Has Time Run Out on Forever Chemicals?

What manufacturers must do to protect their supply chain and their brand Consumer advocates, environmental activists, and the US government are all gunning for PFAS, a class of chemicals used in manufacturing that have been linked to a plethora of health issues. PFAS, which stands for per- and polyfluoroalkyl substances, have been labeled “forever chemicals,” […]

What manufacturers must do to protect their supply chain and their brand

Consumer advocates, environmental activists, and the US government are all gunning for PFAS, a class of chemicals used in manufacturing that have been linked to a plethora of health issues. PFAS, which stands for per- and polyfluoroalkyl substances, have been labeled “forever chemicals,” because they take such a long time to break down. Moreover, health experts have advised consumers to limit their exposure to PFAS, because of their connection to a wide range of health issues. However, the prevalence of these chemicals in consumer products makes avoidance nearly impossible. Thus, The US Environmental Protection Agencies are introducing new rules, which force manufacturers to report PFAS use. These rules will not only add substantial compliance costs for manufacturers, but they could lay the groundwork for crushing liability in future EPA enforcement actions and consumer lawsuits. In this article, we’ll discuss the problems related to PFAS and the steps manufacturers should take to limit their environmental and legal exposure.

Understanding “forever chemicals”

PFAS have been used in industry and consumer products since the 1940s because of their many useful properties, such as durability and water resistance. PFAS can be found in products related to automobiles, aerospace engineering; communications networks, such as Wi-Fi and cellular data networks; consumer goods, including non-stick cookware, food packaging, cosmetics, and clothing; electronics, medical technologies and devices, and pharmaceuticals. Ironically, PFAS are key elements in products designed for sustainable living and renewable energy production, including solar panels, windmills, fuel cells, and microprocessors.

PFAS is a broad category, encompassing thousands of compounds. Some have been used more widely than others, and more is known about them. For example, perfluorooctanoic acid (PFOA) and perfluoro octane sulfonate (PFOS), were two of the most widely used and studied PFAS compounds. Concerns over the health effects of these compounds led to them being replaced by other PFAS in the United States.

A common characteristic of PFAS that has raised concern is the length of time many take a breakdown in the environment, which allows these chemicals to build up over time in the air and water, as well as in people and animals.

Health risks associated with PFAS

According to the US EPA, research indicates that exposure to certain PFAS may lead to adverse health outcomes. However, EPA admits much of this research is inconclusive and/or incomplete. For example, we do not know how exposure to low levels of PFAS over extended periods might affect individuals, especially young children. What US EPA claims to know is that exposure to certain levels of PFAS may lead to:

  • Decreased fertility
  • Increased high blood pressure in pregnant women
  • Developmental problems in children, including low birth weight, accelerated puberty, bone variations, or behavioral changes
  • Increased risk of some cancers, including prostate, kidney, and testicular cancers
  • Immune system deficiency
  • Hormonal interference
  • Increased cholesterol levels
  • Increased risk of obesity

Although there are thousands of PFAS whose toxicity levels may vary, most studies have focused on a limited number of better-known and widely used compounds. Moreover, health effects are difficult to specify for a variety of reasons, such as:

  • Different means of exposure
  • Exposure at different stages of life
  • Difficulty tracking the specific PFAS to which individuals are exposed

Yet, even if studies are incomplete, continued use of PFAS inevitably means more compounds in the environment and increasing levels of exposure. Barron’s has estimated the cost of cleaning up existing PFAS contamination at $200 billion. The US government and the various states will not bear the cost of cleanup alone; they will attempt to trace causation and attach liability to companies that have profited from the use of PFAS. Thus, it makes little sense for companies to continue using chemicals that will only compound environmental contamination and increase the cost of a remedy.

What the new EPA rules mean

Over the last several months, US EPA has taken aggressive steps to address the perceived threat posed by PFAS. These include:

  • Final Rule to Enhance PFAS Toxics Release Inventory Reporting — In October 2023, EPA imposed a final rule that eliminates an exemption for facilities using PFAS in small concentrations. The elimination of the de minimis exemption means that more companies will be required to report their usage, including small companies for whom compliance is financially burdensome.
  • Second Annual PFAS Strategic Roadmap Progress Report — In December 2023, the EPA released a report on PFAS touting the Biden-Harris administration’s all-of-government strategy on PFAS use. According to the US EPA, “The roadmap sets timelines by which EPA plans to take specific actions and commits to bolder new policies….”
  • Final Significant New Use Rule for Inactive PFAS — In January 2024, the EPA banned companies from using 329 PFAS without a complete EPA review and risk determination.
  • Requiring Toxics Release Inventory Reporting for Seven Additional PFAS — In January 2024, the EPA announced the automatic addition of seven PFAS to the list of chemicals covered by the Toxics Release Inventory. TRI is a public database, which allows anyone to obtain information on a manufacturing facility’s use of chemicals of concern. This can expose companies to greater public scrutiny and pressure from activist consumers.
  • Final CERCLA Hazardous Substances Designations for PFOA and PFOS — In April 2024, the EPA designated PFOA and PFOS as hazardous substances under the Superfund. Additionally, the EPA issued a separate CERCLA enforcement discretion policy announcing its intention to focus enforcement measures on parties “who significantly contributed to the release of PFAS chemicals into the environment.”
  • First-Ever National Drinking Water Standard for PFAS — In April 2024, EPA paved the way to take enforcement measures against companies that may have contributed to PFAS contamination of water supplies. EPA also allocated $1 billion to implement PFAS testing and treatment of water systems.

These measures indicate the US EPA’s determination to hold companies that use PFAS accountable for the costs of cleanup, as well as potential compensation for individuals harmed by the substances. Importantly, US EPA rules for PFAS also affect importers of products made overseas.

It’s important to note that the submission period opens on November 12, 2024, with the general submission deadline set for May 8, 2025. Under certain circumstances, a company might receive an additional six months to comply.

The storm of litigation over PFAS manufacturing

According to McGlinchy, “the EPA has signaled its intent to ‘take significant action’ through its ‘enforcement discretion and other approaches’ to ‘protect people and communities’ with a particular focus on the manufacturing industry.” If your company is using PFAS, you are placing yourselves directly in the crosshairs of EPA enforcement actions.

Some companies have read the handwriting on the wall. 3M, a leading manufacturer of PFAS, has stated its intention to eliminate PFAS by 2025. RQMplus.com attributes this decision to “mounting legal challenges” the industrial giant is facing. “In June 2023, for instance, 3M settled approximately 300 lawsuits for $10.3 billion.” DuPont is also implicated in a blizzard of more than “4,000 lawsuits by states and municipalities and another 6,000 personal injury lawsuits” related to PFAS manufacturing.

If your company’s PFAS use is exclusive to outsourced manufacturing, your liability under US EPA regulations will be less than if you did your manufacturing stateside and thus contributed to the contamination of US soil, air, and water. However, importing products that contain potentially toxic “forever chemicals” puts you at risk of liability within the United States.

How manufacturers should respond to heightened criticism of PFAS

According to CBSNews.com, “Some retailers, such as Dick’s Sporting Goods and REI, have recently announced plans to remove the chemicals from many of their products.” This seems to be the prudent course, considering the damage that liability for PFAS harm can do to a company’s reputation and its bottom line. No company wants to be labeled a toxic offender. Demonstrating your seriousness about correcting past practices can go a long way toward protecting your brand image. It can also mitigate your future liability.

Companies with a history of PFAS use in outsourced manufacturing should take certain steps to understand the problem and correct course. These include:

  • Conducting a PFAS audit — Identify where in your supply chain your processes might involve PFAS usage. This audit should ascertain sources of potential PFAS contamination in wastewater, air emissions, and waste disposal. State and federal voluntary action programs can provide guidance.
  • Develop a sampling analysis plan — It’s important to understand the potential areas of contamination that your importation of PFAS products might have created. This includes storage facilities and waste disposal.
  • Collaborate with suppliers on a PFAS transition plan — Once you understand where in your supply chain you encounter PFAS, you should work with your suppliers to reduce your PFAS footprint. This includes developing new processes that eliminate PFAS usage and remediate contamination from prior use.
  • Develop of disclosure plan — Manufacturers should establish a plan to disclose to all stakeholders the company’s PFAS history and strategy for moving forward. These include owners, board members and officers, consumers, suppliers, and regulators.
  • Legal analysis — Companies must prepare for potential legal action arising from prior use of PFAS by identifying potential liabilities, developing defense strategies, and earnestly maintaining compliance with evolving regulations.
  • Insurance audit — Contemporary insurance policies contain pollution exclusion clauses. However, older policies that were executed before those exclusions may provide coverage.

There are significant challenges to addressing current and prior PFAS use. Companies may be unaware of the extent of their involvement and may have difficulty obtaining accurate information from overseas suppliers. Many smaller companies might be blindsided when they learn they are now answerable to EPA reporting regulations. This can lead to severe time pressure to submit at the deadline.

Companies that have engaged a turn-key manufacturing provider, such as Genimex, can request much-needed assistance during this critical period. Our knowledge of our client’s supply chain can be a critical asset as those companies seek to comply with the new rules.