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The Toxic Substances Control Act (TSCA) has been regulating new and existing chemicals for almost 50 years. Under the TSCA, the EPA was given broad authority to track the thousands of existing commercial chemicals and regulate any new chemicals before they enter the market.

The TSCA requires manufacturers that intend to use a chemical that is designated as a “significant new use” to notify the EPA at least 90 days before they manufacture, import or process the chemical for that use, i.e., the “significant new use rule” (SNUR). This pre-manufacture notice requirement gives the EPA the opportunity to evaluate the potential use and, if necessary, to place restrictions on the chemical or prohibit its use to manage any risks before they can occur.

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On April 19, 2024, the Environmental Protection Agency (EPA) finalized its long-awaited rule designating two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as “hazardous substances” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or Superfund). The final rule will take effect 60 days after EPA publishes it in the Federal Register.

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The Biden Administration is continuing its efforts to regulate per- and polyfluoroalkyl substances (PFAS). On April 15, 2024, the White House Office of Management and Budget (OMB) completed its review of an Environmental Protection Agency (EPA) proposal designating two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), as “hazardous substances” under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA).

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On April 10, 2024, the Environmental Protection Agency (EPA) finalized a National Primary Drinking Water Regulation under the Safe Drinking Water Act to establish Maximum Contaminant Levels (MCLs) for five 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)

Additionally, EPA required the use of the Hazard Index to establish site-specific limitations for PFAS mixtures of two or more of PFHxS, GenX, PFNA, and perfluorobutane sulfonate (PFBS).

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As regulation of the use of PFAS in consumer products continues to develop at a rapid pace in the United States, businesses that manufacture or sell products internationally should also keep their fingers on the pulse of foreign regulatory developments.

On April 4, members of the French Parliament unanimously approved a bill calling for the ban on the manufacture, import and sale of certain products containing per- and polyfluoroalkyl substances (PFAS), starting January 1, 2026. The bill applies to any cosmetic product, wax product (for skis), or clothing textile product, except for protective clothing for safety and civil security professionals. The ban will extend to all textiles starting on January 1, 2030. Kitchen utensils, which were originally included in the ban as proposed, were removed from the bill following pushback from the cookware industry, which has historically utilized perfluorooctanoic acid (PFOA) for nonstick cookware.

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The Environmental Protection Agency (EPA) is continuing its push to regulate per- and polyfluoroalkyl substances (PFAS). Just last week, the agency’s revised PFAS regulations under the Safe Drinking Water Act (SDWA) cleared a key regulatory hurdle and could be finalized in the very near future. Similarly, the agency continues to review stakeholder comments on its proposal to designate two PFAS compounds as hazardous substances, under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA or “Superfund”), and a recent Congressional hearing on EPA’s proposal signals continued interest from Capitol Hill on PFAS issues. EPA also faces a looming deadline; the agency must finalize rules by mid-May or else risk the possibility of the 2024 election causing a change in administration and control of Congress, leading to repeal of rules under the Congressional Review Act (CRA).

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The clock is winding down on businesses interested in commenting on EPA’s proposal to designate nine per- and polyfluoroalkyl substances (PFAS) as hazardous constituents under the Resource Conservation and Recover Act (RCRA). See Listing of Specific PFAS as Hazardous Constituents (89 Fed. Reg. 8,606, Feb. 8, 2023).

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As in 2023, Congress continues to focus on PFAS issues in the first months of 2024. In this 118th Congress, at least 39 bills focused on PFAS have been introduced along with several dozen additional bills that tangentially address “forever chemicals.”

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Yet another new horizon looms for PFAS litigation. Numerous PFAS claims, like those involving deceptive trade practices due to PFAS in food packaging, seldom withstand a motion to dismiss, but the emergence of a novel liability theory could expose corporations to PFAS litigation of a different sort.

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Abstract: This article provides overviews the status of PFAS regulation in the United States. Given the ubiquity of PFAS in commercial products, the expectation is that the United States’ regulation of PFAS and liability risks associated with PFAS will be of interest to a wide array of Japanese businesses, including specialty chemical companies, industrial manufacturers, oil and gas operations, and trading companies. Indeed, it is to be understood that many businesses, including those that have never knowingly used PFAS in their operations, may have a nexus to PFAS without knowing that they do. This article briefly describes PFAS, the types of products that include it, the recent wave of litigation involving PFAS contamination, which has involved settlements above $10 billion, and developments in federal and state regulation of these chemicals. This is followed by a brief discussion of specific scenarios in which these developments may affect Japanese corporations. The article ends with the recommendation that businesses that manufacture, distribute, use, or dispose of PFAS or products containing PFAS should stay abreast of these developments and develop proactive strategies to minimize their potential liability.

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