In an August 5th letter to the food packaging industry, the U.S. Food and Drug Administration (FDA) issued a reminder to manufacturers, distributors, and users of fluorinated polyethene food packaging of the limitations of fluorinated polyethylene containers that are authorized for food contact use. The FDA also reminded the food packaging industry that the manufacturing of such packaging must be made under specific conditions and in compliance with existing FDA regulations.
The FDA’s letter comes in the wake of recent testing performed by the Environmental Protection Agency (EPA), which discovered certain PFAS can leach from fluorinated high-density polyethylene containers (HDPE). Specifically, the PFAS detected in EPA’s testing are perfluoroalkyl carboxylic acids (PFCAs), several of which are suspected to biopersist in humans and may be linked to certain health problems. However, it is important to note that EPA’s testing was conducted on containers intended to hold mosquito-controlling pesticides, which are not regulated by the FDA or approved for direct use on food crops. Still, the FDA expressed its concern that containers not regulated by the FDA could also be used in contact with food. Studies have found that PFCAs can form when the fluorination of HDPE occurs in the presence of oxygen and water, but not in the presence of nitrogen, which is FDA-authorized for fluorination of polyethylene containers.
The FDA’s regulation, 21 C.F.R. 177.1615, stipulates that only fluorine gas with the combination of nitrogen can be used in the manufacturing process to modify the surface of the fluorinated polyethylene containers used for food. The FDA advised this regulation does not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen. In addition, it does not authorize the use of fluorine gas in combination with other “inert diluents” such as, carbon dioxide, argon, or helium. The FDA warned that using other alternative manufacturing processes are strictly prohibited and not lawful for use in food packaging as these other processes can produce PFAS when the gases react with fluorine. Ultimately, the PFAS from containers can migrate and leach into the food, which poses adverse health risks.
The FDA’s letter to the food packaging industry also comes among a growing scrutiny over food packaging as a potential PFAS pathway. Increased awareness from consumers and public interest groups has led to voluntary bans or limits on PFAS use in food packaging by restaurant and grocery chains that collectively represent nearly 80,000 stores, including Chipotle, Wendy’s, Whole Foods Market, and McDonald’s.
Despite the increased scrutiny over PFAS in food packaging, certain, primarily short chain PFAS are still permitted by FDA for use in food packaging, cookware, and processing equipment. Public interest organizations have pushed the EPA and FDA to develop a unified approach to prevent PFAS contamination in food packaging by drafting joint policies on enforcing the unauthorized use of the chemicals or outright ban their use.
Meanwhile, the House of Representatives last month passed the PFAS Action Act to regulate the use of PFAS. The Act will require (1) the EPA to add two PFAS – PFOA and PFOS – to the list of hazardous substances under CERCLA within one (1) year and assess all other PFAS within five (5) years to determine whether they should be added; and (2) require the EPA to determine whether PFAS should be designated as toxic pollutants under the Clean Water Act. In addition, the bill will require the EPA Administrator to monitor PFAS in drinking water and permit a “PFAS-free” indication on nonstick cookware.
Also last month in the House, Representatives Jan Schakowsky and Rose DeLauro introduced the Food Chemical Reassessment Act of 2021, which would require the FDA to study and reassess certain chemicals use in food, including PFAS. The bill would create an Office of Food Safety Reassessment to reassess the safety of food additives, food contact substances, “Generally Recognized as Safe” substances, and prior-sanctioned substances. Starting in 2022 and at least once every three years, the Office would reassess the safety of at least ten substances, including PFAS. Whether this bill ultimately passes is questionable given the immense amount of resources required to create a new FDA office. Finally, Representative Debbie Dingell is expected to introduce the Keep Food Containers Safe from PFAS Act, which seeks to impose a federal ban on the use of PFAS chemicals in food production and packaging. A 2020 bill of the same name was one of more than 100 pieces of PFAS legislation introduced in Congress last session that would have enacted limits on the compounds’ use.
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Lathrop GPM has deep experience developing regulatory strategy and defending litigation in the area of per- and polyfluoroalkyl substances (PFAS), and we have been involved in some of the nation’s most-publicized cases. The PFAS Playbook blog is dedicated to helping readers stay up to date and understand the latest regulatory updates on PFAS.