Are you curious about what does containing bioengineered food ingredients mean and how it affects your food choices? At FOODS.EDU.VN, we break down the National Bioengineered Food Disclosure Standard, explaining everything from definitions to practical implications for consumers and food manufacturers. Discover how to make informed decisions about the food you consume with our expert insights. Dive in and enhance your understanding of genetically modified foods and their labeling requirements today!
1. Understanding the National Bioengineered Food Disclosure Standard (NBFDS)
What is the National Bioengineered Food Disclosure Standard?
The National Bioengineered Food Disclosure Standard (NBFDS) mandates that food manufacturers, importers, and certain retailers disclose whether their food products for retail sale are bioengineered (BE) or contain bioengineered food ingredients. Essentially, this regulation aims to give consumers more transparency and information about the food they purchase and consume.
What defines a bioengineered food under the NBFDS?
According to the NBFDS, bioengineered foods are those that contain detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques. This modification could not have been achieved through conventional breeding methods or found naturally. This definition is crucial for determining which products require disclosure.
Effective Date vs. Mandatory Compliance Date: What’s the Difference?
Understanding the difference between the effective date and the mandatory compliance date is essential for both consumers and regulated entities.
- Effective Date: This is when the published Final Rule comes into force and becomes operative.
- Mandatory Compliance Date: This is the deadline by which all foods entering commerce must be labeled according to the Standard, and regulated entities using food on the List are required to maintain records.
This distinction ensures that businesses have adequate time to adjust their labeling and record-keeping practices.
2. Who Needs to Comply with the NBFDS?
Which entities are regulated under the NBFDS?
The Standard defines regulated entities as food manufacturers, importers, and certain retailers who label food for retail sale. These entities are responsible for ensuring their products comply with the NBFDS disclosure requirements.
Are there any exemptions to the NBFDS?
Yes, certain entities are exempt from the NBFDS. The law does not apply to:
- 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
However, it’s important to note that dietary supplements are included in the definition of food covered under the standard, so manufacturers and importers of dietary supplements must comply with the disclosure requirements.
How does the NBFDS apply to bakeries and delis?
The application of the NBFDS to bakeries and delis depends on the type of food sold and where it is sold:
- Standalone Restaurants/Similar Retail Food Establishments: If a bakery or deli is a standalone establishment, all restaurant-type foods they sell are exempt from the NBFDS.
- Bakeries/Delis within Larger Retail Establishments: If a bakery or deli is part of a larger retail establishment (e.g., a grocery store), the rules differ:
- Restaurant-type foods intended for immediate consumption (e.g., single-serving salads, muffins, sandwiches, or soups) are not subject to the Standard.
- Foods not intended for immediate consumption (e.g., containers with multiple muffins, loaves of bread, or bags of dinner rolls) are subject to the Standard.
What products require NBFDS disclosure?
Bioengineered foods or foods that contain bioengineered food ingredients must be labeled with the bioengineered food disclosure. Remember, this applies to foods containing detectable genetic material modified through in vitro recombinant DNA techniques that could not otherwise be obtained through conventional breeding or found in nature.
3. Diving Deeper: The List of Bioengineered Foods
What is the List of Bioengineered Foods?
The List of Bioengineered Foods (List) identifies bioengineered foods authorized for commercial production in the producing country and legally produced somewhere in the world. This List serves as a reference for regulated entities, indicating which foods require record-keeping and may necessitate BE disclosures.
What foods are included on the List?
The List currently includes:
- Alfalfa
- Apple (ArcticTM varieties)
- Canola
- Corn
- Cotton
- Eggplant (BARI Bt Begun varieties)
- Papaya (ringspot virus-resistant varieties)
- Pineapple (pink fleshed varieties)
- Potato
- Salmon (AquAdvantage®)
- Soybean
- Summer Squash
- Sugarbeet
This list is regularly updated to reflect the current availability of bioengineered foods.
If a food I use is on the List, do I automatically need to make a bioengineered food disclosure?
Not necessarily. Whether you need to make a disclosure depends on whether the ingredient derived from a bioengineered food contains detectable modified genetic material. If ingredients like corn starch, canola oil, or soy lecithin contain detectable modified genetic material, they are considered bioengineered food ingredients and require disclosure. However, if these ingredients are highly refined, and your records show the modified genetic material is no longer detectable, then they do not require disclosure.
What if a food I use is bioengineered but not on the List?
Regulated entities must disclose foods known to be bioengineered, even if they aren’t on the List. If your records indicate that a food you are selling or using is bioengineered, you must make the appropriate disclosure, irrespective of its presence on the List.
4. Specific Scenarios and Exemptions
Is an animal product considered bioengineered if the animal ate bioengineered feed?
No. According to the Standard, food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal ate such feed. For instance, milk from a cow that consumed bioengineered alfalfa is not considered a bioengineered food.
What about processed forms of foods on the List?
Whether a processed ingredient derived from a bioengineered food requires disclosure depends on whether it contains detectable modified genetic material. For example, if you use corn starch, canola oil, or soy lecithin and these contain detectable modified genetic material, they are considered bioengineered food ingredients and require a bioengineered food disclosure. However, if these ingredients are highly refined, and your records indicate the modified genetic material is no longer detectable, then they do not require disclosure.
Thresholds for Inadvertent Bioengineered Presence
The Standard includes an exemption for foods in which no ingredient intentionally contains a bioengineered substance. An allowance is made for inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient. This means if a food manufacturer sources non-bioengineered corn that inadvertently contains less than 5% of a bioengineered substance, disclosure is not required.
However, this exemption does not apply 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. In such cases, disclosure is required regardless of the amount of modified genetic material that may remain.
How to handle Enzymes, Yeasts, and Other Micro-organisms in Labeling
When dealing with enzymes, yeasts, and other micro-organisms, documentation is required to verify their BE status if you have definitive knowledge that these ingredients are bioengineered.
For foods not on the AMS List of Bioengineered Foods, if a regulated entity’s records demonstrate they have actual knowledge that they are using a bioengineered version of these foods, then they must make a disclosure.
Determining the First Ingredient in a Component Ingredient Statement
When a product label has a component ingredient statement (e.g., FILLING: PORK, ONION, CABBAGE, CORN, SALT, SUGAR. WRAPPER: WHEAT FLOUR, WATER), the first ingredient is identified as the first item listed on the ingredient list of the food label. For purposes of applying 7 CFR 66.3(b), AMS will look at the ingredients in the order in which they appear on the ingredient list of the food label.
In this example, 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.
5. Updating the List of Bioengineered Foods
How often will the List be updated?
USDA will update the List as necessary to reflect the current availability of bioengineered foods. Before making updates, USDA will coordinate with other Federal regulatory agencies that regulate biotechnology.
How is public input considered for the List?
USDA conducts annual reviews of the List and, as necessary, conducts rulemaking to amend it. Public input into the List’s composition is invited on an ongoing basis.
6. Determining Detectable Modified Genetic Material
How can I tell if my food has detectable modified genetic material?
The Standard identifies three ways for a regulated entity to determine that modified genetic material is not detectable:
- Using records to verify that a food is sourced from a non-bioengineered crop.
- Using records to verify that a food has been subjected to a refinement process validated to render modified genetic material undetectable.
- Maintaining certificates of analysis or other testing records appropriate to a specific food that confirm the absence of detectable modified genetic material.
What records are required to show that the presence of a bioengineered substance is inadvertent or technically unavoidable?
To demonstrate that the presence of a bioengineered substance is inadvertent or technically unavoidable, regulated entities must keep records indicating they have sourced a non-bioengineered ingredient and have taken reasonable precautions to keep bioengineered and non-bioengineered ingredients separate. If these conditions are met, AMS may presume that any bioengineered presence below five percent is inadvertent or technically unavoidable.
7. Impact on Trade and International Considerations
Will the Standard impact foreign trade?
The Standard is not intended to disrupt trade. It places the same requirements on domestic and foreign entities. During the rulemaking process, USDA sought comments from all stakeholders regarding unique issues associated with bioengineered food disclosure for imports. The proposed rule was notified to the World Trade Organization and open for comments from trading partners. USDA’s Foreign Agricultural Service is prepared to work closely with countries importing food into the United States to help them understand the requirements of the Standard.
8. Resources and Reporting Violations
What information does AMS provide on its website for items on the List?
The information on the website is designed to help regulated entities understand which varieties of foods on the List may be bioengineered. The website includes specific information about traits, varieties, and production information (i.e., location) that will help regulated entities determine whether they need to make a BE disclosure.
How can I report a food that I suspect is bioengineered but does not include a bioengineered food disclosure?
Anyone who suspects a violation can file a written complaint with the AMS Administrator by mail or on the AMS website.
Does USDA maintain a list of approved laboratories for testing modified genetic material?
No, USDA does not maintain an approved list of labs to test modified genetic material (rDNA). However, USDA has published guidance documents on the validation of a refinement process and the selection of a test method, which can be found on the AMS BE disclosure webpage.
9. Specific Food and Beverage Applications
Are beer, wine, spirits, and foods that contain alcohol subject to the Standard?
The applicability of the Standard to alcoholic beverages depends on the specific product:
- Not Subject to the Standard:
- All beverage spirits, malt beverages, and their products, regardless of alcohol content, are subject to the Federal Alcohol Administration Act (FAA Act) and are not subject to the Standard (27 CFR Parts 4, 5, and 7). This includes distilled spirits mixed with other ingredients.
- Beverage wines and wine products containing at least 7% alcohol by volume (abv) and no more than 24% abv are subject to the FAA Act and not the Standard. This includes grape wines, cider, mead, sake, and kombucha, if the alcohol content is at least 7% abv.
- Subject to the Standard:
- Non-beverage products (regardless of the alcohol base), such as salted cooking wines, cooking sprays, or vanilla extract, are subject to the Standard.
- A malted beverage that is made with other cereal grains and does not include barley with hops (e.g., only malted corn) falls under the Standard.
- 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.
What if alcohol derived from a bioengineered food is used as an ingredient?
If you use alcohol as an ingredient in a product subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA), such as rum cake, your products are subject to the Standard and must include a bioengineered food disclosure if you use any bioengineered foods or bioengineered food ingredients. Even if the rum itself would not be subject to the Standard when sold independently, it requires a disclosure when used as an ingredient in a product subject to the FDCA, provided the rum meets the definition of a bioengineered food at 7 CFR 66.1.
How do broth ingredients impact labeling requirements?
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.
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Meat Broth as the 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. This applies even if any of the remaining ingredients would, on their own, be considered bioengineered foods and otherwise subject to the Standard.
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Poultry Broth as the 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. 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.
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Vegetable Broth as the 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. If the second ingredient is independently 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.
How are pizzas labeled under the standard?
Consider a pizza manufacturer listing ingredients as: Crust, meat pepperoni, cheese, tomato sauce. 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.
10. SECURE Rule and NBFDS
Does the final SECURE rule (7 CFR 340) impact labeling requirements under the National Bioengineered Food Disclosure Standard (NBFDS)?
No, the SECURE rule and NBFDS evaluate products based, in part, on what is possible through conventional breeding. SECURE is a regulatory rule that considers plant pest risk, while the NBFDS is a marketing standard intended to provide consumers with more information about their food. Although there is a likely correlation between products exempt under SECURE and those that do not require a bioengineered food disclosure under the NBFDS, products are subject to a separate evaluation under each of the respective frameworks.
11. Certification and Claims
Does the USDA certify food to be bioengineered, or non-bioengineered?
No, USDA does not certify foods to be bioengineered or non-bioengineered. The Standard requires disclosure for foods that are or may be bioengineered. The Standard does not require any claims to be made about the absence of bioengineered food ingredients.
Can foods be labeled as “non-GMO” if they don’t require a bioengineered food disclosure?
The Standard, at 7 USC 1639c(c), states 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.” As such, just because a food does not require a bioengineered food disclosure does not mean you can make a “non-gmo” claim.
What kind of claims are allowed about bioengineered foods?
The Standard, at 7 CFR 66.118, 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).
12. Key Takeaways for Consumers and Manufacturers
For Consumers:
- The NBFDS aims to provide transparency, helping you make informed choices about bioengineered foods.
- Look for disclosures on food labels to identify products containing bioengineered ingredients.
- Understand that products from animals fed bioengineered feed are not automatically labeled as bioengineered.
For Manufacturers:
- Comply with the NBFDS by accurately disclosing bioengineered foods and ingredients.
- Maintain records to demonstrate compliance, especially when dealing with processed ingredients.
- Stay updated with the List of Bioengineered Foods and any amendments to ensure accurate labeling.
FAQ: Bioengineered Food Ingredients
1. What exactly are bioengineered foods?
Bioengineered foods contain detectable genetic material modified through in vitro recombinant DNA techniques, which cannot be obtained through conventional breeding or found in nature.
2. Why is bioengineered food labeling important?
It provides consumers with more information about their food, allowing them to make informed decisions based on their preferences and beliefs.
3. Who enforces the National Bioengineered Food Disclosure Standard?
The USDA’s Agricultural Marketing Service (AMS) oversees and enforces the National Bioengineered Food Disclosure Standard.
4. How can I identify bioengineered foods in the grocery store?
Look for labels indicating that the food contains bioengineered ingredients, or use a QR code provided on the packaging to get more information.
5. What should I do if I suspect a product is mislabeled?
File a written complaint with the AMS Administrator via mail or through the AMS website with details and evidence.
6. Are there any health risks associated with bioengineered foods?
According to scientific consensus, bioengineered foods currently available on the market are as safe as their non-bioengineered counterparts.
7. What is the purpose of the List of Bioengineered Foods?
The List helps regulated entities identify which foods require record-keeping and may necessitate BE disclosures under the NBFDS.
8. Can a food be labeled as “non-GMO” if it does not require BE disclosure?
No, a food cannot be labeled as “non-GMO” solely because it does not require a BE disclosure. Such claims must comply with other applicable federal laws and regulations.
9. How does the NBFDS affect imported foods?
The NBFDS places the same requirements on domestic and foreign entities, ensuring that imported foods comply with U.S. labeling standards.
10. Where can I find more information about the NBFDS?
You can find comprehensive details and updates on the USDA Agricultural Marketing Service (AMS) website or by contacting FOODS.EDU.VN at 1946 Campus Dr, Hyde Park, NY 12538, United States, Whatsapp: +1 845-452-9600.
Conclusion
Understanding what does containing bioengineered food ingredients mean is essential for both consumers and food manufacturers. The National Bioengineered Food Disclosure Standard is designed to provide transparency and ensure that consumers have the information they need to make informed decisions about the food they purchase. Whether you’re a consumer wanting to learn more about your food choices or a manufacturer ensuring compliance, FOODS.EDU.VN offers a wealth of resources to help you navigate the complexities of bioengineered food labeling.
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