In the authors' first installment in this three-part series on PFAS, we addressed the emergence and proliferation of enforcement and litigation. The second installment focused on state and federal regulation. This third installment discusses how the food industry might look at areas of potential exposure to PFAS, and what steps it might take to test for and mitigate those risks. It also provides a brief update on the latest developments in PFAS litigation.

We recently had an opportunity to speak with Dr. Sarah Parker, a Senior Managing Scientist with a large scientific and engineering consulting company. Dr. Parker is a chemist who specializes in understanding the properties of PFAS and the occurrence of these chemicals in products, materials, and complex supply chains. We discussed an array of issues impacting food producers, processors, suppliers, manufacturers, and marketers. The content of our discussion follows, and we conclude with a brief summary of some of the recent legal developments.

Q: In your experience, what are the unintended mechanisms and routes through which PFAS can be present in raw agricultural ingredients?

SP: PFAS can be introduced unintentionally through groundwater and public water, soil, feeds, and fertilizer used to grow crops. For example, in 2022 in Maine, PFAS-containing biosolids or sludge used as crop fertilizer entered the supply chain, impacting crops and animals, including products such as meats, milk, eggs, and produce.

Since PFAS have the potential to enter a product or process in several different ways, it is important to carefully consider your specific supply chain and the processes that are used in it, to understand where PFAS might be introduced into a specific product.

For example, if you know that your water supply contains certain PFAS, you might consider testing your product for those specific PFAS. If you don't expect PFAS to be present in your supply chain, a more general screening test, like "total organic fluorine," might be appropriate. With any screening approach, however, you must also be careful to check whether your product contains inorganic fluoride, which can cause false positives for some samples. There isn't a single testing approach that would be appropriate in all situations

Q: We know that PFAS use in packaging has been significantly reduced, but are there other considerations for where PFAS may appear?

SP: Intentional use as grease-proofing agents has been phased out, but PFAS may also be unintentionally incorporated into food packaging when used in manufacturing operations as lubricants or manufacturing aids. Several states now regulate the use of PFAS in food packaging. For example, California has set a limit of 100 ppm for unintentionally included PFAS as measured by a method called "total organic fluorine." Unfortunately, this method is not standardized, and there are different ways to run the test, which can greatly affect the results for certain types of samples. Many manufacturers are choosing to proactively test their products to ensure their compliance.

Q: Is there is any concern over effluent from manufacturing facilities?

SP: If PFAS are not intentionally used in a manufacturing facility or process, it's unlikely that waste products from that process would contain high concentrations. However, some states are implementing PFAS testing as part of permitting for certain wastewater discharge and disposal activities. Since food manufacturing can generate wastewater, solid waste, and sludge, depending on your materials and processes, it may be important to consider whether any PFAS testing requirements apply to a specific facility. You might also want to test waste streams if testing identifies higher-than-expected levels of PFAS in products manufactured at that facility.

“There are very few standardized or compendial testing methods [for PFAS], so it's important to choose carefully to make sure the test method is well-matched to the type of sample and the question you are trying to answer.”

Q: How do you determine which testing method to use?

SP: FDA has published a method to test for 30 specific PFAS in foods. Otherwise, there are very few standardized or compendial testing methods, so it's important to choose carefully to make sure the test method is well-matched to the type of sample and the question you are trying to answer.

Several non-standardized testing methods have also been used for food and food packaging; for example, "total organic precursors," "total fluorine," and "total organic fluorine." Each of these methods detects a broader range of PFAS chemicals than FDA's method, in different ways. With each of these methods, however, you get different types of information and may see false positives if you don't consider the results in the appropriate context. For example, a high result in a "total fluorine" test of tea leaves would be misleading, because tea leaves are likely to contain inorganic fluoride. The "total fluorine" test does not distinguish between fluoride and PFAS, so this result might not indicate the presence of PFAS at all. For testing tea leaves, you might consider a different, more targeted approach.

With careful preparation and help from a knowledgeable chemist, you can develop a set of routine tests that can be run periodically on batches of materials or products to help you understand what's really present and allow you to be confident in the composition of your products.

Q: What recommendations would you give manufacturers regarding testing for PFAS in their food products?

SP: First, I always recommend that manufacturers try to thoroughly understand their own manufacturing processes, their supply chains, and the processes happening at prior levels in their supply chain. By identifying which steps in the manufacturing process have a higher likelihood of unintentionally introducing PFAS into the product, manufacturers can focus their monitoring efforts on those weak areas, rather than having to test every material or raw ingredient.

Second, manufacturers should consider working with chemists who understand PFAS and the different ways these chemicals may encounter food products during manufacturing. Bringing together their own technical experts with PFAS specialists to create functional testing procedures that comply with relevant regulations can lead to high-quality product stewardship.

Q: Do you recommend that food processors, producers, and manufacturers employ PFAS audit practices?

SP: Auditing can be the right choice for many producers and manufacturers, because there are many ways that PFAS can be introduced into food products and manufacturing processes. Testing is a great way to gain confidence in your products and supply chains. Ultimately, auditing for PFAS can be a helpful element in your product stewardship process.

Determining which audit practices to use depends on where you are in the supply chain. Compare a seller of apples to a seller of boxed cake mix. If you are the apple grower, or if you purchase apples from a grower, you might ask: How are the apples grown? Do they fertilize with biosolids? Do they test those biosolids for PFAS? Do they test their water supply for PFAS? These questions are relatively easy to answer for single-ingredient products with only one type of supplier.

On the other hand, the cake mix has many ingredients that might come from different regions. Some ingredients, like flour, might already be processed. Furthermore, the flour producer likely purchased the wheat from a third party, or even a fourth if there are additional parties involved. Now, questioning the wheat grower to determine whether they are monitoring for PFAS in their water, soil, and fertilizer is much more challenging.

The cake mix manufacturer may be unable to verify that each of their suppliers is maintaining best practices regarding PFAS contamination and testing. Instead, the cake mix manufacturer might test the flour and other raw materials for PFAS as they come in the door. Or they might test the final product before putting it on the market.

“Since definitions of PFAS have become broader over the past few years, it is important that manufacturers communicate carefully about PFAS with suppliers and business partners.”

Q: As a scientist, what challenges do you see in the current landscape concerning PFAS?

SP: Since definitions of PFAS have become broader over the past few years, it is important that manufacturers communicate carefully about PFAS with suppliers and business partners. Regional differences in regulations and language barriers can present real obstacles to communication. For example, certain overseas suppliers have responded to questions about PFAS in their materials with assurances that the materials don't contain any "regulated" PFAS. But what does that mean? Regulated in their region? Regulated in the United States? The current definitions of the term "PFAS" are very broad in recent state and federal legislation, so it's important to clarify and be very explicit when asking suppliers about the chemicals that might be present in materials and products.

Latest Developments in PFAS Litigation

There are a number of recent litigation developments worth noting. For example, in a case concerning alleged personal injuries, In re E.I. Du Pont (C8 Personal injury Litigation) v. Hardwick, the Sixth Circuit stated:

Seldom is so ambitious a case filed on so slight a basis. The gravamen of Kevin Hardwick's complaint is that his bloodstream contains trace quantities of five chemicals—which are themselves part of a family of thousands of chemicals whose usage is nearly ubiquitous in modern life. Hardwick does not know what companies manufactured the particular chemicals in his bloodstream; nor does he know, or indeed have much idea, whether those chemicals might someday make him sick; nor, as a result of those chemicals, does he have any sickness or symptoms now. Yet, of the thousands of companies that have manufactured chemicals of this general type over the past half-century, Hardwick has chosen to sue the ten defendants present here. His allegations regarding those defendants are both collective—rarely does he allege an action by a specific defendant—and conclusory. Yet Hardwick sought to represent a class comprising nearly every person "residing in the United States"—a class from which, under Civil Rule 23(c), nobody could choose to opt out. And as relief for his claims, Hardwick asked the district court to appoint a "Science Panel"—whose conclusions, he said, "shall be deemed definitive and binding on all the parties[.]"

The Multidistrict Court overseeing the massive PFAS litigation, In Re: Aqueous Film-Forming Foams Product Liability Litigation, MDL 2873, recently selected bellwether personal injury cases to proceed with discovery. In the ensuing months, these bellwethers will test legal causation and human health effects of alleged exposure to PFAS chemicals.

The Circuit Courts have issued additional rulings challenging determinations by the Environmental Protection Agency (EPA). For example, in Chemours v. EPA, the Third Circuit held that the manufacturer did not have standing to challenge EPA's health advisories because they are not final determinations, and in Inhance Technologies v. EPA, the Fifth Circuit vacated two orders from EPA after finding, contrary to EPA's orders, that a longstanding fluorination process employed by Inhance was not a "significant new use" under the Toxic Substances Control Act (TSCA). Significantly, the EPA has not appealed that ruling.

While not yet directly at issue for PFAS is the June 2024 landmark ruling by the U.S. Supreme Court in Loper Bright v. Raimondo, overruling the longstanding doctrine of courts deferring to agency determinations based on the Supreme Court's 1984 decision in Chevron U.S.A. Inc. v. Natural Resources Defense Council Inc. At issue in Loper Bright was whether unelected administrators can fill in neglected details when Congress does a poor job drafting a law. Make no mistake: Loper Bright is no mere fleeting headline. It will take a long time for industry to reap the full benefits of the constraints this ruling places on the executive branch, and industry will now have greater recourse to the courts to question determinations made by governmental agencies.

What does all of this mean for PFAS? It is more likely that agencies will return to their role of applying technical and scientific expertise and for the food industry, having a sound scientific basis for decision-making. As for litigation in the near term, whether any of this can contain the plaintiff's bar is highly doubtful.

References

1. U.S. Food and Drug Administration (FDA). "Proposed Human Foods Program Organization Chart." June 27, 2023. https://www.fda.gov/media/169814/download.
2. Reagan-Udall Foundation. "Operational Evaluation of the FDA Human Foods Program." December 2022. https://reaganudall.org/sites/default/files/2022-12/Human%20Foods%20Program%20Independent%20Expert%20Panel%20Final%20Report%20120622.pdf.
3. Alliance for a Stronger FDA. "Alliance Webinar Budget Series: Webinar Transcript of Jim Jones, FDA's Deputy Commissioner for Human Foods." April 5, 2024. https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:c93c9f5e-07a5-40c4-bad5-8f5a23c2c518?viewer%21megaVerb=group-discover.
4. FDA. "List of Select Chemicals in the Food Supply Under FDA Review." Current as of March 4, 2024. https://www.fda.gov/food/food-chemical-safety/list-select-chemicals-food-supply-under-fda-review.
5. FDA. "FDA, Industry Actions End Sales of PFAS Used in US Food Packaging." February 28, 2024. https://www.fda.gov/news-events/press-announcements/fda-industry-actions-end-sales-pfas-used-us-food-packaging.
6. FDA. "81 Federal Register 5," January 4, 2016, and "81 Federal Register 83672," November 22, 2016.
7. FDA. "FDA Sampling of Food Contact Paper/Packaging for PFAS." June 2024. Keller and Heckman LLP. https://www.khlaw.com/sites/default/files/2024-06/FDA%20Sampling%20of%20Food%20Contact%20PaperPackaging%20for%20PFAS_0.pdf.
8. FDA. "81 Federal Register 54960," August 17, 2016, and "21 CFRPart 170, subpart E (for substances to be used in human food)," and "21 CFR Part 570, subpart E (for substances to be used in animal food)."
9. FDA. Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act. November 2017. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-regulatory-framework-substances-intended-use-human-food-or-animal-food-basis.
10. Maine Department of Environmental Protection. "Maine Toxics in Food Packaging Program." https://www.maine.gov/dep/safechem/packaging/index.html. Note: For example, Maine's Toxic Chemicals in Packaging Law (Public Law c. 277), along with prohibiting the use of certain chemicals including PFAS and phthalates in food packaging, also required the Maine Department of Environmental Protection to develop a list of "Chemicals of High Concern," which may in future years be subject to restrictions or bans on use in Maine.
11. California AB-418. The California Food Safety Act. October 9, 2023. https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB418.
12. FDA. "Authorized Uses of PFAS in Food Contact Applications." February 24, 2022. https://www.fda.gov/food/chemical-contaminants-food/authorized-uses-pfas-food-contact-applications.
13. Rothstein, Jared. "Food Safety Focus: Why FDA's Pre- and Post-Market Authority is Critical." Consumer Brands Association. April 11, 2024. https://consumerbrandsassociation.org/blog/food-safety-focus-why-fdas-pre-and-post-market-authority-is-critical/.
14. Alliance for a Stronger FDA. "Alliance Webinar Series: Webinar Transcript of Jim Jones, FDA's Deputy Commissioner for Human Foods." March 8, 2024. https://acrobat.adobe.com/id/urn:aaid:sc:VA6C2:1a575ac2-3d48-41df-8bfd-fc810b251abc?viewer%21megaVerb=group-discover.