Schakowsky introduces bill to ban PFAS, other chemicals as food contact substances

Regulatory background

• The Federal Food, Drug, and Cosmetic Act (FFDCA) is a set of statutes that broadly authorizes the Food and Drug Administration (FDA) to regulate the production, sale, and distribution of food, drugs, medical devices, and cosmetics. Under the FFDCA, food contact substances are regulated as indirect food additives and must be authorized for use via either a food contact notification or a food additive regulation (alternatively, the substance can also be the subject of a Threshold of Regulation exemption). Substances added indirectly to human food affirmed as Generally Recognized as Safe or GRAS may also be used as food contact substances. FFDCA defines a “ food contact substance” as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.”
• The FDA established a food contact notification process via amendments to the FFDCA in the FDA Modernization Act of 1997 (FDAMA), where a manufacturer could submit a notification to the agency about an intent to use certain food contact substances, and could proceed with the marketing of the product if the FDA did not object within 120 days of the notification. The FDA maintains a database of effective food contact notifications, containing over 1,600 different effective notifications.
• Per- and polyfluoroalkyl substances (PFAS) are a wide group of synthetic organic chemicals that are used in many different industrial and commercial applications. PFAS are allowed in certain food contact applications, including non-stick cookware, gaskets and O-rings for food processing equipment, and processing aids for manufacturing other food contact polymers. PFAS are also allowed as grease-proofing agents in “fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags.”
• Ortho-phthalates (often called phthalates) are a group of chemicals used in plastics to improve the flexibility of the plastic and make it less brittle. The agency currently allows nine phthalates to be used in food contact applications via the production of food contact polymers, but phthalates themselves are not allowed to be directly added to food.

No Toxics in Food Packaging Act of 2023

• On October 26, 2023, Reps. Jan Schakowsky (D-IL), Rosa DeLauro (D-CT), and Debbie Dingell (D-MI) introduced the No Toxics in Food Packaging Act of 2023, focused on banning a specific set of chemicals from food packaging and food contact substances. The bill seeks to deem five different categories of substances as “unsafe” for use in food contact substances: (1) “any chemical belonging to the class of ortho-phthalates”; (2) “any chemical belonging to the class of PFAS”; (3) bisphenol A, B, S, F, AF, or related compounds; (4) styrene; and (5) antimony trioxide.
• The definition of “ortho-phthalates” is a class definition that covers “a class of chemicals that are esters of ortho-phthalic acid,” but the legislation still lists 11 discrete chemicals. These include a range of highly used phthalates like DINP (CAS RN 28553–12–0), DIDP (CAS RN 26761–40–0), and DCHP (CAS RN 84–61–7).
• The bill also utilizes a class-based definition of PFAS, covering any chemical that is “a perfluoroalkyl substance or a polyfluoroalkyl substance that is man-made with at least one fully fluorinated carbon atom.” This definition diverges from many other definitions of PFAS, including the EPA’s recent structural definition.
• The bill includes a separate section that would require that for any alternatives chosen in place of the target chemicals, the FDA would be required to consider potential adverse effects of exposure on “vulnerable populations.” The bill defines “vulnerable populations” as “a human population that is subject to the potential for disproportionate exposure to, or the potential for disproportionate adverse effect from exposure to, a chemical substance or mixture,” including children, the elderly, pregnant women, and residents in communities subject to disproportionate exposures.

Next steps

• The bill was referred to the House Committee on Energy and Commerce, where it will face a difficult road to passage. The bill does not have any bipartisan cosponsors yet, and Congress as a whole will likely be heavily focused on passing spending bills, consequently this bill is likely to be sidelined for some of the more pressing matters in Congress. In addition, due to the significant divisions between Republican and Democrat lawmakers, it is unlikely that an environmentally focused bill would move easily through both houses of Congress.
• If the bill does eventually pass, it would come with a two-year implementation period. After this period, manufacturers would need to adjust product formulations to remove the chemicals from target materials, as well as any substances used in manufacturing, packing, packaging, transporting, or holding of food, which could reach a much larger scope of products than just materials that are in direct contact with food.

To contact the author of this analysis, please email Walker Livingston.
To contact the editor of this analysis, please email Patricia Iscaro.

Key Documents and Dates

• H.R. 6105 – No Toxics in Food Packaging Act of 2023 (October 26, 2023)
• Press release (October 26, 2023)
• Federal Food, Drug, and Cosmetic Act