and pesticide appointee during the Biden administration.

The 2024 rule ensures safeguards are in place for chemicals, including PFAS, when still needed in commerce, she said.

The EPA could speed reviews by telling applicants early on what information it needs to make a decision, said Kimberly Wise White, ACC’s vice president for regulatory and scientific affairs.

Or the agency could decide based on the information the company initially provides, Doa said.

Discussions about statutory change must include resources, because the lack of funding and staff has plagued the agency’s efforts to implement amended TSCA, Freedhoff said.

“Sufficient technical and subject matter expertise and staff will be important to EPA’s ability to meet is statutory requirements,” Jahn said.

EPA and other administrative policies, Congress, and courts all have a role to play as discussions about possible TSCA changes proceed, Karakitsos said.