What Is A Bioengineered Food Ingredient is a common question, and WHAT.EDU.VN is here to provide a comprehensive answer, covering the definition, labeling, and impact of these ingredients. Understand what these engineered components are and how they affect your food choices. Explore the world of bioengineered foods with us and uncover key food industry insights.
1. Understanding the National Bioengineered Food Disclosure Standard
The National Bioengineered Food Disclosure Standard (NBFDS) mandates that food manufacturers, importers, and specific retailers disclose whether their products contain bioengineered (BE) ingredients. This standard aims to enhance consumer knowledge about the foods they purchase.
1.1. Defining Bioengineered Foods
Bioengineered foods, as defined by the Standard, contain detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques. These modifications cannot be achieved through conventional breeding or found naturally.
2. Effective Date vs. Compliance Date: What’s the Difference?
It’s crucial to understand the distinction between the effective and compliance dates related to the NBFDS.
- Effective Date: This is when the Final Rule is published and takes effect.
- Mandatory Compliance Date: On this date, all foods entering commerce must be labeled according to the Standard, and regulated entities must maintain records for foods on the List.
3. When is Food Considered to Have “Entered Commerce” by the USDA?
The USDA considers food to have “entered commerce” on the date it is labeled for retail sale.
4. How Long Can Non-Compliant Labels Remain on Shelves?
The Standard requires all foods entering commerce to be labeled in compliance. There are no regulations regarding how long foods labeled before the mandatory compliance date can remain in retail settings.
5. Who Needs to Comply with the Standard’s Disclosure Requirements?
Regulated entities are required to comply with the Standard. These entities include food manufacturers, importers, and certain retailers who label food for retail sale.
5.1. Exemptions from the Standard
The law exempts restaurants and similar retail food establishments (e.g., cafeterias, food trucks, airplanes) and very small food manufacturers with annual receipts less than $2,500,000. However, dietary supplements are included in the definition of food covered under the standard.
6. Application of the Standard to Bakeries and Similar Establishments
A bakery selling various food items needs to understand which products are subject to the Standard.
- Restaurant-type foods sold inside a standalone restaurant or similar retail food establishment are exempt.
- A bakery or deli within a larger retail establishment, such as a grocery store, selling restaurant-type foods intended for immediate consumption (e.g., single-serving salad, muffin, sandwich, or soup) is considered a restaurant and is exempt for these items.
- Foods not intended for immediate consumption, like multiple muffins, a loaf of bread, or a bag of dinner rolls, are subject to the Standard.
7. Which Products Must Comply with the NBFDS Disclosure Requirements?
Bioengineered foods or foods containing bioengineered food ingredients must be labeled with a bioengineered food disclosure.
7.1. Foods Exempt from Disclosure
Highly refined foods or ingredients that do not contain detectable modified genetic material are not considered bioengineered foods and do not require disclosure.
8. Understanding the List of Bioengineered Foods
The List of Bioengineered Foods identifies foods authorized for commercial production. It assists regulated entities in record-keeping and determining which foods may require BE disclosures.
8.1. Items Included on the List
The List 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 and sugarbeet.
Alt text: Close-up of a sliced Arctic Apple, showcasing its non-browning trait achieved through bioengineering, with a person holding the apple in their hand.
8.2. Trade Names on the List
When only one company produces a bioengineered food, the trade name (e.g., ArcticTM Apples or AquAdvantage® salmon) is included to simplify compliance.
8.3. Responsibility of Regulated Entities
Regulated entities must disclose foods they are selling or using if their records indicate the food is bioengineered, even if the food is not on the List.
8.4. Accessing Additional Information
More information about crops and foods on the List is available on the AMS website. This information is maintained and updated regularly.
8.5. Details on Specific Varieties
The online information includes details about specific varieties of crops and foods that have been bioengineered to help regulated entities easily identify foods that may require disclosure.
9. Disclosure Requirements for Processed Forms of Foods on the List
If you’re using a processed form of a food on the List, whether you need to make a bioengineered food disclosure depends on whether the ingredient contains detectable modified genetic material.
9.1. Determining Disclosure Requirements
If ingredients like corn starch, canola oil, and soy lecithin contain detectable modified genetic material, they are considered bioengineered food ingredients and require disclosure. If these ingredients are highly refined and the modified genetic material is no longer detectable, then they do not require disclosure.
10. Animal Products and Bioengineered Feed
Food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal ate bioengineered feed.
10.1. Example: Milk from Cows Fed Bioengineered Alfalfa
Milk from a cow that ate bioengineered alfalfa is not considered a bioengineered food just because the cow consumed bioengineered alfalfa.
11. How the List Will Be Updated
The USDA will update the List as necessary to reflect the current availability of bioengineered foods.
11.1. Coordination with Federal Agencies
Before updating the List, the USDA coordinates with other Federal regulatory agencies that regulate biotechnology.
11.2. Annual Reviews and Rulemaking
The USDA conducts annual reviews of the List and, when necessary, conducts rulemaking to amend it. Public input into the List’s composition is invited on an ongoing basis.
11.3. Rulemaking Process for Exclusions
The Standard outlines a rulemaking process to determine whether certain “factors and conditions” may exclude specific foods from being considered bioengineered.
12. Determining Detectable Modified Genetic Material
A regulated entity can determine that modified genetic material is not detectable through three methods:
- 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 confirming the absence of detectable modified genetic material.
13. Impact of the Standard on Foreign Trade
The Standard is not intended to disrupt trade and places the same requirements on domestic and foreign entities.
13.1. Stakeholder Comments and Notifications
During the rulemaking process, the 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.
13.2. Support from the Foreign Agricultural Service
The USDA’s Foreign Agricultural Service is prepared to work closely with countries that import food into the United States to help them understand the requirements of the Standard.
14. Information Available on the AMS Website
The information on the website helps regulated entities understand which varieties of foods on the List may be bioengineered.
Alt text: The USDA’s official mark for the National Bioengineered Food Disclosure Standard, indicating that the product contains bioengineered ingredients.
14.1. Specific Information Included
The website includes specific information about traits, varieties, and production information (i.e., location) that helps regulated entities determine whether they need to make a BE disclosure.
15. Reporting Foods Lacking Bioengineered Food Disclosure
Anyone who suspects a violation may file a written complaint with the AMS Administrator by mail or on the AMS website.
16. Disclosure Requirements for Products Supplied to Foodservice End Users
If a regulated entity supplies product to a distributor who only distributes products to 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.
16.1. Exemption for Food Served in Restaurants
Because the Standard exempts food served in a restaurant or similar retail food establishment, food being supplied to such establishments is not subject to the Standard as long as that food is being served in that setting.
17. Allowable Percentage of Recombinant DNA Presence
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.
17.1. Example: Non-Bioengineered Corn
If a food manufacturer sources non-bioengineered corn with an inadvertent amount of a bioengineered substance less than 5 percent, disclosure is not required. However, if a manufacturer intends to use a highly refined ingredient produced from bioengineered corn but does not refine it to the point where modified genetic material is no longer detectable, disclosure is required regardless of the amount of modified genetic material that remains.
17.2. Complexities of the Supply Chain
This threshold recognizes the complexities of the supply chain, acknowledging that bioengineered and non-bioengineered foods may be harvested by and processed on the same equipment.
18. Documentation Requirements for Ingredients
Specifications stating whether ingredients are genetically modified, along with invoices, may be sufficient records if they align with the definition of bioengineered food.
18.1. Compliance with Record-Keeping
If the records kept show whether a food is genetically modified according to the definition of bioengineered food, and appropriate disclosures are made based on those records, then those records should be sufficient to comply with the law.
19. Validating Processes for Highly Refined Ingredients
The requirements for a validated refining process state that once a refining process has been validated to render modified genetic material in a food undetectable, additional testing is not necessary if no significant changes are made to the validated process and records are maintained.
19.1. Validation of the Process, Not the Facility
Validation refers to the process, not the facility. Once a process is validated under the Standard and all record-keeping requirements are followed, that validated process does not need to be revalidated when completed in a different facility.
20. AMS List of Validated Refining Processes
The AMS will not maintain a list of validated refining processes. Given the proprietary nature of food production, the AMS believes regulated entities are best positioned to determine whether their processes make modified genetic material undetectable.
21. Records for Inadvertent Bioengineered Presence
The Standard exempts from disclosure a food in which no ingredient intentionally contains a bioengineered substance, allowing for inadvertent bioengineered presence of up to five percent for each ingredient.
Alt text: Examples of bioengineered food labels, including text and symbols, that manufacturers can use to comply with the National Bioengineered Food Disclosure Standard.
21.1. Reasonable Precautions
If a regulated entity’s records indicate they have sourced a non-bioengineered ingredient and taken reasonable precautions to keep bioengineered and non-bioengineered ingredients separate, the AMS may presume that any bioengineered presence below five percent is inadvertent.
21.2. Insufficient Records
A record that indicates an ingredient has less than or equal to 0.9 percent BE presence, without more, is insufficient because the amount may have been intentionally included.
21.3. Sufficient Records
A record that indicates an ingredient was sourced from a non-bioengineered crop, reasonable precautions have been taken to keep it separate from bioengineered crops, and that any presence of a bioengineered substance is less than or equal to 0.9 percent would be sufficient to demonstrate compliance with the exemption.
22. Documentation for Enzymes, Yeasts, and 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.
22.1. Foods Not on the AMS List
For foods not on the AMS List of Bioengineered Foods, such as enzymes, yeasts, and other micro-organisms, if a regulated entity’s records demonstrate they have actual knowledge that they are using a bioengineered version, then they must make a disclosure.
23. Identifying 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 ingredients are looked at in the order in which they appear on the ingredient list of the food label.
23.1. Application of 7 CFR 66.3(b)
For purposes of applying 7 CFR 66.3(b), the AMS will look at the ingredients in the order in which they appear on the ingredient list. 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.
24. Impact of the SECURE Rule on Labeling Requirements
The final SECURE rule (7 CFR 340) does not impact labeling requirements under the National Bioengineered Food Disclosure Standard (NBFDS).
24.1. Separate Evaluations
Although both the SECURE rule and NBFDS evaluate products based, in part, on what is possible through conventional breeding, SECURE is a regulatory rule considering plant pest risk, while the NBFDS is a marketing standard providing consumers more information about their food. Products are subject to separate evaluations under each framework.
25. USDA List of Approved Laboratories
The USDA does not maintain an approved list of labs to test modified genetic material (rDNA). The USDA publishes guidance documents on validation of a refinement process and selection of a test method.
26. Closed-Faced Sandwich with Meat as the First Ingredient
If meat is the first ingredient in a closed-faced sandwich, it is still exempted even though it is technically not amenable and therefore not covered under the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), or the Egg Products Inspection Act (EPIA).
26.1. Application of 7 CFR 66.3(b)
As stated at 7 CFR 66.3(b), the Standard applies only to a food subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (“FDCA”); or the labeling requirements under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act only if: (i) the most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA; or (ii) 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 of the FDCA.
26.2. Closed-Face Sandwich Subject to the FDCA
Because a closed-face sandwich is subject to the labeling requirements of the FDCA, the closed-face sandwich is subject to the Standard even though the first ingredient is meat.
27. USDA Certification of Foods
The USDA does not certify foods to be bioengineered or non-bioengineered.
27.1. Disclosure Requirements
The Standard requires disclosure for foods that are or may be bioengineered but does not require any claims to be made about the absence of bioengineered food ingredients.
27.2. Absence Claims
While the Standard does not require any absence claims, it does state 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.” Absence claims may be allowed provided they are consistent with applicable Federal law, often regulated by the FDA and FSIS.
28. Alcoholic Beverages and the Standard
Beer, wine, spirits, and foods that contain alcohol are subject to the Standard based on whether they fall under the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) or the Federal Alcohol Administration Act (FAA Act).
28.1. Beverages Not Subject to the FDCA
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. This includes grape wines, cider, mead, sake, and kombucha, if the alcohol content is at least 7% abv.
28.2. Alcohols and Food Products Subject to the Standard
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. This includes:
- 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.
29. Alcohol as an Ingredient in Products
If alcohol derived from a food on the AMS List of Bioengineered Foods is used as an ingredient, a bioengineered food disclosure may be needed.
29.1. Rum Cake Example
If the rum cake or other products produced are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA), then these products are subject to the Standard and must include a bioengineered food disclosure if any bioengineered foods or bioengineered food ingredients are used.
29.2. Exceptions
When independently sold as a spirit, rum would not be subject to the Standard because it is not subject to the labeling requirements under the FDCA. However, when it’s used as an ingredient in a product that’s subject to the FDCA, such as rum cake, if the rum used as an ingredient meets the definition of a bioengineered food at 7 CFR 66.1, then the product requires a disclosure.
30. Broths and the Standard
Foods that are primarily meat or poultry broths are subject to the Standard differently based on the ingredients.
30.1. 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.
30.2. 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.
30.3. 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.
31. Meat Pizzas and the Standard
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).
31.1. Pizza Ingredients
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.
31.2. Crust as the Predominant Ingredient
Since crust is subject to the labeling requirements of the FDCA, even if this were an FSIS regulated product, the pizza would be subject to the Standard.
FAQ: Bioengineered Food Ingredients
| Question | Answer |
|---|---|
| What exactly is a bioengineered food ingredient? | It’s an ingredient containing detectable genetic material modified through in vitro rDNA techniques, which couldn’t be achieved through conventional breeding or found in nature. |
| How can I identify if a product contains bioengineered ingredients? | Look for the bioengineered food disclosure on the product label. If it’s present, the product contains bioengineered ingredients. |
| Are all genetically modified (GM) foods considered bioengineered? | Not necessarily. The NBFDS has a specific definition for bioengineered foods that may differ from general descriptions of GM foods. |
| Does cooking or processing affect the need for disclosure? | If the processing or refining removes detectable modified genetic material, the product may be exempt from disclosure. |
| Is there a difference between “bioengineered” and “genetically modified organism (GMO)”? | While the terms are often used interchangeably, the NBFDS defines “bioengineered” specifically for labeling purposes. |
| What are the potential benefits of using bioengineered food ingredients? | Benefits can include increased crop yields, enhanced nutritional value, and reduced pesticide use. |
| Are bioengineered foods safe to eat? | Regulatory agencies like the FDA and USDA evaluate the safety of bioengineered foods before they are allowed on the market. |
| How does the NBFDS affect international trade? | The standard is designed to apply equally to domestic and foreign entities, aiming not to disrupt trade. |
| What should I do if I suspect a food product is mislabeled or doesn’t disclose bioengineered ingredients correctly? | File a written complaint with the AMS Administrator by mail or on the AMS website. |
| Where can I find more information about bioengineered foods and the NBFDS? | Visit the USDA’s Agricultural Marketing Service (AMS) website for updated lists, details on specific crops, and regulatory information. You can also ask WHAT.EDU.VN and get free answers |
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