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PFAS Regulations – Part 1: Existing Rules

The United States per- and polyfluoroalkyl substances (PFAS) federal regulatory framework is currently limited to reporting, manufacturing, importation, processing, and use of certain PFAS chemicals. However, several United States Environmental Protection Agency (EPA)-led actions, research, monitoring, and toxicity testing will likely result in additional PFAS-related regulations involving drinking and surface water, waste management, contaminated sites, and permitting. Trihydro presents a multi-part series of articles covering PFAS regulations. This article, Part 1, covers existing PFAS rules. Part 2 will discuss emerging and anticipated PFAS rulemaking developments. Finally, Part 3 will delve into PFAS regulatory updates.   

Do Federal PFAS Regulations Currently Apply to My Company?

Any company that manufactures, imports, transports, processes, uses, and/or “releases[1]” PFAS into the environment may be subject to current federal regulations in some aspect. This article series sheds light on what may apply to your organization.  

Reporting Requirements 

Currently, reporting for certain PFAS chemicals is required under the following four main federal programs. Additional details on each are provided below.

TSCA

Background: Since 2002, federal regulations have required that manufacturers, processors, and importers subject to TSCA notify EPA prior to the manufacture (including import) and certain uses (e.g., significant new use rules [SNURs] concerning consumer goods) of PFAS compounds. The original 2002 SNUR included a list of 13 PFAS compounds, followed quickly by 75 more compounds later that year. In 2007, 183 additional PFAS compounds joined the list. Presently, nearly 500 PFAS compounds are required to be reported to EPA for inclusion in the TSCA Active Inventory. Moreover, by amending a PFAS SNUR in 2013, EPA began regulating by broad PFAS chemical categories rather than by individual species. Namely, the 2013 SNUR amendment considered a chemical category called long-chain perfluoroalkyl carboxylates (LCPFAC) used in carpets or carpet treatments as a significant new use. The LCPFAC category encompasses substances with perfluorinated carbon chain lengths equal to or greater than 7 carbons and less than or equal to 20 carbons, inclusive of their permutants and variants such as salts and precursors, to broaden the LCPFAC category even further. That action opened the door for even more PFAS compounds to fall under the TSCA SNUR. The LCPAC concept was reaffirmed and reused in subsequent actions, including the 2020 SNUR concerning LCPFACs in surface coatings, carpets, textiles, furniture, electronics, household appliances, etc.

Recommended Due Diligence: The regulatory due diligence requirements under the TSCA SNURs and TSCA Active/Inactive reporting will endure and should be followed closely, particularly given that TSCA developments occur on regular basis. A considerable challenge associated with TSCA compliance is understanding whether various manufacturers’, processors’, and importers’ specific PFAS compounds are subject to TSCA since certain PFAS are exempt. Given the complex regulations and chemistry that can be involved in assessing whether a given compound is subject to regulation, it may be beneficial to talk to your regulatory affairs coordinator, regulatory chemist, or toxicologist about your PFAS inventory.

EPCRA

Background: Starting with the Reporting Year 2020, the National Defense Authorization Act (NDAA) added 172 PFAS compounds to the Toxics Release Inventory (TRI), and implemented a framework to add additional PFAS to the TRI annually. For the Reporting Year 2021 (the next annual forms are due by July 1, 2022), 3 more PFAS compounds were added (perfluorooctyl iodide, CAS 507-63-1; potassium perfluorooctanoate, CAS 2395-00-8; and silver(I) perfluorooctanoate, CAS 335-93-3) for a total of 175 PFAS compounds.

Under EPCRA, certain facilities that manufacture, process, or otherwise use a chemical on the TRI inventory above a designated threshold (100 pounds each concerning the 175 PFAS compounds) must report the manner of the usage in the reporting calendar along with any related environmental releases and waste management quantities. The de minimis exemption for mixtures containing perfluorooctanoic acid (PFOA) is 0.1%, and 1% for all other TRI PFAS. EPA has provided clarification that the reporting threshold applies to each individual PFAS compound and it is not additive. Furthermore, mere storage of a compound containing PFAS (such as within a fire suppression system) does not trigger reporting, there must have been an active use of PFAS-containing material. In the context of PFAS, TRI maintains nuanced interpretations of 3 key terms: “toxics,” “threats,” and “releases.”

  • “Toxics” are those chemicals that may pose a threat to human health and the environment (hazardous and toxic chemicals).
  • “Threats” are understood as human cancer and other chronic health effects, significant adverse acute human health effects, and significant adverse environmental effects.
  • “Releases” are specified as emissions into air, water, or “some type of land disposal” via direct fugitive fluxes or management through recycling, energy recovery, and treatment. “Land disposal” invariably invokes waste landfills without necessarily venturing into Resource Conservation and Recovery Act (RCRA) implications since PFAS are not (yet) designated as hazardous waste. More details on the RCRA regulatory actions concerning PFAS will be provided in Part 2 of this series.

Since the human health and environmental effects of PFAS are not well understood (other than perhaps for the two most studied PFAS compounds, perfluorooctanesulfonic acid [PFOS] and PFOA), TRI’s interpretation of 175 PFAS as “toxics” – or in the same category as the program’s 600 known human carcinogens, poisonous agents, and contaminants of lethal consequences – can be seen as precautionary in principle rather than based on extensive scientific data. Regardless, the current TRI PFAS compounds (and potentially more to come) will form part of the upcoming reporting obligations, potentially subject to change on annual basis.

Recommended Due Diligence: Facilities subject to TRI reporting should identify, track, and collect data on the 175 PFAS species listed in the TRI inventory. This could be a daunting challenge since safety data sheets (SDSs) do not always list specific PFAS compounds and instead include generic terms such as “proprietary fluorosurfactant or a fluorotelomer.” Operators should understand the new and existing reporting requirements, take advantage of any applicable exemptions, and assemble the data required by EPA. The regulated community should also understand that the rule allows the public to provide input on the addition of PFAS to the TRI list. Therefore, local community concerns and environmental justice issues may influence the PFAS that are selected for future reporting.

PPA

Background: Similar to EPCRA, Section 6607 of the PPA has reporting obligations for chemicals listed on the TRI inventory, including PFAS compounds. Reportable topics include information related to chemical-specific pollution prevention and recycling.

Recommended Due Diligence: Many of the PPA PFAS reporting obligations are inherently covered by EPCRA/TRI’s Form R. Normally, no separate reporting is required.

FFDCA

Background: Under the FFDCA, a food contact notification (FCN) authorized by the Food and Drug Administration (FDA) allows the manufacturer or supplier of a food contact substance to use the substance for purposes outlined in the FCN. In 2016, following voluntary market phase-outs, the FDA revoked previously authorized FCNs for PFOA and PFOS in food packaging. Starting in November 2016, long-chain PFAS (i.e., eight carbon PFAS, or C8) are no longer used in food contact applications sold in the U.S. Beginning in July 2020, the FDA initiated voluntary market phase-outs of certain short-chain PFAS from being used as grease-proofing agents on food packaging. Currently, some PFAS compounds are still authorized for use in non-stick cookware, food processing equipment and aids, and paper/paperboard food packaging.

Recommended Due Diligence: Since FDA continuously reviews and updates information and regulations concerning PFAS, manufacturers of food contact products should closely monitor the FDA regulatory updates/Food Contact Substance (FCS) database. Phase-outs of additional PFAS compounds (including C7 or shorter, although still authorized by FDA for food contact) are being implemented by various organizations based on additional evidence of biopersistence in test animals and potential dietary exposure in consumers.

PFAS regulations diagram


Industry Prepares for Anticipated Increase in PFAS Regulation/Enforcement

Under the current Administration, PFAS regulations and subsequent enforcement are anticipated to be a continued priority for the EPA and several states. Decisions for PFAS regulations, particularly concerning drinking water regulations under the Safe Drinking Water Act (SDWA) may be accelerated. Cleanup levels and discharge levels for PFAS compounds are likely to receive increased attention for regulation.  Companies may be subject to state-level regulations as well. Companies can prepare for upcoming PFAS regulation by staying informed of pending PFAS actions and by investigating how they might be contributing to PFAS contamination—particularly contamination that has the potential to enter water sources either directly, through discharge, or indirectly, by leaching from solid waste. 

Stay Tuned for Part 2 of This Series

Part 2: Emerging and Anticipated Regulatory Developments will be released soon. In Part 2, we will cover EPA’s current actions concerning the SDWA, Clean Water Act (CWA), Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), and RCRA. The advanced status of EPA’s activities in context of these rules will most likely lead to near-term regulations and enforcement. The April 27, 2021 memorandum from EPA’s Michael Rean seems to confirm EPA’s resolve to move forward with a multifaceted PFAS strategy, including regulations.  

Want to Learn More? 

Trihydro’s subject matter experts regularly present on the latest PFAS research and regulatory landscapes (check out an example here) and are available to discuss the dynamic PFAS regulatory environment and the impact of ever-changing regulations on your company’s reporting obligations, compliance, permitting, and overall operations.

Read Part II Now

Part II, covering emerging and anticipated PFAS regulatory developments, is available here

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[1] As defined under EPCRA’s Toxics Release Inventory (TRI) Program

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Andrew Pawlisz, DABT
Andrew Pawlisz, DABT
Senior Toxicologist, Tulsa, OK

Andrew is a board-certified toxicologist with over 20 years of experience in risk assessment and evaluation; hazard assessment; and regulatory compliance, including the legacy and reformed Toxic Substances Control Act (TSCA). Andrew specializes in finding practical solutions to regulatory and human health/environmental issues related to toxicants.
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