December 21, 2018

USDA Publishes Final Rule Establishing GMO Disclosure Requirements

The U.S. Department of Agriculture (USDA) published the final rule establishing a National Bioengineered Food Disclosure Standard on December 20, 2018.  The rule requires food makers, including food manufacturers, importers and certain retailers who package and label food for retail sale or sell bulk food items, to label foods containing bioengineered, also referred to as genetically modified or GMO, ingredients.  The USDA issued the final rule two years after the National Bioengineered Food Disclosure Law was passed by Congress in 2016 and seven months after the USDA published the proposed rule and solicited public comments.  The final rule closely follows the language of the proposed rule. 

The final rule requires food makers to put labels on packages of foods made with bioengineered or GMO ingredients.  Instead of the term GMO, however, the USDA exclusively uses the term “bioengineered” or “BE foods.”  The statutory definition of a bioengineered food provides that the food must contain genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.  The threshold for whether a food contains bioengineered ingredients is the inadvertent or technically unavoidable presence of bioengineered substances of up to 5% for each ingredient.  Notably, foods with undetectable amounts of modified genetic material do not meet the definition of bioengineered foods.  As such, companies will not be required to label highly-refined ingredients that come from BE crops.  That means things like cane sugar, corn syrup, and processed vegetable oil could be exempt from the labeling process, or be labeled on a voluntary basis.   

Food companies will have four options to make BE disclosure: on-package text, electronic or digital disclosure, text message disclosure, or a USDA-approved symbol.  Failure to make a required disclosure is prohibited, and complaints of possible violations may be made to the Agricultural Marketing Service, which may investigate and conduct a records audit.  The determination of the audit will be made public. 

Implementation of the standard begins January 1, 2020 (or January 1, 2021, for food manufacturers with less than $10,000,000 in annual receipts), by which date regulated entities should identify the foods that will need to bear a BE disclosure, the records necessary to meet the recordkeeping requirements, and the type of BE disclosure they will use on their products.  The mandatory full compliance date is January 1, 2022. 

The final rule is published in the Federal Register and available online at


Allison Klein contributed to this alert.