Beginning in 2020, certain food products have contained a bioengineered disclosure, indicating that the food or ingredients in the food may be or are derived from bioengineering. The National Bioengineered Food Disclosure Law was passed by Congress in 2016 and required USDA to establish a mandatory disclosure standard for foods that are or may be bioengineered. After USDA developed the standard, companies were given until January 1, 2022 to comply with the requirements, though voluntary compliance was permitted before then.
What Is Bioengineered Food
USDA has determined that “bioengineered food” includes foods that contain genetic material that has been modified through in vitro rDNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. If, after refinement or other processing, the modified genetic material is not detectable, the product is not considered bioengineered for purposes of the standard. USDA has issued a list of foods that are commercially grown or available that are bioengineered, available at 7 CFR 66.6; this list can be used as the focus for determining if the food or ingredient is bioengineered under the standard. Even if the food is not on the bioengineered list, but contains detectable modified genetic material, the food subject to the disclosure requirements of the standard; the bioengineered list serves only to provide a resource for regulated companies.
When is a Disclosure Required
All foods regulated by the Federal Food, Drug, and Cosmetic Act, meaning the FDA regulates the product, are subject to the mandatory standard. In addition, certain USDA FSIS products also are subject to the standard. If the most predominant ingredient by weight in the FSIS-regulated product would independently be subject to FDA regulation, the product is required to comply with the standard; if the most predominant ingredient is water, broth, stock, or a similar ingredient, and the second most predominant ingredient would independently subject to FDA regulation, the product must comply with the standard.
If a product is subject to standard, a disclosure may be required. Only manufacturers, importers, and retailers who label food for sale (including displaying food in bulk containers or displays) must comply with the standard; restaurants and similar retail food establishments are not subject to the standard. In addition, very small manufacturers are exempt from the disclosure requirements of the standard. To determine if a disclosure is required, a company must determine if any component of the food is considered bioengineered, as discussed above. If the food itself is bioengineered or contains ingredients with detectable modified genetic material, a disclosure is likely required on the food.
The presence of a small amount of modified genetic material that was unintentional, but rather unavoidable when reasonable and customary practices are implemented to separate bioengineered and non-bioengineered foods, does not require a disclosure. Inadvertent and technically unavoidable genetic material, up to five percent, is specifically excluded in the standard from disclosure requirements.
How Must the Disclosure Be Provided
If required, the disclosure can be placed on either the principal display panel or the information panel adjacent to the responsible party’s information; if neither of these panels is large enough to include the disclosure, the disclosure can be included on an alternative panel where it is likely to be seen by the consumer under ordinary shopping conditions. The disclosure can be provided through the use of on-package text, a USDA-approved symbol, through an electronic or digital disclosure, or through a text message to a phone number on the package. The specific requirements for each method of disclosure are defined in the USDA standard. Modified disclosure methods are provided for small manufacturers and small and very small packages as well.
QR Code Ruling
As discussed above, the standard permits multiple methods of disclosure, including digital disclosures. The inclusion of digital disclosures, such as QR codes, as a permissible means of disclosure was challenged in a recent lawsuit, which also challenged the requirement to use the term “bioengineered” and the exclusion of highly refined foods from the disclosure requirements. The Court determined that USDA must reevaluate the permissibility of the digital disclosure because USDA’s studies determined, in part, that consumers may face difficulties in obtaining the information required by the standard through the use of a digital disclosure. Though the use of a digital disclosure remains permissible, USDA may, following its reevaluation, determine that modifications to the digital disclosure requirements may be necessary.
Voluntary Labeling
For companies or products not addressed by the standard, or exempt from disclosure under the standard, USDA and FDA have both issued guidance on when and how voluntary labeling of the status of foods can occur.
First, USDA, in relation to the standard, has identified areas where voluntary disclosure that a food is bioengineered or derives from bioengineering is permissible. First, for companies who are exempt from the standard due to size, voluntary disclosure is permitted; this voluntary disclosure must comply with the requirements of the standard. In addition, when a company uses or packages highly refined ingredients where the modified genetic material is no longer detectable, the product can be permissibly labeled, following the requirements of the standard. However, in this circumstance, the permissible language for disclosure is “derived from bioengineering” or “ingredients derived from a bioengineered source.”
In addition, USDA FSIS has issued guidance on the voluntary labeling of foods as not bioengineered or derived from bioengineering. FSIS permits claims for both meat, poultry, and egg products derived from animals that do not consume bioengineered feed and on foods that do not contain bioengineered ingredients. These claims can include, in the first instance, “fed a diet with no GMO ingredients” on products from animals that do not consume feed derived from bioengineering or, for example, “no GMO ingredients” when a multi-ingredient product does not contain ingredients derived from bioengineering. In both circumstances, FSIS requires that the products are certified by a third-party certifying organization. FSIS, during the label approval process, requires proof of compliance with the certifying organization’s standard, and information about the certifying organization must be included in the product’s label to be approved.
For FDA-regulated products, FDA has also issued guidance for the voluntary inclusion of claims indicating the absence of bioengineered content in foods. Generally, FDA permits voluntary labels with information about whether the foods were not produced using bioengineering, as long as the information is truthful and not misleading. FDA’s guidance indicates that language such as “genetically modified” is discouraged because this language can encompass methods beyond those typically contemplated by bioengineering. If the language used on a label is “false or misleading,” the food can be considered misbranded under the Food, Drug, and Cosmetic Act, so any absence claims made on FDA-regulated foods must be truthful in all considerations.
Liz Presnell is a food industry consultant and lawyer, and has worked in the food industry for nearly a decade. She can be reached at presnell@foodindustrycounsel.com.