Decision Tool – Do I need to make a bioengineered food disclosure?

The following determination tools are designed to help regulated entities who are subject to the National Bioengineered Food Disclosure Standard (the Standard) remain in compliance with the law.  These guides are not designed to provide legal advice and do not include every requirement of the Standard.  The Amended Act and the regulations found at 7 CFR Part 66 govern what foods are subject to disclosure under the Standard. These tools are designed to provide an overview of the major requirements for determining what foods must be disclosed as bioengineered foods.

Determining if a Food Requires a Bioengineered Food Disclosure

As stated at 7 CFR 66.3, the Standard applies to food subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act (FDCA) and certain foods subject to the labeling requirements under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA), if the most predominant ingredient of the food would independently be subject to the FDCA; or 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.

At 7 CFR 66.1, predominance means an ingredient’s position in the ingredient list on a product’s label.  Predominant ingredients are those most abundant by weight in the product, as required under 21 CFR 101.4(a)(1).

USDA is providing the following decision tree from a third party vendor. The vendor may have a different privacy policy than USDA. Use of this resource is optional, regulated entities may also reference the full text of the National Bioengineered Food Disclosure Standard or contact AMS at 202-720-4486 or befooddisclosure@usda.gov.

Determining if Foods Containing Alcohol are Subject to the Standard

Alcohol products that are subject to the labeling provisions of the Federal Alcohol Administration Act (FAA Act) overseen by the Alcohol and Tobacco Tax and Trade Bureau are not subject to the Standard.

Other alcohols and food products containing alcohol that do not fall under the FAA Act jurisdiction are subject to the Standard, as they are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA).

USDA is providing the following decision tree from a third-party vendor. The vendor may have a different privacy policy than USDA. Use of this resource is optional, regulated entities may also reference the full text of the National Bioengineered Food Disclosure Standard or contact AMS at 202-720-4486 or befooddisclosure@usda.gov.

Additional Information

As noted at 7 USC 1639a and 7 CFR 66.3(b), food subject to labeling under the Federal Food, Drug, and Cosmetic Act (FDCA) and certain foods subject to the labeling requirements of the USDA Food Safety Inspection Service (FSIS) are required to comply with the National Bioengineered Food Disclosure Standard (the Standard).

Certain beverages containing alcohol are not subject to the labeling requirements of the FDCA.  The alcohol products below are subject to the labeling provisions of the Federal Alcohol Administration Act (FAA Act) and are not subject to the Standard:

  • All beverage spirits, malt beverages, and their products regardless of the alcohol content (27 CFR Parts 4, 5, and 7). This includes a distilled spirit that is mixed with something else (e.g., vodka mixed with soda water in a can).
  • Beverage wines and wine products containing at least 7% alcohol by volume (abv) and no more than 24% abv.  This includes grape wines, cider, mead, sake, and kombucha, if the alcohol content is at least 7% abv.

Other alcohols and food products containing alcohol that do not fall under the FAA Act jurisdiction are subject to the Standard, as they are subject to the labeling requirements of the FDCA. This includes:

  • Non-beverage products (regardless of the alcohol base), such as salted cooking wines, cooking sprays, or vanilla extract.
  • A malted beverage that is made with other cereal grains and does not include barley with hops (e.g., only malted corn).
  • Wines and wine products that are between 0% abv and 6.99% abv. This may include grape wines, cider, mead, sake, and kombucha if the alcohol content is less than 7% abv.