As we previously reported, nearly four years ago, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (Plaintiffs) filed a complaint against AMS challenging the final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS), also known as the BE labeling rule. Plaintiffs challenged the rule's use of the term "bioengineered" (rather than "GMO" or "genetically engineered"), the rule's limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material, and the rule's options of using a QR code disclosure or a text message for the disclosure statement. In 2022, the U.S. District Court of the Northern District of California largely upheld the standard but remanded (without vacatur) the text and QR disclosure options. Plaintiffs appealed.
On October 31, 2025, the Ninth Circuit reversed several aspects of the district court's ruling, sending AMS back to the drawing board, i.e., it determined that the district court erred in the definition of bioengineered food, and it abused discretion in declining to vacate the two disclosure format provisions. It did affirm the district court's determination regarding the use of the term "bioengineered," however.
First, the Ninth Circuit reversed the district court's ruling that AMS could exempt highly refined foods from the definition of "bioengineered foods." The Ninth Circuit agreed with the plaintiffs that the current rule not requiring a disclosure statement, if the manufacturer concludes the BE ingredients are not detectable, is not the legal "equivalent to saying that the food does not 'contain' such material." The court determined that a food contains modified genetic material "if it actually has modified genetic material within it." The crucial issue is that undetectable is not the same as non-presence; it may contain genetic material even if that is not detectable. That said, the court acknowledged that AMS has the authority to adopt a detectability exception as the statute requires that AMS determine "the amount[] of a bioengineered substance that may be present in food, . . . in order for the food to be a bioengineered food." In other words, AMS could, for example, adopt a limit of detection setting the amount of a BE substance that may be present. If the bioengineered substance is not detectable within the limit, the food would be considered non-BE. The food "would not count as a 'bioengineered food' under the regulatory standard only because it was excluded under a limit-of-detection-based standard" set by AMS. The Ninth Circuit remanded the case to the district court, with instructions to remand the relevant regulations to the AMS and to determine whether any part of the regulation should be vacated in connection with that remand.
The Ninth Circuit also disagreed with the district court's decision to not vacate the regulations allowing the disclosure statement via text or QR code, while AMS is going through the administrative process of reconsidering these options. It reversed the district court's decision to deny vacatur; the district court erred when it allowed the use of disclosure options that were found to be inadequate and unlawful, and remanded with instructions to grant an appropriate prospective vacatur, after receiving input from the parties on that specific point.
AMS did not lose on all fronts. The Ninth Circuit affirmed the district court's decision that AMS had not been arbitrary and capricious in requiring the term "bioengineered" rather than genetically engineered or GMO.
We will be monitoring future actions by AMS related to the threshold setting for detectable modified genetic material and possible actions regarding an electronic option for the disclosure statement.
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