Tag: plastics

Senate Subcommittee Holds Hearing on Public Health Impacts of PFAS Exposures

On December 5, 2024, the Senate Environment and Public Works (EPW) Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee heard from the following witnesses (written testimony is not available at this time):

  • Laurel Schaider, Ph.D., Senior Scientist, Environmental Chemistry and Engineering, Silent Spring Institute;
  • Sue Fenton, Ph.D., Director of the Center for Human Health and the Environment, Professor of Biological Sciences, North Carolina State University; and
  • Michael D. Larrañaga, Ph.D., P.E., President and Managing Principal, R.E.M. Risk Consultants, on behalf of the American Industrial Hygiene Association (AIHA).

Schaider testified that there needs to be a comprehensive strategy to address all per- and polyfluoroalkyl substances (PFAS), including fluorinated polymers, as a class. Schaider described how the manufacture of PFAS can expose workers and nearby communities to PFAS and how the disposal of products that contain PFAS can contaminate the environment. Fenton offered a number of suggestions for possible legislation, including: limiting the production and use of PFAS; requiring health insurance companies to pay for PFAS testing in susceptible populations; phasing out PFAS in firefighting foams (FFF); requiring manufacturers to provide standards in purified forms of their PFAS; and requiring PFAS manufacturers to fund the development of safe destruction methods for PFAS. Larrañaga stated that PFAS are part of our critical infrastructure and are used in the manufacture of products such as semiconductors, electronics, medical equipment, pharmaceuticals, herbicides, insecticides, plastics, airplanes, automobiles, and buildings. Larrañaga urged that the use of PFAS be balanced against the risk of alternatives.

The hearing included discussion of the use of PFAS in consumer products, including non-stick pans and waterproof mascara, versus other products, such as cell phones and semiconductors. Schaider stated that the issue is not only non-essential uses of PFAS, as in cookware, but also the lifecycle of products that contain PFAS. There may be environmental contamination in communities where PFAS are manufactured, workers may be exposed during manufacture, and at the end of the lifecycle of the product, the PFAS could end up in a landfill or in emissions when incinerated.

During the hearing, Senator Roger Wicker (R-MS) asked whether all PFAS cause the same level of harm and noted the common definition of PFAS as “any compound containing at least one fully fluorinated carbon atom.” Larrañaga responded that although fluoropolymers contain one fully fluorinated carbon atom, they are less bioavailable than other PFAS of concern. There could be an issue if heating them, but by removing that use from the marketplace, instead of banning all PFAS, there would be no adverse effect to critical infrastructure or defense. Schaider stated that, to her knowledge, no PFAS is completely safe. According to Schaider, newer PFAS replacement chemicals raise many of the same health concerns. Schaider suggested that an essential uses framework could be used to identify where PFAS uses can be reduced immediately.

The hearing included discussion of the best way to move forward. Fenton noted that even for essential uses, there is potential exposure to the waste and that proper disposal is important. According to Fenton, labeling products with intentionally added PFAS would allow consumers to make more informed choices. Subcommittee Chair Jeff Merkley (D-OR) suggested that there may be product categories where labeling is more important because the contamination pathway is more significant. Merkley concluded that Congress should continue to explore how to reduce the risk of PFAS to citizens.

There is much discussion, seemingly everywhere, about PFAS, but no easy answers to the questions the Subcommittee considered. In a perfect world, PFAS would be comprehensively addressed as Schaider recommends, and all the unknowns about disposal, exposure, and toxicity would be known. But we do not live in that world, and many hard questions remain to be answered. The Subcommittee gets points for raising key issues, but did little to move the needle.

All eyes are now on the new kids in town — the incoming Trump Administration and U.S. Environmental Protection Agency (EPA) Administrator-Designate Lee Zeldin. We expect in 2025 a decidedly different focus on PFAS, but beyond this, much remains to be seen.

©2024 Bergeson & Campbell, P.C.
For more on the PFAS, visit the NLR Environmental Energy Resources section

CalRecycle Seeks Stakeholder Feedback on Single-Use Packaging EPR Program

Tomorrow, February 1, the California Department of Resources Recycling and Recovery (CalRecycle) will host a hybrid question and answer session to discuss the draft rulemaking on their extended producer responsibility (EPR) program, as discussed below. A 45-day public comment period will follow. Members of the regulated community who wish to attend can find in-person and virtual information on the session here.

Members of B&D’s Plastics and Packaging team will attend the public meeting and will be prepared to answer any questions clients and contacts may have. A more substantive update on what to expect from CalRecycle and the rulemaking process is forthcoming.

Background

In June 2022, the California legislature passed a transformational law creating an EPR program with ambitious goals to ensure 100% of single-use packaging and plastic food ware is recyclable or compostable by 2032. The law creates responsibility for producers, typically manufacturers that are brand owners (although it applies to others as well), to join a producer responsibility organization (PRO) that will develop a plan to implement the law, including raising $5 billion from industry members over 10 years. CalRecycle has selected the Circular Action Alliance (CAA) as the PRO and is developing regulations to implement the law.

Companies potentially impacted by the SB 54 regulations should monitor the rulemaking process and prepare to submit comments within the upcoming 45-day public comment period. To receive periodic updates on CalRecycle’s implementation of SB 54, subscribe to the Agency’s SB 54 listserv here.

© 2024 Beveridge & Diamond PC
For more news on California’s Recycling Program, visit the NLR Environmental, Energy & Resources section.

Canadian PFAS Drinking Water Standards Proposed

We have documented for several years now the U.S. EPA’s efforts to propose enforceable drinking water standards with respect to PFAS, and in September 2022, the World Health Organization (WHO) issues its own draft “PFOS and PFOS In Drinking-Water” Background Document.  Now, on the heels of these developments, Canadian PFAS drinking water standards were introduced, which add another regulatory layer to the globally evolving PFAS regulatory scheme. Notably, Canada takes a different approach than both the United States and the WHO in addressing PFAS drinking water issues, but the proposal will nonetheless have impacts on U.S. PFAS litigation if passed.

Canadian PFAS Drinking Water Standards

Canada’s draft proposal sets a limit of 30 ppt for any detected PFAS combined in a given drinking water source. This is in contrast to the WHO, which only addressed PFOA and PFOS in its draft recommendations for drinking water standards, and the EPA, which by all indications will only propose enforceable drinking water standards for a small subset of the over 12,000 PFAS that exist. The Canadian standards, though, do propose requiring that EPA Testing Methods 533 or 537.1 be used for detection, which only tests for 29 PFAS types. Nevertheless, the large group approach to PFAS drinking water standards is unique for the moment to Canada, although the WHO did include in its proposal a similar limited subset of PFAS for countries to consider when setting or proposing drinking water standards.

Comments to the Canadian draft document are being accepted through April 12, 2023.

EPA’s Drinking Water Actions

We previously detailed how, on June 15, 2022, the EPA issued Health Advisories (HAs) for five specific PFAS, PFOA (interim), PFOS (interim), PFBS (final) and GenX (final). While not enforceable levels for PFAS in drinking water, the EPA’s PFAS Health Advisories are nevertheless incredibly significant for a variety of reasons, including influence on future federal and state drinking water limits, as well as potential impacts on future PFAS litigation.

The levels set by the EPA’s PFAS Health Advisories were as follows:

PFOA .004 ppt
PFOS .02 ppt
GenX 10 ppt
PFBS 2,000 ppt

Since the HAs were published, the EPA has faced several lawsuits challenging the HAs. The lawsuits generally allege that the HAs should be struck down and are not valid, as they were created “arbitrarily and capriciously.”  In support, the moving parties say that the HAs were created in an improper manner because (1) they incorporated toxicity assumptions that deviate from the EPA’s own standard methods; and (2) EPA incorporated grossly incorrect and overstated exposure assumptions―in essence, EPA used the wrong chemical when making its exposure assumptions, thereby resulting in a significantly less tolerant health advisory for [PFAS] than is warranted by the data. In addition, the parties argue that the EPA failed to go through the necessary public comment period before issuing its final GenX HA, and that in creating the GenX HA, the EPA exceeded its authority under the Safe Drinking Water Act.

Canadian PFAS Impacts On EPA Efforts and Litigation

When the WHO PFAS report was released, we wrote that the report will have an impact on existing and future litigation that challenges EPA regulatory actions focused on PFAS. Our reasoning for the prediction was that the standards proposed by the WHO were significantly higher than the EPA’s Health Advisories (which may foreshadow where the EPA’s enforceable drinking water limits will be set) even though the WHO had available to it much of the same scientific literature as the EPA. The Canadian PFAS drinking water proposal of 30 ppt is also higher than the EPA’s Health Advisories and what many predict will be the EPA’s proposed enforceable drinking water limit.  Future legal arguments challenging the EPA will likely say that the EPA is acting by ignoring the science and putting politics over the merits of scientific endeavor.

Nevertheless, whether the arguments challenging the EPA are found to be meritorious in litigation or not, the Canadian report will certainly provide ammunition to parties looking to challenge EPA action.

Conclusion

Now more than ever, the EPA is clearly on a path to regulate PFAS contamination in the country’s water, land and air. The EPA has also for the first time publicly stated when they expect such regulations to be enacted. 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 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.

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

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