Are Your Labels Up to Date? Ensuring Compliance With the USDA’s National Bioengineered Food Disclosure Standard
The Situation: The National Bioengineered Food Disclosure Standard, promulgated by the U.S. Department of Agriculture, went into effect on January 1, 2022.
The Result: Food manufacturers, importers, and other entities that label foods for retail sale must now disclose information about bioengineered foods and ingredients on product labels and keep adequate records of any disclosures.
Looking Ahead: Companies should continue to evaluate their products to determine whether they are required to follow the labeling and recordkeeping requirements of the National Bioengineered Food Disclosure Standard.
Effective January 1, 2022, food manufacturers must now comply with the U.S. Department of Agriculture ("USDA")'s National Bioengineered Food Disclosure Standard, 7 CFR Part 66 (the "BE Disclosure Standard" or the "Rule"). The purpose of the Rule is to provide consumers with uniform information about bioengineered ("BE") foods, which are foods that contain "genetic material that has been modified through in vitro recombinant [DNA] techniques" and "for which the modification could not otherwise be obtained through conventional breeding or found in nature." In practice, the Rule requires "food manufacturers, importers, and other entities that label foods for retail sale" to disclose information about BE foods on product labels and to keep adequate records. Now is a good time for companies to confirm they are complying with all requirements of the BE Disclosure Standard.
Foods Subject to the Rule
The Rule generally applies to all products that the U.S. Food and Drug Administration views as "food … intended for human consumption," including conventional foods and beverages, dietary supplements, processing aides, and enzymes. It does not apply, however, to a number of explicitly identified foods, including pet foods, beverages regulated by the U.S. Alcohol and Tobacco Tax and Trade Bureau with more than 7% alcohol, and foods with primary ingredients that are regulated by the USDA, such as meat and poultry.
The Rule also contains a number of disclosure exceptions. First, it expressly exempts food served in restaurants and food from very small food manufacturers, defined as those with less than $2.5 million in annual receipts or 50 or fewer employees. Second, the Rule excludes from disclosure "the inadvertent or technically unavoidable presence" of BE ingredients if a food unintentionally contains less than 5% of a BE substance. Third, the Rule excludes foods derived from animals that consume BE foods, such as milk from a cow that was fed BE alfalfa. Fourth, the Rule excludes foods certified as organic by the USDA National Organic Program ("NOP").
Additionally, the Rule seemingly excludes ingredients subjected to modern gene-editing technologies, such as CRISPR, which do not appear to fall squarely within the Rule's definition of BE, as such technologies do not always require the insertion of foreign DNA and can be achieved through conventional breeding. That being said, determining what can be achieved through "conventional breeding" is not always straightforward, and we anticipate confusion—along with discussion and debate—in the market regarding the distinction between gene-edited ingredients, which fall outside the plain language scope of the BE Disclosure Standard, and BE ingredients.
How to Comply With the Rule
To help companies comply with the requirements of the Rule, the USDA maintains a non-exhaustive list of BE foods (the "List"). Regulated companies must disclose all foods and ingredients included on the List (unless, as detailed below, the company can demonstrate the ingredient it uses is not BE), as well as ingredients not included on the List but that the company knows to contain BE materials. The List currently includes alfalfa, canola, corn, cotton, potato, soybean, and sugarbeet, as well as certain varieties of apple, eggplant, papaya, pineapple, salmon, and squash. If a company is unsure whether a product requires disclosure, they can complete a short questionnaire published by USDA for more information.
To the extent a BE food or ingredient disclosure is required, regulated companies have four disclosure options. First, companies can place text on the product label that states "Bioengineered Food" for single-ingredient BE foods, or "Contains a bioengineered food or ingredient" for multi-ingredient BE foods. Second, companies can include the approved BE Disclosure Standard symbol on the label. Third, companies can utilize an electronic or digital link on the label, accompanied by text stating "Scan here for more food information." The link must (i) take the consumer directly to the product information page, (ii) include the BE food disclosure text or symbol, (iii) not collect information about the consumer or their device, and (iv) include a telephone number the consumer can call for more information. Finally, companies can make the disclosure via text message by including "Text [command word] to [number] for bioengineered food information" on the label and providing a phone number that sends an immediate response to the consumer's device.
The Rule also requires companies to maintain adequate records of BE foods and ingredients. If a BE food disclosure is required and made, the company records should identify the BE food or ingredient. If a food or ingredient is on the List but the company does not believe a disclosure is required, the company records should demonstrate the rationale, such that (i) the food is made from a non-BE food, such as NOP certified organic food, (ii) the food has been refined using a process validated to render the BE material undetectable, or (iii) the food was tested to confirm the absence of detectable BE material. The Rule allows companies to decide its records storage format , but requires all companies to maintain records for at least two years and to produce records within five business days when requested by the USDA.
With the BE Disclosure Standard now in effect, food manufacturers and importers should evaluate their products to determine whether they require BE disclosures under the Rule, if they have not done so already. If disclosures are required, companies should adequately revamp their product disclosure and recordkeeping procedures in order to ensure compliance. Brands that fail to adequately comply with the Rule may face threats of private litigation under state consumer protection and false advertising laws.
Two Key Takeaways
1. Absent any applicable exception in the BE Disclosure Standard, food manufacturers, importers, and other entities that label foods for retail sale must disclose information about bioengineered foods and ingredients on product labels. Companies can consult the USDA's non-exhaustive list of bioengineered foods to understand whether they are required to make any disclosures under the new standard.
2. If a company makes a disclosure for a food product according to the new standard, they must also maintain adequate records of the bioengineered food and/or ingredient used in the product. If a company sells a product containing a bioengineered food or ingredient but does not make a disclosure, they must maintain a record explaining the rationale for not disclosing the bioengineered food or ingredient.
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