GMOs and the National Bioengineered Food Disclosure Standard: Maintaining Compliance

Genetically modified organisms (GMOs) have been a topic of debate for decades, sparking conversations about food safety, environmental impact, and consumer rights. To address concerns about transparency in the food supply, the U.S. Department of Agriculture (USDA) implemented the National Bioengineered Food Disclosure Standard (NBFDS) in 2022. This regulation mandates clear labeling for retail food products containing bioengineered (BE) ingredients, giving consumers more insight into what they are eating. 

In this guide, we will explore what qualifies as a bioengineered food, which products are subject to labeling, and how businesses can comply with the regulations outlined in NBFDS.

What is the National Bioengineered Food Disclosure Standard?

Implemented January 2022, the USDA’s National Bioengineered Food Disclosure Standard (NBFDS), is a mandate aimed at giving consumers more information about the presence of genetically modified foods that they may consume by requiring foods labeled for retail sale to disclose information about BE ingredients.  

The standard applies to any product regulated as a food under the Federal Food, Drug and Cosmetic Act (FDCA), including products regulated by the FDA and USDA, specifically¹: 

• Food manufacturers, importers, and retailers who package and label food for retail or bulk food sales.  
• Products that have or might have BE ingredients.
• Food in which any single ingredient contains more than 5% of a bioengineered substance, regardless of whether its presence is inadvertent or unintentional. 
• Food containing any amount of a bioengineered substance that is not inadvertent or unintentional.

What is a bioengineered food?

A bioengineered food is one that contains genetic material 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 product or ingredient must contain the modified material, so highly refined ingredients with no modified material are exempt, even if they originated from a bioengineered crop.

What is NOT a bioengineered food?

Foods that would not be classified as a bioengineered include: 

• Incidental additives (those not listed as ingredients; e.g., substances that have no technical or function effect at insignificant levels, processing aids, substances migrating to food from equipment or packaging)
• Ingredients or product with no detectable BE genetic material

Proving that a BE genetic material is non-detectable can be done using records showing the ingredient was either made from a non-BE food or refined using a validated process that removes BE genetic material, or testing records showing BE genetic material was not detected. 

Foods considered exempt from the NBFDS: 

• Food or ingredients derived from an animal that consumed BE feed
• Products whose first ingredient is meat, poultry, or eggs
• Products whose first ingredient is water or broth, and second ingredient is meat, poultry, or eggs
• Pet food and animal food. Distilled spirits, wine, malt beverages

Exceptions include: 

• Food served in a restaurant
• Small food manufacturers (< $2.5 million annually)
• USDP National Organic Program (NOP) certified foods

What is the threshold allowance and why does it exist?

The threshold of allowance allows exemptions for inadvertent or technically unavoidable bioengineered material in ingredients under 5% for each ingredient. The threshold exists so bioengineered and non-bioengineered crops can be grown in the same vicinity, recognizing that cross-crop contamination is often unavoidable during harvesting and processing.

What foods and ingredients need to be tested for bioengineered material to meet federal requirements?

Food labeled for retail sale, specifically products in which any ingredient contains more than 5% bioengineered substance, is required to have disclosures about bioengineered materials. 

The current list of BE foods and ingredients derived from such foods² includes: 

• Alfalfa
• Apples (Arctic™ varieties)
• Canola
• Corn
• Cotton
• Eggplant (BARI Bt Begun varieties)
• Papaya (ringspot virus-resistant varieties)
• Pineapple (pink flesh varieties)
• Potato
• Salmon (AquAdvantage®)
• Soybean
• Squash (summer, coat protein-mediated virus-resistant varieties)
• Sugarbeet (Bt insect-resistant varieties)

Ingredients from these foods should be tested for bioengineered material due to the increased risk of unintentional contamination. There is periodic list updates expected, with an 18-month adoption period.  

This tool from the USDA website can help determine if your ingredients require bioengineered material disclosures.

How can companies comply with the NBFDS?

Foods subject to labeling requirements must place a bioengineered food disclosure on the principal display panel or the information panel adjacent to the manufacturer/distributor information³. 

Disclosure can be made using: 

• On-package test, such as “bioengineered food” prominently written on the package
• USDA approved symbol showing “Bioengineered” or “Derived from Bioengineering”
• A digital link, such as a QR code, with clear instructions
• Text message with the statements “text [command word] to [number] for bioengineered food information”

Digital disclosure is the least costly and time-consuming among the options. It allows for labeling updates and flexibility should there be any product changes or new transparency regulations. 

What is the Non-GMO Project?

The Non-GMO Project is a nonprofit organization dedicated to labeling foods as GMO-free. They offer non-GMO certification for products whose ingredients lack genetically modified materials. This is a voluntary program with rigorous standards for verification. 

The core difference between bioengineered food regulations and the Non-GMO Project verification is that one meets regulatory requirements, and one is a marketing tool. There is overlap in the types of products tested with each, however not everything included in the non-GMO verification falls under the bioengineered food regulation. Where the non-GMO verification is voluntary, the National Bioengineered Food Disclosure Standard requires all food products with bioengineered material to include a disclosure.

How do you test to confirm a product is free from bioengineered material and considered non-GMO?

Polymerase chain reaction (PCR) testing is the most widely used and accepted method to search for single or multi-genetic modifications. PCR amplifies small sections of DNA so scientists can detect and measure specific modifications.  

• Qualitative PCR – detects the presence or absence of modified DNA
• Quantitative PCR – reveals how much modified NDA is detectable in a product

How often should I test ingredients and finished products for BE material?

It is a good idea to test early and often. Testing ingredients is important when choosing a supplier to make sure any claims of non-bioengineered ingredients are true before manufacturing starts. Your routine testing timeline depends on the reliability of your supplier and the risk you are willing to take. Key considerations that may influence testing frequency, includes: 

• Using high-risk ingredients derived from products on the BE list
• Reasonable likelihood that the supply chain can be cross contaminated with BE material
• To keep an honest supply chain
• Maintain label integrity
• Reduce liability and protect your brand from getting caught in “gotcha” campaigns

Ensure you're NBFDS compliant

Develop a strategy that starts with a proper evaluation of whether your product falls under the bioengineered food status. A reputable partner in food safety, such as Eurofins Genescan in New Orleans, LA, can help you with that critical analysis.

Connect with an expert.