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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.

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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.

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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.”

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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.

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In all, California, Colorado, Connecticut, Hawaii, Maine, Maryland, Minnesota, New York, Rhode Island, Vermont and Washington have placed or soon will be placing prohibitions on the distribution of per- and polyfluoroalkyl substances (PFAS) in food packaging containers, cookware and, in other cases, a wide range of products under the authority of consumer protection laws. Companies across the supply chain will be impacted by these regulations. Industry has criticized the state laws as overreaching, particularly considering the inability of certain state agencies to enforce these laws effectively.

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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.

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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.

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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.

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(Note: This update involves recent developments on a topic covered in a December 2021 client alert.)

As advised in part by the Biden Administration, developments in the regulation of per- and polyfluoroalkyl substances (PFAS) continue to unfold. Not only did the EPA release its PFAS Strategic Roadmap in October, but it has proposed a potentially significant rulemaking under the Resource Conservation and Recovery Act, initiated a scientific review of the adequacy of its current health advisory level for the two most studied PFAS—perfluorooctanoic (PFOA) acid and perfluorooctane sulfonic acid (PFOS)—and taken steps toward establishing a technical foundation for regulating PFAS air emissions under the Clean Air Act. (Additional impetus for the last action derives from pending congressional legislation.) Additionally, a recent federal court decision in the Northern District of Georgia stands to increase the liability exposure of secondary manufacturers and processors of PFAS products in connection with toxic tort suits involving negligence claims. Meanwhile, state attorneys general are urging continued congressional effort to pass a comprehensive PFAS bill that would expedite and fund several of the PFAS regulatory actions contemplated by EPA.

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Federal efforts to regulate per- and polyfluoroalkyl substances (PFAS) have continued in recent months. Most notably, on October 21, 2021, the U.S. Environmental Protection Agency (EPA or the Agency) released its PFAS Strategic Roadmap. This document promises to establish a comprehensive, whole-of-agency approach to regulating PFAS, by building off the Trump EPA’s 2019 PFAS Action Plan and related federal initiatives. The Roadmap reflects EPA’s intent to regulate a broader range of activities than those contemplated in the 2019 Action Plan, as well as to accelerate the implementation of activities identified in the earlier Agency document.

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