TSCA Insider

TSCA Insider

EPA’s ‘Whole Chemical’ TSCA Approach Faces Mounting Legal Warnings

January 19, 2022

Industry attorneys and former EPA officials are ramping up their attacks on the Biden administration’s adoption of a “whole chemical” approach to TSCA risk findings, as critics have not only renewed arguments that current regulations require use-specific determinations but warned that the new model could all but nullify the law’s preemption provisions.

EPA has floated just a single draft risk determination using the whole-chemical model, as part of its revisions to the Trump-era Toxic Substances Control Act (TSCA) evaluation of a flame retardant cluster known as HBCD. But officials have repeatedly vowed to make that approach the norm for future risk evaluations, spurring push-back from industry and Trump administration veterans.

Those critics have variously charged that dropping the previous practice of making use-by-use risk determinations contradicts TSCA’s intent, violates a Trump-era “framework” rule governing chemical evaluations, and could even undercut preemption of state-level policies that was one of industry’s most prized victories in negotiations that produced an overhauled toxics law in 2016.

And some attorneys say EPA could face legal challenges over the whole-chemical determinations within months, when it is expected to finalize the HBCD revisions -- though others expect litigation to wait until EPA crafts rules based on the risk findings.

But in either case, the agency’s new practice is almost certain to be tested in court, where former officials say it could face an uphill battle. In particular, challengers could rely on a 2019 Supreme Court decision that narrowed judicial deference to regulators’ interpretations of ambiguous rules, which could be key to arguments over whether the framework policy allows whole-chemical determinations.

In the meantime, industry sources fear the new approach will prevent them from invoking TSCA’s preemption provisions, which rely on findings that specific uses pose no unreasonable risk, and discourage companies from voluntarily seeking evaluations of their chemicals -- two key features of the revised law.

Industry Attorneys Say ‘Whole Chemical’ Policy Nullifies TSCA Preemption
Industry attorneys are warning that EPA’s “whole chemical” approach to TSCA risk determinations will effectively negate the law’s preemption of state limits on chemical uses the agency finds to be safe, as the Biden administration’s first proposed use of its new model avoids the “no unreasonable risk” orders needed to trigger preemption.

David Fischer, who served as deputy chemicals chief during the Trump administration and is now counsel with the law firm Keller and Heckman, argued during the firm’s Jan. 12 webinar that EPA’s new TSCA policy appears to exclude any final action that could be the basis for preemption -- either an order that particular chemical uses do not pose unreasonable risks or later risk-management rules that would incorporate such findings.

“At the end of the day, if the whole-chemical risk determination approach continues to move the way this administration would like, the orders are gone, preemption based on those orders is also gone and risk management will only be for unreasonable risk as it applies to the whole chemical,” Fischer said.

Moreover, he and Keller and Heckman partner Herb Estreicher argued that cutting off preemption would also slow or halt requests by companies for EPA to evaluate chemicals they make or use, since there would be no hope for those reviews to focus on specific uses to preempt state regulations. That would deprive the TSCA program of an important revenue stream, they said, since industry must pay the full cost of those “manufacturer-requested” evaluations.

Others are focused on the risk-management rules EPA will eventually craft based on its evaluations, which they say must be narrowly tailored to uses that genuinely carry unreasonable risk in order to survive judicial review.

EPA Faces Pressure To Avoid ‘Whole Chemical’ Model In TSCA Rules
A former Trump EPA official is urging industry to ensure EPA does not use its “whole chemical” approach to risk determinations to justify overly broad TSCA regulations, noting the agency appears to have quietly dropped from its agenda plans for a “framework” rule on writing those risk management rules for individual chemicals.

Erik Baptist, who served as deputy chemicals chief during the Trump administration and is now a partner with the law firm Wiley Rein, urged listeners on a Jan. 11 webinar to stay in contact with EPA throughout the TSCA evaluation and regulation processes and oppose any “misunderstanding” on the statutory limits for those rules.

“You’ll want to see what they propose in the rules and make sure they are abiding by the statute,” he said.

Baptist continued that the Biden EPA’s “whole chemical” risk findings -- under which the agency will identify “unreasonable risks” posed by overall uses of an existing chemical rather than making separate determinations for each condition of use that it evaluates -- opens the possibility for TSCA rules to regulate even those uses that would not warrant an “unreasonable risk” label on their own.

But court challenges to the whole-chemical model could begin even before EPA issues its rules; in a recent webinar Keller and Heckman partner Eric Gotting said the agency is likely to face lawsuits as soon as it finalizes risk findings based on the new approach, and argued that a 2019 Supreme Court decision undercuts the Biden administration’s early legal defenses of its model.

Industry Attorneys See Legal Weakness In TSCA ‘Whole Chemical’ Policy
Industry attorneys say EPA’s “whole chemical” approach to TSCA risk determinations -- and officials’ decision to make the change without a notice-and-comment rulemaking -- is on shaky legal ground due in part to a 2019 Supreme Court decision narrowing deference to agencies’ interpretations of their own rules and could soon face multiple court challenges.

During a Jan. 12 webinar hosted by the law firm Keller and Heckman, firm partner Eric Gotting renewed the mounting industry criticism of EPA’s “whole chemical” approach to TSCA chemical risk findings, under which the agency will identify “unreasonable risks” posed by overall uses of an existing chemical rather than making separate risk determinations for each condition of use that it evaluates.

Gotting in his presentation argued that the agency’s switch violates the Trump-era “framework” rule for TSCA existing-chemical evaluation and the policy can only move forward if EPA first rewrites that rule -- a position several other industry attorneys and former Trump administration officials have taken.

“TSCA itself requires the risk evaluation process to be established through notice-and-comment rulemaking and the Administrative Procedure Act [APA] requires that any time a regulation is changed, the agency has to go through another round of notice and comment,” he said.

Nonetheless, EPA is moving forward with its revisions to the Trump-era evaluations and the next round of 20 reviews, including development of a new systematic review method that will guide staffers’ selections of published research to inform their conclusions.

EPA Names Candidates For SACC Systematic Review Panel
EPA has chosen 26 potential members for a Science Advisory Committee on Chemicals (SACC) panel that will peer-review the TSCA office’s new draft approach to systematic review and is seeking input on the potential selections by Jan. 28, ahead of the body’s planned April 19-21 meeting.

“Comments on the potential candidates will be used to assist the agency in selecting approximately six to eight ad hoc reviewers, depending on a balance of experience, to assist the SACC with their review,” reads EPA’s Jan. 13 release announcing the comment period.

The agency also released brief biographies of all 26 candidates, who include industry figures, consultants, academics and current and former government scientists -- with many of those hailing from the National Toxicology Program.

Once selected, the ad hoc members will join the 17-member SACC to scrutinize EPA’s Dec. 20 draft of the TSCA office’s approach to systematic review -- the process by which staff find and select studies of a chemical for inclusion in a risk evaluation and evaluate their findings.


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