EPA proposes revisions to chemical review process

Washington — The Environmental Protection Agency is seeking to “improve the efficiency” of its chemical review process.

Under a proposed rule unveiled May 16, EPA would institute 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 and went into effect in June 2016. They include:

• Requiring EPA, after receiving a premanufacture, significant new use or microbial commercial 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.”
• Clarifying 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 the notice to be considered complete.
• Requiring EPA approval of an exemption notice before manufacture may begin.
• Making 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.

“Congress expanded EPA’s authority to protect communities from dangerous chemicals, and it’s well past time to modernize 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,” Michal Freedhoff, assistant administrator of the EPA Office of Chemical Safety Pollution Prevention, said in a press release.

In a statement, the American Chemistry Council said that although an initial review of the proposed rule appeared agreeable to the organization, ACC plans to further evaluate the proposal before providing public comment.

“Ultimately, EPA must expeditiously improve the timelines and predictability for new chemical 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.”

At press time, the proposal hadn’t yet been published in the Federal Register. EPA will accept comments until 60 days after publication.