The Chemical Compound—May 2021
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 on chemical substances which are the subject of regulatory activity or scrutiny by various government agencies and potential litigants. This includes emerging contaminants 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, or regulation. The change in administrations has prompted a considerable change in emphasis and new activities at EPA that are significant and which are noted in this edition.
Table of Contents
- Record Penalty Imposed in Home Depot’s Settlement of TSCA Lead Paint Violations
- EPA Notified Ninth Circuit of Intent to Seek Voluntary Remand for HBCD Risk Evaluation
- Four Pending Cases Challenge 1,4-Dioxane Risk Evaluation, with Ramifications for Preemption of State Restrictions
- EPA Granted More Time for Submission of Brief in Challenges to Methylene Chloride Risk Evaluation
- Trade Group Intervened to Defend Asbestos Risk Evaluation
- Lawsuits Challenging DecaBDE and PIP (3:1) Risk Management Rules Put on Hold
- Fifth Circuit Remanded CPSC’s Phthalate Restrictions for Children’s Toys and Child Care Articles
- Oral Argument Held in Challenge to Methylene Chloride Risk Management Rule
- Stay of Fluoridation Case to Continue After EPA Argues that New Rulemaking Petition Is “Most Logical Way” Forward
- Settlement Reached on Next Steps for Asbestos CDR Reporting
- Deadlines Extended in Challenge to EPA Denial of PFAS Petition
- PFAS Accountability Act of 2021 Would Create Federal Cause of Action for PFAS Exposure
- PFAS Action Act of 2021 Would Amend Major Environmental Statutes to Regulate PFAS
- Senate Committee Approved Bill that Would Require Guidance on Reducing Firefighter Exposure to PFAS
- EPA Acting Assistant Administrator Previewed Principles for Biden Administration’s TSCA Implementation
- EPA Makes Changes to New Chemicals Program Likely to Further Complicate, Slow Reviews
- EPA Takes Steps to Set PFAS Agenda
- OSHA Proposed First Updates to Hazard Communication Standard Since 2012
- EPA Said Interim Rule to Amend TSCA Mercury Reporting Requirements Was Forthcoming
- Environmental Groups Seek EPA Actions on Phosphogypsum and Process Wastewater from Phosphoric Acid Production
- EPA Announced Temporary Regulatory Relief for PIP (3:1) Prohibition, Opened Broader Review of Five TSCA PBT Risk Management Rules
- EPA to Move 390 Substances to Public Portion of TSCA Inventory
- GAO Report Identified Decline in EPA’s Chemical Assessment Processes Since 2019
- Chemical Importer to Pay $357,000 Penalty to Resolve Alleged TSCA CDR Violations
- Chemical Distributor Agreed to $128,265 Penalty to Resolve TSCA CDR and Export Notification Violations
- EPA Sought Comment on Manufacturer Request for Risk Evaluation of Fragrance Chemicals
- EPA to Revamp TSCA Systematic Review Process in Response to National Academies’ Critique
Record Penalty Imposed in Home Depot’s Settlement of TSCA Lead Paint Violations
A consent decree entered by the federal district court for the Northern District of Georgia required Home Depot U.S.A, Inc. (Home Depot) to pay a $20.75 million civil penalty and to implement procedures and educational and outreach projects to resolve alleged violations of TSCA Title IV, the EPA Lead Renovation, Repair and Painting Rule, and corresponding state and tribal regulations (the RRP Rules).1 The RRP Rules require that only firms certified by EPA or an authorized state or tribal program perform certain renovation, repair, and painting (RRP) projects that disturb lead-based paint in homes and child-occupied facilities built before 1978. The RRP Rules also require compliance with disclosure, record-keeping, and work practice requirements. The enforcement case was brought by the United States, Utah, Rhode Island, and Massachusetts, and alleged that Home Depot failed to use certified firms for renovations at numerous locations from 2013 to at least 2019, and that Home Depot falsely identified more than 600 pre-1978 homes in its internal tracking system as having had negative tests for lead. The complaint also asserted claims for violations of record-keeping requirements and work practice standards. The compliance measures that the consent decree requires Home Depot to implement include conducting at least 18,000 jobsite inspections over the three-year duration of the consent decree, establishing a renovation complaint process, implementing procedures to ensure Home Depot either determines the year a property was built or assumes the property was built before 1978, and implementing an RRP education program for both do-it-yourself customers and professional and contractor customers. The governmental plaintiffs said the civil penalty was the largest ever assessed under TSCA.
EPA Notified Ninth Circuit of Intent to Seek Voluntary Remand for HBCD Risk Evaluation
On April 23, 2021, EPA and petitioners moved to stay the briefing deadlines in three consolidated proceedings in the Ninth Circuit challenging the final TSCA risk evaluation for the flame retardant cyclic aliphatic bromide cluster (HBCD).2 The parties requested the stay to allow EPA to continue to confer with the petitioners about the Agency’s intended motion for voluntary remand without vacatur and the Agency’s plans for reconsideration of the HBCD risk evaluation. EPA told the court that based on the Agency’s review of the risk evaluation pursuant to President Biden’s Executive Order 13,990—which directed agencies to review actions taken during the Trump Administration—the Agency now believed that reconsideration “may be warranted.” The parties recommended that the court set a briefing schedule for the motion to remand, with the motion due on May 28.
Four Pending Cases Challenge 1,4-Dioxane Risk Evaluation, with Ramifications for Preemption of State Restrictions
A total of four petitions for review have been filed to challenge EPA’s final TSCA risk evaluation for 1,4-dioxane, with two petitions filed since the last edition of the Chemical Compound.3 All four of the cases are now pending in the Ninth Circuit after the DC Circuit granted the parties’ motion to transfer the proceeding filed on February 10, 2021 by the International Union, United Automobile, Aerospace and Agricultural Implement Workers of America (UAW). The UAW’s petition for review indicated it would challenge EPA’s determinations that 1,4-dioxane did not present an unreasonable risk under certain conditions of use as well as EPA’s decision not to consider certain uses and pathways through which the UAW’s members and the public are allegedly exposed. The fourth petition was filed by 15 states and the District of Columbia, led by New York, in the Ninth Circuit on March 22. The risk evaluation’s conclusions that consumer uses do not present an unreasonable risk could preempt state-level restrictions on 1,4-dioxane in personal care, cosmetic, and cleaning products such as restrictions enacted by New York in 2019.4
EPA Granted More Time for Submission of Brief in Challenges to Methylene Chloride Risk Evaluation
In the consolidated proceedings challenging the TSCA risk evaluation for methylene chloride, the Ninth Circuit granted EPA’s request to extend the deadline for the Agency to file its answering brief by 30 days, to May 26, 2021.5 In its request for the extension, EPA told the court that it needed the additional time to complete its review of the risk evaluation and decide whether to pursue reconsideration of one or more of the issues raised by the petitions for review. In February, EPA filed its opposition to a motion by environmental and labor groups to supplement the record with inter-agency comments from the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health, and also with a declaration from an environmental health sciences professor that the petitioners contended was necessary to assist the court in understanding EPA’s evaluation of occupational exposure and risk. A clerk order referred this motion to the panel hearing the merits of the case.
Trade Group Intervened to Defend Asbestos Risk Evaluation
On April 15, 2021, the Ninth Circuit granted the Chlorine Institute’s motion to intervene in the case challenging EPA’s TSCA risk evaluation for chrysotile asbestos.6 The Chlorine Institute—a trade association of chlor-alkali producers—had argued that its member companies who use chrysotile asbestos for the manufacture of chlorine could be directly and adversely affected by the outcome of the case. In its order granting intervention, the Ninth Circuit also set the briefing schedule, with the petitioners’ opening brief due June 1, 2021; respondents’ answering brief due August 20, 2021; the Chlorine Institute’s brief due September 3, 2021; and the petitioners’ optional reply brief due September 24, 2021. The petitioners in the case also sent EPA a notice of intent to sue in January asserting that EPA failed “to perform its non-discretionary duty to address the use and disposal of ‘legacy’ asbestos in its risk evaluation,” a task that EPA indicated it would undertake in a “Part 2” of the risk evaluation.
Lawsuits Challenging DecaBDE and PIP (3:1) Risk Management Rules Put on Hold
Federal courts of appeal are holding in abeyance the challenges to TSCA Section 6 risk management rules for two substances designated by EPA as persistent, bioaccumulative, and toxic (PBT). The abeyance will be in place while the Biden Administration takes comment on all five PBT rules finalized by the Trump Administration in January. In the two proceedings in the Ninth Circuit challenging the risk management rule for decabromodiphenyl ether (decaBDE), the court stayed proceedings until July 1, 2021.7 Those proceedings were filed by non-profit organizations and an Indian Tribe. In the proceeding filed in the DC Circuit by trade groups to challenge the risk management rule for phenol, isopropylated phosphate (3:1) (PIP (3:1), the court held the case in abeyance pending further order of the court, with the parties directed to file motions to govern future proceedings by October 7, 2021.8 In both the decaBDE and PIP (3:1) cases, the Department of Justice argued that abeyance was needed due to the change in administrations, President Biden’s Executive Order 13,990 (which directed agencies to undertake reviews of regulations adopted by the Trump Administration), and EPA’s public notice soliciting comment on the PBT rules pursuant to the Agency’s efforts to reconsider such rules in light of President Biden’s directive.
Fifth Circuit Remanded CPSC’s Phthalate Restrictions for Children’s Toys and Child Care Articles
On March 1, 2021, the Fifth Circuit Court of Appeals remanded a final Consumer Product Safety Commission (CPSC) rule promulgated in October 2017 that continued and expanded a statutory interim prohibition on diisononyl phthalate (DINP) in children’s toys and child care articles at concentrations greater than 0.1% and permanently prohibited four other phthalates in children’s toys and child care articles at levels greater than 0.1%.9 As a threshold matter, the Fifth Circuit found that a trade association with a member that was a DINP producer had associational standing based on the possibility of reduced sales of DINP and the rule’s “stigmatic effect.” The Fifth Circuit also found that it had jurisdiction to review the October 2017 rule because the regulation was a “consumer product safety rule” subject to the Consumer Product Safety Act’s (CPSA’s) procedure for judicial review. On the merits, the Fifth Circuit concluded that the final rule was not the “logical outgrowth” of the proposed rule because the final rule’s justification was based on a different methodology that was not reasonably foreseeable based on the proposed rule. The Fifth Circuit agreed with the CPSC, however, that the Consumer Product Safety Improvement Act’s “necessary to protect the health of children” (for the new and expanded prohibitions) and “reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety” (for the continued prohibition) standards applied rather than the “unreasonable risk of injury” standard of the CPSA. The Fifth Circuit further found, however, that the CPSC was required to consider costs and the effect on utility and availability of products containing DINP to determine whether to continue the interim prohibition to “ensure a reasonable certainty of no harm.” The Fifth Circuit concluded that the consideration of costs was not required for the prohibition on products containing the other four phthalates because Congress had not added a “reasonable” qualifier to that standard. The Fifth Circuit also rejected the petitioners’ contention that the final rule was arbitrary and capricious. The court declined to vacate the rule, finding that there was a “serious possibility” that the CPSC would be able to remedy the failures identified in the opinion.
Oral Argument Held in Challenge to Methylene Chloride Risk Management Rule
On March 4, 2021, the Second Circuit Court of Appeals heard oral argument in the case challenging EPA’s 2019 TSCA Section 6 risk management rule for methylene chloride.10 EPA has argued that the cases—in which the petitioners ask the court to order EPA to finalize restrictions on commercial use of methylene chloride—should be dismissed because EPA is currently developing a risk management rule to address the unreasonable risk that the Agency’s 2020 risk evaluation found to be presented by commercial uses of methylene chloride in paint and coating removal. The 2019 rule banned the manufacture, import, processing, and distribution of methylene chloride in paint and coating removal for consumer use but did not finalize the 2017 proposed rule’s prohibition on commercial paint and coating removal uses of methylene chloride.
Stay of Fluoridation Case to Continue After EPA Argues that New Rulemaking Petition Is “Most Logical Way” Forward
In a case challenging EPA’s denial of a TSCA Section 21 rulemaking petition seeking a prohibition on the fluoridation of drinking water, a federal district court judge in the Northern District of California told parties at an April 22, 2021 hearing that the court would continue to hold the case in abeyance at least until the National Toxicology Program (NTP) releases a study on fluoride exposure and neurodevelopmental and cognitive health effects.11 EPA notified the court in February that the National Academies of Sciences, Engineering, and Medicine (NASEM) had released its review of the NTP’s revised monograph on fluoride exposure and found that it could not be used to draw conclusions regarding low fluoride exposure concentrations such as those usually associated with drinking water fluoridation. At the April 22 hearing, the judge also indicated that the court would grant the plaintiffs’ motion to amend their complaint. The plaintiffs filed their motion to amend after EPA declined to reopen the administrative record and reconsider the Agency’s denial of the original petition.12 The plaintiffs’ amended complaint sought to bolster their standing allegations regarding a member of the lead organizational plaintiff. The plaintiffs argued that there was “no longer a viable dispute” that the organization lacked standing because the individual member had become pregnant in or around December 2020 and feared “the very sort of neurodevelopmental harm that was the focus of Plaintiffs’ trial evidence.” After a delay in the briefing of the motion to allow the parties to engage in settlement discussions, EPA filed its opposition to the motion to amend. The Agency noted that the plaintiffs’ new allegations concerned not only their standing declarant but also new draft scientific documents. EPA contended that the “most logical way” to address these new developments was for the plaintiffs to submit a new petition to EPA to allow the Agency “to comprehensively consider all the evidence, including the new evidence Plaintiffs seek to bring before the Court now.”13 The court said it would issue a written order further explaining its reasoning for granting the motion to amend and continuing to stay the case.
Settlement Reached on Next Steps for Asbestos CDR Reporting
At a status conference on April 15, 2021, EPA told the federal district court for the Northern District of California that the Agency and plaintiffs who seek to expand collection of asbestos information under the TSCA Section 8 Chemical Data Reporting (CDR) rule had reached an agreement in principle to resolve litigation in which the court previously ordered EPA to revise the CDR rule to address “information-gathering deficiencies.”14 The framework for the settlement would require the court to amend its previous order to track language in TSCA Section 21(b)(4)(A), “which the parties agree establishes the Court’s jurisdiction and authority requiring EPA to initiate a rule making proceeding.”15 That provision gives district courts the authority to compel the EPA Administrator “to initiate a rulemaking proceeding as requested in the petition.”16 In addition, the plaintiffs agreed to amend their complaint to establish their claims under Section 21. EPA estimated that it would take no more than four weeks to finalize the settlement.
Deadlines Extended in Challenge to EPA Denial of PFAS Petition
On April 22, 2021, a federal court in California signed off on a stipulation extending EPA’s time to respond to a complaint challenging EPA’s denial of a TSCA Section 21 petition that requested that EPA order health and environmental effects testing for 54 per- and polyfluoroalkyl substances (PFAS) that the petitioners said were manufactured at a facility in North Carolina.17 The stipulation indicated that the parties had agreed to extend EPA’s time to respond until July 6, 2021 (from May 7, 2021) to provide EPA additional time to determine whether reconsideration of the denial was necessary in light of an administrative request for reconsideration submitted by the petitioners.
PFAS Accountability Act of 2021 Would Create Federal Cause of Action for PFAS Exposure
On April 22, 2021, Senator Kirsten Gillibrand (D-NY) introduced the PFAS Accountability Act of 2021 (S. 1334), which has been referred to the Senate Environment and Public Works Committee.18 The bill seeks to create a federal cause of action for individuals alleging they have experienced “significant” exposure to PFAS and to provide a medical monitoring remedy. Such actions could be brought on either an individual or class-wide basis against persons or entities who “(1) engaged in any portion of a manufacturing process that created the PFAS to which the individual was significantly exposed” and (2) “foresaw or reasonably should have foreseen that the creation or use of PFAS would result in human exposure to PFAS.” The bill also would lower certain standards of proof and permit courts to order a defendant to undertake and fund scientific studies. A plaintiff would have to prove four elements: (1) “significant” exposure to PFAS (with a presumption of significant exposure created if certain criteria are met); (2) increased risk of developing a disease “associated” with exposure to PFAS (instead of usual causation requirements); (3) a reasonable basis to undergo periodic diagnostic medical examinations of a nature or frequency that is different from or additional to what would be prescribed in the absence of the exposure; and (4) availability of effective medical exams to detect a disease associated with PFAS exposure. More information about the bill is available in our April 26 Environmental Edge blog post.
PFAS Action Act of 2021 Would Amend Major Environmental Statutes to Regulate PFAS
On April 13, 2021, Representatives Debbie Dingell (D-MI) and Fred Upton (R-MI), along with 25 other co-sponsors, introduced the PFAS Action Act of 2021.19 The bill would require designation of perfluorooctanoic acid and its salts (PFOA) and perfluorooctanesulfonic acid and its salts (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (within one year) and as hazardous air pollutants under the Clean Air Act (within 180 days) and to make a determination within five years as to whether other PFAS also should be designated as hazardous substances and hazardous air pollutants. The bill would amend Section 4 of TSCA to require EPA to issue a testing rule for all PFAS that would require manufacturers and processors of PFAS to develop information “likely to be useful in evaluating the hazard and risk posed by such substances in land, air, and water (including drinking water), as well as in products.” The bill also would amend Section 5 of TSCA to institute a five-year moratorium on the manufacture, processing, and distribution of new PFAS and new uses of PFAS, and would provide that exemptions from new chemical notification and review requirements do not apply for PFAS. In addition, the bill would set a schedule for establishing drinking water standards for PFOA and PFOS under the Safe Drinking Water Act and would establish a grant program to assist community water systems with capital costs for treatment technologies to address PFAS. The Resource Conservation and Recovery Act would be amended to include provisions regulating incineration of PFAS. EPA also would be required to establish a labeling program under the Safer Choice Program for pots, pans, cooking utensils, carpets, or rugs, clothing, or upholstered furniture, or stain resistant, water resistant, or grease resistant coatings that do not contain PFAS. Other provisions of the bill would require EPA to establish water quality criteria and pretreatment standards and effluent limitations for PFAS; develop a risk-communication strategy to inform the public of the risks or potential risk of PFAS; and issue guidance on minimizing use of firefighting foam and related equipment containing PFAS.
Senate Committee Approved Bill that Would Require Guidance on Reducing Firefighter Exposure to PFAS
On March 17, 2021, members of the Senate Homeland Security and Governmental Affairs Committee unanimously approved the Protecting Firefighters from Adverse Substances Act or “PFAS Act” (S. 231). The legislation would require the Federal Emergency Management Agency (FEMA) to develop guidance for firefighters and other emergency personnel on training, education programs, and best practices to reduce exposure to PFAS from firefighting foam and personal protective equipment and to limit or prevent the release of PFAS from firefighting foam into the environment. The law would also require guidance on alternative foams and equipment that do not contain PFAS. In addition, FEMA would be required to create an online public repository on tools and best practices for firefighters and other emergency personnel to reduce, limit, and prevent release of and exposure to PFAS. The Senate passed the PFAS Act in the 116th Congress (S. 2353), but the House of Representatives did not take up the bill.
EPA Acting Assistant Administrator Previewed Principles for Biden Administration’s TSCA Implementation
At a Chemical Watch conference on March 25, 2021, Acting Assistant Administrator Michal Freedhoff discussed how the Biden EPA plans to proceed with implementation of TSCA.20 (On April 22, President Biden formally nominated Dr. Freedhoff to serve as Assistant Administrator for the Office of Chemical Safety and Pollution Prevention.) Dr. Freedhoff’s prepared remarks addressed several key areas or themes, including scientific integrity, racial equity, and worker protection. Her remarks indicated that EPA plans to take a “hard look” at the first 10 risk evaluations and that EPA’s goal is “to move forward [on risk management rules] as much as possible, while looking back surgically at specific areas in some of the risk evaluations to supplement them as appropriate in order to ensure we are meeting our statutory obligations and using the best available science to truly protect human health and the environment.” The remarks also indicated that “[o]ne of the consistent omissions from the first 10 risk evaluations is the consideration of unreasonable risks to fence line communities.” In addition, she said EPA would consider the scope of risk evaluations to ensure all conditions of use and exposures are considered; the remarks were critical of the Trump Administration’s policy decision to exclude exposures that could be addressed by other laws. Her remarks also previewed changes to the new chemicals program (see the item below) and highlighted actions that EPA has taken under TSCA to address PFAS such as the significant new use rule for long-chain perfluoroalkyl carboxylate substances that took effect in 2020.21
EPA Makes Changes to New Chemicals Program Likely to Further Complicate, Slow Reviews
In the first 100 days of the Biden Administration, EPA has already announced significant changes to the TSCA new chemicals program that are likely to disrupt an already backlogged new chemical review process at EPA. First, EPA announced on March 29 that it intended to implement two changes in its review of new chemicals: (1) EPA will no longer issue “not likely to present an unreasonable risk” determinations based on the existence of proposed significant new use rules (SNURs), and will instead issue administrative orders to address potential risks presented by reasonably foreseen conditions of use; and (2) EPA will no longer assume workers are protected by Occupational Safety and Health Administration standards and warnings and directives appearing in updated Safety Data Sheets where the Agency identifies potential unreasonable risk to workers that could be addressed through use of personal protective equipment (PPE). Under this new approach, EPA will instead identify the absence of PPE as a reasonably foreseen condition of use of a new chemical and issue Section 5(e) orders to mandate PPE use and other restrictions EPA deems necessary.22 On April 27, EPA announced a more targeted shift that will affect its review of applications for low-volume exemptions (LVEs) for PFAS.23 EPA revealed that given “the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment,” PFAS were unlikely to be considered eligible for an LVE exemption from the full review and regulatory outcomes given to new chemicals produced in larger volumes. EPA said it generally expected that pending and new LVE applications for PFAS would be denied and would instead go through the complete PMN process, allowing the Agency more time to conduct a thorough review and likely resulting in the imposition of administrative orders requiring further measures to mitigate risk. EPA also announced that it was working with companies to explore ways for the companies to voluntarily withdraw previously granted LVEs for PFAS.
EPA Takes Steps to Set PFAS Agenda
The Biden EPA has taken new steps to address PFAS in the Administration’s first 100 days. In addition to those measures affecting the TSCA new chemicals program discussed above , EPA Administrator Michael S. Regan announced on April 27, 2021 that he had established an EPA Council on PFAS (ECP) comprising senior EPA career officials to develop a multi-year strategy for 2021 through 2025 to address PFAS.24 Administrator Regan directed the ECP to review all ongoing PFAS-related actions, propose modifications, and identify new strategies and priorities, with an initial set of recommendations due in 100 days. The ECP’s mandate also includes “close interagency coordination on regional specific and cross-media issues to assist states, tribes and local communities faced with significant and complex PFAS challenges”; working with all national program offices and EPA regions to maximize the impact of EPA’s funding and financing programs to support PFAS cleanup, particularly in underserved communities; and expanded engagement opportunities with federal, state, and tribal partners.
In his announcement of the convening of the ECP, Administrator Regan identified the following important steps taken by EPA during the new Biden-Harris Administration:
- PFBS toxicity assessment: On April 8, 2021, EPA released an updated toxicity assessment for perfluorobutane sulfonic acid (PFBS), a replacement chemical for PFOA. The Agency said the updated assessment fixed errors and addressed issues of scientific integrity in a version of the assessment issued by the Trump Administration in January.25 Following the transition between administrations, EPA withdrew the January version, finding that its conclusions had been compromised by political interference.26 EPA announced that the updated PFBS toxicity assessment released in April was available for use across EPA program offices and regions, as well as by other federal agencies, states, tribes, and other entities. The chronic oral reference dose (RfD) developed as part of the toxicity assessment was 0.0003 mg/kg-day. The Agency characterized the assessment as suggesting that PFBS is less toxic than PFOA and PFOS, for which the chronic RfD is 0.00002 mg/kg-day.
- National primary drinking water regulations: After initially halting publication of EPA’s final regulatory determinations to regulate PFOA and PFOS under the Safe Drinking Water Act as part of the regulatory freeze imposed on January 20, EPA announced that it will move forward with the final regulatory determinations.27
- Collection of new data on 29 PFAS: EPA also is reproposing the Fifth Unregulated Contaminant Monitoring Rule (UCMR 5) to collect new data on 29 PFAS in drinking water.28
- Solicitation for data on the presence and treatment of PFAS in wastewater discharges: On March 17, 2021, EPA published an advance notice of proposed rulemaking seeking information and data regarding discharges of PFAS from industrial facilities in the Organic Chemicals, Plastics, and Synthetic Fibers point source category.29 EPA is collecting information to support future Clean Water Act rulemaking for effluent limitations guidelines, pretreatment standards, and new source performance standards for manufacturers in this category, as well as potential revisions to such guidelines and standards for formulators. The comment period closes on May 17, 2021.
Administrator Regan also noted EPA’s strong support of President Biden’s American Jobs Plan’s call investment in monitoring for and treating PFAS in drinking water.
Other PFAS actions underway at EPA include preparation of a proposed “PFAS data call” rule required by Section 7351 of the National Defense Authorization Act for Fiscal Year 2020.30 The rule will impose a one-time reporting requirement on persons who have manufactured PFAS in any year since January 1, 2011. The reporting will include information about quantities manufactured or processed and existing information on environmental and health effects, as well as exposure and disposal information. EPA sent the proposed rule to the White House’s Office of Management and Budget on March 1, 2021.31
For more discussion of Biden-Harris Administration actions on PFAS, as well as potential congressional and state actions related to PFAS, see Arnold & Porter’s February Advisory on “Eight Important Updates About Recent PFAS Regulatory Developments.” A report issued by the Government Accountability Office in January 2021 discussed EPA’s progress during the Trump Administration on implementing the PFAS Action Plan.32
Interagency Testing Committee Added High-Priority Substances and Organohalogen Flame Retardants to Priority Testing List
On April 28, 2021, EPA published notice of its receipt of the TSCA Interagency Testing Committee’s (ITC’s) Seventy-Fourth Report, which revised the Section 4(e) Priority Testing List so that the list now includes all 20 of the High-Priority Substances designated by EPA in December 2019 as well as 24 organohalogen flame retardants (in addition to six that were already on the list).33 The ITC also requested that EPA add all 20 High-Priority Substances and 30 organohalogen flame retardants to the Section 8(d) Health and Safety Data Reporting rule, which requires submission to EPA of lists and copies of unpublished health and safety studies. The ITC added the organohalogen flame retardants to the list after the Consumer Product Safety Commission (CPSC) requested that additive, nonpolymeric organohalogen flame retardants be added because the CPSC had granted a rulemaking petition for regulation of these chemicals under the Federal Hazardous Substances Act and needed information to support its rulemaking process. EPA invited public comment on the ITC report, with comments due on or before May 28, 2021.
OSHA Proposed First Updates to Hazard Communication Standard Since 2012
In February 2021, the Occupational Safety and Health Administration (OSHA) issued a proposed rule to amend the Hazard Communication Standard (HCS).34 The HCS establishes a framework for communicating information about hazardous chemicals in the workplace, including requirements for manufacturers and importers of chemicals, as well as employers. The proposed rule would revise the HCS to align it with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Revision 7. The HCS currently is aligned with Revision 3 to the GHS, which is updated biannually. Proposed changes to conform the HCS with GHS Revision 7 include adding classification categories for aerosols, desensitized explosives, and flammable gases, and updating select hazard and precautionary statements for clearer and more precise hazard information. The proposed amendments also would make changes to address issues that have arisen since the last HCS rulemaking in 2012, including changes to labeling requirements for small containers and for packaged containers that have been released for shipment. The proposed amendments are intended to facilitate international trade since a number of US trading partners also are aligning their hazard communication requirements with GHS Revision 7. OSHA is accepting comment on the proposed rule through May 19, 2021.35
EPA Said Interim Rule to Amend TSCA Mercury Reporting Requirements Was Forthcoming
On March 24, 2021, EPA published notice of an Information Collection Request (ICR) related to the TSCA Mercury Inventory Reporting requirements.36 The notice reports that EPA plans to issue an interim final rule to effectuate the Second Circuit’s June 2020 decision vacating the reporting exemption for imported assembled products containing mercury-added components.37 Mercury reporting occurs every three years pursuant to TSCA Section 8(b)(10). The next reporting year to be covered is 2021, with the reports for 2021 scheduled to be filed by July 1, 2022.
Environmental Groups Seek EPA Actions on Phosphogypsum and Process Wastewater from Phosphoric Acid Production
On February 8, 2021, more than 15 environmental groups submitted a rulemaking petition to EPA pursuant to TSCA Section 21 and the Administrative Procedure Act requesting that EPA take actions concerning regulation of phosphogypsum and process wastewater from phosphoric acid production (process wastewater).38 The petitioners requested five actions: (1) reversal of EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from the Resource Conservation and Recovery Act Subtitle C hazardous waste regulations; (2) regulation of the treatment, storage, and disposal of phosphogypsum and process wastewater under Subtitle C; (3) initiation of the TSCA Section 6 prioritization process for designating phosphogypsum and process wastewater as High-Priority Substances; (4) requirement for manufacturer testing on phosphogypsum and process wastewater under TSCA Section 4; and (5) a determination that use of phosphogypsum in road construction is a significant new use under TSCA Section 5. EPA confirmed its receipt of the petition in a letter signed on February 19, 2021. Under TSCA Section 21, EPA has 90 days from the date the petition was filed to grant or deny the petition.
EPA Announced Temporary Regulatory Relief for PIP (3:1) Prohibition, Opened Broader Review of Five TSCA PBT Risk Management Rules
On March 8, 2021, EPA issued a narrowly tailored No Action Assurance (NAA) letter announcing that EPA will not pursue enforcement actions for up to 180 days for violations of a prohibition on processing and distribution in commerce of PIP (3:1) for use in articles or for ancillary recordkeeping violations.39 The prohibition—which was scheduled to take effect on March 8—is part of a rule issued by the Trump Administration in January,40 one of five risk management rules that the Trump EPA promulgated to regulate five substances identified as persistent, bioaccumulative, and toxic. At the same time it announced the NAA, EPA issued advance notice of its c Federal Register notice seeking comments more broadly on all five PBT rules (which regulate decaBDE, 2,4,6-TTBP, PCTP, and HCBD, in addition to PIP (3:1)).41 EPA issued the NAA because it concluded, based on information provided by various stakeholders after the PIP (3:1) rule’s promulgation, that a compliance deadline extension was in the public interest in order to avoid significant supply chain disruptions. The stakeholders had notified EPA of potential significant commercial disruptions they would experience due to the March 8 prohibition on the processing and distribution of PIP (3:1)-containing articles. The NAA does not apply to violations of the January rule’s other provisions, including a prohibition on releases of PIP (3:1) to water, recordkeeping requirements, or downstream notification requirements that apply after July 6, 2021. EPA’s notice seeking public comment on all five PBT risk management rules is intended to allow EPA both to gather information to ascertain what an appropriate compliance deadline would be for the PIP (3:1) prohibition and also to undertake a broader review of the PBT rules pursuant to President Biden’s Executive Order 13990 on “Protecting Public Health and the Environment and Restoring Science To Tackle the Climate Crisis.”42 EPA asked for input on whether the five rules could be revised to achieve further exposure reductions, including for potentially exposed or susceptible subpopulations and the environment, and whether EPA should consider imposing additional or alternative measures. Stakeholders and members of the public have until May 17, 2021 to submit comments. More information about these actions is available in our April 5 Environmental Edge blog post.
EPA to Move 390 Substances to Public Portion of TSCA Inventory
On April 29, 2021, EPA released a list of 390 chemical substances that it intends to move from the confidential to the public portion of the TSCA Inventory when the Agency releases the next update of the Inventory, which is anticipated in late summer 2021.[[N:See Updates to Confidential Status of Chemicals on the TSCA Inventory, EPA (last updated Apr. 29, 2021).] EPA said specific identities of the 390 chemicals were reported as non-confidential in the 2012, 2016, or 2020 reports submitted under the Chemical Data Reporting rule. The Agency advised that stakeholders should contact EPA staff (listed here) by May 14, 2021 with any questions or concerns about the change in confidential status.
GAO Report Identified Decline in EPA’s Chemical Assessment Processes Since 2019
In March 2021, the US Government Accountability Office (GAO) announced its 2021 High-Risk List, which found that EPA’s process for assessing and controlling toxic chemicals had worsened since the GAO issued its 2019 High-Risk List.43 The High-Risk Lists are intended to focus attention on government operations that are vulnerable to fraud, waste, abuse, and mismanagement, or that need transformation to address economy, efficiency, or effectiveness. The GAO cited issues in both TSCA implementation and in the Integrated Risk Information System (IRIS) program. With respect to TSCA, the GAO noted that EPA had not completed workforce or workload planning to ensure the Agency could meet TSCA deadlines and that the Agency had not met TSCA’s statutory deadlines for the first 10 risk evaluations of existing chemicals. With respect to the IRIS program, the GAO cited EPA’s failure to issue a completed chemical assessment between August 2018 and December 2020 and also noted that EPA had not indicated how it was monitoring its assessment nomination process to assure the process was generating quality information about chemical assessment needs and that EPA’s strategic plan lacked information about IRIS program implementation.
Chemical Importer to Pay $357,000 Penalty to Resolve Alleged TSCA CDR Violations
On March 15, 2021, EPA announced a settlement with the chemical company Western Reserve Chemical Corporation over Chemical Data Reporting violations between 2012 and 2015 when the company allegedly failed to submit reports for 18 chemical substances.44 The company—which imports chemicals for companies that formulate rubber, plastics, adhesives, sealants, and coatings—must pay a $357,000 civil penalty.
Chemical Distributor Agreed to $128,265 Penalty to Resolve TSCA CDR and Export Notification Violations
On March 2, 2021, EPA announced that it had entered into a settlement with a chemical distributor to resolve alleged violations of TSCA’s CDR reporting and export notification requirements.45 In particular, EPA alleged that the company failed to comply with CDR reporting requirements for imports between 2012 and 2015 of five chemical substances to a California site and failed to comply with notification requirements in 2016 and 2017 for exports of four substances. The company agreed to pay a civil administrative penalty of $128,265. EPA said it discovered the violations following inspections at the California site and at a site in Alaska.
EPA Sought Comment on Manufacturer Request for Risk Evaluation of Fragrance Chemicals
On February 19, 2021, EPA published notice that it was seeking comments on a manufacturer request for a TSCA risk evaluation of the Octahydro-Tetramethyl-Naphthalenyl-Ethanone (OTNE) chemical category, comprising four chemical substances.46 EPA received the request on November 20, 2020 and determined the request to be facially complete on December 8, 2020. The comment period was originally scheduled to close on April 5, 2021, but EPA extended the deadline by 30 days, to May 5, 2021.47 The OTNE Consortium requested that OTNE manufacturing and OTNE use as a fragrance ingredient in consumer products be evaluated as conditions of use in a risk evaluation. In conjunction with publication of the Federal Register notice, EPA issued lists identifying other potential conditions of use.48 EPA expressed particular interest in hearing from the public about distribution in commerce.
EPA to Revamp TSCA Systematic Review Process in Response to National Academies’ Critique
On February 16, 2021, the National Academies of Sciences, Engineering, and Medicine released a report recommending changes to EPA’s systematic review approach for TSCA risk evaluations.49 On the same day, EPA announced a plan to refine its approach in response to the report’s recommendations.50 EPA indicated that this “ongoing effort” to update the systematic review approach—which determines how the Agency selects and reviews the scientific studies that inform risk evaluations—would be part of EPA’s efforts to review the first 10 risk evaluations. The NASEM report’s recommendations for improvements included that instead of developing an entirely new approach, EPA should consider incorporating components of existing methodologies from the IRIS program and the National Institute of Environmental Health Science’s Office of Health Assessment and Translation. The NASEM report also recommended cross-sector engagement efforts to develop and validate new tools and approaches, documentation of the systematic review process in a handbook, and use of standard descriptors for the strength of evidence instead of interchangeable use of “weight of evidence” and “systematic review.” EPA reported that it had already begun to develop a TSCA systematic review protocol that would incorporate approaches from the IRIS program. The Agency said it expected to publish and take comment on the protocol later this year.
State Regulatory & Legislative Action
Court Said Listing of Spray Polyurethane Foam Systems as Priority Product Violated CEQA
A California Superior Court ordered the Department of Toxic Substances Control (DTSC) to delist spray polyurethane foam (SPF) systems containing unreacted methylene diphenyl diisocyanates as a Priority Product in the Safer Consumer Products program.51 The court ruled that DTSC was required to comply with the California Environmental Quality Act (CEQA) and found that DTSC had engaged in “impermissible piecemealing” of the environmental analysis when it concluded that the listing was exempt from CEQA because it would not result in a potential significant environmental effect. The court rejected arguments that the listing of SPF systems exceeded DTSC’s authority, that DTSC should have considered an enforceable consent agreement as a reasonable alternative to listing SPF systems as Priority Product, and that DTSC violated the Administrative Procedure Act by failing to provide full, final cost estimate for the listing.
DTSC Cited Resource Constraints in Newly Released 2021-2023 Work Plan for Safer Consumer Products
DTSC finalized its three-year Work Plan for the Safer Consumer Products (SCP) Program for 2021-2023.52 Products can only be designated as a Priority Product if they fall within a product category included in this current Work Plan. The Work Plan indicated that the SCP Program was unlikely to initiate many new product research initiatives during this three-year period because of a lack of resources and the need to direct resources to Alternatives Analysis, Regulatory Response, compliance assessment, and enforcement. The 2021-2023 work plan carries over, and in some cases modifies, product categories for Beauty, Personal Care, and Hygiene Products; Cleaning Products; Building Products and Materials Used in Construction and Renovation (Building Products); and Food Packaging. The Building Products category was modified to include outdoor products, including artificial turf, which the Work Plan indicated might be the only new product evaluated in that category in this cycle. A new category for Children’s Products was included, as well as a new category for Motor Vehicle Tires (at the request of the California Stormwater Quality Association). The 2021-2023 Work Plan did not carry over the following categories due to insufficient resources: Household, School, and Workplace Furnishings and Décor; and Consumable Office, School, and Business Supplies. The Work Plan indicated that the only actions in these categories would be to adopt regulations to list two previously evaluated products as Priority Products: carpets and rugs containing PFAS and thermal receipts containing bisphenol A. The 2021-2023 Work Plan did not carry over the Lead-Acid Batteries product category because DTSC concluded that listing lead-acid batteries was not likely to enhance protection of human health, given existing investment in new battery technologies.
Lawsuit Challenged PFAS Drinking Water Standards in Michigan
On April 15, 2021, 3M Company (3M) filed a lawsuit in Michigan state court against the Michigan Department of Environment, Great Lakes, and Energy (EGLE) asserting that EGLE exceeded its authority under the Michigan Safe Drinking Water Act when it adopted drinking water standards for seven PFAS in 2020.53 The lawsuit also claims that the regulations are arbitrary and capricious and that EGLE failed to adequately assess the rule’s impact in a regulatory impact statement. 3M also asserts claims against the Environmental Rules Review Committee—which oversees EGLE rulemaking—for allegedly failing to consider issues and make determinations required by the ERRC review and approval procedures. 3M asked the court to declare the rule invalid and enjoin EGLE from implementing and enforcing it.
Minnesota Published Blueprint for Addressing PFAS
In February 2021, Minnesota released “Minnesota’s PFAS Blueprint,” which describes current and future State initiatives in 10 key issue areas.54 The 10 issue areas are:
- Preventing PFAS pollution
- Measuring PFAS effectively and consistently
- Quantifying PFAS risks to human health
- Limiting PFAS exposure from drinking water
- Reducing PFAS exposure from consuming fish and game
- Limiting PFAS exposure from food
- Understanding risks from PFAS air emissions
- Protecting ecosystem health
- Remediating PFAS contaminated sites
- Managing PFAS in waste
Issue papers for each area describe initiatives already taken or currently underway in that area and identify areas of opportunity for addressing PFAS. For each initiative, the papers set forth leader and partner entities within the government, as well as benefits and challenges associated with the initiative and resources required for its implementation.
New Regulations Set Framework for Removal of Chemicals of High Concern from Certain Children’s Products
Phase 3 regulations for Oregon’s Toxic-Free Kids Act took effect on March 1, 2021.55 The regulations require manufacturers of children’s products to remove Chemicals of High Concern to Children (HPCCCH) from children’s products that are mouthable, a children’s cosmetic, or made for, marketed for use by, or marketed to children under three years of age. Manufacturers also can make a substitution or seek a waiver. Obtaining a waiver requires either a demonstration with a quantitative exposures assessment that the chemical does not move from the product into children’s bodies under conditions of normal use or an alternatives assessment that demonstrates that elimination or substitution of the chemical is not financially or technically feasible. To substitute, a manufacturer must submit a hazard assessment that explains how the product with the substitute chemical is inherently less hazardous than before the substitution was made.
*Margaret Barry also contributed to this newsletter.
© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
New York v. EPA, No. 21-70684 (9th Cir., filed Mar. 22, 2021); Int’l Union, United Automobile, Aerospace & Agric. Implement Workers of Am. v. EPA, No. 21-1057 (D.C. Cir. filed Feb. 10, 2021); see also Envtl. Def. Fund v. EPA, No. 70162 (9th Cir.); Ctr. for Envtl. Health v. EPA, No. 21-70194 (9th Cir.).
Tex. Ass’n of Mfrs. v. U.S. Consumer Prod. Safety Comm’n, 989 F.3d 368 (5th Cir. 2021).
See Judge Maintains Suit Seeking TSCA Fluoridation Ban, But Awaits NTP Study, Inside TSCA (Apr. 23, 2021).
A copy of the bill is available here.
A copy of the bill is available here.
See Maria Hegstad, EPA Will ‘Surgically’ Revise TSCA Evaluations While Advancing Risk Rules, Inside TSCA (Mar. 25, 2021).
85 Fed. Reg. 45109 (July 27, 2021).
News Release, EPA, Important Updates on EPA’s TSCA New Chemicals Program (Mar. 29, 2021).
News Release, EPA, EPA Administrator Regan Establishes New Council on PFAS (Apr. 29, 2021).
News Release, EPA, EPA Releases Updated PFBS Toxicity Assessment After Rigorous Scientific Review (Apr. 8, 2021).
News Release, EPA, EPA Takes Action to Protect Scientific Integrity (Feb. 9, 2021).
86 Fed. Reg. 12272 (Mar. 3, 2021).
86 Fed. Reg. 13846 (Mar. 11, 2021).
86 Fed. Reg. 14560 (Mar. 17, 2021).
Pub. L. No. 116-92, § 7351, 133 Stat. 1198, 2289 (2019) (codified at 15 U.S.C. § 2607(a)(7)).
Pending EO 12866 Regulatory Review, Reginfo.gov (last visited Apr. 29, 2021).
86 Fed. Reg. 22414 (Apr. 28, 2021).
86 Fed. Reg. 9576 (Feb. 16, 2021).
86 Fed. Reg. 18924 (Apr. 12, 2021).
86 Fed. Reg. 15661 (Mar. 24, 2021).
Natural Res. Def. Council, Inc. v. EPA, 961 F.3d 160 (2d Cir. 2020).
See Support Documents for Phosphogypsum and Process Wastewater Section 21 Petition, EPA (last Feb. 23, 2021).
EPA, No Action Assurance Regarding Prohibition of Processing and Distribution of Phenol Isopropylated Phosphate (3:1), PIP (3:1) for Use in Articles, and PIP (3:1)-containing Articles under 40 CFR 751.407(a)(1) (Mar. 8, 2021).
86 Fed. Reg. 894 (Jan. 6, 2021).
86 Fed. Reg. 14398 (Mar. 16, 2021).
86 Fed. Reg. 7037 (Jan. 25, 2021).
GAO, GAO-21-119SP, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas (Mar. 2021).
EPA, Press Release, EPA Settlement with Western Reserve Chemical Corporation in Stow, Ohio Resolves Alleged TSCA Reporting Violations (Mar. 15, 2021).
See News Release, EPA, Major Chemical Distributor to Pay Fine, Correct Violations Under Settlement with U.S. EPA (Mar. 2, 2021); Consent Agreement & Final Order, In re Brenntag Pacific, Inc., Docket No. TSCA-09-2021-0030 (U.S. EPA Region IX Feb. 24, 2021).
86 Fed. Reg. 10267 (Feb. 19, 2021); OTNE Consortium, Request for Risk Evaluation under the Toxic Substances Control Act; Octahydro-Tetramethyl-Naphthalenyl-Ethanone Chemical Category (Nov. 16, 2020).
86 Fed. Reg. 17592 (Apr. 6, 2021).
Nat’l Acads. of Scis., Eng’g, & Med., National Academies Recommend Changes to EPA’s TSCA Systematic Review Process (Feb. 16, 2021).
News Release, EPA, EPA Commits to Strengthening Science Used in Chemical Risk Evaluations (Feb. 16, 2021).
Peremptory Writ of Mandate, Am. Chem. Council v. Cal. Dep’t of Toxic Substances Control, No. 19CECG02938 (Cal. Super. Ct. Mar. 18, 2021); Order After Hearing on Plaintiff/Petitioner American Chemistry Council’s Complaint for Injunctive and Declaratory Relief and Petition for Writ of Mandate, Am. Chem. Council v. Cal. Dep’t of Toxic Substances Control, No. 19CECG02938 (Cal. Super. Ct. Jan. 25, 2021).
Safer Consumer Products Program, Dep’t of Toxic Substances Control, Three Year Priority Product Work Plan (2021-2023).
See Toxic Free Kids Act: Rules and Implementation, Oregon.gov (last visited Apr. 29, 2021).