• The Ninth Circuit has reversed (Law360 subscription required) a district court ruling exempting highly refined foods from the definition of a “bioengineered food.” As we previously blogged, in 2022, the U.S. District Court for the Northern District of California dismissed a challenge by natural and organic grocers and advocacy organizations against USDA’s Agricultural Marketing Service’s (AMS) final regulations implementing mandatory uniform national bioengineered (BE) food disclosure standards for human food.
  • On appeal, the Ninth Circuit agreed with the plaintiffs that AMS’s current rule allowing exemptions if manufacturers conclude the BE ingredients are not “detectable” is not “legally equivalent to saying the food does not  ‘contain’ such material.” Specifically, the court considered what it means to “contain” modified genetic material, determining that a food is considered BE “if it actually has modified genetic material within it.” Thus, the court rejected AMS’s “flawed legal premise that the non-detectability of a substance under the regulation was equivalent to its non-presence.”
  • The court did, however, disagree with the plaintiffs’ contention that AMS lacks any discretionary authority to adopt a detectability exception for highly processed foods made from BE ingredients. Under the statute, the agency is required to determine “the amounts of a bioengineered substance that may be present in food, as appropriate, in order for the food to be a bioengineered food.” Thus, the agency could, for example, adopt a particular limit of detection as fixing the “amount” of a BE substance that may be potentially present, and a showing that the substance cannot be detected within that limit would mean the food does not qualify as BE. According to the court, while that food would otherwise meet the broad statutory definition of BE, “it would not count as a ‘bioengineered’ food under the regulatory standard only because it was excluded under a limit-of-detection-based standard promulgated under the Act.
  • The court remanded the case to the district court with instructions to grant summary judgment to the plaintiffs, remand the regulations to AMS, and determine, after receiving input from the parties, whether any provisions of the regulations should be vacated.
  • The court also affirmed the district court’s decision that AMS was not arbitrary and capricious in requiring the term “bioengineered” in disclosures and reversed the district court’s decision to deny vacatur of disclosure format rules.
  • Keller and Heckman will continue to monitor any developments related to BE foods and labeling.