The U.S. Environmental Protection Agency (EPA) finalized amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA) to ensure that new per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative and toxic (PBT) chemicals with potential for human exposure are always subject to the full, robust safety review process prior to manufacture.
Under TSCA, EPA plays an important role by reviewing the potential risks of new chemicals before they can enter U.S. commerce and, when necessary, putting safeguards in place to protect human health and the environment. The rule also improves efficiency and aligns with the 2016 bipartisan TSCA amendments under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and is largely similar to the rule EPA proposed in May 2023.
“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,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “Today, we’ve modernized our chemical reviews and continued to protect people from unsafe new PFAS.”
Eliminate exemptions for PFAS and PBTs with potential for human exposure
The rule ensures that new PFAS are always subject to the full, robust safety review process prior to manufacture by eliminating their eligibility for a low volume exemption (LVE) or low release and exposure exemption (LoREX). Existing regulations allow 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, robust review prior to manufacture.
In April 2021, EPA announced new PFAS would be unlikely to qualify for these exemptions going forward given the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment. As the Agency then explained, it is challenging to complete a review of PFAS exemption submissions in the 30 days the regulations allow. This rule makes new PFAS categorically ineligible for the LVE and LoREX exemptions and makes PBT chemicals ineligible when environmental releases are anticipated or there are potentially unreasonable exposures.
Align federal regulations with existing law
Under TSCA, manufacturers (including importers) and processors must submit premanufacture notices (PMNs) for new chemical substances, significant new use notices (SNUNs) for significant new uses, and microbial commercial activity notices (MCANs) for microorganisms with commercial applications. Prior to the 2016 amendments, EPA only made formal safety determinations on approximately 20% of new chemical submissions. Now, the new law requires EPA to make one of five possible safety determinations on 100% of new chemical submissions before they can enter the market.
This rule amends the regulations by specifying that EPA must make one of the five specified statutory determinations on each PMN, SNUN, and MCAN received before the submitter may commence manufacturing or processing the new chemical substance. The rule also updates the regulations to list the actions required in association with each of those determinations.
These amendments align the regulations with TSCA section 5 requirements to reflect the full extent of new chemicals review, providing consistency and transparency in new chemicals review processes.
Improve the efficiency of EPA’s review of new chemical submissions to foster innovation
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, 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. This will save time and resources that could instead be spent reviewing complete submissions more quickly.
These reforms will also help the industry to provide complete submissions for review through a new set of information “pick-lists” that will be incorporated into the application form located in EPA’s Central Data Exchange in a phased approach. When submitters provide all the necessary information, EPA can assess risk more quickly and accurately. The rule supplements EPA’s TSCA New Chemical Engineering Initiative, an outreach effort launched in 2022 that helps stakeholders understand how to avoid providing incomplete data in their new chemical submissions. The amendments also include a streamlined process for submitters to request suspension of the review process for 30 days via oral or written request if more time is needed.
