USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes

Kelley Drye & Warren LLP
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Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered.

The proposed rule applies to specific food products: (1) those foods that meet the definition of “food” under the federal Food, Drug, and Cosmetic Act (FDCA); and (2) foods that are subject to Federal Meat Inspection Act, Poultry Products Inspection Act, or the Egg Products Inspection Act, if those foods’ most predominant ingredients would be subject to the FDCA requirements, or its most predominant ingredient is a broth, stock, water, or something similar, and the second-most predominant ingredient is subject to the FDCA. An example would be a chicken pasta soup where chicken broth is the most predominant ingredient, and pasta is the second-most predominant ingredient.

AMS has identified specific products that would be subject to the rule, based on their presence in the United States market. Foods such as field corn and soybeans that are known to be largely bioengineered and have been highly adopted in the United States. will require a bioengineered disclosure, as will products made from those foods, such as corn meal and soy sauce. Other foods, such as sweet corn and summer squash, are not as highly prevalent in bioengineered forms in the United States and thus have different labeling requirements. However they still require some type of bioengineered disclosure.

Under the proposed rule, disclosure requirements would not be triggered by the use of incidental additives that are made from bioengineered organisms, or food derived from animals that consumed bioengineered feed. In addition, the proposed disclosure requirements would not apply to  food that the USDA has certified as organic.

AMS has proposed a variety of options in terms of how the products can be labeled, and has provided a few different design options as well. Some examples are below:

These labeling requirements are proposed to go into effect on the same dates as the updated FDA labeling rules. For more information about the proposed rule, see our client advisory here.

Comments on this proposal will be accepted until July 3, 2018. AMS does not intend to extend the comment period beyond this date. AMS must provide a final rule by July 29, 2018.

On the same day, the FDA provided a final rule extending the date for required compliance for the final rules for the Nutrition Facts Label and Serving Size Label. Manufacturers that have more than $10 million in annual food sales have an extension from July 26, 2018 to January 1, 2020, and manufacturers with less than $10 million in annual food sales have an extension from July 26, 2019 to January 1, 2021.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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