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
- 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.