The Chemical Compound—September 2022

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, including 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

Litigation

• Ninth Circuit Granted EPA Request for Voluntary Remand of DecaBDE Risk Management Rule
• EPA Asks North Carolina Federal Court to Dismiss Challenge to Response to TSCA PFAS Testing Petition or to Limit Review to Administrative Record
• EPA Seeks Dismissal of Lawsuit Challenging Transparency of New Chemicals Program
• Cases Challenge First TSCA Section 4 Test Order for PFAS and Test Orders for Substances Undergoing Risk Evaluations

Federal Developments

• Legislative Developments

• Regulatory Developments

» State Regulatory & Legislative Action

• California
• Colorado
• Delaware
• Hawaii
• Maine
• New York
• North Carolina
• Oregon
• Rhode Island
• Washington

Litigation

Ninth Circuit Granted EPA Request for Voluntary Remand of DecaBDE Risk Management Rule

On June 23, 2022, the Ninth Circuit Court of Appeals granted EPA’s motion for voluntary remand in a lawsuit challenging the Agency’s final risk management rule for the flame retardant decabromodiphenyl ether (decaBDE).¹The final rule was promulgated pursuant to TSCA Section 6(h) in January 2021,² and was challenged by nongovernmental organizations and the Yurok Tribe. In September 2021, EPA announced its plan to propose amendments to its rules for decaBDE and four other persistent, bioaccumulative, and toxic substances and moved to remand the decaBDE challenges in March 2022.³The Ninth Circuit’s order states that “[t]his matter is remanded to the agency for the limited purpose of permitting the agency to reconsider the rule at issue.” The court denied the petitioners’ request that the court impose deadlines on the Agency’s reconsideration and potential amendment of the rule. The order further stated that proceedings on the petitions to the Ninth Circuit “will be held in abeyance pending the agency’s completion of reconsideration proceedings or further order of the court.” EPA must file a status report or motion with the court within 14 days of completion of EPA’s proceedings. In the Spring 2022 Unified Agenda, EPA set June 2023 as the anticipated date for a proposed rule and September 2024 as the date for a final rule.⁴

EPA Asks North Carolina Federal Court to Dismiss Challenge to Response to TSCA PFAS Testing Petition or to Limit Review to Administrative Record

On June 23, 2022, EPA moved to dismiss the Center for Environmental Health and other plaintiffs’ lawsuit challenging EPA’s responses to the plaintiffs’ TSCA Section 21 petition that asked the Agency to require health- and environmental-effects testing of 54 PFAS allegedly released into the Cape Fear River watershed in North Carolina.⁵EPA argued that judicial review was not available because the Agency granted the plaintiffs’ petition in December 2021 after reconsidering its January 2021 denial of the petition. EPA acknowledged that it had not committed “to every aspect of the proposed testing program” requested by the plaintiffs but argued that Section 21 only required the Agency to commence an “appropriate proceeding” for issuance of a rule or order under TSCA Section 4. EPA also argued that the plaintiffs’ claims were moot because EPA had reconsidered its January 2021 denial and granted the petition all statutory relief available under Section 21. The court therefore would be unable to provide additional relief. The plaintiffs opposed dismissal, arguing that EPA’s response to their petition amounted to “a near-blanket rejection” and that, accepting as true their allegations regarding EPA’s failure to grant nearly all their testing requests, the court should deny the motion. The plaintiffs further argued that the case was not moot because there were “numerous unresolved controversies,” including whether EPA had effectively denied the petition and whether the plaintiffs could demonstrate on a de novo basis that the 54 PFAS met TSCA Section 4’s criteria for testing. On August 19, EPA moved to limit judicial review to the administrative record. EPA contended that while there was no dispute that the court would conduct a de novo review of the TSCA Section 21 petition if it did not dismiss the case, the plain language, structure, and legislative history of TSCA confirmed that the scope of review should be limited to the petition, and administrative law principles confirmed that the review should be based on the record.

EPA Seeks Dismissal of Lawsuit Challenging Transparency of New Chemicals Program

In a lawsuit concerning EPA’s disclosure of information and documents related to its review of new chemical substances under TSCA Section 5, EPA filed a motion on June 14, 2022 seeking judgment on the pleadings.⁶EPA contended that, although “the parties have fundamentally disagreed about the validity” of the lawsuit, EPA had committed to provide the plaintiffs and the public “with the legally required information that EPA had initially failed to disclose,” with one exception related to confidentiality. EPA said the plaintiffs now sought, through a motion to compel the production of an administrative record, “hundreds of ‘administrative records’ for every instance where EPA published notice that it received a new chemical submission or provided the public files to Plaintiffs.” EPA argued that the relief sought by the plaintiffs was not available under either TSCA’s citizen suit provision or the Administrative Procedure Act. EPA therefore asked the court for judgment on the pleadings and alternatively argued that the court should deny the plaintiffs’ motion to compel because the plaintiffs’ claims alleged a failure to act, in which case there would not yet be administrative records. Even if the claims could be construed as challenging EPA action, the Agency argued that there were no administrative records for the “clerical” tasks of publishing notices or compiling public files. EPA also argued that the question of whether EPA had an obligation to review confidentiality designations prior to public disclosure of files would not require additional facts to resolve. In response, the plaintiffs argued that EPA had not committed to providing plaintiffs with all documents that were the subject of the suit, including health and safety information designated by manufacturers as confidential. The plaintiffs therefore argued that judicial resolution of questions regarding EPA’s disclosure obligations remained “vital.”

Cases Challenge First TSCA Section 4 Test Order for PFAS and Test Orders for Substances Undergoing Risk Evaluations

Since May 2022, four lawsuits have been filed to challenge TSCA Section 4 test orders issued by EPA.

In the first lawsuit, filed in federal court in the DC Circuit Court of Appeals on May 23, 2022, Vinyl Institute challenged a 2022 test order requiring companies to develop information regarding 1,1,2-trichloroethane, a chemical substance primarily used in plastic and petrochemical manufacturing for which EPA is conducting a risk evaluation under TSCA Section 6.⁷The information required by the test order included an Avian Reproduction Test. In the petition for review, Vinyl Institute asserted that the test order violates TSCA, the Administrative Procedure Act, and EPA regulations. Issues that Vinyl Institute said it planned to raise included EPA’s alleged failures to adequately justify requiring the Avian Reproductive Test. Vinyl Institute also intends to raise issues related to whether EPA failed to consider structural analogues and recent information showing “rare and low” detections of 1,1,2-trichloroethane in environmental media. On August 19, Vinyl Institute filed a motion under TSCA Section 19(b) to submit additional information to the administrative record that Vinyl Institute contended could compel EPA to withdraw the test order “or at least employ a more reasonable tiered testing approach.”

In the second case, LANXESS Corporation challenged EPA’s 2022 test order for o-dichlorobenzene (o-DCB), a chemical substance used in the manufacturing of dyes, paints, and pigments and in products used for cleaning, degreasing, and painting.⁸EPA is conducting a TSCA Section 6 risk evaluation of o-DCB. LANXESS was also a recipient of a 2021 test order for o-DCB and exercised an option provided by EPA during the Trump Administration to avoid the test order by ceasing all importation, manufacturing, and processing of the substance. LANXESS intends to argue that it is not subject to the test order because EPA previously agreed that LANXESS was not subject to the 2021 test order, which included two tests also required in the 2022 test order. LANXESS also said it intended to raise the issue of whether TSCA Section 4(b)(3)(C) authorizes EPA to issue a test order to a person who ceased all importing, manufacturing, and processing prior to the test order’s issuance. On August 5, 2022, EPA modified the 2022 test order to remove LANXESS as well as another recipient of the test order—M.A. Global Resources—that had also elected to cease all importation, manufacturing, and processing after receiving the 2021 test order. Two related policy documents that EPA issued in conjunction with its modification of the 2022 test order are discussed below.

In the third lawsuit, which was filed on August 15, 2022 in the DC Circuit, a company that makes aqueous film-forming foams (AFFFs) challenged a test order for 6:2 fluorotelomer sulfonamide betaine (6:2 FTSB), the first PFAS for which EPA issued a test order pursuant to its National PFAS Testing Strategy (see additional discussion of test order below).⁹ The company—National Foam Inc.—disputes that it is a manufacturer or processor of 6:2 FTSB, contending that “[a]t no time does National Foam ever purchase, possess, handle, use or process 6:2 FTSB, as a segregable, solid substance.” Instead, according to National Foam, the company purchases a mixture in which 6:2 FTSB is dissolved in an ethanol/water base and uses the mixture in making AFFFs. National Foam said EPA has agreed that the company is not a manufacturer of 6:2 FTSB but continues to assert that the company processes the chemical substance. National Foam asserts that the test order, as applied to the company, is unlawful.

The fourth lawsuit was filed in the DC Circuit on August 22, 2022 by a consortium of manufacturers and processors to challenge the test order for trans-1,2-dichloroethylene (TDCE).¹⁰The petition asks the DC Circuit to determine that the test order is unlawful and to set it aside but did not provide further detail about the basis for the challenge.

Federal Developments

Legislative Developments

Senate Passed Bill for Federal Funding of Equipment to Prevent Airport PFAS Releases

On September 6, 2022, the Senate passed, by unanimous consent, a bill that would temporarily authorize the federal government to cover 100% of the costs of aqueous film forming foam (AFFF) input-based testing equipment at airports.¹¹The AFFF input-based equipment does not require external discharges. The legislation, known as the “Preventing PFAS Runoff at Airports Act,” would require the Federal Aviation Administration (FAA) to conduct outreach efforts to make airports aware of the 100% cost-share authority. It also would require 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 would expire 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.

PFAS Ban in Food Packaging Approved by Senate Committee; Bill Also Would Require Assessment of Safety of PFAS in Cosmetic Products

On July 13, 2022, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022—which was amended to include a provision banning food packaging that contains PFAS—was reported out of the Senate Committee on Health, Education, Labor, and Pensions.¹²The food packaging provision would amend the Federal Food, Drug, and Cosmetic Act to prohibit “[t]he introduction or delivery for introduction into interstate commerce of food packaging containing intentionally added PFAS.” The prohibition would take effect on January 1, 2024. The FDASLA Act of 2022 also includes a provision requiring the Secretary of Health and Human Services to assess and publish a report on the use of PFAS in cosmetic products and evidence regarding the safety of, and any risks associated with, such use.

House and Senate Defense Bills Contain Different PFAS Provisions

The House of Representatives passed the National Defense Authorization Act (NDAA) for Fiscal Year 2023 on July 14, 2022. The House bill included provisions for PFAS prohibitions as well as treatment and study of PFAS contamination.¹³Here are several of the more noteworthy PFAS-related provisions:

• Section 341:Prizes for the development of non-PFAS containing turnout gear
• Section 342: Modification to restriction on Department of Defense (DOD) procurement of certain items containing PFAS
• Section 343: Prohibition on purchase by DOD of firefighting equipment containing PFAS
• Section 344: Standards for response actions with respect to PFAS contamination
• Section 345: List of certain PFAS uses deemed essential; briefing on DOD procurement of certain items containing perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS)
• Section 5803: Expansion of study of PFAS contamination

Later in July, the Senate’s version of the NDAA became available.¹⁴The PFAS provisions in the Senate bill include the following:

• Section 331: Increase on transfer authority for funding of study and assessment of health implications of PFAS contamination in drinking water by Agency for Toxic Substances and Disease Registry
• Section 332: Modification of limitation on disclosure of results of testing for PFAS on private property
• Section 333: DOD research relating to PFAS
• Section 383: Restriction on DOD procurement or purchasing of turnout gear for firefighters containing PFAS

Regulatory Developments

EPA Began Issuing TSCA Section 4 Test Orders as Part of PFAS Testing Strategy

On June 6, 2022, EPA announced that it had issued a first set of TSCA Section 4 test orders as part of its National PFAS Testing Strategy.¹⁵The orders were issued to five companies that EPA identified as manufacturers and/or processors of 6:2 fluorotelomer sulfonamide betaine, a chemical substance used to make commercial fire-fighting foams and also found in certain floor finishes. The companies are subject to the order if they manufactured or processed the substance at any time during the preceding 10 years or intend to manufacture or process the chemical during the testing period. (As discussed above, one company has filed a lawsuit contesting the order’s application to the company.) The recipients of the order must conduct testing of physical-chemical properties and health effects from inhalation, or alternatively must provide EPA with existing information that they believe EPA has not considered. EPA said testing on this substance would inform EPA’s understanding of the human health effects of 503 additional PFAS with similar structures. This is likely to be the first of at least 25 test orders for specific PFAS in accordance with the Agency’s Testing Strategy.

EPA Issued TSCA Section 4 Test Order Policies

In early August 2022, EPA posted two policies that address the Agency’s identification of parties that are subject to TSCA Section 4 test rules, orders, or consent agreements.¹⁶EPA summarized the policies as follows:

• Policy 1: Companies engaged in manufacturing activities for a chemical substance during the five years prior to the signature date or effective date of a Section 4(a) action (i.e., a rule, consent agreement, or order) will generally be included in the scope of the action. However, EPA may apply a longer or shorter period of time when appropriate in specific cases.
• Policy 2: Section 4 actions will not include an option to cease manufacturing to satisfy the requirements of the action.

Recognizing that some companies that received a January 2021 test order had relied on EPA’s representation that testing would not be required if they ceased manufacture, EPA posted a second document announcing that it would remove companies from March 2022 orders issued for the same substances as those orders previously issued in the preceding year, if the company had successfully made use of the cease manufacture option at that time.¹⁷EPA described the removal of companies from the March 2022 orders as a “unique situation” and said that for future orders, recent cessation of manufacturing would not absolve companies from their obligations to generate information under a TSCA Section 4 order.

EPA Amended TSCA Significant New Use Regulations

On July 5, 2022, EPA published a rule finalizing a 2016 proposal for amendments to the general requirements for significant new use rules (SNURs).¹⁸The rule is intended to align current requirements with updated Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Safety and Health respiratory protection requirements and the modified OSHA Hazard Communications Standard. EPA also has included a provision (in 40 CFR § 721.63) requiring (for future SNURs) that persons who manufacture or process a SNUR substance for which workplace controls are required implement a program that adheres to a “hierarchy of controls” approach, whereby administrative procedures and engineering controls are implemented to limit worker exposure, with personal protective equipment used as the last option to control exposures. The rule also modifies the bona fide inquiries procedure in 40 CFR § 721.11 so that the procedure enabling entities that are considering manufacturing or processing a substance subject to a SNUR to submit bona fide inquiries will now apply to all SNURs containing any CBI, including the terms of significant new use. Also, where the use is not confidential, EPA intends to identify the significant new use in a new chemical SNUR by explicitly describing the use. In addition, the rule makes changes to the method that may be used when computing estimated surface water concentrations of a substance for which specified release limits are established under a SNUR. EPA also has revised requirements in 40 CFR §§ 720.38, 720.45, and 723.50 to specify that any safety data sheet (SDS) required by a SNUR (whether already developed or even only in draft form) must comply with OSHA requirements and must be submitted as part of any new notification or exemption application provided to EPA under TSCA Section 5 (i.e., as part of a premanufacture notice or significant new use notice, or in a low volume exemption, low release and exposure exemption, or test marketing exemption application). The final rule became effective September 6, 2022.

EPA Announced It Would Not Apply Exposure Modeling Threshold in New Chemical Reviews

On August 22, 2022, EPA announced that it was discontinuing use of exposure modeling thresholds in its assessment of the health and environmental risks of new chemical substances under TSCA Section 5.¹⁹EPA said the policy of using these thresholds had been established in the 1990s “to focus limited resources on exposures with the greatest potential to affect human health and the environment.” EPA indicated that in the ensuing years, automation of modeling and other factors has decreased the burden of quantifying risks. EPA also said the change in policy would support the equity goals of President Biden’s Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, by providing a more complete understanding of potential risks to overburdened and vulnerable communities. EPA said the policy change would be reflected in removal of the thresholds in the New Chemical Review application and in updates to standard operating procedures and training materials. EPA intended to implement the policy change “as soon as feasible.” The Agency said it anticipated “minimal impact” on the amount of time required for new chemical reviews. Nevertheless, submitters of premanufacture notices have voiced concerns that the policy change will serve to create additional work for already overworked EPA personnel and create further delays in the new chemicals review process.

EPA Conducting Stakeholder Outreach to Increase Transparency and Reduce “Rework” in New Chemicals Program

In June 2022, EPA launched an outreach effort to discuss how the Agency evaluates data in new chemical submissions under TSCA Section 5 and to identify common issues that require EPA to reconduct new chemical assessments (“rework”), including submission of certain types of additional information after EPA has begun a risk assessment.²⁰Based on an analysis of 94 new chemical submissions between 2019 and 2022, EPA found that the additional information that most often led to rework included information on planned engineering controls, environmental release media and waste disposal methods, batch parameters (such as days of operation and mass of chemical produced), and planned production volume, as well as information on sites not under submitter control (such as downstream customer sites). EPA held a webinar about this analysis on July 27 and intends to hold future webinars that will discuss considerations in EPA evaluation of qualitative claims and quantitative data, especially when the information deviates from model defaults, and considerations for evaluating sites not controlled by the submitter.

TSCA Section 6 News: More Revised Risk Determinations, Scope for Part 2 of Asbestos Regulation, and News on Scope for Supplemental 1,4-Dioxane Evaluation

Since the last edition of the Chemical Compound, EPA has continued to take steps in its revisiting of the first 10 TSCA Section 6 risk evaluations completed by the Trump Administration in 2020 and 2021. Since June, the Agency has issued six more draft revised risk determinations as well as final revised risk determinations for cyclic aliphatic bromide cluster HBCD and Colour Index Pigment Violet 29 (PV29). The final revised risk determinations for HBCD and PV29 applied the Biden Administration’s two new policies: (1) the “whole chemical approach,” pursuant to which EPA made each unreasonable risk determination for the chemical as a whole chemical substance rather than making a separate determination for each condition of use and (2) elimination of the assumption that personal protective equipment (PPE) is used.²¹EPA determined that HBCD presents an unreasonable risk to health and the environment under the conditions of use, with the determination driven by risks associated with Manufacturing—Import; Processing: Incorporation into a Formulation, Mixture, or Reaction Products; Processing: Incorporation into Article; Processing: Recycling (of extruded polystyrene and expanded polystyrene foam, resin, and panels containing HBCD); Commercial Use: Building/Construction Materials (Installation); and Disposal (Demolition). Consumer use associated with building/construction materials was not found to drive unreasonable risk. For PV29, the unreasonable risk determination was driven by the same 10 conditions of use that EPA previously identified as presenting an unreasonable risk; 4 out of 14 conditions of use did not drive the revised unreasonable risk determination. The six draft revised risk determinations were for perchloroethylene (PCE),²²n-methylpyrrolidone (NMP),²³methylene chloride,²⁴trichloroethylene (TCE),²⁵1-bromopropane (1-BP),²⁶and carbon tetrachloride.²⁷These draft determinations also incorporated EPA’s two new policies, which, in the cases of PCE, NMP, methylene chloride, and 1-BP resulted in additional conditions of use being found to drive the unreasonable risk determinations due to the elimination of the PPE assumption. Removal of the PPE assumption also resulted in additional risks and/or routes of exposure driving the unreasonable risk determination for conditions of use previously identified as presenting an unreasonable risk for each of the six substances. The public comment period for the carbon tetrachloride risk determination remains open through September 28, 2022; the comment periods on the other substances have closed. The comment period also closed for the previously released revised risk determination for Pigment Violet 29.

Other steps taken by EPA regarding the first 10 risk evaluations included finalizing the scope for Part 2 of the asbestos risk evaluation, which will consider legacy uses and associated disposals, other types of asbestos fibers in addition to chrysotile, and conditions of use of asbestos-containing talc.²⁸In addition, as reported by Inside TSCA, EPA has added memoranda regarding existing chemical exposure limits (ECELs) for occupational use to the risk management dockets for 5 of the first 10 substances that have undergone risk evaluations: 1-BP, carbon tetrachloride, methylene chloride, PCE, and TCE.²⁹

In addition, on August 5, 2022 EPA provided a status report on its reconsideration of its no-unreasonable risk determinations for 1,4-dioxane.³⁰The Ninth Circuit granted EPA’s motion for voluntary remand without vacatur in August 2021 in lawsuits challenging these determinations. In the status report, EPA said that the supplemental risk evaluation for 1,4-dioxane would apply elements of its peer-reviewed approach to analyzing ambient air and water exposures to fenceline communities and that EPA also would analyze the impacts to the general population from “down-the-drain releases” of 1,4-dioxane.

EPA also has reopened the dockets for the next 20 chemical substances that are undergoing risk evaluation.³¹EPA designated these chemical substances as high-priority substances in December 2019, triggering a three- to three-and-a-half-year timeline for issuing a final risk evaluation. EPA issued final scopes for the risk evaluations for these substances in August 2020. The reopening of the dockets will allow for submission of more use, hazard, exposure, and other information to be used for risk evaluation purposes. The dockets will remain open through December 31, 2022.

TSCA Rulemaking Petition Seeks Unreasonable Risk Determination for Greenhouse Gas Emissions and Fossil Fuels

On June 16, 2022, five individuals—including climate scientists and a psychiatrist with expertise in the physical and mental health effects of climate disruption—and two non-profit organizations submitted a TSCA Section 21 petition to EPA requesting that the Agency make a determination under TSCA Section 6 as to whether the manufacture, processing, distribution in commerce, use, or disposal of greenhouse gas emissions, fossil fuels, and fossil fuel emissions present an unreasonable risk of injury to health or the environment.³²The petition also stated that upon making an unreasonable risk determination, EPA should commence a Section 6 rulemaking that would impose requirements to phase out greenhouse gas emissions, fossil fuels, and fossil fuel emissions to the maximum extent feasible; reduce emissions; and remove and sequester legacy and residual greenhouse gas emissions. In addition, the petition calls on EPA to commence a legal action against major fossil fuel producers and importers pursuant to TSCA Section 7 to contain the “imminent and unreasonable risk of serious or widespread injury” presented by the substances. TSCA requires that EPA grant or deny the petition by September 14, 2022.

EPA Office of Inspector General Found Lack of Transparency Regarding Post-Signature Changes to LCPFAC SNUR in 2020

In a July 2022 report, the EPA Office of Inspector General (OIG) found that EPA did not follow applicable policies, procedures, and guidance when the Agency made changes to the significant new use rule for long-chain perfluoroalkyl carboxylate chemical substances (LCPFAC SNUR) after the EPA Administrator signed the final rule in June 2020 and before publication in the Federal Register in July 2020.³³The report said the Agency failed to docket a memorandum explaining the post-signature changes as provided for in EPA guidance and that OIG was unable to identify the origin of requested changes because the request was communicated via telephone, leaving OIG unable to determine whether EPA complied with transparency provisions of Executive Order 12866 requiring identification of changes made at the suggestion or recommendation of the Office of Information and Regulatory Affairs (OIRA). The changes included removal of language that described what constituted a surface coating for imported articles and replacement with a statement that this topic would be addressed in guidance. The OIG report included three recommendations: (1) updating the docket to include the post-signature memorandum; (2) updating applicable policy or guidance documents to require docketing of such memorandums; and (3) updating applicable policies to require that EPA identify changes resulting from OIRA suggestions or recommendations between the time an action is submitted to OIRA and when an action is published in the Federal Register. EPA resolved the first two recommendations, but disagreed with the third recommendation. EPA contended that the OIG’s interpretation of Executive Order 12866’s requirements was not consistent with EPA’s implementation, which applies docketing requirements only to the “centralized review” required by the executive order.

Five PFAS Added to Toxics Release Inventory List, DINP Proposed for Listing, and NAICS Codes to Be Updated

On July 18, 2022, EPA published a final rule codifying the addition of five PFAS to the Toxics Release Inventory (TRI) list.³⁴Their addition was required by the National Defense Authorization Act for Fiscal Year 2020, which specified certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI list. Four of the PFAS were added effective January 1, 2022—three because EPA finalized toxicity values for perfluorobutane sulfonic acid (PFBS) and its related salt in April 2021³⁵and one because the PFAS was added to the non-confidential portion of the TSCA Inventory in 2021 after initially being added to the existing significant new use rule for long-chain perfluoroalkyl carboxylate chemical substances in 2020 with its identity shielded. The fifth PFAS was added effective January 1, 2021 due to a triggering activity in 2020—the PFAS was subject to a determination that a use was a significant new use and was designated as an active substance under TSCA Section 8(b)(5)(B).

EPA also has proposed other changes to the TRI program: the addition of a diisononyl phthalate (DINP) category to the TRI list, which EPA initially proposed in September 2000,³⁶and updates to the list of North American Industry Classification System (NAICS) codes subject to TRI to implement the Office of Management and Budget’s 2022 NAICS code revision.³⁷EPA said an updated hazard assessment demonstrated that the proposed DINP category meets the Emergency Planning and Community Right-to-Know Act toxicity criterion because members of the category can reasonably be anticipated to cause cancer and serious or irreversible chronic health effects in humans. Regarding the updated NAICS codes, EPA said the update would not affect the universe of facilities required to report and would not change the data required by the TRI form. The deadline for comments on the NAICS code update is September 20, 2022. The deadline on the proposal to add a DINP category to the TRI list is October 7, 2022.

In addition, on August 15 EPA sent a proposed rule to the Office of Management and Budget for interagency review that would add PFAS subject to TRI reporting requirements to the list of Chemicals of Special Concern, which would eliminate the availability of the de minimis exemption, eliminate the option to use Form A, and limit the use of range reporting.³⁸The rule would also eliminate the use of the de minimis exemption under the Supplier Notification Requirements for facilities that manufacture or process all chemicals included on the Chemicals of Special Concern list.

Other PFAS Roadmap News: Forthcoming IRIS Assessments, New Health Advisories for Drinking Water, and Proposed Hazardous Substance Designations

In addition to its first TSCA Section 4 test order for a PFAS and the forthcoming rule to make changes to the application of the TRI program to PFAS, EPA has moved forward on several other components of its PFAS Strategic Roadmap,³⁹including the following actions:

• IRIS Health Assessments. In June 2022, the Integrated Risk Information System (IRIS) Program published a schedule of projected dates for public release of health assessments that are currently in development, including for five PFAS: perfluorobutanoic acid (PFBA); perfluorodecanoic acid (PFDA); perfluorohexanoic acid (PFHxA); perfluorohexanesulfonic Acid (PFHxS); and perfluorononanoic acid (PFNA).⁴⁰Final assessments for PFBA and PFHxA are anticipated in the first quarter of fiscal year 2023 (FY23 Q1), which corresponds to October–December 2022. Public comment drafts for PFDA, PFHxS, and PFNA are expected in FY23 Q1, FY23 Q2, and FY23 Q3, respectively. EPA released the final peer review report on the PFHxA assessment in August 2022.
• Drinking Water Health Advisories. On June 15, 2022, EPA issued interim updated drinking water health advisories under the Safe Drinking Water Act for PFOA and PFOS and final health advisories for perfluorobutane sulfonic acid and its potassium salt (PFBS) and hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt (GenX chemicals).⁴¹The health advisories “identify the concentration of chemicals in drinking water at or below which adverse health effects are not anticipated to occur.” For PFOA, EPA reduced the health advisory to 0.004 parts per trillion (ppt) from 70 ppt. For PFOS, EPA reduced the health advisory to 0.02 ppt from 70 ppt. For PFBS, EPA set a final health advisory of 2,000 ppt. For GenX chemicals, EPA set a final health advisory of 10 ppt. EPA issued the previous health advisories for PFOA and PFOS in 2016. The Agency said that data and draft analyses released in November 2021 and currently under review by the Science Advisory Board (SAB) indicated that negative health effects could occur at much lower levels than previously understood. EPA said the SAB comments would inform the Agency’s development of maximum contaminant level goals as part of the National Primary Drinking Water Regulation for PFOA and PFOS, which EPA expects to propose later in 2022. Both the PFOA/PFOS and the HFPO Dimer Acid health advisories have been challenged in circuit courts of appeal.⁴² CERCLA Hazardous Substance Designations. On September 6, 2022, EPA published a proposed rule that would designate PFOA and PFOS, including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).⁴³ EPA stated that it believed that “the totality of evidence about PFOA and PFOS . . . demonstrates that they can pose substantial danger to public health or welfare or the environment” and that “[t]his level of evidence is more than sufficient to satisfy the CERCLA section 102(a) standard.” Direct effects of the listing would include requirements for reporting releases of PFOA or PFOS of one pound or more within a 24-hour period, requirements for the sale or transfer of federally owned property, and listing of PFOA and PFOS as hazardous materials under the Hazardous Materials Transportation Act. The listing also would give EPA, delegated agencies, and private parties the ability to recover cleanup costs from potentially responsible parties (PRPs) and would authorize EPA and delegated agencies to address PFOA and PFOS releases or require PRPs to address releases. EPA stated that it also is developing an advance notice of proposed rulemaking that will seek comments and data to inform the potential designation of other PFAS as hazardous substances. For additional discussion of the implications of the proposed designation, see our Advisory.

EPA Added 22 Chemicals to Safer Chemical Ingredients List and Marked One Chemical for Removal

On August 11, 2022, EPA updated its Safer Chemical Ingredients List (SCIL), adding 22 chemicals and marking a chemical for deletion from the list. EPA marked the chemical with a grey square to provide notice that the chemical may no longer be acceptable for use in Safer Choice-certified products. It will be removed after one year unless health and safety information provided to EPA adequately justifies continued listing. A chemical marked with a grey square will not be allowed for use in new products applying for Safer Choice certification, and any existing Safer Choice-certified products that contain the PFAS must be reformulated. A spreadsheet of the SCIL with a tab showing the recent updates is available here.

FDA Issued Request for Information on Fluorinated Polyethylene Food Containers

On July 20, 2022, the US Food and Drug Administration (FDA) published notice that it had opened a docket to obtain information on the use of fluorinated polyethylene for food contact applications.⁴⁴FDA requested scientific data and information on current food contact uses of fluorinated polyethylene, current manufacturing processes for fluorinated polyethylene containers, potential consumer dietary exposure resulting from use of fluorinated polyethylene containers in food contact, and safety of fluorinated polyethylene containers, including unpublished safety studies of substances that may migrate from fluorinated polyethylene. FDA noted that EPA had found—in testing on containers that were not FDA-regulated—that certain PFAS can form and migrate from some fluorinated high-density polyethylene containers into the pesticide within containers. FDA said that although EPA’s testing did not involve containers intended for food contact, the testing raised “questions about the potential for PFAS to form and migrate from fluorinated polyethylene containers that are intended for food contact use.” FDA said it might use the information it received in the docket to update dietary exposure estimates and safety assessments.

OSTP Requested Information to Inform Development of Strategic Plan for PFAS Research and Development

On July 13, 2022, the White House Office of Science and Technology Policy (OSTP) published a notice requesting information to inform a strategic plan for federal coordination of PFAS research and development.⁴⁵OSTP is required to develop the strategic plan by the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021. The notice identified five goals for PFAS research and development: (1) removal of PFAS from the environment; (2) safe destruction or degradation of PFAS; (3) development and deployment of safer and more environmentally friendly PFAS alternatives; (4) understanding of sources of environmental PFAS contamination and pathways to exposure; and (5) understanding of the toxicity of PFAS to humans and animals. The notice also set forth nine questions to which OSTP sought responses concerning priorities, criteria, and challenges for PFAS research and development. OSTP said it would accept comments until 5 PM ET on August 29, 2022.

CEQ Guidance Made Recommendations on Federal PFAS Procurement Policies

On August 31, 2022, the White House Council on Environmental Quality released a guidance document to assist federal agencies with their implementation of President Biden’s Executive Order 14057 on Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability.⁴⁶Although much of the guidance is focused on greenhouse gas emissions and other climate-related sustainability goals, the document includes two implementation actions concerning procurement and PFAS-containing materials. First, the document recommends that EPA consider expanding its Recommendations of Specifications, Standards, and Ecolabels for Federal Procurement to identify products that do not contain PFAS. Second, the document recommends that the General Services Administration consider updates to the Federal Procurement Data System to facilitate tracking of sustainable procurement policy, including agency avoidance of products containing PFAS. For additional background and analysis of the Biden Administration’s policies on federal procurement of PFAS-containing products, see our Environmental Edge blog post.

State Regulatory & Legislative Action

California

Department of Toxic Substances Control Proposed Alternatives Analysis Threshold for Toluene in Nail Products and Will Propose to List Nail Products Containing TPhP as Priority Product

On July 8, 2022, the California Department of Toxic Substances Control (DTSC) opened a 30-day public comment period on a modified proposal to list nail products containing toluene as a Priority Product in the Safer Consumer Products program.The modified proposal would set an Alternatives Analysis Threshold (AAT) of 100 parts per million (ppm), which would allow a manufacturer to submit an AAT Notification instead of an Alternatives Analysis if the manufacturer can demonstrate—with laboratory testing results or with information from ingredient suppliers—that the concentration of toluene does not exceed 100 ppm. DTSC reported that industry stakeholders requested during the comment period on the original proposal that DTSC set an AAT above contaminant levels. The stakeholders said the concentration of toluene in nail products when present as a contaminant was generally 100 ppm or lower. DTSC also cited programs in other states (Oregon, Vermont, and Washington) that require reporting when children’s products contain toluene and other specified chemicals above a contamination threshold of 100 ppm. Earlier in July, DTSC—which also has proposed nail products containing methyl methacrylate (MMA) as a Priority Product—released a “Chemicals in Nail Products Background Document.”⁴⁷The document reports on DTSC’s evaluation of 36 chemicals (not including toluene and MMA) in nail products. DTSC has identified four of those chemicals for further evaluations: triphenyl phosphate (TPhP), N,N-dimethyl-p-toluidine (DMPT), acrylic acid, and NMP. DTSC is preparing to propose nail products containing TPhP as a Priority Product and is soliciting further information on DMPT, acrylic acid, and NMP, which may be considered for future regulation.

Colorado

Colorado Enacted Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act that Will Phase in Prohibitions on Many PFAS-Containing Products

On June 3, 2022, Colorado Governor Jared Polis signed the Perfluoroalkyl and Polyfluoroalkyl Chemicals Consumer Protection Act, which will prohibit the sale or distribution of certain products containing intentionally added PFAS.⁴⁸The prohibitions will be phased in based on product category. The first prohibitions take effect on January 1, 2024 and apply to carpets or rugs, fabric treatments, food packaging, juvenile products, and oil and gas products. On January 1, 2025, prohibitions on PFAS-containing cosmetics, indoor textile furnishings, and indoor upholstered furniture take effect. Prohibitions on PFAS-containing outdoor textile furnishings and outdoor upholstered furniture take effect on January 1, 2027. Beginning on January 1, 2024, the law also will require labeling of cookware that contains intentionally added PFAS in a product handle or in any product surface that comes into contact with food, foodstuffs, or beverages. In addition, the law provides that persons using PFAS-containing class B firefighting foam shall not allow a release of the foam; shall fully contain the foam by implementing appropriate containing measures; shall safely store all class B firefighting foam and any associated waste until EPA publishes guidance on the proper disposal and destruction methods for PFAS; shall report releases; and shall document any measures taken pursuant to the law’s requirements. The law also changes the effective date of a law restricting use of PFAS-containing class B firefighting foam at structures used for aircraft storage or maintenance at public-use airports from January 1, 2023 to January 1, 2024. Beginning January 1, 2024, any use of class B firefighting foam containing intentionally added PFAS must be reported.

Delaware

Delaware Enacted Bans on Certain Flame Retardants in Children’s Products, Upholstered Furniture, and Mattresses

On August 4, 2022, Delaware Governor John Carney signed a bill that prohibits the manufacture, sale, offering for sale, or distribution of upholstered furniture and children’s products if the product contains, or has a constituent component that contains, more than 0.1% of specified flame-retardant chemicals or more than 0.1% of a mixture that includes one or more of the flame-retardant chemicals.⁴⁹The flame-retardant chemicals subject to these bans are 2-ethylhexyl-2,3,4,5-tetrabromobenzoate (TBB), antimony, bis(2-ethylhexyl) tetrabromophthalate (TBPH), chlorinated paraffins, decaBDE, hexabromocyclododecane (HBCD), tetrabromobisphenol A (TBBPA), tris(1,3-dichloro-2-propyl)phosphate (TDCPP), tris(2-chloroethyl)phosphate (TCEP), and tris(1-chloro-2-propyl)phosphate (TCPP). In addition, the law bars the manufacture, sale, offering for sale, or distribution of mattresses that contain, or have a constituent component that contains, more than 0.1% of an organohalogen or more than 0.1% of a mixture that includes one or more organohalogen. The law, which takes effect on July 1, 2023, provides for exemptions for the prohibitions, including for used products.

Hawaii

Hawaii Banned Certain PFAS-Containing Food Packages and Restricted PFAS-Containing Firefighting Foams

Legislation signed by Hawaii Governor David Y. Ige on June 27, 2022 establishes restrictions on PFAS in certain food packaging and on class B firefighting foam containing intentionally introduced PFAS chemicals.⁵⁰With respect to food packaging, the law prohibits, beginning on December 31, 2024, the manufacture, sale, offering for sale, or distribution for sale or use in the state of wraps and liners, plates, food boats, and pizza boxes to which PFAS have been intentionally introduced. With respect to firefighting foam, the law bars discharge or use for training or testing purposes of class B firefighting foam that contains intentionally introduced PFAS. This restriction takes effect on July 1, 2024, as does a ban on the manufacture, sale, offering for sale, distribution for sale, or distribution for training or testing purposes of such firefighting foam.

Maine

Maine Sought Feedback Plans for PFAS Consumer Product Notification Requirements

On June 30, 2022, the Maine Department of Environmental Protection (Maine DEP) held a stakeholder meeting concerning the State’s PFAS Consumer Products Registration Program, which a 2021 law provides shall take effect on January 1, 2023.⁵¹During the meeting, Maine DEP provided an overview of how the agency intends to proceed with rule development to implement the Registration Program, which requires manufacturers of products that contain intentionally added PFAS to submit a written notification to Maine DEP that includes a product description, the amount of PFAS in the product, the purpose for which PFAS is used in the product, manufacturer contact information, and other information as provided by rule. Maine DEP also released a concept draft of a proposed rule to implement the Registration Program. Maine DEP sought feedback on various issues, including the following: What should be the basis for an extension of the notification deadline? What would be a reasonable range for a PFAS reporting range and should Maine DEP approve of using one? What would be the qualifications for a product type to be reported as a group or category? What would stakeholders deem “substantially equivalent information” with regard to the law’s provision for a waiver where Maine DEP “determines that substantially equivalent information is already publicly available”? What are the anticipated number of products that DEP can expect to be reported initially? Comments on the concept draft were due July 18, 2022, and Maine DEP has indicated it intends to begin a formal rulemaking process by early fall. For additional discussion of the concept draft, see our Environmental Edge blog post.

New York

New York Court Dismissed Challenge PFOA and PFOS Drinking Water Standards on Standing Grounds

A New York State trial court ruled that the manufacturer 3M Company (3M) did not have standing to challenge the New York State Department of Health’s adoption of maximum contaminant levels (MCLs) for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) in drinking water.⁵²First, the court rejected the argument that “mere presence of business operations” in New York was sufficient to establish standing, finding that the alleged injury would not be different in kind or degree from that suffered by the public at large. The court also said the company could not establish standing based on its employees’ interests in drinking water. Second, the court determined that 3M’s participation in the administrative process did not—in the absence of an additional alleged direct harm—establish standing. Third, the court concluded that 3M could not establish standing based on its potential tort liability and litigation costs because the MCL rule itself did not establish those harms. Fourth, the court found that the connection between the MCL rule and potential increased regulatory compliance costs due to independent decisions by the New York State Department of Environmental Conservation was “too tenuous and ephemeral” to establish injury in fact. The court further found that potential tort liability and regulatory compliance costs would not fall in the Public Health Law’s zone of interests and therefore would not confer standing.

North Carolina

North Carolina Published PFAS Action Strategy

In June 2022, the North Carolina Department of Environmental Quality released an Action Strategy for PFAS that outlines the agency’s current and planned work in three key action areas: (1) Protecting Communities; (2) Protecting Drinking Water; and (3) Cleaning Up Existing Contamination.⁵³ “Protecting Communities” actions include prioritizing testing of public drinking water systems and private drinking water wells to inform future actions to protect water supplies; prioritizing the reporting of PFAS emissions from industrial sites, municipal wastewater treatment plants, landfills, sites where firefighting foam is used, and other priority sites; and identification of PFAS for further examination. “Protecting Drinking Water” actions involve proposing and implementing regulatory standards for groundwater, surface waters, and drinking water. “Cleaning Up Existing Contamination” activities include remediation to address known sites of PFAS, setting remediation goals for PFAS-contaminated sites, and recovering costs from responsible parties.

Oregon

Federal Court Dismissed Industry Challenge to Oregon Chemical Notification Rule for Children’s Products

On June 22, 2022, a federal district court in Oregon dismissed four trade associations’ lawsuit challenging parts of Oregon’s Toxic-Free Kids Act (TFK Act) and implementing regulations.⁵⁴The court rejected the associations’ claims that the Federal Hazardous Substances Act (FHSA) or the Consumer Product Safety Act (CPSA) expressly preempted (1) portions of the TFK Act regulations that required submission of documentation and payment of a fee to qualify for the TFK Act’s exemption for products that comply with federal law and (2) portions of the TFK Act and regulations that require testing and disclosure of chemicals in parts of children’s toys that are not accessible to children. With respect to the FHSA, the court found that because the Consumer Products Safety Commission (CPSC) had not regulated 69 of the 73 chemicals identified as high priority chemicals of concern by the TFK Act, the FHSA did not, at least on a facial challenge, preempt the contested statutory and regulatory provisions. The court said that “[i]f the CPSC has not exercised its authority to regulate a specific substance, then a State is free to do so.” With respect to the CPSA, the court similarly noted that 57 of the 73 chemicals were not expressly mentioned in any relevant regulation under the CPSA. The court concluded that the plaintiffs’ arguments relying on the regulatory definition of “banned hazardous substance” (which restated the statutory definition) to establish a basis for preemption were not persuasive and would upset the “careful federalism balance intended under the law governing express preemption.”

Rhode Island

Rhode Island Enacted PFAS Food Package Prohibition

On June 29, 2022, Rhode Island amended its Toxic Packaging Reduction Act, which, as of January 1, 2024, will prohibit the sale of food packages to which PFAS has been intentionally added.⁵⁵The legislation added to existing prohibitions on lead, cadmium, mercury, or hexavalent chromium in packages or packaging components. Other new provisions included a requirement that any substitute material that replaces a regulated chemical must not create “a hazard as great as or greater than the hazard created by the regulated chemical.” The law also authorizes the Rhode Island Department of Environmental Management’s participation in a regional, national, or multi-state clearinghouse to assist in implementing the Act. The Act defines PFAS as “all members of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom” and defines “intentional introduction of PFAS” to mean deliberate utilization of PFAS “where its continued presence is desired in the final package or packaging component to provide a specific characteristic, appearance, or quality.” Through July 1, 2027, the term will not include use of post-consumer recycled materials as feedstock for new packaging materials, where some portion of the feedstock material may contain the regulated chemical. The term does, however, include “use of a regulated chemical as a processing agent, mold release agent or intermediate . . . where the regulated chemical is detected in the final package or packaging component.”

Washington

Washington Department of Ecology Released Preliminary Safer Products Draft Rule Two Months After Issuing Final Report on Regulatory Determinations

In June 2022, the Washington State Department of Ecology (Ecology) released its Final Regulatory Determinations Report to the Legislature as part of the state’s Safer Products program.⁵⁶On August 9, Ecology released a preliminary draft rule for implementation of the regulatory determinations.⁵⁷The final report and preliminary draft address PFAS, orthophthalates, flame retardants, alkylphenol ethoxylates, and bisphenols in various categories of consumer products. For PFAS, the preliminary draft rule would prohibit manufacture, sale, and distribution of aftermarket stain- and water-resistant treatments, carpets and rugs, and leather and textile furniture and furnishings that contain intentionally added PFAS and are intended for indoor use. Reporting requirements would apply to PFAS-containing leather and textile furniture and furnishings intended for outdoor use. For orthophthalates, the preliminary draft rule would restrict manufacture, sale, and distribution of fragrances in beauty and personal care products containing intentionally added orthophthalates and vinyl flooring containing more than 1,000 parts per million (ppm) of orthophthalates. For organohalogen flame retardants (OFRs), the preliminary draft rule would phase in restrictions on OFRs in plastic external enclosures of electric and electronic products intended for indoor use, starting with TVs and displays, where the product contains more than 1,000 ppm of any individual intentionally added OFR or more than 1,500 ppm of any intentionally added combined OFR. The preliminary draft provides for exclusions for certain types of products and components, including plastic external enclosure parts that weigh less than 0.5 grams and inaccessible components such as printed circuit boards and internal fans. For electric and electronic products with OFRs in plastic enclosures intended for outdoor use, the preliminary draft rule would institute reporting requirements. Reporting requirements would apply to use of OFRs or certain organophosphate flame retardants in recreational covered wall padding made from polyurethane foam, and manufacture, sale, and use of other recreational products made from polyurethane foam containing more than 1,000 ppm of any of OFRs or the organophosphate flame retardants would be prohibited. The preliminary draft rule also would prohibit laundry detergents containing more than 1,000 ppm of any alkylphenol ethoxylates; drink can linings containing a bisphenol-based epoxy can liner, excluding TMBPF-based epoxy can liners; and thermal paper containing more than 200 ppm of any individual bisphenol. A reporting requirement would apply to use of a bisphenol-based epoxy food can liner, excluding TMBPF-based epoxy can liners. The rulemaking process must be completed by June 1, 2023.

Washington Department of Ecology Soliciting Input on Accelerated Regulation of PFAS Products and Next Cycle of Safer Products Program

On September 1, Ecology announced two sets of Safer Products for Washington webinars for stakeholders.⁵⁸ The first webinars (scheduled for September 20 and 22) are focused on potential fast-tracking of the Safer Products for Washington process for PFAS-containing products listed in the Per- and Polyfluoralkyl Substances Chemical Action Plan. The second webinars (scheduled for September 27 and 29) are focused on identification of priority chemicals for the next cycle of the Safer Products program.

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© Arnold & Porter Kaye Scholer LLP 2022 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.