The U.S. Environmental Protection Agency (EPA) has finalized amendments to its regulations for reviewing new chemicals under the Toxic Substances Control Act (TSCA). These changes aim to ensure that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative, and toxic (PBT) chemicals undergo a comprehensive safety review before they are manufactured. The EPA's role under TSCA is to assess potential risks of new chemicals before they enter U.S. commerce and implement necessary safeguards to protect human health and the environment.
Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff stated, "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."
The final rule eliminates exemptions for PFAS with potential human exposure from low volume exemption (LVE) or low release and exposure exemption (LoREX), ensuring these substances are subject to full safety reviews. This action aligns with the Biden-Harris Administration's commitment to addressing "forever chemicals" impacts and advances EPA’s PFAS Strategic Roadmap.
In April 2021, the EPA announced that new PFAS would likely not qualify for these exemptions due to their complex chemistry, potential health effects, longevity, and environmental persistence. The rule now categorically excludes new PFAS from LVE and LoREX exemptions and PBT chemicals when environmental releases or unreasonable exposures are anticipated.
Under TSCA, manufacturers must submit premanufacture notices (PMNs), significant new use notices (SNUNs), or microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Before the 2016 amendments, formal safety determinations were made on about 20% of submissions. Now, EPA must make one of five possible safety determinations on all submissions before market entry.
The rule specifies that EPA must determine each PMN, SNUN, and MCAN received before manufacturing or processing begins. It updates regulations to list actions required with each determination, aligning them with TSCA section 5 requirements for consistency in chemical reviews.
To improve efficiency in reviewing new chemical submissions, the final rule clarifies detail levels needed in notices and amends procedures for handling incomplete submissions. The EPA will now declare original submissions incomplete if errors exist rather than accepting amended notices post-submission. This change aims to save time by focusing on complete submissions initially.
These reforms include a phased approach incorporating information "pick-lists" into application forms via EPA’s Central Data Exchange. This helps industry provide complete data quickly for risk assessment. The rule supports EPA’s TSCA New Chemical Engineering Initiative launched in 2022 to help stakeholders avoid incomplete data submissions.
The rule will take effect 30 days after publication in the Federal Register.
