Bioengineered disclosure, non-GMO claims and verification
| Bioengineered (BE) disclosure | Non-GMO claim | Third-party verification | |
|---|---|---|---|
| Required? | Yes, when the rule applies | No, voluntary | No, voluntary |
| Who oversees it | USDA Agricultural Marketing Service | FDA (absence claims) | The private program you choose |
| What it says | "Bioengineered food", "Contains a bioengineered food ingredient" or the BE symbol | "Not bioengineered", "not genetically engineered" and similar | The program's own mark and standard |
| Rule | 7 CFR Part 66 | FD&C Act 403(a)(1), FDA guidance | The program's rules |
Since the national disclosure law, FDA no longer handles labels that say a food does contain GE content. It kept authority over labels that say a food does not.
What USDA counts as a bioengineered food
The same definition excludes food in which the modified genetic material is not detectable, and USDA's records rules say how to show that. Your records have to cover any ingredient made from a food on USDA's list:
- Alfalfa
- Apple (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
- Sugarcane (Bt insect-resistant varieties)
Foods and businesses exempt from BE disclosure
- Very small food manufacturers, meaning those with annual receipts below $2,500,000
- Food served in restaurants and similar retail food establishments, such as cafeterias, food trucks and delis
- Food certified under the National Organic Program
- Food in which no ingredient intentionally contains a BE substance, allowing up to 5% inadvertent or technically unavoidable BE presence per ingredient
- Meat, milk and eggs are not bioengineered just because the animal ate bioengineered feed
For the 5% allowance, USDA says a record showing an ingredient has 0.9% BE presence or less is not enough on its own, because that amount could have been added on purpose. Sourcing records for a non-bioengineered ingredient plus reasonable steps to keep it separate let USDA presume small traces were unavoidable.
How a bioengineered disclosure looks on the label
| Option | What goes on the package | Rule |
|---|---|---|
| Text | "Bioengineered food" for a single-ingredient or all-BE food, "Contains a bioengineered food ingredient" for others | 7 CFR 66.102 |
| Symbol | USDA's round symbol with the word "BIOENGINEERED", in color or black and white, unchanged | 7 CFR 66.104 |
| Electronic or digital link | "Scan here for more food information" and a phone number, leading to a page with no marketing | 7 CFR 66.106 |
| Text message | "Text [command word] to [number] for bioengineered food information", free, with a one-time reply | 7 CFR 66.108 |
| Small manufacturers only ($2.5M to under $10M receipts) | "Call for more food information" or "Visit [URL] for more food information" | 7 CFR 66.110 |
| Small packages (under 40 sq in) and very small packages (under 12 sq in) | "Scan for info", "Text for info" or "Call for info" | 7 CFR 66.112 |
- Place it on the information panel right next to your name and address, on the principal display panel, or on another panel shoppers will see if those two are full
- Make it big and clear enough to be read under ordinary shopping conditions
- Prepackaged food: the manufacturer or importer is responsible. Food a store packs or sells in bulk: the store is
- Hold on to your records for two years or more beyond the date the food is sold or distributed for retail sale, and give them to USDA within 5 business days when asked
A food made from a listed crop that falls outside the definition, for example because the modified material is not detectable, may say so voluntarily: "derived from bioengineering" or "ingredient(s) derived from a bioengineered source", where "ingredient(s)" may be replaced by the crop or ingredient name.
Parts of the BE rule a court sent back to USDA
Be careful with two parts of the rule. In Natural Grocers v. Rollins, the federal appeals court for the Ninth Circuit held that USDA erred by generally excluding highly refined foods from "bioengineered food". It told the district court to send those rules back to USDA and to decide whether any part of them should be vacated in the meantime. It also directed the district court to vacate, going forward, the electronic or digital link (QR code) and text message options in 66.106 and 66.108, which that court had already found invalid. The court upheld the word "bioengineered" itself.
The text on eCFR has not changed yet. Before you rely on a QR code alone, a text message option, or the exclusion for highly refined oils and sugars, check USDA AMS for the current status. A text or symbol disclosure was not affected by the ruling.
Non-GMO claim wording FDA recommends
FDA's guidance lists statements it considers accurate because they clearly refer to bioengineering:
- "Not bioengineered."
- "Not genetically engineered."
- "Not genetically modified through the use of modern biotechnology."
- "We do not use ingredients that were produced using modern biotechnology."
- "This oil is made from soybeans that were not genetically engineered."
- "Our corn growers do not plant bioengineered seeds."
What about "non-GMO"? FDA prefers the wording above, but says it does not intend to take enforcement action against a label using "GMO" when the food really is not from a genetically engineered plant and the label is otherwise truthful. FDA recommends against "GMO free" and "GE free": "free" means zero, which is hard to prove. FDA has also said it is reviewing this guidance in light of the bioengineered disclosure law, so watch for an update.
How a true non-GMO statement can still mislead
| Situation | Why FDA sees a problem |
|---|---|
| "Does not contain bioengineered soybean oil" on a product made mostly from GE corn flour | Shoppers may think the whole product is free of bioengineered material |
| "None of the ingredients in this food is genetically engineered" when some ingredients, like salt, can't be engineered at all | It may need to be qualified |
| A non-GE claim with pictures suggesting the food is safer or more nutritious because of it | It implies a difference that doesn't come from the claim |
| "Certified non-GE soybean oil" written inside the ingredient list | The ingredient list takes the common name only ("soybean oil"). Put the claim elsewhere on the label |
How to back up a non-GMO claim
- Records of how you grow, store and handle the crop, including how you keep it separate
- Certifications or affidavits from farmers, processors and suppliers, if you buy your ingredients
- USDA organic certification: FDA says it is enough to support a claim that a food was not produced using bioengineering
- Validated tests, which FDA says are more useful for showing BE material is present than that it is absent, and hard to use on highly refined foods like oils
A food that simply doesn't need a BE disclosure is not automatically non-GMO. USDA quotes the law on this:
Third-party non-GMO programs set their own standards and testing. We don't certify or verify products, and USDA does not certify foods as bioengineered or not bioengineered.
Example: which cornbread ingredients need records
Our engine's ingredient statement for a batch of cornbread muffins: Whole milk, enriched bleached flour (wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), yellow cornmeal, canola oil, sugar, eggs, baking powder (sodium bicarbonate, sodium aluminum sulfate, cornstarch, monocalcium phosphate), salt.
| Ingredient | From a food on USDA's list? | What you need |
|---|---|---|
| Yellow cornmeal | Yes, corn | Supplier records showing whether it is bioengineered |
| Canola oil | Yes, canola | Records, including whether the refined oil has detectable modified material |
| Sugar | Possibly: sugarbeet and some sugarcane are listed | Records of the source crop |
| Cornstarch in the baking powder | Yes, corn | Supplier records for the baking powder |
| Whole milk, eggs | No | Not BE because of the animals' feed |
| Flour, salt | No | Nothing for BE |
To print "made with corn that was not genetically engineered", you need records for the cornmeal and for the cornstarch in the baking powder, since that is corn too.
Where our labels fit
Nutrition Label Studio builds your Nutrition Facts panel, ingredient statement and allergen line, with every store-bought ingredient opened up, which is exactly the list you check against USDA's list. It doesn't know where your corn or canola was grown, so it never adds a BE disclosure or a non-GMO claim. Both are decisions you make from your supplier records, and both go on your package artwork.
Make your ingredient statement and label →