Bioengineered food ingredients are increasingly common, and understanding them is essential for making informed choices. Have questions about genetically modified organisms (GMOs) and bioengineered foods? WHAT.EDU.VN is here to provide clear, concise answers. Explore the world of bioengineered food disclosure, labeling requirements, and the impact on your dinner plate.
1. What Is The National Bioengineered Food Disclosure Standard?
The National Bioengineered Food Disclosure Standard (NBFDS) is a federal law requiring food manufacturers, importers, and certain retailers to disclose whether their products contain bioengineered (BE) ingredients. This standard aims to provide consumers with more transparency and information about the food they purchase. Think of it as a way to shed light on how some of our food is made, ensuring you’re in the know.
2. What’s The Difference Between The Effective And Compliance Dates?
Understanding the difference between the effective and compliance dates helps clarify when the NBFDS regulations came into play.
- Effective Date: This is the date when the final rule of the NBFDS officially went into effect.
- Mandatory Compliance Date: This is the date by which all regulated entities must label their foods according to the standard. It’s when the rubber meets the road, and compliance becomes mandatory.
3. When Does USDA Consider A Food As Having “Entered Commerce?”
According to the USDA, food is considered to have “entered commerce” when it is labeled for retail sale. This is a crucial point because it marks the moment when the labeling requirements of the NBFDS apply.
4. How Long Can Non-Compliant Labels Remain On Store Shelves?
The NBFDS mandates that all foods entering commerce must be labeled in compliance with the standard. The standard doesn’t govern how long foods labeled before the mandatory compliance date can remain on store shelves.
5. Who Must Comply With The Disclosure Requirements?
Compliance with the NBFDS is required for regulated entities. This includes:
- Food manufacturers
- Importers
- Certain retailers who label food for retail sale
However, there are exceptions:
- Restaurants and similar retail food establishments: This includes cafeterias, food trucks, and airplanes.
- Very small food manufacturers: Those with annual receipts of less than $2,500,000.
- Dietary Supplements: The manufacturers and importers of dietary supplements must comply with the disclosure requirements of the Standard.
6. How Does The Standard Apply To Bakeries And Delis?
The application of the NBFDS to bakeries and delis depends on the nature of the food being sold.
- Exempt: Restaurant-type foods sold for immediate consumption (e.g., a single-serving salad, a single muffin, or a sandwich) in a standalone restaurant or similar retail food establishment are exempt.
- Subject to the Standard: Foods not intended for immediate consumption, such as a container with multiple muffins, a loaf of bread, or a bag of dinner rolls, are subject to the standard.
7. What Products Must Comply With NBFDS Disclosure Requirements?
Bioengineered foods or foods containing bioengineered ingredients must be labeled with a bioengineered food disclosure. According to the USDA, bioengineered foods contain detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, which could not otherwise be obtained through conventional breeding or found in nature.
8. What Is The List Of Bioengineered Foods?
The List of Bioengineered Foods identifies foods authorized for commercial production and in legal production worldwide. The list helps regulated entities identify foods for which they must keep records and may need to make bioengineered disclosures.
As of the latest update, the 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
- Sugarbeet
The USDA maintains this list and updates it as necessary.
9. Do Processed Forms Of Foods On The List Require Disclosure?
Whether a processed ingredient derived from a bioengineered food requires disclosure depends on whether it contains detectable modified genetic material.
- Disclosure Required: If the ingredient, such as corn starch, canola oil, or soy lecithin, contains detectable modified genetic material, it is considered a bioengineered food ingredient and requires disclosure.
- Disclosure Not Required: Highly refined ingredients where the modified genetic material is no longer detectable do not require disclosure.
10. Is An Animal Product Considered Bioengineered If The Animal Ate Bioengineered Feed?
According to the Standard, 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 ate bioengineered alfalfa is not considered a bioengineered food.
11. How Will The List Be Updated?
The USDA will update the List of Bioengineered Foods periodically to reflect the current availability of bioengineered foods. Before updating the list, the USDA coordinates with other federal regulatory agencies who regulate biotechnology. The USDA conducts annual reviews of the list, invites ongoing public input, and may conduct rule-making to amend the list as necessary.
12. How Can I Tell If My Food Has Detectable Modified Genetic Material?
Regulated entities can determine whether modified genetic material is 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 that has been 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.
13. Will The Standard Impact Foreign Trade?
The NBFDS is not intended to disrupt trade and places the same requirements on domestic and foreign entities. The USDA sought comments from all stakeholders regarding bioengineered food disclosure for imports during the rule-making process. The proposed rule was also notified to the World Trade Organization for comments from trading partners.
14. What Information Does AMS Provide On Its Website For Each Item On The List?
The USDA’s Agricultural Marketing Service (AMS) provides information on its website to help regulated entities understand which varieties of foods on the List of Bioengineered Foods may be bioengineered. This includes specific details about traits, varieties, and production information.
15. How Do I Report A Food That I Suspect Is Bioengineered But Does Not Include A Disclosure?
Anyone who suspects a violation of the NBFDS can file a written complaint with the AMS Administrator by mail or on the AMS website.
16. Is A Product Supplied To A Distributor Who Only Distributes To Foodservice End Users Required To Have A BE Disclosure?
Food supplied to a restaurant or similar retail food establishment is not subject to the Standard as long as it is served in that establishment. This exemption aligns with the exclusion of food served in restaurants from the NBFDS requirements.
17. Is There Any Allowable Percentage Of Recombinant DNA Presence That Would Exempt A Food Product From Labeling?
The Standard includes an exemption for foods in which no ingredient intentionally contains a bioengineered substance, with an allowance for inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient. Any intentional use of a bioengineered food or bioengineered food ingredient requires disclosure.
18. Are Existing Specifications On Ingredients Sufficient For Compliance?
Disclosure is required for a food that is a bioengineered food or contains a bioengineered food ingredient. Regulated entities must keep records that demonstrate compliance with the disclosure requirements. If the current records show whether a food is genetically modified and align with the definition of bioengineered food, and disclosures are made based on those records, then the records should be sufficient.
19. Will Each Facility Be Required To Validate A Process For Highly Refined Ingredients?
No, the validation refers to the process, not the facility. Once a refining process has been validated to render modified genetic material undetectable, additional testing is unnecessary, provided that no significant changes are made to the validated process and that records are maintained.
20. Will AMS Maintain A List Of Validated Refining Processes?
No, AMS will not maintain a list of validated refining processes, believing that regulated entities are best positioned to determine whether their processes make modified genetic material undetectable.
21. What Types Of Records Are Required To Show Inadvertent Or Technically Unavoidable Presence Of A Bioengineered Substance?
If a regulated entity’s records indicate they have sourced a non-bioengineered ingredient and have taken 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. A record that indicates an ingredient was sourced from a non-bioengineered crop and reasonable precautions were taken to keep it separate, and that any presence of a bioengineered substance is less than or equal to 0.9 percent, would be sufficient to demonstrate compliance.
22. Is Documentation Required To Verify The BE Status Of 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 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.
23. How Do I Identify The First Ingredient In A Component Ingredient Statement?
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.
24. Does The Final SECURE Rule Impact Labeling Requirements Under The National Bioengineered Food Disclosure Standard?
No. Although both 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.
25. Does USDA Maintain A List Of Approved Laboratories For Testing The Modified Genetic Material?
No, USDA does not maintain an approved list of labs to test modified genetic material. USDA published guidance documents on validation of a refinement process and selection of a test method, available on the AMS BE disclosure webpage.
26. If Meat Is The First Ingredient In A Closed Faced Sandwich, Is This Still Exempted?
No, a closed-face sandwich is subject to the Standard even though the first ingredient is meat, because it is subject to the labeling requirements of the FDCA.
27. Does The USDA Certify Food To Be Bioengineered, Or Non-Bioengineered?
No, USDA does not certify foods to be bioengineered or non-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.”
28. Are Beer, Wine, Spirits, And Foods That Contain Alcohol Subject To The Standard?
Certain beverages containing alcohol are not subject to the labeling requirements of the FDCA. These alcohol products are subject to the labeling provisions of the Federal Alcohol Administration Act (FAA Act) and are not subject to the Standard, including:
- 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.
29. We Use Alcohol As An Ingredient In Our Rum Cake. If The Alcohol Is Derived From A Food On The AMS List Of Bioengineered Foods, Do We Need To Make A Bioengineered Food Disclosure?
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.
30. We Manufacture Foods That Are Primarily Meat Or Poultry Broths, Are Our Products Subject To The Standard?
-
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.
-
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.
-
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. A Pizza Manufacturer Lists Their Ingredients As: Crust, Meat Pepperoni, Cheese, Tomato Sauce. Are These Meat Pizzas Subject To The Standard?
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. Since crust is subject to the labeling requirements of the FDCA, the pizza would be subject to the Standard even if it were an FSIS regulated product.
Navigating the World of Bioengineered Foods
Understanding bioengineered food ingredients is essential for making informed decisions about your food choices. The National Bioengineered Food Disclosure Standard aims to provide consumers with the information they need to make these decisions confidently.
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