January 25, 2022

Isn’t It Ironic?

Posted on January 25, 2022 by Lynn L. Bergeson

The Biden Administration’s U.S. Environmental Protection Agency (EPA) is laser focused on achieving several “whole-of-government” priorities: addressing climate change, identifying and giving environmental justice greater consideration in decision-making, and following the science wherever it may lead. Knowing and respecting leadership in the Office of Chemical Safety and Pollution Prevention (OCSPP) tasked with achieving these laudable yet daunting objectives, there is no question the commitment is genuine. It is ironic, however, that EPA is applying the Toxic Substances Control Act (TSCA) in ways that are counterproductive to achieving these goals.

Since enactment in 2016 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to TSCA, there has been a disturbing decline in the commercialization of new chemical substances. Each year, fewer Section 5 notified substances are entering into commerce. This is not good news for product manufacturers desperately seeking new chemicals to make their products better, greener, and more sustainable.

Because Lautenberg fundamentally changed the new chemical review process, some disequilibrium was expected. TSCA now requires, for example, an EPA finding during the chemical review process regarding whether a new chemical substance is expected to pose an unreasonable risk. If so, EPA must propose regulations to control those risks. The requirement to make an affirmative determination during the review period has resulted in more new chemicals being regulated. Unsurprisingly, chemical innovators may be reluctant to devote the considerable resources necessary to market a new chemical knowing that it will likely be the subject of a Consent Order and eventually a Significant New Use Rule (SNUR), both of which tend to diminish market appeal. But five years in, disequilibrium has morphed into stagnation, all to the detriment of achieving the Administration’s priorities.

The real deterrent to new chemical innovation is not the law; it is how EPA is applying it. Specific examples will not do justice to the complexities of new chemistries, but they may illustrate some of the ironies OCSPP’s policies create.

Consider, for example, the irrelevance of a comparative risk inquiry in the new chemical review process. That a new chemical is considerably less risky than an existing chemical it is designed to replace is not factored into the current review process. Under old TSCA, “pollution prevention” attributes were at least “optional” disclosures officially solicited in the notification form. This anomalous situation brings renewed relevance to the “new chemical bias” baked into the TSCA program where new chemicals are held to a very different standard than the thousands of existing chemicals that have not yet undergone prioritization for review.

As a result, new chemicals face regulatory burdens that existing chemicals will not face for a very, very long time as EPA works through the over 40,000 existing chemicals at the pace of a few chemicals a year. This bias makes new chemical commercialization immensely more difficult, and the possibility of competing with existing chemicals virtually impossible. But this is not the core problem. The problem is that EPA interprets unreasonable risk in a contextual vacuum since comparative risk is not an element in the approval process.

Consider, too, EPA’s interpretation of “reasonably foreseen”. If a condition of use is “reasonably foreseen”, TSCA requires EPA to regulate it to prevent the risk, the unreasonable risk, or possible unreasonable risk derivative of the “reasonably” foreseen use. Key to the analysis is the “reasonable” foreseeability of that use.

Since 2016, the range of circumstances that EPA has deemed “reasonably foreseen” has taken on an Alice in Wonderland quality of incredulity. EPA’s only stated exclusion, as articulated in the first footnote to a 2019 SNUR, is that “[r]easonably foreseen conditions of use will not be based on hypotheticals or conjecture”. New chemical submitters are quick to remind EPA that the “merely hypothetical”, a standard defined purely by the limits of one’s imagination, is not “reasonably” foreseen, but to no avail. The unbounded limits of foreseeability pave the way for manufacturing and use restrictions that overregulate otherwise promising new technologies and chill innovation. EPA’s current approach is that if a substance is not low hazard (a classification defined by explicit criteria), “somebody might” someday exceed a hazard threshold, leading to risk, necessitating a regulation that prohibits the hypothetical scenario. But that is not a risk-based standard, as required by the law. It is a hazard-based standard explicitly rejected by Congress in amending TSCA.

Restoring “reasonableness” to the process would go a long way toward rightsizing EPA’s policies. Elevating the comparative risk of chemicals in the new chemical review process is consistent with the law and would minimize the insidious effects of the new chemical bias. Climate change mitigation and environmental justice are not going to happen because supporters wish them into existence. We need new chemistries, new chemical products, and new TSCA policies to support new chemical commercialization.