Mandatory Bioengineered Food Labeling Rule Went Into Effect on January 1, 2022 – Are You Ready?

By: Amy Wong

Summary: In 2018, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) implemented the National Bioengineered Food Disclosure Standard (NBFDS). While some food companies have voluntarily complied with the NBFDS since 2018, the new regulations make compliance mandatory as of January 1, 2022.

Key Takeaway: The NBFDS is an extensive marketing standard with which every regulated entity should become familiar.  While the USDA does not have authority to issue a recall or impose civil penalties for violations of the NBFDS, the AMS could initiate an investigation and publicly publish the findings of its investigation.  It is also possible that States will adopt the same or similar requirements and impose remedies for violations of their standards, such as damages, penalties, injunctive relief, and attorney’s fees.

Who does the NBFDS apply to?  The new standards apply to food manufacturers, importers, and retailers that package and label food for retail or bulk food sales. Certain foods and entities are exempt from the disclosure requirement: (i) restaurants and similar retail food establishments; (ii) very small food manufactures (less than $2,500,000 of annual receipts); (iii) a food in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable bioengineered presence of up to 5% for each ingredient; and (iv) food certified under the National Organic Program.  (7 C.F.R. § 66.5) 

What are bioengineered foods?  The regulations define “bioengineered food,” in part, as “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.”  (7 C.F.R. § 66.1)

Excluded from the definition of bioengineered food are incidental additives, and ingredients or products in which the modified genetic material is not detectable pursuant to [certain validated tests].”  (7 C.F.R. § 66.1 (1) and (2))

The AMS developed a List of Bioengineered Foods (“the List”), which consists of: Alfalfa, apple (ArcticTM varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet.  (7 C.F.R. § 66.6)  If a food (including any ingredient produced from such food) is on the List, and the records maintained by a regulated entity demonstrate that the food is bioengineered, the regulated entity must make the appropriate disclosures.  (7 C.F.R. § 66.102)  Even if a food or ingredient is not on the List, disclosure is required if the regulated entity has actual knowledge that the food is bioengineered.  (7 C.F.R. § 66.109)  It is important to remember the NBFDS’s definition of “bioengineered food” when deciding whether disclosure is required.  If a food is on the List, disclosure is not required if a processed food derived from the bioengineered ingredient does not contain any detectable modified genetic material that could be considered bioengineered.  (7 C.F.R. § 66.9)  Therefore, it would be prudent for the regulated entity to maintain records to show that modified genetic material is not detectable in the food or ingredient.  (Id.) 

AMS will review the List annually and update it as appropriate.  (7 C.F.R. § 66.7)  AMS will solicit recommendations regarding updates to the List through the Federal Register and on the AMS website.  (Id.) 

Forms of Disclosure: The regulations allow for four types of bioengineered food disclosures: labeling text, a symbol, an electronic/digital link (QR code), or a text-messaging phone number, each with its own specific requirements.  (7 C.F.R. § 66.100(b))  The disclosure must be of “sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions.”  (7 C.F.R. § 66.100(c))

Recordkeeping: Regulated entities must maintain records (electronic or paper) that are customary or reasonable to demonstrate compliance with the disclosure requirements.  (7 C.F.R. § 66.302(a))  Examples of customary or reasonable records include, but are not limited to: supply chain records, bills of lading, invoices, supplier attestations, labels, contracts, brokers’ statements, third party certifications, laboratory testing results, validated process verifications, and other records generated or maintained by the regulated entity in the normal course of business.  (7 C.F.R. § 66.302(a))

If a food (including an ingredient produced from such food) is on the List, the regulated entity must maintain records regarding that food or ingredient.  (7 C.F.R. § 66.302(b)(1))

Even if a food (including an ingredient produced from such food) is not on the List, the regulated entity must keep records if it has actual knowledge that the food or ingredient is bioengineered.  (7 C.F.R. § 66.302(b)(2))

Regulated entities must maintain records of their compliance with the NBFDS requirements for two years after the date the food or food product is sold or distributed for retail sale.  (7 C.F.R. § 66.302(a))

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