The Chemical Compound—February 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, jurisdictions outside the US, 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
- Petitioners Dismissed Challenges to TSCA Section 6 Risk Determinations for HBCD; Dismissal of Challenge to Methylene Chloride Determination in the Works
- Enforcement Action and Citizen Suit Launched Regarding Alleged PFAS in Pesticide Containers
- Court Restarted Case Challenging EPA’s Denial of TSCA Petition to Prohibit Drinking Water Fluoridation
- Plaintiffs Argue EPA’s Withholding of CBI-Designated Information About New Chemicals Was Unlawful
- European Chemicals Agency Released PFAS Restriction Proposal
- Legislative Developments
- Regulatory Developments
- New York
Petitioners Dismissed Challenges to TSCA Section 6 Risk Determinations for HBCD; Dismissal of Challenge to Methylene Chloride Determination in the Works
The Ninth Circuit Court of Appeals granted voluntary dismissal of challenges to EPA’s 2020 determinations that Cyclic Aliphatic Bromide Cluster (HBCD) did not present an unreasonable risk for six conditions of use.1 EPA withdrew these determinations of no unreasonable risk in June 2022 when it issued a revised risk determination finding that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment under the conditions of use.2
EPA has also told the Ninth Circuit that the Agency is conferring with parties challenging 2020 determinations of no unreasonable risk for methylene chloride regarding potential voluntary dismissal of the cases after EPA issued a revised risk determination in November 2022 that found that methylene chloride, as a whole chemical substance, presents an unreasonable risk to health and the environment.3 EPA said the parties expected to file a stipulation or motion regarding future proceedings prior to April 10, 2023.
Enforcement Action and Citizen Suit Launched Regarding Alleged PFAS in Pesticide Containers
On December 19, 2022, EPA filed an enforcement action in the federal district court for the Eastern District of Pennsylvania asserting that a manufacturer of plastic containers violated the significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances promulgated by EPA in 2020.4 EPA alleged that the defendant manufactured a substance covered by the rule as a byproduct of its plastic fluorination process. EPA’s complaint—the unredacted version of which was initially sealed to protect information potentially subject to TSCA protections for confidential business information (CBI)—sought declaratory and injunctive relief. The court, however, granted EPA’s motion to unseal the complaint after the defendant informed the US that it did not believe the redacted information constituted CBI. The federal filing is somewhat unusual because TSCA civil violations are frequently resolved through administrative complaints handled by the Agency without the need for judicial proceedings.
On December 27, 2022, two nonprofit organizations filed a citizen suit concerning the same alleged violation of the LCPFAC SNUR.5 The citizen-suit plaintiffs alleged that they were concerned that EPA would not diligently prosecute its enforcement action due to the complaint’s “many redactions” and “the lengthy two-year delay” between EPA’s initiation of discussions with the defendant and the filing of the enforcement action. The defendant sought to dismiss the citizen suit, arguing that it was barred by TSCA’s diligent prosecution provision and that the plaintiffs should have intervened in the federal enforcement action.
Court Restarted Case Challenging EPA’s Denial of TSCA Petition to Prohibit Drinking Water Fluoridation
On January 20, 2023, the federal district court for the Northern District of California denied EPA’s request that it wait to schedule expert discovery in litigation challenging EPA’s denials of a TSCA Section 21 petition that requested that EPA prohibit the fluoridation of drinking water.6 EPA argued that the court should allow the National Toxicology Program (NTP) more time to complete the review of draft documents issued in 2022 that EPA described as “of unquestionable relevance and importance to inform a decision whether the practice of community water fluoridation presents an unreasonable risk of injury to human health.” The court previously granted, in October 2022, the plaintiffs’ motion to lift a stay that had been in place since 2020.7 The court found that the plaintiffs had cured previously identified standing defects and concluded that waiting for publication of final NTP review documents was not warranted. The court stated that publication of final documents was not guaranteed and noted that other relevant scientific studies had been published since the stay was instituted. The October 2022 order provided that, to permit commencement of expert review of the new evidence, the stay should be lifted for production of the NTP draft documents subject to a protective order, but that further expert discovery would await further scheduling. In its administrative motion urging the court to hold off on scheduling the additional expert discovery, EPA again contended that it was important to wait for NTP’s final documents since the drafts could change in meaningful ways. The court was not persuaded by EPA’s arguments, finding that no additional factual developments warranted the six-month delay sought by the Agency. The court said it would adjudicate EPA’s assertion of privilege over the draft NTP report and whether the plaintiffs were entitled to discovery into comments received from other federal agencies on the drafts, and that it would consider setting an expedited trial date after adjudicating those issues.
Plaintiffs Argue EPA’s Withholding of CBI-Designated Information About New Chemicals Was Unlawful
On January 4, 2023, EPA notified the federal district court for the District of Columbia that it had completed its efforts to provide premanufacture notices (PMNs) and related documents that were at issue in a lawsuit filed in 2020 in which the Environmental Defense Fund and other plaintiffs alleged that EPA had failed to make information about new chemicals publicly available, as required by TSCA.8 In its January 4 notice, EPA said it had posted complete versions of PMNs to ChemView and had provided other previously omitted documents submitted separately from PMNs directly to the plaintiffs. EPA noted that it had not provided or posted any information designated by PMN submitters as confidential business information (CBI). On January 18, the plaintiffs submitted a notice informing the court that, in their view, the withholding of the information designated as CBI—which the plaintiffs said included health and safety studies—was unlawful. The plaintiffs contended that the “central merits question” of the case—“whether it is consistent with TSCA for EPA to withhold information simply because the submitter designated the information as confidential even though the information does not meet the statutory requirements for protection” as CBI under TSCA Section 14—was not ripe for resolution because EPA’s pending motion for judgment on the pleadings only raised threshold justiciability and jurisdiction questions.
Developments Outside the United States
European Chemicals Agency Released PFAS Restriction Proposal
On February 7, 2023, the European Chemicals Agency (ECHA) released a 211-page restriction proposal regarding PFAS.9 The restriction proposal was prepared based on a dossier submitted by authorities in Denmark, Germany, the Netherlands, Norway, and Sweden. The proposed restrictions were submitted to ECHA on January 13, 2023, and include measures effectively prohibiting or limiting the manufacture, placing on the market, and use of PFAS substances as substances and in mixtures or articles above certain concentration levels.
The proposal defines the scope of substances affected based on a “structural definition”—specifically, “[a]ny substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it),” with certain exceptions. The definition aligns with the Organisation for Economic Co-operation and Development definition for PFAS published in 2021. ECHA reports the definition could include as many as 10,000 individual substances (however, no reference was made with regard to how many substances are on the market in the EU which meet the definition). A few substances within the scope of the definition but which are more readily degradable, and would not qualify under Registration, Evaluation, and Authorization of Chemicals (REACH) persistence standards, are excluded from the restrictions proposal. Specifically, “a substance that only contains the following structural elements is excluded from the scope of the restriction: CF3-X or X-CF2-X’, where X = -OR or -NRR’ and X’ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR’’, -SR’’ or –NR’’R’’’; and where R/R’/R’’/R’’’ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).”
The proposal will generally prohibit the manufacture, use, or placement on the market of PFAS on their own or in another substance, as a constituent, a mixture, or an article, in a concentration (1) at or above 25 parts per billion (ppb) for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification); (2) 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis (polymeric PFAS excluded from quantification); or (3) 50 ppm for PFAS (with polymeric PFAS included). The proposal discusses how a polymeric material will qualify as being below this threshold limit. The restrictions will not apply to active substances in biocidal products (Regulation (EU) 528/2012), plant protection products (Regulation (EC) 1107/2009), or human and veterinary medicinal products (Regulation (EC) No 726/2004, Regulation (EU) 2019/6, and Directive 2001/83/EC), as these products/uses are addressed under separate EU regulations.
The prohibitions will become effective 18 months after the proposed restrictions are finalized. An outright prohibition on all PFAS was among the restriction options considered; however, the proposal would phase in many of the restrictions over the course of either 5 or 12 years for certain uses. The exemptions, or derogations, assume that there are, or will be, suitable alternatives available for each type of use by the end of the derogation period. Some five-year exemptions cover PFAS in polymerization aids, certain refrigerants, and fluoropolymers and perfluoropolyethers used in food contact materials as needed for industrial and professional food and feed production. Some 12-year exemptions include PFAS uses in textiles used in personal protective equipment, other refrigerants, diagnostic laboratory testing, certain lubricants, and implantable medical devices.
Following this announcement and publication of the proposed restrictions, ECHA’s scientific committees for Risk Assessment and for Socio-Economic Analysis will review the proposal to verify that it meets REACH’s legal requirements. If it does, the committees will begin their respective evaluations of the proposal, with a six-month consultation period planned to begin on March 22, 2023. An online information session will be held on April 5, 2023 to explain the restriction process and to help persons interested in participating in the consultation.
Appropriations Act Required Health and Human Services Activities on Asbestos and PFAS in Cosmetic Products
The appropriations bill signed by President Biden on December 29, 2022 included provisions requiring regulations regarding asbestos in talc-containing cosmetic products and a report on PFAS in cosmetic products.10 Section 3505 requires the Secretary of Health and Human Services (Secretary) to promulgate regulations “to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.” The law directs that the regulations be proposed by December 29, 2023 and finalized within 180 days of the end of the public comment period on the proposed regulations. Section 3506 requires that the Secretary “assess the use of [PFAS] in cosmetic products and the scientific evidence regarding the safety of such use in cosmetic products, including any risks associated with such use.” The law provides that the Secretary may consult with the National Center for Toxicological Research. The report must be published by December 29, 2025.
Defense Funding Bill Sets October 2026 Start Date for Ban on Procurement of PFAS-Containing Personal Protective Firefighting Equipment; Report Required on PFAS Uses That Are Critical for National Security
The James M. Inhofe National Defense Authorization Act (NDAA) for Fiscal Year 2023 included a subtitle on “Treatment of Perfluoroalkyl Substances and Polyfluoroalkyl Substances.”11 Section 345 prohibits the Department of Defense from entering into contracts on or after October 1, 2026 for procurement or purchase of personal protective firefighting equipment for use by federal or civilian firefighters if the equipment contains intentionally added PFAS. The law explicitly provides that existing inventories of equipment are not impacted and that the Defense Department does not have an obligation to test equipment to confirm the absence of PFAS. If the Secretary of Defense determines that no “sufficiently protective” personal protective firefighting equipment is available, the statutory deadline may be extended. Another provision (Section 343) provides that the Department of Defense may award prizes—pursuant to authority granted by the NDAA for Fiscal Year 2021—for development of personal protective firefighting equipment that does not contain intentionally added PFAS. Section 347 directs the Defense Department to submit a report to Congress by June 1, 2023 outlining uses of PFAS that are critical to US national security, with a focus on sectors in the Department’s February 2022 report on “Security Defense-Critical Supply Chains” and on “sectors of strategic importance for domestic production and investment to build supply chain resilience, including kinetic capabilities, energy storage and batteries, and microelectronics and semiconductors.” The Defense Department must also brief Congress annually regarding procurement of nonstick cookware and cooking utensils and upholstered furniture, carpets, and rugs that may have been treated with stain-resistant coatings. The briefing must cover steps taken to identify items that contain perfluorooctane sulfonate (PFOS) or perfluorooctanoic acid (PFOA) and steps to limit procurement of items containing PFOS and PFOA. Other provisions in the subtitle concerned publication of Defense Department research on PFAS (Section 341) and funding for the Agency for Toxic Substances and Disease Registry’s study of the health implications of PFAS in drinking water (Section 342).
New Federal Law Requires Development of Guidance and Curriculum to Reduce Firefighter Exposure to PFAS
On December 20, 2022, President Biden signed the Protecting Firefighters from Adverse Substances Act (PFAS Act), which requires the Department of Homeland Security (Department) to publish guidance and develop a curriculum to reduce the exposure of firefighters and other emergency response personnel to PFAS.12 The Department is to make the curriculum available in consultation with the US Fire Administration, EPA, the National Institute for Occupational Safety and Health, and other agencies. The curriculum must be designed to (1) reduce and eliminate exposures to PFAS from firefighting foam and personal protective equipment, (2) prevent the release of PFAS from firefighting foam into the environment, and (3) educate firefighters and other emergency response personnel on firefighting tools and equipment that do not contain PFAS. The Department also must develop and publish guidance for firefighters and emergency response personnel on training, education programs, and best practices and create a regularly updated online repository of tools and best practices for reducing, limiting, and preventing release of and exposure to PFAS. The US Fire Administration must consult with interested parties to inform its recommendations for the curriculum. The PFAS Act identifies parties who should be consulted, including firefighters and other emergency response personnel, communities impacted by PFAS contamination, scientists, voluntary standards organizations, state fire training academies, state fire marshals, and manufacturers of firefighting tools and equipment. The law requires development of the guidance, curriculum, and online repository by December 20, 2023 and requires that the guidance and curriculum be reviewed and updated every three years.
PFAS Runoff at Airports Act Signed into Law
On December 20, 2022, President Biden also signed the Preventing PFAS Runoff at Airports Act into law.13 This law temporarily authorizes the federal government to cover 100 percent of the costs of aqueous film forming foam (AFFF) input-based testing equipment at airports. The AFFF input-based equipment does not require external discharges. The law requires the Federal Aviation Administration (FAA) to conduct outreach efforts to make airports aware of the 100 percent cost-share authority. It also requires the FAA to provide a congressional briefing on the outreach efforts and on options to reimburse airports that have acquired such input-based testing equipment without federal funding or with less federal funding. The increased cost-share authority expires after the earlier of five years or 180 days after the FAA terminates the eligibility of the input-based testing equipment for Airport Improvement Program funding.
EPA Issues Second TSCA Test Order Under National PFAS Testing Strategy
On January 4, 2023, EPA announced its issuance of a second TSCA Section 4 test order under its National PFAS Testing Strategy.14 The order is directed to four companies that EPA has identified as manufacturers or processors of trifluoro(trifluoromethyl)oxirane (HFPO), which is a substance used in making plastics and in organic chemical manufacturing. EPA said it had concluded, based on existing hazard and exposure data, that HFPO may present an unreasonable risk of injury to health or environment and that there is insufficient information to determine the effects on human health from inhalation of HFPO. EPA stated that the test order would address this data need with respect to HFPO, as well as improve the Agency’s understanding of structurally similar PFAS. The order provides that recipients must respond to the order within 30 days by identifying as a manufacturer or processor (or both) of HFPO or by claiming that they are not subject to the order. Recipients subject to the order must then either conduct testing on their own or as part of a consortium, submit existing studies and information that they believe EPA did not consider, or apply for an exemption from the testing requirements if another company is submitting the required testing. The HFPO test order includes requirements and associated deadlines for Tier 1 testing of physical-chemical properties and inhalation-based health effects. EPA review of Tier 1 data will then inform EPA determinations regarding further testing.
EPA Proposed SNUR for Inactive PFAS
On January 26, 2023, EPA proposed a significant new use rule (SNUR) for 330 PFAS designated as inactive on the TSCA Chemical Substance Inventory that are not subject to an existing SNUR.15 The designation of these PFAS as inactive generally indicates the substances have not been manufactured (including imported) or processed in the US since June 21, 2006 in a manner that would have previously triggered a TSCA reporting requirement. If the SNUR is finalized, any person who intends to manufacture or process one of the chemicals for any use would have to notify EPA at least 90 days before commencing the manufacture or processing. EPA would then be required either to determine that the new use was not likely to present an unreasonable risk of injury to health or the environment or to take alternative regulatory action. EPA proposed exemptions from the notice requirement for PFAS present as impurities, certain byproducts, and importing or processing of articles containing the inactive PFAS. The proposed SNUR is part of EPA’s implementation of the “PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024.” EPA said it would accept comments on the proposed SNUR—including specific documentation of ongoing uses of the 330 PFAS—through March 27, 2023.
EPA Proposed SNURs for 35 PFAS Subject to TSCA Section 5(e) Orders
On December 2, 2023, EPA opened a public comment period on proposed SNURs for 35 PFAS that previously were the subject of premanufacture notices (PMNs) and also subject to orders issued by EPA pursuant to TSCA Section 5(e) that required protective measures to limit exposures or otherwise mitigate potential unreasonable risk.16 The proposed SNURs also are in furtherance of the Agency’s PFAS Strategic Roadmap and would define significant new uses as manufacturing (including importing), processing, use, distribution in commerce, or disposal that does not conform to the restrictions in the Section 5(e) orders. EPA said it believed the SNURs were necessary to ensure that all manufacturers and processors of the chemicals—not just the original submitters of the PMNs—adhere to the standards imposed in the Section 5(e) orders. EPA also said the proposed SNURs would prevent uses that could significantly increase the magnitude and duration of exposure to humans and the environment. The comment period on the proposed SNURs closed on January 17, 2023.17
Rulemaking Petition Filed to Rescind TSCA Exemptions for 600 PFAS
On October 13, 2022, Earthjustice submitted a petition to EPA to revoke approvals of approximately 600 PFAS that were granted through the Low Volume Exemption (LVE) or Low Release and Exposure Exemption (LoREX) to TSCA’s premanufacture notice requirements.18 The petition incorporates by reference a 2021 petition that asked EPA to prohibit use of the Byproducts Exemption, the LVE, the LoREX, and the Polymer Exemption for PFAS.19 The October 2022 petition states: “As a result of the well-established harms that PFAS pose to human health and the environment, EPA cannot continue to conclude that PFAS ‘will not present an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation’—the finding that is required for an LVE or LoREX application to satisfy TSCA.” The petition contends that, to comply with TSCA, EPA regulations, and the Administrative Procedure Act, EPA must revoke previously granted LVEs and LoREXs for PFAS.
Industry Petitions EPA to Make Changes to Premanufacture Notice Reviews
On November 11, 2022, a coalition of companies petitioned EPA to amend its regulations concerning premanufacture notices. The coalition filed the petition pursuant to the Administrative Procedure Act and included an appendix specifying amendments that the coalition said would facilitate efficient review of new chemical substances. The proposed amendments would, among other things, establish an option to administratively appeal a PMN risk determination. Other proposed changes are intended to speed reviews, including by limiting extensions of the notice review period, requiring reimbursement of 50 percent of the notice fee if the extension does not fall under the good cause exemption, and requiring EPA to notify submitters of errors or missing information in PMNs within 15 days of receipt. The proposed changes also would require EPA to rely on data provided by the submitter unless EPA demonstrates that the data does not represent best available science. In addition, the proposed amendments specify standards for evaluating unreasonable risk and require EPA to include a brief written statement identifying the basis for an unreasonable risk determination, including identification of foreseeable uses that were the basis for the determination.
Board of Scientific Counselors Reviewing the New Chemicals Collaborative Research Program
On October 24–25, 2022, an ad hoc committee of the Board of Scientific Counselors (BOSC) met to consider EPA research plans for the New Chemicals Collaborative Research Program (NCCRP). In advance of the meeting, an updated review draft of a report on the NCCRP was issued for BOSC review.20 The updated report details specific research projects proposed for the NCCRP. The BOSC—which is a federal advisory committee that provides recommendations and advice to EPA’s Office of Research and Development (ORD) on ORD research programs—is expected to provide comments and recommendations. The NCCRP’s goal is to bring innovative science to inform risk assessment and decisionmaking in order to help EPA overcome information gaps and meet statutory new chemical review requirements in a timely, effective, and efficient manner. Under the NCCRP, ORD is working with the Office of Pollution Prevention and Toxics (OPPT) to advance five key Research Areas: (1) updates and refinements to chemical analog and category approaches; (2) development and expansion of databases containing TSCA chemical information; (3) development and refinement of predictive models for physicochemical properties, environmental fate/transport, hazard, exposure, and toxicokinetics; (4) integration and application of in vitro new approach methodologies (NAMs); and (5) development of a TSCA new chemicals decision support tool that utilizes curated data. Earlier in 2022, EPA convened a public meeting to discuss the NCCRP initiative and the main research areas.
EPA Announced Initiative to Streamline New Chemicals Process for Electric Vehicle, Semiconductor, and Renewable Energy Sectors
On October 5, 2022, EPA announced a new initiative to streamline reviews of certain new chemical substances with applications in batteries, electric vehicles, semiconductors, and renewable energy generation.21 The initiative encompasses reviews for mixed metal oxides (MMOs), including new and modified cathode active materials (CAMs). MMOs have electric applications in batteries, including lithium-ion batteries used in electric vehicles. MMOs may also be used for semiconductors and in solar cells and wind power turbines. EPA also issued a compliance advisory reaffirming that MMOs are chemical substances subject to TSCA and advising that anyone who plans to manufacture (which TSCA defines to include import) an MMO must comply with TSCA Section 5 requirements.22 EPA also reaffirmed that modified CAMs are considered chemical substances, not mixtures. EPA has conducted training and outreach regarding the standardized approach it will apply to new chemical reviews for MMOs, including a kick-off webinar in November 2022.23 The webinar addressed, among other things, potential consent order terms for MMOs, including worker protection and hazard communication requirements and restrictions on manufacturing, processing, use, and disposal. A second webinar is planned for early 2023 and will address details of standardized risk assessment for MMOs/CAMs, share a risk calculator and decision tree, and provide hands-on training using case studies.
Roundup of TSCA Section 6 News
On November 22, 2022, EPA sent its proposed TSCA Section 6(a) risk management rule for methylene chloride to the Office of Management and Budget for review. Twelve days earlier EPA published notice of its final revised risk determination for methylene chloride, which determined that methylene chloride, as a whole chemical substance, presents an unreasonable risk of injury to health when evaluated under its conditions of use.24 The revised risk determination removed the assumption that workers wear personal protective equipment (PPE) appropriately at all times, which resulted in five additional conditions of use (for a total of 52 conditions of use) driving the determination of unreasonable risk. In the notice regarding the revised risk determination, EPA said it was conducting a screening approach to assess potential risks from air and water pathways for methylene chloride to identify if there might be risks that the risk evaluation did not account for. EPA said it would address the screening-level approach in the forthcoming proposed risk management rule.
EPA finalized revised risk determinations for five other chemicals in December 2022 and January 2023: perchloroethylene,25 n-methylpyrrolidone,26 1-bromopropane,27 carbon tetrachloride,28 and trichloroethylene.29 These revised determinations also used the whole chemical approach and removed the assumption of appropriate PPE use.
For 1,4-dioxane—another of the first 10 chemical substances for which EPA conducted risk evaluations—EPA is preparing a supplemental risk evaluation that applies the screening-level approach to evaluate potential exposures and associated risks to fenceline communities. EPA told the Ninth Circuit Court of Appeals that it also is developing an analysis of impacts to the general population from “down-the-drain” releases of 1,4-dioxane and that it is developing methods to consider aggregate general population exposures from multiple sources of 1,4-dioxane.30 EPA anticipates issuing the 1,4-dioxane supplemental risk evaluation for public comment in early 2023.
Other actions that EPA anticipates taking under TSCA Section 6 in 2023 include proposed amendments to its Section 6(h) risk management rules for five persistent, bioaccumulative, and toxic (PBT) substances, for which EPA’s Unified Agenda estimated a November 2023 issuance. EPA also said it planned to issue proposed Section 6(a) risk management rules in 2023 for perchloroethylene, trichloroethylene, carbon tetrachloride, 1-bromopropane, and n-methylpyrrolidone, as well as a final risk management rule for chrysotile asbestos (anticipated in October 2023).
EPA Proposed Substantial Increases to TSCA Fees; Proposal Would Also Codify Fee Exemptions
On November 16, 2022, EPA published a supplemental notice of proposed rulemaking to amend its 2018 TSCA Fees Rule.31 The supplemental proposal modifies a proposed rule published in January 2021 at the end of the Trump administration.32 The supplemental proposal included significant fee increases for TSCA Section 4(a) test orders, test rules, or enforceable consent agreements (ECAs); TSCA Section 5 notices and exemptions; and TSCA Section 6 risk evaluations. EPA said the increases were necessary to provide a sustainable source of funds for EPA to use to fulfill its legal obligations under TSCA. Fees for test orders would increase to $25,000 (from current fee of $11,650); fees for test rules and ECAs would increase to $50,000 (from $35,080 and $27,110, respectively); fees for premanufacture notices, significant new use notices, and microbial commercial activity notices (MCANs) and consolidated MCANs would increase to $45,000 (from $19,020); fees for Section 5 exemptions such as the low releases and low exposures (LoREX) exemption would increase to $13,320 (from $5,590); and fees for EPA-initiated risk evaluations would increase to $5,081,000 (from the current level of $1,605,000). In the supplemental notice, EPA retained its proposal to codify exemptions from fees for EPA-initiated risk evaluations under TSCA Section 6 for imported articles, byproducts, impurities, non-isolated intermediates, research and development, and chemical substances with production volume less than 2,500 pounds (unless all manufacturers of a chemical manufacture a substance in quantities below 2,500 pounds). In the supplemental proposed rule, EPA included a new proposal for self-identification requirements for manufacturers and importers of chemical substances with production volume less than 2,500 pounds. EPA also proposed to apply the six exemptions to fees for TSCA Section 4 test rules, but with an 1,100-pound threshold for the production volume exemption. EPA also proposed to narrow the byproducts exemption so that it only would apply to byproducts not later used for commercial purposes or distributed for commercial use. Other proposed modifications included changes to the payment plan for fees for manufacturer-requested risk evaluations and to the allocation of fees for EPA-initiated risk evaluations. EPA dropped proposals to add new fee categories for amended test orders under TSCA Section 4 and for bona fide intent to manufacture or import notices and notices of commencement of manufacture or import under TSCA Section 5. Other elements of the supplemental proposed rule include a partial refund of 20 percent for TSCA Section 5 submissions withdrawn after the first 10 business days during the assessment of the chemical and a requirement for processors subject to TSCA Section 4 test orders and enforceable consent agreements to pay fees.
EPA’s Updated Economic Analysis for TSCA PFAS Reporting Rule Estimated Cost at $876 Million
On November 23, 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis for the proposed TSCA Section 8(a)(7) rule33 for PFAS reporting and recordkeeping.34 The FY 2020 National Defense Authorization Act directed EPA to promulgate the final Section 8(a)(7) rule by January 1, 2023, but EPA missed this deadline. EPA initially certified the proposed Section 8(a)(7) rule as not having a significant economic impact on a substantial number of small entities. After the proposed rule was published, EPA received feedback and found additional data, including information on the number of article importers that would be affected by the rule. After updating its analysis and determining that the previous certification regarding the rule’s impact on small entities was not supported, EPA convened a Small Business Advocacy Review Panel and then prepared an IRFA under the Regulatory Flexibility Act (RFA). The IRFA includes an updated economic analysis that discusses cost estimates for all affected entities, not just small entities, as well as the discussions required under the RFA. The RFA requires that the IRFA discuss, among other things, any significant alternatives that would accomplish the stated objectives while minimizing any significant economic impact on small entities. In the updated economic analysis, EPA revised the estimates of the proposed rule’s industry costs from approximately $10.8 million in the original draft analysis to $876 million. Estimated agency costs increased from $948,078 to $1.6 million. Affected small businesses are expected to incur $863.5 million in costs. This increase in estimated costs to industry was a result of EPA’s inclusion of article importers in the updated analysis. EPA estimates that 131,157 firms import articles potentially containing PFAS and that 13,116 of those firms (10 percent) import articles containing PFAS. EPA also estimates that 97.3 percent of article importers would be small importers (127,615) and that 12,762 would have to report. In addition to including article importers in its analysis, EPA also updated cost estimates for activities that affected entities will have to perform, including rule familiarization (understanding the rule and its requirements and understanding the structural definition of PFAS); article importer compliance determination; form completion; confidential business information (CBI) substantiation; recordkeeping; and CDX registration and electronic signature. Comments on the IRFA and Updated Economic Analysis were due on December 27, 2022.
EPA Partially Granted Massachusetts Petition to List Chemicals on TRI List
On November 30, 2022, EPA published a final rule adding 12 chemicals to the Toxics Release Inventory (TRI) list in response to a 2014 petition by the Toxics Use Reduction Institute (TURI).35 The TURI petition requested the addition of 25 chemicals to the TRI list. EPA determined that 12 of the chemicals met Emergency Planning and Community Right-to-Know Act (EPCRA) criteria for listing. Three of the remaining 13 chemicals had already been added to the TRI list in unrelated actions, and EPA determined that available data for nine of the chemicals was not sufficient to establish that the EPCRA criteria were met. For the remaining chemical—octabromodipheynyl ether (octaBDE)—EPA noted that EPA had issued a SNUR that required notification of manufacture or import after January 1, 2005, that no SNUNs had been submitted, and that there had been no octaBDE submissions under the Chemical Data Reporting rule since 2006. EPA therefore did not add octaBDE to the TRI list because the Agency did not expect that TRI reports would be filed. The 12 chemicals added to the TRI list are:
- Dibutyltin dichloride; 683-18-1;
- 1,3-Dichloro-2-propanol; 96-23-1;
- Formamide; 75-12-7;
- 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB); 1222-05-5;
- N-Hydroxyethylethylenediamine; 111-41-1;
- Nitrilotriacetic acid trisodium salt; 5064-31-3;
- p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9;
- 1,2,3-Trichlorobenzene; 87-61-6;
- Triglycidyl isocyanurate; 2451-62-9;
- Tris(2-chloroethyl) phosphate; 115-96-8;
- Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8; and
- Tris(dimethylphenol) phosphate; 25155-23-1.
EPA also added HHCB to the list of chemicals of special concern with a 100-pound reporting threshold.
EPA Proposed to Add PFAS to List of Chemicals of Special Concern for TRI Reporting
EPA published a proposed rule on December 5, 2022 that would include PFAS added to the TRI list pursuant to the National Defense Authorization Act for Fiscal Year 2020 on the list of chemicals of special concern.36 The result of this listing would be to eliminate the availability of the de minimis exemption from reporting for these PFAS and removal of the option to use Form A, a simplified reporting form that does not include information on releases or other waste management, source reduction information, or chemical-specific information beyond the chemical’s identity. In addition, range reporting for these PFAS would be limited. The proposed rule also would remove the availability of the de minimis exemption under the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. That exemption is a small concentration exemption, as opposed to a small quantity exemption. The current exemption allows suppliers to elect not to provide notifications to customers who receive mixtures or trade name products containing a listed chemical if the chemicals are present at concentrations below one percent of the mixture (or 0.1 percent for carcinogens). EPA stated the proposed rule would provide “a more complete picture” of PFAS releases and waste management quantities and help ensure that purchasers of mixtures and trade name products are aware of the presence of the PFAS in mixtures and products they purchase. The comment period on the proposed rule closed on February 3, 2023.
Other TRI Reporting News: Release of 2021 Data, Amended Definition of Parent Company, and Updated List of NAICS Codes
On October 26, 2022, EPA release updated TRI data about chemical releases, chemical waste management, and pollution prevention activities at more than 20,000 federal and industrial facilities during the 2021 calendar year.37 EPA released preliminary data in July 2022 and will publish a full analysis of the data in early 2023. In its announcement of the 2021 data, EPA reported that it had received 89 PFAS reporting forms on 44 discrete PFAS from 44 facilities, with data on the forms indicating that the 44 facilities managed more than 1,306,481 pounds of production-related PFAS waste, up from a reported 841,000 pounds of production-related PFAS waste in 2020. EPA noted that PFAS is used in low concentrations in many products and that it expected its proposed elimination of the TRI de minimis exemption for PFAS to result in reporting of more releases and waste management quantities.
On October 21, 2022, EPA finalized a rule that codified a definition of “parent company” for purposes of TRI reporting.38 The term is defined as “the highest-level company (or companies) of the facility’s ownership hierarchy as of December 31 of the year for which data are being reported” according to instructions that specify what the parent company is in various ownership scenarios. EPA said the rule clarified existing guidance and provided reporting clarity for facilities owned by corporate subsidiaries, multiple owners, or foreign entities, as well as publicly owned facilities. The codified definition is “more closely aligned” with definitions under other EPA reporting programs such as the Chemical Data Reporting rule and the Greenhouse Gas Reporting Program rule. The final rule also requires that facilities report their highest-level foreign parent company, when applicable. This requirement takes effect for the 2023 reporting year, for which TRI forms are due by July 1, 2024.
On November 28, 2022, EPA published a final rule updating the list of North American Industry Classification System (NAICS) codes that are subject to TRI reporting.39 The final rule reflects the Office of Management and Budget’s 2022 revisions to the NAICS codes. Facilities reporting to TRI must use the updated codes on reports for the 2022 calendar year, for which forms are due to EPA by July 1, 2023. The rule does not affect which facilities must report and does not change the data required on TRI forms.
EPA Released Final IRIS Assessment for PFBA
On December 22, 2022, EPA released the final Integrated Risk Information System (IRIS) toxicological review of perfluorobutanoic acid (PFBA) and related salts.40 The final assessment found that sufficient oral exposure to PFBA likely causes thyroid, liver, and developmental effects. The assessment also included a noncancer estimate of the amount of PFBA that can be ingested every day that is likely to be without harmful effects. This overall reference dose for PFBA was derived based on liver and thyroid effects and is 1 × 10−3 mg/kg-day. Regarding PFBA’s potential cancer effects, the final assessment concludes that there is “inadequate information to assess carcinogenic potential.” In EPA’s announcement of the release of the final IRIS assessment, the Agency noted that the assessment could be used to support “a wide variety of decision-making needs across EPA’s program offices and regions, and state agencies.” EPA further noted that “IRIS assessments are only part of a risk assessment” and that “[t]he scientific conclusions regarding hazard identification and dose response from IRIS assessments are typically combined with other scientific information, including information on human exposure, to inform decisions.” EPA has IRIS assessments for four other PFAS underway: PFHxA, PFHxS, PFNA, and PFDA.
EPA Releases New Draft IRIS Assessment for Hexavalent Chromium
On October 20, 2022, EPA opened a 60-day comment period on a draft IRIS Toxicological Review of hexavalent chromium (Cr(VI)).41 EPA’s Science Advisory Board will lead a peer review of the draft assessment during which the external peer reviewers will consider public comments. Public comments also will inform EPA’s revision of the assessment after the peer review is complete. The draft assessment found that evidence indicates that Cr(VI) is likely to cause gastrointestinal (GI) tract, liver, developmental, and lower respiratory toxicity in humans, and may cause male reproductive effects, immune effects, and hematologic toxicity in humans. The draft assessment includes organ/system-specific reference values for GI tract, liver, developmental, hematological, lower respiratory, and nasal effects. The overall chronic reference dose (RfD) for oral ingestion is 9 × 10-4 mg/kg-d. The overall chronic reference concentration (RfC) for inhalation exposure is 1 × 10-5 mg/m3. The draft assessment said Cr(VI) is likely to be carcinogenic to the human GI tract and calculated a total lifetime oral slope factor of 0.5 (per mg/kg-d). The assessment also developed an inhalation unit risk (IUR) for human lung cancer, with a total lifetime IUR of 2 × 10-2 (per µg Cr(VI)/m3). A final IRIS Toxicological Review of Cr(VI) was issued in September 1998. A draft assessment was released in September 2010, but was never finalized. The comment period on the draft assessment closed on December 19, 2022.
New TSCA Section 21 Petition on PVOH (Polyvinyl Alcohol) Films
A petition submitted to EPA on November 15, 2022 under TSCA Section 21 requested that EPA require health and environmental safety tests of polyvinyl alcohol (PVA), as used in plastic film in consumer-packaged goods and in dishwasher and laundry pods and sheets.42 The petition also requested that PVA be removed from the “Safer Choice List” and Safer Chemical Ingredients List until the requested testing is completed. In January 2023, the petition was withdrawn and an updated petition was submitted.43 The resubmitted petition requests that EPA issue a TSCA Section 4 test order requiring health and effects testing of PVA by PVA manufacturers and processers who are part of the EPA Safer Choice Program, who have products with the EPA Safer Choice certification, or who are seeking an EPA Safer Choice certification for pods or sheets products. The updated petition also requests that the status of PVA be updated on the Safer Chemical Ingredients List, from a “green circle” (indicating that a chemical has been verified to be of low concern based on experimental and modeled data) to a “gray square” (indicating that a chemical will not be acceptable for use in products that are candidates for the Safer Choice label and that currently labeled products must reformulate) until EPA completes a full review of the requested health and environmental safety tests. EPA must respond to the resubmitted petition by April 26, 2023.
EPA Removed PFAS from Safer Chemicals Ingredients List
On January 12, 2023, EPA announced updates to its Safer Chemicals Ingredients List (SCIL), including the removal of a PFAS—halogenated aliphatic acid—and the addition of nine chemicals. EPA said the PFAS was added to the SCIL in 2012 based on the data then available and the state of EPA’s knowledge at the time. EPA updated the halogenated aliphatic acid listing to a gray square based on “a growing understanding of the toxicological profiles for certain PFAS and incomplete information on the potential health and environmental effects of these substances.” The gray square means that the chemical is not allowed for use in products that are candidates for EPA’s Safer Choice label and that current Safer Choice-certified products containing the chemical must be reformulated unless health and safety data is provided to justify continuation of the chemical’s listing on the SCIL. The chemical will be removed from the list entirely in 12 months unless information is provided that justifies continued listing.
EPA Denied Petition Requesting Regulation of Greenhouse Gases and Fossil Fuels Under TSCA; Lawsuit Filed to Challenge Denial
On September 21, 2022, EPA published notice of its denial of a TSCA Section 21 petition in which two nonprofit organizations, individual scientists, and a psychiatrist requested that EPA take risk management actions under TSCA Section 6(a) to phase out the anthropogenic manufacture, processing, distribution, use, and disposal of greenhouse gas emissions, fossil fuels, and fossil fuel emissions.44 EPA said it shared the petitioners’ concerns regarding the threat posed by climate change and that the government “will continue to combat the climate crisis with a whole of government approach.” The Agency found, however, that the petition was “insufficiently specific” and that the petitioners did not meet their burden under TSCA Section 21(b)(1) of establishing that it is necessary to issue a risk management rule under TSCA Section 6(a). EPA’s notice did not address other actions requested by the petitioners pursuant to Sections 7 and 9 of TSCA, the Clean Air Act, the Comprehensive Environmental Response, Compensation, and Liability Act, and the Independent Offices Appropriations Act. EPA is treating these other requested actions as petitions under the Administrative Procedure Act. On November 12, 2022, the petitioners filed a lawsuit in federal court in Oregon seeking review of the denial of the petition.45
EPA Removed 12 PFAS From List of Approved Pesticide Inert Ingredients
On December 14, 2022, EPA published notice of its removal of 12 PFAS from the list of inert ingredients approved for use in pesticide products.46 EPA said that EPA records indicated that none of the 12 substances was currently being used in a pesticide product and that no pesticide products containing the substances had been identified during the public comment period. EPA said it therefore was removing the PFAS from the inert ingredient list to prevent their introduction into pesticide formulations without additional EPA review. Prior to adding a substance to the list of pesticide inert ingredients, EPA may require the submission of studies evaluating the potential carcinogenicity, adverse reproductive effects, developmental toxicity, and genotoxicity, as well as environmental effects in the context of considering the new inert ingredient.
EPA Solicited Third-Party Standards for Achievement of Sustainable Federal Purchasing Goals
On November 2, 2022, EPA formally invited applications by managers of standards development organizations, ecolabel programs, and associated conformity assessment bodies for potential assessment and inclusion in an expanded Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (the Recommendations), which help purchasers identify environmental performance standards, ecolabels, and certifications for incorporation into federal procurement.47 Applications were due January 1, 2023. EPA will next assess the submissions against the Framework for the Assessment of Environmental Performance Standards and Ecolabels for Federal Purchasing. EPA said it was interested in assessments in purchase categories that support federal goals and mandates, including safer chemicals (citing, for example, products that do not contain PFAS). EPA said it was particularly interested in standards and ecolabels in the following product categories: building/construction, infrastructure, landscaping, food and cafeteria services, uniforms/clothing, professional services, and laboratories and health care. EPA noted that implementation of the Infrastructure Investment and Jobs Act’s grant program for safer, more sustainable, and environmentally preferable products, purchasing, and supply chains would reference and utilize the Recommendations.
State Regulatory & Legislative Action
New California Laws Restrict PFAS in Cosmetics and Textiles; Vetoed Bill Would Have Required Reporting on PFAS-Containing Products
On September 29, 2022, Governor Gavin Newsom signed legislation that, beginning on January 1, 2025, bans the manufacture, sale, delivery, holding, or offering for sale of any cosmetic product that contains intentionally added PFAS.48 The law defines PFAS as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” “Intentionally added PFAS” is defined as either PFAS “that a manufacturer has intentionally added to a product and that have a functional or technical effect on the product” or that “are intentional breakdown products of an added chemical.”
The governor also signed into law a bill that restricts PFAS in textile articles beginning on January 1, 2025.49 Beginning on that date, no person may manufacture, distribute, sell, or offer for sale any new textile articles containing “regulated perfluoroalkyl and polyfluoroalkyl substances or PFAS,” which is defined to mean either “PFAS that a manufacturer has intentionally added to a product and that have a functional or technical effect in the product, including the PFAS components of intentionally added chemicals and PFAS that are intentional breakdown products of an added chemical that also have a functional or technical effect in the product” or the “presence of PFAS in a product or product component” at or above 100 parts per million (ppm). In 2027, this threshold decreases to 50 ppm. The ban does not apply to outdoor apparel for severe wet conditions until 2028, but a labeling requirement takes effect for such articles in 2025.
A third bill signed by the governor in September 2022 would create an option in the Safer Consumer Products program for the California Department of Toxic Substances Control (DTSC) to proceed directly to a regulatory response based on publicly available studies rather than requiring submission of Alternatives Analyses for Priority Products.50
Governor Newsom declined to sign a bill that would have required DTSC to contract with a multistate chemical data collection entity to implement a publicly accessible data collection interface for collecting information about PFAS and products and product components containing intentionally added PFAS.51 The governor said the bill might be premature because EPA was currently conducting rulemaking (under TSCA Section 8(a)(7)) to require reporting of PFAS.
California Listed Nail Products Containing Toluene as Priority Product, Proposed Modifications to Final Rule Outline Criteria for Demonstrating Toluene Threshold Not Exceeded
Effective January 1, 2023, nail products containing toluene were listed as a Priority Product in California’s Safer Consumer Products program.52 The regulation also established an Alternatives Analysis Threshold (AAT) of 100 parts per million for toluene in nail products. A manufacturer does not have to conduct an Alternatives Analysis for its Priority Product if it submits an AAT Notification to DTSC that demonstrates that the concentration of toluene does not exceed the AAT. On January 20, 2023, the California Department of Toxic Substances Control opened a public comment period on proposed modifications to the final rule. The revisions set forth criteria for demonstrating compliance with the AAT Notification requirements. The comment period ended on February 6, 2023.
California Appellate Court Upheld Designation of Spray Foam Systems as Priority Product
The California Court of Appeal upheld DTSC’s listing of spray polyurethane foam systems containing unreacted methylene diphenyl diisocyanates as a Priority Product.53 In doing so, the court reversed a trial court’s determination that the listing violated the California Environmental Quality Act (CEQA) but upheld the trial court’s determinations that DTSC acted within its authority and consistent with the California Administrative Procedure Act. The appellate court ruled that the CEQA claim was untimely.
Maine Moves Forward With Proposed Regulations to Implement PFAS in Products Notification Requirements; PFAS Bans in Carpets, Rugs, and Fabric Treatments Take Effect
On October 13, 2022, the Maine Department of Environmental Protection (Maine DEP) released a revised concept draft rule for the Maine PFAS in Products Program.54 Maine DEP accepted comments on the revised concept draft until November 10, 2022. Based on comments received, Maine DEP revised the draft and submitted a proposed rule to the Maine Board of Environmental Protection. On January 19, 2023, the Board voted to issue the proposed rule,55 and Maine DEP formally proposed the rule on February 14.56 The comment deadline is May 19 at 5 PM. The rule ultimately will address the details of procedures manufacturers of PFAS-containing products must follow when submitting notifications of products and product components sold, offered for sale, or distributed for sale in Maine that contain intentionally added PFAS. The statutory notification requirement took effect on January 1, 2023 for companies that had not requested and received extensions from Maine DEP. Statutory prohibitions on the sale, offering for sale, or distribution for sale of carpets, rugs, and fabric treatments containing intentionally added PFAS also took effect on January 1, 2023.
New York Laws Restricting Chemicals in Consumer Products Took Effect at Beginning of 2023; DEC Released Draft Chemical Lists for Toxic Chemicals in Children’s Products Program
Several laws restricting chemicals in consumer products in New York took effect on January 1, 2023. One law prohibits the sale and distribution of food packaging containing intentionally added PFAS.57 Another state law sets maximum allowable concentrations of 1,4-dioxane of two parts per million (ppm) in household cleaning and personal care products and 10 ppm for cosmetics.58 Effective December 31, 2023, the maximum 1, 4-dioxane concentration permitted for household cleaning and personal care products will decrease to 1 ppm. In addition, on January 1, 2023, the Toxic Chemicals in Children’s Products (TCCP) program’s restrictions on sales of children’s products containing intentionally added benzene, asbestos, or tris (1,3-dichloro-2-propyl) phosphate took effect. Disclosure of the presence of certain other chemicals in children’s products also will be required. The New York State Department of Environmental Conservation (DEC) is in the process of developing regulations to implement the 1,4-dioxane restrictions and the TCCP program. The TCCP program rule will address which product categories are covered, which chemicals and supporting information must be disclosed, details regarding the process for obtaining waivers from the reporting requirements and sales prohibitions, and fees for reporting and for waiver applications. On February 10, 2023, DEC announced that it had posted on its website a list of Chemicals of Concern and High Priority Chemicals under consideration for the TCCP program.59 The list includes practical quantitation limits, as well as information on documented test methods. The final lists will dictate chemicals that must be disclosed if present in children’s products sold or offered for sale in New York. DEC is holding a webinar on February 16 to review features of the program and will accept comments on the lists until March 20, 2023.
Laws Enacted in New York at End of 2022 to Limit Mercury in Cosmetics, PFAS in Apparel and Carpet; New Law Also Restricts Animal Testing for Cosmetics
In December 2022, Governor Kathy Hochul signed several laws restricting chemicals in consumer products. One law prohibits the sale of cosmetic and personal care products containing mercury.60 Amendments to that law are expected in 2023 to address a federal preemption concern. Another law prohibits the sale of apparel containing PFAS with exemptions for professional uniforms and outerwear intended for extreme conditions.61 Though the effective date for the PFAS-in-apparel ban was December 31, 2023, Governor Hochul said she and the legislature had agreed to amendments to allow additional time and to make other changes to provide more clarity to consumers and manufacturers. A law requiring the establishment of an extended producer responsibility program for carpet included a prohibition on the sale of carpet containing or treated with PFAS.62 Governor Hochul also signed a law prohibiting manufacturers from importing or selling cosmetics for which the manufacturer knew or reasonably should have known that animal testing was conducted or contracted by or on behalf of the manufacturer or any supplier of the manufacturer if the animal testing was conducted after January 1, 2023.63 The law provides for certain exceptions where federal, state, or foreign regulatory agencies require the testing.
DEC Releases Guidance for Annual Reporting on Flame Retardants in Electronic Display Stands and Enclosures
On November 30, 2022, DEC issued guidance concerning reporting requirements for organohalogen flame retardants (OFRs) in the stands or enclosures of electronic displays. Beginning January 1, 2023, the Family and Fire Fighter Protection Act enacted in 2021 provides that electronic displays may not be sold in New York State unless the manufacturer has submitted an annual report on the presence of OFRs in the enclosures or stands of the displays. The guidance states that reports are due annually, starting in 2022, and that DEC would accept the reports between November 1 and December 31. Product information required in the reports includes the Global Product Classification (GPC) brick code for the product that contains the OFR; the identity (brand, make, and unique model identifier, or the brand name and Universal Product Code) of each product sold, offered for sale, or that will be offered for sale in the state in the current calendar year that contains an OFR in its enclosure or stand; and the identity of each OFR in the enclosure or stand (the Chemical Abstracts Service registry number and the chemical name). DEC also requests that manufacturers provide information on the concentration ranges of OFRs used in the enclosures or stands of the products, but submission of this information is optional.
Washington Issued Proposed Rule for Cycle 1 of Safer Products Program
In December 2022, the Washington Department of Ecology issued a proposed rule to implement the final regulatory determinations for the first cycle of the Safer Products program.64 The proposed rule establishes reporting requirements or restrictions for priority consumer products containing priority chemicals, including PFAS in aftermarket stain- and water-resistance treatments, carpets and rugs, and leather and textile furnishings; ortho-phthalates in personal care products (fragrances) and vinyl flooring; flame retardants in electric and electronic products and recreational polyurethane foam; and phenolic compounds in laundry detergent, food, and drink can linings, and thermal paper. The comment period on the proposal closed on February 5, 2023. The rule must be finalized by June 1, 2023.
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© Arnold & Porter Kaye Scholer LLP 2023 All Rights Reserved. This Advisory 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.
87 Fed. Reg. 38747 (June 29, 2022).
See ECHA, Annex XV Restriction Report: Proposal for a Restriction (Feb. 7, 2023); Press Release, ECHA, ECHA Publishes PFAS Restriction Proposal (Feb. 7, 2023).
Consolidated Appropriations Act, 2023, Pub. L. No. 117-328, §§ 3505–3506, __ Stat. __ (2022).
Pub. L. No. 117-263, §§ 341–347, __ Stat. __ (2022).
Pub. L. No. 117-248, 136 Stat. 2348.
Pub. L. No. 117-254, 136 Stat. 2361.
News Release, EPA, EPA Issues Next Test Order Under National Testing Strategy for PFAS Used in Plastics, Chemical Manufacturing (Jan. 4, 2023); EPA, Order Under Section 4 of the Toxic Substances Control Act (TSCA) (HFPO) (Jan. 4, 2023).
88 Fed. Reg. 4937 (Jan. 26, 2023).
87 Fed. Reg. 74072 (Dec. 2, 2022).
88 Fed. Reg. 41 (Jan. 3, 2023).
Earthjustice, Petition to EPA to revoke the approval of approximately 600 per- and polyfluoroalkyl substances (PFAS) that were granted through low-volume or low-release and low-exposure exemptions to the premanufacture notice requirements of the Toxic Substances Control Act (Oct. 13, 2022).
Earthjustice, Petition to EPA prohibit the use of certain exemptions to the premanufacture notice requirements of the Toxic Substances Control Act for per- and polyfluoroalkyl substances (PFAS) (Apr. 27, 2021).
Office of Rsch. & Dev. & Office of Chem. Safety & Poll. Prevention, EPA, The New Chemicals Collaborative Research Program: Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA (BOSC Review Draft) (Oct. 2022).
News Release, EPA, EPA Announces Innovative Effort to Bring New Chemicals Used in Electric Vehicle, Semiconductor, Clean Energy Sectors to Market (Oct. 5, 2022).
87 Fed. Reg. 67901 (Nov. 10, 2022).
87 Fed. Reg. 76481 (Dec. 14, 2022).
87 Fed. Reg. 77596 (Dec. 19, 2022).
87 Fed. Reg. 77603 (Dec. 19, 2022).
87 Fed. Reg. 79303 (Dec. 27, 2022).
88 Fed. Reg. 1222 (Jan. 9, 2023).
87 Fed. Reg. 68647 (Nov. 16, 2022).
86 Fed. Reg. 1890 (Jan. 11, 2021).
87 Fed. Reg. 33926 (June 28, 2021).
87 Fed. Reg. 72439 (Nov. 25, 2022); Office of Pollution Prevention & Toxics, EPA, Initial Regulatory Flexibility Analysis and Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Nov. 2022).
87 Fed. Reg. 73475 (Nov. 30, 2022).
87 Fed. Reg. 74379 (Dec. 5, 2022).
Press Release, EPA, EPA Releases Updated Data for 2021 Toxics Release Inventory Reporting (Oct. 26, 2022).
87 Fed. Reg. 63950 (Oct. 21, 2022).
87 Fed. Reg. 72891 (Nov. 28, 2022).
News Release, EPA, EPA Publishes IRIS Handbook and Final IRIS Assessment of Perfluorobutanoic Acid (PFBA) and Related Salts (Dec. 22, 2022); see EPA, EPA/635/R-22/277Fa, IRIS Toxicological Review of Perfluorobutanoic Acid (PFBA, CASRN 375-22-4) and Related Salts (Dec. 2022).
87 Fed. Reg. 63774 (Oct. 20, 2022); EPA, EPA/635/R-22/191a, IRIS Toxicological Review of Hexavalent Chromium [Cr(VI)] (Oct. 2022).
Blueland & Plastic Poll. Coal., Petition to Request Health and Environmental Testing and Regulation on Polyvinyl Alcohol Under the Toxic Substances Control Act and an Update to the Chemical Safety Status of Polyvinyl Alcohol on the EPA’s Safer Chemical Ingredients Lists (Nov. 15, 2022).
Blueland & Plastic Poll. Coal., Petition to Request Health and Environmental Testing and Regulation on Polyvinyl Alcohol Under the Toxic Substances Control Act and an Update to the Chemical Safety Status of Polyvinyl Alcohol on the EPA’s Safer Chemical Ingredients Lists (Jan. 26, 2023).
87 Fed. Reg. 57665 (Sept. 21, 2022).
Climate Protection & Restoration Initiative v. Regan, No. 6:22-cv-1772 (D. Or.).
87 Fed. Reg. 66176 (Nov. 2, 2022).
See Nail Products Containing Toluene, DTSC (last visited Feb. 12, 2023).
Am. Chem. Council v. Dep’t of Toxic Substances Control, No. F082604 (Cal. Ct. App. Nov. 18, 2022).
See PFAS in Products, Me. Dep't of Env't Prot. (last updated Dec. 30, 2022).
See Calendar and Prior Meeting Materials, Me. Bd. of Env’t Prot. (last updated Feb. 8, 2023).
Chapter 90: Products Containing Perfluoroalkyl and Polyfluoroalkyl Substances, Maine DEP (Feb. 14, 2023).
See Safer Products for Washington, EZ View: Dep’t of Ecology (last visited Feb. 13, 2023).