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Summer Updates from the Pesticides and Chemicals Committee

Nancy Beck, Lynn L. Bergeson, Ryan Joseph Sylvester Carra, Lawrence E Culleen, Andrea J Driggs, Mark N Duvall, Amy L Edwards, Henry Goodwin, David Fischer, Keith A Matthews, Marshall Robert Morales, Ariel Neumann, Paul Nyffeler, Judah Prero, Kathryn E Szmuszkovicz, Javaneh Tarter, and Sara Beth Watson


  • Provides articles written by members of the Pesticides and Chemicals committee in one location.
  • Explores recent updates and cases in Pesticides and Chemicals law.
Summer Updates from the Pesticides and Chemicals Committee
Antonio Hugo Photo via Getty Images

Featured article:

Proposed Rule to Update New Chemicals Regulations Under TSCA

Ariel Neumann
Ariel Neumann is an associate attorney at Verdant Law, PLLC.

The U.S. Environmental Protection Agency (EPA) has proposed amendments to regulations governing the agency's review of new chemicals, chemicals with significant new uses, and microorganisms with commercial applications under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100 (May 26, 2023). The changes will affect future submitters of premanufacture notices (PMNs) and significant new use notices (SNUNs). Additionally, EPA proposed amendments to the low-volume exemptions (LVEs) and low-release and low-exposure exemptions (LoREXs). Some of these proposed amendments, if implemented, may have a significant impact on the industrial chemical industry. Other changes are intended to improve the review process’s efficiency and reduce the need for re-work. One of the key provisions of the New Chemicals Regulations that EPA is reinforcing and clarifying in this rulemaking is that information that is known or reasonably ascertainable by the submitter must be included in a new chemical notice. Simply put, companies must take care to submit available data to EPA.

Amendments to Improve Efficiency and Reduce Re-Work

Various proposed amendments are intended to address a problem EPA believes hinders the agency's ability to process PMNs and SNUNs efficiently, namely re-work. Re-work is the process of EPA redoing its risk assessment, for any number of reasons, including new information, corrections of misinterpretation of submitted information, and other reasons. The Federal Register notice explains that EPA has observed that most PMN, SNUN, and exemption notices do not contain all required information at the level of detail that EPA needs to perform refined, quantitative risk assessments. In these instances, EPA uses conservative assumptions and default values in its quantitative risk assessments to ensure the assessment protects human health and the environment. Often, EPA’s estimated level of risk is higher than the submitter believes is accurate or appropriate; it is only at that time that the submitter will amend their application to provide the necessary information. The agency calls the process of considering this new information and redoing the risk assessments “re-work.” As noted, but less discussed by EPA, is the need to disabuse EPA of misinterpretation of and/or overlooked submitted data. These events also contribute to delays and re-work at no fault of the submitter.

EPA notes that the re-work cycle diverts EPA’s attention from processing new submissions and delays the review process generally. EPA notes that previous efforts to reduce re-work, including the publication of Points to Consider and TSCA New Chemical Engineering Initiative to Increase Transparency and Reduce Re-work, have not been fully successful. For that reason, the agency is clarifying that a notice is not considered complete at the time of the initial notice submission if the submitter submits additional information at any time during the review period that was known to or reasonably ascertainable at the time of the initial submission.

In the Federal Register notice, EPA noted that “[t]he existing regulation at 40 CFR 720.65(c)(2)(ii) states that if EPA obtains additional information during the review period that indicates the original submission was incomplete, EPA can restart the applicable review period to Day 1 if a submission is later amended during the review period and such amendment demonstrates that the original submission was incomplete.”

The agency announced that it will be changing the current practice of accepting amendments that contain information that was known or reasonably ascertainable at the time of the original submission and then accepting a request to suspend the review period under 40 C.F.R. section 720.75(b). In other words, this policy change means that if EPA obtains additional information during the review period that leads EPA to declare the initial notice submission incomplete, in accordance with 40 C.F.R. section 720.65(d)(2) (proposed to be redesignated from current 40 C.F.R. section 720.65(c)(2)(ii)), the applicable review period would restart at day 1 upon receipt of the complete notice. The agency believes these chemical review process changes will greatly improve efficiency and reduce wait times for notice approvals.

New Data Requirements

EPA is reinforcing the data requirements, including technical data related to the physical and chemical properties of chemical substances, as well as substance use information and specifics on the production, manufacture, and processing of the substances at a facility level.

Amendments to Physical and Chemical Properties and Environmental Fate Characteristics

The agency proposed requiring additional information regarding physical and chemical properties, including submitting surface tension and ultraviolet-visible (UV-VIS) absorption data and aspect ratio, thickness, and number of layers or walls for nanomaterials. Additionally, the amendments clarify what environmental fate characteristic data are required. Currently, the regulation states only that environmental fate characteristic data are required but fails to detail what the relevant characteristics include. The additional requirements will be added in a new provision at 40 C.F.R. section 720.45(j).

Requirement for Categories of Use

Under TSCA section 5(a)(1), a submitter must include the information described in TSCA section 5(d)(1) if the information is reasonably ascertainable by the submitter related to the health or environmental effects of any use or disposal of any chemical substance or any article containing such substance and provide a description of any other information regarding the environmental and health effects of the substance. EPA is proposing amendments to 40 C.F.R. section 720.45(f) that would require information on additional categories of use for the chemical substance.

This amendment would require detailing the types of products or articles that would incorporate the new chemical substance (for example, household cleaners or plastic articles); how and where the product or article incorporating the new chemical substance would be used (for example, sprayed indoors, brushed on outdoor surfaces, etc.); and consumption rates, frequency, and duration of use for products or articles containing the new chemical substance by potentially exposed or susceptible populations. It is not clear whether such information will be known or reasonably ascertainable to the submitter.

Proposed Manufacture, Processing, and Use Information Additions

EPA proposes adding an additional set of information requirements to 40 C.F.R. section 720.45 related to each site where the chemical substance will be manufactured, processed, or used. Changes would be made for both sites controlled by submitters and sites controlled by others, including requirements to add information regarding site addresses for every site where the chemical substance will be manufactured, processed, or used. Additionally, submitter-controlled sites will be required to provide manufacture or processing information related to production (for example, batch as opposed to continuous production and the amount of the substance being produced or processed). This information is included in the chemical data exchange (CDX) but is not specifically detailed in the regulations where they are to be added at 40 C.F.R. section 720.45(g)(1)-(2).

EPA further proposes adding separate and unique information requirements at 40 C.F.R. section 720.45(g)(2) and (h)(2) and new fields in the PMN form to clarify the level of detail needed in the process diagram or description for each site controlled by the submitter and each site not controlled by the submitter. This specific information includes but is not limited to approximate weight per batch or per day for continuous production, the entry point for all products, recycle streams and wastes, and any points of release. Submitters that are familiar with EPA’s Points to Consider and already prepare robust PMNs will recognize these key information needs.

LVEs and LoREX Exemptions Amendments

EPA is proposing three notable amendments related to LVE and LoREX exemptions. The first amendment at 40 C.F.R. section 723.50(g) will prohibit submitters from manufacturing the subject substance until EPA has approved the LVE or LoREX notice. This differs from the current status, detailed at 40 C.F.R. section 723.50(g)(2), in which the submitter can commence manufacture of the subject substance upon expiration of the 30-day review period, even if EPA has not made a determination. It should be noted that despite the regulation stating a submitter can commence manufacture following the expiration date, in practice, EPA will either move to deny the application if it is unable to complete the full review before the expiration or grant the submitter’s request for a review period extension. This change aligns the LVE regulations with the statutory requirement for PMN review.

Second, EPA is proposing that the agency may proactively inform LVE and LoREX holders if the subject substance becomes subject to a significant new use rule (SNUR). Under current confidential business information (CBI) practices, when a substance is listed on the confidential Inventory, CBI protections prevent the public from knowing the identity of the substance that is subject to the SNUR. An LVE or LoREX holder would not know that the substance is now listed on the Inventory or that it is subject to a SNUR. The amendment will allow the agency to notify the LVE and LoREX holder of these changes in status in a manner that still protects the PMN holder's CBI.

EPA proposes making per- and polyfluoroalkyl substances (PFAS) categorically ineligible for LVE and LoREX exemptions. This proposed prohibition would be detailed at 40 C.F.R. section 723.50(d)(i). Further, EPA is codifying its current policy of denying persistent, bioaccumulative, and toxic (PBT) chemical LVE and LoREX submissions. The agency has been denying PBT LVE or LoREX submissions under 40 C.F.R. section 723.50(d). Currently, the provision does not explicitly prohibit PBTs, but it does provide EPA the authority to deny a submission for substances that may cause serious acute or chronic effects or significant environmental effects, which PBT chemicals are proven to produce. The amendment will be added at 40 C.F.R. section 723.50(d) to explicitly prohibit LVE and LoREX exemptions for PBTs.

Comments were accepted up to July 25, 2023.

Featured article:

EPA Releases Draft Strategy to Meet ESA Requirements during Herbicide Registration

Henry Goodwin
Henry Goodwin is an intern at Verdant Law, PLLC.

On July 24, 2023, the U.S. Environmental Protection Agency (EPA) released a draft strategy designed to help the agency navigate its obligations under the Endangered Species Act (ESA) during herbicide registration and registration review for this type of pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA asserts that the strategy, which focuses specifically on agricultural uses of conventional herbicides in the lower 48 states, “would provide early protections for over 900” endangered and threatened species (listed species) and their habitats.

Pursuant to section 7(a)(2) of ESA, EPA must ensure that any action authorized, funded, or carried out by the agency is not likely to jeopardize the continued existence of listed species or result in a critical adverse modification to those species’ habitats. If necessary, this determination is made following consultation with the Fish and Wildlife Service and the National Marine Fisheries Service. Under FIFRA, all pesticides sold or distributed in the United States must be registered by EPA. Each pesticide registration—as well as its subsequent registration reviews, which occur every 15 years—constitutes an action that is subject to ESA.

Currently, EPA attempts to meet these statutory requirements with a “chemical-by-chemical, species-by-species approach.” According to the agency, it can take 4 to 15 years of analysis and consultation to complete this process for a single pesticide. As a result, EPA has been unable to keep up with its ESA workload: EPA estimates that it has met less than 5 percent of its ESA obligations for its pesticide actions in past decades, including completing its ESA obligations for only “a handful” of conventional herbicides. This creates uncertainty for farmers and pesticide registrants, and legal vulnerabilities for the agency.

The draft strategy proposes a three-step framework to “determine the need for, the level of, and geographic extent of early mitigations” designed to minimize listed species’ exposure to the subject herbicide.

First, EPA would identify the herbicide’s population-level impacts by building on the existing standard ecological risk assessment for plants that the agency uses to support new active ingredient registrations and registration reviews. To determine the degree of impact, EPA would rely on the herbicide’s exposure-to-toxicity ratio, referred to as the magnitude-of-difference. If a listed plant species is potentially impacted, or if a plant that a listed animal species relies on for diet or habitat is potentially impacted, the strategy would continue to step two.

Second, EPA would identify the type and degree of mitigation measures necessary to reduce listed species’ exposure to the herbicide. These mitigation measures fall under two categories: spray drift mitigation, which would limit herbicide exposure by air and wind, and runoff/erosion mitigation, which would limit herbicide exposure with water and soil. Spray drift mitigation measures such as buffer areas and windbreaks would be prescribed based on the magnitude-of-difference and other situational factors. Runoff/erosion mitigation measures would be implemented using a point system where the number of required points would depend on the magnitude-of-difference and other situational factors. Growers would choose which mitigations to implement to meet their point total, with more effective mitigation measures earning more points.

Third, EPA would identify the geographic extent of the mitigations. Some mitigations would apply across the full spatial extent of an herbicide’s use pattern, while others would only apply to particular regions. If mitigations are necessary only in specific geographic areas, EPA would delineate pesticide use limitation areas where a pesticide limitation specific to a listed species applies. To make the process more efficient, EPA expects to develop pesticide use limitation areas representing groups of listed plants with related taxonomy and habitat types.

According to EPA, the agency focused the strategy on agricultural uses of herbicides because agricultural uses of herbicides constitute the plurality of pesticide use in the United States, and because many listed species live adjacent to farmlands. EPA expects that the strategy would expedite the consultation process by allowing the agency to identify and mitigate potential impacts to listed species before consultation even begins, which would also decrease the likelihood that consultation results in a determination that a listed species would be jeopardized.

EPA plans to issue the strategy in final in early 2024. Though EPA plans to begin implementing the strategy at that time, the agency recognizes that it will not be feasible to implement the strategy’s proposed mitigations on all herbicides at that time. Instead, EPA plans gradually to apply the strategy to applicable herbicides, beginning with several herbicides currently under registration review that are scheduled for a proposed interim decision in 2024.

The draft strategy is part of a larger EPA initiative to rework the agency’s ESA-FIFRA processes. In January 2022, EPA committed to complying with ESA before registering any new conventional pesticide active ingredients. In April 2022, EPA released a workplan outlining the agency’s vision for how EPA’s Pesticide Program will better meet ESA obligations. Most recently, in November 2022, EPA released a workplan update describing the agency’s efforts to reduce nontarget organisms’ exposures to pesticides during the pesticide registration review process and through other FIFRA actions.

The draft strategy is open for public comment through September 22, 2023. The docket for the strategy can be found here.

Updates from the Pesticides and Chemicals (PC) Committee

EPA Denies Petition Seeking TSCA Section 4 Testing of PVA

Published May 1, 2023, by Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on April 27, 2023, that it denied a January 26, 2023, petition from Blueland, Plastic Pollution Coalition, and partners, including Beyond Plastics, Plastic Oceans International, The Shaw Institute, Lonely Whale, 5 Gyres, Global Alliance for Incinerator Alternatives (GAIA), Oceanic Global Foundation, The Last Beach Cleanup, Rio Grande International Study Center, Inland Ocean Coalition, Occidental Arts and Ecology Center, Turtle Island Restoration Network, Friends of the Earth, Surfrider, and Made Safe. 88 Fed. Reg. 25590. The petition, filed under section 21 of the Toxic Substances Control Act (TSCA), requested that EPA require manufacturers and processors of polyvinyl alcohol (PVA) affiliated with EPA’s Safer Choice certification program to fund and conduct health and environmental safety testing using independent, third-party scientists. The petition also requested, under the Administrative Procedure Act (APA), that EPA update the status of PVA on its Safer Chemical Ingredients List (SCIL) from “green circle” to “gray square” until testing is completed and reviewed by EPA. EPA states that “[a]fter careful consideration,” it has denied the TSCA petition and APA petition requests.

EPA Proposes to Ban Most Uses of Methylene Chloride

Published May 3, 2023, by Ryan Carra and Mark Duvall

EPA has proposed to ban almost all uses of methylene chloride (also called dichloromethane), a widely used solvent and processing aid. The chemical was manufactured or imported in volumes of 100 to 250 million pounds in 2019, so this proposed ban would have a substantial impact on many industrial sectors. The few remaining uses, including use as a reactant to make HFC-32, would be restricted much more heavily than under the current Occupational Safety and Health Administration (OSHA) standard.

EPA announced the proposed ban and restrictions in a proposed rule published May 3, 2023, 83 Fed. Reg. 28284. The proposal would ban all remaining consumer uses of methylene chloride. All industrial and commercial uses of methylene chloride, including use as a heat transfer fluid or other processing aid and most solvent uses, would also be banned except for ten specific uses, two of which are very specialized. The banned and excluded uses are listed at the end of this alert. A future significant new use rule (SNUR) would likely cover any uses not included in either list.

EPA Will Extend Compliance Date for decaBDE PBT Rule, Issues Enforcement Statement

Published May 8, 2023, by Lynn L. Bergeson and Carla N. Hutton

On May 3, 2023, EPA announced its intent to extend the January 6, 2023, compliance date on the prohibition on the processing and distribution of decabromodiphenyl ether (decaBDE) for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation. As reported in our December 23, 2020, memorandum, decaBDE is one of the persistent, bioaccumulative, and toxic (PBT) chemicals that are the subject of risk management rules under TSCA issued in 2021. EPA states that it “expects to propose this compliance date extension as part of a rulemaking on the chemical this fall.”

EPA also issued a related temporary Enforcement Statement, which indicates that it does not intend to pursue violations of this prohibition on processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, “as long as the entities involved are diligently working to qualify their alternative components in accordance with Nuclear Regulatory Commission regulations and guidance.” EPA also announced a settlement agreement with RSCC Wire & Cable, LLC (RSCC), “the only known supplier of qualified decaBDE-containing wire and cable, regarding TSCA violations.”

Canada Proposes to Unmask the Identities of 132 Substances on the DSL

Published May 10, 2023, by Lynn L. Bergeson and Carla N. Hutton

According to a May 6, 2023, Canada Gazette notice, the Minister of the Environment, pursuant to the Canadian Environmental Protection Act, 1999 (CEPA), intends to unmask the identities of 132 substances currently on Part 3 of the Domestic Substances List (DSL) in accordance with the Approach to disclose confidential information and promote transparency in chemicals. The annexed proposed Order includes the masked names and confidential accession numbers of the substances proposed for unmasking. The notice states that any person who objects to the unmasking of a substance subject to the notice should submit a masked name application for each substance to the Substances Management Information Line, including a masked name that complies with the Masked Name Regulations and the justification outlined in section 7.2.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).

California Agency Proposes to List Microplastics and PPD derivatives to Candidate Chemical List

Published May 11, 2023, by Marshall R. Morales, Samuel B. Boxerman, and Maureen F. Gorsen

The California Department of Toxic Substances Control (DTSC) has proposed adding microplastics and para-phenylenediamine (PPD) derivatives to its Candidate Chemicals List. This listing positions microplastics, and products containing them, for regulation and potential restrictions under the agency’s Safer Consumer Products Program. Companies with products containing microplastics and PPD derivatives should engage with DTSC in coming regulatory proceedings.

PEER Calls for “Transparent Public Process” for Inhance PFAS SNUNs

Published May 20, 2023, by Lynn L. Bergeson and Carla N. Hutton

On April 20, 2023, the Public Employees for Environmental Responsibility (PEER) issued a press release announcing that, together with the Center for Environmental Health (CEH), it sent a letter to EPA asking EPA to “fix” the public comment process for 18 significant new use notices (SNUN) for per- and polyfluoroalkyl substances (PFAS) created by Inhance Technologies in the fluorination of millions of plastic containers. PEER states that “[t]he public comment process is a critical opportunity for stakeholders to provide data and analysis to EPA as it decides whether it will allow Inhance Technologies to continue to use a process that creates highly toxic PFAS during fluorination.” 

EPA Proposes Updates to TSCA New Chemicals Regulations

Published May 30, 2023, by Lynn L. Bergeson and Carla N. Hutton

On May 26, 2023, EPA proposed amendments to the new chemicals procedural regulations under TSCA. 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process, and “update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA states that the proposed rule includes amendments that would “reduce the need to redo all or part of the risk assessment by improving information initially submitted in new chemicals notices, which should also help reduce the length of time that new chemicals notices are under review.” More information on the proposed rule is available in our May 24, 2023, memorandum.

Minnesota Becomes Second State To Pass Sweeping PFAS Ban and Reporting Law Targeting All Products

Published June 8, 2023, by Javaneh S. Tarter, Nancy B. Beck, PhD, DABT, Gregory R. Wall, Matthew Z. Leopold, and Paul T. Nyffeler, PhD

In May 2023, Minnesota’s governor Walz signed into law HF 2310, which bans the sale of certain products containing “intentionally added” PFAS in 2025 and then all products in 2032, and also establishes reporting requirements for products containing PFAS starting in 2026. Following Maine’s lead, Minnesota has now become the second state in the country to pass a broad ban on PFAS-containing products sold in the state. While reporting requirements apply to product manufacturers, the bans on sale, offer for sale, or distribution in the state apply to “persons,” including retailers. Companies who manufacture products for sale (and who sell) products in the state of Minnesota will need to prepare to assess the presence of PFAS in their supply chains to comply with these new requirements.

Maine Legislature Passes Bill to Postpone PFAS Reporting Requirement

Published June 8, 2023, by Lynn L. Bergeson and Carla N. Hutton

On June 6, 2023, the Maine Senate passed LD 217, “An Act to Support Manufacturers Whose Products Contain Perfluoroalkyl and Polyfluoroalkyl Substances” (Act). Passed by the House on June 1, 2023, the bill would postpone the January 1, 2023, reporting requirement for products and product components containing intentionally added PFAS. As reported in our February 17, 2023, memorandum, the Maine Department of Environmental Protection (MDEP) issued a proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions under the Act. Comments were due May 19, 2023.

U.S. EPA Finalizes Rule Limiting Confidentiality Designations Under the Toxic Substances Control Act

Published June 8, 2023, by Marshall R. Morales, Jack Raffetto, and Samuel B. Boxerman

On May 31, 2023, EPA finalized a rule designed to tighten confidential business information (CBI) designations in submissions under TSCA. EPA has touted this rule as providing “transparency” and providing the agency leeway to make “more health and safety data publicly available more quickly.” Given the sensitive nature of the data often provided in TSCA submission, regulated entities should carefully consider the provisions of the new rule and what steps they must take to ensure that confidential information is not subject to public disclosure.

Maine Amends Notification Requirement in PFAS-Containing Products Law

Published June 9, 2023, by Ryan Carra, Nessa Coppinger, Graham Zorn, and Robert Denney

Maine has enacted an amendment to the state’s statute regulating the use of PFAS in products. Under the law as originally passed, manufacturers of products containing intentionally added PFAS were required to provide certain detailed information to the MDEP beginning January 1, 2023. The amendment extends this statutory deadline to January 1, 2025, and makes certain changes to the required substance of notifications. The amendment applies retroactively to January 1, 2023. 

Bicameral Bill Would Establish Consortium to Identify Safer Chemicals

Published June 13, 2023, by Lynn L. Bergeson and Carla N. Hutton

On May 18, 2023, senator Alex Padilla (D-CA) and representative Zoe Lofgren (D-CA) introduced the Supercomputing for Safer Chemicals (SUPERSAFE) Act (S. 1685, H.R. 3457). According to Padilla’s May 18, 2023, press release, the legislation would establish a SUPERSAFE Consortium led by EPA “to identify chemicals that are safe to use in commerce through science-backed decision making.” 

ECHA Adds Two Chemicals to Candidate List of SVHCs

Published June 16, 2023, by Lynn L. Bergeson and Carla N. Hutton

The European Chemicals Agency (ECHA) announced on June 14, 2023, that it has added two new chemicals to the Candidate List of substances of very high concern (SVHC). One is toxic for reproduction, and the other has very persistent and very bioaccumulative (vPvB) hazardous properties. According to ECHA, their uses include in inks and toners and in the production of plastic products. 

Washington State Finalizes Chemical in Product Restrictions; Announces Next Targets

Published June 19, 2023, by Ryan Carra, Russ LaMotte, Dave Weber, and Kirstin Gruver

The Washington State Department of Ecology (Ecology) has completed Cycle 1 of its Safer Products for Washington program and signaled its direction for Cycle 2. To complete Cycle 1, Ecology finalized rules restricting the presence of certain chemicals in certain products and imposing reporting requirements for other chemical product combinations. Ecology also established a process by which companies may request an exemption from Safer Products for Washington requirements. Separately, Ecology published its Draft Report to the legislature identifying potential priority chemicals for Cycle 2 of the program.

How Does TSCA Define “unreasonable risk of injury to health or the environment”?

Published June 22, 2023, by David B. Fischer, M.P.H.

Perhaps the most important term in TSCA is the term “unreasonable risk of injury to health or the environment” (or simply “unreasonable risk”). Under section 6 of TSCA, EPA evaluates the risk of chemicals to determine whether uses present “unreasonable risk.” A determination of unreasonable risk triggers risk management regulations to ensure that the chemical no longer presents unreasonable risk. Thus, knowing what is and isn’t unreasonable risk is critical to effectively eliminating that risk. Yet, TSCA does not define unreasonable risk. Even in amending TSCA in 2016, Congress avoided a definition.

In finalizing the rule on procedures for chemical risk evaluation under TSCA, EPA could have defined the term “unreasonable risk,” but like Congress, it opted not to. Instead, EPA delineated a list of “relevant factors” it will consider, including the following:

  • The effects of the chemical substance on health and human exposure to such substance under the conditions of use (including cancer and non-cancer risks); the effects of the chemical substance on the environment and environmental exposure under the conditions of use; the population exposed (including any susceptible populations), the severity of hazard (the nature of the hazard, the irreversibility of hazard), and uncertainties.

Given this rather lengthy list of “relevant factors,” one might assume that unreasonable risk would defy a succinct and easily understood definition. But if unreasonable risk is to be eliminated, then the regulated community needs to know precisely when a workplace, for example, poses unreasonable risk.

EPA Implements Statutory Addition of Certain PFAS to TRI Beginning with Reporting Year 2023

Published June 26, 2023, by Lynn L. Bergeson and Carla N. Hutton

On June 23, 2023, EPA updated the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 88 Fed. Reg. 41035. Specifically, EPA updated the regulations to identify nine PFAS that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) enacted on December 20, 2019. EPA states that “[a]s this action is being taken to conform the regulations to a Congressional legislative mandate, notice and comment rulemaking is unnecessary.” The final rule was effective July 24, 2023. For Toxics Release Inventory (TRI) Reporting Year 2023 (reporting forms due by July 1, 2024), reporting is required for nine additional PFAS, bringing the total PFAS subject to TRI reporting to 189.

EPA Proposes Pesticide Conservation Measures for Protected Species

Published June 26, 2023, by David Barker, Parker Moore, Kathryn Szmuszkovicz, Liz Johnson, and Jonas Reagan

Last year, EPA launched its Vulnerable Species Pilot to identify (1) at-risk species reasonably certain to be adversely affected by non-residential outdoor uses of pesticides and (2) proposed conservation measures (described by EPA as “mitigation measures”) for reducing those impacts to the species and their habitat. A key objective of the Pilot is to decrease the potential jeopardy or adverse modification determinations during future Endangered Species Act section 7 consultations and to reduce species take overall. On June 22, 2023, EPA published a draft white paper identifying the initial set of listed species and EPA’s proposed mitigation measures. The draft white paper includes a proposed mitigation implementation plan and a plan to expand the pilot to other species in the future.

Maine Delays PFAS Reporting Requirement For Two Years

Published June 27, 2023, by Joseph J. Green, and Zachary Lee

In the midst of already tumultuous regulatory change, MDEP has officially delayed the reporting requirements of their landmark PFAS regulation for two years. The delay was promulgated pursuant to legislation passed by the Maine legislature that not only stalls the reporting rule but similarly creates new reporting exemptions. The bill was the only one of five proposed amendments that passed both chambers and received a signature from governor Janet Mills.

The bill delays the reporting requirement’s effectiveness two years from January 1, 2023, to January 1, 2025. The bill also outlines specific reporting requirements that must now be included in manufacturers’ reports, including “an estimate of the total number of units of the product sold annually in the State or nationally.” Interestingly, the bill also creates two reporting exemptions: one for manufacturers that employ 25 or fewer people, and another for a “used product or used product component.

Challenge to PFAS Test Order Held in Abeyance After EPA Granted Exemption to Fire-Fighting Foam Maker

Published June 28, 2023, by Lawrence E. Culleen and Judah Prero

On May 10, 2023, the D.C. Circuit Court of Appeals ordered that a challenge to EPA’s first TSCA section 4 test order under its National PFAS Testing Strategy be held in abeyance.

The challenge to the test order for 6:2 fluorotelomer sulfonamide betaine (6:2 FTSB) was brought by a company that makes aqueous film-forming foams (AFFFs) used as fire suppressants. The company contended that it was not subject to the test order because it was neither a manufacturer nor a processor of 6:2 FTSB. (EPA determined that the company was a processor.) The company and EPA jointly requested that the proceeding be held in abeyance after EPA granted the company’s request for an exemption, “conditional upon the completion of the required tests by another party according to the specifications” of the test order. In their abeyance request, the parties said the exemption potentially obviated the need for the company to comply with the testing obligations and that an abeyance would “avoid protracted and potentially unnecessary litigation.” The parties said that the abeyance should continue either until EPA notified the company that its exemption was terminated and that the company must conduct testing or until five years after the later of either completion of the testing or the resolution of any cost sharing obligation on the company’s part to the parties conducting the testing. The company continued to deny that it was a “processor” subject to the test order, and EPA reserved its defenses to the company’s defenses. EPA must file status reports at 120-day intervals beginning on September 7, 2023.

PFAS Settlements: How Much is Enough?

Published June 28, 2023, by Jessica K. Ferrell, Jeff B. Kray, and Jack L. Ross

Decisions loom for water suppliers nationwide after settlements totaling over $11 billion with PFAS manufacturers 3M and DuPont were recently announced. Just days before a bellwether trial was scheduled to begin, the most well-known defendants in the aqueous film-forming foam multidistrict litigation in South Carolina (AFFF MDL) reached settlements to resolve all water supplier claims against them. The MDL itself includes over 420 water supplier plaintiffs, but several thousand water suppliers are eligible to share in the settlement funds. Now comes the hard part: determining whether to participate in the settlements, assuming the court approves the proposed deals. This article summarizes publicly available information on the status of the settlements, and considerations relevant to water providers and other claimants in deciding whether to participate or opt out.

PFAS Food Packaging Regulations Boil Over: Time to Develop a Compliance Plan

Published June 29, 2023, by Dianne R. Phillips, Robert P. Frank, and Michael V. Fiorillo

Forever chemicals are about to be forever regulated. With the most recent ban on PFAS in food packaging set to go in effect in Vermont on July 1, 2023, this Holland & Knight alert focuses on the current state regulatory landscape for PFAS in food packaging. The two-sentence takeaway: Plot your PFAS compliance path now. Inaction is not a path toward compliance.

The term PFAS refers to an entire family of wholly synthetic chemicals. Most state statutes and regulations that regulate the use of these substances in food packaging define PFAS broadly as any compound with at least one fully fluorinated carbon atom. Though estimates vary, as many as 12,000 unique compounds may exist within this family. The vast majority of these chemicals has not been studied, but recent research suggests that certain PFAS may cause adverse health effects in humans.

EPA Proposes SNURs for Flame Retardants in Support of Risk Evaluations

Published July 3, 2023, by Lynn L. Bergeson, Richard E. Engler, Carla N. Hutton, and Todd J. Stedeford

On June 22, 2023, EPA published proposed SNURs for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2,6-dibromophenol], also known as “tetrabromobisphenol A” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing risk evaluations under TSCA. 88 Fed. Reg. 40728. EPA states that the proposed significant new uses are manufacture (including import) or processing for any use, “with the exception that the conditions of use [(COU)] the Agency expects to consider within the scope of the TSCA section 6 risk evaluations are not proposed as significant new uses.” Persons subject to the SNURs would be required to notify EPA at least 90 days before commencing any manufacturing (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. Comments were due August 7, 2023. EPA states in its June 21, 2023, press release that it “is particularly interested in comments on uses that should or should not be included in the SNUR.” According to EPA, this information will help guide its approach to assessing these chemicals and protecting human health and the environment.

SCHEER Opinion on the Safety of Titanium Dioxide in Toys Recommends Further Studies

Published July 3, 2023, by Lynn L. Bergeson and Carla N. Hutton

The European Commission’s (EC) Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) announced the release of its final opinion on the safety of titanium dioxide in toys on June 27, 2023. Following the mandate from the EC, the scientific opinion evaluates whether the uses of pigmentary titanium dioxide in toys and toy materials can be considered safe in light of the exposure identified and in light of the classification of titanium dioxide as carcinogenic category 2 after inhalation. SCHEER notes that it should be recognized that the safety evaluation as presented is limited to the levels of titanium dioxide in the toys used for the various evaluated exposure scenarios. Although the evaluated exposure scenarios have the highest possibility for titanium dioxide exposure, SCHEER states that some toys containing titanium dioxide may result in exposures for children that were not evaluated in the opinion. In addition, SCHEER did not consider aggregated exposure due to other sources of titanium dioxide exposure, e.g., via food or cosmetics. The opinion states that nanoscale/nanosized particles (1-100 nanometers (nm)) are indicated as ultrafine particles in line with conventions in inhalation toxicology. Microscale particles with an aerodynamic diameter above 0.1 micrometers (μm) are indicated as fine particles. When referring to studies performed with titanium dioxide as nanomaterials, the opinion retains the original wording of nanoparticle/nanomaterial/nanofraction.

Focus on Recyclability, Plastics as FTC Updates Green Guide

Published July 5, 2023, by Ryan Carra, Daniel Eisenberg, and Kirstin Gruver

Key Takeaways

  • What’s happening? On May 23, 2023, the Federal Trade Commission (FTC) hosted a public workshop––“Talking Trash at the FTC: Recyclable Claims and the Green Guides”––to discuss “recyclable” advertising claims as part of its regulatory review of its Guides for the Use of Environmental Marketing Claims (Green Guides).
  • What’s the background? The FTC initiated its review of the Green Guides in late 2022, when it sought comment on several topics, such as the enforceability of the Green Guides, recyclability claims, and recycled content claims. The public workshop is the latest in the FTC’s efforts to update the Green Guides.

Navigating the PFAS Regulatory Landscape: Insights for Consumer Brands and Retailers

Published July 6, 2023, by Jeffrey L. Hunter, Andrea Driggs, Aubri N. Margason, and Sara Cloon

PFAS, known as “forever chemicals,” have been in use since the 1940s and have been added to a wide variety of products to make them resistant to heat, water, oil, and corrosion. PFAS chemicals are not only in firefighting foam but can also be found in numerous consumer products, including food packaging, cosmetics, personal care products, cookware, furniture, carpets, textiles, clothing, and apparel. PFAS chemicals have recently garnered significant attention due to their ubiquitous presence, alleged health risks, and environmental persistence.

This update examines current state law developments in regulating PFAS chemicals in consumer products and food packaging, summarizes recent litigation against product manufacturers, and outlines next steps that manufacturers, retailers, and distributors of consumer products should consider to minimize their potential liability and risk.

NASEM Report Recommends that EPA Develop Framework for Evaluating NAMs for Toxicity Testing

Published July 10, 2023, by Lynn L. Bergeson

On June 16, 2023, the National Academies of Sciences, Engineering, and Medicine (NASEM) announced the release of a new report providing an overview of new approach methods (NAM) in human health risk assessment of chemicals and calling on EPA to develop a framework for evaluating and building trust in NAMs. NASEM states that some pollutants, such as lead, benzene, and ozone, are well studied, enabling EPA to characterize their hazards and risks to human health. For many chemicals in commerce and in the environment, such as PFAS, there is little or no data on their potential health effects, however. As a result, only a small fraction of chemicals and other toxicants to which people are exposed have undergone formal assessment of hazards and risks by EPA.

Recent Regulatory Agendas Show Robust Slate of Rulemakings Coming for TSCA and PFAS

Published July 13, 2023, by Nancy B. Beck, PhD, DABT, Gregory R. Wall, Matthew Z. Leopold, Javaneh S. Tarter, and Paul T. Nyffeler, PhD

EPA and the U.S. Department of Defense (DoD) released their Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions detailing upcoming rulemakings, including actions related to PFAS. As reflected by EPA’s release of a proposed national primary drinking water regulation in March 2023, the release of an advanced notice of proposed rulemaking to designate additional PFAS as CERCLA Hazardous Substances in April 2023, and EPA’s new TSCA Framework to Prevent Unsafe PFAS from Entering the Market, federal agencies are initiating PFAS-related regulatory actions that will pose new compliance challenges with far-reaching implications for a broad spectrum of the regulated community and affected stakeholders. 

U.S. EPA Announces New Framework for Assessing New PFAS

Published July 13, 2023, by Samuel B. Boxerman, Marshall R. Morales, and Jagdeep Sing

On June 29, 2023, EPA announced a framework for its approach to reviewing new PFAS and significant new uses of existing PFAS. Stakeholders in sectors such as food packaging, textiles, semiconductors, and aerospace industries that continue to rely on PFAS compounds should take note. In general, EPA’s approval of new PFAS or new significant uses of existing PFAS may require additional testing—with substantial additional testing in some cases.

Under TSCA, EPA generally reviews new chemicals (i.e., those not already in commerce in the United States) for whether they present an unreasonable risk to human health or the environment prior to allowing import or manufacture. For certain existing chemicals (i.e., those already in commerce in the United States), EPA also reviews proposed significant new uses for whether they present an unreasonable risk. EPA’s new framework is intended to make more rigorous the review of new PFAS compounds or new uses of existing PFAS compounds.

PFAS Update: State-by-State Consumer Products Regulations, July 2023

Published July 18, 2023, by John R. Kindschuh, Emma R. Cormier, and Thomas S. Lee

Manufacturers, distributors, and retailers of consumer products across a broad spectrum of industries are being impacted by regulations regarding the presence of PFAS in their products. This area is rapidly developing as states create new laws, and the penalties and litigation risk for noncompliance can be significant.

EPA Finalizes Reporting and Recordkeeping Rule for Asbestos

Published July 25, 2023, by Ryan Carra, Mark Duvall, Russ LaMotte, and Robert Denney

EPA has finalized a rule requiring asbestos manufacturers, importers, and processors to report certain asbestos exposure–related information. The rule applies to companies that manufactured, imported, or processed asbestos during 2019–2022 and which have annual sales over $500,000 in any of those calendar years. The rule imposes a one-time reporting requirement on these companies to provide information from the past four calendar years on the presence, types, and quantities of asbestos they have handled, as well as types of use and employee data. The rule encompasses reporting on asbestos in bulk form, in an article or product, as an impurity, or as a component of a mixture. Affected companies must submit the required information to EPA within nine months from the rule’s effective date (i.e., by May 24, 2024).

EPA Will Propose to Ban Uses of CTC That Have Been Phased Out and Establish WCPP for Uses Not Prohibited

Published July 26, 2023, by Lynn L. Bergeson, Richard E. Engler, and Carla N. Hutton

On July 17, 2023, EPA announced that it will propose to ban uses of carbon tetrachloride (CTC) that have been phased out and establish a workplace chemical protection program (WCPP) for uses not prohibited to address the unreasonable risk to human health. EPA states in the prepublication version of the proposed rule that it determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and dermal exposures and liver toxicity from chronic inhalation, chronic dermal, and acute dermal exposures in the workplace. To address the identified unreasonable risk, EPA will propose under TSCA to establish workplace safety requirements for most conditions of use (COU), including the COU related to the making of low Global Warming Potential (GWP) hydrofluoroolefins (HFO), to prohibit the manufacture (including import), processing, distribution in commerce, and industrial/commercial use of CTC for COUs where information indicates use of CTC has already been phased out, and to establish recordkeeping and downstream notification requirements. EPA notes that the use of CTC in low GWP HFOs “is particularly important in the Agency’s efforts to support the American Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, which was ratified on October 26, 2022.” Comments will be due 45 days after the proposed rule is published in the Federal Register. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best ensured of consideration if the Office of Management and Budget (OMB) receives them 30 days after the proposed rule is published in the Federal Register.

Minnesota Joins Maine in Enacting Comprehensive PFAS Reporting Requirements

Published July 27, 2023, by Dianne R. Phillips and Michael V. Fiorillo

Minnesota is competing with Maine to have the most rigorous regulations for PFAS. Minnesota governor Tim Walz signed HF 2310 into law on May 24, 2023. Like Maine’s PFAS requirements, which were passed in 2021, HF 2310 section 21 [116.943], titled “Products Containing PFAS” includes reporting requirements, a certificate of compliance process and a total ban effective January 1, 2032. For the reporting requirement, manufacturers must submit the following information by January 1, 2026:

  1. a brief description of the product, including a universal product code (UPC), stock keeping unit (SKU), or other numeric code assigned to the product;
  2. the purpose for which PFAS are used in the product, including in any product components;
  3. the amount of each PFAS, identified by its chemical abstracts service registry number, in the product, reported as an exact quantity determined using commercially available analytical methods or as falling within a range approved for reporting purposes by the commissioner [of Minnesota’s Pollution Control Agency (MPCA)];
  4. the name and address of the manufacturer and the name, address, and phone number of a contact person for the manufacturer; and
  5. any additional information requested by the [MPCA] commissioner as necessary to implement the requirements of this section.

EPA Issues Final TSCA Section 8(a) Reporting and Recordkeeping Rule for Asbestos

Published July 28, 2023, by Lynn L. Bergeson and Carla N. Hutton

On July 25, 2023, EPA issued a final rule regarding the reporting and recordkeeping requirements for asbestos under TSCA. 88 Fed. Reg. 47782. EPA states in its July 6, 2023, press release that under the reporting rule, manufacturers (including importers) or processors of asbestos between 2019 and 2022 with annual sales above $500,000 in any of those years are required to report exposure-related information, including quantities of asbestos manufactured or processed, types of use, and employee data. Manufacturers (including importers) and processors subject to the rule will have nine months following the effective date of the final rule to collect and submit all required information to EPA. In the final rule, EPA “emphasizes that this requirement includes asbestos that is a component of a mixture.” EPA and other federal agencies will use reported information in considering potential future actions, including risk evaluation and risk management activities. The final rule was effective August 24, 2023. There will be a three-month submission period for reporting that will begin six months following the effective date of the final rule. More information is available in our July 12, 2023, memorandum.

Bipartisan Group of Representatives Calls on EPA to Assess the Risks of PFAS in Fluorinated Containers

Published July 31, 2023, by Lynn L. Bergeson and Carla N. Hutton

On July 25, 2023, 12 members of the House sent a letter to EPA administrator Michael Regan urging EPA “to conduct a rigorous, comprehensive, and transparent assessment of the risks of PFAS in fluorinated containers.” The letter states that EPA is mandated by TSCA to address the risks of new PFAS and significant new uses of existing PFAS. According to the letter, the TSCA program “is now facing a major test of this authority from the submission of nine Significant New Use Notices (SNUNs) by Inhance Technologies, a Texas company that fluorinates plastic containers.” The letter states that the Inhance fluorination process “results in the formation of at least 13 individual PFAS, nine of which are long-chain perfluoroalkyl carboxylate (LCPFAC) substances.” The letter notes that LCPFACs are subject to a 2020 SNUR promulgated by EPA and that “[i]t is our understanding that Inhance fluorinates over 200 million containers a year, which are used to package numerous consumer and industrial products.”

Draft Supplement to Risk Evaluation and Draft Revised TSCA Risk Determination for 1,4-Dioxane for Public Comment

Published July 31, 2023, by Lynn L. Bergeson, Richard E. Engler, Carla N. Hutton, and Todd J. Stedeford

On July 10, 2023, EPA announced the availability of the draft supplement to the risk evaluation for 1,4-dioxane for public comment and peer review. 88 Fed. Reg. 43562. EPA states in its July 7, 2023, press release that the draft supplement to the 2020 risk evaluation considers air and water exposure pathways that were excluded from the earlier risk evaluation and exposure to 1,4-dioxane generated as a byproduct. The draft supplement estimates risks to the general population, including to people living in fenceline communities, and aggregate exposures from multiple facilities located in the same area. EPA requests public comment on the analysis presented in the draft supplement to the risk evaluation for 1,4-dioxane. Comments on the draft supplement were due September 8, 2023.

EPA Announces $1.3 Million in Research Funding to Develop Nanosensors to Detect Pesticides and Mitigate Their Impacts

Published July 31, 2023, by Lynn L. Bergeson and Carla N. Hutton

On July 31, 2023, EPA announced that it provided more than $1.3 million in funding to a team of researchers from the University of Wisconsin-Madison to develop nanosensor technology that can detect, monitor, and degrade commonly used pesticides found in water that can harm human health. According to EPA, using funding from the grant, researchers will develop an integrated, portable, sensor-controlled water treatment technology that itself generates the chemicals needed for treatment. EPA states that the University of Wisconsin-Madison’s Integrated Portable Raman and Electrochemical NanoSystem (I-PRENS) will be used for rapid onsite detection and degradation of neonicotinoid pesticides in drinking water supplies. Researchers will develop a small-scale I-PRENS prototype for deployment in Alabama’s Black Belt region for long-term monitoring and remediation of neonicotinoid-impacted drinking water supplies. EPA notes that the Black Belt of Central Alabama, “known for the region’s rich, dark topsoil, faces many factors that make traditional wastewater treatment challenging, including its rural landscape and heavy clay soils.” EPA notes that it expects the results of the research to help low-income, underrepresented, rural communities in Alabama.

PFAS Update: State Soil Concentration Regulations

Published July 31, 2023, by John R. Kindschuh, Emma R. Cormier, and Thomas S. Lee

In the absence of binding federal standards for PFAS in soil, several states have started the process of regulating PFAS in soil themselves. These regulations have implications for site investigations as well as remediation decisions. This client alert explores the current landscape of state regulations regarding the guidance, notification, and clean up levels for PFAS—most commonly perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) —in soil.

EPA Announces Reversal of Policy Regarding Availability of Pesticide Incident Information

Published July 31, 2023, by Keith A. Matthews and Sara Beth Watson

On Thursday, July 27, 2023, EPA announced an important change in policy for making alleged adverse incident reports on pesticides available to the public. EPA informed registrants and the public via an announcement on its website that it has made publicly available 10 years of pesticide incident reports. EPA’s website now includes a portal that posts information from EPA’s Incident Data System (IDS) and allows users to access a summary of information submitted on pesticide exposure incidents. The announcement is a major shift from EPA’s previous practice of only releasing reported incident information when responding to requests under the Freedom of Information Act (FOIA), or in summary fashion during pesticide Registration Review.

Canada Issues Mandatory Information Request for 850 Chemical Substances

Published August 2, 2023, by Lynn L. Bergeson and Carla N. Hutton

Canada published a notice in the Canada Gazette on June 24, 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. Canada is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (for example, releases), and uses of these substances in Canada, pursuant to section 71 of CEPA. According to the notice, the Minister of the Environment requires the information to assess whether the listed substances are toxic or can become toxic, or to assess whether to control, or the manner in which to control, the listed substances. The persons described in the notice must provide the specified information that may be in their possession, or to which they would reasonably be expected to have access. Responses are due January 17, 2024.

EPA Publishes Semiannual Agenda Previewing PFAS-Related Agency Actions

Published August 3, 2023, by Jose A. Almanzar, Amy L. Edwards, Dianne R. Phillips, Meaghan A. Colligan

EPA published a notice of proposed rulemaking on June 28, 2021, and a proposed rule on Nov. 25, 2022, addressing reporting and recordkeeping requirements (R&R Requirements) for PFAS under section 8(a)(7) of TSCA. EPA's proposed rule would require all importers and manufacturers of PFAS since 2011 to report certain information to EPA related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal of the chemicals.

The public submitted to EPA more than 100 unique comments on the proposed PFAS R&R Requirements rule, including many suggesting that the proposed rule lacked sufficient data to support its estimates of burden and cost on small entities and PFAS importers. Based on these public comments, the agency convened a panel to research the economic impacts of the proposed PFAS R&R Requirements rule on small entities. The EPA panel also explored alternatives to the proposed R&R Requirements rule that may minimize significant economic impacts on small entities while accomplishing the agency's objectives.

Maine Invites Stakeholder Comment on Rule Concept Draft Language Prohibiting Sale of Food Packages Containing PFAS

Published August 7, 2023, by Lynn L. Bergeson and Carla N. Hutton

On August 3, 2023, MDEP announced that it would accept stakeholder comment on its rule concept draft language that would prohibit manufacturers, suppliers, and distributors from offering for sale or for promotional purposes in Maine certain types of food packaging to which PFAS have been intentionally introduced. MDEP states that it has the authority to prohibit the sale of a food package to which PFAS have been intentionally introduced in any amount greater than an incidental presence if MDEP “determines that a safer alternative to the use of PFAS in a specific application to a food package is readily available in sufficient quantity and at a comparable cost, and that the safer alternative performs as well or better than PFAS in the specific application of PFAS to a food package.” MDEP notes that in February 2021, the Washington State Department of Ecology (WDOE) published the Per- and Poly-fluoroalkyl Substances in Food Packaging Alternatives Assessment, identifying four types of food packaging that meet Washington’s statutory criteria for a prohibition.

OIG Reports that EPA “Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions”

Published August 7, 2023, by Lynn L. Bergeson, Richard E. Engler, and Carla N. Hutton

On August 2, 2023, EPA’s Office of Inspector General (OIG) released a report entitled The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions. According to OIG, EPA’s New Chemicals Division (NCD) “lacks assurance that the new chemicals review process operates as intended and achieves its objective to protect human health and the environment.” OIG made four recommendations, including that EPA develop, update, and issue final guidance for the New Chemicals Program; assess and update NCD’s recordkeeping applications, as needed; and address workload issues. EPA agreed to all four recommendations, “which are resolved with corrective actions pending.”

TSCA Section 21 Citizen Petition Seeks Prohibition of 6PPD in Tires

Published August 9, 2023, by Lynn L. Bergeson and Carla N. Hutton

On August 1, 2023, Earthjustice filed a citizen petition under section 21 of TSCA asking EPA to establish regulations prohibiting the manufacturing, processing, use, and distribution of N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) (Chemical Abstracts Service Registry Number® (CAS RN®) 793-24-8) for and in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians. According to Earthjustice’s August 1, 2023, press release, “[w]hen 6PPD reacts with ground-level ozone, it breaks down into 6PPD-q -- the second most toxic chemical to aquatic species ever evaluated by the EPA.” The press release states that exposure to 6PPD-q “can kill coho salmon within hours, and the chemical is responsible for ‘urban runoff mortality syndrome,’ which kills up to 100% of coho returning to spawn in urban streams.” The Tribes contend that 6PPD in tires poses unreasonable risks to the environment, requiring EPA to regulate the chemical under TSCA.

AGs and Water Utilities Oppose 3M Settlement, Criticize DuPont’s as Too Small

Published August 14, 2023, by Jessica K. Ferrell, Jeff B. Kray, Victor Y. Xu, Isabel Q. Carey

Nearly two dozen states and territories (the “Sovereigns”)—along with a number of municipalities, water districts, the California State Water Board, and the California Department of Corrections and Rehabilitation—have lodged objections to a proposed nationwide class settlement between PFAS manufacturer 3M Company and drinking water providers (“3M Settlement”). The objections, filed in the Aqueous Film-Forming Foam Multi-District Litigation (“AFFF MDL”) pending in the U.S. District Court for the District of South Carolina, raise issues with the terms of the agreement and adequacy of a settlement that thousands of water utilities nationwide may be asked to sign on to in the next few months—and with which many are unfamiliar.

Water Utilities Must Decide Whether to Give Up PFAS Claims Against 3M, Dupont

Published September 13, 2023, by Jessica K. Ferrell, Jeff B. Kray, and Victor Y. Xu

Drinking water providers across America have received notices (or will soon) requiring them to decide under imminent court-ordered deadlines whether to join in two multibillion-dollar class settlements in return for releasing their known and unknown PFAS-contamination claims against two of the largest global PFAS manufacturers: 3M Company and DuPont de Nemours, Inc. (and companies associated with DuPont). Members of the proposed class of drinking water providers—estimated at over 12,000—have until December 4, 2023 to decide whether to join in the proposed DuPont settlement and until December 11, 2023 to decide whether to join the proposed 3M settlement. If the water providers simply ignore the class settlement notices, they could unwittingly release their claims against both companies whether or not they receive any settlement payments in return.