Background
AMS established the List of Bioengineered Foods at 7 CFR § 66.6 as part of its obligation to establish a standard national disclosure for bioengineered foods under the NBFDS. Bioengineered foods are those that contain genetic material that has been modified through in vitro recombinant DNA (rDNA) techniques where the modification could not have been achieved by conventional breeding or found in nature.1 Foods included on the List are presumed to be bioengineered, and a regulated entity must make a disclosure on a product containing a listed food unless they have maintained records establishing the ingredient is not bioengineered, such as records the food is not from a bioengineered source or is certified organic, or for ingredients derived from the listed food, have data from the ingredient supplier demonstrating the manufacturing process results in an ingredient that does not have detectable levels of rDNA. Regulated entities must also make a disclosure under the NBFDS if they have actual knowledge a food is bioengineered or contains a bioengineered ingredient, regardless of whether the food is on the List.
AMS must consider updates to the List annually. The existing List includes the following foods: alfalfa, apple (ArcticTM varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet.
Changes to the List of Bioengineered Foods
On November 29, 2023, AMS published a final rule finalizing a July 2022 proposed rule. The final rule will make the following changes to the List:
- Add “sugarcane (Bt insect-resistant varieties)”
- Modify the existing entry for squash to read “squash (summer, coat protein-mediated virus-resistant varieties).”
The compliance date for the new requirements is June 23, 2023, which is 18 months from the effective date of the rule (the date of publication).
With these changes, companies subject to NBFDS disclosure requirements should review their supply chains for products containing these varieties of sugarcane or squash, determine whether a disclosure is required, and update their labels or electronic disclosures if needed by the June 23, 2025 compliance date. The types of records that would establish a disclosure is not required might include, for example, documentation confirming that sugar processed from sugarcane does not contain detectable rDNA or is from identity-preserved sugarcane, records confirming summer squash is not from resistant varieties, or records confirming certified organic ingredients are used. AMS recognizes in the final rule that like with beet sugar, “it is unlikely that refined sugarcane would contain detectable levels of modified genetic material.”2 Regulated entities that have records from their suppliers to that effect would not need to make a disclosure based on the sugar ingredient but would need to maintain records showing that modified genetic material is not detectable.
To help regulated entities understand if their products require a BE disclosure, AMS maintains information on its website with information on each listed food, including FDA-reviewed BE events in the food supply, BE varieties, trade names, and more. We expect AMS will soon update its website to add more details on the two new foods added by the final rule.
We will continue to monitor AMS’s implementation of the NBFDS. Please contact us if you have any questions about disclosure requirements for bioengineered foods.
