The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1, 2022, the NBFDS will require manufacturers, importers, and retailers that package or sell food in bulk to disclose the presence of bioengineered food or food ingredients on product labels intended for retail sale.
A “bioengineered food” is defined, 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 CFR Section 66.1). Bioengineered food does not include food that “does not contain modified genetic material if the genetic material is not detectable pursuant to [validated analytical testing]” (7 CFR Section 66.1). Food derived from an animal cannot be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance.
The USDA has developed a non-exhaustive list of bioengineered foods to help regulated entities determine if their products are subject to the NBFDS. If a food or food ingredient appears on the list, the regulated entity will be required to keep records for two years showing that the food does not need to bear a bioengineered food disclosure on its label. Regulated entities are also required to disclose bioengineered foods or ingredients if they have actual knowledge that the food is bioengineered.
The NBFDS regulations include several exemptions from the disclosure requirement, including: (1) foods served in a restaurant, (2) very small food manufacturers with annual receipts of less than $2.5 million, (3) food certified under the USDA National Organic Program, and (4) food in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable presence of up to 5% for each ingredient. Food in which any single ingredient contains more than 5% of a bioengineered substance, regardless of whether its presence is inadvertent or unintentional, is subject to disclosure. Further, food containing any amount of a bioengineered substance that is not inadvertent or unintentional is also subject to disclosure.
Forms of Disclosure and Recordkeeping
The NBFDS regulations allow for four types of bioengineered food disclosures: labeling text, a symbol, an electronic/digital link (QR code), or a text-messaging phone number, each with its own specific requirements. The disclosure must be of “sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions” (7 C.F.R. § 66.100(c)).
Regulated entities are required to maintain ongoing records of their compliance with the NBFDS requirements for two years beyond the date the food or food product is sold or distributed for retail sale.
As the NBFDS is a marketing standard that is unrelated to food safety, the USDA has limited enforcement options against regulated entities that fail to disclose bioengineered foods. The USDA may not recall or seize products, or issue fines for a failure to make a bioengineered food disclosure. The agency is limited to publicly disclosing the results of an investigation at the conclusion of a hearing for a noncompliant entity. However, a public finding of noncompliance with the NBFDS requirements is likely to draw litigation from consumers and competitors. As such, regulated entities should ensure that their product labeling complies with the disclosure requirements prior to January 1, 2022.