Elaine Meloan
Elaine Meloan

The National Bioengineered Food Disclosure Law passed by Congress in July of 2016, and now fully implemented as of January 1, 2022, established a national mandatory USDA standard for disclosing foods made with bioengineered ingredients (see https://www.ams.usda.gov/rules-regulations/be). The Bioengineered Food standard defines bioengineered foods as containing detectable genetic material modified through certain lab techniques and that cannot be created through conventional breeding or found in nature.

The standard requires food manufacturers, importers, and certain retailers to appropriately disclose bioengineered foods. This standard went into effect on January 1, 2020, with small food manufacturers going into effect January 1, 2021. The mandatory compliance date was January 1, 2022.

In order to learn more about mandated bioengineered labeling means for product manufacturers like snack producers and bakers, we reached out to Elaine Meloan, manager, labeling, AIB International, Manhattan, KS.


Douglas J. Peckenpaugh: What do the new Bioengineered Disclosure labeling requirements entail?

Elaine Meloan: Any item that is or contains a food from the “AMS List of Bioengineered Foods” will need to include a disclosure on the packaging that informs the consumer of the presence of a BE substance or substances.  The disclosure may be a text statement, such as “Bioengineered Food” or “Contains a bioengineered food ingredient,” a symbol, an electronic or digital link, or a text message disclosure sent to the consumer’s mobile device.

Foods subject to the regulations include almost all FDA regulated retail foods and FSIS regulated retail foods when the most predominant ingredient would independently be subject to the labeling requirements under the FD&CA, or when the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second-most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA. Like most rules, there are exemptions spelled out for certain categories of foods. These exemptions include foods served in a restaurant or similar retail food establishment, foods from very small food manufacturers, foods in which no ingredient intentionally contains a bioengineered substance, and foods certified under the National Organic Program. Additionally, foods derived from an animal shall not be considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a BE substance.


DJP: What do food producers need to consider from a recordkeeping point of view when running non-GMO products, as well as products that include bioengineered ingredients?

EM: Since “non-GMO” is not defined by the BE disclosure standard, recordkeeping documents that state that the food is “non-GMO” would not be sufficient to comply with the standard. For any items in a manufacturing facility that are, or contain a food from, the list of BE foods, the manufacturer will need to keep records verifying the BE status of those items. A disclosure will not be needed for any items with records showing that:

  • The food is sourced form a non-bioengineered crop or source
  • The food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable
  • Testing of the food confirmed the absence of modified genetic material

Note that the final regulations also provide for a voluntary disclosure, “Derived from Bioengineering,” for those items that undergo a validated refinement process and no longer contain detectible modified genetic material.

When requesting information for the recordkeeping requirement, food manufacturers should let the supplier know they are requesting the information specifically for the BE disclosure standard. If you also participate in a third-party non-GMO disclosure, you can ask for separate records to validate that information.


DJP: What do food producers need to consider from an operational and sanitation point of view?

EM: Foods are exempt from the BE disclosure standard when no ingredient intentionally contains a bioengineered substance. However, the disclosure standard does allow for inadvertent or technically unavoidable BE presence of up to five percent for each ingredient. So, in general, cross-contamination isn’t much of a concern for the BE disclosure standard.  


DJP: What do you anticipate will be the biggest challenges related to Bioengineered Disclosure labeling requirements, and how can we overcome those challenges?

EM: Obtaining the proper information about the BE status of ingredients from suppliers has been one of the most-significant challenges. Suppliers are trying to use one document for different standards, and that doesn’t always work. When requesting BE documentation, a company should be very specific about the information they need.

Also, with the current problems with the supply chain, manufacturers are having to use substitute ingredients. During the public health emergency brought on by the COVID-19 pandemic, FDA allows some of these substitutions without label changes (see “Temporary Policy Regarding Certain Food Labeling Requirements during the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines”). But nothing was addressed concerning the presence of BE substances. Companies will need to be diligent about identifying risks with any substitute ingredients they plan to use.