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PFAS Emissions and Exposure thumb

PFAS: EPA and FDA Continually Lower the Testing Bar, Litigation Threatens to Lower the Boom

Poster-FDA at SETAC Annual Mtg 5.26-30.2019
[1]Investigation of Per- and Polyflouroalkyl (PFAS) in US Food Products

[1]


TABLE OF CONTENTS

Introduction........................................................................................ 1

EPA......................................................................................................... 1

CPSC...................................................................................................... 5

FDA........................................................................................................ 5

The History of Use........................................................................... 8

A. Timeline of key events:................................................ 9

B. Litigation......................................................................... 12

C. Science............................................................................. 13

Conclusion....................................................................................... 17

Introduction

While much of the scientific, regulatory, enforcement and litigation focus is on the upstream manufacturers and suppliers of PFAS compounds, downstream suppliers, processors, distributors and end users are increasingly coming on the legislative, administrative, judicial and media radar. Because of the decades of use and exposure what was known and when it was known, will pay a key role either avoiding or allocating potential risk as the legal landscape migrates.

Science suggests that persistent chemicals migrate downstream where natural attenuation renders the substance increasingly harmless and more difficult to detect. Yet science evolves and the detection level goal posts continually move by orders of magnitude to detect them. From a risk perspective, the question becomes whether at the intersection of science and law, liability also migrates downstream in the vertical commercial market place of distributors and end users, where natural attenuation renders identifying parties nearly impossible and damages proportionately less capable of allocation. Historically, the answer for fungible and ubiquitous products is that market share, or marketplace attenuation, renders identifying potentially responsible parties incapable of proof thus shielding the downstream market from liability. But the ramparts are not immune from aerial bombardment from Congress or administrative agency action, nor are they immune from Courts employing novel theories extrapolating on decades old concepts of market share and alternative liability theories.

EPA

Pursuant to the Emergency Planning and Community Right-to-Know Act of 1986 EPA collects and publishes Toxics Release Inventory (TRI) data and, on July 29, 2021, EPA published preliminary TRI data about chemical releases, chemical waste management, and pollution which included the first-ever reporting on PFAS. EPA’s March 2022 TRI data observed that the low reporting data was mostly manufacturers reporting hazardous waste and that reporting should increase with the roll-back of the Trump era de minimis exemption from PFAS.

On June 15, 2022 the Environmental Protection Agency (EPA) issued Interim Health Advisories (and a couple Final Health Advisories) replacing those issued in 2016 regarding PFAS[2] setting levels that were not detectable when these chemical compounds were developed. EPA also announced $1 Billion in related infrastructure spending related to PFAS.

In addition to the interim health advisories, EPA issued Final Health Advisories for PFAS known as “GenX chemicals”.[3] GenX is a class of products designed as a replacement for PFOA and PFOS. The new advisory levels are based on newly gathered data which extrapolate lifetime exposure and suggest potential negative health effects that may occur at certain concentrations in water. These interim health advisories will remain in place until EPA establishes a National Primary Drinking Water Regulation[4] in the Fall of 2022.

EPA’s Health Advisories identify concentrations of chemicals in drinking water at or below which adverse health effects are not anticipated to occur. Those levels are: 0.004 parts per trillion (ppt) for PFOA, 0.02 ppt for PFOS, 10 ppt for GenX chemicals, and 2,000 ppt for PFBS.”[5] These values are orders of magnitude lower than the 2016 interim updated Health Advisories for PFOA and PFOS which were both set at 70 ppt.

At the “invitation” of the EPA in 2006, the leading PFAS manufacturers agreed to phase out manufacturing PFOA and PFOA and most have already phased the products out. While PFAS is now included in EPA’s Toxic Substances Control Act (TSCA). A Significant New Use Rule (SNUR) issued in January 2015, further ensures that EPA review any effort to reintroduce the chemical into the marketplace. Limited existing uses of PFOA-related chemicals, including as a component of anti-reflective coatings in the production of semiconductors, were excluded from the regulations (U.S. EPA, 2021e).[6]

Efforts Outside the U.S.

Scrutiny over PFAs is not unique to the U.S. and the World Health Organization (WHO) has a PFAS Project Lab[7] and the European Union (EU) has taken an approach similar to that in the U.S. focusing on the science and medicine:

With more than 4,700 known PFAS, undertaking substance-by-substance risk assessments and comprehensive environmental monitoring to understand exposure would be an extremely lengthy and resource-intensive process. As a result, complementary and precautionary approaches to managing PFAS are being explored.[8]

Rpt of the EU Comm depicting Uses Distrib and Exp to PFAS During Lifecycle
Report of the EU Commission depicting uses, distribution and exposure to PFAS during their lifecycle

[9]

Degradation and Migration Issues

In March 2022, EPA provided information to manufacturers, importers, processors, distributors, users, and disposal entities concerning fluorinated high-density polyethylene (HDPE) plastics addressing the potential for PFAS to form and migrate from these items. EPA determined in March 2021 that certain PFAS form and migrate from these substances. EPA issued an open letter notifying industry of this issue to outline the requirements under TSCA which includes steps to further the science and research to “restrict these dangerous chemicals from impacting human health and the environment.”[10]

The White House also piped in on the issue in October 2021 issuing a “Fact Sheet to Combat PFAS Pollution”[[11] and Congress has been toying relentlessly with a number of bills to amend the Comprehensive Environmental Response, Compensation and Liabilities Act of 1980 (CERCLA) and Toxic Substances Control Act (TSCA), among the proposals is the creation of a federal cause of action with remedies for “actual or potential” personal injuries. According to Congress, “peer reviewed studies” have shown that PFAS chemicals have been found in the blood serum and there is no natural source of PFAS in human blood, further guess-timating exposure through “drinking water of at least 200,000,000 individuals in the United States.”

Included in the all-federal hands-on-deck approach, the Centers for Disease Control and Prevention (CDC) National Health and Nutrition Examination Survey (NHANES) conducted biomonitoring studies to measure blood serum concentrations of PFAS to approximate exposure in the general population and concluded that PFOA was detected in 98% of serum samples collected. Significantly, in later testing blood levels of PFOA declined by more than 60% between 1999 and 2014, after commercial usage ceased in the mid-2000s.

The 2022 EPA Health Advisory detection levels were unimaginable in the 1940’s when these compounds were developed and entered into commerce and it wasn’t until the early 2000s that detections were even observed in human blood. Since then, reports of finding PFAS persisting in water, soil and air have proliferated. While the old longer chain PFOA and PFOS reportedly bioaccumulate and persist in the environment, the newer GenX are more quickly eliminated in the human body.

The EPA’s interim updated health advisories for PFOA and PFOS are based on human epidemiology studies in exposed populations and human studies reporting “associations” between exposure and health effects, including the immune system, cardiovascular system, human development (e.g., decreased birth weight), and cancer. One additional non-cancer effect that prompted the interim updated health advisories is the claimed suppression of vaccine response (decreased serum antibody concentrations) in children. GenX chemicals have also been reportedly linked to health effects on the liver, the kidney, the immune system, and developmental effects, as well as cancer. The most sensitive non-cancer effect and the EPA’s stated basis for the final health advisories for GenX chemicals is a liver effect (constellation of liver lesions).

In May 2018 the EPA opened a PFAS 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.”[12] On February 13, 2019 the EPA announced its “First-Ever Comprehensive Nationwide Per- and Polyfluoroalkyl Substances (PFAS) Action Plan.”[13] EPA commented that “[d]ue to their widespread use and persistence in the environment, most people in the United States have been exposed to PFAS. There is evidence that continued exposure above specific levels to certain PFAS may lead to adverse health effects.”[14]

The EPA is responding under its authority under TSCA, the Safe Drinking Water Act (SDWA), and the CERCLA, EPA’s Action Plan sets priority actions, short-term actions, risk communication and engagement, and long-term actions and each includes “hold[ing] responsible parties accountable for PFAS releases into the environment.”

CPSC

In a statement issued by the Commissioner of the United States Consumer Product Safety Commission (CPSC) on June 17, 2022 the CPSC is considering bold action

People are exposed to PFAS by consuming contaminated water and food, breathing in dust with PFAS, and touching consumer products that contain PFAS. PFAS and PFOS often originates in consumer products. EPA is doing its part, now CPSC must do our part to determine if we can regulate any hazards at the source.[15]

Downstream PFAS users and processors, manufacturers, packers, sellers and hazardous waste generators and disposers may look to lessons learned (and some currently being forged) from enforcement and tort litigation concerning other chemicals to understand the risk profile of these chemicals in this emerging regulatory and litigation landscape. The scenario concerning PFAS is familiar; decades ago industry developed a product with important and unquestioned utility (i.e. it is very good at what it does) but over the ensuing decades as human exposure increased advancement in science and detection evolved, and environmental and health associations emerged, the risk benefit equation began to shift and the foreground increasingly occupied by federal and state regulatory initiatives. All the while, the scientific and medical literature exponentially expands, with the mass of enforcement actions and litigation in the wings.

PFAS Emissions and Exposure
PFAS Emissions and Exposure

FDA

In the early 2000s, studies raised safety questions with PFAS compounds that contained 8 or more carbon atoms in length, commonly referred to as C8 compounds or long-chain, suggesting that these compounds persist in the environment and animal tissue and have potential adverse effects on humans and animals.

In 2016, the FDA revoked the regulations authorizing the remaining uses of these long-chain PFAS in food packaging (see 81 FR 5, January 4, 2016 and 81 FR 83672, November 22, 2016). As of November 2016, long-chain PFAS were no longer used in food contact applications sold in the United States.

PFAS is used in non-stick cookware food processing and packaging[16] And negligible amounts can migrate from cookware and processing but there is a claim of greater potential for PFAS migration to food from packaging. Significantly, all four manufacturers of PFAS with FDA approved food contact substance notifications (FCNs) agreed to cease manufacture no later than January 2024 and already ceased or begun transitioning to alternative compounds.

On August 5, 2021, FDA issued a rarely issued “Dear Industry Letter” addressing the EPA publication of product testing analytical results. Buried in the cited EPA report is reference to research being conducted in the European Union on the health effects of PFAS. In its “Dear Industry” letter, FDA reminds us that violating the Federal Food Drug and Cosmetic Act (FDCA) is a federal crime and FDA then explained 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.

In April 2021 FDA submitted its 2022 “Justification of Estimates for Appropriations Committees” detailing how FDA intends to spend its $6.5 billion dollar budget with resources allocated to reducing PFAS in the food supply, referring to PFAS as “forever chemicals.” In its Appropriation request FDA states bioaccumulation of certain PFAS “may cause serious health conditions [and] new resources would make it possible for the agency to recruit additional experts such as toxicologists and environmental scientists to conduct this work.[17]

While exposure alone is not necessarily a concern, both FDA and EPA are focusing on two issues; bio accumulation and persistence in the environment and in human tissue. In other words, nature is not efficient at disposing of these substances once they enter the environment or into living organisms and the substances tend to persist in the body and in the environment. Persistence may not be a health and safety concern unless there is scientific or medical evidence demonstrating more than mere association with potential adverse health effects. Enter the EU researchers who published extensively in July 2020 on the “Risk to human health related to the presence of perfluoroalkyl substances in food” who conclude, among other things, that

Diet is the major source of PFAS exposure for most of the population, but on an individual basis, other routes such as dust ingestion and indoor air inhalation may also contribute substantially.

Considering toxicokinetics, many of the 27 PFASs considered in this Opinion are shown to be readily absorbed through the gastrointestinal tract in mammals, including humans. They distribute to the plasma and other parts of the body and depending on the specific PFAS, tend to accumulate in the liver.

The previous Opinion [in 2018] extensively reviewed the existing data on potential associations, but this was restricted to PFOS and PFOA. For some potential critical effects, new studies appeared since then. Epidemiological studies published since the publication of the previous EFSA CONTAM Panel Opinion on PFOS and PFOA provide further support for the conclusion that PFOS and PFOA are associated with reduced antibody response to vaccination, observed in several studies.

The EU epidemiological research sounds no urgent health alarm and presents a mixed bag of potential associations while calling for further research. In the U.S., Congress is considering legislation seeking, among other things, to designate PFAS as hazardous substances under CERCLA (42 U.S.C. 9602(a)), setting drinking water standards, and labeling requirements for drugs and medical devices.

PFAS authorized for use in contact with food generally fall into four application categories:

  • Non-stick cookware: PFAS may be used as a coating to make cookware non-stick.
  • Gaskets, O-Rings, and other parts used in food processing equipment: PFAS may be used as a resin in forming certain parts used in food processing equipment that require chemical and physical durability.
  • Processing aids: PFAS may be used as processing aids for manufacturing other food contact polymers to reduce build-up on manufacturing equipment.
  • Paper/paperboard food packaging: PFAS may be used as grease-proofing agents in fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags to prevent oil and grease from foods from leaking through the packaging.

In the spring of 2020, the FDA published findings from its scientific review and analysis of then available data on short-chain PFAS and reached out to the four manufacturers holding the 15 Food Contact Notifications (FCNs) for PFAS compounds. One of the manufacturers had already stopped sales and the three others voluntarily agreed in July, 2020 to a 3-year phase-out of their sales of these compounds for use in food contact applications beginning in January, 2021.

FDA issued encouraging news in a February, 2022 Constituent Update on its survey of the food supply, finding that 97% of food samples had no detectable levels of PFAS. It further advises that since 2019, a total of only ten (10) samples from seafood had detectable PFAS levels and concludes that there is no cause for avoiding foods.[18]

The “short-chain PFAS” that have 7 or less carbons (typically 6 carbons) emerged to replace long-chain PFAS after they stopped being sold in the United States in 2011. The FDA has authorized the use of certain short-chain PFAS as grease-proofing agents on food contact paper and paperboard packaging.

The European Union’s Food Safety Authority is in lock step with FDA, or vice versa, referring to PFAS chemicals as “everywhere” and “forever” chemicals urging new regulation and urgent action.

The History of Use

PFAS were developed and initially manufactured by 3M Corporation in the late 1930s.[19] Several other companies, including DuPont (now known as Chemours), manufactured PFAS, and many other companies used these chemicals in product manufacturing and processing.[20]

PFAS is a broad array of related chemicals that were developed in the mid 1900’s due to their resistance to grease, oil, water and heat. They were and to a lesser degree, still are, widely used on fabrics, carpets, cleaning products, paints, fire-fighting foams, medical devices and equipment, food contact substances including cookware, packaging and processing equipment. [21] They are (or were) applied to or in contact with virtually everything that we touch, apply, implant, inhale and ingest.

Initially, two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), predominated in the market. Related compounds proliferated and now number into the thousands.[22] In discussing the scope of potential human exposure, EPA has concluded that PFAS are “ubiquitous” and can be found in

  • Food packaged in PFAS-containing materials, processed with equipment that used PFAS, or grown in PFAS-contaminated soil or water.
  • Commercial household products, including stain- and water-repellent fabrics, nonstick products (e.g., Teflon), polishes, waxes, paints, cleaning products, and fire-fighting foams (a major source of groundwater contamination at airports and military bases where firefighting training occurs).
  • Workplaces, including production facilities or industries (e.g., chrome plating, electronics manufacturing or oil recovery) that use PFAS.
  • Drinking water, typically localized and associated with a specific facility (e.g., manufacturer, landfill, wastewater treatment plant, firefighter training facility).
  • Living organisms, including fish, animals and humans, where PFAS have the ability to build up and persist over time.[23]

PFAS may also be found as a legacy chemical at facilities where they were manufactured or used in production or processing.

A. Timeline of key events:

  • From the 1930s through the early 2000s: Perfluorinated compounds were manufactured for use in production processes to enhance mixing, and in finished products for fire resistance and oil, stain, grease, and water repellency qualities. The scientific consensus was that PFAS were generally not toxic and regulators did not consider these chemicals to be of regulatory concern.[24]
  • 1970s: DuPont learned that PFOA was persistent in the bodies of workers.[25]
  • 1999- 2000: Detection of PFAS in the blood of the general human population began in the 1990s. Manufacturers provided information to EPA on its studies of PFOS. PFAS became chemicals of potential regulatory concern as studies emerged suggesting the chemicals were resistant to degradation in the environment. The chemicals were absorbed but poorly metabolized through blood circulation and crossing the placental barrier.[26]
  • 2002: 3M voluntarily phased-out its manufacture of PFAS chemicals in the United States.
  • 2002 through 2015: EPA issued Significant New Use Rules (SNURs) involving PFOS and 183 other PFA chemicals in 2007, and another 20 proposed new SNURs for long-chain perfluoroalkyl carboxylates in 2015.[27]
  • 2005: EPA settled a Toxic Substances Control Act (TSCA) Section 8(e) claim for failure to disclose “significant risk” information associated with PFASs, which ultimately led to a cleanup action against the manufacturer.[28] EPA’s action was triggered by citizen complaints in West Virginia.
  • 2006: Eight major manufacturers agreed to a 95 percent reduction in global emissions and product content of PFOA and related chemicals by 2010, and to work toward eliminating emissions and product content by 2015.[29] This response was prompted by the presence of PFAS in human blood and animal studies. The EPA took a voluntary phase out approach, as opposed to a ban, because it found no reasonable basis to conclude manufacturing, processing, distributing, using, or disposing of PFOA presented an unreasonable risk of injury to health or the environment sufficient to meet the statutory threshold for a ban under TSCA.[30]
  • January 8, 2009: EPA issued a PFOA drinking water advisory of 0.40 µg/L,[31] which was used to lower allowable limits in the EPA administrative order issued against one manufacturer.
  • December 30, 2009: EPA issued its Long-Chain Perfluorinated Chemicals (PFCs) Action Plan.[32]
  • January 2016: Because industry had already abandoned the use of these substances, the FDA amended the food additive regulations to no longer provide for the use of three specific “long-chain” perfluorinated substances as oil and water repellants for paper and paperboard in contact with aqueous and fatty foods in food-contact substances (FCS), suggesting there is no longer a reasonable certainty of no harm from use of these chemicals in FCSs.[33]
  • 2016: EPA issued a nonbinding PFOA and PFOS drinking water advisory of 0.07 micrograms per liter (70 parts per trillion).[34]
  • 2016-2019: Seven states, Health Canada, and Australia issued drinking water standards or advisories for PFOA, ranging from 0.014 to 1.6 µg/L[35] New Hampshire proposed a PFOA drinking water standard of 0.038 µg/L.[36] The World Health Organization and the European Union have not established a limit for PFOA in drinking water.[37]
  • November 10, 2017: PFOA and PFOS were listed by California as Proposition 65 chemicals known to cause reproductive toxicity. This listing also applies to products containing PFOA and PFOS imported into the US.
  • 2018: National Association of Clean Water Agencies (NACWA), which represents sewer authorities and drinking water suppliers, urged EPA to focus its PFA Action Plan on placing liability with those entities that are the source of PFAS [38] in drinking water or municipal wastewater and biosolids can act as the pathway through which the original sources of PFAS contaminate the environment. Conventional wastewater treatment plants are not designed to remove these synthetic industrial chemicals, suggesting communities may face operational and technical challenges and costs to test, treat or otherwise address the presence of these substances in wastewater effluent and biosolids.
  • 2018-2019: Increasing levels of information, research, and guidance issue from states, ITRC, DOD, DOE, and other groups, along with site specific information from cleanup efforts.[39] These actions focus on remediation of PFAS in drinking water, groundwater, and soil. According to the litigation advocacy group the Environmental Working Group (EWG), the EPA “suggests” that up to 110 million Americans could have PFAS in their water at concentrations of 1 ppt or greater.[40]

B. Litigation

Regulatory actions and reports received intense media coverage, much of which criticized EPA regulatory action as “inadequate.” Criticism, in turn, increased pressure for groundwater and soil remediation actions not only against manufacturers of PFOA and PFOS, but also companies that use PFASs in making their products. On December 7, 2018, the Judicial Panel on Multidistrict Litigation (JPML) established the Aqueous Film-Forming Foams (AFFF) Products Liability Litigation, MDL 2873,[41] transferring the first of more than 500 cases claiming property damage and medical monitoring for alleged groundwater contamination at or near military bases, airports and industrial sites where PFOA and PFOS foam were used to extinguish liquid fuel fire (known as aqueous film-forming foams or AFFFs). These developments have given rise to personal injury and property damage litigation and settlements are already topping $1 billion.[42]

PFAS

Exposure in search of damages.

PFAS are not going away anytime soon.

PFAS Exposure in Search of Damages

Litigation and regulatory initiatives arise from the physical properties of chemically persistent chemicals, and the products containing these compounds in commerce as well as their disposal for potential migration, spills or run-off into drinking water supplies. Because these compounds are detected away from source areas, water treatment utilities are focusing on monitoring and treating drinking water to reduce public exposure. Public water utilities serve to quantify the cost as litigation attempts to frame the liability and causation issues.

Neither courts nor legislatures have defined the universal “cleanup” strategy or financial responsibility for emerging contaminants and, historically, civil litigation has been an expensive, inefficient and unreliable arbiter of public policy.

C. Science

Early reports of global detection of PFAS in wildlife and human blood, publications on the environmental and toxicology of these chemicals have grown exponentially, now exceeding hundreds of scientific and medical articles per year. While the volume of publications is not evidence of the quality of the underlying data or the conclusions of any reports, the scale and scope of the routes of exposure serve as a reliable barometer for the increased risk to both the upstream manufacturers and suppliers and the downstream processors and end users.

Media attention follows, with attention-grabbing headlines often outpacing careful analysis. For example, claims abounded more than a decade ago that Teflon cookware was unsafe because it released perfluorinated chemicals when heated to high temperatures. The manufacturer responded aggressively, citing EPA, FDA and Consumer Product Safety Commission (CPSC) scientific positions on the safety of Teflon.[43] Similarly, the American Cancer Society stated that “[o]ther than the possible risk of flu-like symptoms from breathing in fumes from an overheated Teflon-coated pan, there are no known risks to humans from using Teflon-coated cookware. While PFOA is used in making Teflon it is present in extremely small amounts in Teflon-coated products.”[44]

The personal injury litigation brought against DuPont, had a science panel for settlement purposes which found “no probable link” for 18 diseases (including broad categories of diseases).[45] The panel found a statistical “association,” not causation, of a “probable link” between exposure to PFOA and high cholesterol, ulcerative colitis, pregnancy-induced hypertension, and kidney cancer.

Literature review conducted by EPA, Health Canada,[46] the European Chemical Agency,[47] CDC,[48] and the ATSDR,[49] concluded that epidemiological studies of PFOA and PFOS failed to establish causality between exposure and toxicological endpoints. The International Agency for Research on Cancer (IARC), an international regulatory body that classifies substances as to their carcinogenicity, stated that listing of PFOA as “possibly carcinogenic to humans” was based on “limited evidence in humans” and “limited evidence in animals.”[50]

A more recent review, the December 2018 ATSDR draft Toxicological Profile, concluded that “[a]lthough a large number of epidemiology studies have examined the potential of perfluoroalkyl compounds to induce adverse health effects, most of the studies are cross-sectional in design and do not establish causality. Based on a number of factors… including the consistency of findings across studies, the available epidemiology studies suggest associations between perfluoroalkyl exposure and several health outcomes.”[51] While there is “suggestive evidence” of carcinogenicity, “there is no conclusive evidence of causation for PFAs.”[52]

Animal studies have also not reached definitive causation conclusions. A 1997 Presidential and Congressional Commission on Risk Assessment and Risk Management, EPA, EPA’s Science Advisory Board peer reviewers,[53] Health Canada, ATSDR (2018),[54] and other scientific literature concluded that animal data may not be relevant to humans. Health Canada concluded that the relevance of PFOA-induced liver tumors to humans “is limited,” given differing biological mechanisms of action as between rats and humans.[55]

Unclear adverse effects and uncertainties in dose-response on decreased birth weights or elevated cholesterol, as well as epidemiology[56] studies on other endpoints (e.g. immunotoxicity) were also considered not robust enough to be included in a quantitative assessment characterization.[57] The December 2018 draft ATSDR report noted that many adverse health effects observed in laboratory animals were subject to differing sensitivity among species, limiting the ability to extrapolate results to humans.[58]

The CDC biomonitoring program has measured PFAS in the general population since 1999 (during which time the 50th percentile concentration of PFOA decreased from 5.2 to 3.20 micrograms per liter (µg/L) in blood).[59] Significantly, PFA chemicals have no signature from which a particular source can be determined. In light of these exposure statistics, the CDC has repeatedly stated, “[f]inding a measurable amount of” PFCs or PFOA “in serum does not imply that the levels cause an adverse health effect. Nonetheless, biomonitoring studies on levels of PFCs provide physicians and public health officials with reference values so that they can determine whether people have been exposed to higher levels.”[60] The 2018 ATSDR draft report concludes that “for the most part, adverse health effects in studies in animals have been associated with exposure concentrations or doses that resulted in blood levels of perfluoroalkyl compounds that were significantly higher than those reported in perfluoroalkyl workers or in the general population;”[61] “the human health effects from exposure to low environmental levels of PFOA are unknown;” and “[h]uman health effects from PFCs [which include PFOA] at low environmental doses or at bio-monitored levels from low environmental exposures are unknown.”[62]

Shorter Chain PFAs

While the scientific and medical spotlight had long focused on PFOA and PFOS, newer PFAS compounds have also received scrutiny, in part because of general concern about chemicals containing fluorine. For example, a study assessed the PFAS in food contact substances, such as paper and wrapping, by measuring total fluorine in the samples.[63] Many state regulatory agencies now require an expanded list of perfluoroalkyl substances (short and long chain), and fluorotelomers and polyfluoroalkyl substances are also receiving increased attention.[64] Much of the scientific research has focused on the impact of short-chain fluorotelomer-based products on human health and the environment.[65]

EPA has repeatedly acknowledged that short-chain PFAS are likely less toxic than long-chain PFAS and reported that “PFCA chemicals with fewer than eight carbons, such as perfluorohexanoic acid (PFHxA), and PFAS chemicals with fewer than six carbons, such as perfluorobutane sulfonic acid (PFBS), are generally less toxic and less bioaccumulative in wildlife and human”[66] and EPA’s reference levels for PFOA and PFOS differ by a factor of 500 from the higher exposure limits it has set for other PFAS compounds.[67]

Based on scientific reviews, short-chain fluorotelomer-based PFAS do not currently trigger the criteria for regulation laid out in international treaties and European Union regulations.[68] In addition, the materials used to produce these products (manufacturing intermediates) and the degradation products formed as these materials break down in the environment currently do not meet these criteria.

Conclusion

In the meantime, politicians, the media and trial lawyers are doing what they have done since the advent of mass torts in the 1980’s, whittling at the edges to find a foothold to penalize resourceful companies for conduct and products once praised as miraculous advances and now vilified.

As science develops and evolves identifying more persistent chemicals in the environment, and at lower concentrations than were imaginable when the products were in distribution, so too has the world in which cases and controversies are litigated. Prior large-scale litigation focused on large, deep pocket, upstream manufacturers and producers, and for good reason; upstream manufacturers have proven far easier to identify and vilify. On the other hand, downstream processors, distributors and end users are not immune from enforcement and litigation and, collectively, have massive resources. In prior litigation involving horizontal and vertical market-based allocation schemes, these downstream defendants present a far more complex evidentiary challenge for identifying the proper party, and marshaling evidence to establish liability, causation and damages. No prior litigation has presented the potential scope of exposure, risk and industry liability that PFAS presents. While much is being done industry-wide to mitigate risk, individual downstream processors, distributors and users, sitting idle in response to this looming liability does not guarantee that coming litigation freight train will hit you but taking a few proactive steps may nudge you off the rails.

[1] Poster presented by FDA at the Society of Environmental Toxicology and Chemistry (SETAC) annual meeting, Helsinki, Finland, May 26-30, 2019.

[2] The hundreds of man-made chemicals that fall under the umbrella of per and polyfluoroalkyl substances and will be referred to generically as “PFAS.”

[3]GenX chemicals" are hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt.

[4] https://www.epa.gov/sdwa/drinking-water-health-advisories-pfoa-and-pfos

[5] https://www.epa.gov/system/files/documents/2022-06/prepublication-four-pfas-june-2022.pdf

[6] https://www.epa.gov/system/files/documents/2022-06/interim-pfoa-2022.pdf

[7] https://pfasproject.com/about/

[8] Emerging chemical risks in Europe — ‘PFAS’ — European Environment Agency (europa.eu)

[9] Image: From the report of the EU Commission depicting uses, distribution and exposure to PFAS during their lifecycle (source: EEA-ETC report, Systemic view on fluorinated polymers, 2020).

[10] https://www.epa.gov/system/fil...

[11] https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/18/fact-sheet-biden-harris-administration-launches-plan-to-combat-pfas-pollution/

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

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

[14] Id. at 1

[15] https://www.cpsc.gov/s3fs-publ...

[16] Authorized Uses of PFAS in Food Contact Applications | FDA

[17] https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2020.6223

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

[19] See background information on PFAS available at https://fluorocouncil.com/; the Interstate Technology Regulatory Council, PFAS – Per- and Polyfluoroalkyl Substances, available at https://pfas-1.itrcweb.org/ (Updated March 2018; Last visited January 9, 2019); EPA, Basic Information on PFAS, available at https://www.epa.gov/pfas/basic..., .” and EPA, Long-Chain Perfluorinated Chemical (PFC) Plan at 2 (December 30, 2009), available at https://www.epa.gov/sites/prod...; and, among others.

[20] Interstate Regulatory Technology Council, History and Use of Per- and Polyfluoroalkyl Substances (PFAS) at 1 (2017), available at https://pfas-1.itrcweb.org/wp-content/uploads/2017/11/pfas_fact_sheet_history_and_use__11_13_17.pdf.

[21] Interstate Regulatory Technology Council, History and Use of Per- and Polyfluoroalkyl Substances (PFAS) at 1 (2017), available at https://pfas-1.itrcweb.org/wp-content/uploads/2017/11/pfas_fact_sheet_history_and_use__11_13_17.pdf.

[22] Interstate Regulatory Technology Council, History and Use of Per- and Polyfluoroalkyl Substances (PFAS) at 1 (2017), available at https://pfas-1.itrcweb.org/wp-content/uploads/2017/11/pfas_fact_sheet_history_and_use__11_13_17.pdf.

[23] https://www.epa.gov/pfas/basic-information-pfas#health

[24] “To date, significant adverse effects have not been found in the general human population.” EPA, Long-Chain Perfluorinated Chemical (PFC) Plan at 2 (December 30, 2009), available at https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.

[25] DuPont Statement on PFOA (2018), available at http://www.dupont.com/corporate-functions/our-company/insights/articles/position-statements/articles/pfoa.html.

[26] Citing long-chain PFC’s presence in human blood; persistent, bioaccumulative, and toxic (PBT)3 characteristics; use in consumer products; production volume; and other similar factors. EPA, Long-Chain Perfluorinated Chemical (PFC) Plan at 2 (December 30, 2009), available at https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.

[27] EPA. Long-Chain Perfluoroalkyl Carboxylate and Perfluoroalkyl Sulfonate Chemical Substances; Significant New Use Rule, 80 Fed. Reg. 2,8850 (January 21, 2015) (Proposed Rule), available at https://www.govinfo.gov/content/pkg/FR-2015-01-21/pdf/2015-00636.pdf.

[28] Memorandum from Granta Y. Nakayama, Assistant Administrator to Environmental Appeals Board (December 14, 2005), available at https://www.epa.gov/sites/production/files/2013-08/documents/eabmemodupontpfoasettlement121405.pdf.

[29] EPA, Fact Sheet: 2010/2015 PFOA Stewardship Program, (Last Updated on August 9, 2018; last viewed January 10, 2019), available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/fact-sheet-20102015-pfoa-stewardship-program.

[30] EPA staff prior to the 2016 amendments expressed concerns that the health data concerning PFAs (even long-chain PFAs) were not sufficient to make the Toxic Substance Control Act Section 6(a) regulatory finding for taking regulatory action that these PFAs “present or will present an unreasonable risk.” As a result, EPA used the PFOA Stewardship program to obtain voluntary cessation of manufacturing followed by the issuance of significant new use rules to prevent return to manufacturing of PFAs without EPA review.

[31] EPA, Provisional Health Advisories for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) at 4 (January 8, 2009), available at https://www.epa.gov/sites/production/files/2015-09/documents/pfoa-pfos-provisional.pdf.

[32] Long-Chain Perfluorinated Chemicals (PFCs) Action Plan. https://www.epa.gov/sites/production/files/2016-01/documents/pfcs_action_plan1230_09.pdf.

[33] FDA, Indirect Food Additives: Paper and Paperboard Components, 81 Fed. Reg. 5 (January 4, 2016) (final rule), available at https://www.federalregister.gov/documents/2016/11/22/2016-28116/indirect-food-additives-paper-and-paperboard-components.

[34] EPA, Fact Sheet, PFOA & PFOS Drinking Water Health Advisories (November 2016), available at https://www.epa.gov/sites/production/files/2016-06/documents/drinkingwaterhealthadvisories_pfoa_pfos_updated_5.31.16.pdf.

[35] Maine (0.07 µg/L, guidance, 2016); Michigan (0.42 µg/L, guidance; 2016); Minnesota 0.3 µg/L (chronic limit) (0.035 health-based guidance value, 201); Nevada 0.667 µg/L, guidance, 2017); New Jersey 0.014 µg/L (limit, 2015, 2017); North Carolina (1-1.6 µg/L (interim guidance, 2012, 2013); Vermont 0.02 µg/L (guidance, 2017). ATSDR, Toxicological Profile for Perfluoroalkyls at Table 7-2. Select State Drinking Water and Daily Intake Levels for Perfluoroalkyls at 646 (June 2018), available at https://www.atsdr.cdc.gov/toxp... (2017) 0.56 µg/L) and Health Canada (2018) Health Canada (2018) 0.2 µg/L tolerable daily intake. Health Canada, Guidelines for Canadian Drinking Water Quality Guideline Technical Document Perfluorooctanoic Acid (PFOA) at 1, 2 (December 7, 2018), available at /healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document/PFOA_2018-1130-eng.pdf.

[36] New Hampshire Department of Environmental Services, Summary Report On The New Hampshire Department Of Environmental Services Development Of Maximum Contaminant Levels And Ambient Groundwater Quality Standards For Perfluorooctanesulfonic Acid (PFOS), Perfluorooctanoic Acid (PFOA), Perfluorononanoic Acid (PFNA), And Perfluorohexanesulfonic Acid (PFHXS)at 46 (January 4, 2019), available at https://www.des.nh.gov/organization/commissioner/pip/publications/documents/r-wd-19-01.pdf.

[37] ATSDR, Toxicological Profile for Perfluoroalkyls at Table 7-2. Select State Drinking Water and Daily Intake Levels for Perfluoroalkyls at 646 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf).

[38] Letter from NACWA to EPA (July 20, 2018), regarding EPA’s Request for Comment on Per- and Polyfluoroalkyl Substances (PFAS), available at http://www.nacwa.org/docs/default-source/clean-water-current-pdf/nacwa-comment-for-docket-epa.pdf.

[39] ITRC, PFAS - Per- and Polyfluoroalkyl Substances, available at http://pfas-1.itrcweb.org/. ITRC is public-private coalition (with private and public sector members from all 50 states and the District of Columbia) that produces documents, guidance, and training that can be particularly utilized by States and SERDP/ESTCP, Per- and Polyfluoralkyl Substances, available at https://www.serdp-estcp.org/Featured-Initiatives/Per-and-Polyfluoroalkyl-Substances-PFASs.

[40] Environmental Working Group, Update: Mapping the Expanding PFAS Crisis Known Contamination from Toxic Fluorinated Chemicals Keeps Spreading, With No End in Sight (April 18, 2018, available at https://www.ewg.org/research/update-mapping-expanding-pfas-crisis.

[41] https://www.scd.uscourts.gov/mdl-2873/index.asp

[42] Jeff Mordock, DuPont, Chemours to pay $670 million over PFOA, The Delaware News Journal, (Published 8 online Feb. 13, 2017 ), available at https://www.delawareonline.com/story/news/2017/02/13/dupont-and-chemours-pay-670m-settle-pfoa-litigation/97842870/. In 2005, DuPont agreed to pay at least $107.6 million and was liable to pay up to another $235 million for medical monitoring of local residents, depending on the outcome of a new C8 study. Ken Ward, Judge approves DuPont settlement. Company agrees to pay at least $107.6 million over use of chemical C8, Charleston Gazette (West Virginia) March 1, 2005 Judge approves DuPont settlement Company agrees to pay at least $107.6 million over use of chemical C8. In 2012, the C8 Science Panel of epidemiologists found a probable link between C8 and kidney cancer, testicular cancer, and several other diseases. Thus, the total liability is approximately $1 billion.

[43] See Chemours, Are cookware products that are coating with Teflon™ nonstick coatings safe? available at “https://www.chemours.com/Teflo...

[44] American Cancer Society, What Causes Cancer: Teflon and Perfluorooctanoic Acid (PFOA) (Last Medical Review: January 5, 2016; last view January 10, 2019), available at https://www.cancer.org/cancer/cancer-causes/teflon-and-perfluorooctanoic-acid-pfoa.html. See also Green Facts, Hazards and risk associated to Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances (December 2018), available at https://www.greenfacts.org/en/pfoa-cookware-waterproofing/index.htm.

[45] C8 Science Panel, C8 Probable Link Reports, available at http://www.c8sciencepanel.org/prob_link.html.

[46] According to Health Canada the epidemiological studies that have shown statistical associations between exposure to PFOA and multiple non-cancer health outcomes “cannot be used to derive the non-cancer” limit for PFOA “due to limitations in terms of design, bias, confounding, and possibility of chance findings.” “Health Canada, Guidelines for Canadian Drinking Water Quality Guideline Technical Document Perfluorooctanoic Acid (PFOA) at 80 (December 7, 2018), available at https//healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document/PFOA_2018-1130-eng.pdf.

[47] “Due to unclear adversity and uncertainties in dose-response, RAC is of the opinion that this does not allow for the use of these epidemiology data in a quantitative way for risk characterization.” European Chemical Agency, Committee for Risk Assessment (RAC) Committee for Socio-economic Analysis (SEAC), Opinion on an Annex XV dossier proposing restrictions on Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances, available at https://echa.europa.eu/documents/10162/3d13de3a-de0d-49ae-bfbd-749aea884966.

[48] “Due to marked intergender differences in the elimination of PFOA in rats and substantial differences in the half-life of PFOA in rats, monkeys, and humans, the potential to estimate risks to humans from animal doses is uncertain.” Centers for Disease Congrol, Biomonitoring, Perfluorochemicals (last updated October 12 2017), available at https://www.cdc.gov/biomonitoring/PFAS_BiomonitoringSummary.html (last viewed January 8, 2019).

[49] “In general, no consistent associations were found between serum PFOA and HDL cholesterol or triglyceride levels.” ATSDR, Toxicological Profile for Perfluoroalkyls at 10, 186 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf).

[50] IARC, Monogram on Perfluorooctanoic Acid at 97-98 (2016), available at https://monographs.iarc.fr/wp-content/uploads/2018/06/mono110-01.pdf.

[51] ATSDR, Toxicological Profile for Perfluoroalkyls at 5 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

[52] ATSDR, Toxicological Profile for Perfluoroalkyls at 5 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

[53] “EPA peer reviewers raised concerns that there is no agreed upon mechanism that is relevant in humans” EPA Response to External Peer Review Comments on EPA Draft Documents: Health Effects Support Document for Perfluorooctanoic Acid (PFOA) and Health Effects Support Document for Perfluorooctane Sulfonate (PFOS) at 7, 8,13-14, 16-17,38, 43 (May 2016), available at https://www.epa.gov/sites/production/files/2016-05/documents/response_to_pfoa_pfos_peer_review_comments_508.pdf.

[54] “Available evidence suggests that the increased liver weight, hypertrophy, and serum lipid alterations are likely due to PPARα initiation and therefore, may not be relevant to humans.” ATSDR, Toxicological Profile for Perfluoroalkyls at 10, 187 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf). A number of factors, plus issues related to the mode of action of perfluoroalkyls … make it somewhat difficult at this time to determine the true relevance of some effects reported in animal studies to human health.” ATSDR, Toxicological Profile for Perfluoroalkyls at 10 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.. “Species differences in the response to PPARα agonists have been found; rats and mice are the most sensitive species and guinea pigs, nonhuman primates, and humans are less responsive. … humans are less responsive to PPARα agonists.” ATSDR, Toxicological Profile for Perfluoroalkyls at 10, 187 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

[55] Health Canada, Guidelines for Canadian Drinking Water Quality Guideline Technical Document Perfluorooctanoic Acid (PFOA) at 66-67 (December 7, 2018), available at https//healthy-living/guidelines-canadian-drinking-water-quality-technical-document-perfluorooctanoic-acid/document/PFOA_2018-1130-eng.pdf.

[56] https://www.greenfacts.org/glossary/def/epidemiology.htm

[57] Green Facts, Hazards and risk associated to Perfluorooctanoic acid (PFOA), its salts and PFOA-related substances (December 2018), available at https://www.greenfacts.org/en/pfoa-cookware-waterproofing/index.htm.

[58] Add citation from deleted material.

[59] CDC, Fourth National Report on Human Exposure to Environmental Chemicals Updated Tables, March 2018, Volume One at 403 (2018), available at https://www.cdc.gov/exposurereport/pdf/FourthReport_UpdatedTables_Volume1_Mar2018.pdf.

[60] CDC, Biomonitoring Summary. Perfluorochemicals, available at https://www.cdc.gov/biomonitoring/PFAS_BiomonitoringSummary.html [The] animal and human serum PFOA levels have been compared: serum levels associated with toxic effects in animals were 66-11,108 times higher than background serum levels in humans (Butenoff et al., 2004; U.S. EPA, 2003). A study of workers chronically exposed to primarily PFOA showed no biochemical evidence of hepatotoxicity or hormonal changes (adrenal, reproductive, thyroidal), and there was no clear evidence of excess all-cause or disease-specific mortality, or increased cancer rates (Alexander et al., 2003; Olsen et al., 1999; U.S. EPA, 2003). … Serum PFOS levels associated with toxicity in test animals were 310-1550 times higher than 95 percent of the levels found in a study of adults (Olsen et al., 2003a, 2005).”

[61] ATSDR, Toxicological Profile for Perfluoroalkyls at 10 (June 2018), available at https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.

[62] Id.

[63] Schaider, Laurel et al. Fluorinated Compounds in U.S. Fast Food Packaging, Environ. Sci. Technol. Lett., 2017, 4 (3), pp 105–111 (published February 1, 2017), available at https://pubs.acs.org/doi/10.1021/acs.estlett.6b00435. The coauthors included members of Silent Spring Institute and the EWG. The study also cites preliminary toxicity testing that “suggests” certain short-chain PFAs have “some of the same adverse effects.

[64] ITRC, Interstate Regulatory Technology Council, History and Use of Per- and Polyfluoroalkyl Substances (PFAS) at 3 (2017), available at https://pfas-1.itrcweb.org/wp-content/uploads/2017/11/pfas_fact_sheet_history_and_use__11_13_17.pdf.

[65] FluoroCouncil, Scientific Studies, available at http://accfc.sachsdigital.com/health-environment/scientific-studies/.

[66] EPA, Risk Management for Per- and Polyfluoroalkyl Substances (PFASs) under TSCA, available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-and-polyfluoroalkyl-substances-pfass (LAST UPDATED ON JULY 20, 2018; last visited January 8, 2019).

[67] EPA, Fact Sheet: Draft Toxicity Assessments of rGenX Chemicals and PFBS at 3 (November 2018), available at https://www.epa.gov/sites/production/files/2018-11/documents/factsheet_pfbs-genx-toxicity_values_11.14.2018.pdf.

[68] FluoroCouncil, Scientific Studies, available at http://accfc.sachsdigital.com/health-environment/scientific-studies/; see also, https://echa.europa.eu/documents/10162/13643/information_requirements_part_c_en.pdf.

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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