Washington DC, US – The US Environmental Protection Agency has proposed amendments to the rules by which it reviews new chemicals under the Toxic Substances Control Act (TSCA). Proposed changes include the removal of low volume and exposure exemptions for a number of persistent chemicals. The agency said this will ensure a robust safety review.
“Congress expanded EPA’s authority to protect communities from dangerous chemicals, and it’s well past time to modernise the regulations that govern new chemicals, increase efficiency to foster innovation, and strengthen our commitment to ensuring that new chemicals can be used safely before they are allowed into commerce,” said Michal Freedhoff, assistant administrator for the Office of Chemical Safety and Pollution Prevention.
Under TSCA, manufacturers, importers and processors have to submit pre-manufacture notices for new chemical substances, notices for a significant new use, and microbial commercial activity notices for microorganisms with commercial applications. Currently EPA has to make one of five possible safety determinations on all new chemicals before they can enter the market. The proposed amendments mean that one of these determinations will be required before manufacturing or processing begins.
The proposal would also make changes to make the new chemicals review process more efficient, EPA said. This includes clarifying the level of detail required, and amending procedures for EPA review where notices are incomplete or contain errors. This would allow EPA to declare submissions incomplete and restart the review period, saving resources to spend on reviewing complete submissions more quickly.
“Upon a quick initial review, EPA’s proposal looks to include a codification of approaches the Agency is already taking in its implementation of the New Chemicals Program,” the American Chemistry Council said in a statement. “That said, we plan to review the proposal further and provide detailed comments to the public docket. It is also critical that EPA and the Executive Branch ensure that the TSCA New Chemicals program policies do not negatively affect the supply chain and manufacturer’s ability to bring new and innovative products and materials to market.
“Ultimately, EPA must expeditiously improve the timeliness and predictability for new chemicals reviews, enhance Agency engagement with TSCA submitters and the regulated community, maintain critical exemptions, and provide clear and concise direction on what information is required of new chemical submitters.”
