Bioengineered (BE) foods is a familiar term that has created consumer confusion in the United States over the past few years. Though this term has become commonplace to see in the grocery store on the labels of popular foods, there tends to be a lot of consumer confusion about both the safety of consuming BE foods and the presence of BE ingredients in foods. To increase transparency for consumers and require disclosures for regulated entities using BE foods, the U.S. Department of Agriculture’s (USDA) Agriculture Marketing Service (AMS) maintains a List of BE Foods (the List). The List identifies foods with BE forms available and is reviewed annually by AMS. Recently, AMS published a final rule updating the List to include “sugarcane (Bt insect-resistant varieties)” and amending “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).”
National BE Food Disclosure Standard
In 2016, Congress passed the National BE Food Disclosure Law to increase transparency for consumers. This Law directed USDA to create a national mandatory standard for disclosing foods that are or may be BE. USDA, under AMS, established the National BE Food Disclosure Standard (the Standard) which requires food manufacturers, importers, and certain retailers to disclose the presence of BE foods or BE food ingredients on certain foods. Specifically, the Standard provides “regulated entities” various disclosure options, including 1) printing a disclosure on the food label, 2) placing the BE symbol on the packaging, 3) printing a digital link on the label, or 4) including a text message disclosure on the packaging. To learn more about the Standard, click here to read NALC factsheet “The Bioengineered Food Disclosure Standard.”
Under the Standard, BE foods are defined as “food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” 7 C.F.R. § 66.1(1)(i). The Standard applies to foods which are subject to labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA). Additionally, the Standard applies to foods subject to the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspections Act in certain situations. To help discern if a food requires BE disclosure, click here to view AMS’ “Disclosure Determination Tool.”
The Standard requires “regulated entities” to properly disclose bioengineered foods. Regulated entities are defined as a “food manufacturer, importer, or retailer that is responsible for making BE food disclosures.” 7 C.F.R. § 66.1. The Standard exempts food served in restaurants, retail food establishments, food certified under the National Organic Program, and food manufacturers with annual receipts below $2,500,000. Additionally, regulated entities must keep records that demonstrate their compliance with the Standard.
What is the List of Bioengineered Foods?
AMS maintains the List of BE Foods in order to identify what items are subject to disclosure. In compliance with the Standard, the List is reviewed annually and updated as needed by AMS. To be added to the List, a BE food must be both 1) authorized for commercial production somewhere in the world and 2) currently in legal commercial production for human food somewhere in the world. 7 C.F.R. § 66.7(a)(4). AMS annually reviews the List and updates it when necessary. Currently, the List includes, Alfalfa, apple (Arctic™ 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. 7 C.F.R. § 66.6. On November 29, 2023, AMS published a final rule updating the List to include “sugarcane (Bt insect-resistant varieties)” and amend “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).”
Sugarcane (Bt insect-resistant varieties)
Following the rule’s proposal, most public comments were in favor of the addition of sugarcane to the List; however, a few commentors opposed its inclusion because BE sugarcane is not currently sold in the United States. Currently, BE sugarcane is both authorized for commercial production and in legal commercial production for human food in Brazil. AMS responded to negative comments by clarifying that a BE food does not specifically have to be authorized for commercial production in the U.S. or in currently in legal commercial production for human food in the U.S., but only “somewhere in the world.”
Additionally, commentors opposed BE sugarcane’s inclusion on the basis that, as a highly refined product, it “does not contain detectable modified genetic material,” and its inclusion would serve as an undue burden for regulated entities. AMS responded by clarifying that a food or food ingredient’s inclusion on the List does not automatically mean it or food produced from it is considered a BE food. Instead, a food’s inclusion on the List creates a presumption that the food or food ingredient may be BE. AMS further explains that a regulated entity who produces a product without detectable modified genetic material will not be required to disclose if they keep records in accordance with 7 C.F.R. § 66.9. This portion of the Standard states that if a regulated entity verifies through records that a food is either sourced from a non-bioengineered crop, has been subjected to a refinement process validated to make the modified genetic material in the food undetectable, or confirms the absence of modified genetic material through certified testing, then the modified genetic material is considered not detectable. Therefore, a regulated entity who produces highly refined sugarcane and proves the modified genetic material is undetectable, will not be required to disclose.
Squash (summer, coat protein-mediated virus-resistant varieties)
In addition to sugarcane, the final rule amends “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).” Although BE squash is already on the List, the rule is narrowing the description of squash through the inclusion of modifiers to provide more information to consumers. Under the proposed rule, AMS proposed the modifiers “squash (summer, mosaic virus-resistant varieties).” However, after the public comment period, the agency changed the modifier from “mosaic” to “coat protein-mediated” because the description “mosaic virus-resistant varieties” pertains to more than just BE squash. As a result, AMS decided to abandon the use of “mosaic” because the modifier should only reflect BE varieties, according to the agency. Currently, only the two varieties of BE squash use coat protein-mediation to achieve mosaic virus resistance. Thus, this term describes a type of mosaic virus resistance only achieved in BE squash varieties. AMS determined “coat protein-mediated virus-resistant varieties” is the more appropriate term because it is more specific, used by both academics and industry, and reflects the reality that only BE squash varieties can achieve mosaic virus resistance through the coat protein mediated virus resistance method.
Conclusion
The National BE Food Disclosure Standard and the List of BE Foods are two tools AMS and USDA use to increase transparency with consumers about BE foods. This year, AMS updated the List to include specific varieties of sugarcane and summer squash. The rule goes into effect on December 29, 2023, and regulated entities have 18 months following the effective date to update food labels to reflect the changes.
To view AMS’ BE Disclosure page, click here.
To learn more about bioengineered foods, click here to visit the NALC Biotechnology reading room.
To learn more about the required disclosure of bioengineered foods, click here to read NALC article “Focus on Food: Bioengineered Foods Now Require Disclosure”