Beginning January 1, 2022, food manufacturers and other regulated entities will be required to comply with the first-ever national label disclosure requirements for bioengineered foods. Issued by the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) on December 20, 2018, the new National Bioengineered Food Disclosure Standard (NBFD or Standard), requires food manufacturers, importers, and other entities that label foods for retail sale, to disclose information about bioengineered food and bioengineered food ingredients. Authorized by the 2016 amendments to the Agricultural Marketing Act (7 U.S.C. § 1621 et seq.) and first proposed in May, the Standard establishes compliance deadlines, defines the scope of the labeling mandate, and creates exemptions for certain entities and products. Notably, the new regulation limits the definition of “bioengineered food” to articles modified using in vitro recombinant deoxyribonucleic acid (rDNA) techniques and therefore excludes products developed using gene-editing or other advanced biotechnology methods that do not rely on rDNA manipulation (e.g. CRISPR and TALENS). At the same time, AMS declines to identify specific technologies either inside or outside of the regulation’s scope, and preserves for itself the continuing right to consider whether foods derived from “new and emerging technologies” meet the definition of “bioengineered food.” See 83 Fed. Reg. 65835 (December 21, 2018). Food manufacturers, technology developers, and other stakeholders should pay close attention to the regulatory definitions and exemptions to identify if and when compliance is required.

Highlights

The Standard adopts a phased compliance approach, establishing both implementation dates and mandatory compliance date:

• Implementation begins on January 1, 2020, for regulated entities (above $10 million in gross receipts), and on January 1, 2021, for small manufacturers (between $2.5 million and $10 million).
• Mandatory compliance for both categories is not required until January 1, 2022.
• The period between implementation and compliance is termed the “voluntary compliance period” during which entities must identify covered products and may (but are not required to) disclose bioengineered foods and ingredients. Regulated entities may achieve voluntary compliance by adding stamps or stickers to their existing label inventories, or by using labels that are already compliant with preempted State labeling laws.

Disclosure is required for foods that contain genetic material that has been modified through in vitro rDNA techniques and that would not have been otherwise possible through traditional breeding methods. Even if covered above, disclosure is excused for:

• Restaurants and retail food establishments.
• Very small manufacturers (less than $2.5 million in annual receipts).
• Refined foods or ingredients if the food does not contain a “detectable amount” of modified genetic material.
• An animal product solely on the basis of the animal’s consumption of bioengineered feed.

To account for crop commingling, the Standard also exempts “inadvertent” or “unavoidable” amounts of bioengineered substances, up to 5 percent for each ingredient.

AMS will maintain a List of Bioengineered Foods for which disclosure is required, but the list is not exhaustive. Regulated entities with actual knowledge that their products are bioengineered as defined in the Standard must make appropriate disclosures.

What is Bioengineered Food?

The Standard incorporates the statutory definition of “bioengineered food,” which means a food “that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature provided that such a food does not contain modified genetic material if the genetic material is not detectable pursuant to § 66.9.” 7 C.F.R. § 66.1. More advanced genetic editing techniques, such as CRISPR and TALENS, that do not involve rDNA manipulation are not covered by the rule’s definition. Importantly, the definition also excludes refined foods in which bioengineered substances are not detectable, as well as those that contain an incidental presence at an insignificant level (up to 5 percent), which do not have any technical or functional effect in the food. This means that refined foods (e.g. sugar, corn syrup) and commingled produce do not trigger the disclosure requirements. The Standard also incorporates the Federal Food, Drug, and Cosmetic Act’s (FFDCA) definition of food as that which is intended for human consumption, and does not apply to meat, poultry, or animal feed products.

Disclosure Requirement

Unless otherwise exempt, the presence of a bioengineered food or food ingredient must be disclosed by the regulated entity. Three categories of entities are responsible under the Standard:

1. Manufacturers.
2. Importers.
3. Certain retailers.

Manufacturers and importers must ensure proper labeling in accordance with the Standard if the food is packaged prior to receipt by the retailer. Alternatively, if the retailer packages the food, or sells food in bulk containers/displays, the retailer must ensure the food bears the proper disclosure. 

Disclosure can take a variety of forms including:

1. Text (either “Bioengineered food” or “Contains a bioengineered food ingredient”).
2. Symbols (see below).
3. Electronic or digital link (e.g. a QR code).
4. Text message. 

Small manufacturers may additionally comply by providing a telephone number or website hyperlink. For foods contained in small or very small packages (defined at 21 C.F.R § 109.9), additional leeway is provided, such as relying on the preexisting website included on the label.

Symbols used for disclosure. Courtesy of USDA.

Exemptions

In addition to the definitional exemptions for refined foods and inadvertent presence discussed above, the Standard exempts the following from the disclosure requirements at 7 C.F.R. § 66.5:

• Food served in a restaurant or similar retail food establishment, including portions of grocery stores and similar retail establishments that prepare food for immediate consumption.
• Very small food manufacturers, defined as those with annual receipts of less than $2.5 million in annual receipts.
• Food products from animals fed with bioengineered feed.
• Food certified under the National Organic Program.

Other Provisions

The standard also includes provisions requiring limited voluntary disclosures for otherwise exempt foods, and for establishing a process to request a further limitation of the definition of bioengineered foods based on additional “factors or conditions.” The Standard provides one such “factor or condition” – foods with incidental additives – and reserves space for additional limitations as may be approved by AMS in the future. Additionally, the Standard mandates that entities disclosing bioengineered foods (by rule or voluntarily) must maintain records for two years beyond the date the product is sold or distributed. The Standard does not specify what records must be maintained, requiring only that entities keep “customary or reasonable” business records which demonstrate compliance. See 7 C.F.R. § 66.302. Lastly, the Standard does not provide AMS with the authority to recall foods or impose civil penalties on entities failing to comply. Instead, AMS may perform records audits and hearings and publicly disclose noncompliance.