On October 20, 2023, EPA released a final rule under the Emergency Planning and Community Right to Know Act (“EPCRA”) relating to per- and polyfluoroalkyl substances (“PFAS”). The Rule makes important revisions to EPA’s Toxic Release Inventory (“TRI”) program relating to 189 specified PFAS.
Broadly speaking, as relevant to PFAS the TRI program imposes two set of reporting obligations: first, an annual reporting obligation to EPA for facilities that use more than 100 pounds of PFAS annually, and second, a requirement for business-to-business downstream notification of the presence of PFAS in certain products. For both sets of obligations, the Rule’s key change is removal of the de minimis exception, which previously exempted products containing less than 1% of PFAS (or 0.1% for PFAS qualifying as carcinogens, such as PFOA) from needing to be considered for either reporting or notification purposes. Now, any quantity of PFAS covered by the Rule counts towards the 100 pound obligation and triggers the downstream notification obligation. This may be particularly significant as it could result in numerous products being newly identified as containing PFAS throughout the supply chain. Below are key takeaways companies that may be subject to these reporting requirements should keep in mind.
1. The Rule Expands PFAS Reporting Obligations to EPA By Removing the De Minimis Exception.
Under the general TRI requirements, covered facilities (defined by Standing Industrial Classification (SIC) codes) must report annually to EPA if they “manufacture” (including import), “process,” or “otherwise use” more than a certain amount of specified toxic chemicals a year. 40 C.F.R. §§ 372.22, 372.25. For specified PFAS, that threshold is 100 pounds. 40 C.F.R. § 372.29.
The Rule is significant because it removes the de minimis exception that previously applied to PFAS, such that any quantity of PFAS that is manufactured, processed, or otherwise used now counts towards the 100 pound threshold—and if that threshold is exceeded, that PFAS must be reported to EPA.
Accordingly, covered facilities that utilize PFAS will need to carefully evaluate whether they have any reporting obligations under the Rule. This can be a complex exercise: for example, the terms “manufacture,” “process,” and “otherwise use” all have specific definitions, and so certain activities might not be covered. For example, “[r]elabeling or redistributing of the toxic chemical where no repackaging of the toxic chemical occurs does not constitute otherwise use or processing of the toxic chemical.” 40 C.F.R. § 372.3. Likewise, for determining whether the 100 pound threshold is met, “articles” are generally not counted. 40 C.F.R. § 372.38(b). Thus, covered entities will need to conduct a close evaluation of the relevant reporting requirements to ensure they are in compliance with their reporting obligations, but not engaging in potentially unnecessary reporting.
2. The Rule Expands Downstream Notification Obligations for PFAS-Containing Products By Removing the De Minimis Exception.
Under the general TRI requirements, facilities in SIC codes 20-39 that manufacture (including import) or process specified chemicals and then sell or otherwise distribute a mixture containing those chemicals must notify certain downstream purchasers of the presence of those chemicals. Specifically, downstream purchasers must be notified if they are either themselves covered “facilities” or the if the downstream purchaser might in turn sell or distribute the product to such a downstream purchaser (for example, a wholesaler or distributor). 40 C.F.R. § 372.45. Covered facilities are generally defined by SIC codes, and include SIC codes 20-39. See 40 C.F.R. § 372.23. Notably, this requirement is a business-to-business notification obligation, not a consumer-facing notification obligation. See 53 Fed. Reg. 4,500, 4,510 (Feb. 16, 1988) (“[T]he types of products covered by these notices are products that will be further processed or used by facilities potentially required to report. Notices are not required for products sold for individual consumer use.”).
The Rule removes the de minimis exception that previously applied to PFAS, such that any quantity of PFAS contained in a mixture would now trigger the downstream reporting obligation. This is particularly significant because concentrations of PFAS lower than those required to be reported on Safety Data Sheets (1% or 0.1% for carcinogens) will now be required to be reported to covered downstream purchasers under the Rule.
As with the EPA reporting obligations, a careful assessment of the Rule will be necessary for entities to determine whether they have downstream reporting obligations. For example, downstream notification is not required “to the extent the person does not know that the facility or establishment(s) is selling or otherwise distributing a toxic chemical to another person in a mixture or trade name product.” 40 C.F.R. § 372.45(g). Likewise, downstream notification is not required with respect to certain categories of products, such as “articles,” “[f]oods, drugs, cosmetics, alcoholic beverages, tobacco, or tobacco products packaged for distribution to the general public,” and “[a]ny consumer product as the term is defined in the Consumer Product Safety Act (15 U.S.C. 1251 et seq.) packaged for distribution to the general public.” 40 C.F.R. § 372.45(d)(2).
These downstream notification obligations are also potentially significant for those who receive such notifications, who may learn for the first time that certain products they are receiving contain PFAS. This may, in turn, trigger notification (or other) obligations of those downstream entities under other federal or state laws.
3. Product Testing Is Not Required.
EPA’s longstanding position is that its TRI rule “do[es] not impose any obligation to test a mixture or trade name product to determine whether it contains a toxic chemical. However, if a person has tested such a mixture or trade name product for its own reasons, it must consider the results in determining whether to report.” 53 Fed. Reg. at 4,511.
4. The Rule Applies to Particular Subset of PFAS.
The Rule currently applies to 189 specified PFAS, though EPA has authority to add additional PFAS. A list of PFAS subject to the Rule is available here: https://www.epa.gov/toxics-release-inventory-tri-program/list-pfas-added-tri-ndaa.
5. The Rule Also Applies to Other Chemicals of Special Concern.
Beyond PFAS, the de minimis requirement has been eliminated for a number of other chemicals of special concern, including dioxins, lead, mercury, and polycyclic aromatic hydrocarbons. The Rule sets forth a complete list of such chemicals.
6. The Rule Applies to PFAS, or Other Chemicals of Special Concern, Present as Impurities.
The TRI regulations expressly include impurities within the definition of “manufacture” and “mixture,” and so PFAS or other chemicals of special concern that are present as impurities are generally subject to the Rule. 40 C.F.R. § 372.3.
7. The Rule Is Effective 30 Days After Publication.
The Rule will take effect 30 days after publication in the Federal Register. For annual reporting purposes, the Rule will apply to the reporting year that begins on January 1, 2024.
Companies should promptly move forward with developing a compliance strategy for the Rule. Companies that manufacture, process, or otherwise use PFAS in their operations will need to evaluate whether annual reporting obligations may be triggered. Companies that supply PFAS-containing products to downstream business purchasers will need to evaluate whether additional notifications of the presence of PFAS in the products they supply. Companies that receive any supplier notifications will need to evaluate the implications of those notices, both for reporting purposes under this Rule, as well as under other federal or state regimes. In each case, companies should rely on sound legal and technical advice to ensure compliance.