The National Bioengineered Food Disclosure Standard Is Now in Effect

As of January 1, 2022, foods that are deemed “bioengineered” must be accompanied by labels disclosing that the food is bioengineered or contains a bioengineered ingredient. This disclosure requirement is the culmination of a decades-long battle and a legislative compromise over what has been commonly known as “GMO labeling.”


After multiple unsuccessful West Coast ballot initiatives, advocates for requiring the disclosure of ingredients derived through genetic engineering gained a foothold in several New England states. In 2014, Vermont enacted legislation that made it the first state in the U.S. to require food manufacturers to disclose the use of genetic engineering on food labels. Vermont’s law was set to go into effect on July 1, 2016 (with a 6-month grace period). Not coincidentally, Congress passed the National Bioengineered Food Disclosure Standard (the Bioengineered Standard) in July 2016.


In the Bioengineered Standard, USDA’s Agricultural Marketing Service (AMS) was directed to promulgate regulations to implement a scheme to require the disclosure of “bioengineered foods.” Also, the Bioengineered Standard immediately preempted all state GMO labeling laws; this move prevented the possibility of a patchwork of conflicting state labeling laws.


 On December 21, 2018, USDA AMS published the National Bioengineered Food Disclosure Standard  final rule (the BE Rule) to implement the Bioengineered Standard. One notable departure from genetic engineering disclosure laws in the EU is the BE Rule’s disclosure requirement is triggered by the presence of bioengineered genetic material. Specifically, the BE Rule defines “bioengineered food”, in relevant 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 § 66.1).


[NOTE: USDA has published a number of guidance documents to help regulated entities and consumers implement and understand the BE Rule. In particular, the FAQ Guidance is helpful.]


Under the BE Rule, many ingredients derived from bioengineered crops will not trigger labeling disclosure requirements because they are highly refined to the extent that the food and/or food ingredient does not contain genetic material. For instance, high fructose corn syrup, sugar from sugarbeets, and soybean and canola oils should not trigger labeling requirements as long as the manufacturer has records indicating the products do not contain bioengineered genetic material. The BE Rule permits manufacturers to voluntarily disclose if a food contains ingredients derived from a bioengineered crop.


Further, the BE Rule only applies to packaged and bulk foods sold in retail settings, such as grocery stores and convenience stores. There are no disclosure requirements for restaurants or food service. Also, the BE Rule does not apply to most meat and poultry products. For instance, the BE Rule does not apply to FSIS-inspected meat and poultry products if the first ingredient is meat or poultry, or if the most predominant ingredient is a liquid (e.g., broth, stock, water) and the second-most predominant ingredient is meat or poultry.


Notably, the Bioengineered Standard is a “marketing standard.” USDA AMS has limited enforcement options against regulated entities that do not properly disclose bioengineered foods. For instance, USDA AMS may not recall products, issue fines, or seek criminal enforcement for failure to disclose, the agency can publicly disclose the finding of lack-of-compliance. This disclosure can generate negative publicity and may lead to enforcement under state consumer protection laws.


The Bioengineered Standard was the result of a compromise and some advocates for robust disclosure of genetic engineering are not pleased with the outcome. On July 27, 2020, the Center for Food Safety (CFS), along with several other food organizations, filed a lawsuit in federal court challenging the BE Rule under the Administrative Procedure Act on the grounds that it is unconstitutional and inconsistent with the authorizing statute under the Bioengineered Standard. The plaintiffs challenge the BE Rule, in relevant part, on the following grounds. First, as explained above, the BE Rule exempts highly processed foods which contain no detectable BE material. The plaintiffs argue that this exemption not only contradicts the Bioengineered Standard, which covers the disclosure of “any bioengineered food and any food that may be bioengineered,” but also it harms consumers who are interested in whether they are eating bioengineered food and/or food ingredients and are not focused on whether BE material is detectable or not in food. Second, the plaintiffs argue that the BE Rule, which mandates the use of the term “bioengineered,” and prohibits the use of the terms “genetically engineered” and “GMO,” results in misleading speech and therefore discriminates against consumers because these prohibited terms are better understood by consumers and are widely used by a variety of stakeholders.


The CFS lawsuit is unlikely to succeed, but the organization is drawing attention to what it feels are shortfalls in Congress and USDA’s approach to the disclosure of bioengineered foods.


Although the BE Rule lacks harsh enforcement measures, such as recalls, fines, or criminal penalties, one potential compliance risk for companies is the threat of private actions brought under state consumer protection laws. Although the Bioengineered Standard preempted states from establishing a conflicting regime for disclosing bioengineered foods, Congress also explicitly provided the Bioengineered Standard’s preemption provisions do not preempt “any remedy created by a State or Federal statutory or common law right.” We anticipate the plaintiffs’ bar may attempt to bring a state law claim seeking monetary damages against a manufacturer that fails to comply with the Bioengineered Standard on the basis the failure to disclose bioengineered content deceived consumers.


OFW Law will continue to monitor bioengineered labeling standards. Please reach out if you have any questions.