By Lynn L. Bergeson and Carla N. Hutton

On April 6, 2023, the U.S. District Court for the District of Columbia dismissed a suit brought by the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) to prevent Inhance Technologies USA (Inhance) from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. As reported in our January 6, 2023, blog item, CEH and PEER sought a court order restraining Inhance from continued manufacture of PFAS in violation of a 2020 significant new use rule (SNUR) “requiring it to stop all distribution of fluorinated containers in commerce until and unless [Toxic Substances Control Act (TSCA)] requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to [perfluorooctanoic acid (PFOA)] and other PFAS.” While CEH and PEER filed suit on December 27, 2022, the U.S. Environmental Protection Agency (EPA) filed suit on December 19, 2022, in the U.S. District Court for the Eastern District of Pennsylvania. According to the court’s April 6, 2023, opinion, Inhance filed a motion to dismiss the case brought by CEH and PEER, “arguing that the TSCA’s diligent-prosecution bar requires dismissal of this separate action.” The court states that the United States filed an amicus brief in support of Inhance’s motion, “arguing that this lawsuit ‘is a textbook case for application of the diligent prosecution bar.’” The court found that CEH and PEER failed to prove that the U.S. Department of Justice (DOJ) is not “diligently prosecuting” the action. The court reviewed the days between when DOJ filed its suit and CEH and PEER filed their suit, and found “[n]othing in the eight days between when DOJ filed its lawsuit and when Plaintiffs filed theirs suggests that Justice was not diligently prosecuting the case.” The court granted Inhance’s motion, dismissing the case without prejudice. The court noted that CEH and PEER have “the options of intervening in DOJ’s separate action or returning to court another day if Justice starts to slack at the reins.” According to an April 7, 2023, PEER press release, PEER and CEH will now move to intervene in DOJ’s suit in the U.S. District Court for the Eastern District of Pennsylvania.

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By Lynn L. Bergeson and Carla N. Hutton
 
On September 6, 2022, the U.S. Environmental Protection Agency proposed to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 87 Fed. Reg. 54415. According to EPA, “[s]uch a designation would ultimately facilitate cleanup of contaminated sites and reduce human exposure to these ‘forever’ chemicals.” Comments are due November 7, 2022. EPA states that under the Paperwork Reduction Act, “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before October 6, 2022.”
 
Upon designation, any person in charge of a vessel or an offshore or onshore facility, as soon as they have knowledge of any release of such substances at or above the reportable quantity (RQ) must immediately report such releases to the federal, state, tribal, and local authorities. The RQ for these designations is one pound or more in a 24-hour period. EPA states that once it has collected more data on the size of releases and the resulting risks to human health and the environment, it may consider issuing a regulation adjusting the RQs for these substances.
 
The five broad categories of entities potentially affected by this action include:

• PFOA and/or PFOS manufacturers (including importers and importers of articles);
• PFOA and/or PFOS processors;
• Manufacturers of products containing PFOA and/or PFOS;
• Downstream product manufacturers and users of PFOA and/or PFOS products; and
• Waste management and wastewater treatment facilities.

More information is available in our August 29, 2022, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
On August 12, 2022, the Office of Management and Budget (OMB) completed its review of a proposed rule that would designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Such designations would require facilities to report on PFOA and PFOS releases that meet or exceed the reportable quantity. Publication of the proposed rule in the Federal Register will begin a public comment period.
 
As reported in our October 19, 2021, memorandum, as part of a multi-agency effort to address pollution from per- and polyfluoroalkyl substances (PFAS), the U.S. Environmental Protection Agency (EPA) released its PFAS Strategic Roadmap on October 18, 2021. The key actions outlined in the roadmap include proposing to designate PFOA and PFAS as CERCLA hazardous substances.

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By Lynn L. Bergeson and Carla N. Hutton
 
On July 28, 2022, the National Toxicology Program (NTP) announced that the following revised Technical Reports on the Toxicity Studies are available on the NTP website:

• Perfluoroalkyl Sulfonates (Perfluorobutane Sulfonic Acid, Perfluorohexane Sulfonate Potassium Salt, and Perfluorooctane Sulfonic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-96); and
   
• Perfluoroalkyl Carboxylates (Perfluorohexanoic Acid, Perfluorooctanoic Acid, Perfluorononanoic Acid, and Perfluorodecanoic Acid) Administered by Gavage to Sprague Dawley (Hsd:Sprague Dawley SD) Rats (Revised TOX-97).

According to NTP, transcription errors were identified in these reports, and an audit was conducted. NTP revised and republished the reports with an appendix that identifies the corrections. NTP notes that the final tables are available in the Chemical Effects in Biological Systems (CEBS) database.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on October 26, 2021, that it is acting upon a petition from New Mexico Governor Michelle Lujan Grisham (D) to address per- and polyfluorinated substances (PFAS) under the Resource Conservation and Recovery Act (RCRA). EPA states that in responding to the petition, it outlined plans to initiate the rulemaking process for two new RCRA actions, “reflecting the agency’s focus on using best available science and leveraging authorities to combat this shared challenge.” First, EPA will initiate the process to propose adding four PFAS as RCRA Hazardous Constituents under Appendix VIII, by evaluating the existing data for these chemicals and establishing a record to support such a proposed rule. The four PFAS that EPA will evaluate are perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorobutane sulfonic acid (PFBS), and GenX. EPA states that adding these chemicals as RCRA Hazardous Constituents “would ensure they are subject to corrective action requirements and would be a necessary building block for future work to regulate PFAS as a listed hazardous waste.” The second rulemaking effort will clarify in EPA’s regulations that the RCRA Corrective Action Program has the authority to require investigation and cleanup for wastes that meet the statutory definition of hazardous waste, as defined under RCRA Section 1004(5). According to EPA, this modification would clarify that emerging contaminants such as PFAS can be cleaned up through the RCRA corrective action process.

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By Susan M. Kirsch

On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C.  The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and representative from the environmental non-governmental organization (NGO) community.  The goals of the Summit were:

• To share information on efforts to characterize risks from PFAS and to develop monitoring and remediation technologies/techniques;
• To identify near-term actions to address current state and local challenges; and
• To develop risk communication strategies to address public concerns and questions surrounding PFAS.

EPA broadcast the opening remarks and perspectives delivered by EPA Administrator Pruitt; Peter Grevatt, Director of the Office of Ground Water and Drinking Water; Jeff Morris, Director of the Office of Pollution Prevention and Toxics (OPPT); Craig Butler, Direct of the Ohio Environmental Protection Agency and Chair of the Environmental Council of the States (ECOS) Water Committee; and Jessica Bowman, Senior Director of Global Fluoro-Chemistry, at the American Chemistry Council.  During his remarks, Pruitt announced that EPA will soon classify two fluorochemicals, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS), as hazardous substances, and that EPA will begin to development maximum contaminant levels (MCL) for PFOA and PFOS under the Safe Drinking Water Act.  PFOA and PFOS are largely legacy chemicals that were the subject of voluntary phase out by chemical manufacturers.  The presence of PFOA and PFOS at former manufacturing sites and detections in groundwater and drinking water have raised public health concerns and made headlines over the last several months, particularly in Northeast states.

Butler’s remarks highlighted the key questions that ECOS and state participants hoped to have addressed by EPA over the course of the Summit, including any plans for MCL development, guidance on contaminated site remediation and PFAS analytical methods, and EPA’s plan to address data and knowledge gaps about PFOA and PFOS, as well as the alternative short-chain PFAS chemistry that makes up the majority of current and new uses of PFAS.  States are eager for direction and assistance from EPA on standard-setting and, in the absence of federal standards, some states have begun to set their own standards.  A copy of the ECOS statement is available here.

Grevatt shared plans for further co-regulator discussions and community engagement as part of an EPA “roadshow” beginning in late June in Portsmouth, New Hampshire.  Morris provided an overview of the rigors of the pre-market review process under the Toxic Substances Control Act (TSCA) and OPPT’s ongoing work to better understand the diverse range of PFAS in the marketplace. 

EPA intended for the Summit to serve as a formal launch of an ongoing dialogue with states, the public, and industry on PFAS, and more details will likely be shared in the coming weeks and months.  A recording of the May 22, 2018, broadcast is available on EPA’s YouTube channel.  Copies of the slide presentations from the Summit are available on EPA’s PFAS Summit website.

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