A range of industry and nonprofit attorneys have warned that companies are not sufficiently engaged on TSCA issues to appropriately respond to, and comply with, a coming wave of section 6(a) risk management rules.
The compliance confusion and alarm seen with 2021 TSCA rules restricting the flame retardants PIP (3:1) and decaBDE could only grow as the EPA regulates widely used solvents like trichloroethylene (TCE), perchloroethylene (Perc) and n-methylpyrrolidone (NMP), according to TSCA practitioners. And with the EPA indicating it does not plan to extend the 60-day comment period for its methylene chloride proposal, industry groups must be prepared to quickly review and respond to looming complex rules.
"Everyone is affected by TSCA in most industries, and it's something that's not on a lot of companies' radars or even trade associations' radars, and it should be", Mark Duvall, a principal with Beveridge & Diamond, told Chemical Watch.
Up until Congress amended the law in 2016, TSCA "pretty much only affected the chemical industry", Duvall said.
But that has changed, with the EPA now in the early stages of adopting rules for its first tranche of ten priority chemicals. If the early proposals are any indication, the finalised rules would impose requirements impacting global supply chains for several high-production volume chemicals with hundreds of unique applications.
And as the TSCA landscape has changed, many worry that industry has not kept a close enough eye on developments.
"There's a big problem here, which is that the people subject to these requirements are asleep at the switch," said Bob Sussman, a former EPA official who serves as an attorney to environmental NGOs.
"They are not following the development of EPA regulations, they're not identifying the potential relevance of regulations to their operations until after they have been promulgated, and then they wake up and say 'gee, the sky is falling, help me!’" he said. "I don't think that's the way this process should work."
Time to act
Release of the methylene chloride proposal in May shone new light on the importance of early industry engagement, with the EPA proposing to prohibit several workplace applications due to an absence of information demonstrating the feasibility of complying with a strict existing chemical exposure limit (ECEL).
The American Chemistry Council (ACC) was quick to decry the agency’s move, arguing that the EPA never indicated that companies would need to submit proof of their ability to meet workplace requirements to avoid a ban.
"We are concerned that value chain segments will not understand the potential effect of this proposal and will not be prepared to submit the suggested information within the comment period," the ACC said. "This is setting up another ‘PIP 3:1’ crisis, as businesses do not have enough notice, or understanding of potential impacts, to be able to respond".
Industry attorneys said those with other substances in the queue for risk management rulemaking can learn from the EPA’s approach thus far and plan ahead.
"The methylene chloride [proposal] should be a wake-up call to companies dealing with the other substances where EPA has already indicated what the ECEL will be in the risk management rule," said David Fischer and Herb Estreicher, attorneys at law firm Keller and Heckman.
"It is time for these companies to assemble and get the evidence in to EPA that they can meet the ECEL", they said, noting that TSCA 6(g) exemptions "may prove to be a temporary alternative in certain cases".
'Serious mistake to assume you won't be shut down’
Above all, industry should not expect the EPA to offer the type of enforcement relief it extended to the electronics and nuclear energy industries after the sectors realised their inability to comply with restriction on PIP (3:1) and decaBDE, TSCA practitioners said.
"I think it would be a serious mistake to assume you won't be shut down", Duvall said. Each time the agency has experienced these scenarios with pushback from industry, "it has expressed unhappiness with the lack of participation ... and warnings that companies have to be taking responsible action", he said.
Sussman acknowledged that the agency needs to tread carefully when it decides how to handle a compliance issue that could trigger widespread supply chain disruptions, but said the EPA needs to be clear "there's no free lunch here".
"Maybe it needs to impose very heavy fines on people who belatedly determined that they're not in compliance, but it's got to do something to send a message to everybody out there that they need to be following the development of the EPA regulations and how it applies to them," he said.
As we enter "this new phase of TSCA", Sussman said, the EPA needs to figure out how it can have "a credible threat of enforcement under the TSCA programme which, frankly, has not been an enforcement priority for the last several years. That has to change."