Navigating U.S. Federal and State Regulations of PFAS in Applications Involving Food

As the focus on per- and polyfluoroalkyl substances (PFAS) intensifies, multiple states and some U.S. federal agencies are implementing or considering implementation of restrictions or bans on the use of these products in food contact articles. The problem for manufacturers is these restrictions and bans are not consistent and, therefore, determining compliance presents numerous challenges.

This article will focus on the restrictions and bans in the U.S. that impact the use of PFAS in food packaging, and includes a discussion on the challenges manufacturers face due to inconsistent science and policy decisions related to the use of these chemicals in food packaging. It is important to note that food-contact materials are only one source of PFAS. They have also been used in fire extinguishing foam; in stain and water-repellent materials used on clothing, upholstery, and other fabrics and textiles; and in personal care products, such as certain shampoos, dental floss, and cosmetics. Due to this widespread use, PFAS have been found in soil and water at or near waste sites and manufacturing or chemical production facilities that use or produce PFAS.

PFAS Lack Universal Definition

PFAS are a diverse group of synthetic chemicals with strong carbon-fluorine bonds that are chemically inert and resistant to high temperatures. They are often referred to as “forever chemicals” due to their biopersistence. Importantly, there is not a universally agreed-upon definition for PFAS. For example, the Environmental Protection Agency (EPA) defines PFAS as “chemicals with at least two adjacent carbon atoms, where one carbon is fully fluorinated and the other is at least partially fluorinated.”[1] Alternatively, the Organization for Economic Co-operation and Development (OECD) defines PFAS as consisting of “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any H/Cl/Br/I atom attached to it); i.e., with a few noted exceptions, any chemical with at least a perfluorinated methyl group (-CF3) or a perfluorinated methylene group (-CF2-) is a PFAS.”[2]

Some groups argue that EPA’s definition of PFAS is too narrow. One of these groups, the Public Employees for Environmental Responsibility (PEER), filed a lawsuit against EPA in the U.S. District Court for the District of Columbia claiming that the agency is “withholding documents explaining why [EPA] has adopted an exceedingly limited definition of per- and polyfluoroalkyl substances (PFAS).”[3]

In addition, a bipartisan bill (H.R. 5987)[4] pending in the House of Representatives would amend the Toxic Substances Control Act (TSCA) by expanding the definition of PFAS to include substances that contain at least one fully fluorinated carbon atom. No action has been taken on this bill since it was referred to the Subcommittee on Environmental and Climate Change on November 17, 2021. However, several recently enacted state laws use exactly this definition.

Despite the varying definitions, not all PFAS are the same and, therefore, many argue that they should not be regulated the same way. Different PFAS are treated differently by EPA, the U.S. Food and Drug Administration (FDA), and certain other regulatory bodies. FDA points out, “[w]ithin PFAS there is a wide range of chemical structures with very different chemical and physical properties.”[5]

EPA explains that, “exposure to some PFAS in the environment may be linked to harmful health effects in humans and animals” but adds, “[t]here are thousands of PFAS chemicals…mak[ing] it challenging to study and assess the potential human health and environmental risks.”[6] The agency further explains that each of the PFAS chemicals has varying toxicity. “Robust information about PFAS is needed to better understand the risks they pose and to be able to take effective actions to protect human health and the environment,” states EPA on its website.[7]

Recently, a panel of scientists with expertise on PFAS technology agreed to the following:

• All PFAS should not be grouped together for risk assessment purposes
• “Persistence” is not sufficient for grouping PFAS for the purposes of assessing human health risk
• It is inappropriate to assume equal toxicity/potency for PFAS without confirmatory information[8]

Federal Agencies Take Action on PFAS

Based on new scientific studies indicating the potential for negative health effects with perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) (so-called long-chain PFAS), EPA issued interim updated lifetime drinking water health advisories (HAs) of 0.004 part per trillion (ppt) and 0.02 ppt, respectively, on June 15, 2022. The agency stated that lifetime exposure to PFOA and PFOS can compromise the immune and cardiovascular systems and are linked to decreased birth weights[9] (the previous levels were 70 ppt for both chemicals[10]).

At the same time EPA issued HAs for PFOA and PFOS, the agency also issued final health advisories for perfluorobutanesulfonic acid (2,000 ppt) and what are known as GenX chemicals (10 ppt), which to some extent may be used as replacements for PFOS and PFOA, respectively.

On the food side, since the 1960s FDA has authorized the use of certain PFAS for specific food-contact applications. PFAS authorized for use in contact with food generally fall into four applications categories:

• Non-stick cookware
• Gaskets, O-Rings, and other parts used in food processing equipment
• Processing aids for the production of food contact polymers to reduce build-up on manufacturing equipment
• Paper/paperboard food packaging for use as grease-proofing agents[11]

In the early 2000s, when new scientific studies raised safety questions with long-chain C₈ PFAS compounds (i.e., PFOA and PFOS), FDA worked with several manufacturers to voluntarily stop their sales of grease-proofing agents containing C₈ compounds for use in food contact applications in the U.S. market. In 2016, FDA revoked the regulations authorizing the remaining uses of these long-chain PFAS in food packaging.[12] Interestingly, the basis for the revocation was U.S. industry’s “abandonment” of the technology—i.e., the cessation of the compounds’ uses in the U.S.—rather than a negative safety evaluation.

When additional studies became available to FDA indicating biopersistence issues with certain short-chain PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH) used for grease-proofing in paper and paperboard for food packaging, FDA announced a voluntary phase-out by the manufacturers of these products.[13] Three manufacturers voluntarily agreed in July 2020 to a three-year phase-out of sales of these compounds for use in food contact applications in the United States, beginning in January 2021. After the three-year period, it is anticipated that it may take up to 18 months to exhaust existing stocks of products containing these food contact substances. Another manufacturer had already informed FDA in 2019 that it had stopped sales of its products containing 6:2 FTOH in the U.S. market.

Finally, FDA issued a request for information on the use of fluorinated high-density polyethylene (HDPE) containers for food-contact applications.[14] These containers are cleared by FDA in 21 C.F.R. § 177.1615. Specific information that FDA requested includes current food-contact uses, manufacturing conditions, analyses of the migrating substances from the containers, estimated consumer exposure, and safety of fluorinated polyethylene. Comments are due (requested) by October 18, 2022.

FDA Tests for PFAS in Food

To better understand the potential dietary exposure to PFAS from food for people in the United States, FDA began testing foods collected as part of its Total Diet Study (TDS)[15] for certain PFAS in 2019. The results did not show a widespread presence of PFAS at detectable levels in the food products sampled, ranging from a low of one finding in 94 samples to three in 92 samples.[16] In a February 2022 announcement on the results of the sample testing, FDA stated, “Based on the best available current science, the FDA has no scientific evidence that the levels of PFAS found in the TDS samples tested to date indicate a need to avoid any particular food.”[17]

More recently, FDA announced in July of this year that it had tested 81 samples of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia imported from China, from which it determined that estimated exposure to PFOA from samples of canned clams were likely a potential health concern. FDA explained, “For the canned clam samples with the two highest levels of PFOA, there would be a potential health concern for consumers who eat more than approximately 10 ounces (oz) of these clams per month, except for young children, who should limit consumption to 2 oz per month.”[18]

The two distributors of the samples with the highest levels of PFOA issued voluntary recalls of the product. FDA said that it is working with distributors of canned clam product to better understand potential sources of contamination.

FDA looks at a number of factors to determine possible human health concerns from substances, such as whether there is an established action level or tolerance, how much of the specific food people typically eat, the level of the contaminant detected in that food, and the toxicity of the specific contaminant(s).

PFAS Bans and Restrictions Imposed by States

A number of states have enacted PFAS bans in food packaging. All of these states define PFAS as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom. Washington and Maine were the first states to lead the charge on banning PFAS in food packaging. Notably, both required alternative assessments by the state before specific uses could be banned. Based on assessments completed so far, Washington has scheduled PFAS bans in the following products, all food service items, scheduled for the noted dates: as of February 2023, wraps and liners, plates, food boats, and pizza boxes; and as of May 2024, bags and sleeves (made from flexible material), bowls, flat service ware (such as trays and plates), open-top containers, and closed containers.

Below is a list of states that have subsequently enacted bans, none of which require an alternative assessment.

• California (January 1, 2023): Bans the sale of “plant fiber-based food packaging” that contains PFAS that has been intentionally added to have a functional or technical effect in the product or is present in the product at or above 100 ppm.
• Colorado (January 1, 2024): Bans any paper-based food packaging with intentionally added PFAS.
• Connecticut (December 31, 2023): Bans food packaging to which PFAS have been intentionally introduced during manufacturing or distribution, and prohibits substituting any component that creates a hazard as great as or greater than PFAS.
• Maryland (January 1, 2024): Bans a manufacturer or distributor from manufacturing or knowingly selling, offering for sale, or distributing for sale or use in the state a food package or food packaging component designed and intended for direct food contact to which PFAS chemicals were intentionally added.
• Minnesota (January 1, 2024): Bans food packaging containing intentionally added PFAS.
• New York (December 31, 2022): Bans the distribution and sale of food packaging containing PFAS as intentionally added chemicals.
• Rhode Island (January 1, 2024): Bans food packaging to which PFAS have been intentionally introduced during manufacturing or distribution.
• Vermont (July 1, 2023): Bans the sale, distribution for sale, and distribution for use of any food package to which PFAS have been intentionally added or are present in any amount. 

The Rhode Island law also specifies, "The use of a regulated chemical as a processing agent, mold release agent, or intermediate is considered intentional introduction…where the regulated chemical is detected in the final package or packaging component." However, FDA maintains that, “the amount of PFAS used as processing aids in the manufacture of other food contact polymers is so small that a negligible amount of PFAS is capable of migrating to food from this use.”[19]

Numerous other states—including Alaska, Arizona, California, Colorado, New Jersey, Pennsylvania, and Virginia—are considering PFAS bans.

Congress Introduces Bill to Ban PFAS in Food Packaging

On June 14, 2022, the Keep Food Containers Safe from PFAS Act[20] was passed as an amendment to the FDA Safety and Landmark Advancements (FDASLA) Act of 2022 (S.4348)[21] on a bipartisan vote (13-9) in the Senate Committee on Health, Education, Labor, and Pensions. The amendment would ban the use of PFAS in food packaging effective January 1, 2024.*

Takeaway

Thousands of PFAS chemicals can be found for a wide variety of uses in different consumer, commercial, and industrial products. Not all of these substances are of the same chemistry or necessarily similar toxicology. Some may have applications that are intended primarily for consumer convenience or enhancement of certain product qualities, while others may be critical to the production of goods or the delivery of services that are crucial to maintaining health and safety. Thus, it is challenging, to say the least, to assess the potential human health and environmental risks of these various PFAS, particularly in regard to the risks that may be presented against the benefits that are provided.[22]

However, if the states keep moving in the direction in which several have started, then these assessments may be stunted. Precipitous decisions at this level may result in the premature retirement of many of these products and product applications without adequate consideration of the existence of substitutes or the health and safety benefits that may be lost.

*After this article went to press, on September 30, 2022, President Joe Biden signed a continuing resolution funding bill, H.R.6733, which included reauthorizing FDA user fees. The ban on the use of PFAS in food packaging was not included in that bill.

This article is reprinted with the permission of Food Safety Magazine. It first appeared in the October/November 2022 issue.

[1] U.S. Environmental Protection Agency (EPA). "National PFAS Testing Strategy: Identification of Candidate Per- and Poly-fluoroalkyl Substances (PFAS) for Testing." October 2021. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/national-pfas-testing-strategy.

[2] Organization for Economic Cooperation and Development. "Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances: Recommendations and Practical Guidance." Series on Risk Management No. 61. July 9, 2021. https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)25&docLanguage=En.

[3] “EPA Sued Over Failure to Explain Its Narrow PFAS Definition.” Public Employees for Environmental Responsibility. April 28, 2022. https://peer.org/epa-sued-over-failure-to-explain-its-narrow-pfas-definition/.

[4] Congress.gov. "H.R.5987—117th Congress (2021–2022): PFAS Definition Improvement Act." November 17, 2021. https://www.congress.gov/bill/117th-congress/house-bill/5987?r=52&s=1.

[5] U.S. Food and Drug Administration (FDA). "Questions and Answers on PFAS in Food." July 6, 2022. https://www.fda.gov/food/chemical-contaminants-food/questions-and-answers-pfas-food.

[6] EPA. "PFAS Explained." April 28, 2022. https://www.epa.gov/pfas/pfas-explained.

[7] EPA. "Increasing Our Understanding of the Health Risks from PFAS and How to Address Them." November 3, 2021. https://www.epa.gov/pfas/increasing-our-understanding-health-risks-pfas-and-how-address-them.

[8] Anderson, J.K., et al. "Grouping of PFAS for human health risk assessment: Findings from an independent panel of experts." Regulatory Toxicology and Pharmacology. July 8, 2022.

[9] EPA. "Drinking Water Health Advisories for PFOA and PFOS." July 12, 2022. https://www.epa.gov/sdwa/drinking-water-health-advisories-pfoa-and-pfos.

[10] EPA, PFOA & PFOS Drinking Water Health Advisories. 2016. https://www.epa.gov/sites/default/files/2016-06/documents/drinkingwaterhealthadvisories_pfoa_pfos_updated_5.31.16.pdf. 

[11] 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.

[12] 81 Federal Register 5, January 4, 2016 and 81 Federal Register 83672, November 22, 2016.

[13] FDA. "FDA Announces the Voluntary Phase-Out by Industry of Certain PFAS Used in Food Packaging." July 31, 2020. https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-voluntary-phase-out-industry-certain-pfas-used-food-packaging.

[14] 87 Federal Register 43274, July 20, 2022.

[15] FDA. FDA Total Diet Study (TDS). July 15, 2022. https://www.fda.gov/food/science-research-food/fda-total-diet-study-tds.

[16] FDA. "Analytical Results of Testing Food for PFAS from Environmental Contamination." July 6, 2022. https://www.fda.gov/food/chemical-contaminants-food/analytical-results-testing-food-pfas-environmental-contamination.

[17] FDA. "Update on FDA's Continuing Efforts to Understand and Reduce Exposure to PFAS from Foods." February 24, 2022. https://www.fda.gov/food/cfsan-constituent-updates/update-fdas-continuing-efforts-understand-and-reduce-exposure-pfas-foods.

[18] FDA. "FDA Shares Results on PFAS Testing in Seafood." July 15, 2022. https://www.fda.gov/food/cfsan-constituent-updates/fda-shares-results-pfas-testing-seafood.

[19] 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.

[20] Congress.gov. "Text—S.3169—117th Congress (2021–2022): Keep Food Containers Safe from PFAS Act of 2021." November 4, 2021. https://www.congress.gov/bill/117th-congress/senate-bill/3169/text.

[21] Congress.gov. "S.4348—117th Congress (2021–2022): FDASLA Act of 2022." July 13, 2022. https://www.congress.gov/bill/117th-congress/senate-bill/4348.

[22] U.S. Environmental Protection Agency (EPA). "National PFAS Testing Strategy: Identification of Candidate Per- and Poly-fluoroalkyl Substances (PFAS) for Testing." October 2021. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/national-pfas-testing-strategy.