The U.S. Environmental Protection Agency said Dec. 4 it has eliminated low-production exemptions for chemicals containing per- and polyfluoroalkyl substances, or PFAS, under the agency’s Toxic Substances Control Act review process.
The new ruling will ensure that new PFAS and persistent, bioaccumulative and toxic (PBT) chemicals with potential for human exposure are always subject to the full safety reviews prior to manufacture, the agency said.
The ruling is similar to an amendment proposed by the Biden administration in 2023.
“Today, we’ve modernized our chemical reviews and continued to protect people from unsafe new PFAS," said Michal Freedhoff, assistant administrator for the Office of Chemical Safety and Pollution Prevention.
Existing regulations allow the EPA to grant safety review exemptions for the manufacturing of chemicals with low production quantities, environmental releases or human exposures. These exemptions allow the chemicals, which historically have included some PFAS, to undergo a shorter review instead of the full review prior to manufacture.
This rule makes new PFAS categorically ineligible for exemptions and makes PBT chemicals ineligible when environmental releases are anticipated or there are potentially unreasonable exposures, the EPA said.
The final rule also makes several other changes to add efficiencies to the new chemicals review process, including clarifying the level of detail needed in new chemical notices and amending the procedures for EPA’s review of notices that have errors or are incomplete.
EPA is changing its longstanding practice of accepting amended notices that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period. Instead, the EPA will now exercise its authority under the regulations to declare the original submission incomplete and restart the review period when the completed submission is received.
The agency said these measures will improve efficiencies. The EPA will also provide “pick-lists” in the application form to help applicants complete their submissions.
The new ruling allows submitters to request suspension of the review process for 30 days via oral or written request if more time is needed.
This rule will go into effect 30 days after publication in the Federal Register.
