In response to emerging scientific and medical data concerning the ubiquity of thousands of per- and polyfluoralkyl substances (PFAS) used worldwide for many decades, academia, the media, and virtually every branch of state and federal government are focused on reducing exposure, assessing the risk, and allocating responsibility. New regulations and laws concerning PFAS have impacted nearly all industries, and the food industry is no exception.  

Notwithstanding the heightened focus on these chemicals and their widespread use in food processing and packaging, the U.S. Food and Drug Administration (FDA) has not yet established maximum levels in food for PFAS. At present, FDA exercises discretion on a case-by-case basis to determine whether substances present in a food product render it adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA). For example, in March 2024, prompted by testing data on food, FDA issued an Import Alert to detain food products with PFAS (and other chemicals) on the grounds that they "may render the product injurious to health."¹ 

The good news for the food and beverage industry is that it will take time to replace PFAS with substances that are recognized as safe. It will also take time for comprehensive regulations and enforcement to be established. The bad news is that the window is closing. 

State and Federal Regulation of PFAS for the Food Industry 

As referenced in our previous article, in many instances, states are considerably outpacing the federal government when it comes to enacting new rules governing PFAS, and this is true for regulations related to the food industry. For example, Colorado, Maine, and Minnesota have enacted phase-outs of PFAS in cookware, and 12 states—California, Colorado, Connecticut, Hawaii, Maine, Maryland, Minnesota, New York, Oregon, Rhode Island, Vermont, and Washington—have enacted phase-outs of PFAS in food packaging. 

Comparing Enacted State Laws and Regulations 

States have employed various definitions for "food packaging," "food package," "foodware," and similar terms in newly enacted and proposed laws governing PFAS. While ostensibly similar, these slight differences in language among state regulations can have a significant impact on the breadth of products affected by new PFAS regulation. 

Several states have limited their regulatory efforts to plant-based packaging, which uses materials derived from renewable resources such as corn, sugarcane, potatoes, and other plant-based sources rather than fossil-fuel-based plastics. These regulations seek to address the perceived hypocrisy of "eco-friendly" packaging that still contains harmful PFAS. For example, California enacted a law² that prevents the distribution and sale of any plant-based food packaging that contains either intentionally added PFAS that has a functional and/or technical effect in a product, or more than 100 ppm of PFAS substances as measured in total organic fluorine. Similarly, Colorado,³ New York,⁴ Maryland,⁵ and Hawaii⁶ have banned the manufacture, distribution, and/or sale of food packaging derived from plant fibers that contains intentionally added PFAS substances.  

Conversely, several states have broadened their regulatory reach to include all food packaging, defined by its function rather than its components. For example, Connecticut⁷ regulates all food packaging to which PFAS substances are intentionally introduced in any amount during manufacturing or distribution and forbids the sale or use of such products for promotional purposes. And in Minnesota,⁸ Oregon,⁹ Rhode Island,¹⁰ and Vermont,¹¹ it is unlawful for a person to manufacture, sell, distribute, or offer for use a food package that contains intentionally added PFAS in any amount. 

“With respect to food packaging, FDA's approach generally remains the pursuit of voluntary market phase-out.”

Proposed State Laws Regarding PFAS in Food Packaging 

State action is ongoing, and many other states are currently seeking to adopt new rules for PFAS in food packaging or expand the scope of existing laws. For example, Massachusetts, Michigan, New Hampshire, and Tennessee have proposed legislation to ban all food packaging with intentionally added PFAS.¹² Illinois and New Jersey have proposed restrictions on intentionally added PFAS in plant-based food packaging,¹³ although New Jersey exempts products that contain "a technically unavoidable trace quantity of PFAS, which stems from impurities of natural or synthetic ingredients or the manufacturing process, storage, or migration from packaging of the product." Similarly, Vermont has also proposed a ban on PFAS in all food packaging, but with a qualification that the Vermont Department of Health shall determine if the use of PFAS in a product is currently an unavoidable use.¹⁴ 

Hawaii¹⁵ recently proposed a law with no strict definition of food packaging, that nonetheless expands its existing ban of only certain types of food packaging (specifically wraps and liners, plates, food boats, and pizza boxes) to include all kinds of food packaging (including food serviceware). New York¹⁶ similarly proposed to broaden its existing law to: "No person or entity shall sell or distribute any packaging material containing PFAS substances." 

Lastly, North Carolina and Pennsylvania have proposed stricter regulation of all food packaging containing a PFAS substances in any amount, intentionally added or not.¹⁷ 

Federal Regulation of PFAS in the Food Industry 

Up to this point, most federal law addressing PFAS with respect to the food industry has come in the form of regulations passed by the U.S. Environmental Protection Agency (EPA) and FDA, and the authors' prior article touched on a number of different activities undertaken by FDA. It is important to remember that FDA authorized the use of certain fluorinated polyethylene for use in contact with food and that alternative processes for fluorination are not compliant. Moreover, FDA, citing EPA data, has stated that, "PFAS can form and migrate from some [HDPE] containers."¹⁸ 

With respect to food packaging, FDA's approach generally remains the pursuit of voluntary market phase-out. On February 28, 2024, FDA announced the completion of a voluntary market phase-out of grease-proofing substances containing PFAS used on food packaging paper and paperboard, eliminating the primary source of dietary exposure to PFAS from authorized food contact uses.¹⁹ In addition, FDA has confirmed that other manufacturers have voluntarily stopped sales of other food contact substances (which contain different types of PFAS) intended for use as grease-proofing agents in the U.S. 

EPA Activity 

In addition to FDA, EPA has also taken a number of actions to regulate PFAS. Some of the more recent developments of note include an October 2023 rule under the Toxic Substances Control Act (TSCA) requiring manufacturers and importers to submit a one-time report of their use of PFAS from 2011 through 2022, followed by a six-month reporting period cycle.²⁰ Notably, the TSCA rule relies on a structural definition (and not specifically identified chemicals) to determine which PFAS are applicable, encompassing a broader range of chemicals.   

EPA also recently sought to circumvent ordinary TSCA rulemaking procedures and prohibit the use of PFAS in the fluorination process for plastic containers by declaring that a manufacturer's decades-old fluorination process was a "significant new use." On appeal, the Fifth Circuit held that EPA had exceeded its statutory authority and the process was not a "significant new use" of PFAS under TSCA.²¹ 

In another October 2023 rule under the Emergency Planning and Community Right to Know Act (EPCRA), EPA designated all PFAS included on the Toxic Chemical Release Inventory (TRI) as Chemicals of Special Concern under EPCRA, meaning that certain reporting exemptions (e.g., a de minimis exemption) no longer apply.²² There are now 196 PFAS subject to TRI reporting, and this number will only continue to grow.  

“The presence of PFAS in biosolids currently is regulated by a patchwork of state laws and regulations (or not regulated at all), pending the development of federal requirements.”

Regulation of PFAS in Biosolids 

PFAS often are found in biosolids (i.e., treated sewage) that are beneficially applied to agricultural land, which has caused concerns over impacts to produce and livestock. The presence of PFAS in biosolids currently is regulated by a patchwork of state laws and regulations (or not regulated at all), pending the development of federal requirements. EPA is conducting a biosolids risk assessment for two PFAS compounds, perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS).²³ Once complete (anticipated in December 2024), EPA intends to publish a new biosolids rule for PFAS. 

EPA's eventual rule will be a risk-based approach similar to an interim strategy implemented by Michigan's Department of Environment, Great Lakes, and Energy (EGLE), which prohibits the application of biosolids with certain PFOS or PFOA concentrations unless EGLE approves an alternative risk mitigation strategy.²⁴ Conversely, other states have rejected a risk-based approach. For example, in April 2022, Maine became the first and only state to enact legislation that strictly bans land application of biosolids containing PFAS.²⁴ 

Effluent Guidelines for Concentrated Animal Feeding Operations 

In January 2023, EPA published its Effluent Guidelines Program Plan 15.²⁵ Effluent limitations guidelines and pretreatment standards (ELGs) are technology-based standards to address industrial wastewater discharges. Among other announcements, and specifically with respect to the food industry, Plan 15 declared that EPA was initiating or further expanding PFAS-related studies concerning concentrated animal feeding operations (CAFO), and these studies would likely lead to revised ELGs governing CAFO operations.  

Hazardous Designations and Cleanup Standards 

In April 2024, EPA designated PFOA and PFOS as hazardous substances under the federal Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, also known as the "Superfund" law).²⁶ This designation requires liable parties to investigate and remediate releases of PFOS and PFOA, and imposes certain reporting obligations for releases of PFOA and PFOS.  

Notably for the food industry, EPA also issued a new "PFAS Enforcement Discretion and Settlement Policy Under CERCLA" indicating, among other things, that EPA does not "intend to pursue entities where equitable factors do not support seeking response actions or costs under CERCLA."²⁷ Farms where biosolids are applied to the land are included among these entities. For other entities, including companies operating food manufacturing facilities and other industrial operations, the rule could result in the designation of new CERCLA cleanup sites or remedy modification (or even potentially the "reopening") of existing CERCLA sites. 

EPA has also asked for public input regarding the proposed CERCLA designation of groups of PFAS that share similar characteristics.²⁸ There are thousands of PFAS, and EPA appears to be eyeing a shift in its regulatory approach from utilizing rulemaking for specific individual PFAS to a broader, group-based approach. Therefore, future CERCLA PFAS designations could have much more significant and far-reaching impacts than the current CERCLA designation of PFOA and PFOS.²⁸ 

Additionally, in February 2024, EPA proposed two more PFAS-related rules under the Resource Conservation and Recovery Act (RCRA) intended to set the foundation for EPA regulating a group of nine PFAS as hazardous wastes.^29,30 In April 2024, EPA adopted drinking water standards for a group of six different PFAS. While these standards officially govern only drinking water, they also effectively establish new groundwater cleanup standards in some states and, with respect to PFOA and PFOS, under CERCLA.  

“Each step in the 'rings of defense' must be used consciously and with proper consideration, as it may be obvious what caused the noncompliance, and its resolution may be straightforward, simple, and not costly.”

Conclusion

PFAS have been essential components in a tremendous number of processes and products over many years. Finding adequate substitutes to replicate the properties and functions of PFAS will take time. Furthermore, an emphasis will be placed on potential health consequences of PFAS and their proposed substitutes that will shape what consumers demand, what regulators require, and what industry can deliver.     

While PFAS has been on the FDA and EPA radar for more than 20 years, with the expansive growth of state and federal legislation, regulation, and litigation, coupled with evolving data on health issues, the window on PFAS is closing "PFASter." 

References

1. U.S. Food and Drug Administration (FDA). "Import Alert 99-48: Detention without Physical Examination of Foods Due to Chemical Contamination." March 19, 2024. https://www.accessdata.fda.gov/cms_ia/importalert_1180.html.  
2. California Health and Safety Code § 109000. "Chapter 15. Chemicals of Concern in Food Packaging and Cookware, Article 1. Plant-Based Food Packaging Containing PFAS." January 1, 2022. https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=109000.&lawCode=HSC.  
3. Colorado General Assembly. "House Bill 22-1345: Concerning Measures to Increase Protections From Perfluoroalkyl and Polyfluoroalkyl Chemicals." Regular Session 2022. https://leg.colorado.gov/sites/default/files/2022a_1345_signed.pdf.  
4. New York State Senate. "Senate Bill S8817: Relates to the use of perfluoroalkyl and polyfluoroalkyl substances in food packaging." Regular Session 2019–2020. https://www.nysenate.gov/legislation/bills/2019/S8817.  
5. Maryland General Assembly. Annotated Code of Maryland Environment § 9-1901. 
6.  Hawaii Revised Statue § 321-602. 
7.  Connecticut General Statute § 22a-255i. 
8.  Minnesota Statue § 325F.075. 
9.  Oregon State Legislature. "Senate Bill 543: Relating to prohibitions for certain products." Regular Session 2023. https://olis.oregonlegislature.gov/liz/2023R1/Measures/Overview/SB543.  
10.  Rhode Island "House Bill 7438, H 5861 Substitute A: Toxic Packaging Reduction Act." Regular Session 2022. 
11.  Vermont Statutes, Title 18 § 1671. 
12. Massachusetts [S 143, HB 2197, H 767] (all food packaging; no intentionally added PFAS); Michigan [SB 327] (all food packaging; "A person shall not manufacture, sell, or distribute food packaging that has PFAS intentionally added in any amount greater than an incidental presence"); New Hampshire [HB1630, HB242] (all food packaging; "No person or entity may sell or distribute any packaging containing PFAS substances"); Tennessee [SB 0573, SB 1786] (all food packaging; "A person shall not sell or distribute any packaging designed to include PFAS substances"). 
13. Illinois Senate Bill 0088: "EPA-PFAS Consumer Protection"; New Jersey Assembly Bill A1421: "Protecting Against Forever Chemicals Act." 
14. Vermont House Bill 152: "An act relating to regulating products containing certain chemicals and chemical classes." 
15. Hawaii House Bill 1896: "Relating to Environmental Protection." 
16. New York Assembly Bill 05322: "Enacts the 'packaging reduction and recycling infrastructure act' to require companies selling, offering for sale, or distributing packaging materials and products to register with a packaging reduction organization to develop a packaging reduction and recycling plan." 
17. North Carolina House Bill 279: "Break Free from Plastics & Forever Chemicals"; Pennsylvania House Bill 1122: "An Act amending Title 3 (Agriculture) of the Pennsylvania Consolidated Statutes, in food protection, further providing for penalties and prohibiting certain food packaging." 
18. Keefe, Dennis M., and FDA. "Letter to Manufacturers, Distributors, and Users of Fluorinated Polyethylene Food Contact Articles." August 5, 2021. https://www.fda.gov/media/151326/download.  
19. FDA. "FDA Announces PFAS Used in Grease-Proofing Agents for Food Packaging No Longer Being Sold in the U.S." Feb. 28, 2024. https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-pfas-used-grease-proofing-agents-food-packaging-no-longer-being-sold-us.  
20. Federal Register 88 FR 70516. "Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances." Environmental Protection Agency (EPA). October 11, 2023. https://www.federalregister.gov/documents/2023/10/11/2023-22094/toxic-substances-control-act-reporting-and-recordkeeping-requirements-for-perfluoroalkyl-and.  
21. Inhance Technologies LLC v. United States Environmental Protection Agency. 96 F.4th 888 (5th Circuit 2024). On May 13, 2024, EPA voluntarily dismissed an underlying lawsuit. 
22. Federal Register 88 FR 74360. "Changes to Reporting Requirements for Per- and Polyfluoroalkyl Substances and to Supplier Notifications for Chemicals of Special Concern; Community Right-to-Know Toxic Chemical Release Reporting." EPA. October 31, 2023. https://www.federalregister.gov/documents/2023/10/31/2023-23413/changes-to-reporting-requirements-for-per--and-polyfluoroalkyl-substances-and-to-supplier.  
23. EPA. "Risk Assessment of Pollutants in Biosolids." Last updated June 4, 2024. https://www.epa.gov/biosolids/risk-assessment-pollutants-biosolids.   
24. Michigan Department of Environment, Great Lakes, and Energy (EGLE). "Interim Strategy—Land Application of Biosolids Containing PFAS (2024)." https://www.michigan.gov/egle/about/organization/water-resources/biosolids/pfas-related.; Maine Legislature. HP 1417, LD 1911: "An Act To Prevent the Further Contamination of the Soils and Waters of the State with So-called Forever Chemicals." April 20, 2022. https://www.mainelegislature.org/legis/bills/getPDF.asp?paper=HP1417&item=8&snum=130.  
25. Federal Register 88 FR 6258. "Effluent Guidelines Program Plan 15." EPA. Jan. 31, 2023. https://www.federalregister.gov/documents/2023/01/31/2023-01413/effluent-guidelines-program-plan-15.  
26. Federal Register 89 FR 39124. "Designation of Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS) as CERCLA Hazardous Substances." EPA. May 8, 2024. https://www.federalregister.gov/documents/2024/05/08/2024-08547/designation-of-perfluorooctanoic-acid-pfoa-and-perfluorooctanesulfonic-acid-pfos-as-cercla-hazardous.  
27. Uhlmann, David M. and EPA. "PFAS Enforcement Discretion and Settlement Policy Under CERCLA." April 19, 2024. https://www.epa.gov/system/files/documents/2024-04/pfas-enforcement-discretion-settlement-policy-cercla.pdf.  
28. Federal Register 88 FR 22399. "Addressing PFAS in the Environment." EPA. April 13, 2023. https://www.federalregister.gov/documents/2023/04/13/2023-07535/addressing-pfas-in-the-environment.  
29. Federal Register 89 FR 8606. "Listing of Specific PFAS as Hazardous Constituents." EPA. February 8, 2024. https://www.federalregister.gov/documents/2024/02/08/2024-02324/listing-of-specific-pfas-as-hazardous-constituents.  
30. Federal Register 89 FR 8598. "Definition of Hazardous Waste Applicable to Corrective Action for Releases From Solid Waste Management Units." EPA. Feb. 8, 2024. https://www.federalregister.gov/documents/2024/02/08/2024-02328/definition-of-hazardous-waste-applicable-to-corrective-action-for-releases-from-solid-waste.