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Toxic Substances Law Creating More Confusion for Legal Teams and Public

Feb. 15, 2023
Chemical producers face new challenges after the Environmental Protection Agency (EPA) changes the risk evaluation process for toxic substances.

Co-authored by L. Claire Hansen*

Chemicals are the foundational origin of just about everything we enjoy and possibly cannot live without. The Toxic Substances Control Act (TSCA) is a federal law that authorizes the Environmental Protection Agency (EPA) to regulate industrial chemical substances. This 46-year-old law significantly changed in 2016 under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). Lautenberg’s passage marked the do-over of a deeply flawed law that many stakeholders believed did not ensure chemical safety. However, the past six years are no cause for celebration; the three different administrations to occupy the White House since then have made a mess of TSCA implementation.

This article focuses on one of many abrupt, and in some views, unlawful, EPA policy shifts frustrating lawyers and confusing the public. The EPA moved in 2021 from a “conditions of use” approach to evaluating chemical risk to a “whole chemical” approach. This seemingly modest change is a key reason why lawyers advising chemical stakeholders are struggling and why there may be a lot of TSCA litigation in the EPA’s future.


Lautenberg mandates the EPA to evaluate risks posed by existing chemicals. Under TSCA, the EPA “shall … assess available information on hazards and exposures for the conditions of use of the chemical substance[s] ….” The agency’s risk evaluation final rule states “EPA will determine whether the chemical substance presents an unreasonable risk of injury … under each condition of uses [sic] within the scope of the risk evaluation.”

The agency issued final risk evaluations through 2020 for the first 10 chemical substances reviewed. The EPA determined which conditions of use posed unreasonable risks and which uses posed “no unreasonable risk.” After a risk evaluation, the uses of a chemical would have both unreasonable and no unreasonable risk determinations. But on June 30, 2021, the EPA shifted course and decided to issue a single risk determination for chemicals undergoing evaluation under a “whole chemical” approach.

The EPA’s policy pivots have made advocacy efforts immeasurably more challenging.

The EPA issued a revised draft and final risk determinations for the original ten chemicals reviewed using the new approach. The agency rescinded all “no unreasonable risk” orders, finding each chemical, as a “whole chemical substance,” presents unreasonable risk of injury when evaluated under their conditions of use.


Why does this matter? If the EPA determines a chemical undergoing risk evaluation poses an “unreasonable risk,” the agency must, under TSCA, mitigate that risk. The EPA is authorized to impose, through rulemaking, risk-mitigation measures, including, among others, banning a chemical, requiring labeling or the use of personal protective clothing and equipment, and/or imposing discharge limitations.

The EPA determining a chemical poses an unreasonable risk of injury in a certain condition of use, or now as a “whole chemical,” makes it imperative that chemical producers or users consider carefully the legal, regulatory, commercial and optical implications of this determination. If you are a chemical producer, your employees and neighbors might well be alarmed by news that the chemical to which they are exposed poses “unreasonable risks.” Consumer product companies are especially concerned, as consumers can be expected to present a range of legal and commercial challenges, including enhanced tort liability, breach of contract claims and product-sourcing uncertainty as some chemical producers will exit the market. The optics of these unreasonable risk determinations are especially difficult to manage.

Issues on which the EPA is legally vulnerable include violation of TSCA science standards. The agency must consider “best available science” based on the “weight of evidence,” standards the whole chemical approach violates. The EPA cannot lawfully “reevaluate” risk determinations and change them without violating the Administrative Procedure Act’s notice and comment rulemaking requirements, amending the risk evaluation rule, and modifying the underlying administrative record. Even though TSCA is a risk-based statute, many industrial chemical stakeholders believe the whole-chemical approach would make TSCA a hazard-based law, which is a violation of TSCA.

The EPA’s policy pivots have made advocacy efforts immeasurably more challenging. TSCA disallows judicial review of risk determinations. Stakeholders must therefore wait to appeal final risk management standards, issued years after the risk findings. That is a long time to straddle the inferences that flow from the almost inevitable finding of “unreasonable risk” of injury the whole chemical approach elicits.

*L. CLAIRE HANSEN is a legal intern at Bergeson & Campbell, P.C.

About the Author

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.

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