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Posted 30 June 2021 | By Karin Moore, JD, and Ricardo Carvajal, JD, MS
With the approach of the 1 January 2022 mandatory compliance deadline for the National Bioengineered Food Disclosure Standard (BE standard), manufacturers and importers of dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so. This article reviews the requirements for disclosure under the BE standard.
In May 2014, the Vermont legislature passed an act requiring “the labeling of food produced with genetic engineering.”1 That set off a flurry of federal legislative activity and advocacy that culminated in the passage of Public Law 114-216, which amended the Agricultural Marketing Act of 1946 to establish a BE standard.2 The secretary of the US Department of Agriculture (USDA) was tasked with establishing the standard and the requirements and procedures for executing it,2 and the agency’s Agricultural Marketing Service (AMS) issued the final rule on 21 December 2018 (7 CFR Part 66).3 The mandatory compliance date for all foods entering commerce is 1 January 2022 (§66.13(c)).
The mandatory disclosure requirement of the BE standard applies to human food, including dietary supplements, that is subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act, as well as some products under the jurisdiction of the USDA’s Food Safety and Inspection Service. There are several express exemptions to the disclosure requirement in the regulations, including an exemption for very small manufacturers, a threshold for inadvertent or technically unavoidable presence of BE substances of up to 5% for each ingredient, and food and supplements certified under AMS’s National Organic Program (§66.5(e)).
The BE standard and the final rule incorporate the definition of “food” in the FDCA (section 201, 21 USC 321). This broad definition of food includes articles used for food or drink and articles used for components of any such article. Dietary supplements, dietary ingredients, and other ingredients (such as diluents, carriers, and processing aids), are included in this definition of “food.” Entities regulated under the BE standard include manufacturers (unless they qualify as very small manufacturers), importers, and retailers (§66.5). If a food is packaged before receipt by the retailer, then the manufacturer or importer is responsible for disclosure. If a retailer packages or sells the food in bulk, then the retailer is responsible for disclosure.
The BE standard defines “bioengineered food,” in part, as “a 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 USC 1639(1)). The regulations excluded certain items from the definition of bioengineered food and thus from the scope of the BE standard, including food that “does not contain modified genetic material.” As discussed below, under the heading Detectability, a food does not contain genetic material if the genetic material is not “detectable” within the meaning of the regulation (§66.1; 66.9). Selection of test methods and validation of refining processes are addressed in AMS’s guidance documents.4,5 There is no affirmative requirement to identify the BE status of all ingredients in a product if a company has determined that a product must bear the disclosure based on some ingredients in the product.6
List of bioengineered foods
To aid companies considering whether they need to make a BE food disclosure, AMS developed a list of BE foods.7 If a regulated entity uses a food or an ingredient produced from food that is on the list, the entity’s records will determine whether the food must bear a BE food disclosure. The list is not exhaustive and will be updated as necessary. Entities are still required to disclose BE foods if they have actual knowledge that the food is BE, even if it is not on the list.7
If the genetic material in a food or dietary supplement is not detectable, then, under AMS’s regulations, the food or dietary supplement is not BE, and therefore disclosure is not required (§66.1). This concept may be especially important in determining whether some refined ingredients produced from those on the list of BE foods (e.g., high-fructose corn syrup, canola oil) are exempt from the disclosure requirement. There are three ways under the regulations to demonstrate modified genetic material is not detectable:
Tags: BE, bioengineering