Category: Chemicals

EU PFAS Ban Should Raise U.S. Corporate Concerns

On February 7, 2023, the European Chemical Agency (ECHA) unveiled a 200 page proposal that would ban the use of any PFAS in the EU. While the proposal was anticipated by many, the scope of the ban nonetheless drew reactions from a myriad of sectors – from environmentalists to scientists to corporations. U.S. based companies that have any industrial or business interests in the EU must absolutely pay close attention to the EU PFAS ban and consider the impact on business interests.

EU PFAS Ban Proposal

The EU PFAS ban currently proposed would take effect 18 months from the date of enactment; however, the ECHA is contemplating phased-in restrictions of up to 12 years for uses that the group considers challenging to replace in certain applications. The proposal is only the inception of the ECHA regulatory process, which next turns to a public comment period that opens on March 22, 2023 and will run for at least six months. ECHA’s scientific committees to review the proposal and provide feedback. Given the magnitude of comments expected and the likely hurdles that the ECHA will face in finalizing the proposal, it is not expected that the proposal would be finalized prior to 2025.

The EU PFAS ban seeks to prohibit the use of over 10,000 PFAS types, excluding only a sub-class of PFAS that have been deemed “fully degradable.” The proposal indicates: “…the restriction proposal is tailored to address the manufacture, placing on the market, as well as the use of PFASs as such and as constituents in other substances, in mixtures and in articles above a certain concentration. All uses of PFASs are covered by this restriction proposal, regardless of whether they have been specifically assessed by the Dossier Submitters and/or are mentioned in this report or not, unless a specific derogation has been formulated.” (emphasis added) Several specific types of uses and consumer product applicability would be included in the first phase of the proposed ban, including cosmetics, food packaging, clothing and cookware. This first phase of the ban implementation would include uses where alternatives are known, but not yet widely available, which is the reason why the first phase would take effect within 5 years. The second phase of the ban anticipates a 12 year period of time for ban implementation and encompasses uses where alternatives to PFAS are not currently known. Significantly for U.S. business, the proposed ban includes imported goods.

Impact On U.S. Companies

In 2022, U.S. companies exported just shy of $350 billion in goods to the EU. In many instances, companies do not deliberately, intentionally, or knowingly add or utilize PFAS in finished products that are sent to the EU. However, PFAS may be used in manufacturing processes that inadvertently contaminate goods with PFAS. In addition, many U.S. companies rely on overseas companies for supply chain sourcing. Quite commonly, supply chain sources outside of the U.S. do not voluntarily provide chemical composition information for components or goods that they supply. Inquiring of those companies for such information, or certifications that the good contain no PFAS, can be extremely difficult. Getting overseas companies to provide such information often proves impossible and even when certifications are made, the devil may be in the details in terms of what is actually being certified. For example, certifying that goods contain “no hazardous substances” or “no hazardous PFAS” sound reassuring, but by what measure of “hazardous” is the statement being made? Under what country’s regulations? Using which scientific definition? The result of all of these complexities may be that many U.S. based companies need to test their products themselves, which not only increases time to market issues and financial costs associated with production, but also risks to the companies doing business in the U.S. that they may open themselves up to environmental pollution or personal injury lawsuits by conducting such testing. In addition, alternatives may not be as cost effective as PFAS, which impacts businesses and has the potential trickle-down impact of passing some of the costs on to consumers.

While debate continues in the U.S. as to the scientific validity of the “whole class” approach to regulating PFAS (of which there are over 12,000 types according to the EPA), the EU PFAS ban leapfrogs the U.S. debate stage and goes directly to proposing a regulation that would embrace such a “whole class” regulatory scheme. Without a doubt, chemical manufacturers, industrial and manufacturing companies, and some in the science community are expected to strenuously oppose such an approach to regulations for PFAS. The underlying arguments will follow ones advanced and debated already in the U.S. – i.e., not all chemicals act identically, nor have the vast majority of PFAS been shown to date to present health concerns. Proper scientific method does not permit sweeping attributions of testing on legacy PFAS like PFOA and PFOS to be extrapolated and applied to all PFAS. The EU’s response to this via their proposal is that the costs of remediating PFAS from the environment are significant enough that it warrants regulating PFAS as a class to avoid costly, decades-long, and potentially repetitive remediation work in the EU.

Conclusions

It is of the utmost importance for businesses to evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate these compounds in the U.S. and abroad. One major point of contention among members of various industries is whether to regulate PFAS as a class or as individual compounds.  While each PFAS compound has a unique chemical makeup and impacts the environment and the human body in different ways, some groups argue PFAS should be regulated together as a class because they interact with each other in the body, thereby resulting in a collective impact. Other groups argue that the individual compounds are too diverse and that regulating them as a class would be over restrictive for some chemicals and not restrictive enough for others.

Companies should remain informed so they do not get caught off guard. States are increasingly passing PFAS product bills that differ in scope. For any manufacturers, especially those who sell goods overseas, it is important to understand how the various standards among countries will impact them, whether PFAS is regulated as individual compounds or as a class. Conducting regular self-audits for possible exposure to PFAS risk and potential regulatory violations can result in long term savings for companies and should be commonplace in their own risk assessment.

©2023 CMBG3 Law, LLC. All rights reserved.
For more Environmental Law news, click here to visit the National Law Review

Washington PFAS Soil Standards

To start off the new year, Washington introduced its “Draft Guidance for Investigating and Remediating PFAS Contamination In Washington State”, which provides guidance principles for companies looking to remediate land of six specific types of PFAS – PFOA, PFOS, PFNA, PFHxS, PFBS, and GenX. The Washington PFAS soil standards follow similar guidance documents by New Jersey (2022) and Pennsylvania (2021). None of the three states have soil standards that would be used for the purposes of identifying potential responsible parties. As other states follow suit, though, it is likely that other states will begin setting PFAS soil standards that include both a remediatory guideline and liability purpose. Companies are well-advised to closely follow developments at the state level with respect to PFAS soil standards.

PFAS Soil Standards In Washington

Washington’s guidance would, if approved, be able to be utilized for both private cleanups (or diligence initiatives) and state-led remediation efforts. The draft guidance document cautions that even if finalized, parties engaged in site cleanup need to be aware that the science and regulations with respect to PFAS are changing, so coordination with the state is key. The state would still need to approve proposed remediation plans, even if in line with the Guidance document, as state approval of remediation proposals is highly fact-specific. In addition, the state will look at proposed plans through the lens of future reopener issues, and will aim to work with parties at the outset to avoid such issues.

Impact On Businesses

As noted above, the PFAS soil standards do not create liability if soil is discovered to contain levels of PFAS above the noted limits. Instead, the regulations provide guidance to site remediators, to provide clarity as to the extent and scope of PFAS remediation necessary from contaminated sites. Nevertheless, companies in Washington are advised to use the limits in the regulations as baselines testing during the diligence phase of any property or corporate acquisition. It is critical to determine whether or not sites owned by the businesses or sites that companies may inadvertently be polluting with PFAS have elevated levels of PFAS such that future liability concerns may arise.

Businesses outside of Washington must be aware of the regulations and closely follow legislation and regulatory action in discussion with respect to PFAS soil standards. While drinking water and wastewater have certainly received the most attention from a PFAS regulatory perspective, efforts are being made in several states to collect data with respect to PFAS soil contamination, with the long-term goal of enacting science based PFAS soil standards.

©2023 CMBG3 Law, LLC. All rights reserved.
For more Environmental Law News, click here to visit the National Law Review.

Federal PFAS Drinking Water Standards: 2023 Is the Year

On Friday, October 7, 2022, the EPA formally sent its proposed federal PFAS drinking water standards to the White House Office of Management and Budget (OMB) for consideration and approval or rejection. The proposed rule cleared OMB review on November 30, 2022; however, the EPA has not yet released the proposed rule. While the details of the rule under consideration are not yet known, what is evident from the title of the document logged on the OMB website is that the drinking water standards will address PFOA and PFOS. At least from the document title, it does not appear that any other PFAS will be subject to Safe Drinking Water Act (SDWA) regulation at the moment.

The delay in releasing the proposed drinking water standards for over a month now, though, could suggest that the proposed rule may seek to regulate more than just PFOA and PFOS, and the EPA may be looking to shore up language and support language in the proposed rule for such a proposal in light of comments from the OMB. Similarly, many wonder whether the EPA proposed a limit so low that the OMB had concerns as to whether the limits were detectable. With the EPA keeping its proposed language a closely guarded secret for the time being, much of the discussions rest on speculation. What we do know is that he EPA is statutorily required to put forth a proposed standard before the first half of 2023, and it has publicly pledged repeatedly to act more quickly than that statutory requirements.

Thus, 2023 will see federal PFAS drinking water standards for at least two PFAS from the EPA and we predict that it is only a matter of days before the country sees the EPA’s proposal, which will kick off what promises to be an extremely contentious public comment period.

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. These regulations will require states to act, as well (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Beyond drinking water, though, the EPA PFAS Roadmap from 2021 shows the EPA’s desire to take regulatory action well beyond just drinking water, and companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

Article By John Gardella of CMBG3 Law

For more environmental legal news, click here to visit the National Law Review.

©2023 CMBG3 Law, LLC. All rights reserved.

PFAS Medical Monitoring Goes To State Supreme Court

A year-and-a-half ago, we predicted that in the PFAS litigation world, medical monitoring claims would quickly become a claim that finds its way into numerous PFAS cases with ever-increasing risks and cost to companies embroiled in the lawsuits. On November 15, 2022, the viability of medical monitoring claims with respect to PFAS found its way to the New Hampshire Supreme Court for oral argument. While courts are currently divided as to whether medical monitoring claims should be permitted to proceed without proof of actual injury to the plaintiffs, the result of the New Hampshire Supreme Court case will likely have ripple effects in other states where medical monitoring claims continue to proliferate.

PFAS Medical Monitoring Costs – The Current Landscape

PFAS medical monitoring costs is not a new topic for the litigation – it is something that plaintiffs’ counsel push for either as a damages component to a cause of action or as a term for settlement negotiations in PFAS cases. Yet, to date, only a few states allow for medical monitoring costs to be pled as a cause of action unto itself. Instead, states either require an underlying harm to be proven before the courts will consider awarding medical monitoring costs or states have outright rejected the medical monitoring theory of damages altogether.

The American Law Institute (ALI) is a prestigious legal organization that develops “Restatements” of various laws in the United States, including tort law. The ALI’s work and the Restatements, while not binding on courts, are widely regarded by attorneys, judges and legal scholars as a comprehensive understanding of many of the nuanced parts of legal theories. Through decades of work and revisions, the Restatement (Third) of Torts is now nearing the final stages of completion.

Significantly, the Restatement (Third) is contemplating including recommendations that courts allow plaintiffs to recover monetary damages for medical monitoring expenses, even though the plaintiffs do not have any present bodily harm. With respect to PFAS litigation, medical monitoring costs have been awarded in some states or through settlements to plaintiffs alleging some degree of injury from PFAS. The Restatement (Third) approach, though, opens the door to citizens in the country with no bodily injury from PFAS to participate in free (to the plaintiffs) medical monitoring to ensure that health issues do not arise related to PFAS.

The ALI’s approach to medical monitoring is a topic that is hotly contested in many legal circles, as awarding medical monitoring costs absent any injury is a highly controversial recommendation that seems to upend decades of tort law. Opponents argue that one of the very tenants of tort law is that there is an injury to the plaintiff – without an injury, there is no tort. Courts are currently split on whether they permit medical monitoring costs to be awarded to plaintiffs without any injury.

PFAS Medical Monitoring In New Hampshire

In Kevin Brown v. Saint Gobain, the plaintiffs’ drinking water was allegedly contaminated with PFOA as a result of a Saint-Gobain facility that discharged PFOA into local waterways, which fed drinking water sources. The case made its way through the USDC-NH, but the defendant certified the question to the New Hampshire Supreme Court of whether New Hampshire law permits the plaintiffs, who are asymptomatic, to bring a claim for the costs of their being periodically medically monitored for symptoms of disease caused by exposure to PFOA.

At oral argument on the issue, the parties and the Court held a spirited debate as to whether the seventeen states that allow medical monitoring as a form of relief are similar legally to New Hampshire, such that the state should adopt a broad interpretation and allow medical monitoring claims without proof of present injury. Defendant and parties who filed amicus briefs in support of defendants argued that the Court should defer to the legislature on the issue, as the legislature has primary responsibility for declaring public policy.

Impact On Companies

The issue of permitting PFAS medical monitoring claims without any present injury is one that has enormous impacts not only on PFAS manufacturers, but any downstream commerce company that finds itself in litigation (often class action lawsuits) alleging medical monitoring damages. The litigation is already shifting in such a way that downstream commerce companies (i.e. – companies that did not manufacture PFAS, but utilized PFAS in manufacturing or products) are being named in lawsuits for personal injury and environmental pollution at increasing rates. Allowing a medical monitoring component to the recoverable costs that can pled would significantly raise the risks and potential liability costs to downstream companies.

It is of the utmost importance that businesses along the whole supply chain in various industries evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate PFAS at an ever-increasing pace. Similarly, state level EPA enforcement action is increasing at a several-fold rate every year. Companies that did not manufacture PFAS, but merely utilized PFAS in their manufacturing processes, are therefore becoming targets of costly enforcement actions at rates that continue to multiply year over year. Lawsuits are also filed monthly by citizens or municipalities against companies that are increasingly not PFAS chemical manufacturers.

Article By John Gardella of CMBG3 Law

For more environmental legal news, click here to visit the National Law Review.

©2022 CMBG3 Law, LLC. All rights reserved.

EPA Announces the Release of Its Endangered Species Act Workplan Update

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) announced it released an Endangered Species Act (ESA) Workplan Update (Workplan Update) that outlines major steps to increase protections for wildlife and regulatory certainty for pesticide users. The Workplan Update details how EPA will pursue protections for nontarget species, including federally listed endangered and threatened (i.e., listed) species, earlier in the process for pesticide registration review and other Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) actions. According to EPA, these early protections will help EPA comply with the ESA, thus reducing its legal vulnerability, providing farmers with more predictable access to pesticides, and simplifying the ESA-FIFRA process that, left unchanged, creates both significant litigation risk and a workload far exceeding what EPA has the resources to handle.

EPA states this update is a follow-up to EPA’s April 2022 ESA Workplan that addresses the complexity of meeting its ESA obligations for thousands of FIFRA actions annually. The ESA Workplan prioritizes certain FIFRA actions for ESA compliance, outlines how EPA will pursue early mitigation for listed species under FIFRA, and describes directions for expediting and simplifying the current pesticide consultation process.

As part of registering new pesticides or reevaluating pesticides during registration review, EPA has a responsibility under the ESA to ensure certain pesticide registrations do not jeopardize the continued existence of listed species or adversely modify their designated critical habitats. EPA states that it has seen in the past few decades an increase in litigation due to EPA’s failure to meet its ESA obligations when taking FIFRA actions. Over the next six years, existing court-enforceable deadlines will require EPA to complete ESA reviews for 18 pesticides — the most EPA estimates it can handle during this period based on its current capacity and processes. Ongoing litigation and settlement discussions for other lawsuits cover dozens of additional pesticides and will likely fill the EPA’s ESA workload well beyond 2030. According to EPA, if its ESA efforts continue at this pace, a future court may decide to curtail drastically pesticide use until EPA meets its obligations. EPA believes this situation would be unsustainable and legally tenuous and provide inadequate protection for listed species and create regulatory uncertainty for farmers and other pesticide users.

The Workplan Update is EPA’s first update to the ESA Workplan and covers four main goals:

  1. Describes EPA’s overall approach to mitigating ecological risks in registration review, which includes prioritization of registration review cases based on opportunities to reduce a pesticide’s risk to human health or the environment.

  2. Proposes a menu of FIFRA Interim Ecological Mitigation measures that EPA will draw from for many future conventional and biological pesticide registration and registration review actions to protect nontarget species. For each FIFRA action, EPA will consider this menu and propose, based on the risks and benefits of the particular pesticide, which specific measures to include on the pesticide label.

  3. Proposes label language to expand the use of online endangered species protection bulletins to implement geographically specific mitigation measures for individual listed species. These measures are designed to focus protections only in specific needed areas, thus minimizing impacts to agriculture. Where needed, EPA may develop these measures to complement the generic FIFRA ecological mitigation described above.

  4. Describes current and future programmatic initiatives with other federal agencies to prioritize mitigation for listed species that are particularly vulnerable to pesticides and to improve the efficiency and timeliness of the ESA-FIFRA process.

The first strategy described in EPA’s ESA Workplan is to “meet ESA obligations for FIFRA actions.” EPA states as part of its work to execute this strategy, it has identified a menu of Interim Ecological Mitigation measures it will use as a starting point to address pesticide risks to nontarget species during registration and registration review.

The menu of Interim Ecological Mitigation will include measures to reduce pesticide spray drift and pesticide runoff and will be considered as part of EPA’s upcoming proposed interim registration review decisions. While EPA intends for this set of Interim Ecological Mitigation measures to apply widely to many pesticides, EPA will consider the menu of options for any given pesticide depending on the level of risk that it poses to species and the exposure route.

EPA anticipates that this approach will more efficiently establish protections for nontarget species, including listed species, and standardize the protections across similar pesticides, in contrast to identifying mitigation measures pesticide by pesticide or species by species, as EPA has typically done in the past.

EPA states it will also work with registrants to add language on pesticide incident reporting, advisory language to protect insect pollinators, and language to most outdoor-use pesticide labels that directs users to reference Bulletins Live! Two, a website where pesticide users can find endangered species protection bulletins. These bulletins describe geographically specific use limitations to protect threatened and endangered species and their designated critical habitat.

EPA expects that once consultation with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service is completed for any given outdoor-use pesticide, endangered species protection bulletins may be necessary for at least one listed species.

EPA also expects that working with registrants proactively to add the reference to Bulletins Live! Two to pesticide labels in advance of consultation will ultimately save EPA, state partners, and registrants time and resources by minimizing the number of amendments to labels.

The ESA Workplan Update also describes initiatives that, according to EPA, will help it and other federal agencies improve approaches to mitigation under the ESA and improve the interagency consultation process outlined in the ESA Workplan. These initiatives include EPA’s work to identify ESA mitigation measures for pilot species, incorporate early ESA mitigation measures for groups of pesticides (e.g., herbicides), and develop region-specific ESA mitigations.

Comments on the proposed set of interim mitigation measures and the proposed revisions to label language included in the Workplan Update appendix are due on or before January 30, 2023. Comments can be submitted at EPA-HQ-OPP-2022-0908.

Commentary

This next phase of the ESA Workplan provides more detail about how EPA plans to impose various mitigation measures to meet its ESA obligations when registering a pesticide. The most favorable view of what EPA has presented is that it continues the march toward ESA compliance, which is long overdue, and provides more detail about the kinds of mitigation approaches it will place on pesticide labels to meet ESA requirements. The less favorable view here is that EPA has outlined a number of “off the shelf” mitigation options (buffers to reduce pesticide drift and water runoff), and EPA might impose such conditions in many instances where more careful analysis of usage data and site- or use-specific considerations might lessen the areas where such mitigation measures are needed.

EPA has stated previously as part of its earlier Workplan document, issued in April 2022, that using the present approaches EPA would complete only 5 percent of the ESA required reviews in about 18 years — implying that the current approach would take about 360 years to complete. This next iteration of the Workplan, describing “early mitigation” strategies, is designed to reduce this unacceptable timeframe (360 years), but is likely to lead to fears among some stakeholders that in a “rush” to complete this work, EPA will make overly conservative label restrictions and reduce availability of the pesticide without increased species protections. Such concerns raise immediate ancillary concerns about stakeholder involvement in decision-making, compliance with what might be complicated label requirements, and enforcement of what is already typically a long list of label requirements for many current products. An example of such issues: one mitigation option example discussed is “do not use when rain is expected in the next 48 hours” — which could raise issues concerning what or how compliance might be proven or enforced.

Again, to be sure, this next document about how EPA plans to make significant progress in meeting its ESA obligations continues the effort to convince courts that it is meeting its ESA obligations. As such, it represents a large step forward where in the past EPA was left with little progress or plans to present in court as part of litigation over ESA compliance. As it continues to reveal its plans and options, however, stakeholders will need to follow closely and consider the possible impacts of the Workplan and the resulting label proposals to follow.

For more Environmental Law news, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

REI PFAS Consumer Fraud Lawsuit Continues Trend of Similar Lawsuits

On October 28, 2022, a PFAS consumer fraud class action lawsuit was filed in Washington against REI over alleged PFAS content in various articles of waterproof clothing sold by the company. The REI PFAS consumer fraud lawsuit is but the latest in a growing line of PFAS lawsuits that allege that certain consumer goods contain PFAS, that the products or company’s values were marketed as healthy or environmentally friendly, and that consumers would not have purchased the products if they knew that the products contained PFAS.

As we predicted in early 2021, the increased attention on PFAS content in consumer goods in the scientific community and media presented significant risks to various industries, including the apparel and cosmetics industry, and our prediction was that the developments would lead to a significant number of lawsuits alleging consumer fraud. Consumer goods industries, insurers, and investment companies interested in the consumer goods vertical with niche interest in cosmetics companies must pay careful attention to the cosmetics lawsuits and the increasing trend of lawsuits targeting the industry.

REI PFAS Consumer Fraud Lawsuit

On October 28, 2022, plaintiffs Jacob Krakauer and Joyce Rockwood filed a lawsuit in Washington federal court seeking a proposed class action against REI. The lawsuit alleges that REI markets the company and its products as environmentally friendly and sustainable. Further, the lawsuit cites to statements made by REI that the company is taking proactive steps with respect to chemical use in its products to argue that such statements were false, misleading or induced consumers to purchase products when the presence of PFAS in the products was not disclosed.

In the Complaint, plaintiffs allege the following counts against REI:

  • Violation of state consumer protection laws and the federal Magnuson-Moss Warranty Act

  • Breach of warranty (implied and express)

  • Fraud (actual and constructive)

  • Fraudulent inducement

  • Money had and received

  • Fraudulent omission or concealment

  • Fraudulent misrepresentation

  • Negligent misrepresentation

  • Unjust enrichment

  • Negligent failure to warn

The plaintiffs seek certification of a nationwide class action lawsuit, with subclasses defined as consumers n Washington and Arizona. In addition, the lawsuit seeks damages, fees, costs, the establishment of medical monitoring, and a jury trial.

Just the Beginning For Consumer Products Companies

With studies underway, legislation pending that targets consumer goods, and increasing media reporting on PFAS in consumer goods and concerns over human health, product manufacturers should be increasingly wary of lawsuits similar to the REI lawsuit being filed against them. There are an increasing number of PFAS consumer fraud cases being filed, with some of the below as representative of recent trends:

  • Cosmetics industry:

    • Brown v. Cover Girl, New York (April 1, 2022)

    • Anderson v. Almay, New York (April 1, 2022)

    • Rebecca Vega v. L’Oreal, New Jersey (April 8, 2022)

    • Spindel v. Burt’s Bees, California (March 25, 2022)

    • Hicks and Vargas v. L’Oreal, New York (March 9, 2022)

    • Davenport v. L’Oreal, California (February 22, 2022)

  • Food packaging industry:

    • Richburg v. Conagra Brands, Illinois (May 6, 2022)

    • Ruiz v. Conagra Brands, Illinois (May 6, 2022)

    • Hamman v. Cava Group, California (April 27, 2022)

    • Azman Hussain v. Burger King, California (April 11, 2022)

    • Little v. NatureStar, California (April 8, 2022)

    • Larry Clark v. McDonald’s, Illinois (March 28, 2022)

  • Feminine hygiene products:

    • Gemma Rivera v. Knix Wear Inc., California (April 4, 2022)

    • Blenis v. Thinx, Inc., Massachusetts (June 18, 2021)

    • Destini Canan v. Thinx Inc., California (November 12, 2020)

As the above is indicative of, several major companies now find themselves embroiled in litigation focused on PFAS false advertising, consumer protection violations, and deceptive statements made in marketing and ESG reports. The lawsuits may well serve as test cases for plaintiffs’ bar to determine whether similar lawsuits will be successful in any (or all) of the fifty states in this country. Companies must consider the possibility of needing to defend lawsuits involving plaintiffs in all fifty states for products that contain PFAS.

It should be noted that these lawsuits would only touch on the marketing, advertising, ESG reporting, and consumer protection type of issues. Separate products lawsuits could follow that take direct aim at obtaining damages for personal injury for plaintiffs from consumer products. In addition, environmental pollution lawsuits could seek damage for diminution of property value, cleanup costs, and PFAS filtration systems if drinking water cleanup is required.

Conclusion

It is of the utmost importance that businesses along the whole supply chain in the consumer products industry evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate PFAS at an ever-increasing pace. Similarly, state level EPA enforcement action is increasing at a several-fold rate every year. Now, the first wave of lawsuits take direct aim at the consumer products industry. Companies that did not manufacture PFAS, but merely utilized PFAS in their manufacturing processes, are therefore becoming targets of costly enforcement actions at rates that continue to multiply year over year. Lawsuits are also filed monthly by citizens or municipalities against companies that are increasingly not PFAS chemical manufacturers.

For more Environmental Law news, click here to visit the National Law Review.

©2022 CMBG3 Law, LLC. All rights reserved.

EPA’s Contaminant List Includes All PFAS

We previously reported on the EPA’s announcement for its Draft Fifth Contaminant Candidate List (CCL 5), which contemplated listing all PFAS as an entire class on the Contaminant List. On October 28, 2022, the EPA issued its prepublication version of the final CCL 5 rule. The EPA’s contaminant list final version is the first step in the Safe Drinking Water Act regulatory process, which will allow the EPA to begin its assessment into any of the over 12,000 PFAS as to whether they should be included in a drinking water enforceable limit. Such a move would build upon the EPA’s current progress towards regulating PFOA and PFOS with an enforceable drinking water limit, and open the door to significant future enforcement action and litigation.

EPA’s Contaminant List and PFAS

On October 28, 2022, the EPA announced its Final Fifth Contaminant Candidate List (CCL 5). The CCL is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, but are known or anticipated to occur in public water systems. Contaminants listed on the CCL may require future regulation under the Safe Drinking Water Act (SDWA). On the CCL 5 are 66 individual chemicals, but notably PFAS as an entire class are also listed on the CCL 5. Simply because PFAS are listed on the CCL 5 does not guarantee that regulation will occur; however, it does open doors to research that are not otherwise available without the listing on the CCL.

The EPA’s contaminant list rule is not the only step the agency has taken with respect to PFAS and drinking water, but developing the CCL is the first step under the Safe Drinking Water Act (SDWA) in potentially regulating drinking water contaminants. SDWA requires EPA to publish a list of currently unregulated contaminants that are known or anticipated to occur in public water systems and that may require regulation. EPA must publish a CCL every five years. The CCL does not create or impose regulatory burden on public water systems or state, local, or Tribal governments. EPA has completed four rounds of CCLs since 1996. The last cycle of CCL, CCL 4, was published in November 2016. EPA began the development of the CCL 5 in 2018 by asking the public to nominate chemicals, microbes, or other materials for consideration for the CCL 5.

Impact On Businesses and Litigation

Many companies assume that any regulation under the Safe Drinking Water Act will not impact them, as virtually no industries, aside from water utilities, have any direct impact on drinking water. However, this belief provides a false sense of security that must immediately be dispelled. There are three specific ways that drinking water limits for PFAS will trigger scrutiny on environmental practices of businesses: (1) elffluent discharges into water sources; (2) waste sent to landfills that may leach into drinking water sources; and (3) properties abutting or in the vicinity of water sources.

Direct industry effluent discharges into water sources (which may not be drinking water sources, but may feed into drinking water sources) will be the low-hanging fruit target for local environmental agencies at the state level. Companies must ensure that they have all permitting in order, and it is advisable that the permitting specifically encompasses PFAS. Failing to do so will cause issues down the line when local environmental regulatory bodies look to determine, even retroactively, who PFAS water polluters are or were, as those agencies seek to hold businesses responsible for the costs associated with cleaning up PFAS in drinking water.

Companies that send their industrial waste to landfills are also well advised to do a full compliance check. While many companies do not use PFAS directly in their own manufacturing processes, do the parts or other raw materials used in the manufacturing process have PFAS contamination issues? If so, a company could unknowingly send PFAS-laden industrial waste products to landfills, and so these are questions that companies must get answers to. Over time, it is possible that the PFAS may leach out of the landfill and find their way into local water sources. Environmental regulatory agencies will look to these sites, the owners of the sites, and potentially companies sending waste to the sites as responsible parties for PFAS contamination in waterways.

Finally, even businesses having nothing to do with PFAS or manufacturing from which PFAS could be a contaminant need to follow news regarding PFAS regulations. For example, has the property on which your business sits ever had fires that have required a local fire department to extinguish flames using foam (historically, a PFAS containing product)? What did the owner of the site prior to you use the site for? Were there possible PFAS contamination issues stemming from that prior business? Did your due diligence reports and tests when purchasing the property take PFAS into consideration? If PFAS were a contaminant on the land on which your business now operates, local environmental agencies will pursue cleanup costs from any such business regardless of knowledge or intent, and regardless of whether the PFAS issues were the result of a prior company on the site. These investigations and remediations can be extremely expensive and disruptive to businesses.

Should the EPA broaden its regulations for PFAS in drinking water to include more than PFOA and PFOS, this will trigger considerable enforcement action at the state level to identify responsible parties and ensure that the parties pay for remediation costs. Historically, this has also led to civil litigation, as companies identified as responsible parties litigate the percent allocation that they are responsible for the alleged pollution, and look to bring in additional companies to reduce allocation shares for remediation costs.

Conclusion

Future regulatory steps for certain PFAS under the Safe Drinking Water Act will require states to act (and some states may still enact stronger regulations than the EPA). Both the federal and the state level regulations will impact businesses and industries of many kinds, even if their contribution to drinking water contamination issues may seem on the surface to be de minimus. In states that already have PFAS drinking water standards enacted, businesses and property owners have already seen local environmental agencies scrutinize possible sources of PFAS pollution much more closely than ever before, which has resulted in unexpected costs. Companies absolutely must begin preparing now for regulatory actions that will have significant financial impacts down the road.

Article By John Gardella of CMBG3 Law

For more environmental legal news, click here to visit the National Law Review.

©2022 CMBG3 Law, LLC. All rights reserved.

Biden Administration Expands Public-Private Cybersecurity Partnership to Chemical Sector

On October 26, 2022, the Biden Administration announced that it is expanding the Industrial Control Systems (ICS) Cybersecurity Initiative to the chemical sector. The White House’s fact sheet states that the majority of chemical companies are privately owned, so a collaborative approach is needed between the private sector and government. According to the fact sheet, “[t]he nation’s leading chemical companies and the government’s lead agency for the chemical sector — the Cybersecurity and Infrastructure Agency (CISA) — have agreed on a plan to promote a higher standard of cybersecurity across the sector, including capabilities that enable visibility and threat detection for industrial control systems.”

The fact sheet states that the Chemical Action Plan will serve as a roadmap to guide the sector’s assessment of their current cybersecurity practices over the next 100 days, building on the lessons learned and best practices of the previously launched action plans for the electric, pipeline, and water sectors to meet the needs for this sector. The Chemical Action Plan will:

  • Focus on high-risk chemical facilities that present significant chemical release hazards with the ultimate goal of supporting enhanced ICS cybersecurity across the entire chemical sector;
  • Drive information sharing and analytical coordination between the federal government and the chemical sector;
  • Foster collaboration with the sector owners and operators to facilitate and encourage the deployment of appropriate technologies based on each chemical facility’s own risk assessment and cybersecurity posture. The federal government will not select, endorse, or recommend any specific technology or provider; and
  • Support the continuity of chemical production critical to the national and economic security of the United States. The chemical sector produces and manufactures chemicals that are used directly or as building blocks in the everyday lives of Americans, from fertilizers and disinfectants to personal care products and energy sources, among others.

The ICS Cybersecurity Initiative emphasizes that cybersecurity continues to be a top priority for the Administration.

For more Cybersecurity Legal News, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

California PFAS Legislation Will Dramatically Impact Businesses

We previously reported on three significant pieces of California PFAS legislation that were before California’s Governor Newsom for ratification. Two of the bills were passed, which means that several categories of products will have applicable PFAS bans. The third bill was not signed by the Governor, which would have required companies to report certain data to the state for goods  sold in or otherwise brought into California that contain PFAS.

With increasing attention being given to PFAS in consumer goods in the media, scientific community, and in state legislatures, the California PFAS bills underscore the importance of companies anywhere in the manufacturing or supply chain for consumer goods to immediately assess the impact of the proposed PFAS legislation on corporate practices, and make decisions regarding continued use of PFAS in products, as opposed to substituting for other substances.  At the same time, companies impacted by the PFAS legislation must be aware that the new laws pose risks to the companies involvement in PFAS litigation in both the short and long term.

California PFAS Bills

One of our prior reports was on the first significant PFAS bill that Governor Newsom was expected to sign into law – AB 2771 – and which was indeed passed into law. The bill prohibits the manufacture, sale, delivery, hold, or offer for sale any cosmetics product that contains any intentionally added PFAS. The law would go into effect on January 1, 2025. The bill defines a cosmetics products as “an article for retail sale or professional use intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

The second bill signed into law by the Governor is AB 1817, which bans the use of PFAS in textiles manufactured and sold in California. More specifically, the bill prohibits, beginning January 1, 2025, any person from “manufacturing, distributing, selling, or offering for sale in the state any new, not previously owned, textile articles that contain regulated PFAS” and requires a manufacturer to use the least toxic alternative when removing PFAS in textile articles to comply with these provisions. The bill requires a manufacturer of a textile article to provide persons that offer the product for sale or distribution in the state with a certificate of compliance stating that the textile article is in compliance with these provisions and does not contain any regulated PFAS. The bill specifically regulates three categories of textiles:

(1) “Textile articles” means textile goods of a type customarily and ordinarily used in households and businesses, and include, but are not limited to, apparel, accessories, handbags, backpacks, draperies, shower curtains, furnishings, upholstery, beddings, towels, napkins, and tablecloths;

(2) “Outdoor apparel” means clothing items intended primarily for outdoor activities, including, but not limited to, hiking, camping, skiing, climbing, bicycling, and fishing; and

(3) “Apparel”, defined as “clothing items intended for regular wear or formal occasions, including, but not limited to, undergarments, shirts, pants, skirts, dresses, overalls, bodysuits, costumes, vests, dancewear, suits, saris, scarves, tops, leggings, school uniforms, leisurewear, athletic wear, sports uniforms, everyday swimwear, formal wear, onesies, bibs, diapers, footwear, and everyday uniforms for workwear…outdoor apparel and outdoor apparel for severe wet conditions.

The bill that California’s Governor vetoed was AB 2247, which would have established reporting requirements for companies that utilize products or substances that contain PFAS and which are used in California in the stream of commerce. “The bill would [have] require[d], on or before July 1, 2026, and annually thereafter, a manufacturer, as defined, of PFAS or a product or a product component containing intentionally added PFAS that, during the prior calendar year, is sold, offered for sale, distributed, or offered for promotional purposes in, or imported into, the state to register the PFAS or the product or product component containing intentionally added PFAS, and specified other information, on the publicly accessible data collection interface.”

Impact of California PFAS Legislation On Businesses

California PFAS legislation places some of the most significant and widely used consumer products in the crosshairs with respect to PFAS. While other states have banned or otherwise regulated PFAS in certain specific consumer goods, California’s bills are noteworthy given the economic impact that it will have, considering that California is the fifth largest economy in the world.

It is of the utmost importance for businesses along the whole cosmetics supply chain to evaluate their PFAS risk. Public health and environmental groups urge legislators to regulate these compounds. One major point of contention among members of various industries is whether to regulate PFAS as a class or as individual compounds.  While each PFAS compound has a unique chemical makeup and impacts the environment and the human body in different ways, some groups argue PFAS should be regulated together as a class because they interact with each other in the body, thereby resulting in a collective impact. Other groups argue that the individual compounds are too diverse and that regulating them as a class would be over restrictive for some chemicals and not restrictive enough for others.

Companies should remain informed so they do not get caught off guard. States are increasingly passing PFAS product bills that differ in scope. For any manufacturers, especially those who sell goods interstate, it is important to understand how those various standards will impact them, whether PFAS is regulated as individual compounds or as a class. Conducting regular self-audits for possible exposure to PFAS risk and potential regulatory violations can result in long term savings for companies and should be commonplace in their own risk assessment.

Article By John Gardella of CMBG3 Law

For more environmental legal news, click here to visit the National Law Review.

©2022 CMBG3 Law, LLC. All rights reserved.

Ethylene Oxide Verdict First of Its Kind, and It’s Eye Opening!

Our prior reports discussed when an ethylene oxide case would go to verdict, and what the ensuing result would look like.  We no longer need to speculate.  On September 19, 2022, a Cook County (Illinois) jury awarded $363 million to a plaintiff who alleged that she developed breast cancer as a result of ethylene oxide emissions from the Sterigenics Willowbrook plant.  This was the first ethylene oxide personal injury case to go to trial, but there are hundreds of cases behind it waiting their turn.

Trial

After a five week trial in the Circuit Court of Cook County, Illinois, Law Division (Sue Kamuda v. Sterigenics et al, case number 2018-L-010475), the jury returned a verdict in the amount of $363 million.  Plaintiff had requested $21 million in compensatory damages and $325 million in punitive damages.

Plaintiff Kamuda argued that the ethylene oxide utilized at the Willowbrook plant, opened in 1984 and used primarily to sterilize medical equipment, caused serious cancer and reproductive health risks. Kamuda alleged that the company failed to analyze how long the chemical would stay in the air in the Willowbrook community or the distance it would travel. Further, Kamuda argued that Sterigenics recklessly failed to install emission controls decades earlier to reduce releases of the chemical.

For its part, Sterigenics argued that plaintiff Kamuda’s reliance on risk assessment and regulatory studies inaccurately led to her assertion that her breast cancer resulted in part from the plant’s ethylene oxide emissions.

Notably, the facility was closed a few years ago after the state of Illinois issued a seal order in February 2019 directing that ethylene oxide emissions had to be reduced significantly. Ultimately, the company decided to keep the facility closed.

Analysis

With this very large jury verdict, plaintiff firms will surely be pushing to get their ethylene oxide cases to trial, or, at a minimum, leverage steep pre-trial settlements.  Further, plaintiff firms will surely recruit new plaintiffs who allege some type of cancer as a result of residing in the vicinity of an ethylene oxide plant.

The next ethylene oxide case to go trial is scheduled for two weeks from now in the same court, though with different plaintiff counsel and judge, as well as a different alleged disease (leukemia).

We note that it remains to be seen whether the Kamuda verdict will be appealed. It also remains to be seen whether this verdict is aberrational or is a bellwether for future trials. Will juries return verdicts based on one type of cancer but not for another?  We will continue to report as these ethylene oxide trials go to verdict and analyze the ramifications.

Article By David A. Goldman of CMBG3 Law

For more environmental, energy, and resources legal news, click here to visit the National Law Review.

©2022 CMBG3 Law, LLC. All rights reserved.