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PFAS, EPA and “Forever Chemicals”: Rumor has it, forever is a long time! Buckle-Up as EPA Doubles Down – Hazardous Substance Designation for PFAS

In October 2021, EPA released the PFAS Strategic
United States Environmental Protection Agency Placard
United States Environmental Protection Agency
Roadmap[1] laying out an overall approach to addressing PFAS. True to its word and on the heels of controversial June 2022 Interim and Final Health Advisories,[2] the EPA has published a Proposed Rule entitled “Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances.” [3] designating per- and polyfluoroalkyl substances (PFAS) - perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) (collectively “PFAS”) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) (i.e., Superfund).

This rule generally applies to the “release” of at least one pound in a 24-hour period and, since federal facilities were major users of PFAS in firefighting foams on military bases, additional notice is required for transfer of federal lands. Under the proposed rule, EPA will have significant enforcement authority that is not currently available and rights for recovery of clean-up costs. Clean-up recovery rights extend to subsequent owners and others.

The EPA identifies five general categories of entities that will be impacted by this new rule, including:

  1. manufacturers (including importers including articles containing PFAS/PFOA;
  2. processors;
  3. manufacturers of products containing PFOA/PFOS;
  4. downstream product manufacturers and users of PFOA/PFOS products;
  5. waste management and wastewater treatment facilities.

PFAS are referred to by EPA as “forever chemicals” because their strong carbon-fluorine bonds cause PFOA and PFOS to be extremely resistant to degradation in the environment. PFAS are found in outdoor air at locations in the United States, Europe, Japan, and over the Atlantic Ocean. PFAS are also allegedly found in the artic snow and air.[4] According to the EPA,

Safe Drinking Water Act Placard
Safe Drinking Water Act - Title XIV of Public Health Service Act

“the totality of evidence about PFOA and PFOS” demonstrates they pose a substantial health risk and “[t]his proposed [hazardous substance] rulemaking would increase transparency around releases of these harmful chemicals and help to hold polluters accountable for cleaning up their contamination” and require EPA to be notified of releases of PFAS that meet or exceed the “reportable quantity”. EPA specifically identifies a broad array of industries that may be affected, including:

  • Aviation operations
  • Carpet manufacturers
  • Car washes
  • Chemical manufacturing
  • Chrome electroplating, anodizing, and etching services
  • Coatings, paints, and varnish manufacturers
  • Firefighting foam manufacturers
  • Landfills
  • Medical Devices
  • Municipal fire departments and firefighting training centers, including Federal agencies that use, trained with, and tested firefighting foams
  • Paper Mills
  • Pesticides and Insecticides
  • Petroleum and Coal product manufacturing
  • Petroleum refineries and terminals
  • Photographic film manufacturers
  • Polish, wax, and cleaning product manufacturers
  • Polymer manufacturers
  • Printing facilities where inks are used in photolithography
  • Textile mills (textiles and upholstery)
  • Waste management and remediation services
  • Wastewater treatment plants

Iin May 2018 the EPA opened a new docket, noting its intention to “tak[e] action to identify solutions to address PFAS in the environment.” The same month, EPA hosted a Summit to “to aid in identifying solutions to address PFAS challenges in drinking water and at contaminated sites.”[5] On February 13, 2019 the EPA announced its “First-Ever Comprehensive Nationwide Per- and Polyfluoroalkyl Substances (PFAS) Action Plan.”[6]

EPA is Not Done yet - Drinking Water Standards expected in the Fall 2023

EPA established extraordinarily low health advisory standards in June 2022 and will further a “key initiative” in its “road-map” by establishing National Primary Drinking Water Regulations (NPDWR) for PFOA and PFOS. EPA plans to issue its drinking water regulation in fall 2022 and a final regulation in fall 2023.

In its various pronouncements, EPA states that PFOA and PFOS are persistent and mobile in the environment, and exposure can lead to adverse human health effects, including high cholesterol, changes in liver enzymes, decreased immune response to vaccination, thyroid disorders, pregnancy-induced hypertension and preeclampsia, and cancer (testicular and kidney for PFOA, liver and thyroid cancer for PFOS).

With PFAS now an all-hands on deck frontal assault from almost every acronym in the federal armada (EPA, CPSC, FDA, USDA, to name a few), the challenge to allocate risk is underway in earnest. PFAS has applications in many FDA regulated products, including medical devices, cosmetics and drugs. FDA published a survey in February, 2022 that found that 97% of food samples had no detectable levels of PFAS and concluded that there is no cause for avoiding foods.[7] Nevertheless, on August 5, 2021, FDA had issued a very rare “Dear Industry Letter” addressing EPA’s publication of product testing analytical results. Industry doesn’t get “Dear Industry” letters often (if ever) and FDA reminds us that violating the Federal Food Drug and Cosmetic Act is a federal crime. FDA then explains the chemical process of how PFAS (Per- and Polyfluoroalkyl Substances) are formed in fluorinated and non-fluorinated HDPE (High Density Polyethylene) containers and how that process renders products adulterated and mislabeled. We have not heard the last on this from either FDA or the USDA.

The controversy over PFAS is far from settled and may only be getting underway in earnest with multiple litigations against industry by states and individuals as well as significant cases filed by industry challenging EPA determinations. The backdrop to these disputes is a Supreme Court that has moved decided against the historical judicial rubberstamping of administrative determinations.


[1] https:// www.epa.gov/pfas/pfas-strategicroadmap-epas-commitments-action2021-2024

[2] In June 2022 EPA advisories set levels orders of magnitude allegedly 1,000 times below current detection level testing methods.

[3] EPA-HQ-OLEM-2019-0341

[4] Scientific Reports (2016) Natural Poly-/perfluoroalkyl Substances in Air and Snow from the Artic https://www.nature.com/articles/srep08912

[5] https://www.regulations.gov/docket?D=EPA-HQ-OW-2018-0270

[6] https://www.epa.gov/newsreleases/media-advisory-epa-announce-first-ever-comprehensive-nationwide-pfas-action-plan-0

[7] https://www.fda.gov/food/chemical-contaminants-food/and-polyfluoroalkyl-substances-pfas

Walsh Michael 2 5x3 5 1
About the author Michael A. Walsh Shareholder, Dallas, TX

Mike devotes much of his practice to counseling clients in regulated industry on issues related to manufacturing, labeling, compliance and transportation. He has extensive experience defending clients in complex administrative law and litigation matters, and has served as national coordinating counsel, regional trial counsel and as local Texas counsel in environmental and toxic tort litigation. Mike has practiced in Dallas since 1994. Prior to 1994, he practiced in New York City as a trial lawyer handling a broad range of matters including securities, commercial, real estate, intellectual property, pharmaceutical, toxic tort and environmental contamination matters. He is the author of the law book, The Supply and Distribution of FDA Regulated Products published by Thompson Reuters. Mike is a frequent writer and speaker on issues related to compliance and litigation for regulated industry and is regularly published on issues concerning toxic exposure, compliance and marketing. Mike is the founder of a daylong educational program designed for lawyers and senior industry executives in industry regulated by the federal Food and Drug Administration.

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