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November 30, 2023

Lynn L. Bergeson and Richard E. Engler, Ph.D. Quoted in Chemical Watch Article “TSCA risk evaluation for formaldehyde will follow existing procedural rule”

Bergeson & Campbell, P.C.

On December 6, 2023, comments by Lynn L. Bergeson and Richard E. Engler, Ph.D. were featured in Chemical Watch’s article on the U.S. Environmental Protection Agency’s (EPA) plan to conduct its TSCA risk evaluation of formaldehyde following procedures in its existing risk evaluation ‘framework’ rule, rather than those set out in a recent regulatory proposal.

Lynn Bergeson and Richard Engler of law firm Bergeson & Campbell said they were surprised to hear the agency would rely on the existing framework rule for formaldehyde. 

They noted that the proposed rule indicates the EPA plans to apply the new procedures to ongoing TSCA risk evaluations “to the extent practicable”. 

“Therefore, it is unclear why EPA would allow preferential treatment on formaldehyde and not the other 19 chemicals EPA identified as high-priority substances at the same time,” they said. 

The EPA in the past has invoked its authority to reconsider previous decisions, provided they are permitted by law and supported by “reasoned explanation”, and it may well use this same approach in the future, Bergeson and Engler said.

Namely, the agency could “announce the policy changes, make conforming changes in ongoing or final risk evaluations, and then propose changes to the respective regulation”, they said, similar to what the agency did by announcing policy changes in June 2021 and then proposing a rework of the framework rule. 

Moreover, it is possible that the EPA plans to issue a final risk evaluation for formaldehyde before finalising the update to the procedural framework rule, which could justify reliance on the earlier version. 

However, if the agency opts to follow the new, proposed rule after informing industry it would follow the old one, that could establish “a reliance interest that ACC could use as a basis for challenging the final risk management rule on formaldehyde”. 

There is also potential legal vulnerability for chemicals that have already undergone risk evaluation. 

The proposed framework rule states that the requirements “shall not apply retroactively to risk evaluations already finalised”. However, the EPA already has applied many of the proposed provisions to its first ten risk evaluations through its June 2021 policy changes, some of which “conflict with the plain language of the current regulation”, Bergeson and Engler said.

“We believe that this creates a significant legal vulnerability for EPA” for risk management rules that rely on risk evaluations finalised before the new rule takes effect, they said.

See – https://chemicalwatch.com/894510/tsca-risk-evaluation-for-formaldehyde-will-follow-existing-procedural-rule (subscription required)