As we have been reporting in this blog, regulators are increasing their focus on the latest group of “forever chemicals.” This month, the U.S. Environmental Protection Agency (“EPA”) published a final rule requiring manufacturers of perfluoroalkyl and polyfluoroalkyl substances (“PFAS”) to undertake a massive reporting effort. The rule (40 CFR Part 705) applies to “any entity” that, at any time since 2011, manufactured, produced (including as a byproduct), or imported certain PFAS chemicals for a commercial purpose. Reporting entities must disclose the type of PFAS chemical, volume, uses (by the entity or downstream in the marketplace), byproducts, disposal information, and worker exposure. Any environmental or health effect information in the entity’s possession or control must be reported, even if such information was developed prior to 2011.
The scope of the rule is breathtaking. It covers manufacturers, producers and importers, regardless of size. There is no minimum quantity of reportable PFAS. The amounts in mixtures must be reported, as well as the volume (in pounds) of PFAS-containing articles. The rule applies to PFAS substances or mixtures containing at least one of three chemical substructures…an estimated 1,462 PFAS chemicals. Exemptions are few – they include non-commercial research and development and importers of municipal solid waste. Information that is “known or reasonably ascertainable” must be reported. The rule elaborates on this standard by listing examples and defining the level of due diligence required. EPA has published a Small Entity Compliance Guide as well as reporting and recordkeeping instructions.
EPA estimates that 97% of the firms potentially affected by the rule are small businesses, for a total of 128,051 small PFAS manufacturers and article importers. An EPA Initial Regulatory Flexibility Analysis and Updated Economic Analysis performed on the proposed rule estimated per-firm costs for manufacturers to be $6,553 to $1,800,068 and per-firm costs for article importers to be $4,046 to $224,734. Interestingly, EPA suggests that a small portion of the firms obligated to perform due diligence will ultimately have relevant known or reasonably ascertainable information. Thus, only 13,021 small entities are estimated to report. It is important to note that the rule imposes a “one-time” reporting burden.
The rule is issued pursuant to amendments to the Toxic Substances Control Act (TSCA) section 8(a)(7), which were part of a National Defense Authorization Act passed in 2019. Reportedly, the amendment resulted from Congress’ dissatisfaction with EPA’s slow pace in addressing and preventing PFAS contamination.
Beginning in 2000 in the United States, the only U.S. manufacturer of PFOS—one type of the thousands of PFAS substances—voluntarily agreed to phase it out and find safe substitutes for products, including Scotchgard. Around that time, 3M’s own data showed PFOS was “very persistent in the environment” with “a strong tendency to accumulate in human and animal tissues” and could potentially pose a long-term risk to human health and the environment. TSCA rules since 2002 have required that EPA be notified before certain PFAS could be manufactured, used, or imported. In 2006, the eight major manufacturers voluntarily committed to the PFOA Stewardship Program, by which the PFOA content in emissions and product content was reportedly reduced 95% by 2010 and eliminated by 2015. These efforts have apparently paid off, as concentrations of PFAS (especially PFOS) in human blood have decreased steadily since 2000. But new PFAS continue to be created, and their resistance to heat, oil, stains, and water means there is seemingly no end to their usefulness in consumer and industrial products.
Advances in testing technology have spurred greater attention to PFAS chemicals’ prevalence and persistence in the environment, animal tissue, and human blood serum. Laboratory studies using animals and epidemiological studies of humans show a possible association of some PFAS substances with adverse health effects, including liver damage, decreased fertility, thyroid disease, and cancer. EPA expects data from the rule will support future “activities and programs” under TSCA and other environmental statutes. The disclosures may also provide evidence that the public or regulators could use to claim that entities are liable for injuries, cleanups, or cost recovery.
The deadline for reporting is 18 months from November 13, 2023. Small article importers have an additional six months. Par for the course with other complex environmental regulations, this new PFAS rule will be a full employment act for consultants versed in TSCA reporting. Hopefully, the forthcoming trove of information will expand our understanding of PFAS and how to manage it.
receive news & alerts
Yes! I’d like to receive updates with firm news and insights that are relevant to me!