Food + Drink

USDA Has Released the Draft GMO (Bioengineered Food) Rule for Comments

By  |  

As a food and beverage producer, you already know that the regulations governing your business can be a little…complex. The USDA’s draft GMO regulations are no exception, so this is a lengthy update.

The quick and dirty is that comments are due by July 3 on everything from which foods should be included to how the government will maintain a list of bioengineered food.

Read on to get a full understanding of the draft regulations and learn how to comment.


Last Friday, May 4, the USDA released its long-awaited draft Rule for disclosing genetically modified ingredients in foods and beverages manufactured for retail sale. The National Bioengineered Food Disclosure Standard Rule (NBFSD Rule) will provide a national uniform standard for disclosing the presence of bioengineered (also known as genetically-engineered or GMO) food so that manufacturers and retailers will not be subjected to the burden of complying with differing and potentially conflicting state laws.

Enacted in 2016, the federal law gave the USDA Agricultural Marketing Service (AMS) two years to devise and implement Rules. In June of last year, the AMS published thirty questions and invited public comment. Now the draft rule is public, and the AMS seeks another round of comments, which must be delivered by July 3.


The Rule introduces a new term, and it’s not GMO

 The USDA found that the more commonly known term, “genetically-engineered” or “GMO,” was not adequately descriptive, so the Rule settled on the word “bioengineered food” to describe “a food that contains genetic material that has been modified through in vitro recombinant DNA techniques” and material that cannot “be obtained through conventional breeding or found in nature.”


The USDA does not consider bioengineered food a safety issue

The USDA has always appeared uneasy about the claim that GMO or bioengineered foods are a public health concern. When asked to opine on the issue in the past, they have pointed out that studies show most bioengineered foods and non-bioengineered foods share nearly identical nutrition content and safety profile. The USDA makes clear in its Rule, therefore, that for the purposes of complying with the law, labeling a food as containing or lacking bioengineered ingredients is a matter of transparency, not safety.


What foods fall under the proposed National Bioengineered Food Disclosure Standard (NBFDS) Rule?

  • The Rule generally applies only to certain foods that fall under the FDA and USDA labeling regulations and which are intended for human consumption (but, of course, with exceptions). This means the Rule applies to most prepared foods (as well as produce), but an the Rule carves out foods with more than one ingredient for which meat, poultry, eggs or catfish are the first or second most predominant ingredient (like in soup, for example). FDA-regulated foods not intended for human consumption, such as pet food, are also excluded from the Rule. 
  • Chewing gum, raw produce, seafood, dietary supplements, breads, cereals, frozen food, snacks, desserts and nonalcoholic drinks will all be subject to the Rule. Maple syrup would technically be subject to the rule as well, but unless a sugarmaker committed the unthinkable and added corn syrup to the maple, no maple syrup is likely to contain bioengineered (“BE”) ingredients. Cheese, however, may come under the rule depending on the final decision regarding enzymes, which will be discussed below.
  • The Rule does not apply to restaurants or “very small food manufacturers,” defined as a manufacturer realizing less than $2.5 million in receipts.
  • The Rule does not apply to any food certified as organic by the National Organic Program.
  • The Rule does not apply to the meat, eggs or other food derived from an animal solely on the basis that the animal was fed BE feed.
  • The Rule specifically identifies the bioengineered foods that must be disclosed when present in foods above a certain threshold percentage:
    • Commercially available bioengineered food that is common and widely used:
      Canola, Field Corn, Cotton, Soybean and Sugar Beets
    • Bioengineered food that is commercially available but not yet common:
      Apples, sweet corn, papayas, potatoes, summer squash varieties


What does the Rule mandate about disclosure?

  • The Rule requires only disclosure of the existence of bioengineered food, not any qualification as to BE foods’ health, safety or environmental impact.
  • The Rule allows manufacturers to choose between disclosure options:
    • A one-sentence disclosure that states the product contains a bioengineered food ingredient
    • Use of a seal yet to be determinedBE logos
    • A QR code together with the words: “Scan here for more food information.” If a QR code is used, there must also be a phone number, with the words “Call for more food information.” The disclosures must be available regardless of the time of day, but a recorded message is deemed sufficient.
    • A study is being conducted to consider disclosure by text.
  • The Rule gives a break to small manufacturers. “Small” manufacturers (earning more than $2.5 million but less than $10 million annually) may opt for any of the disclosures above, or may disclose by a recorded message reached by telephone (without the QR code) or a website. If a small manufacturer chooses disclosure by telephone, it must display on the label the number and the words, “call for more food information.” If the disclosure is by website, the web address must be accompanied by the words, “Visit [website] for more food information.” The website will have to meet certain product information requirements under the rules.
  • The Rule requires the disclosure to be near the name and location of the manufacturer/distributor on either the front (principal display) panel or the information panel. (Additional options are available for products with very small packages, eg, “Text for info”).
  • The Rule requires certain disclosure language for certain products.

For foods that contain one of the ingredients list above as commercially available bioengineered food that is common and widely used, called “high adoption bioengineered food,” the statement must say that the food “contains” a bioengineered food ingredient or that the food “is” a bioengineered food.The disclosure cannot state that the food “may” contain bioengineered ingredients, for anything containing these foods.

For foods that are a “non-high adoption BE food,” the Rule’s language for the list of bioengineered foods that are commercially available but not yet common, the label can state that it “may be bioengineered food,” or “may contain a bioengineered food ingredient,” if the producer isn’t certain if all the product or ingredient is bioengineered. Of course, if the producer does know that the product is bioengineered, then the disclosure must say so.

  • The Rule does not require additional document retention.
  • For foods that display a BE disclosure, producers do not otherwise need to maintain documented verification that he food is a BE food, other than the records the producer is already required to maintain.
  • The Rule places some requirements on retailers.
  • In the case of bulk foods, the burden falls on the retailer to make the disclosures.

The USDA seeks further input for the final rule

Highly processed foods: The USDA is still deciding whether to exempt highly processed foods, such as high-fructose corn syrup, sugar made from sugar-beets, corn, canola and soybean oils, and it seeks further comment on the question. Studies indicate that extensive refining of a food breaks down the DNA to such an extent that bioengineered and non-bioengineered highly-refined foods are nearly identical at the molecular and chemical levels.

Incidental Additives:  The USDA seeks comment on whether incidental additives should trigger disclosure. Incidental additives are additives “present in food at an insignificant level and do not have any technical or functional effect in the food.” Incidental additives are currently exempt from most FDA labeling requirements.

Thresholds: Similarly, the USDA has not decided whether labeling will be required regardless of the amount of bioengineered food present or whether a smaller amount (between 0.9 or 5 percent of the finished product’s weight) may not require disclosure. Some threshold discussion involves the practical realities of the food supply chain.

Undetectable Recombinant DNA: The USDA seeks comment on whether the NBFDS should exclude food where the modified genetic material cannot be detected.

Enzymes.  Bioengineered enzymes, yeast and similar foods used in the production of baked goods, fermented foods and yogurts may not have to be disclosed. The USDA seeks further common on this matter.

List of bioengineered foods.  At present, the BE foods list is only proposed. The AMS proposes a process by which the list would be maintained and revised and how they might treat technologies as they develop.


Comments on the Rule are due July 3, 2018. If you want to participate in developing joint comments for submission, give me a call at 802-658-0220 or e-mail me at and keep an eye on this blog for further developments as they arise.