The National Bioengineered Food Disclosure Standard (NBFDS) mandates that food manufacturers, importers, and certain retailers disclose whether food products for retail sale are bioengineered (BE) or contain BE food ingredients. This standard aims to give consumers more clarity about the food they purchase. Let’s delve into the details of what this means for you.
Understanding Bioengineered Foods
The NBFDS defines bioengineered foods as 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.
Effective vs. Compliance Dates
It’s important to distinguish between the effective date, when the Final Rule becomes operative, and the mandatory compliance date, when all foods entering commerce must be labeled accordingly and regulated entities must maintain necessary records.
What Does “Entered Commerce” Mean?
The USDA considers food to have “entered commerce” when it is labeled for retail sale. This is the trigger for labeling compliance.
Shelf Life of Non-Compliant Labels
The Standard mandates compliant labeling for foods entering commerce. However, it does not regulate how long foods labeled before the mandatory compliance date can remain on store shelves.
Who Needs to Comply?
Regulated entities, including food manufacturers, importers, and specific retailers who label food for retail sale, are required to comply with the Standard.
Exemptions
- Restaurants and Similar Retail Food Establishments: This includes cafeterias, food trucks, and airplanes. However, they may voluntarily comply.
- Very Small Food Manufacturers: Those with annual receipts of less than $2,500,000 are exempt.
- Restaurant-type foods in larger retail: A bakery within a grocery store selling single-serving items (salads, muffins, sandwiches, soup) for immediate consumption is considered a “similar retail food establishment.” Multi-serving items (containers of muffins, loaves of bread) are subject to the Standard.
Dietary Supplements
The law encompasses dietary supplements, making their manufacturers and importers subject to the disclosure requirements.
Which Products Must Comply?
Bioengineered foods and foods containing bioengineered food ingredients must be labeled with a bioengineered food disclosure.
Defining Bioengineered Foods Again
Bioengineered foods, as defined by the Standard, contain detectable genetic material modified through in vitro recombinant DNA (rDNA) techniques that cannot be obtained through conventional breeding or found in nature.
Highly Refined Foods
Highly refined foods or ingredients lacking detectable modified genetic material are not considered bioengineered foods and do not require labeling.
The List of Bioengineered Foods
The List of Bioengineered Foods identifies foods authorized for commercial production and in legal production globally. This list helps regulated entities determine which foods necessitate record-keeping and potential BE disclosures.
Current List Includes:
Alfalfa, apple (Arctic™ varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-resistant varieties), pineapple (pink fleshed varieties), potato, salmon (AquAdvantage®), soybean, summer squash, and sugarbeet.
Caption: Alfalfa, one of the bioengineered foods on the USDA’s list, often used as animal feed.
Trade Names
When a bioengineered food is produced by a single company, like Arctic™ Apples or AquAdvantage® salmon, the AMS includes the trade name on the List for compliance simplification.
Responsibility
Regulated entities must disclose bioengineered foods even if they are not on the List, as long as their records indicate the food is bioengineered. The AMS website offers regularly updated information to assist with identification.
Processed Forms of Food on the List
The need for bioengineered food disclosure for ingredients derived from bioengineered foods (e.g., corn, canola, soybeans) depends on whether the ingredient contains detectable modified genetic material.
Detectability is Key
If ingredients like corn starch, canola oil, or soy lecithin contain detectable modified genetic material, they are considered bioengineered food ingredients and require disclosure. Conversely, highly refined ingredients where the modified genetic material is undetectable 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 animal’s diet.
Example
Milk from a cow that consumed bioengineered alfalfa is not considered a bioengineered food due to the feed.
Updating the List
The USDA updates the List periodically to reflect the availability of bioengineered foods.
Coordination
The USDA collaborates with other federal regulatory agencies involved in biotechnology regulation before updating the List. Public input is continuously welcomed, and annual reviews are conducted to amend the List as necessary.
Rulemaking
The Standard includes a rulemaking process to determine whether specific “factors and conditions” may exclude certain foods from being classified as bioengineered.
How to Determine Detectable Modified Genetic Material
Regulated entities can determine the absence of detectable modified genetic material in three ways:
- Records verifying the food is sourced from a non-bioengineered crop.
- Records confirming the food underwent a refinement process validated to render modified genetic material undetectable.
- Certificates of analysis or testing records confirming the absence of detectable modified genetic material.
Impact on Foreign Trade
The Standard aims to avoid trade disruption by applying the same requirements to both domestic and foreign entities. The USDA sought stakeholder feedback regarding unique issues concerning bioengineered food disclosure for imports during the rulemaking process. The proposed rule was notified to the World Trade Organization for comments from trading partners.
Information on the AMS Website
The AMS website provides information designed to help regulated entities identify varieties of foods on the List of Bioengineered Foods that may be bioengineered.
Caption: The USDA (United States Department of Agriculture) logo, the organization responsible for maintaining the NBFDS.
Details Included
Specific information about traits, varieties, and production information (location) will 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 on the AMS website.
Product Supplied to Foodservice End Users
If a regulated entity supplies a product to a distributor who exclusively serves foodservice end users (restaurants), the manufactured product does not require a BE disclosure, provided it is served in a restaurant or similar retail food establishment.
Allowable Percentage of Recombinant DNA
The Standard allows for inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient in foods where no ingredient intentionally contains a bioengineered substance.
Example
If non-bioengineered corn contains less than 5 percent of a bioengineered substance due to unavoidable circumstances, disclosure is not required. However, if a food manufacturer intends to use a highly refined ingredient from bioengineered corn but doesn’t refine it enough to eliminate detectable modified genetic material, disclosure is still required.
Specifications and Records
If current records and specifications on ingredients align with the definition of bioengineered food and disclosures are made accordingly, those records should suffice for compliance.
Validating Refining Processes
The requirements for validating a refining process are explained in 7 CFR 66.9(b). Once a refining process has been validated to render modified genetic material undetectable, further testing is unnecessary, provided no significant changes are made to the validated process and that records are maintained. Validation refers to the process, not the facility.
AMS List of Validated Refining Processes
The AMS does not maintain a list of validated refining processes due to the proprietary nature of food production. Regulated entities are best positioned to determine whether their processes eliminate detectable modified genetic material.
Records for Enzymes, Yeasts, and Micro-Organisms
If a regulated entity has actual knowledge that enzymes, yeasts, or other micro-organisms are bioengineered, they must make an appropriate disclosure, as required by 7 CFR 66.109.
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 food label’s ingredient list for applying 7 CFR 66.3(b).
Example
In the example above, pork would be considered the first ingredient. Because pork is subject to the Federal Meat Inspection Act, the food would not be subject to the Standard.
SECURE Rule Impact
The final SECURE rule (7 CFR 340) does not impact labeling requirements under the National Bioengineered Food Disclosure Standard (NBFDS). SECURE considers plant pest risk, while NBFDS is a marketing standard to inform consumers.
USDA Approved Laboratories
The USDA does not maintain a list of approved labs for testing modified genetic material (rDNA). However, the USDA published guidance documents on validating a refinement process and selecting a test method.
Meat as First Ingredient in a Sandwich
A closed-face sandwich is subject to the Standard even if meat is the first ingredient because it is subject to the labeling requirements of the FDCA.
USDA Certification of Food
The USDA does not certify food to be bioengineered or non-bioengineered. The Standard requires disclosure for foods that are or may be bioengineered, but does not require claims about the absence of bioengineered food ingredients. Foods that do not require a bioengineered food disclosure cannot be labeled “non-GMO” solely on that basis.
Absence Claims
The Standard allows other claims to be made about bioengineered foods, provided that such claims are consistent with applicable Federal law. In most cases, the use of absence claims such as “non-gmo” are regulated by the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS).
Alcohol and Foods Containing Alcohol
Certain beverages containing alcohol are not subject to the labeling requirements of the FDCA and, therefore, are not subject to the Standard.
Alcohol Products Subject to FAA Act
- All beverage spirits, malt beverages, and their products regardless of the alcohol content (27 CFR Parts 4, 5, and 7). This includes a distilled spirit that is mixed with something else (e.g., vodka mixed with soda water in a can).
- Beverage wines and wine products containing at least 7% alcohol by volume (abv) and no more than 24% abv. This includes grape wines, cider, mead, sake, and kombucha, if the alcohol content is at least 7% abv.
Alcohol Products Subject to FDCA
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.
- Non-beverage products (regardless of the alcohol base), such as salted cooking wines, cooking sprays, or vanilla extract.
- A malted beverage that is made with other cereal grains and does not include barley with hops (e.g., only malted corn).
- Wines and wine products that are between 0% abv and 6.99% abv. This may include grape wines, cider, mead, sake, and kombucha if the alcohol content is less than 7% abv.
Rum Cake Example
If a 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 or 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.
Meat Broth as First Ingredient
If a product is subject to the labeling requirements of the FMIA, PPIA, or EPIA, and its first ingredient is meat broth that is individually subject to the Federal Meat Inspection Act, that food is not subject to the Standard.
Poultry Broth as First Ingredient
If a product is subject to the labeling requirements of the FMIA, PPIA, or EPIA, and its first ingredient is poultry broth, it is subject to the Standard because poultry broth is independently subject to the labeling requirements of the FDCA.
Vegetable Broth as First Ingredient
If a product is subject to the labeling requirements of the FMIA, PPIA, or EPIA, and its first ingredient is vegetable broth, that food product would only be subject to the Standard if its second ingredient was subject to the labeling requirements of the FDCA.
Pizza Example
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. 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 what constitutes a bioengineered food ingredient and the regulations surrounding its disclosure is crucial for both consumers and food industry stakeholders. By adhering to the NBFDS, food manufacturers and retailers can provide greater transparency and enable consumers to make informed choices about the food they purchase.
For further questions or if you would like more specific information pertaining to the Standard, please e-mail [email protected]
