TSCA New Chemicals Programme Named a Top Regulatory Burden

Chemical manufacturers say the TSCA new chemicals review programme is one of the biggest regulatory burdens impeding domestic manufacturing, according to recent comments submitted to the Department of Commerce.

The feedback came in response to a request from Secretary of Commerce Wilbur Ross Jr, who asked American manufacturers for input on the "unnecessary burdens manufacturers face from federal permitting and regulatory requirements". This was issued at the direction of President Trump’s 24 January memo on reducing such burdens for domestic manufacturers.

In its response, the American Chemistry Council (ACC) named among the "four most burdensome regulations impacting companies" the TSCA new chemicals review programme, and the backlog for review of pre-manufacture notices (PMNs) that has grown since passage of the Lautenberg Act last year.

3M agreed that the new chemicals programme is among the most onerous, and said the current delays result in a "powerful disincentive to manufacture new chemicals in the US".

It said the EPA could improve this process by "restoring clarity on information requirements and maximising use of modelling and analogue data to minimise the need for animal testing".

The ACC suggested that the agency resume the use of non-5(e) significant new use rules (Snurs) and explore alternatives ways of mitigating identified risks beyond consent orders.

TSCA proposals cause concern

Other industry groups criticised proposals introduced under the recently reformed TSCA.

The American Wood Council, for example, said the EPA’s approach under its proposed TSCA risk evaluation rule to evaluate all foreseeable uses of a chemical in commerce would lead to "overly conservative assessment for uses that have a low exposure potential".

It urged the agency to identify substances with low exposure as low priority for risk evaluation, and to rely on best available science and weight of evidence in its assessments.

Petrochemicals manufacturer Valero raised concerns with the TSCA ‘inventory reset’ proposal and the potential for substances identified as ‘inactive’ to be restricted from import. It called for clarification on enforcement of this issue.

And the Halogenated Solvents Industry Alliance said three proposed TSCA section 6 rules that would ban certain uses of trichloroethylene, Methylene Chloride and N-methylpyrrolidone (NMP) should not be adopted, as "the existing comprehensive regulatory framework adequately protects worker, consumer and public health."

"TSCA was intended as gap-filling legislation. Here there is no gap to fill," it added.

Overlapping regulations, risk assessments

Other groups urged the department to reduce regulatory overlap and "redundant" agency efforts.

The American Composites Manufacturers Association (Acma) questioned the necessity of various chemical hazard and risk assessment activities, including the EPA's Integrated Risk Information System (IRIS), TSCA risk evaluations, the Center for Disease Control’s Agency for Toxic Substances and Disease Registry (CDC/ATSDR) and the National Toxicology Program’s Report on Carcinogens (NTP RoC).

"Many of these redundant programmes could be profitably eliminated and the resource savings invested in improving the quality, reliability and timeliness of a well-managed and properly focused chemical risk assessment programme," it said.

The plastics industry trade group PLASTICS urged collaboration and communication between federal, state and agencies in countries such as Canada to reduce overlap.