Key Contacts
TSCA Continues Focus on PFAS, CBI and Risk Evaluation
TSCA PFAS Activities
Over the past year, EPA continued to use its rulemaking authority under the Toxic Substances Control Act (TSCA) to address the manufacture and use of per- and polyfluoroalkyl substances (PFAS). Under TSCA Section 8(a)(7), which was added as part of the National Defense Authorization Act for fiscal year 2020, EPA was required to promulgate a rule by December 31, 2022, requiring each person that has manufactured a PFAS since January 1, 2011 to report certain information to EPA. On June 28, 2021, EPA published a proposed rule that required manufacturers and importers of PFAS in any year since 2011 to report chemical identity, categories of use, volumes manufactured or imported, and other information. Based on initial feedback, in November 2022, EPA announced that the agency would consider revisions to the PFAS reporting rule that would incorporate a number of exemptions analogous to the ones applicable to the TSCA Chemical Data Reporting Rule (CDR).
At the end of September 2023, EPA released a final rule, but rejected most of the previously suggested exemptions. Under the final PFAS reporting rule, any person who has manufactured for commercial purposes certain PFAS substances at any period from January 1, 2011 through December 31, 2022 must report specific information to EPA, including, among other things, chemical identity, use information, manufactured amounts, environmental and health effect data, and worker exposure data. This rulemaking will result in the publication of the largest-ever dataset of PFAS manufactured in the United States. Whether a PFAS substance is subject to reporting is determined using a structural definition that EPA estimates expands the number of PFAS that must be reported to potentially 1,462 substances. “Manufacturers” includes importers of both PFAS chemical substances and articles that contain PFAS. Like the CDR, manufacturers are required to report information “to the extent known or reasonably ascertainable by” the manufacturer, but there is no de minimis threshold or exemption for unintentional impurities or byproducts as there is in the CDR. Accordingly, the final rule imposes some level of diligence that could include inquiries outside the organization to “fill gaps in the submitter’s knowledge.” Persons who have only processed, distributed in commerce, used and/or disposed of PFAS, however, are not subject to the final rule. The deadline for most subject PFAS manufacturers to submit the required information is May 8, 2025 (entities that qualify as “small manufacturers” are granted an extra six months). Accordingly, in 2024 companies potentially subject to the PFAS reporting rule will need to conduct the diligence necessary diligence to evaluate the extent of their reporting obligations under the rule.
In addition, in May 2023 the EPA proposed revisions to its Section 5 new chemicals procedural regulations to ensure that new PFAS go through a full safety review process before entering commerce, which would eliminate eligibility for exemptions that had allowed some substances to go through an abbreviated analysis. This includes proposed amendments to the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs), which include requiring EPA approval of an exemption notice prior to commencement of manufacture, making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for these exemptions. A final rulemaking is expected in April 2024.
Further tightening the review of new chemicals, in June 2023 the EPA announced a new framework for addressing new PFAS and new uses of PFAS. Under Section 5, EPA is typically required to review new chemicals, including new PFAS and new uses of PFAS, within 90 days, assess the potential risks to human health and the environment of the chemical, and make one of five possible risk determinations. The new framework will categorize PFAS uses that have (1) negligible exposures or no releases under use scenarios, (2) have low - but greater than negligible - potential for release and environmental exposure, and (3) PFAS uses expected to lead to exposure and environmental releases. For negligible or no release scenarios, EPA generally expects to allow the PFAS or the new use of a PFAS to enter commerce after receiving basic information, such as physical-chemical property data about the substance. For greater than negligible PFAS potential for release, EPA anticipates that it will generally expect to require test data in addition to physical chemical properties, such as toxicokinetic data, before allowing manufacturing to commence. For more significant exposure and release scenarios, the EPA generally expects that the substance would not be allowed to enter commerce before extensive testing is conducted on physical/chemical properties, toxicity and fate. The Framework applies to new PFAS or new use notices that are currently under EPA review, as well as any that EPA may receive in the future moving forward.
Finally, on January 8, 2024, EPA announced that it had finalized a significant new use rule (SNUR) under section 5(a)(2) that prohibits the manufacture, import or processing of “inactive” PFAS without notice to EPA and a review by the agency of the risks associated with that PFAS under EPA’s framework for new PFAS and new uses of PFAS (referenced above). According to EPA, this SNUR would affect 329 PFAS that have not been manufactured, imported, or processed in the United States since June 21, 2006. In short, anyone wishing to manufacture or process any of the 329 PFAS is now required to seek EPA review of the activity by submitting a Significant New Use Notice to EPA and complying with any applicable requirements resulting from such review.
CBI Claims under TSCA
In June 2023, EPA published a final rule concerning submitting and supporting confidential business information (CBI) claims under TSCA. The final rule attempts to consolidate the TSCA CBI provisions currently found in other TSCA regulations and EPA’s FOIA regulations into a new Part 703. Substantively, the proposed regulations are generally consistent with the guidance and forms the EPA has been using to implement the confidentiality provisions of the 2016 Lautenberg Act amendments to TSCA. In particular, the new rules confirm that CBI claims must be accompanied by substantiation at the time of submission and provides standardized questions that must be answered on items such as the extent and likelihood of competitive harm upon release of the information. Consistent with the standardized approach, the final rule contemplates using the electronic Central Data Exchange (CDX) platform to submit nearly all substantiation information and for EPA to communicate to submitters any follow-up questions, determinations, or notices of pending expiration of CBI claims. Likewise, any conclusion that a CBI claim is deficient will be communicated through CDX and the submitter will have ten days to correct the deficiency. Notably, EPA declined to include a proposed reconsideration process for denied CBI claims. Instead, the final rule keeps in place an existing process whereby submitters are welcome to contact EPA with any concerns before filing a judicial appeal.
The final TSCA CBI rule may not be the final word on this issue, however, as both environmental and industry groups have challenged the rule before the DC Circuit, with the environmental groups arguing that the rule unlawfully allows EPA to withhold information as CBI, while the industry groups argue that the rule does not do enough to protect CBI from disclosure.
TSCA Risk Evaluations—TCE in the Spotlight
Finally, in 2023, EPA continued to conduct risk re-evaluations, using a “whole chemical approach,” for the “first ten” high priority substances previously evaluated during the Trump Administration. Most notably, in October 2023, EPA proposed a rule that would ban the manufacture, import, processing and distribution in commerce of trichloroethylene (TCE) for all uses, and prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works. While not unexpected, the decision to ban TCE is not without controversy, and litigation will likely follow adoption of any final rule in 2024. Along these lines, in 2024 EPA is expected to propose rules that would ban the use of methylene chloride, phase out the use of perchloroethylene (PCE), and restrict the use of carbon tetrachloride and asbestos.
EPA has also announced that it is initiating the risk prioritization process for five chemical substances, acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and 4,4’-Methlynebis (2-chloronailine) (MBOCA), to determine whether they should be designated as “High Priority Substances” for risk evaluation under TSCA Section 6(b). In addition, EPA indicated that it plans to issue a proposed rule that would require manufacturers and importers to submit to EPA certain unpublished health and safety studies. The agency is currently planning for a final rule to be issued in September 2024.
