The Nickel Report

EPA’s plans to investigate – and eventually establish limits on and liability for – PFAS in wastewater discharges and biosolids crossed a significant milestone on January 31, 2024, with the completion of two new analytical methods to detect these ubiquitous contaminants. The most significant of the two is Method 1633, which provides a standardized quantitative method for laboratories to detect 40 different PFAS compounds, at very low levels, in wastewater, surface water, groundwater, soil, biosolids, sediment, landfill leachate, and fish tissue. Method 1621 is a low-cost screening method for the presence of fluorine-containing organic compounds, which could lead to use of the more sensitive Method 1633 to further characterize any PFAS in the sample. EPA’s public statements provide no timeline for seeking approval of these methods for PFAS monitoring of wastewater discharges as part of 40 C.F.R. Part 136, but a Method Update Rule is likely to be proposed before the end of the year.

EPA has big plans for the PFAS data that these two new methods will generate.

In December 2023, federal agencies released their “Fall 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals that could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s chemical regulatory team has provided analyses of these upcoming regulatory actions:

• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming PFAS-Related Actions
• EPA’s Recent Release of its “Fall 2023” Regulatory Agenda: Upcoming Toxic Substances Control Act (TSCA) Actions

In 2022 and 2023, the United States Environmental Protection Agency (EPA) proposed five risk management rules under Section 6(a) of the Toxic Substances Control Act (TSCA) imposing restrictions and bans on chemical uses. This is the first group of risk management rules that EPA has published since Congress amended TSCA in 2016, establishing EPA’s process to address “unreasonable risks” identified for certain uses of existing chemicals. These proposed rules provide a roadmap for EPA’s approach to chemical regulation under Section 6(a), establishing the precedent for future regulation.

Companies should anticipate more proposed bans, especially for consumer uses of a chemical, along with significantly lower chemical exposure limits compared to occupational exposure limits. Rigorous workplace requirements, including exposure monitoring, respiratory protection and additional personal protective equipment (PPE) requirements are also expected. And, the absence of industry data on a chemical’s use may lead to more stringent proposed regulation.

As states across the country develop laws addressing per- and polyfluoroalkyl substances (PFAS), a patchwork of requirements has begun to emerge, creating challenges for those who manufacture, distribute, and sell products around the country. In 2023, over 200 bills were introduced addressing PFAS, including restrictions for PFAS in products. This trend is expected to continue.

In June 2023, federal agencies released their “Spring 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals which could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s regulatory team have provided analyses of these upcoming regulatory actions:

• EPA’s Spring 2023 Unified Regulatory Agenda—Upcoming PFAS-Related Actions
• EPA’s Spring 2023 Regulatory Agenda—Upcoming TSCA Actions

On August 26, 2022, the US Environmental Protection Agency (EPA) released a pre-publication copy of its much-anticipated proposed rule adding perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) to the list of “hazardous substances” under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). EPA asserts that this regulatory escalation of PFOA and PFOS will facilitate faster cleanup of contaminated sites and reduce exposures to these “forever chemicals.” If finalized, these hazardous substances designations will have significant and immediate impacts on many industries, from creating new reporting obligations to increased compliance, enforcement, and litigation risks related to site cleanup. EPA’s efforts involving PFOA and PFOS fall within the broader, whole-of-agency approach to addressing PFAS first announced in its PFAS Strategic Roadmap and represent its first ever exercise of its authority under CERCLA section 102(a) to designate a hazardous substance.

On April 12, 2022, the United States Environmental Protection Agency (EPA) announced a sweeping proposed ban on ongoing uses of chrysotile asbestos, the only form of asbestos known to still be imported into the United States. EPA’s proposed ban is the first risk management rule issued under the Toxic Substances Control Act (TSCA) since the 2016 Lautenberg Act overhauled the statute to give EPA new powers to review and regulate existing chemicals.

On December 29, the chemicals program at EPA closed out 2021 by proposing revisions to its risk determinations for the Cyclic Aliphatic Bromide Cluster (HBCD), a solvent used as a flame retardant and wetting agent which has not been manufactured in the United States in nearly five years. In doing so, the Biden EPA made good on its June 2021 promise to revisit risk determinations previously made during the Trump Administration in accordance with the Toxic Substances Control Act (TSCA). The draft “revisions” represent a significant shift from EPA’s prior approach to existing chemical risk evaluation and foreshadow increased regulatory and litigation risk for all companies—not just those whose operations may have historically involved HBCD.

On January 26, 2021, a coalition of advocacy groups and prominent asbestos plaintiffs’ experts launched two challenges to “Part 1” of the asbestos risk evaluation recently released by the United States Environmental Protection Agency (EPA).  EPA concluded in Part 1 that 16 of the 32 “conditions of use” analyzed pose an “unreasonable risk” to human health, but advocacy groups have criticized EPA for only addressing risks associated with chrysotile asbestos and excluding review of other fiber types.  Now, those groups have teamed up on a pair of legal challenges that could force EPA to revisit its Part 1 asbestos risk evaluation, which could delay risk management regulations.

On November 9, 2020, EPA’s Office of Research and Development (ORD) released its long-awaited draft handbook that details the office’s process for developing chemical hazard assessments for its Integrated Risk Information System (IRIS) Program. The ORD Staff Handbook for Developing IRIS Assessments (IRIS Handbook) gives useful insight into ORD’s process to develop its IRIS assessments, which provide important toxicological information that federal and state environmental agencies consider when making regulatory and cleanup decisions under multiple statutory programs. EPA will accept comments on the draft handbook and charge questions until March 1, 2021.

In the age of COVID-19, demand for surface wipes, sprays and similar products is at record levels. Retail stores have struggled to keep supplies stocked and shelves may once again be emptied when the winter flu season arrives. If schools and businesses reopen concurrently, the prospects of securing these products becomes even bleaker, which may re-fuel consumer stockpiling. To meet this surging demand, manufacturers have ramped up production and new entrants are pouring into this market space in unprecedented numbers. Supply chains are already stressed and further straining is expected to continue.

On June 11, 2020, the California Assembly passed the Toxic-Free Cosmetics Act, Assembly Bill (A.B.) 2762 [1], by a bipartisan vote of 54-0.  If enacted by the Senate, the law would be the first in the United States to ban twelve ingredients, including mercury and formaldehyde, from beauty and personal care products sold in California due to toxicity concerns.

In June 2016, Congress did something it had not done in over a quarter century: it enacted comprehensive, bipartisan revisions to a major environmental statute. More specifically, it substantially overhauled the Toxic Substances Control Act, or TSCA, a law that was first passed in 1976 and was widely considered to be in need of an update. The TSCA reform law, also known as the Lautenberg Act, expands EPA’s role in reviewing new chemical substances; gives EPA new authority to require testing of chemicals; and directs EPA to prioritize, evaluate and regulate the risks from existing chemicals. It also imposes strict deadlines on EPA for carrying out its new duties under TSCA.

And EPA has apparently taken these deadlines to heart.