Halt on TSCA ‘non 5(e) Snurs’ raises industry concerns

Consent orders causing delays, stifling innovation, say stakeholders

The US EPA’s apparent policy to stop using ‘non-5(e) Snurs’ under the new TSCA is delaying products from coming to market and stifling innovation of safer alternatives, according to some chemical manufacturers and industry consultants.

At the American Chemistry Council’s (ACC) recent GlobalChem conference in Washington, DC, concerns were raised over growing pains in the EPA’s new chemicals programme since passage of the Lautenberg Act.

Several industry representatives pointed to the agency’s altered approach on consent orders and significant new use rules (Snurs) as a source of this anxiety.

Under the reformed TSCA, the new chemicals review process has slowed, and the percentage of substances subject to consent orders has risen sharply. And with these changes, it appears that the EPA has also discontinued its use of so-called non-5(e) Snurs to manage potentially concerning uses outside of those enumerated in a pre-manufacture notice (PMN).

Speaking at an SME session during GlobalChem, attorney Jamie Conrad said that "the EPA is saying unofficially that they can’t do [non-5(e) Snurs] anymore because of the new law."

"I have yet to figure out what provision of the new law prevents them from doing it, and they haven't ever said that officially so that we can have a conversation," he added.

The EPA did not respond to a Chemical Watch request for comment by publishing time. But the agency's website indicates that "a small subset of PMNs that previously would have been 'dropped' from review and for which a non-section 5(e) Snur would have been issued ... will now be subject to [5(e)] orders."

'Life has changed'

Speaking at the event, Marcia Levinson, regulatory affairs specialist at chemicals firm Covestro, said that “life has changed for industry” as far as new chemicals are concerned.

The advent of the EPA no longer using non-5(e) Snurs means that now new substance manufacturers must frequently enter into a consent order for "something that they did not even foresee in their PMN application", she said.

And while the order is being written, the manufacturer must wait beyond the 90-day PMN review period before their new substance can go to market – a process she says takes a minimum of 60 days. The resulting consent order may also contain testing requirements for foreseeable uses.

"This definitely has an impact on our innovative spirit," she said.

Further, she said that it is more challenging to sell a regulated product than a non-regulated one.

"The perception is that a regulated chemical is much more hazardous than a non-regulated chemical," said Ms Levison. "Therefore we've got a discrepancy in terms of the perception of the impact of this regulation."

Even if companies are able to work with customers to explain that this is simply the new way of doing business, there is still the added burden of managing a regulated chemical, such as recordkeeping requirements, export notifications, lower chemical data reporting (CDR) rule reporting thresholds, or changes to existing hazcom practices.

For these reasons, she said, "it's hard to get customers to go toward these new chemicals."

Lisa Marie Nespoli, also of Covestro, agreed: "We're creating safer models that are more sustainable, and nobody wants to buy them because they have the recordkeeping [requirements]."

"That is our biggest concern for our innovation pipeline – we are creating things that are better, this is what everybody wants – but yet we can't get them through, and I don't know how we fix that."

Changes to consent orders, Snurs under new TSCA