EPA introduces rule revising chemical review process

Washington — The Environmental Protection Agency is set to publish a final rule intended to “improve the efficiency” of the agency’s chemical review process and provide better information.

Under the rule, unveiled Dec. 4, EPA will implement amendments that align chemical review process rules with provisions in the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substances Control Act. Among them:

• Require EPA – after receiving a premanufacture, significant new use or microbial activity notice – to “make a determination” on each notice received “before the submitter may commence manufacturing or processing of the chemical substance that is the subject of the notice.”
• Clarify the level of detail expected for the information that a submitter is required to include in a premanufacture notice, significant new use notice or exemption notice for it to be considered complete.
• Require EPA approval of an exemption notice before manufacture may begin.
• Make per- and polyfluoroalkyl substances – also known as “forever chemicals” because they break down slowly over time – ineligible for low-volume exemptions and low-release and exposure exemptions.

“EPA’s review of new chemicals should encourage innovation while also making sure that new chemistries can be used safely before they are allowed to enter commerce,” Michal Freedhoff, assistant administrator of the EPA Office of Chemical Safety and Pollution Prevention, said in a press release. “Today, we’ve modernized our chemical reviews and continued to protect people from unsafe new PFAs.”

EPA issued a proposed rule in May 2023. The rule is slated to go into effect 30 days after publication in the Federal Register.