FDA Ramps Up Actions On PFAS

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The U.S. Food and Drug Administration (FDA) has increased regulatory activity with regard to per- and polyfluoroalkyl substances (PFAS).
United States Food, Drugs, Healthcare, Life Sciences
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Highlights

  • The U.S. Food and Drug Administration (FDA) has increased regulatory activity with regard to per- and polyfluoroalkyl substances (PFAS).
  • The FDA's actions follow completion of a voluntary phaseout of one form of PFAS that acts as a grease-proofing agent.
  • This Holland & Knight alert reviews actions taken recently by the FDA regarding food packaging, food and PFAS.

With the completion of the voluntary phaseout of one form of short-chain per- and polyfluoroalkyl substances (PFAS) as a grease-proofing agent, the U.S. Food and Drug Administration (FDA) has rejected the view that short-chain PFAS are uniformly less hazardous than long-chain PFAS and may be opening the door to wider regulation of the short-chain compounds. The FDA has been slow to adopt the view of several states that all PFAS, both long-chain and short-chain, require phaseout, but that trend seems to be changing.

PFAS are synthetic chemical compounds that number in the thousands. Each such compound is formed by linking carbon and fluorine atoms in chains of varying lengths depending on the particular PFAS. The length of the fluorinated carbon chain is a key trait that distinguishes PFAS. Chains of eight or more carbon-fluorine bonds are called "long-chain PFAS" or "C8." Chains of seven or fewer carbon-fluorine bonds are called "short-chain PFAS." Within both long- and short-chain PFAS, further distinctions are sometimes made by adding another chemical group – usually a carboxylic acid, sulfonic acid or alcohol. However long the chain may be, and regardless of whether another chemical group is added, the carbon-fluorine bond in PFAS is one of the strongest chemical bonds known. For this reason, PFAS do not readily degrade in the environment. Because they cannot be metabolized, PFAS may accumulate in the body over time – in short, they may "biopersist."

FDA Announces Completion of Voluntary Food Packaging 6:2 FTOH PFAS Phaseout

On Feb. 28, 2024, the FDA announced that three manufacturers of grease-proofing agents containing a short-chain PFAS called "6:2 fluorotelomer alcohol" (6:2 FTOH) had, after three years, met their voluntary commitment to the FDA, initially made in July 2020, to phase out the sale of these PFAS for use as grease-proofing agents in paper packaging for food. Grease-proofing agents are used on paper and paperboard packaging to prevent the leaking of grease and oil and to increase water resistance.

Also in summer 2020, the FDA sought voluntary commitments to phase out the use of short-chain PFAS containing 6:2 FTOH as grease-proofing agents in food packaging. The FDA sought these commitments after publishing in spring 2020 its scientific review and analysis of recently received data. This data showed that if dietary exposure resulted from the migration into food packaging on which they had been used as grease-proofing agents, short-chain PFAS containing 6:2 FTOH had the potential to persist in humans.

The three-year phaseout to which the three manufacturers voluntarily committed in July 2020 began in January 2021. Completion of the voluntary phaseout ends sales in the U.S. market of compounds that contain 6:2 FTOH for use as grease-proofing substances in food packaging. Completing the phaseout, however, will not immediately end distribution and use of this food packaging paper, since the FDA anticipates that it may take until June 2025 to exhaust existing stocks of this paper.

The voluntary phaseout the FDA announced in February 2024 is not the first the FDA has obtained involving PFAS. In November 2011, almost 10 years before the voluntary phaseout of the sale of grease-proofing paper food packaging containing short-chain 6:2 FTOH PFAS began in January 2021, the FDA obtained from three manufacturers of C8 PFAS voluntary commitments to end the use of long-chain PFAS in food contact applications in the U.S. Questions about the safety of the food applications of certain C8 PFAS in 2011 – specifically, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS) – had arisen in the early 2000s. In 2016, the FDA revoked regulations authorizing use of these long-chain PFAS in food packaging. 81 Fed. Reg. 5 (Jan. 4, 2016) and 81 Fed. Reg. 83762 (Nov. 22, 2016). Long-chain PFAS, the FDA then stated, "demonstrate biopersistence in chronic feeding studies, while those with extended perfluorinated alkyl chains less than eight carbons in length do not." 81 Fed. Reg. at 7. As a result, as of November 2016, long-chain PFAS ceased to be used in food-contact applications sold in the U.S.

The FDA continues to authorize the use of certain PFAS as aids in the manufacturing of food contact polymers and in food processing equipment. Nevertheless, the FDA acknowledges that PFAS have the potential to cause harm and includes the substances on its list of select chemicals under ongoing review. With the voluntary phaseout of short-chain PFAS containing 6:2 FTOH completed, the question of whether these short-chain PFAS containing 6:2 FTOH will be the only short-chain PFAS to be phased out for food contact use remains.

The distinction FDA noted between long-chain PFAS and short-chain PFAS when use of C8 PFAS in food-contact applications ceased in November 2016 – that, unlike long-chain PFAS, "chains less than eight carbons in length do not" demonstrate biopersistence – may not now be as supportable as it appeared to be in 2011. Though the FDA notes that its authorization of certain short-chain PFAS as grease-proofing agents was based on "data available at the time of authorization that supported the safety of these" PFAS, the FDA readily acknowledges that by spring 2020, safety concerns for this use had emerged. By July 31, 2020, for short-chain PFAS having 6:2 FTOH, it was "the potential that 6:2 FTOH may also persist" – and not any demonstration of biopersistence – that the FDA deemed sufficient to support the voluntary phaseout of short-chain PFAS having 6:2 FTOH as a grease-proofing agent in food packaging.

Short-chain PFAS containing 6:2 FTOH, however, are not the only PFAS that have been found in food contact materials. On March 19, 2024, shortly after the FDA announced completion of the voluntary phaseout of the sale of short-chain PFAS having 6:2 FTOH, a study published by the American Chemical Society Systematically mapped evidence of PFAS detected in extracts or migrates of food contact materials. This study found that 68 PFAS have been identified in paper, plastic and coated metal that come into contact with food. The study grouped these 68 PFAS by chemical structure. The vast majority of these 68 PFAS – 87 percent – belong to the perfluorocarboxylic acids and fluorotelomer-based compounds. Data on the hazards of the 68 PFAS identified in food contact material was found for slightly more than half – 39 – of these 68 PFAS. Despite the phaseout in the U.S., data the authors examined found that long-chain PFAS were still regularly detected in food contact materials. How the FDA will respond to this study is not yet clear.

The American Chemical Society's March 19, 2024, study suggested that the regulation of PFAS as a group be considered. As of March 21, 2024, 12 states – Washington, Oregon, California, Colorado, Minnesota, Maryland, Connecticut, Rhode Island, Maine, Vermont, New York and Hawaii – have followed this approach when they enacted statutes addressing PFAS in food containers and packaging materials. These laws do not all target the same sort of food packaging. Some states – California, Colorado, Hawaii, New York, Maryland and Washington – address only plant-based food packaging. Others – Maine, Minnesota, Oregon, Rhode Island, Vermont and Connecticut – regulate any kind of food packaging. None of these statutes addresses metallic containers. Furthermore, although these laws all require determination of whether any PFAS has been intentionally added or introduced to food packaging, they do not agree in how to make this determination. Two states – California and Washington – do not define "intentionally added" despite using the term. The definitions of such terms as "intentionally added" and "intentionally introduced" in the remaining statutes vary and could lead to different outcomes.

Despite these differences, these statutes share a common feature that contrasts with the FDA's approach to PFAS in food packaging. The state laws do not distinguish between long-chain PFAS and short-chain PFAS, and none of them says or implies that the latter may be safer than the former. In all of these statutes, substances having "at least one fully fluorinated carbon atom" are defined as PFAS and can be subject to regulation. Regardless of the length of the chain of the particular PFAS or the concentration or absence of 6:2 FTOH or any other chemical, the presence of one fully fluorinated carbon atom in the regulated food packaging suffices to prohibit that packaging's sale or distribution if the PFAS are intentionally added or introduced to the packaging. Given the sweep of the enacted statutes and the possibility that other states may follow them soon, these statutes may ultimately have a greater effect on reducing PFAS in food packaging than the completion of the voluntary phaseout the FDA announced.

FDA's Import Alert 99-48

On March 20, 2024, the FDA announced the issuance of Import Alert 99-48, a document published on March 19, 2024, and titled "Detention Without Physical Examination of Foods Due to Chemical Contamination." This alert informs FDA field personnel that following a 2022 targeted survey for PFAS analytes in 81 samples taken at retail outlets of various kinds of seafood, the FDA has determined that "the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from the samples of canned clams from China, is likely a health concern." FDA field personnel may, under Section 801(a) of the Federal Food, Drug, and Cosmetic Act, as amended (FD&C Act), 21 U.S.C. § 381(a), refuse admission into the U.S. of articles that appear to violate the FD&C Act. As a result, the food products described in Import Alert 99-48 "may be subject to detention without physical examination (DWPE)."

The extent to which the FDA will itself test food offered for importation is unclear. The FDA states in Import Alert 99-48 that the agency "has not set levels for most chemical contaminants in food, including PFAS." But the FDA's lack of testing or a specified level of any PFAS will not prevent the agency from detaining proposed imports of food without physical examination.

The FDA refers importers to Chapter 9-8 of its Regulatory Procedures Manual (RPM) for guidance on how to remove their product from the scope of the alert. Section 9-8-2 of the RPM makes it clear that the FDA puts the burden on an importer to ensure that the product offered for importation is not contaminated and complies with the FD&C Act. The practical effect of Import Alert 99-48 will be to alert importers if seafood that may contain PFAS to the need to be able to demonstrate to the FDA that the conditions that contributed to the appearance of a violation have been overcome. RPM § 9-8-15.

FDA Amends Its Rule on Food Contact Notifications

In its Feb. 28, 2024, announcement concerning the voluntary phaseout of the sale of PFAS containing 6:2 FTOH for use as a grease-proofing agent in food packaging, the FDA noted that four manufacturers continue to hold 15 food contact notifications (FCNs) for 11 short-chain PFAS compounds that may contain 6:2 FTOH.1 FCNs are proprietary notices to the FDA from manufacturers of a food contact substance who seek FDA's premarket review and authorization for a new or expanded use of a food contact substance in a particular food application. 21 C.F.R. Part 170 Subpart D.

Before it sought a voluntary phaseout of the sale of PFAS containing 6:2 FTOH as a grease-proofing agent in food packaging paper, the FDA had regulatory authority to determine that a premarket notification originally given in an FCN is no longer effective. 21 C.F.R. § 170.105. In a final rule published on March 22, 2024, the FDA amended this regulations to revise the procedures for determining that an FCN is no longer effective. 89 Fed. Reg. 20306 (March 22, 2024). The amended rule was issued "to provide additional reasons that may be the basis for FDA to determine that an FCN is no longer effective and to provide the manufacturer or supplier of the substance an opportunity to provide input before" FDA made such a determination. 89 Fed. Reg. at 20307.

As of Feb. 28, 2024, the FDA had not withdrawn the 15 FCNs to which it referred in its same-day announcement of the completion of the voluntary phaseout, despite its acknowledgment when it mentioned these FCNs that, in spring 2020, its own findings raised safety questions about human exposure to short-chain PFAS containing 6:2 FTOH and migrating from grease-proofing paper containing this PFAS into food. The extent to which the FDA's amended rule for determining that an FCN is no longer effective may invalidate these or other FCNs remains to be seen.

Footnote

1. One of these four manufacturers in 2019 informed FDA that it had stopped sales in the U.S. of its food contact substances that might contain short-chain 6:2 FTOH PFAS. The remaining three manufacturers were the three who made in July 2020 the voluntary commitments which began in January 2021 and which FDA announced the completion of on Feb. 28, 2024.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

FDA Ramps Up Actions On PFAS

United States Food, Drugs, Healthcare, Life Sciences

Contributor

Holland & Knight is a global law firm with nearly 2,000 lawyers in offices throughout the world. Our attorneys provide representation in litigation, business, real estate, healthcare and governmental law. Interdisciplinary practice groups and industry-based teams provide clients with access to attorneys throughout the firm, regardless of location.
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