The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS), as covered in July’s column “EPA Announces Blockbuster PFAS Actions.” This column focuses on one of them: an ambitious proposal intended to obtain comprehensive data on more than 1,000 PFAS manufactured in or imported into the United States. As discussed below, the proposal’s scope is enormous.
The EPA’s proposed rule would require all manufacturers, including importers, of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. The EPA recommends manufacturers report information to the extent the information is known to or reasonably ascertainable by the manufacturer. The proposed rule states that “known to or reasonably ascertainable by” would be defined to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” This would require reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether additional information exists that a reasonable person, similarly situated, would be expected to know, possess or control.
This reporting standard would require submitters to conduct a reasonable inquiry within the full scope of their organizations, not just the information known to managerial or supervisory employees. According to the EPA, such activities may include phone calls or e-mail inquiries to “upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.” Examples of information include files maintained by the manufacturer, such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a safety data sheet or a supplier notification; and information from Chemical Abstracts Service or from Dun & Bradstreet. This information may also include knowledge gained through discussions, conferences and technical publications.
The EPA intends to use the information to support assessments of new and existing chemicals under the Toxic Substances Control Act (TSCA). The EPA will also use it to fulfill additional environmental protection mandates beyond the TSCA program, such as regulatory activities under the Safe Drinking Water Act; the Resource Conservation and Recovery Act; and the Comprehensive Environmental Response, Compensation, and Liability Act. The EPA states that data on PFAS manufacturing sites and disposal methods may bolster contaminant characterizations conducted to support contaminated site work and solid waste management programs.
Importantly, the manufacture of PFAS as a byproduct, impurity, or polymer would not be exempt for the purpose of the proposed rule. No de minimis threshold is provided either. Articles containing PFAS imported into the United States are not exempt. Unlike TSCA Section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, the provision requiring PFAS reporting provides no exemption. The proposed rule thus would not exempt small manufacturers.
The proposal answers the question of what a PFAS is. The EPA defines a PFAS as any substance including at least two fluorine atoms on one saturated carbon and at least one fluorine on an adjacent saturated carbon, with neither carbon bound to a hydrogen. This much at least brings certainty.
There are many troubling aspects of the proposal, however. Key among them is the lack of an exemption for small businesses. The EPA views the statutory language that “each person who has manufactured a chemical substance… shall be subject to the rule” to mean that Congress’s intent was to require small businesses to report as well. The EPA acknowledges that some article manufacturers, including importers, may meet the “not known or reasonably ascertainable” criterion. It is also unclear about the standard of “known or reasonably ascertainable,” which further confounds the proposal. Finally, the rule goes back 10 years to 2011, a very long time by any standard.
No doubt many will comment on these issues and others. The real question is, “Will the rule provide meaningful information to the EPA?” This remains unclear.
LYNN L. BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at [email protected]
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006). The views expressed herein are solely those of the author. This column is not intended to provide, nor should be construed as, legal advice.