What changes to the National Bioengineered Food Disclosure Standard are likely if USDA follows the Ninth Circuit remand on highly refined ingredient exemptions?
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Executive summary
The Ninth Circuit ruled on October 31, 2025 that USDA exceeded its authority by exempting “highly refined” foods when modified genetic material was undetectable, and remanded those regulatory provisions to USDA for revision, while also questioning digital/text disclosure methods and leaving the statutory term “bioengineered” intact [1][2][3]. If USDA follows the remand, expect a rewrite of the BE definition to remove the detectability loophole, the possible adoption of a quantitative threshold or other bright‑line test for when an ingredient triggers disclosure, and reconsideration of QR/text disclosure options through new rulemaking or guidance [1][4][5].
1. The court’s instruction: send the “not‑detectable” exemption back to AMS
The Ninth Circuit reversed the district court on the “not detectable” exemption, instructed the lower court to enter judgment for the plaintiffs on detectability, and remanded the relevant regulatory sections (7 C.F.R. §66.1 and §66.9) to USDA’s Agricultural Marketing Service (AMS) for further consideration and possible vacatur of parts of the rule [2][6][7]. The panel held that Congress gave USDA authority to set amounts of a bioengineered substance that may be present in food “in order for the food to be a bioengineered food,” signaling that USDA must articulate a legally defensible approach on thresholds, not simply rely on detectability [1][4].
2. The most likely concrete change: elimination of detectability as the sole test
Because the court found the detectability‑based exemption unlawful, USDA will likely abandon a rule that exempts ingredients merely because genetic material cannot be detected in the finished product; multiple legal analyses and firm alerts interpret the opinion as directing AMS to revisit how it treats highly refined ingredients and to consider quantitative thresholds or other criteria [1][8][9]. The Ninth Circuit explicitly left open USDA’s authority to adopt a threshold amount of BE substance that must be present to trigger disclosure, so a numeric cutoff or contamination floor is a plausible outcome [4][10].
3. How broad the coverage could become — from ingredient lists to “farm gate” implications
Commentators warn that a redefinition could broaden the universe of products subject to BE disclosures, potentially reaching refined ingredients previously outside the rule and thereby affecting labeling obligations across supply chains; some industry observers say changes could “reach all the way back to the farm gate” depending on USDA’s chosen standard [11][12]. That said, the decision does not instantaneously change label obligations — the BE Rule remains in force during remand and AMS will need to engage in new rulemaking or other formal action before requiring altered labels [9][11].
4. Disclosure format: QR codes and text messages face likely curbs
The Ninth Circuit also criticized USDA’s approval of electronic/digital link and text‑message disclosure methods as failing to guarantee “meaningful access,” directing reconsideration and potential prospective vacatur of those disclosure options; USDA previously solicited comments on digital disclosure and had signaled forthcoming rule activity, so rulemaking to tighten on‑package, on‑face disclosure options is likely [4][5][3].
5. What AMS will probably do procedurally and on timing
Practitioners expect AMS to take the remand through notice‑and‑comment rulemaking or an interim regulatory process: the agency already issued a Request for Information in April 2024 on electronic disclosures and observers forecast proposals could appear as part of the remand process [4][5]. Courts left open whether portions of the rule should be vacated while AMS rewrites rules, so a phased approach that preserves current labels in the near term while soliciting public input is the most likely path [2][9].
6. Industry consequences and litigation risks
If USDA adopts a low numeric threshold or a broad definition that includes highly refined ingredients, manufacturers and ingredient suppliers could face a wave of relabeling, reformulation, or supply‑chain tracing costs; many legal commentators and trade groups advise close monitoring because changes would materially affect compliance burdens and potential renewed litigation over scope and terminology [8][2].
7. Important uncertainties and limits of the reporting
The sources agree on the remand and likely topic areas for revision but do not specify what numeric threshold, if any, USDA will pick or exactly which disclosure formats will be retained, and the Ninth Circuit preserved USDA’s use of the statutory term “bioengineered” rather than forcing adoption of “GMO” [3][13]. Therefore, while rule changes are probable — tighter definitions, possible thresholds, and restricted digital‑only disclosures — precise regulatory text, compliance deadlines, and the ultimate market impact remain unresolved until AMS issues formal proposals and invites public comment [6][9].
Conclusion
Following the Ninth Circuit remand, USDA is likely to discard a detectability‑only exemption for highly refined ingredients and either adopt a quantitative threshold or another clear rule to determine when an ingredient triggers BE disclosure, while simultaneously reworking or limiting QR/text disclosure options; the agency will use rulemaking processes and stakeholder input to craft those changes, leaving specific outcomes and timelines uncertain until AMS publishes proposals [1][4][5].