Three notable settlements from June 2023 highlight the immense scale of liability for primary manufacturers of per- and polyfluoroalkyl substances (PFAS).
From a stream of legal challenges, to ever-expanding regulations on things like cosmetics and drinking water, PFAS are the “forever chemicals” keeping companies and consumers on high alert. While industries scramble to remove the synthetic compounds from products, scientists are researching new techniques for scrubbing PFAS from the environment. There is money to be had for those who can find a more streamlined method of purging the substances—the U.S. Army Corps of Engineers has an $800 million contract on the table for the handling, destruction and replacement of PFAS-laden fire-fighting foam—leaving technology companies racing to create solutions. The three main PFAS cleaning techniques currently relied upon can be very effective but are also costly and may leave questionable byproducts in their wake.
On April 13, 2023, the Environmental Protection Agency (EPA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) requesting input on seven potential future hazardous substance designations of per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). (See Addressing PFAS in the Environment, 88 Fed. Reg. 22399, Apr. 13, 2023.)
On December 29, 2022, President Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) into law. (See Consolidated Appropriations Act, 2023, Pub. L. No: 117-328, § 3501-06.) MoCRA substantially expands the authority of the Food and Drug Administration (FDA) to promulgate new regulations over cosmetics and initiate enforcement against manufacturers and distributors of cosmetic products that present health risks. Most MoCRA provisions, including those dealing with facility registration and product listing, take effect on December 29, 2023, and existing facilities will have to register and comply with its product listing requirements as of this date.
Maine and Massachusetts have both joined the expanding number of states restricting or considering the restriction of PFAS-containing products.
Maine Regulators Propose Rules Providing Guidance on Newly Enacted Ban
The Maine Department of Environmental Protection has proposed a new rule intended to establish, in greater detail, the procedures necessary for compliance with Public Law c. 477, entitled “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution.” As discussed in a previous post, this law, which went into effect January 1, 2023, imposes reporting requirements for consumer products with intentionally added per- and polyfluoroalkyl substances (PFAS) and phases out products containing PFAS beginning with carpets, rugs and fabric treatments. The proposed regulation largely echoes the language of the statute itself but does provide new definitions material to the statute’s “currently unavailable use” exemption and elaborates on the required content of the statutorily prescribed notices regarding PFAS-containing products. A public hearing is being held on the proposed rule on April 20, 2023, with comments due May 19, 2023.
Parties interested in influencing or narrowing the scope of the Maine PFAS law may wish to consider the benefits of submitting public comments by this deadline.
On March 14, 2023, the EPA proposed a National Primary Drinking Water Regulation under the Safe Drinking Water Act to establish Maximum Contaminant Levels (MCLs) for six per- and polyfluoroalkyl substances (PFAS):
- Perfluorooctanoic acid (PFOA)
- Perfluorooctane sulfonic acid (PFOS)
- Perfluorononanoic acid (PFNA)
- Hexafluoropropylene oxide dimer acid (HFPO-DA, commonly known as GenX)
- Perfluorohexane sulfonic acid (PFHxS)
- Perfluorobutane sulfonic acid (PFBS).
The EPA anticipates finalizing the regulation by the end of 2023. Although the science around PFAS is still evolving, the EPA has touted the proposed rule as an essential measure that “will prevent thousands of deaths and reduce tens of thousands of serious PFAS-attributable illnesses.”
In the last eight months, the attorneys general of North Carolina, California, Wisconsin and Illinois have sued various primary manufacturers of per- and polyfluoroalkyl substances (PFAS), as well as over a dozen secondary manufacturers of PFAS-containing products. Each lawsuit alleges that the manufacture and distribution of PFAS and PFAS-containing products has led to widespread environmental contamination and harmful exposure.
Per- and polyfluoroalkyl substances (PFAS) continue to garner regulatory attention at the federal and state levels. One of the regulatory milestones set forth in the Biden EPA’s 2021 PFAS Strategic Roadmap was the finalization and implementation of a one-time reporting rule that the Agency had proposed in June 2021 under TSCA Section 8(a)(7). This rule will require manufacturers, including importers, of PFAS to provide EPA with certain information regarding their introduction of PFAS into commerce, as well as on the resulting exposure to and downstream uses of such PFAS. Although the public comment period on this rule has long since closed, we are only months away from the targeted date by which EPA has promised to publish the final regulation. Specifically, EPA must promulgate the final rule by January 1, 2023. Thereafter, subject businesses must submit the requisite information to EPA within six months following the effective date of the final rule.
On Friday, August 26, 2022, the U.S. Environmental Protection Agency (EPA) released a pre-publication notice of a long-awaited proposed rule to designate two of the most-studied per- and polyfluoroalkyl substances (PFAS)—perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS)—as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). In an accompanying statement, EPA indicated that the proposed rule will be published in the Federal Register within the next few weeks. That publication will commence a 60-day public comment period. EPA appears to be targeting final rule promulgation by Summer 2023.
On June 15, 2022, the EPA released drinking water health advisory levels for four per- and polyfluoroalkyl substances (PFAS): PFOA, PFOS, PFBS and GenX. The announcement reflects the Biden administration’s continued push to regulate PFAS.
In requesting information from its Scientific Advisory Board (SAB) on PFOA and PFOS last fall, the EPA signaled that it would seek to regulate these two chemicals at concentrations below the existing advisory levels of 70 parts per trillion (ppt). The revised advisory levels for these two substances confirm that suspicion and present new technical challenges in PFAS detection and treatment, as do the new advisory levels for PFBS and GenX.