The National Bioengineered Food Disclosure Standard (NBFDS) is designed to provide consumers with more information about the foods they purchase. It mandates that food manufacturers, importers, and certain retailers disclose whether food offered for retail sale is bioengineered (BE) or contains bioengineered food ingredients. Let’s delve into the specifics of this standard and what it means for you.
Defining Bioengineered Foods
The Standard defines bioengineered foods as those containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques. Crucially, this modification couldn’t be achieved through conventional breeding or found naturally. This distinction is key to understanding the scope of the regulation.
Key Dates: Effective vs. Mandatory Compliance
It’s important to understand the difference between the effective date and the mandatory compliance date. The effective date marks when the published Final Rule becomes operative. The mandatory compliance date signifies when all foods entering commerce must be labeled in accordance with the Standard. This is also the date when regulated entities using food on the List of Bioengineered Foods are required to maintain records.
“Entered Commerce” Defined
USDA considers a food to have “entered commerce” on the date it is labeled for retail sale. This clarifies the point at which the labeling requirements apply.
How Long Can Non-Compliant Labels Remain?
The Standard mandates that all foods entering commerce after the mandatory compliance date must be labeled accordingly. It does not regulate how long foods labeled before this date can remain on store shelves.
Who Must Comply? Identifying Regulated Entities
Regulated entities, defined as food manufacturers, importers, and certain retailers who label food for retail sale, must comply with the Standard. However, the law excludes restaurants and similar retail food establishments (e.g., cafeterias, food trucks, airplanes). Very small food manufacturers, with annual receipts of less than $2,500,000, are also exempt. Notably, dietary supplements are included in the definition of food covered under the standard, so their manufacturers and importers must adhere to the disclosure requirements.
Application to Bakeries and Similar Establishments
The Standard doesn’t apply to restaurants and similar retail food establishments. This exemption covers all restaurant-type foods sold within these establishments, whether standalone or part of a larger retail setting. So, a bakery selling single-serving salads or sandwiches within a grocery store is considered a restaurant when selling those items. However, foods not intended for immediate consumption, such as loaves of bread or bags of rolls, are subject to the Standard.
Products Subject to NBFDS Disclosure Requirements
Bioengineered foods, or foods containing bioengineered food ingredients, necessitate a bioengineered food disclosure. This hinges on the definition of bioengineered foods: those containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques where the modification couldn’t be achieved through conventional breeding or found naturally. Highly refined foods or ingredients lacking detectable modified genetic material are not considered bioengineered foods.
The List of Bioengineered Foods: A Key Resource
The List of Bioengineered Foods identifies foods authorized for commercial production and in legal production globally. It serves as a reference for regulated entities to determine which foods require record-keeping and potentially necessitate BE disclosures.
The List includes:
- Alfalfa
- Apple (ArcticTM varieties)
- Canola
- Corn
Alt text: Cross-section of an Arctic Apple, showcasing its non-browning trait.
- Cotton
- Eggplant (BARI Bt Begun varieties)
- Papaya (ringspot virus-resistant varieties)
- Pineapple (pink fleshed varieties)
- Potato
Alt text: Close-up of a pile of Yukon Gold potatoes, showcasing their smooth skin and yellow flesh.
- Salmon (AquAdvantage®)
- Soybean
- Summer Squash
- Sugarbeet
The list may include trade names for single-producer bioengineered foods like ArcticTM Apples or AquAdvantage® salmon to simplify compliance. Even if a food isn’t on the List, regulated entities must disclose it if their records indicate it is bioengineered. The AMS website provides updated information on crops and foods on the List, including details about specific varieties.
Processed Foods and Disclosure
Whether an ingredient derived from a bioengineered food (corn, canola, or soybeans) requires disclosure depends on whether it contains detectable modified genetic material. If ingredients like corn starch, canola oil, and soy lecithin contain detectable modified genetic material, they are considered bioengineered food ingredients and require disclosure. However, highly refined ingredients where the modified genetic material is no longer detectable do not require disclosure.
Animal Products and Bioengineered Feed
Food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because of the feed. For instance, milk from a cow that consumed bioengineered alfalfa is not automatically classified as bioengineered.
List Updates and Public Input
USDA will update the List as needed to reflect the current availability of bioengineered foods. This process involves coordination with other Federal regulatory agencies and annual reviews. Public input is encouraged on an ongoing basis to ensure the List remains relevant and accurate. The Standard also outlines a rulemaking process to determine if certain “factors and conditions” may exclude specific foods from being considered bioengineered.
Determining Detectable Modified Genetic Material
Regulated entities can determine that modified genetic material is not detectable through three methods: verifying the food is sourced from a non-bioengineered crop, verifying the food has undergone a validated refinement process, or maintaining certificates of analysis confirming the absence of detectable modified genetic material.
Impact on Foreign Trade
The Standard aims to avoid disrupting trade by applying the same requirements to both domestic and foreign entities. During the rulemaking process, USDA sought input from all stakeholders regarding unique issues associated with bioengineered food disclosure for imports. The proposed rule was notified to the World Trade Organization for comments from trading partners. USDA’s Foreign Agricultural Service assists countries importing food into the United States in understanding the Standard’s requirements.
AMS Website Information
The AMS website provides information to help regulated entities identify which varieties of foods on the List may be bioengineered. This includes specific information about traits, varieties, and production information to assist in determining whether a BE disclosure is necessary.
Reporting Non-Compliance
Anyone suspecting a violation can file a written complaint with the AMS Administrator via mail or the AMS website.
Products Supplied to Foodservice End Users
If a regulated entity supplies product to a distributor who exclusively serves foodservice end users, the product manufactured by the regulated entity and sold by a distributor exclusively to a foodservice establishment does not require the BE disclosure. This is because the Standard exempts food served in a restaurant or similar retail food establishment.
Allowable Percentage of Recombinant DNA
The Standard includes an exemption for foods in which no ingredient intentionally contains a bioengineered substance, allowing for inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient. However, if a food manufacturer intends to use a highly refined ingredient produced from a bioengineered food but doesn’t refine it to the point where modified genetic material is no longer detectable, that ingredient still requires disclosure, regardless of the amount of modified genetic material remaining.
Sufficient Records for Compliance
Disclosure is required for food that is a bioengineered food or contains a bioengineered food ingredient. Regulated entities must keep records demonstrating compliance with the disclosure requirements. If current records align with the definition of bioengineered food and appropriate disclosures are made, those records should be sufficient.
Validated Refining Processes
Once a refining process has been validated to render modified genetical material in a food undetectable, additional testing isn’t necessary, provided no significant changes are made to the process and records are maintained. Validation refers to the process, not the facility, meaning a validated process doesn’t need revalidation when completed in a different facility. AMS doesn’t maintain a list of validated refining processes.
Threshold for Inadvertent Presence
The Standard exempts from disclosure a food in which no ingredient intentionally contains a bioengineered substance, allowing up to five percent inadvertent or technically unavoidable bioengineered presence for each ingredient. If records indicate a regulated entity sourced a non-bioengineered ingredient and took reasonable precautions to keep bioengineered and non-bioengineered ingredients separate, AMS may presume that any bioengineered presence below five percent is inadvertent or technically unavoidable.
Enzymes, Yeasts, and Other Micro-Organisms
If a regulated entity has actual knowledge that a food is a bioengineered food or contains a bioengineered food ingredient, it must make an appropriate disclosure. For foods not on the AMS List, if records demonstrate they have actual knowledge they are using a bioengineered version of these foods, then they must make a disclosure.
Component Ingredient Statements
When a product label has a component ingredient statement (e.g., FILLING: PORK, ONION, CABBAGE, CORN, SALT, SUGAR. WRAPPER: WHEAT FLOUR, WATER.), AMS will consider the ingredients in the order they appear on the ingredient list for purposes of applying 7 CFR 66.3(b).
Impact of the SECURE Rule
The final SECURE rule (7 CFR 340) does not impact labeling requirements under the National Bioengineered Food Disclosure Standard (NBFDS). Although both evaluate products based on what is possible through conventional breeding, SECURE is a regulatory rule considering plant pest risk, while NBFDS is a marketing standard providing consumers information.
USDA Approved Laboratories
USDA does not maintain an approved list of labs to test modified genetic material (rDNA). USDA published guidance documents on validation of a refinement process and selection of a test method on the AMS BE disclosure webpage.
Sandwiches and the Standard
Even if meat is the first ingredient in a closed-face sandwich, the sandwich is subject to the Standard because it’s subject to the labeling requirements of the FDCA.
USDA Certification
USDA does not certify foods to be bioengineered or non-bioengineered. The Standard requires disclosure for foods that are or may be bioengineered. While the Standard does not require any absence claims, it does state at 7 USC 1639c(c) that “a food may not be considered to be ‘not bioengineered’, ‘non-GMO’, or any other similar claim describing the absence of bioengineering in the food solely because the food is not required to bear a disclosure that the food is bioengineered.”
Alcoholic Beverages
Certain beverages containing alcohol are not subject to the labeling requirements of the FDCA. The alcohol products below are subject to the labeling provisions of the Federal Alcohol Administration Act (FAA Act) and are not subject to the Standard: All beverage spirits, malt beverages, and their products regardless of the alcohol content. Beverage wines and wine products containing at least 7% alcohol by volume (abv) and no more than 24% abv.
Other alcohols and food products containing alcohol that do not fall under the FAA Act jurisdiction are subject to the Standard, as they are subject to the labeling requirements of the FDCA.
Alcohol as an Ingredient
If the rum cake or other products you produce are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA), then your products are subject to the Standard and must include a bioengineered food disclosure if you use any bioengineered foods or bioengineered food ingredients.
Meat and Poultry Broths
The Standard applies to food subject to (1) the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) or (2) food subject to the labeling requirements under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA) if the most predominant ingredient of the food would independently be subject to the FDCA; or the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA.
Pizza
Here, if the pizza is subject to the FDCA, the product would be subject to the Standard and would require a disclosure if any of the ingredients are bioengineered, unless you maintain records that demonstrate the food does not meet the definition of a bioengineered food, found at 7 CFR 66.1. If the pizza is subject to the FMIA, PPIA, or EPIA, you would then look to the most predominant ingredient to determine if the product is subject to the Standard. Crust is subject to the labeling requirements of the FDCA, and accordingly, even if this were an FSIS regulated product, the pizza would be subject to the Standard.
Conclusion
Understanding the National Bioengineered Food Disclosure Standard (NBFDS) is crucial for both consumers and food industry professionals. By providing clear definitions, outlining compliance requirements, and offering resources for further information, the USDA aims to promote transparency and informed decision-making in the food marketplace. For further questions or more specific information, you can email [email protected].
