On December 21, 2018, the Agricultural Marketing Service (“AMS”) of the United States Department of Agriculture (“USDA”) issued its long-anticipated final rule establishing requirements for the disclosure of food that is bioengineered (“BE”) or contains a BE ingredient. Failure to include a required label disclosure is prohibited. Key elements of the Final Rule are summarized below.
The Final Rule applies to: (1) all human food that is subject to the labeling requirements of the Federal Food, Drug and Cosmetic Act; and (2) some foods regulated by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act or the Egg Products Inspection Act, as long as the predominant ingredient in the food would be regulated by the Food and Drug Administration. The entity that packages the food (which may be the manufacturer, importer or retailer) is responsible for compliance with the disclosure requirement.
Definition of Bioengineered Food
“Bioengineered Food” is food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid techniques, and the modification could not otherwise be obtained through conventional breeding or found in nature.
List of Bioengineered Foods
The Final Rule establishes a single, consolidated list of foods that are currently available in bioengineered form:
- 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.
AMS will review this list annually and will consider updates as necessary through rulemaking. Importantly, the list is not considered exhaustive, and companies must make appropriate disclosure for foods they sell which they know to be bioengineered, even if those foods do not appear on the list.
Exemptions and Exclusions
Certain entities and foods/ingredients are not subject to disclosure requirements:
- Food served in a restaurant or similar retail food establishment. Exempt entities include traditional food establishments such as cafeterias, lounges and lunch rooms, as well as food trucks, transportation carriers and locations within retail establishments that provide ready-to-eat foods for immediate consumption on or outside the premises.
- Very small food manufacturers (defined as having annual receipts of less than $2.5 million).
- Incidental Additives. The Final Rule exempts incidental additives – i.e., additives present in a food at an insignificant level and which do not have any technical or functional effect in the food – from the definition of bioengineering (and thus from disclosure), thereby aligning BE disclosure requirements with FDA ingredient declaration requirements.
- Refined foods without detectable modified genetic material. The definition of “BE food” does not include – and disclosure is not required for – refined foods or ingredients derived from BE sources (such as high fructose corn syrup), if those foods or ingredients do not contain detectable modified genetic material. Companies may rely on a variety of methods to demonstrate the absence of detectable modified genetic material, including records verifying the food is sourced from a non-bioengineered crop, records verifying that the food has been subjected to a refinement process validated to render modified genetic material undetectable or certificates of analysis or other testing records.
- Animals fed with BE feed and their products. Products like milk and eggs will not be considered BE solely because the animals from which they are sourced consumed BE feed.
- Food certified under USDA’s National Organic Program. This exemption covers foods eligible to bear the claims “100% organic,” “organic” or “made with organic ingredients”.
- Food in which no ingredient intentionally contains a BE substance, with a permissible threshold for the inadvertent or technically unavoidable BE presence of up to 5% for each ingredient.
The Final Rule permits voluntary disclosure in limited circumstances:
- If a food is subject to disclosure, entities that are exempt from the rule may voluntarily provide that disclosure in the same manner as non-exempt entities.
- A company making a food that contains a refined product originating from BE crops but without any detectible modified genetic material may voluntarily disclose that the product is “derived from bioengineering.”
Mandatory Disclosure Options
Where BE disclosure is required, companies may use any of the following methods (modified requirements apply to small and very small packages, food sold in bulk containers and small food manufacturers):
- On-pack text statement. The statement must read either: (a) “bioengineered food” if the food is itself BE or contains only BE ingredients; or (b) “contains a bioengineered ingredient” for a multi-ingredient food where some, but not all, ingredients are BE. A “may contain” statement is not permitted.
- On-pack symbol. AMS has adopted the symbol (seen here) for mandatory disclosure, which may be used in color or in black and white (a separate symbol is available for voluntary disclosure).
- Electronic or digital link. This disclosure must consist of a link (such as a QR code or other technology) accompanied by the statement “scan here for more food information” (or equivalent language) and a telephone number that will provide the BE disclosure to the consumer at any time of day (which must be accompanied by the statement “Call [number] for more food information”). The link must provide the BE disclosure on the first page product information accessed through the link.
- Text message. A text message disclosure must state, on the label, “Text [command word] to [number] for bioengineered food information.” The automated response must provide the same disclosure statement as required for on-pack text disclosures.
Regulated entities must maintain customer or reasonable records to demonstrate compliance with the BE disclosure requirements. Entities have flexibility to determine which records are appropriate, as long as the records contain sufficient detail as to be readily understood and audited.
The implementation date is January 1, 2020 for all regulated entities other than small manufacturers and January 1, 2021 for small manufacturers. Mandatory compliance for all regulated entities begins on January 1, 2022.