June 17, 2021
California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer, and health organizations recently filed a citizen petition with the U.S. Food and Drug Administration (FDA) calling on the agency to regulate PFAS more heavily at the federal level.
Background
As we have previously discussed, PFAS are a large class of man-made chemicals with water- and grease-resistant properties that are used widely in industrial processes and consumer products, such as food packaging and nonstick cookware.[1] PFAS have been authorized by the FDA for various uses in contact with food, especially the following two application categories:
- Non-stick cookware: PFAS may be used as a coating to make cookware non-stick.
- Paper/paperboard food packaging: PFAS may be used as grease-proofing agents in fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags to prevent oil and grease from foods from leaking through the packaging.[2]
Most of the research on PFAS and potential health effects is based on two types of PFAS, perfluorooctanoate (PFOA) and perfluoro-octane sulfonate (PFOS). While there have been some studies linking PFOA and PFOS to certain health effects, the associated health effects for many of the other PFAS molecules are currently unknown. Recently, both state and federal regulators have been increasing their scrutiny of the potential presence of PFAS in consumer products.
Vermont PFAS updates
On 18 May Vermont Governor Phil Scott signed S.20 into law, which bans the sale of food packaging, as well as other products, containing PFAS or ortho-phtalates.[3] Specifically, the law would prohibit the manufacture, sale, or distribution of a food package to which PFAS or ortho-phtalates have been intentionally added and are present in any amount. Unlike some other state laws on PFAS discussed below, the Vermont law does not require the identification of safer alternatives before the ban takes effect. The law defines “package” as “a container providing a means of marketing, protecting, or handling a product and shall include a unit package, an intermediate package, and a shipping container. “Package” also means unsealed receptacles, such as carrying cases, crates, cups, pails, rigid foil and other trays, wrappers and wrapping films, bags, and tubs.” The law also includes the condition that the Attorney General may request a certificate of compliance from a manufacturer of food packaging. Within 30 days of receipt of a request, the manufacturer must either (1) provide the Attorney General with a certificate attesting that the manufacturer’s product or products comply with the law; or (2) notify persons who are selling the manufacturer’s product in Vermont that the sale is prohibited because the product does not comply with the law, and provide the Attorney General with a list of the names and addresses of those persons notified. [4]
The ban on PFAS in food packaging will go into effect on 1 July 2023.
California PFAS updates
On 22 April, California passed Assembly Bill 1200 (AB 1200), which would ban the use of per- and polyfluoroalkyl substances (PFAS) in food packaging made from plant-derived fibers and imposed certain disclosure and labeling requirements.[5] If the governor signs AB 1200 into law, it would, among other things, prohibit any person from distributing, selling, or offering for sale in the state “any food packaging that contains intentionally added PFAS” starting from 1 January 2023.[6] “Food packaging” is defined in AB 1200 as a nondurable package, packaging component, or food service ware that is intended to contain, serve, store, handle, protect, or market food, foodstuff, or beverages, and is comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers. “Food packaging” includes, but is not limited to, food or beverage containers, take-out food containers, unit product boxes, liners, wrappers, serving vessels, eating utensils, food boxes, and disposable plates, bowls, or trays. The term “intentionally added PFAS” is defined to include either of the following: (1) the presence or use of PFAS in a product or product component that has a functional or technical effect in the product or product component; and (2) the presence of PFAS in a product or product component at or above 100 ppm. The bill was sponsored by the non-profit organizations Environmental Working Group, Breast Cancer Prevention Partners, Clean Water Action, the Natural Resources Defense Council, and the Center for Environmental Health.
Relatedly, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA), California’s lead agency in implementing Proposition 65, recently published two notices regarding PFOA and PFOS. For PFOA, OEHHA intends to list the chemical as known to the state to cause cancer under Proposition 65.[7] For PFOS, OEHHA is conducting a review through its Carcinogen Identification Committee (CIC) to assess whether the chemical has been clearly shown to cause cancer.[8] While currently there is no confirmed timeline for their listing as potential carcinogens under Proposition 65, we note both PFOA and PFOS have already been listed under Proposition 65 effective in 2017 as chemicals known to the state to cause reproductive toxicity.[9]
Other State Updates
Maine, New York, and Washington also have adopted similar laws aiming to limit the manufacture, distribution and sale of food packaging containing intentionally added PFAS, although none of the laws are effective as of today. The New York law will go into effect 31 December 2022. The Maine and Washington laws, however, will go into effect two years after a “safer alternative” determination is identified and reported to the legislature.
In February of this year, the Washington Department of Ecology (DoE) completed its Alternatives Assessment Report for PFAS in food packaging, which determined that PFAS alternatives are available for four packaging applications:
- Wraps and liners (wax-coated options)
- Plates (clay-coated and reusable options)
- Food boats (clay-coated and reusable options)
- Pizza boxes (uncoated options)[10]
Therefore, with respect to these food packaging categories, the Washington law will go into effect February 2023 (i.e., two years after the “safer alternative” determination). A safer alternative determination has not yet been made in Maine.
Citizen petition for FDA PFAS regulation
On 3 June a number of interest groups filed a citizen petition with the FDA requesting the agency take action to ban the use of all PFAS that biopersist in the human body.[11] The petition comes in response to a Freedom of Information Act (FOIA) request response disclosing FDA concerns over the use of small- and long-chain PFAS in food contact substances. The response revealed that the FDA ordered manufacturers of small-chain PFAS to provide evidence that the chemicals were safe for continued use to stay in operation. In response, one manufacturer offered to conduct the necessary trials over a two year period, but the FDA rejected this proposal in favor of an agreement that the manufacturers would voluntarily phase-out these products from food use over five years.
The citizen petition asserts that the FDA took inadequate action in response to concerns over the health risks of PFAS in food products. The petition demands that the FDA:
- Revoke the approval of all food contact substances containing small- and large-chain PFAS as an ingredient, manufacturing byproduct, impurity, breakdown product, or metabolite;
- Remove approvals for any food additive or GRAS regulations that contain small- or large-chain PFAS;
- Issue a regulation banning the use of small- and large-chain PFAS in food contact substances;
- Require industry to affirmatively demonstrate that any PFAS, as well as its impurities, byproducts, and metabolites do not pose serious health risks before continued use in food products can be authorized.
The FDA is required to answer this petition within 180 days of its filing. However, the agency routinely requests additional time to offer a substantive response.
Next steps
We will continue to monitor the legal and regulatory developments related to food packaging and the use of PFAS at the state and federal level.
Source:
https://www.jdsupra.com/legalnews/mounting-pressure-at-both-federal-and-6517750/