EPA’s newly adopted PFAS TSCA rules spell significant compliance obligations for businesses

The US Environmental Protection Agency (EPA) recently announced two long-anticipated per- and polyfluoroalkyl substances (PFAS)-related final rules under the Toxic Substances Control Act (TSCA), both of which are likely to impact numerous stakeholders across a variety of industries. These rules represent the latest significant fulfillment under EPA’s PFAS Strategic Roadmap to regulate and address PFAS nationwide.

TSCA Section 8(a)(7) – PFAS reporting and recordkeeping

In October 2023, EPA published a final rule under TSCA section 8(a)(7) imposing substantial new reporting and recordkeeping requirements on manufacturers and importers of PFAS or PFAS-containing articles (ie, finished products). The rule will become effective November 13, 2023 and will facilitate EPA’s intent to utilize reporting returns to establish a more comprehensive database of manufactured and imported PFAS to support its efforts to regulate the chemicals under a variety of federal environmental laws.

Wide-ranging applicability: The final rule requires any person that has manufactured or imported PFAS, PFAS-containing articles, PFAS in mixtures, byproducts, or as an impurity, in any amount, for commercial purposes (including marketing and research and development) since January 1, 2011 to electronically report information regarding PFAS uses, production volumes, disposal, exposures, hazards, and environmental or health effects.

Broad definition of PFAS: The final rule categorically defines the PFAS chemical family to include those substances which contain at least one of the following three structures:

1. R-(CF₂)-CF(R’)R’’, where both the CF₂ and CF moieties are saturated carbons
2. R-CF₂OCF₂-R’, where R and R’ can either be F, O, or saturated carbons, and
3. CF₃C(CF₃)R’R’’, where R’ and R” can either be F or saturated carbons.

EPA expanded its PFAS definition from the draft rule to now cover approximately 1,462 known TSCA chemical substances, including fluoropolymers. EPA plans to provide a list of substances that meet the definition on the CompTox Chemicals Dashboard.  However, this list is not finite; substances that are not on the list but which otherwise meet the rule’s definition are still subject to the rule.

Enhanced reporting and recordkeeping: Covered entities must report the following information regarding each manufactured or imported PFAS analyte or mixture to EPA to the extent it is known or reasonably ascertainable:

• Chemical identifying information
• Categories of use
• Total manufactured or processed amounts
• Descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture
• Existing information regarding environmental and health effects (intended to be interpreted broadly to include any information which bears on the effects of PFAS on human health or the environment; this may include toxicity information, monitoring data, adverse effect reports, medical screening, and other information and data – whether formally or informally derived – in a reporting entity’s possession or control)
• Information about worker exposure
• Information about releases or disposal

Given the substantial information that must be reported, EPA also published reporting instructions to assist stakeholders with the rule’s reporting requirements, which include step-by-step guidance on whether a chemical substance is subject to the new rule, whether an entity qualifies for streamlined reporting (eg, article importers and manufacturers of less than 1 kg of a substance used exclusively for research and development), and what information must be reported. Reporting is to be submitted on EPA’s electronic reporting site, Central Data Exchange. Covered entities must retain records documenting any information reported to EPA for five years, starting on the last date of the information submission period.

Compliance is not without complexity, risk, or uncertainty. To adhere to the “known or reasonably ascertainable” standard, covered entities must assess both their current knowledge about their manufactured and imported products and additional information that a similarly situated reasonable person would be expected to know. EPA expects regulated entities to conduct reasonable due diligence, including organization-wide investigation, outreach to suppliers, and potentially additional efforts depending on the nature of a company and its products.

Minimal exemptions: EPA’s final rule eliminates all exemptions from reporting for commercial entities. It does not adopt a de minimis volume threshold or an exemption for small manufacturers. Only certain municipal solid waste imports and federal agency imports are exempt.

Reporting deadline: Most covered entities must submit reports to EPA by May 8, 2025, and given the substantial amount of information that must be reported, such length of time is warranted to gather such data. Small manufacturers (as defined under 40 C.F.R. § 704.3 to mean manufacturers or importers whose annual sales and/or production volumes are below certain thresholds) whose reports exclusively pertain to article imports have until November 10, 2025, to submit their reports.

Looking ahead: The final rule comes with an exorbitant price tag: EPA estimates compliance efforts to levy approximately 11 million hours of work and $843 million in costs on regulated stakeholders.

Given the time-intensive and potentially laborious diligence efforts necessary to meet the rule’s reporting requirements, covered entities should soon commence compliance efforts, maintain detailed records of all diligence activities, and evaluate opportunities to designate submitted information as confidential business information. Changes in product materials and components over the reporting timeframe may further complicate information gathering and reporting, so an advanced start to compliance activities may fend off last minute difficulties in meeting EPA’s strict deadline.

Changes to Toxic Release Inventory reporting

As an update to our prior alert, this month EPA also issued a pre-published version of its Toxic Release Inventory (TRI) final rule, which designates all PFAS listed on the TRI as chemicals of special concern (CSC) for reporting purposes. Under the 1986 Emergency Planning and Community Right-to-Know Act (EPCRA), EPA uses the TRI public database to track certain chemicals, support emergency planning, and provide the public with information on chemicals in their communities.

EPCRA requires industrial and federal facilities engaged in manufacturing, metal mining, electric power generation, chemical manufacturing, and hazardous waste treatment to annually report environmental releases and waste management quantities of TRI chemicals above reporting thresholds. EPCRA also requires companies to disclose how much of each chemical is released into the environment and/or managed through recycling, energy recovery, and treatment, along with pollution prevention and recycling data.

EPA’s final rule eliminates the de minimis exemption for PFAS, which had allowed regulated entities to disregard low concentrations of PFAS in products and mixtures otherwise subject to reporting. Beginning January 1, 2024, industry will be required to report information for the over 172 PFAS substances added to the TRI list regardless of their concentrations – including in mixtures. The rule also excludes TRI reporting for PFAS from simplified Form A reporting and requires precise reporting for PFAS rather than ranges or estimates.

EPA has also eliminated the de minimis exemption for Supplier Notification Requirements for PFAS and all other CSCs – including, for example, dioxins, lead, mercury, and other persistent and bioaccumulative substances. Suppliers must now provide notifications to downstream purchasers for mixtures or trade name products containing CSCs at any concentration.

The final rule’s updates to the TRI reporting requirements are expected to significantly increase compliance burdens and costs for a wide array of industry stakeholders. At bottom, EPA’s efforts to boost its PFAS information gathering come at great expense to the regulated sector. Designing efficient compliance workstreams can help businesses quickly prepare for the current and future anticipated increase in PFAS regulations.

DLA Piper’s Environmental Practice Group and PFAS Task Force continue to assist clients with navigating the constantly evolving PFAS regulatory landscape. Please contact the authors with any questions or for assistance.