Lynn L . Bergeson of Bergeson Campbell explains why the Biden administration ’ s new chemicals policies portend major delays to new chemical commercialisation
Just as the industrial chemical community was getting into a predictable , somewhat comfortable groove regarding commercialising new chemicals under the Toxic Substances Control Act ( TSCA ), the US Environmental Protection Agency ( EPA ) decided to blow up the process . With it went any hope for business certainty in this highly volatile regulatory area . While new administrations are entitled to shape policies to align with their agendas , the Biden administration ’ s decision to rescind the new chemicals policies bodes badly for when chemical innovation at the very time new , sustainable chemical innovations are most needed .
The new chemical review was not the subject of fierce criticism leading up to the 2016 amendments to TSCA . Most stakeholders agreed that the old TSCA was deficient in key respects . These included the EPA ’ s seemingly limited ability to regulate existing chemicals under Section 6 ; its blunted authority to compel the production of chemical data under Section 4 ; and the fact that it bore the burden of demonstrating that a chemical posed unreasonable risks , as opposed to a manufacturer proving that it did not . Under Section 5 , the EPA assesses a new chemical based on the information presented in the premanufacture notification ( PMN ). Most experts were not anticipating wholesale revisions to Section 5 when TSCA was amended in 2016 , as the new chemicals programme was relatively popular . The 2016 amendments retain much of Section 5 but make important changes . In particular , the EPA is now required to make one of three determinations and to take required actions . In determining whether a new chemical poses an unreasonable risk , the agency cannot consider costs or other non-risk factors and is explicitly required to consider risks to potentially exposed or susceptible populations and conditions of use . The three alternative determinations under ‘ new TSCA ’ are as follows . First , the new chemical presents an unreasonable risk of injury to health or the environment . If so , the EPA must regulate it under Section 5 ( f ) and issue a significant new use rule ( SNUR ) or explain why not . Second , the EPA can determine that it lacks sufficient information to make a determination , or that the chemical will be produced in sufficient quantities to pose significant human exposure potential . In either case , it is required to issue an order under Section 5 ( e ) and implement a SNUR , or explain why it did not . Thirdly , the EPA can determine that a new chemical is ‘ not likely ’ to