On Thursday, December 20, 2018, the U.S. Department of Agriculture (USDA) released a pre-publication copy of the final rule establishing the national bioengineered (BE) food disclosure standard. This rule is the first time that a uniform, federal mandatory standard for the disclosure of genetically modified (GM) foods will be implemented.
In 2016, Congress amended the Agricultural Marketing Act, directing USDA to establish a national uniform marketing standard for bioengineered food products. See 7 U.S.C. §§ 1639—1639j. In the press release accompanying the rule, U.S. Secretary of Agriculture Sonny Perdue stated that the disclosure standard “ensures clear information and labeling consistency for consumers about the ingredients in their food” and “avoids a patchwork state-by-state system that could be confusing to consumers.”
Foods Subject to Disclosure
In general, the disclosure standard applies only to food, as that term is defined under the Federal Food, Drug and Cosmetic Act (FDCA), intended for human consumption and which is subject to labeling requirements under the FDCA. This includes items such as raw produce, seafood, dietary supplements, and prepared foods, such as breads, cereals, frozen foods, beverages, and snacks. The labeling standard also applies to products subject to the labeling requirements of the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, if the predominant ingredient (excluding broth, stock, water, or a similar solution) would independently be subject to the FDCA.
Distilled spirits, wine, and malt beverage subject to the labeling requirements in the Federal Alcohol Administration Act are not subject to the disclosure standard, but beverages not subject to the FAAA, such as wines with less than seven percent alcohol by volume and beers brewed without malted barley and hops, are subject to the disclosure standard.
Definition of Bioengineered Food and the Bioengineered Food List
The disclosure standard defines bioengineered foods as those that “contain [detectable] 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” and is not a food that meets one of the factors and conditions outlined in the final rule or is an incidental additive. This means that foods with undetectable modified genetic material are not bioengineered foods and not subject to the disclosure requirements.
The final rule recognizes that whether a food or ingredient contains modified genetic material may vary depending upon the refining process used to produce the food. Therefore, USDA provides multiple methods to establish that a food or ingredient does not contain detectable modified genetic material. These methods include maintaining (1) records verifying that the food is sourced from non-bioengineered crops or other food sources, (2) records verifying that the food has been subjected to a refinement process “validated” to render modified genetic material undetectable, or (3) certificates of analysis or other testing records that confirm the absence of modified genetic material.
Similar to the proposed rule, USDA has developed a list of bioengineered foods to assist food companies in identifying crops or foods that are available in bioengineered form and which may require disclosure. While the list includes bioengineered foods for human consumption that may be produced anywhere in the world, it should not be considered exhaustive, as new BE foods and products are being developed. Therefore, even if a food is not on the list, food companies with actual knowledge that the food they are selling is BE would need to provide the appropriate disclosure.
Food included on the list are alfalfa, apple (Arctic™ varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virusresistant varieties), pineapple (pink flesh varieties), potato, salmon (AquAdvantage®), soybean, squash (summer), and sugarbeet. This list is supposed to be updated by USDA on a periodic basis through rulemaking.
Threshold of Bioengineered Substance
In the final rule, USDA has established a threshold for the inadvertent or technically unavoidable presence of bioengineered substances of up to five percent (5%) for each ingredient, but does not provide an allowance for any BE presence that is intentional. Thus, when a food contains a single ingredient composed of more than five percent BE substance, regardless of whether it is inadvertent or unintentional, the food is subject to disclosure.
According to the rule’s preamble, USDA believes that setting the threshold amount at five percent balances providing disclosure to consumers with the realities of the food supply chain, allowing for the coexistence of BE and non-BE production systems. This is intended to reduce disruption and supply chain burdens.
Mandatory Disclosure Mechanics
Under the final rule, the disclosure is closely tied to whether a food appears on the list of BE foods. As described above, USDA intends food companies to use the list as a means to determine if a food may be required to bear a disclosure. In the rule’s preamble, USDA states “[i]f a food or food ingredient is on the List of Bioengineered Foods, and the regulated entity’s records show that the food is a bioengineered food or does not indicate whether or not the food is bioengineered, the food must bear a BE disclosure.”
The final rule provides food companies several methods to disclose the BE content of their foods, including through text, symbol, or electronic or digital link. Like the proposed rule, the final rule also includes the option of a text message disclosure as an additional means of compliance.
The BE foods list is used to determine the appropriate text for the disclosure if a food manufacturer chooses this option. Foods that are raw agricultural commodities, foods that have records which indicate the food is bioengineered or do not indicate the bioengineered status, and multi-ingredient foods that are composed only of ingredients on the BE food list and have records which indicate the food is bioengineered or do not indicate the bioengineered status, the text disclosure must be “bioengineered food.” For multi-ingredient foods that contain some ingredients that are not on the BE foods list and others that are on the list and records indicate that the food is bioengineered or do not indicate the bioengineered status, the text disclosure must be “contains a bioengineered food ingredient.”
Unlike the proposed rule, USDA only finalized one symbol for use when a food company opts to disclose through symbol, regardless of whether the food contains both BE and non-BE ingredients.
The final rule also provides additional disclosure options for foods sold in bulk, foods produced by small manufacturers, and foods contained in small and very small packages where labeling space is limited.
The final rule also establishes mechanisms under which food companies may voluntarily disclose the BE content of a product in limited circumstances: (1) when an entity exemption from the mandatory disclosure requirements applies (i.e. very small food manufacturers or restaurants, or similar retail food establishments) or (2) when the food does not meet the definition of “bioengineered food” under the regulation (i.e. does not contain detectable modified genetic material), but is otherwise derived from a bioengineered crop or food. Voluntary labeling is not allowed in any other circumstance or by any other method than those outlined by USDA in the regulation.
This allows for entities, such as very small food manufacturers, restaurants, or similar retail food establishments, to include voluntary disclosure on their labeled products in the same manner as those required under USDA’s rule.
Additionally, food companies may voluntarily disclose BE content in foods or food ingredients derived from the BE foods list. However, companies are prohibited from voluntary disclosure on foods that meet a factor or condition outlined in the standard (i.e. incidental additives), contain less than five percent inadvertent or unavoidable BE presence, are derived from animals fed BE feed, and food certified under the National Organic Program. When making these types of voluntary disclosures, a food company must use the proscribed modified text disclosure “derived from bioengineering” or “ingredient(s) derived from a bioengineered source,” a symbol declaring “derived from bioengineering,” or through electronic or digital link or text message.
Exemptions from the Disclosure Standard
The final rule embraces several exemptions from disclosure that were included in the proposed rule:
- Very Small Food Manufacturer: The final rule defines “very small food manufacturer” as a food manufacturer with less than $2.5 million in annual receipts. USDA notes that this will exempt 74% of food manufacturers and 45% of dietary supplement manufactures from the disclosure requirements. This translates to excluding four percent (4%) of food products, two percent (2%) of dietary supplements, and one percent of both food and dietary supplement purchases.
- Foods Served in Restaurants or Similar Retail Food Establishments: The final rule broadly defines the exemption for “similar retail food establishment” to apply to “cafeteria, lunch room, food stand, food truck, transportation carrier (such as a train or airplane), saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bars, delicatessens, and other food enterprises located within retail establishments that provide ready-to-eat foods that are consumed either on or outside of the retailer’s premises.”
- Foods from Animals Fed Bioengineered Feed: The 2016 legislation prohibits animal-based products such as beef, pork, poultry, eggs and milk from being considered bioengineered foods solely because the animal consumed feeds that contain bioengineered feeds or feed ingredients. Consistent with the legislation and proposed rule, USDA has incorporated this statutory exemption into the final rule.
- Certified Organic Foods: Foods that are certified organic under USDA’s National Organic Program are also exempt from any disclosure or recordkeeping requirements. Note that this exemption does not apply to “products with less than 70 percent organically produced ingredients.”
Recordkeeping and Enforcement
The recordkeeping requirements are closely tied to the BE foods list and USDA requires all entities that manufacture, import or sell food on the BE foods list to maintain records to demonstrate compliance with the disclosure standard. The final rule provides flexibility in the types of records that may be used. The preamble notes that customary business records, such as bills of lading, invoices, supply chain records, and laboratory testing results, should satisfy USDA’s recordkeeping requirements.
The final rule also includes a mechanism under which any interested person may file a complaint with USDA alleging non-compliance with the disclosure requirements. USDA will use these complaints to determine if further investigation is warranted, such as an audit or review of records. Additionally, the final rule outlines the procedures a food company must follow if the company objects to USDA’s audit findings. USDA intends to make public a summary of all final audit results.
USDA has established a phased in implementation and compliance plan for food companies based on size to reduce the regulatory burden of the disclosure standard and provide regulated entities sufficient time to transition their recordkeeping and labeling programs.
By January 1, 2020, regulated entities, other than small food manufacturers, must begin implementing the disclosure standard. Small food manufacturers will have one additional year to begin implementing the disclosure standard. USDA has stated that implementing means identifying the (1) foods subject to disclosure, (2) records necessary for compliance, and (3) type of BE disclosure used on the products.
As for compliance dates, USDA has established a voluntary compliance period and a mandatory compliance date. During the voluntary compliance period, food companies are allowed to use the new BE disclosures on their products prior to the compliance deadline. Unlike the proposed rule, USDA has chosen not to allow companies extra time to use up existing labeling stock of non-compliant labels after the compliance date, and instead have set a hard deadline for compliance. All food companies, regardless of size, must meet the mandatory BE disclosure requirements by January 1, 2022.
Should you have any questions or wish to discuss the impact of the BE disclosure rule on your business, please contact the FDA Regulatory team.