After several deadline extensions, the EPA released its final per- and polyfluoroalkyl substances (PFAS) data reporting rule in late September 2023. The rule is expected to provide the “EPA, its partners, and the public with the largest-ever dataset of per- and polyfluoroalkyl substances (PFAS) manufactured and used in the United States,” according to an Agency news release. “This rule builds on over two years of progress on the Biden-Harris Administration’s action plan to combat PFAS pollution, safeguarding public health and advancing environmental justice, and is a key action in EPA’s PFAS Strategic Roadmap.”
PFAS are a group of manufactured chemicals that include chemicals known as perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and GenX. PFAS are also referred to as “forever chemicals” because of their resistance to breaking down in the environment over time. There are nearly 5,000 different types of PFAS, some of which have been more widely used and studied than others, according to the U.S. Food and Drug Administration (FDA).
EPA authority for this rule falls under the Toxic Substances Control Act (TSCA). The rule is a statutory requirement under the FY2020 National Defense Authorization Act (NDAA) that 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 the EPA.
“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,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff in the EPA news release.
To effectively research, monitor, and regulate PFAS, this action is expected to help the EPA better understand who is using PFAS, how they are being used, and in what quantities.
“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 Agency news release continues.
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. The EPA has determined that at least 1,462 PFAS that are known to have been made or used in the United States since 2011 will be subject to the final rule, better capturing the important data the Agency needs to protect human health and the environment from these chemicals.
“In addition to evaluating whether they have manufactured or imported PFAS chemicals or articles containing PFAS during the reporting period, regulated entities should consider and begin planning for foreseeable next steps after submission of their report,” advises Morgan, Lewis & Bockius LLP.
Surprisingly, there was no exception created within the rule for small businesses. During the comment period on the proposed rule, much concern was raised regarding the economic and regulatory burden it would place on industry, particularly on small businesses.
“These comments prompted EPA to form a small business advocacy review panel to gather additional feedback, and to later revise an early economic assessment that was found to have significantly underestimated compliance costs,” Morgan, Lewis & Bockius says. “These issues are thought to be the reason for the delay in the final rules, which were released nearly 10 months after the statutory deadline.
“In an effort to alleviate some of the burden, however, the final rule includes an option for article importers to use a ‘streamlined reporting form’ if they do not know, and cannot reasonably ascertain, the information otherwise required. In addition, reporting of production volumes for imported articles may be based on the article volume, rather than the volume of PFAS contained in the article—a potentially significant change for some regulated entities, relative to the draft rules.”
Data is due to the EPA within 18 months of the effective date of the final rule, with an additional 6 months for reports from small businesses that are solely reporting data on importing PFAS contained in articles.
“For many regulated entities, the preparation of the report under these rules may appear to be a daunting task. … [R]egulated entities would be well advised to familiarize themselves with the information that will need to be provided and begin the legwork of collecting it well in advance.
“Further, the challenge of preparing the report may only be the beginning. The information EPA is gathering can, and likely will, be used to inform future regulation and enforcement actions concerning PFAS—and, because the reports will be publicly accessible (apart from redactions of business-sensitive information), they may influence public perception of products and businesses. Responding to these challenges will require careful consideration and preparation to mitigate both legal and business risks,” Morgan, Lewis & Bockius adds.