USDA's Bioengineered Food Disclosure Rule — What Manufacturers Need To Know
By Karen Ellis Carr, Arent Fox LLP
On December 21, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS or Agency) issued its final rule establishing a National Bioengineered (BE) Food Disclosure Standard (NBFDS). The rule implements amendments to the Agricultural Marketing Act made by Public Law 114-216 on July 29, 2016 (the Act) and follows an initial request for comment by AMS on June 28, 2017 and publication of a proposed rule on May 4, 2018. This two-part article will summarize key provisions of this new federal marketing standard, including the Agency’s approach to defining “bioengineered foods” and addressing refined ingredients, voluntary labeling, absence claims, and the applicable disclosure threshold.
Outlook
USDA has promulgated a rule that strikes a careful balance between providing additional information to consumers, who have expressed interest in learning more about their food, and hewing closely to the Agency’s statutory mandate, which strictly defines “bioengineering.” Our firm has been closely involved in the legislative process leading to passage of the Act and in implementation of the Act through the rulemaking process.
Compliance Date
The rule sets January 1, 2020 as the “implementation date” for most regulated entities (and January 1, 2021 for “small food manufacturers,” which are those with annual receipts of at least $2.5 million but less than $10 million). All regulated entities may voluntarily comply with the NBFDS until December 31, 2021. During this period, regulated entities may also use their existing label inventories, including labels that are compliant with state labeling laws that were preempted by the Act. Compliance with the NBFDS becomes mandatory for all regulated entities on January 1, 2022.
Responsible Parties
“Regulated entities,” defined as food manufacturers, importers, and certain retailers who label food for retail sale, are responsible for complying with the NBFDS. In addition, importers of BE foods are subject to the requirements of the NBFDS and are required to make appropriate disclosures on the labels of BE foods imported and sold in the United States.
Bioengineered Food
The rule defines “bioengineered food” as containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques for which the modification could not otherwise be obtained through conventional breeding or found in nature. Such bioengineered foods are subject to the BE disclosure requirement, unless exempted. Under the Act, “food” means food as defined under the Federal Food, Drug, and Cosmetic Act “that is intended for human consumption.” Pet food and animal feed are not BE foods and are not subject to disclosure. The Act further specifies that the NBFDS applies only to food subject to FDA’s labeling requirements, including raw and processed foods and dietary supplements, and to USDA’s labeling requirements for meat, poultry, and egg products under certain specified conditions.
Unless they meet FDA’s definition of “incidental additives” or are otherwise exempted, foods produced using BE processing aids and enzymes are also subject to the rule. Refined ingredients or other ingredients that do not contain detectable modified genetic material are not BE foods and are not subject to disclosure.
Refined Ingredients and Modified Genetic Material
AMS has provided regulated entities with three ways to demonstrate that food products do not contain modified genetic material: (1) through verification that a product is sourced from a non-BE crop or food, (2) through verification that the product has been subjected to a refinement process that has been validated to render modified genetic material undetectable, or (3) by maintaining certificates of analysis or other testing records appropriate to the specific product tested that confirm the absence of modified genetic material.
List of Bioengineered Foods
In an effort to simplify compliance, the rule establishes a list of bioengineered foods (the List). The List is intended to include BE foods currently produced domestically and in other countries that could be offered for retail sale in the United States but is non-exhaustive. A regulated entity must comply with the NBFDS when it has actual knowledge that a food is BE or contains a BE food ingredient, whether or not the BE food is on the List.
The rule establishes a process for updating the List on an annual basis. AMS will announce its annual review in the Federal Register and on its website, requesting public comment on recommendations for additions to or deletions from the List. The Agency will use the rulemaking process to make changes to the List. Regulated entities will have eighteen (18) months from the effective date of any List revision to comply.
The current version of the List includes: 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 has prepared fact sheets for each of these foods and is maintaining them on its website with information regarding the specific BE trait, trade names, and links to FDA’s food safety review materials, among other information. The fact sheets are available here: https://www.ams.usda.gov/rules-regulations/be/bioengineered-foods-list
Exemptions
Five categories of foods are exempt from disclosure under the rule.
1. Threshold
One of the rule’s most-watched provisions is the establishment of a threshold for BE content, under which foods are not subject to disclosure. The rule establishes that foods with inadvertent or technically unavoidable presence of BE substances of up to 5 percent for each ingredient are exempt from disclosure. The threshold applies on an ingredient-by-ingredient basis so that if any single ingredient in a multi-ingredient food contains more than 5 percent of a BE substance, the food is subject to disclosure. Stated differently, disclosure is required for foods with any intentional BE content or that contain more than 5 percent of a BE substance for any single ingredient.
2. Foods Served in a Restaurant or Similar Retail Food Establishment
The rule provides clarity on what constitutes a “similar retail food establishment,” which AMS has defined as a cafeteria, lunch room, food stand, food truck, transportation carrier, saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bar, delicatessens, and other food enterprise located within retail establishments that provides ready-to-eat foods that are consumed either on or outside the retailer’s premises. The Agency also clarified that salads, soups, and other ready-to-eat items prepared by grocery stores are exempt from the disclosure requirements.
3. Very Small Food Manufacturers
Manufacturers with annual receipts below $2,500,000 are exempt from the disclosure requirements.
4. Animals Fed with Bioengineered Feed and Their Products
The rule carries forward the statutory prohibition on food derived from an animal being considered a BE food solely because the animal consumed feed produced from, containing, or consisting of a BE substance. But AMS declined to extend that exemption to yeast, rennet, or enzymes produced by fermentation using a BE substrate. Those products remain subject to disclosure unless they meet FDA’s definition of “incidental additive” or if they do not contain detectable modified genetic material. While the Agency indicated that it could not categorically exempt microorganisms in this final rule, it noted that such an exemption would be possible through the factors and conditions process (which will be covered in the next article) in future rulemakings.
5. Food Certified Under the National Organic Program
Foods certified under the National Organic Program, i.e., those bearing certified labels including “100% Organic,” “Organic,” and “Made with Organic,” are exempt from the BE disclosure requirement. Such foods are also permitted under the Act and the rule to be labeled as “non-bioengineered”, “Non-GMO,” or a similar claim. Food products with less than 70 percent organically produced ingredients are not exempt and remain subject to disclosure “because those products may include bioengineered ingredients along with organic ingredients.”
In Part 2, we cover disclosure options, voluntary disclosure, absence claims, administrative issues, and enforcement. The published version of the final rule and preamble (63 pages) can be accessed here:
https://www.govinfo.gov/content/pkg/FR-2018-12-21/pdf/2018-27283.pdf
About The Author:
Karen Ellis Carr is a partner at Arent Fox. She focuses her food and agriculture practice on regulatory counseling and litigation related to products regulated by USDA, EPA, and FDA. Carr works on issues related to biotechnology and other agricultural technologies, pesticides, food safety, advertising, and labeling, and environmental law. In addition to her work with individual companies, Carr has represented a number of industry associations on development and coordination of regulatory strategy, in litigation, and on federal and state legislative issues. She has first- and second-chaired matters in state and federal trial and appellate courts throughout the country and in arbitration and mediation, and has experience in all phases of litigation from pre-litigation strategy and counseling to settlement negotiation and appeals.