The U.S. Department of Agriculture issued long-anticipated final rules Thursday for mandatory labeling of bioengineered foods. The National Bioengineered Food Disclosure Standard helps to protect the use of agriculture biotechnology, provide certainty to farmers and the supply chain, and ensure consumers have greater access to food information.  The Standard requires food manufacturers, importers and certain retailers to ensure bioengineered foods are appropriately disclosed.

The bipartisan National Bioengineered Food Disclosure Standard, S.764, crafted by Senate Agriculture Committee Chairman Pat Roberts (R., Kan.) and ranking member Debbie Stabenow (D., Mich.), was signed into law on July 29, 2016. The law has the support of more than 1,000 food and agriculture groups.

Seen as a way to avoid the piecemeal effect of labeling requirements after Vermont passed its own standard on mandatory labeling for foods with genetic material, Congress asked USDA to step in and write a rule to avoid confusing consumers and offer a way for businesses to comply.

In the rule, USDA noted, “The final rule is intended to provide for disclosure of foods that are or may be bioengineered to consumers, but also seeks to minimize implementation and compliance costs for the food industry – costs that could be passed on to all consumers. To that end, AMS [Agricultural Marketing Service] has tried to craft requirements that are clear and straightforward, incorporating flexibility where appropriate.”

Secretary of Agriculture Sonny Perdue noted, “The National Bioengineered Food Disclosure Standard increases the transparency of our nation’s food system, establishing guidelines for regulated entities on when and how to disclose bioengineered ingredients. This ensures clear information and labeling consistency for consumers about the ingredients in their food.”

Roberts said, “We began our work more than three years ago to avert this wrecking ball from wreaking havoc on the entire food chain, and today USDA has done the right thing to ensure agriculture biotechnology will continue to be used by farmers to feed a rapidly growing population.”

The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through lab techniques and cannot be created through conventional breeding or found in nature. As the plain language of the law specifies, the new rule will require disclosure only when foods contain genetic material introduced through bioengineering. That means it does not apply to pure oils, starches, and sugars because they do not contain genetic material even when produced from bioengineered crops.

USDA’s Agricultural Marketing Service (AMS) developed the List of Bioengineered Foods to identify the crops or foods that are available in a bioengineered form throughout the world and for which regulated entities must maintain records. The following foods comprise the List of Bioengineered Foods: alfalfa, apple (Arctic varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet.

The records will inform regulated entities on whether the food must have a bioengineered disclosure to be communicated to consumers. Regulated entities have several disclosure options: text, symbol, electronic or digital link, and/or text message. Additional options such as a phone number or web address are available to small food manufacturers or for small and very small packages.

The statutory definition of “bioengineering” makes clear that food must “contain[] genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques. . . ” to be labeled as a “bioengineered food.”

A multi-ingredient food product that contains meat, poultry, or egg product (including beef broth, if identified as a composite ingredient), as the first ingredient of the ingredient list on the food label would not be subject to the NBFDS, per the amended Act.

A multi-ingredient food product that contains broth, stock, water, or similar solution as the first ingredient, and a meat, poultry, or egg product as the second ingredient on the food label would also not be subject to the NBFDS. For example, a canned stew where pork is the primary ingredient followed by other ingredients such as sweet corn, would not be subject to the NBFDS. The corn may be bioengineered, but pork, which is subject to the labeling requirements of the FMIA (Federal Meat Inspection Act), is the predominant ingredient, so the canned stew product is not subject to the NBFDS, per the amended Act.

If, however, a meat, poultry, or egg product is the third most predominant ingredient or lower, the food would be subject to the NBFDS. For example, a soup with the following ingredient list – broth, carrots, chicken, etc., would be subject to disclosure under the NBFDS, and the analysis as to whether it would be considered a “bioengineered food” subject to the NBFDS’s disclosure requirements would continue.

American Farm Bureau Federation President Zippy Duvall welcomed the proposal, saying Perdue and USDA undersecretary Greg Ibach should be commended for this rule, which follows the intent of Congress while protecting future agricultural innovation. 

“The rule is a victory not only for consumers who want transparency but for the entire food value chain, from the farmer to food manufacturers. It provides clarity to the marketplace so that consumers can make informed decisions on the issues that matter to them, and protects the innovation that is critical to the sustainability of agriculture,”  Duvall said.

The implementation date of the Standard is January 1, 2020, except for small food manufacturers, whose implementation date is January 1, 2021. The mandatory compliance date is January 1, 2022. Regulated entities may voluntarily comply with the Standard until December 31, 2021.

The final rule will be published in the Federal Register on December 21, 2018. Following publication of this rule, USDA will provide outreach and education to inform regulated entities and the public about the new disclosure terms.

The implementation of the Standard concludes a rulemaking process begun in July 2016. AMS gathered information needed to develop the National Bioengineered Food Disclosure Standard and program, in part, through a public comment period. More than 14,000 comments were received and taken into consideration during the rulemaking process. Prior to this, AMS received over 112,000 comments in response to 30 questions provided on the AMS website regarding establishment of the Standard.

Additional information regarding the rule can be found here.