
Daniel T. McKillop
Partner
201-896-7115 dmckillop@sh-law.comFirm Insights
Author: Daniel T. McKillop
Date: October 24, 2023
Partner
201-896-7115 dmckillop@sh-law.comOn October 11, 2023, the Environmental Protection Agency (EPA) finalized its Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Final Rule). In accordance with obligations under the Toxic Substances Control Act (TSCA), as amended by the National Defense Authorization Act for Fiscal Year 2020, the EPA is requiring any person that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.
While some manufacturers are accustomed to complying with TSCA reporting obligations, this is unchartered territory for many companies. The PFAS reporting obligations are also extremely broad and span a significant period of time. Given these compliance challenges, we encourage impacted entities to work with experienced counsel to devise a plan of action.
As discussed in greater detail in prior posts, PFAS, also known as “forever chemicals,” have been used for decades to make goods such as nonstick cookware, waterproof clothing, and firefighting foam. Unfortunately, scientific research increasingly shows that these substances can pose significant risks to human health. As a result, federal and state regulators have stepped up efforts to address PFAS pollution.
According to the EPA, its latest rule aims to better understand who is using PFAS, how they are being used, and in what quantities. While this is a laudable goal, the new reporting requirement will be onerous for impacted entities. The EPA estimates that the reporting requirement will apply to an estimated 130,000 entities across a wide range of industries, including manufacturing, wholesale trade, retail trade, construction, and waste management/remediation. The cost of compliance is predicted to exceed $800 million.
TSCA section 8(a)(7) required the EPA to promulgate a rule requiring each person who has manufactured a PFAS in any year since January 1, 2011, to report certain information for each year since January 1, 2011. Below are several key provision of the agency’s Final Rule:
PFAS Definition
The EPA’s Final Rule mandates reporting of over 1,450 types of PFAS. Rather than providing a discrete list of chemicals, the EPA has established a structural definition under which PFAS is defined as including at least one of these three structures: R-(CF2)-CF(R′)R′′, where both the CF2 and CF moieties are saturated carbons; R–CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; CF3C(CF3)R′R′′, where R′ and R′′ can either be F or saturated carbons. While it will not be exhaustive, the EPA plans to provide a list of substances that satisfy the above definition in the CompTox Chemicals Dashboard at https://comptox.epa.gov/dashboard/.
Covered Entities
Anyone who has manufactured (including imported) a PFAS for a commercial purpose in any year since January 1, 2011, is covered by the Final Rule. Notably, the term ‘‘manufacture for a commercial purpose’’ is not limited to intentional PFAS manufacturing, but also includes the coincidental manufacture of PFAS as byproducts or impurities. Also, there is no reporting threshold or de minimis level for PFAS (whether manufactured or imported), which differs from other TSCA reporting obligations.
Exceptions
The Final Rule does not apply to entities who have only processed, distributed in commerce, used, and/or disposed of PFAS. For instance, if a wastewater treatment plant is simply processing PFAS they received domestically, and not also manufacturing PFAS, including as a byproduct, then the entity is not covered by the rule. Non-commercial R&D activities, such as science experimentation, research, or analysis conducted by academic, government, or independent non-profit research organizations, are also excluded.
The Final Rule also creates a narrow exception for certain waste management activities involving the importation of municipal solid waste (MSW) streams for the purpose of disposal or destruction. Nonetheless, waste management sites must still report the PFAS contents in any non-MSW imported waste and any waste (including MSW) imported with the intent to recycle or reuse PFAS-containing products.
Reporting Standard
Covered entities are obligated to report information known to or reasonably ascertainable by the manufacturer. ‘‘Known to or reasonably ascertainable by’’ is 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.’’ As explained by the EPA, this standard carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.
The EPA also make clear that the standard may entail inquiries outside the organization to “fill gaps in the submitter’s knowledge.” According to the agency, such activities may, though not necessarily, include phone calls or email 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. However, if particular information cannot be derived or reasonably estimated without conducting further customer surveys (i.e., without sending a comprehensive set of identical questions to multiple customers), it would not be ‘‘reasonably ascertainable’’ to the submitter. Thus, entities are not obligated to conduct new surveys for purposes of the Final Rule.
Required Data Reporting
Entities subject to the EPA’s Final Rule must submit a report that includes, for every year since January 1, 2011, detailed information on manufactured or imported PFAS, including: company and site information, chemical-specific information, categories of use, total amounts manufactured/imported of each PFAS (including the amounts manufactured in each calendar year for each category of use), number of individuals exposed, byproducts and disposal information, and health and environmental effects.
The Final Rule does allow reasonable estimates to be used when exact calculations are unavailable. Additionally, if manufacturers do not know nor can reasonably make estimates for certain data elements, except for production volumes, they may indicate such information is ‘‘Not Known or Reasonably Ascertainable’’ (NKRA) to them in lieu of the requested estimate or range.
Record Keeping Requirements
Entities subject to the Final Rule must retain records that document information reported to EPA for five years, which is calculated from the last date of the information submission period.
Compliance Deadlines
Any entities, including small entities, that have manufactured (including imported) PFAS in any year since 2011 will have 18 months following the effective date of the Final Rule to report PFAS data to EPA. Small manufacturers (as defined at 40 CFR 704.3) whose reporting obligations rule are exclusively from article imports will have 24 months from the effective date of the rule to report PFAS to the EPA.
Penalties for Non-Compliance
Separate violations of the TCSA reporting requirement are subject to a maximum penalty of $46,989 per violation per day, and this amount will be adjusted upwards for inflation no later than 2025.
Given the significant burden of compliance, the first step for any entity is to determine if you are subject to the new rule. If so, it is imperative to devise an action plan as soon as possible. For assistance navigating these daunting new obligations, we encourage entities to contact a member of the Scarinci Hollenbeck Environmental Law Group.
If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.
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