The Chemical Compound'March 2022

• Published date: 16 March 2022
• Subject Matter: Environment, Government, Public Sector, Energy and Natural Resources, Environmental Law, Chemicals, Government Contracts, Procurement & PPP
• Law Firm: Arnold & Porter
• Author: Mr Lawrence E. Culleen and Judah Prero

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, or regulation.

Table of Contents

Litigation

• Petitioners Alleged EPA's Granting of TSCA Section 21 Petition for Testing of 54 PFAS Was "in Reality" a Denial; Government Seeks Change of Venue
• Organizations Challenged TRI Reporting Exemptions for PFAS; EPA Announced Plan to Propose Elimination of Exemption
• FOIA Lawsuit Filed Seeking TSCA Section 8(e) Substantial Risk Reports
• Chemical Company Paid $600,000 Civil Penalty in Settlement of Alleged TSCA and EPCRA Violations
• FDA Pledged Response to 2016 Ortho-phthalates Petition After Organizations Filed Lawsuit
• EPA Prevailed in FOIA Suit Concerning TSCA Communication

Federal Developments

Legislative Developments

• Defense Authorization Act Required DOD Actions on PFAS Testing Remediation, and Risk Management

Regulatory Developments

• EPA Extended TSCA Risk Management Rule's Compliance Date for PIP (3:1)-Containing Articles to October 2024
• EPA Published Update to TSCA Inventory
• EPA to Accept Feedback on TSCA Collaborative Research Program for New Chemical Reviews
• EPA Revised Guidelines for Making Corrections to the TSCA Inventory and Set April 26 Deadline for Submissions Under Old Guidelines
• EPA Released Mercury Inventory Reporting Compliance Guide
• Science Advisory Board to Consult with EPA on Improving the Science for Cumulative Impact Assessment
• EPA Released Draft IRIS Toxicological Review of PFHxA
• EPA Added Four PFAS to Toxics Release Inventory for 2022
• TSCA Risk Evaluation Update: HBCD and PV29 Revised Risk Determination, Asbestos Part 2 Scope, Fenceline Screening Approach and Related Developments
• Biden Administration Prioritized Reduction in Procurement of PFAS-Containing Items
• EPA Updated New Approach Methods (NAMs) Work Plan

State Regulatory & Legislative Action

• New York

Litigation

Petitioners Alleged EPA's Granting of TSCA Section 21 Petition for Testing of 54 PFAS Was "in Reality" a Denial; Government Seeks Change of Venue

On December 28, 2021, EPA announced that it had granted a TSCA Section 21 petition requesting that the Agency order health and environmental effects testing for 54 PFAS that the petitioners said were manufactured at a facility in North Carolina.¹ EPA previously denied the petition in January 2021, but agreed to reconsider the denial in September 2021. In its December 2021 letter granting the petition, EPA said it "generally expects to take some immediate actions and to defer certain other actions pending the development of additional information that will inform future decision-making." EPA stated that most of the chemicals identified in the petition were covered by categories included in the Agency's National PFAS Testing Strategy released in October 2021. In particularly, EPA said the Agency's first test orders pursuant to the Testing Strategy would cover 30 of the 54 PFAS and that subsequent testing might cover nine of the 54 PFAS. EPA said it had decided it was not appropriate to require development of information on the remaining 15 PFAS because they did not fit the definition of PFAS used in the Testing Strategy, but the Agency also said it had determined there was "robust data" on some of them and that the Agency would be conducting "more in-depth analyses of the existing data." EPA's response also described EPA's plans with respect to mixtures studies and human studies. In addition, the letter explained EPA's conclusion that a "narrow subset" of the petitioners' requests fell outside TSCA Section 21 and/or EPA's statutory authority. On January 27, 2022, the petitioners and EPA filed a stipulation in the federal district court for the Northern District of California, where the petitioners' lawsuit challenging the January 2021 denial was pending.² The petitioners contended that EPA's December 2021 response had in fact rejected "virtually all" of their requests. They therefore sought to amend their complaint. After the court granted this request, the petitioners filed an amended complaint on February 1, alleging that EPA's response to their petition failed to require testing on 47 of the 54 PFAS and provided no assurance that all requested studies would be conducted the remaining seven PFAS. The petitioners also alleged that EPA's response failed to address requests for certain studies and rejected other requests for testing, monitoring, and development of analytical standards and methods. On March 3, EPA filed its motion to transfer the case to the Eastern District of North Carolina, noting that all of the plaintiffs are located in the district or have offices there, and that the facility from which plaintiffs allege the discharges of PFAS occurred also is located in that district.

Organizations Challenged TRI Reporting Exemptions for PFAS; EPA Announced Plan to Propose Elimination of Exemption

On January 20, 2022, three plaintiffs-National PFAS Contamination Coalition, Sierra Club, and Union of Concerned Scientists-filed a lawsuit against EPA asserting that the Agency's rules adding PFAS to the Toxics Release Inventory (TRI) chemical list violated the statute that required their addition, as well as the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Administrative Procedure Act (APA).³ The plaintiffs alleged that EPA violated the National Defense Authorization Act for Fiscal Year 2020 (NDAA), which mandated the addition of the PFAS to the TRI list, by making the PFAS reporting obligations subject to exemptions in the EPCRA regulations for substances present in mixtures at de minimis concentrations and for facilities that qualify for an "alternative threshold" because they certify that reportable releases and disposals were 500 pounds or less combined. The plaintiffs contended that because the NDAA established a reporting threshold of 100 pounds for the PFAS, Congress did not intend for the EPCRA exemptions to apply since the exemptions generally do not apply to other chemicals with 100-pound thresholds. The plaintiffs also asserted that application of the exemptions in the PFAS listing rules violated EPCRA because the exemptions themselves-which were established in 1988 and 1994-exceeded EPA's authority under EPCRA. In addition, the plaintiffs contended that the PFAS listing rules were arbitrary and capricious because EPA premised the exemptions "on a view that relatively low concentrations or levels of manufacture, processing, use, and/or release will not present danger and do not need to be publicly disclosed, despite the known fact that PFAS are toxic at very low levels of exposure." Alternatively, the plaintiffs asserted that if EPA had discretion to apply the exemptions in the PFAS listing rules, the Agency violated APA procedural requirements by issuing the final rules without providing notice and an opportunity for public comment. On March 3, EPA announced that it planned to propose a rule in summer 2022 to make PFAS ineligible for the de minimis exemption. EPA said the proposal "would also make unavailable the de minimis exemption with regard to providing supplier notifications to downstream TRI facilities for PFAS and persistent, bioaccumulative, and toxic chemicals."

FOIA Lawsuit Filed Seeking TSCA Section 8(e) Substantial Risk Reports

On January 4, 2022, Public Employees for Environmental Responsibility (PEER) filed a Freedom of Information Act (FOIA) lawsuit to compel EPA to disclose documents related to submissions the Agency received since January 2019 pursuant to TSCA Section 8(e)'s requirement that manufacturers, distributors, and processors of chemical substances and mixtures submit information they obtain that "reasonably supports the conclusion" that a chemical substance of mixture "presents a substantial risk of injury to health or the environment."⁴ PEER alleged that its FOIA request was prompted by a November 2021 article in The Intercept, which reported that EPA had received 1,240 Section 8(e) submissions since January 2019 but had made only one of the reports available to the public. PEER's FOIA request asked for copies of all Section 8(e) submissions since January 2019 as well as documents related to EPA policies and decision-making regarding the posting of Section 8(e) information. On February 3, EPA announced that it had resumed publishing Section 8(e) notices to its ChemView database.⁵ EPA said it had begun publishing notices it had received since the procedure lapsed in 2019 due to resource limitations after the staff person responsible for publication of the notices to the ChemView database retired. The Agency plans to develop an automated process for publication of the notices.

Chemical Company Paid $600,000 Civil Penalty in Settlement of Alleged TSCA and EPCRA Violations

On December 15, 2021, EPA's Environmental Appeals Board ratified a consent agreement that resolved a chemical company's alleged violations of EPCRA TRI reporting requirements, TSCA Chemical Data Reporting (CDR) requirements, and TSCA restrictions on exports of elemental mercury. The consent agreement required the company to pay a $600,000 civil penalty.⁶ EPA found that the respondent failed to make TRI submissions for 17 chemicals at a New...