EPA issues final rule on mandated PFAS reporting

WASHINGTON—The U.S. Environmental Protection Agency has taken the next step in its PFAS Strategic Roadmap, issuing its final rule mandating reporting tied to the manufacture and usage of the "forever chemicals."

The rule requires all manufacturers—including importers—of PFAS and PFAS-containing articles in any year since 2011 to report "information related to chemical identity, uses, volumes made and processed, byproducts, environmental and health effects, worker exposure, and disposal to EPA," the agency said in a Sept. 28 news release.

The rule falls under the Toxic Substances Control Act (TSCA) and is a statutory requirement of the 2020 National Defense Authorization Act. The EPA said it will provide the agency, its partners and the public with the largest set of data for per- and polyfluoroalkyl substances made and used in the U.S.

It builds on two years of progress on the Biden-Harris Administration's plan to combat PFAS pollution, safeguarding public health and advancing environmental safety, according to the agency.

"The data we'll receive from this rule will be a game-changer in advancing our ability to understand and effectively protect people from PFAS," Michal Freedhoff, assistant administrator for the Office of Chemical Safety and Pollution Prevention, said in a statement.

The term PFAS covers more than 10,000 chemicals that have been used in industrial and consumer products since the 1940s. Fluoroelastomers and fluoropolymers are included under PFAS-containing materials, though makers and users of these materials argue that the PFAS used there brings no threat to human health and the environment, and should be classified differently than applications that have been tied to a variety of adverse impacts.

"In order to effectively research, monitor and regulate PFAS, EPA is taking action to better understand who is using PFAS, how they are being used and in what quantities," the agency said in its release. "This rule will produce actionable data that can be used by EPA, as well as state, local and Tribal governments to craft policies and laws that protect people from dangerous 'forever chemicals.' "

The law firm Crowell and Moring L.L.P. said in an Oct. 2 client alert that the rule will impact a wide range of applications, including fluoropolymers.

"For purposes of the rule, the term PFAS is defined broadly, to include thousands of different compounds with vastly different properties," the client alert said. "Because the definition of PFAS includes fluoropolymers, and because fluoropolymers are prevalent in many types of complex articles, including automotive, aerospace, electronics, and manufacturing equipment, a broad swath of industry is likely to be impacted by this rule."

The law firm said the new PFAS reporting regulation doesn't include many of the exemptions that are typically found in regulations issued under TSCA. For example, there is no minimum production or import threshold that triggers reporting and no "de minimis" level of PFAS content below which reporting is not required.

Crowell and Moring advised clients not to delay understanding obligations and initiating investigations to comply with the new EPA rule

"To ascertain the information required to be reported under this rule, companies may be required to navigate multi-tiered global supply chains to identify which components of a manufactured article contain PFAS compounds, the specific identities of those PFAS compounds, and the quantities of those compounds that might be present in an article," the alert said. "This is a highly complicated and time-consuming process, and the obligation to collect this information for every year since 2011 makes this task even more complex."

The EPA proposed the rule in June 2021, and since then the agency provided several opportunities for public comment and stakeholder input, including a Small Business Advocacy Review Panel in April 2022 and an Initial Regulatory Flexibility Analysis (IRFA) released for public comment in November 2022.

The final rule expands on the definition of PFAS in the proposed rule to include 41 additional PFAS that were identified as being of concern. EPA has determined that at least 1,462 PFAS that are known to have been made or used in the U.S. since 2011 will be subject to the final rule.

According to the IRFA, the EPA estimates the rule will result in $876 million in industry costs and $1.6 million in agency costs.

The final rule also streamlines reporting requirements and reduces the burden for those who made or used small quantities of PFAS for research and development purposes and for companies that only imported PFAS contained in articles into the U.S.

Data is due to EPA within 18 months of the effective date of the final rule, with an additional six months for reports from small businesses that are solely reporting data on importing PFAS contained in articles.

The rule mandates the following to be reported:

• The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
• Categories or proposed categories of use for each substance or mixture;
• Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use and reasonable estimates of the respective proposed amounts;
• Descriptions of byproducts resulting from the manufacture, processing, use or disposal of each substance or mixture;
• All existing information concerning the environmental and health effects of each substance or mixture;
• The number of individuals exposed, and reasonable estimates on the number of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure; and
• The manner or method of disposal of each substance or mixture, and any change in such manner or method.

"A key priority in EPA's PFAS Strategic Roadmap is to ensure science-based decision-making," the agency told Rubber News in August. "EPA is investing in scientific research to fill gaps in understanding of PFAS, to identify which additional PFAS may pose human health and ecological risks at which exposure levels, and to develop methods to test, measure, remove and destroy them."

Current scientific evidence, the EPA added, "clearly indicates that there are real, present and significant hazards associated with specific PFAS, but significant gaps remain related to the impacts of other PFAS on human health and in the environment."