The Chemical Compound — November 2023
This quarterly newsletter provides essential updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our primary focus continues to be matters affecting chemical substances which are the subject of regulatory activity or scrutiny by various federal and state government agencies and potential litigants. This includes emerging contaminants such as per- and polyfluoroalkyl substances (PFAS), as well as substances identified by the Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, and regulation.
Table of Contents
- Final TSCA PFAS Reporting Rule Starts Clock for Extensive Reporting on Manufacture and Import of PFAS Since 2011
- TSCA Section 6 Updates: Proposed Risk Management Rules for Carbon Tetrachloride and Trichloroethylene, Plus News on PBTs, TCEP, 1,4-Dioxane, Asbestos, and Prioritization
- EPA Proposed Amendments to TSCA Risk Evaluation Procedures
- EPA Granted Tribes’ TSCA Petition Seeking Ban on 6PPD in Tires
- EPA Issued Final Asbestos Reporting and Recordkeeping Rule
- EPA Issued Third PFAS Test Order Under National Testing Strategy
- EPA Proposed SNUR for Three Flame Retardants Undergoing Risk Evaluations
- EPA Proposed SNURs for 18 Chemicals Made From Plastic Waste Feedstocks
- EPA Releases TSCA Framework for Introducing New PFAS and PFAS Uses Into Commerce
- EPA Office of Inspector General Audit Found Operational Shortcomings in New Chemicals Program but No Evidence That EPA Tied Employee Performance Standards to TSCA’s 90-Day Review Requirement
- Consumer Product Safety Commission Sought Information on PFAS in Consumer Products
- EPA Finalized TRI Reporting Amendments that Eliminate De Minimis Exemption for PFAS; Nine PFAS Added to Reporting List
- EPA Added DINP Category to TRI List
- EPA Released Draft IRIS Toxicological Reviews of Perfluorohexanesulfonic Acid and Inorganic Arsenic
- National Academies Issued Report on IRIS Review for Formaldehyde; Trade Group Seeks to Block Reliance on Report
- EPA Asked for Comments on Expansion of Safer Choice and Design for the Environment Programs
- EPA Added 10 Chemicals to Safer Chemical Ingredients List
- Federal Enforcement Action Against eBay Alleged Illegal Sale of Methylene Chloride Consumer Products
- Groups Filed Lawsuit to Compel EPA To Complete TSCA Risk Evaluations; American Chemical Council Moved To Intervene
- Lawsuit Filed To Compel TSCA Rulemaking on Lead Wheel Weights
- D.C. Circuit to Hear Oral Argument on December 1 in Challenge to TSCA Test Order for 1,1,2-TCE
- Environmental Defense Fund and Trade Groups Challenge TSCA Confidential Business Information Rule
- EPA Entered Into Consent Decree With Electronics Manufacturer To Resolve Violations of TSCA Section 5 and 13
Federal Regulatory Developments
Final TSCA PFAS Reporting Rule Starts Clock for Extensive Reporting on Manufacture and Import of PFAS Since 2011
On October 11, EPA published its final rule establishing the scope and requirements for one-time reporting by anyone who has manufactured (including imported) a PFAS in any year from January 1, 2011 to the end of 2022.1 EPA was directed to promulgate the rule by TSCA Section 8(a)(7), which was added by the National Defense Authorization Act (NDAA) for Fiscal Year 2020.2 Under the final rule, the reporting requirement applies only to manufacturers, including importers, of PFAS “for commercial purposes,” which includes the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. The rule makes clear that importers of PFAS in mixtures and “articles” are considered PFAS manufacturers. (“Articles” are manufactured items that have characteristics set forth in TSCA regulations3 and include items such as switches, gaskets, tubing, electronics, textiles, furniture, kitchenware, vehicles, and more.) Persons who have only processed, distributed in commerce, used, and/or disposed of PFAS are not required to report under this rule, unless they also have manufactured PFAS for a commercial purpose. Manufacturers must report when the PFAS-related information is “known to or reasonably ascertainable by the manufacturer.” “Known to or reasonably ascertainable by” is defined to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” The final rule includes a structural definition that defines PFAS as a chemical substance including at least one of the following three structures:
- R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons
- R–CF2 OCF2 -R′, where R and R′ can either be F, O, or saturated carbons
- CF3 C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons
EPA estimates that the known universe of TSCA chemical substances meeting this definition of PFAS is 1,462. EPA also affirmed that there are fluoropolymers that meet this definition. Reporting is required for each site where there is a PFAS and for each PFAS at that site. The final rule sets forth the information to be included in the report, which must be submitted electronically through EPA’s Central Data Exchange. The data required to be included in a report includes information about chemical identity, use, production volume, worker exposure, releases, disposals, and health and environmental effects. Streamlined reporting options are available for imported articles and for research and development substances manufactured in volumes under 10 kilograms per year if the manufacturer does not know and cannot reasonably ascertain information requested on the longer standard form. The reporting window will open on November 12, 2024, and reports are due no later than May 8, 2025, except that small manufacturers that are subject to the rule solely because they are importers of articles containing PFAS have an additional six months to report (until November 10, 2025). For more information about and analysis of the rule, please see our previously published Advisory.
TSCA Section 6 Updates: Proposed Risk Management Rules for Carbon Tetrachloride and Trichloroethylene, Plus News on PBTs, TCEP, 1,4-Dioxane, Asbestos, and Prioritization
Since the last edition of the Chemical Compound, EPA has proposed risk management rules for two more chemical substances: carbon tetrachloride (CTC)4 and trichloroethylene (TCE).5 Both are volatile organic compounds.
Carbon tetrachloride. The proposed CTC rule would require a workplace chemical protection program (WCPP) to be in place for conditions of use that “account for essentially all of the production volume of CTC,” which is primarily used as a feedstock in the making of products such as refrigerants, aerosol propellants, and foam-blowing agents. EPA noted that the WCPP requirements would apply to use of CTC as a reactant in the production of low Global Warming Potential (GWP) hydrofluoroolefins, which are important to EPA’s efforts to phase down high-GWP hydrofluorocarbons (HFC) pursuant to 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. The WCPP would include an existing chemical exposure limit (ECEL) of 0.03 parts per million (ppm) as an eight-hour time-weighted average to address risk from inhalation exposure in combination with direct dermal contact controls. The proposed rule also would require use of a fume hood and dermal personal protective equipment for industrial and commercial uses as a laboratory chemical. Uses that have already been phased out would be prohibited. In addition, the proposed rule would require manufacturers (including importers), processors, and distributors to provide downstream notification of the rule’s restrictions. The proposed rule also included requirements to maintain records regarding compliance for five years. EPA took comments on the rule for 45 days. The comment period closed on September 11.
Trichloroethylene. The proposed TCE rule would prohibit — eventually — the manufacture (including import), processing, and distribution in commerce of TCE for all uses. The proposed rule also would prohibit industrial and commercial use of TCE. EPA estimates that 83.6% of TCE’s annual production volume is for use as an intermediate during manufacture of refrigerants, but noted that it also is used as a solvent in commercial and consumer applications. Longer compliance timeframes would apply to certain uses, including manufacturing and processing of TCE as an intermediate for generation of an HFC that is important to the phasedown of HFCs under the AIM Act. Longer phaseouts also would apply to conditions of use for which there are not readily available alternatives, and time-limited exemptions would be granted for specific uses that are important for national security applications or other critical infrastructure or needs. The proposal would require strict workplace controls, including compliance with a WCPP, for uses allowed to continue for more than one year. The proposed WCPP would include an ECEL of 0.0011 ppm to protect potentially exposed or susceptible subpopulations, particularly older pregnant workers and occupational nonusers, which was the group identified as most susceptible to cardiac defect in developing fetuses. EPA also proposed a primary alternative regulatory action that included a WCPP with an ECEL of 0.0040 ppm based on an immunotoxicity endpoint. The proposed rule also includes downstream notification requirements and recordkeeping obligations. EPA said it would take comment on the proposed rule for 45 days. Among the issues on which EPA requested comment were the selection of endpoints for determination of the ECEL and whether the Agency should consider a de minimis level in formulations to account for impurities. The comment period will close on December 15.
Other developments under TSCA Section 6 include:
- PBTs. The Office of Information and Regulatory Affairs (OIRA) completed its Executive Order 12866 regulatory review for EPA’s proposed amendments to risk management rules for five persistent, bioaccumulative, and toxic (PBT) chemicals on November 6. The proposal had been at OIRA since July 21.6 EPA promulgated the PBT rules under TSCA Section 6(h) in January 2021, just before President Biden took office.7 The five chemicals are decabromodiphenyl ether; phenol, isopropylated phosphate (3:1); 2,4,6-tris(tert-butyl)phenol; hexachlorobutadiene; and pentachlorothiophenol.
- N-Methylpyrrolidone (NMP). OIRA received the proposed NMP TSCA risk management rule on November 2.
- TCEP Risk Evaluation. In September, EPA published notice that the Agency was seeking nominations for scientific and technical experts to review the draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP), which EPA plans to release for public review and comment in December 2023.8 TCEP is one of the 20 high-priority substances that EPA designated at the end of 2019.
- 1,4-Dioxane Risk Evaluation. In July 2023, EPA published notices of the availability of a draft supplement to the 1,4-dioxane risk evaluation9 and a draft revised risk determination for 1,4-dioxane.10 EPA prepared the draft supplement to consider exposure pathways not assessed in the December 2020 final risk evaluation, including conditions of use in which 1,4-dioxane is present as a byproduct in industrial processes and commercial products. The risk evaluation also considered general population exposures, including fenceline community exposures, to 1,4-dioxane released to ambient surface water and groundwater, ambient air, and land. The draft revised risk determination concluded that 1,4-dioxane, as a whole chemical substance, presents an unreasonable risk of injury to health. In making the revised risk determination, EPA did not assume that all workers would always appropriately use personal protective equipment (PPE). The draft revised risk determination identified two additional industrial/commercial conditions of use assessed in the 2020 risk evaluation as contributing to the determination of unreasonable risk due to the removal of the PPE assumption. EPA also proposed to identify six additional conditions of use assessed in the 2023 supplement as contributing to unreasonable risk based on risks to workers. In addition, EPA proposed that risks to the general population and fenceline communities from exposures to 1,4-dioxane in drinking water from surface water contaminated with industrial discharges of 1,4-dioxane contributed to the proposed unreasonable risk determination. EPA did not identify consumer conditions of use as contributing to the unreasonable risk determination. The Science Advisory Committee on Chemicals conducted a public meeting for review of the draft supplement on September 12-15.11
- Asbestos Part 2 Risk Evaluation. In August 2023, EPA announced the availability of a white paper detailing its quantitative approach for assessing cancer and non-cancer human health hazards in Part 2 of its risk evaluation of asbestos, which will consider legacy uses of asbestos and associated disposals.12 EPA accepted public comment on the white paper through October 2. The white paper will be subject to letter peer review by seven experts.13 EPA expects the draft Part 2 risk evaluation to be released for public comment in early 2024.14
- Prioritization. It was reported that Assistant Administrator Michal Freedhoff announced at a September conference that EPA would propose in December five substances for designation as the next high-priority substances to enter the queue for risk evaluations.15 It was later reported that EPA staff had identified a list of 15 chemical substances from which those five substances would be drawn in meetings with trade groups.16 The 15 substances are 4,4’-methylene bis(2-chloroaniline); 4-tert-octylphenol; acetaldehyde; acrylonitrile; benzenamine; benzene; bisphenol-A; ethylbenzene; naphthalene; styrene; tribromomethane; triglycidyl isocyanurate; vinyl chloride; hydrogen fluoride; and n-(1,3-dimethylbutyl)-n’-phenyl-p-phenylenediamine (6PPD).
EPA Proposed Amendments to TSCA Risk Evaluation Procedures
On October 30, EPA published its proposed revisions to the procedural framework rule for conducting TSCA risk evaluations.17 EPA said the amendments were needed to better align the procedures with the statutory text and the Ninth Circuit’s review of the original 2017 procedures, and also to reflect EPA’s experience implementing risk evaluations and to allow for consideration of future scientific advances without the need for further amendments of the regulations. Proposed changes to the definitions section include elimination of regulatory definitions of “best available science” and “weight of scientific evidence”; EPA said the codified definitions are “unnecessary” and also “inhibit the Agency’s flexibility to quickly adapt to and implement changing science.” EPA also proposes to add “overburdened communities” to the definition of “potentially exposed or susceptible subpopulation.” Regarding the scope of risk evaluations, EPA proposed to remove language indicating that EPA has broad discretion to exclude certain conditions of use from analysis. EPA also proposes to explicitly require that each risk evaluation assess all exposure routes and pathways relevant to the chemical substance under the conditions of use, including those that are regulated under other federal statutes. In addition, while EPA proposes to maintain the requirement to publish a draft scope, it proposes an approach under which the Agency will publish the scope information during the prioritization process, if early indications suggest that the chemical is likely to meet the criteria for a high-priority designation. With respect to risk determinations, EPA proposes to codify the “whole chemical approach” it announced in June 2021. EPA said it now believes that the statute requires that approach — which requires a single risk determination on chemical substances rather than use-by-use determinations. In addition, EPA proposes to distinguish between an “assumed” use of PPE and PPE use supported by reasonably available information demonstrating that the PPE use is “inherent in the performance of an activity.” EPA also proposes changes to peer review requirements for risk evaluations and to procedures for modifying risk evaluations or the scope of risk evaluations. In addition, the proposed rule would allow manufacturers to request only risk evaluations of entire chemical substances rather than allowing manufacturers to request evaluations of particular conditions of use. Comments on the proposed rule are due December 14.
EPA Granted Tribes’ TSCA Petition Seeking Ban on 6PPD in Tires
On August 1, three tribes submitted a petition to EPA under TSCA Section 21 requesting that EPA establish regulations under TSCA Section 6(a) prohibiting the manufacturing, processing, use, and distribution of N-(1,3-Dimethylbutyl)-N’-phenyl-p-phenylenediamine (6PPD) for and in tires.18 They asserted that 6PPD transforms in products or byproducts when released into the environment, including 6PPD-quinone, which is “the second most toxic chemical to aquatic species ever evaluated by EPA.” The tribes said 6PPD-quinone had contributed to the dramatic decline in salmon and steelhead populations. They argued that best available scientific information compelled a conclusion that 6PPD presents an unreasonable risk to the environment, while also citing evidence that 6PPD and 6PPD-quinone pose risks to human health. The tribes contended that regulation under TSCA Section 6(a) was necessary to eliminate the unreasonable risk to the environment because other federal statutes did not provide sufficient protection and the tire industry was unlikely to act expeditiously on its own to remove 6PPD from tires. EPA acknowledged receipt of the petition on August 8 and was required to grant or deny the petition by October 30.
On November 2, EPA notified the petitioners that it was granting the petition.19 EPA found that the petition, “taken together with information reasonably available to the EPA, sets forth facts establishing that it is necessary to initiate a TSCA Section 6(a) rule to address risk to the environment from 6PPD-quinone.” EPA said the Agency would issue an advance notice of proposed rulemaking under TSCA Section 6, with the intent to publish it by fall 2024, and also would initiate rulemaking under TSCA Section 8(d) “to require persons who manufacture (including import) 6PPD to submit certain lists and copies of available unpublished health and safety studies,” with the goal of finalizing the Section 8(d) rule before 2025.
EPA Issued Final Asbestos Reporting and Recordkeeping Rule
On July 25, EPA published final one-time reporting requirements for asbestos under TSCA Section 8(a)(1).20 EPA was required to promulgate this rule pursuant to a June 2021 settlement agreement in litigation that challenged EPA’s failure to collect information about asbestos-containing articles, asbestos impurities in products, and asbestos processing.21 The final rule requires persons who manufactured (including imported) or processed asbestos and asbestos-containing articles between 2019 and 2022 to report exposure-related information. The data required to be reported includes information about the presence, types, and quantities of asbestos and asbestos-containing articles, types of use, and employee data. Asbestos that is a component of a mixture is subject to the reporting requirement, as is asbestos present as an impurity. EPA said the collected information would inform future actions, including risk evaluations and risk management. The final rule requires small manufacturers (including importers) and processors to comply with reporting and recordkeeping requirements, except with respect to Libby amphibole asbestos, but an annual sales threshold of $500,000 (including sales of any parent company) applies. The rule also excludes asbestos in small quantities solely for research and development. The reporting obligation may be fulfilled through the electronic filing of a standard or full form (Form B) or a short form (Form A), which is for submitters who are aware of asbestos in a product but do not know and cannot reasonably ascertain the quantity. The rule establishes a five-year recordkeeping requirement for records that document information reported, beginning on the last date of the submission period. The submission period begins on February 24, 2024 and ends on May 24, 2024. In October 2023, EPA released detailed guidance and instructions for reporting.22
EPA Issued Third PFAS Test Order Under National Testing Strategy
On August 15, EPA announced its issuance of a third TSCA Section 4 test order under its National PFAS Testing Strategy. The order directed three companies to conduct and submit testing on 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride, which EPA described as a reactant in organic chemical manufacturing that was used to produce hexafluoropropylene oxide dimer acid (known by its trade name GenX), which was widely used to replace perfluorooctanoic acid.
EPA Proposed SNUR for Three Flame Retardants Undergoing Risk Evaluations
On June 22, EPA published proposed significant new use rules (SNURs) under TSCA Section 5 for three flame retardants for which EPA is currently conducting risk evaluations pursuant to Section 6. The three substances are tris(2-chloroethyl) phosphate, tetrabromobisphenol A, and triphenyl phosphate . EPA stated that the SNURs are intended to ensure that no one may commence manufacturing or processing these chemicals for a significant new use without a complete EPA review and risk determination, which could help ensure that EPA’s risk evaluations for these chemicals include a consideration of such new uses. Without the proposed SNUR, EPA is concerned that companies could initiate new uses or resume discontinued uses of these chemicals without notification to and review by EPA, and such uses would not be considered in the Section 6 risk evaluation. The proposed rules therefore include manufacture (including import) or processing for any use other than conditions of use expected to be within the scope of the Section 6 risk evaluations. EPA has stated that going forward, EPA plans to consider similar SNURs for the phthalates, solvents, and other chemicals undergoing TSCA risk evaluations.23 EPA took comment on the proposed rule through August 7.
EPA Proposed SNURs for 18 Chemicals Made From Plastic Waste Feedstocks
On June 20, EPA proposed SNURs under TSCA Section 5 for 18 chemical substances made from plastic waste-derived feedstocks.24 These SNURs are an element of EPA’s National Strategy to Prevent Plastic Pollution. Premanufacture notices (PMNs) were submitted and approved for the 18 chemicals in 2015 and 2019, and EPA issued orders pursuant to TSCA Section 5(e)(1)(A) that required protective measures to limit exposures or otherwise mitigate potential unreasonable risk. EPA said that after issuing the Section 5(e) orders, the Agency became aware that precursor chemicals for the 18 substances might contain contaminants of concern that had not been previously identified. The proposed SNURs therefore identify significant new uses to include not only any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the Section 5(e) orders’ requirements but also manufacturing or processing of the chemicals using feedstocks that contain contaminants listed in the proposed rule. The listed contaminants are heavy metals, PFAS, polybrominated diphenyl ethers, alkylphenols, perchlorates, benzophenone, bisphenol A, organochlorine pesticides, ethyl glycol, methyl glycol, and NMP. EPA also proposed to make the general reporting exemption for persons subject to Section 5(e) orders inapplicable, which would require notice to EPA before the chemicals are used in any way that could increase exposures or environmental releases. As of the date that the proposed SNURs were signed, manufacture of the 18 chemicals, which are to be used for new transportation fuel applications, had not commenced. EPA noted that it planned to issue separate SNURs for chemicals made from bio-based feedstocks. EPA took comment on the proposed SNURs through August 19.25
EPA Releases TSCA Framework for Introducing New PFAS and PFAS Uses Into Commerce
On June 29, EPA announced its “Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs),” which outlines EPA’s planned approach for reviewing new PFAS and new uses of existing PFAS.26 Under the framework, EPA will make a determination regarding whether a PFAS is a persistent, bioaccumulative, and toxic (PBT) chemical using a weight of evidence approach based on data for the specific PFAS or appropriate analogues. Testing needs will be considered where there is a lack of information. EPA stated that it expects that some PBT PFAS will not result in worker, general population, or consumer exposure and are not expected to result in releases to the environment, such as PFAS used in a closed system to make semiconductors or other electronic components. In such a negligible exposure and environmental release scenario, if EPA can ensure that such PBT PFAS can be disposed of properly and no consumer exposure is expected, EPA generally expects to allow the PFAS or the new use of a PFAS to enter commerce after receiving basic information, such as physical-chemical property data, about the substance. If this initial data causes concern, then EPA will require additional testing and risk mitigation before moving forward. For PBT PFAS that are expected to have a low — but greater than negligible — potential for release and environmental exposure, EPA generally expects to require test data such as toxicokinetic data in addition to physical-chemical property data before allowing manufacturing to commence. If initial test results cause concern, then EPA will require additional testing and risk mitigation before moving forward. For PBT PFAS that are expected to lead to exposure and environmental releases, and absent a critical use or military need for the substance that necessitates limited and restricted manufacture while testing is ongoing, EPA generally expects that the substance would not be allowed to enter commerce before extensive testing is conducted on physical/chemical properties, toxicity, and fate. The framework is a component of EPA’s PFAS Strategic Roadmap. EPA said it would apply the framework to new PFAS or new use notices that were currently under EPA review, as well as any that EPA received in the future.
EPA Office of Inspector General Audit Found Operational Shortcomings in New Chemicals Program but No Evidence That EPA Tied Employee Performance Standards to TSCA’s 90-Day Review Requirement
On August 2, the EPA Office of Inspector General (OIG) released a report on its audit of the extent to which EPA used and complied with records management requirements, quality assurance requirements, and employee performance standards in the Agency’s New Chemicals Division (Division).27 The OIG conducted the audit in response to complaints submitted in the summer of 2021 to the OIG Hotline regarding these topics, including concerns that employees were rewarded for completing new chemical reviews within TSCA’s 90-day time limit. The audit found that the Division did not have guidance for many activities involved in the new chemicals review process, that it had not finalized guidance for recordkeeping of scoping meetings, that its multiple recordkeeping applications were not integrated and that some systems were frequently inaccessible, and that EPA did not track edits to documents that supported the Agency’s decision-making regarding new chemicals. OIG found that the deficiencies existed because EPA lacked staff resources to both conduct timely reviews and develop and finalize guidance, including because EPA did not fully use its authority under TSCA to collect fees. OIG recommended four actions: (1) development and implementation of a plan to review and update new chemicals guidance; (2) development of a process to periodically assess, and update as needed, the Division’s recordkeeping systems for TSCA confidential business information (CBI); (3) development and implementation of a plan to identify root causes for frequent technical issues, with prioritization of actions to address the TSCA CBI systems; and (4) periodic reviews of the Division’s workforce and workload analysis. EPA’s Office of Chemical Safety and Pollution Prevention agreed with the recommendations and proposed corrective actions. The report found no evidence that EPA’s employee performance standards explicitly addressed TSCA’s imposition of a 90-day review requirement.
Consumer Product Safety Commission Sought Information on PFAS in Consumer Products
On September 20, the Consumer Product Safety Commission (CPSC) published a notice requesting information on PFAS used in commerce or potentially used in consumer products, potential exposures associated with the use of PFAS in consumer products, and potential human health effects associated with exposures to PFAS from their use in consumer products.28 CPSC previously contracted with an outside firm to complete an overview of PFAS that focused on PFAS in consumer products. In the September request for information, CPSC sought information from consumers, manufacturers and importers, government agencies, nongovernmental organizations, and researchers to supplement the information already available to CPSC in the contract report. CPSC’s notice sought comment on specific issues, including the definition of PFAS; how to prioritize specific PFAS and consumer products for assessment; information about PFAS that may be present in consumer products other than for intentional, functional uses; studies or data regarding emission or migration of PFAS from consumer products data and information regarding the potential for exposure and risk from the presence of PFAS in consumer products; and “reports and underlying data for data sources that could inform whether individual PFAS or subclasses or categories of PFAS have potential for adverse human health effects.” The deadline for comments is November 20.
EPA Finalized TRI Reporting Amendments that Eliminate De Minimis Exemption for PFAS; Nine PFAS Added to Reporting List
These PFAS are reportable beginning with the 2023 reporting year (i.e., in reports due July 1, 2024).
EPA Added DINP Category to TRI List
Effective September 12, EPA added a diisononyl phthalate (DINP) category to the TRI list.32 EPA first proposed listing the DINP category in 2000 in response to a petition and then issued a supplemental proposal in August 2022 after agreeing through a consent decree either to finalize a rule adding a DINP category or to withdraw the 2000 proposal.33 EPA based the addition of the category on its conclusion that DINP is reasonably anticipated to cause serious or irreversible reproductive dysfunctions and other serious or irreversible chronic health effects in humans, including developmental, kidney, and liver toxicity. EPA described the members of the DINP category as widely used as plasticizers, with DINP-treated plastics used in the production of coated fabrics, plastic toys, electrical insulation, and vinyl flooring.34 The rule requires reporting by certain facilities in certain industry sectors that manufacture or process more than 25,000 pounds of DINP-category chemicals per year, or otherwise use more than 10,000 pounds of DINP-category chemicals per year. The obligation to track activities involving DINP begins as of January 1, 2024.35 EPA also is conducting a risk evaluation of DINP.
EPA Released Draft IRIS Toxicological Reviews of Perfluorohexanesulfonic Acid and Inorganic Arsenic
In July 2023, EPA announced the release of the draft Integrated Risk Information System (IRIS) Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS) and Related Salts.36 Comments were due on September 22 in advance of a contractor-led peer review. This is one of five PFAS assessments being developed by the IRIS Program as a component of EPA’s PFAS strategic roadmap. The draft assessment found that available evidence indicates “that PFHxS exposure is likely to cause thyroid and developmental immune effects in humans, given sufficient exposure conditions.” An oral reference dose of 4 × 10-10 mg/kg-day was selected on the basis of developmental immune effects. No reference dose was derived for inhalation exposure because there were no studies or models from which to derive it. EPA also concluded that there was inadequate information to assess carcinogenic potential. EPA noted that the draft assessment does not represent, and should not be construed to represent, Agency policy or views.
In October 2023, EPA released the draft IRIS Toxicological Review of Inorganic Arsenic.37 Comments are due December 15 in advance of a Science Advisory Board managed peer review. Inorganic arsenic is naturally occurring and is used in paints, dyes, metals, drugs, soaps, semiconductors, and wood preservatives. Agricultural applications, mining, and smelting may result in releases of arsenic into the environment. The draft review retains EPA’s earlier classification of arsenic as carcinogenic. It also finds that currently available evidence demonstrates that inorganic arsenic causes diseases of the circulatory system and diabetes and likely causes pregnancy and birth outcomes and neurodevelopmental effects in humans. EPA selected an overall reference dose of 0.031 µg/kg-day based on increased cardiovascular disease in humans. Based on lifetime risks of bladder and lung cancers, EPA estimates a combined cancer slope factor of 5.3 × 10-2 (µg/kg-day)-1. EPA noted that the draft assessment does not represent, and should not be construed to represent, Agency policy or views.
National Academies Issued Report on IRIS Review for Formaldehyde; Trade Group Seeks to Block Reliance on Report
On August 9, the National Academies of Sciences, Engineering, and Medicine (National Academies) released its report with recommendations for improving EPA’s 2022 draft IRIS Toxicological Review of Formaldehyde.38 The draft IRIS review found, among other things, that evidence demonstrates that inhalation of formaldehyde causes nasopharyngeal and sinonasal cancers and myeloid leukemia, as well as increased sensory irritation and respiratory tract pathology. The National Academies’ report found that EPA’s “findings on hazard and quantitative risk are supported by the evidence identified in the document” and recommended revisions to improve organization and clarity and to ensure consistency and coherence. The National Academies noted that the Committee on the Review of EPA’s 2022 Draft Formaldehyde Assessment had not been asked to conduct its own risk assessment of formaldehyde or to provide a recommendation for a safe level of formaldehyde for humans.
The American Chemistry Council (ACC) filed a lawsuit in federal district court in the District of Columbia in July 2023 alleging that the National Academies failed to comply with the requirements of the Federal Advisory Committee Act.39 In October 2023, ACC filed a motion requesting that the court enjoin EPA from citing, incorporating, relying on, or otherwise using the National Academies’ report.
EPA Asked for Comments on Expansion of Safer Choice and Design for the Environment Programs
On July 27, EPA announced a stakeholder engagement opportunity to gather input on proposed expansion of the voluntary Safer Choice and Design for the Environment (DfE) programs to include certification of product categories other than cleaners and disinfectants.40 Safer Choice helps buyers identify products with chemical ingredients that meet human health and environmental toxicological criteria. DfE helps buyers identify antimicrobial products that meet Federal Insecticide, Fungicide and Rodenticide Act and other criteria. EPA asked stakeholders to provide comment on which new product categories the Safer Choice and DfE programs could expand into and why. EPA held a listening session on August 29 and accepted written comments through September 11.
EPA Added 10 Chemicals to Safer Chemical Ingredients List
On September 29, EPA announced that it had added 10 chemicals to the Safer Chemical Ingredients List (SCIL), which includes chemicals that EPA’s Safer Choice program has evaluated and determined meet the program’s criteria.41 Updates to the SCIL can be viewed on EPA’s website.42 Six of the 10 new chemicals were listed with a “green circle,” which indicates that the chemical has been verified to be of low concern based on experimental and modeled data. The other four chemicals were listed with a “green half-circle,” which means the chemical is expected to be of low concern based on experimental and modeled data and that additional data would strengthen EPA’s confidence in the chemical’s safer status.
Federal Enforcement Action Against eBay Alleged Illegal Sale of Methylene Chloride Consumer Products
On September 27, the U.S. Department of Justice announced that it had filed an enforcement action in federal district court for the Eastern District of New York alleging that eBay Inc. unlawfully sold and distributed hundreds of thousands of products in violation of the Clean Air Act; Federal Insecticide, Fungicide and Rodenticide Act; and TSCA.43 The complaint’s TSCA allegations included that eBay distributed over 5,600 items in violation of the methylene chloride risk management rule that prohibits retailers from distributing in commerce products that contain methylene chloride for paint and coating removal.
Groups Filed Lawsuit to Compel EPA To Complete TSCA Risk Evaluations; American Chemical Council Moved To Intervene
On September 18, five organizations filed a lawsuit in federal district court in the District of Columbia to compel EPA to complete 22 risk evaluations for existing chemical substances.44 The plaintiffs alleged that EPA’s failure to complete the risk evaluations within the three-and-a-half year timeframe mandated by TSCA harmed their members and staff by prolonging exposure to the chemicals and depriving them of procedures guaranteed to them by TSCA for timely evaluation and management of the chemicals. The 22 chemicals include the 20 high-priority substances designated by EPA in December 2019 and two chemicals for which manufacturers requested evaluations. On October 25, ACC filed a motion to intervene in the case, citing its unique interest in the two manufacturer-requested evaluations, which ACC requested on behalf of its members. ACC contended that the case’s resolution would likely require the court to set a schedule for completion of the 22 risk evaluations and that ACC has an interest in the order in which the evaluations are completed.
Lawsuit Filed To Compel TSCA Rulemaking on Lead Wheel Weights
On August 22, four environmental groups petitioned the Ninth Circuit Court of Appeals for a writ of mandamus requiring EPA to conclude a TSCA rulemaking regulating lead wheel weights within six months.45 The groups contended that EPA committed to prompt action when it granted their 2009 TSCA Section 21 petition requesting that EPA establish regulations prohibiting the manufacture, processing, and distribution in commerce of lead wheel balancing weights. EPA granted the petition in August 2009. The groups argued that “EPA’s nearly 14-year delay is well outside the bounds of what is reasonable, puts human health at risk, prejudices individuals who continue to be exposed to this source of lead in the face of EPA’s inaction, and cannot be justified by competing priorities.” On October 5, the Ninth Circuit granted a joint motion to refer to mediation and extended the deadline for EPA to respond to the petition.
D.C. Circuit to Hear Oral Argument on December 1 in Challenge to TSCA Test Order for 1,1,2-TCE
Oral argument is scheduled for December 1, in a D.C. Circuit Court of Appeals case challenging EPA’s TSCA Section 4(a)(2) test order for 1,1,2-trichloroethane (1,1,2-TCE), a chemical substance primarily used in plastic and petrochemical manufacturing for which EPA is conducting a risk evaluation under TSCA Section 6.46 Judges Karen LeCraft Henderson, Justin R. Walker, and Florence Y. Pan will hear the case. The case was held in abeyance from August 10 to October 11 while EPA evaluated feasibility concerns raised by the petitioner (the Vinyl Institute) regarding the feasibility of the avian reproduction test required by the test order. On October 10, EPA reported to the court that preliminary testing had resolved the technical concerns and that EPA had notified the Vinyl Institute that the required testing should proceed.
Environmental Defense Fund and Trade Groups Challenge TSCA Confidential Business Information Rule
On June 29, Environmental Defense Fund (EDF) filed a petition for review in the D.C. Circuit Court of Appeals challenging EPA’s new regulations for CBI claims under TSCA.47 Two trade groups, ACC and American Fuel & Petrochemical Manufacturers (AFPM), filed a petition challenging the CBI regulations on August 4. The D.C. Circuit consolidated the proceedings, and EDF and ACC each intervened on behalf of EPA in each other’s proceedings.
In August, EDF submitted its preliminary and non-binding statement of issues, which included whether the final rule allows submitters to shield information from the public that TSCA makes ineligible for CBI protection; whether the rule impermissibly allows a chemical to be commercialized without requiring substantiation or EPA review of a CBI claim that shields specific chemical identity; whether the rule unlawfully adopts a too-narrow definition of “health and safety study,” a category of information to which TSCA mandates public access; whether EPA purports to give itself unlawfully broad discretion; and whether the rule reduces transparency previously required by EPA procedures without adequate justification.
ACC and AFPM’s statement of issues, filed on September 8, stated more generally that the issues presented for review are whether the CBI rule “is contrary to TSCA, unreasonable, arbitrary and capricious, an abuse of discretion, without adequate explanation of its reasoning, or otherwise not in accordance with law.” In its motion to intervene, EDF anticipated that ACC and AFPM would argue for restricting public access to information that EPA receives and uses under TSCA or that was not properly asserted or substantiated as CBI.
Briefing in the consolidated cases is scheduled to be complete on April 12, 2024.
EPA Entered Into Consent Decree With Electronics Manufacturer To Resolve Violations of TSCA Section 5 and 13
On September 5, the EPA Environmental Appeals Board ratified a consent agreement between EPA and Kyocera International Inc. (Kyocera) that resolves violations of TSCA Sections 5 (new chemicals) and 13 (import certification).48 Kyocera voluntarily disclosed potential noncompliance with TSCA requirements in June 2021. Kyocera disclosed that it had imported three chemicals that were not on the TSCA Inventory prior to submitting a PMN or low volume exemption application; had imported two polymer chemical substances without complying with recordkeeping measures required for the exemption for certain polymers from PMN requirements; and had failed to submit proper import certifications pursuant to TSCA Section 13 prior to importing four chemicals. EPA concluded that Kyocera qualified for a 75% reduction of the gravity component of the civil penalty pursuant to EPA’s Audit Policy. The parties agreed to a penalty of $105,937.
State Regulatory and Legislative Action
California Law Banned Additional Ingredients in Cosmetic Products. On October 8, Governor Gavin Newsom signed legislation that amended California’s existing law (enacted in 2020) that prohibits the manufacture, sale, delivery, holding, or offering for sale of cosmetic products that contain certain intentionally added ingredients.49 The legislation added 26 substances or groups of substances to the list of prohibited ingredients. The prohibitions for those 26 substances take effect on January 1, 2027. “Cosmetic product” is defined as “an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Governor Newsom Vetoed Single-Product PFAS Bans. Governor Newsom vetoed several bills that would have restricted PFAS in various categories of products. First, he vetoed a bill that would have prohibited manufacture, distribution, or sale of menstrual products that contain intentionally added PFAS or PFAS above a certain concentration.50 Second, he vetoed a bill that would have prohibited manufacture, sale, delivery, distribution, holding, or offer for sale in commerce of cleaning products containing intentionally added PFAS or PFAS exceeding certain concentrations; the prohibition would have phased in to apply to floor sealer and floor finish products.51 Third, he vetoed a bill that would have prevented public entities and public and private schools and institutions of higher education from purchasing or installing artificial turf containing intentionally added PFAS or PFAS above a certain concentration.52 In veto messages concerning these three bills, the governor expressed concern that single-product chemical bans lack regulatory oversight and therefore “fall short of providing enhanced protection to California consumers.”53 He directed the Department of Toxic Substances Control to work with the legislature on alternative approaches to regulating chemicals in consumer products.
Tires Containing 6PPD Added as Priority Product in California’s Safer Consumer Product Program; DTSC Proposes Action To Prevent Regrettable Substitutes. On July 26, the California Department of Toxic Substances Control (DTSC) announced that it had finalized a regulation listing motor vehicle tires containing 6PPD as a Priority Product in its Safer Consumer Products program.54 The regulation took effect on October 1. As a result, manufacturers of motor vehicle tires that contain 6PPD and that are place into the stream of commerce in California must submit a Priority Product Notification by November 30, and then have the option to submit a Chemical Removal Intent/Confirmation Notification, Product Removal Intent/Confirmation Notification, Product-Chemical Replacement Intent/Confirmation Notification, or Preliminary Alternatives Analysis Report (or alternate reporting option) by March 29, 2024.
DTSC also has proposed to add other para-phenylenediamine (PPD) derivatives to the Candidate Chemicals List based on aquatic toxicity and skin sensitization.55 DTSC said adding PPD derivatives to the CCL could help prevent regrettable substitutions. The comment period closes on November 15.
DTSC Added Requirements for Demonstrating Concentration of Toluene in Nail Products. In addition, amendments to the Priority Product Criteria for nail products containing toluene took effect on July 26.56 The amendments establish requirements that manufacturers must meet to demonstrate and certify that the concentration of toluene in nail products they make does not exceed the Alternatives Analysis Threshold of 100 parts per million.
Maine DEP Published Draft Rule to Implement Bans on PFAS and Phthalates in Food Packaging. On October 23, the Maine Department of Environmental Protection (DEP) published notice of a proposed rulemaking to amend its regulations on toxics in packaging to implement statutory prohibitions on phthalates and PFAS in food packaging.57 With respect to phthalates, the proposed rule prohibits manufacturers, suppliers, and distributors from offering for sale or for promotional purposes “a food package that includes inks, dyes, pigments, adhesives, stabilizers, coatings, plasticizers, or any other additives to which phthalates have been intentionally introduced in any amount greater than an incidental presence.” With respect to PFAS, the proposed rule prohibits “food packaging intended for direct food contact comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers which are intended for short-term storage or to hold freshly prepared food, to which PFAS have been intentionally introduced in any amount greater than an incidental presence” and where the packaging falls into one of the following categories, which the proposed regulation describes in more detail: bags and sleeves, bowls, closed containers, flat serviceware, food boats, open-top containers, pizza boxes, plates, and wraps and liners. The prohibitions do not apply to manufacturers with less than US$1 billion of total annual national sales of food and beverage products. The comment deadline on the proposed rule is November 30.
Minnesota Requested Comments to Guide PFAS in Products Reporting Rules. On September 25, the Minnesota Pollution Control Agency (MPCA) published two requests for comments to inform future rulemaking related to reporting of products containing PFAS.58 The reporting of PFAS in products is required to start by January 1, 2026 under a law enacted earlier in 2023.59 MPCA requests comments on relevant issues that MPCA should consider as it develops rules to establish the reporting program as well as a fees program to recover MCPA’s costs to administer the reporting system. The deadline for comments is November 28 at 4:30 p.m.
Nevada Adopts Ingredient Disclosure Requirement for Menstrual Products. On June 2, Governor Joe Lombardo signed a bill that will require packages or boxes containing feminine hygiene products manufactured for sale or distribution in Nevada to bear a label that lists all ingredients in the product.60 “Ingredient” is defined to mean “a fragrance ingredient or other intentionally added substance or combination of substances in a feminine hygiene product, unless the intentionally added substance or combination of substances is confidential business information.” The ingredient list must also be posted on the manufacturer’s website if the manufacturer has one, and a manufacturer may use technology, including a link to a website, to communicate the required information. The requirements apply on and after January 1, 2025.
Amendments to Oregon Chemicals in Children’s Products Law Authorizes Designating Classes of Chemicals as High Priority. On July 27, Governor Tina Kotek signed legislation amending Oregon’s Chemicals in Children’s Products law to allow the Oregon Health Authority to add to its list of high priority chemicals a “class of chemicals.”61 If added, the Authority may exclude from the list specific members of the class or a subclass of chemicals if they do not share the same hazards as other members of the class of chemicals.
Oregon Law Bans Certain Chemicals from Cosmetics and Requires Notifications for Other High Priority Chemicals of Concern. Governor Kotek signed a bill into law on July 31 that requires the Oregon Health Authority to adopt and maintain a list of high priority chemicals of concern used in cosmetic products.62 The list also must include practical quantification limits for each of those chemicals. Effective January 1, 2027, if a manufacturer sells or offers for sale in the state a cosmetic product that contains a high priority chemical of concern at or above a de minimis level, the manufacturer must provide a notice for Oregon consumers on the manufacturer’s website. Effective January 1, 2027, the law also prohibits a person from manufacturing, selling, offering for sale, or distributing for sale or use in the State any cosmetic product that contains various chemicals that have been intentionally added above the practical quantification limit. Those chemicals are ortho-phthalates, PFAS, formaldehyde, methylene glycol, mercury and mercury compounds, triclosan, m-Phenylenediamine and its salts, and o-Phenylenediamine and its salts. The law also includes a prohibition on cosmetic products containing lead or lead compounds at or above 10 parts per million.
Vermont Enacted Law Requiring Stewardship Programs for Hazardous Household Products. Vermont Governor Phil Scott signed legislation on June 12 that requires the State to implement a program to require manufacturers of household products containing a hazardous substance to implement a stewardship organization to collect those products free of charge to the public.63 A stewardship organization must submit a collection plan prior to July 1, 2025. Beginning six months after a final decision on the adequacy of a collection plan, manufacturers of covered household hazardous products may not sell, offer for sale, or deliver to a retailer for subsequent sale such products unless the manufacturer is participating in a stewardship organization implementing an approved collection plan and other related requirements are met.
Follow this link to read previous editions of The Chemical Compound.
* Margaret Barry contributed to this Newsletter. Ms. Barry is employed as an Environmental Law Writer at Arnold & Porter’s New York Office.
© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
88 Fed. Reg. 70516 (Oct. 11, 2023).
Pub. L. No. 116-92 (Dec. 20, 2019).
88 Fed. Reg. 49180 (July 28, 2023).
88 Fed. Reg. 74712 (Oct. 31, 2023).
See “Pending EO 12866 Regulatory Review: Revisions to Regulations on Persistent, Bioaccumulative, and Toxic Chemicals Subject to the Toxic Substances Control Act (TSCA),” Reginfo.gov (last visited Oct. 25, 2023).
See “Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h),” EPA (last updated May 3, 2023).
88 Fed. Reg. 67278 (Sept. 29, 2023).
88 Fed. Reg. 43562 (July 10, 2023).
88 Fed. Reg. 48249 (July 26, 2023).
88 Fed. Reg. 50863 (Aug. 2, 2023).
88 Fed. Reg. 51309 (Aug. 3, 2023).
Press Release, EPA, EPA Announces Experts Selected for the Letter Peer Review of White Paper for Asbestos Part 2 Risk Evaluation under TSCA (Oct. 25, 2023); 88 Fed. Reg. 40819 (June 22, 2023).
See “Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos,” EPA (last updated Aug. 3, 2023).
Maria Hegstad, “EPA Prepares To ‘Onboard’ Five Chemicals For Possible TSCA Evaluation,” Inside TSCA (Sept. 20, 2023).
Maria Hegstad, “EPA Floats 15 Chemicals As Candidates For Next TSCA Prioritization Cycle,” Inside TSCA (Oct. 5, 2023).
88 Fed. Reg. 74292 (Oct. 30, 2023).
“TSCA Section 21,” EPA (last updated Aug. 14, 2023).
Press Release, EPA, EPA Grants Tribal Petition to Protect Salmon from Lethal Chemical (Nov. 2, 2023).
88 Fed. Reg. 47782 (July 25, 2023).
Office of Poll. Prevention & Toxics, EPA-740-B-23-005, Guidance and Instructions for Reporting Asbestos Under TSCA Section 8(a)(1) (Oct. 2023).
88 Fed. Reg. 40728 (June 22, 2023).
88 Fed. Reg. 39804 (June 20, 2023).
88 Fed. Reg. 46726 (July 20, 2023).
Press Release, EPA, EPA Announces New Framework to Prevent Unsafe New PFAS from Entering the Market (June 29, 2023); “Framework for Addressing New PFAS and New Uses of PFAS,” EPA (last updated Sept. 13, 2023).
Office of Inspector Gen., EPA, 23-P-0026, The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions (Aug. 2, 2023).
88 Fed. Reg. 64890 (Sept. 20, 2023).
88 Fed. Reg. 74360 (Oct. 31, 2023).
88 Fed. Reg. 41035 (June 23, 2023).
88 Fed. Reg. 45089 (July 14, 2023).
Press Release, EPA, EPA Requires Toxics Release Inventory Reporting on DINP (July 13, 2023).
“Addition of Diisononyl Phthalate Category Rule,” EPA (last updated July 14, 2023).
News Release, Nat’l Acads. of Sci., Eng’g, & Med., New Report Provides Scientific Review of EPA’s Draft Formaldehyde Assessment (Aug. 9, 2023).
88 Fed. Reg. 48463 (July 27, 2023).
Press Release, EPA, EPA Updates Safer Chemical Ingredients List (Sept. 29, 2023).
“Safer Chemical Ingredients List,” EPA (last updated Sept. 29, 2023).
Press Release, U.S. Dept. of Justice, Justice Department Files Complaint Alleging Environmental Violations by eBay (Sept. 27, 2023). See United States v. EBay, Inc., No. 1:23-cv-07173 (E.D.N.Y., filed Sept. 27, 2023).
Env’t Def. Fund v. EPA, No. 23-1166 (D.C. Cir.); 88 Fed. Reg. 37155 (June 7, 2023).
In re Kyocera Int’l, Inc., No. TSCA-HQ-2023-5005 (EAB Sept. 5, 2023).
“Adopted Priority Product: Motor Vehicle Tires Containing 6PPD,” DTSC (last visited Nov. 3, 2023).
“Proposed Candidate Chemical: PPD Derivatives,” DTSC (last visited Nov. 3, 2023).
“Effective January 1, 2023: Nail Products Containing Toluene,” DTSC (last visited Nov. 3, 2023).
“Chapter 80: Reduction of Toxics in Packaging,” Maine DEP (last visited Nov. 3, 2023).