TSCA Risk Evaluation Approach Foreseeably on House Dems' Agenda

The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments were supposed to fix problems with the decades-old Toxic Substances Control Act. But, two years after enactment, could the U.S. hazardous chemicals regulatory system already be bogging down again in controversies and concerns about ineffective protections?

Chemical manufacturers are lauding EPA’s approach to reviewing the potential risks posed by new chemicals before they are allowed into commerce. But Senator Tom Udall (D-AZ), a key architect of the new law, in October echoed broad environmental community criticisms by calling the Trump administration’s implementation of the statute a “remarkable disaster.”

Assuredly, the new Democratic-majority House will take up this issue because other Democrats share Udall’s and environmental groups’ growing concerns. Critics charge that chemical manufacturers have used a political opening created by anti-regulatory Trump administration officials to drive the agency’s adoption of weak regulatory policies for both new and existing chemicals.

While political considerations are unavoidable in implementing a law, says Richard Denison, the Environmental Defense Fund’s lead senior scientist, EPA’s interpretation has been so one-sided toward industry that the only recourse at present is the courts. In working for passage of the law, EDF had sought a middle ground, joining with industry in agreeing a stronger law was necessary so the public could trust the safety of chemical products.

But that balance “has gone completely to the wayside,” Denison adds, and “confidence in the new system has vanished.” The revised law is strong, but implementation has been “disastrous,” Denison says, expressing extreme disappointment in the way industry has brought its influence to bear at EPA as the agency executes the amendments.

But CEO Cal Dooley of the American Chemistry Council, representing U.S. manufacturers, told an audience last year that the industry is “not deviating in any way” from what it committed to do when working with both Democratic and GOP members of Congress to negotiate support for the law. He characterized the ACC goal as “an intellectually consistent, science-based approach to the implementation of TSCA” and suggested that a “gold standard in scientific risk assessments” being developed at EPA should be expanded to other federal agencies, such as the Food and Drug Administration.

According to EDF and other environmentalists who have sued the agency, a “major point of controversy” centers on how EPA evaluates chemical risks and, in turn, regulates them. Specifically, the amended law requires the agency to examine the “conditions of use” of a substance in deciding whether a chemical’s exposures can be deemed safe. Environmentalists view the law as requiring “conditions” to encompass “the whole life cycle” of “reasonably foreseen” exposure points from manufacturing, processing, use, and disposal.

But under its framework for deciding when a chemical is “unlikely to pose risk,” EPA stated that, when evaluating a new chemical, it would only consider the substance’s “intended” uses, as defined in a company’s non-binding premanufacture notice to the agency before starting product creation. Similarly, for existing chemicals, EPA abandoned a proposed rule issued in the final days of the Obama administration that said TSCA required “all conditions of use” — intended, known, and reasonably foreseen — to be considered in chemical risk evaluations. Instead, the final rule asserts broad EPA discretion in defining the conditions it will consider, excluding, for example, the “legacy conditions” of asbestos used in insulation, fire retardancy, and elsewhere because no active manufacturing is occurring for such uses.

To environmentalists, EPA’s focus on evaluating individual uses in isolation from the collective-use conditions lacks legal and scientific legitimacy. But industry applauds the agency’s approach. In August comments on EPA’s first 10 “problem formulation” documents, ACC calls for more explicit guidance on when conditions of use will be in or out of a risk evaluation’s scope, but commends the agency’s initial clear decision to focus on only those conditions that “represent the greatest potential risk.”

“It’s a lot easier to find a chemical to be safe if you divvy up its exposures into small enough pieces and never put them back together again,” Denison says. But EPA has said that its risk evaluations would exclude all releases to the air, water, and in waste disposal facilities based on the fact that the Clean Water Act, Clean Air Act, and other laws exist. That may be so, but there is a large variation in the extent to which other laws actually regulate their listed chemicals, and TSCA requires the agency to decide after a comprehensive evaluation whether to rely on the other authorities, he adds, deriding the further narrowing of risk evaluations.