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October 28, 2022
Lynn L. Bergeson Quoted by Chemical Watch in Article “Scientific standards could take centre stage in future TSCA litigation"

On October 27, 2022, Chemical Watch quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding the U.S. Environmental Protection Agency's (EPA) announcement that it would reissue risk determinations for seven of the first ten existing substances evaluated under TSCA using an updated approach.

The EPA issued "a very consequential memorandum" in June 2021 when it said it would reissue risk determinations for seven of the first ten existing substances evaluated under TSCA using an updated approach, Lynn Bergeson of Bergeson and Campbell said this month at Chemical Watch’s US Regulatory Summit.

Under the change, the EPA applied a "whole chemical" approach to its risk determinations and changed its assumptions on workers’ use of personal protective equipment (PPE), leading it to identify additional applications posing unreasonable risk for some chemicals – like N-methylpyrrolidone (NMP).

The revised approach may run afoul of TSCA provisions that require the agency to issue rules and make decisions in a manner consistent with the best available science and consider reasonably available information, said Ms Bergeson, whose firm represents a group of NMP producers.

In comments on the revised assessment of NMP, Bergeson & Campbell said the EPA violated section 26 of TSCA when it failed to rely on evidence that PPE is routinely worn. This "exaggerates" the EPA’s risk determinations because it dismisses information entities submitted to the agency demonstrating that PPE is being used, she said.

Moreover, several industry groups have said the EPA cannot make so substantial a policy shift without formally revising the risk evaluation ‘framework’ rule undergirding its processes.

"We certainly will" have legal challenges as the EPA finalises its TSCA risk management rules, she said.

On that "fateful day in June", the EPA laid out a new policy and "laid itself open to the assertion that it made a significant policy change without the process needed to do so. That’s where litigation may come in."

[…]

The challenge for industry is that under TSCA it can take years from the time the EPA prioritises a substance for risk evaluation and when it completes a final risk management rule that can be litigated in court. 

You generally cannot bring a legal challenge in the middle of the process, Ms Bergeson said, not until there is a final agency action, like a final rule. 

The US EPA is not expected to finalise its first TSCA risk management rule for chrysotile asbestos until November 2023, with proposed rules for additional chemicals to follow in subsequent years. 

Companies could therefore spend years marketing and asking workers to handle a chemical the EPA has said poses an unreasonable risk before the agency determines a regulatory response, and months more for any ensuing lawsuits to play out.

In the interim, concern over the EPA’s risk findings could have a commercial impact, driving chemicals out of the market and adding a spectre of potential legal action from workers, Ms Bergeson said. 

In response, upstream companies have already started expanding their communication efforts, she said. 

Where there is a sense that the EPA’s risk evaluations did not get something right, "you don’t just submit comments to the record, you work with customers and take time in the product literature to make clear what your product does and does well", she said. "That’s what produce stewardship is all about." 

"If nothing else, all the advocacy and good effort from stakeholders of all stripes has really driven much better supply chain education," she said. 

See - https://chemicalwatch.com/595466/scientific-standards-could-take-centre-stage-in-future-tsca-litigation (subscription required)


 
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