US EPA pilots new pre-manufacture notice guidelines

12 September 2017 / New TSCA/LCSA, Substance notification & inventories, United States

The US EPA is conducting a small pilot study, aimed at developing guidance to support the pre-manufacture notice (PMN) process. This has been dogged by problems since its revamp under new TSCA – also known as the Frank R Lautenberg Chemical Safety for the 21st Century Act (LCSA).

Initially the process slowed down, as the agency applied greater scrutiny to check the safety of chemicals and their uses covered in PMN submissions. This led to a huge backlog of chemicals waiting to enter the market.

In August, the agency announced it had processed many of these submissions. However, companies continue to be concerned by reported inconsistencies and a lack of clarity in some of the EPA’s findings. Specifically, they report that the agency is requesting additional testing or risk management measures without providing clear justification.

One industry source said: "We need to know in detail what information is required by EPA for the agency to do an effective evaluation. Hopefully, it will provide some clarifying guidance soon."

Industry groups, such as the American Chemistry Council and the Society of Chemical Manufacturers and Affiliates, are supportive of EPA's promise of additional guidance.

"Socma is hopeful that any EPA guidance on PMNs will clarify that the agency will have an improved, more focused view on the uses of chemicals," said Robert F Helminiak, managing director of government relations.

Collaborations

In December last year, the ACC created the Center for Chemical Safety Act Implementation to serve as a scientific, technical and advocacy hub to help both members and non-members implement new TSCA. It says this collaboration can also help inform EPA decisions on chemical risk evaluations and risk management options.

And, the law firm Bergeson & Campbell has formed the TSCA New Chemicals Coalition which is intended to give the chemical community greater opportunity to engage with EPA on constructive improvements to the new chemical review process.

"About 50 companies so far have expressed interest in joining the coalition," said the firm's managing partner Lynn Bergeson. "One of the key objectives is to work with EPA's Office of Pollution Prevention and Toxics (OPPT) to ensure it has as much information as possible to make informed decisions."

NGO concern

Meanwhile, Richard Denison of the Environmental Defense Fund (EDF)says: "I think it is a good thing for EPA to issue more specific guidance to companies so that they understand what information will be needed by the agency to conduct its reviews of new chemicals. Our concern is with other aspects of EPA's announced changes to [these]."

These include the agency's apparent intent to promulgate so-called significant new use rules to require notification of reasonable uses, which Dr Denison says is squarely at odds with what the law requires. He adds that it also appears to be seeking to recreate the 'infamous Catch-22' of old TSCA, under which it could only require testing where it already had evidence of risk.

He also describes the agency’s tendency only to share information on the anticipated changes with new chemical submitters as "highly disturbing, and further undercuts public confidence in EPA's implementation of the reformed law".

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