The Chemical Compound'August 2021

• Published date: 28 August 2021
• Subject Matter: Environment, Food, Drugs, Healthcare, Life Sciences, Energy and Natural Resources, Environmental Law, Chemicals
• Law Firm: Arnold & Porter
• Author: Mr Lawrence E. Culleen, Michael D. Daneker, Sean Morris, Allison B. Rumsey and Thomas E. Santoro

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

'Litigation

• EPA and Environmental Groups Reported Negotiations to Settle Claims About New Chemical Notice and Disclosure
• EPA Development of PFAS Testing Strategy Cited as Reason to Extend Deadlines in Challenge to Denial of PFAS Testing Petition
• Ninth Circuit Granted EPA's Request for Remand Without Vacatur of No-Unreasonable-Risk Determinations for Three Substances
• EPA in Settlement Talks Regarding Asbestos Risk Evaluation Lawsuits Delayed
• EPA Sought Continued Abeyance of Case Challenging DecaBDE Risk Management Rule
• Citizen Suits Alleged CDR Violations Against Chemical Importers and Manufacturers
• EPA Agreed to Develop Asbestos Reporting Rule to Address "Information-Gathering Deficiencies"
• Ninth Circuit Said EPA Lead Paint Rule Violated TSCA Title IV

'Federal Developments

Legislative Developments

• Senate Passed Bill to Require Development of Resources to Prevent Emergency Responder PFAS Exposure
• Comprehensive PFAS Bill Passed House
• Bills Introduced that Would Ban PFAS in Cosmetics
• Bill in Senate Would Ban Defense Department Procurement of Many PFAS-Containing Products
• House and Senate Bills Would Require Drinking Water Standards for PFAS

Regulatory Developments

• EPA to Revisit First 10 Risk Evaluations to Incorporate Policy Changes
• EPA Released Preliminary Proposal for Tiered Data Reporting to Support Work on Existing Chemicals
• EPA Proposed One-Time TSCA Reporting Rule for PFAS
• Draft IRIS Assessment Released for Perfluorobutanoic Acid
• EPA Added Substances to Safer Chemical Ingredients List
• ATSDR Released Final Toxicological Profile for Certain PFAS and Six Draft Updated Profiles for Chemicals on Substance Priority List
• Preliminary 2020 TRI Dataset Shows "Seemingly Limited" Scope for PFAS Reporting
• Three More PFAS Added to Toxics Release Inventory List for 2021 Reporting Year; EPA Announced Plans for More Additions to List
• EPA Sought Information to Inform Regulation of 1-Bromopropane as Hazardous Air Pollutant
• Draft Contaminant Candidate List Included All PFAS
• EPA Required Health and Safety Data Reporting for 50 Substances
• EPA Withdrew Compliance Guide for the Long-Chain Perfluoroalkyl Carboxylate Significant New Use Rule
• EPA Announced Electronic Option for TSCA Export Notifications Other TSCA Communications Also Now Available Via CDX
• EPA's Spring 2021 Regulatory Agenda Contained Multiple TSCA Rulemaking Actions
• "Secret Science" Rule Formally Removed
• EPA Denied TSCA Section 21 Petition Regarding Phosphogypsum
• EPA Rescinded Procedural Rule for Issuing Guidance Documents

'State Regulatory & Legislative Actions

• California
• Connecticut
• Illinois
• Maine
• Maryland
• New York
• Vermont

Litigation

EPA and Environmental Groups Reported Negotiations to Settle Claims About New Chemical Notice and Disclosure

In environmental groups' action alleging that EPA failed to comply with TSCA's Section 5 requirements for notice and disclosures related to applications to manufacture new chemical substances, the parties reported to the federal district court for the District of Columbia that they had met three times in June, July, and August 2021 to evaluate the potential for settlement.¹ The parties also reported that they continued to negotiate over whether there are administrative records for EPA actions and whether there should be discovery related to the groups' claim that EPA engaged in a pattern or practice of violating TSCA's notice and disclosure requirements. The court directed the parties to file an update on the progress of their negotiations by September 3, 2021.

EPA Development of PFAS Testing Strategy Cited as Reason to Extend Deadlines in Challenge to Denial of PFAS Testing Petition

In a lawsuit challenging EPA's January 2021 denial of a TSCA Section 21 petition requesting 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, the parties agreed to extend the time for EPA to respond to the complaint until September 27, 2021.² The lawsuit is pending in the federal district court for the Northern District of California. The stipulation noted that EPA had announced that the Agency is developing a PFAS testing strategy that could impact the 54 PFAS in the petition. The stipulation also said an extension would provide EPA with more time to consider an administrative request for reconsideration of the petition denial.

Ninth Circuit Granted EPA's Request for Remand Without Vacatur of No-Unreasonable-Risk Determinations for Three Substances

In July and August 2021, the Ninth Circuit Court of Appeals granted EPA's motions to remand without vacatur the no-unreasonable-risk determinations for methylene chloride, 1,4-dioxane, and hexabromocyclododecane (HBCD) issued following risk evaluations conducted under TSCA Section 6.³ In all three cases, remand was granted for the limited purpose of allowing EPA to reconsider the no-unreasonable-risk determinations. The cases will be held in abeyance, and EPA will file status reports every 90 days about the progress of its reconsideration proceedings. EPA said remand would allow the Agency to revisit certain legal, policy, and scientific assumptions, approaches, and decisions. Specific issues identified in EPA's remand motions included the Agency's approach of making risk determinations "on a condition-of-use by condition-of-use basis rather than a determination for the chemical as a whole"; assumptions regarding workers' use of personal protective equipment (PPE); decisions not to analyze certain populations as "potentially exposed or susceptible subpopulations"; and decisions not to consider certain environmental exposure pathways. EPA said it would continue to move forward with the risk management process for uses of the three substances found to present an unreasonable risk while reconsidering the no-unreasonable risk determinations. Petitioners in all three cases opposed remand, arguing that EPA had not admitted any error and that remand would not resolve all the disputed issues. They also urged the Ninth Circuit to vacate the no-unreasonable-risk determinations if remand was granted, and also to impose conditions such as time limits and reporting requirements. The petitioners contended that leaving the no-unreasonable-risk determinations in place risked allowing claims that the determinations preempted state regulation. The issues EPA said it would consider on remand in these three cases overlap with policy changes EPA announced at the end of June that will require changes, to some extent, to each of the first 10 risk evaluations. EPA's June announcement is discussed below.

EPA in Settlement Talks Regarding Asbestos Risk Evaluation; Lawsuits Delayed

Briefing was delayed in the Ninth Circuit proceeding challenging EPA no-unreasonable-risk determinations made in its initial TSCA Section 6 risk evaluation for certain uses of asbestos. The litigation was delayed to allow EPA and the petitioners to continue settlement negotiations.⁴ The opening brief is now due October 27. In a related case filed in the Northern District of California in May to compel EPA to address use and disposal of "legacy" asbestos in a TSCA Section 6 risk evaluation, the deadline for EPA's response to the complaint has been extended to October 18 to allow continued settlement negotiations.⁵ EPA has acknowledged that it must address legacy asbestos and has said it plans to prepare a second (supplemental) risk evaluation to do so. The district court complaint alleges that TSCA required EPA to complete the asbestos risk evaluation by June 19, 2020 and asks the court to issue an order setting a schedule for completion of the risk evaluation.

EPA Sought Continued Abeyance of Case Challenging DecaBDE Risk Management Rule

On June 30, 2021, EPA filed a motion in the Ninth Circuit requesting that the court continue to hold in abeyance through October 7, 2021 a case challenging the Agency's TSCA Section 6(h) risk management rule for decabromodiphenyl ether (decaBDE).⁶ DecaBDE is a brominated flame retardant that EPA selected for expedited regulatory action under Section 6(h), which was added to TSCA in 2016 to require EPA to take risk management action to reduce exposures to the extent practicable on certain persistent, bioaccumulative, and toxic (PBT) substances. EPA finalized a risk management rule for decaBDE and four other PBT substances in early January.⁷ After President Biden took office, EPA undertook a review of the rules pursuant to Executive Order 13990 on "Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis."⁸ In March, EPA published a notice inviting public comment on all five final PBT rules.⁹ In its June 30 motion, EPA reported that it had received 19 sets of comments addressing decaBDE, that it was reviewing all comments, and that it was possible that its review of the rule and comments "could obviate the need for further proceedings here or refine the questions presented." Petitioners opposed continuation of the abeyance, arguing that EPA would not face hardship from having to simultaneously review and defend the rule, that the petitioners and the public would be harmed by further delay...