Articles Posted in Environmental Protection Agency (EPA)

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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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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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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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On October 2023, the U.S. Environmental Protection Agency (EPA) published a final rule in the Federal Register modifying reporting requirements for per- and polyfluoroalkyl substances (PFAS) in the Toxics Release Inventory (TRI) under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). (See 88 Fed. Reg. 74,360 (October 31, 2023).) Specifically, EPA proposed that PFAS compounds on the TRI should be classified as “chemicals of special concern.” Such classification would eliminate the availability of the de minimis exemption to TRI reporting (also known as Section 313 reporting) for both manufacturers and suppliers. It would also require the use of a specific reporting form for the listed PFAS substances (a Form A instead of a Form R).

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On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized the long-awaited one-time reporting rule for per- and polyfluoroalkyl substances (PFAS) that the Agency had proposed in June 2021 under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The finalization of this rule is one of the regulatory milestones set forth in the Biden EPA’s 2021 PFAS Strategic Roadmap. This rule will require businesses to provide the EPA information regarding their manufacture or importation of subject PFAS, as well as, most importantly, articles including covered PFAS, since January 1, 2011.

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On August 17, 2023, the U.S. Environmental Protection Agency (EPA) released preliminary results from the fifth Unregulated Contaminant Monitoring Rule (UCMR) under Section 1445(a)(2) of the Safe Drinking Water Act (SDWA). The UCMR provides a mechanism for the EPA to collect data regarding impacts to public water systems from “emerging contaminants,” for which the SDWA does not otherwise require sampling and mitigation. The purpose of the UCMR is to allow the agency to collect data regarding the scope and magnitude of impacts to potable water supplies that can serve as the basis for science-based decisions regarding future regulations. Notably, the EPA has indicated that it will interpret the data obtained from the fifth UCMR—or UCMR 5, as it is called—with an eye toward environmental justice.

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