Bioengineered food ingredients are those that contain detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, offering both promise and controversy. FOODS.EDU.VN is here to clear up any confusion. This guide breaks down everything you need to know about bioengineered foods, from what they are to how they’re regulated, ensuring you’re well-informed about the foods you consume. Explore the facts and discover the benefits and implications of genetically modified organisms (GMOs) and bioengineered crops in our food supply.
1. 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 products are bioengineered (BE) or contain bioengineered food ingredients. This standard, designed to increase consumer knowledge about their food choices, aims to provide transparency in the food industry.
The NBFDS defines bioengineered foods as those containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, where such modification couldn’t be achieved through conventional breeding or found naturally. This ensures clear guidelines for identifying and labeling bioengineered foods, giving consumers the information they need.
2. What are the Effective and Compliance Dates Under the NBFDS?
The effective date refers to when the published Final Rule takes effect and becomes operative. This is when the regulations officially start to be enforced.
The mandatory compliance date is when 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 is the deadline for full compliance.
3. When Does USDA Consider a Food as Having “Entered Commerce?”
The USDA considers a food to have entered commerce on the date it is labeled for retail sale. This means that the labeling requirements apply as soon as the product is prepared for sale to consumers.
This definition ensures clarity on when products must comply with the NBFDS, helping manufacturers and retailers adhere to the regulations effectively.
4. How Long Can Non-Compliant Labels Remain on Grocery Store Shelves?
All foods entering commerce must be labeled in compliance with the Standard. The Standard does not regulate how long foods that entered commerce prior to the mandatory compliance date can remain in retail settings.
This ensures that while older, non-compliant products can remain until sold, all new products must meet the labeling requirements.
5. Who Must Comply with the Disclosure Requirements?
Regulated entities, including food manufacturers, importers, and certain retailers who label food for retail sale, must comply with the Standard. These entities are responsible for ensuring that their products meet the NBFDS requirements.
The law specifically excludes restaurants and similar retail food establishments (e.g., cafeterias, food trucks, airplanes) and very small food manufacturers with annual receipts of less than $2,500,000. However, dietary supplements are included in the definition of food, meaning their manufacturers and importers must also comply with the disclosure requirements.
6. Are Bakeries Selling Various Food Items Subject to the Standard?
Bakeries that sell a variety of food items have specific guidelines under the NBFDS. All restaurant-type foods sold inside a standalone restaurant or a similar retail food establishment are exempt.
A bakery or deli that is part of a larger retail establishment, such as a grocery store, that sells restaurant-type foods intended for immediate consumption (e.g., a single-serving salad, a single muffin, a sandwich, or a single serving of soup) is considered a restaurant or similar retail food establishment for those items. These foods are not subject to the Standard.
However, foods such as a container with multiple muffins, a loaf of bread, or a bag of dinner rolls that are not intended for immediate consumption are subject to the Standard.
7. Which Products Must Comply with the NBFDS Disclosure Requirements?
Bioengineered foods or foods that contain bioengineered food ingredients must be labeled with the bioengineered food disclosure. The Standard defines bioengineered foods as those containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, where such modification couldn’t be achieved through conventional breeding or found naturally.
Highly refined foods or ingredients that do not contain detectable modified genetic material are not considered bioengineered foods and do not require disclosure.
8. What is the List of Bioengineered Foods?
The List of Bioengineered Foods (List) identifies bioengineered foods authorized for commercial production and in legal production worldwide. This list guides regulated entities on which foods require record-keeping and potential BE disclosures.
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
- Sugarbeet
Regulated entities must disclose bioengineered foods, even if they are not on the List, if their records indicate the food is bioengineered. Additional information about crops and foods on the List is available on the AMS website, which is regularly maintained and updated.
9. Do Processed Foods Derived from the List Require Disclosure?
Whether an ingredient derived from a bioengineered food (such as corn, canola, or soybeans) is considered bioengineered depends on whether the ingredient includes 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, if these ingredients are highly refined and the modified genetic material is no longer detectable, they do not require disclosure.
10. Are Animal Products Considered Bioengineered if the Animal Ate Bioengineered Feed?
The Standard states that food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal ate bioengineered feed. For example, milk from a cow that ate bioengineered alfalfa is not considered a bioengineered food just because the cow ate bioengineered alfalfa.
This clarifies that the bioengineered status does not automatically transfer through animal feed to the animal products.
11. How Will the List of Bioengineered Foods Be Updated?
The USDA will update the List when necessary to reflect the current availability of bioengineered foods. Before updating the List, the USDA will coordinate with other Federal regulatory agencies who regulate biotechnology.
The USDA will conduct annual reviews of the List and, as necessary, conduct rulemaking to amend the List. Public input into the List’s composition is invited on an ongoing basis. The Standard also outlines a rulemaking process to determine whether certain “factors and conditions” may exclude certain foods from being considered bioengineered.
12. 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 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.
These methods provide clarity and options for regulated entities to ensure compliance.
13. Will the Standard Impact Foreign Trade?
The Standard is not intended to, nor is it expected to, disrupt trade. It places the same requirements on domestic and foreign entities, ensuring fair and equal treatment.
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 our trading partners.
The USDA’s Foreign Agricultural Service is prepared to work closely with countries who import food into the United States to help them understand the requirements of the Standard.
14. What Information Does AMS Provide on Its Website for Each Item 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) to help regulated entities determine whether they need to make a BE disclosure.
This detailed information helps in identifying foods that may require disclosure, simplifying the compliance process.
15. How Do I Report a Food That I Suspect Is Bioengineered But Lacks Disclosure?
Anyone who suspects a violation may have occurred can file a written complaint with the AMS Administrator by mail or on the AMS website. This ensures that there is a system in place for reporting and addressing potential non-compliance issues.
16. Is Disclosure Required for Products Supplied to Foodservice End Users?
Food supplied to a distributor who only distributes products to foodservice end users does not require BE disclosure, as long as that food is being served in a restaurant or similar retail food establishment. This exemption aligns with the Standard’s exclusion of food served in restaurants.
However, food subject to labeling under the Federal Food, Drug, and Cosmetic Act and certain foods subject to the labeling requirements of the USDA Food Safety Inspection Service are required to comply with the National Bioengineered Food Disclosure Standard.
17. Is There an Allowable Percentage of Recombinant DNA Presence That Would Exempt a Food Product from Labeling?
The Standard includes an exemption that does not require disclosure 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.
For example, if a food manufacturer sources non-bioengineered corn with an inadvertent or technically unavoidable amount of a bioengineered substance less than 5 percent, disclosure is not required. However, if a food manufacturer intends to use a highly refined ingredient produced from bioengineered corn but does not refine that ingredient to the point where modified genetic material is no longer detectable, that ingredient still requires disclosure, regardless of the amount of modified genetic material that may remain.
This threshold exemption recognizes the complexities of the supply chain and acknowledges that bioengineered and non-bioengineered foods may be harvested by and processed on the same equipment.
18. What Records Are Sufficient to Demonstrate 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 for bioengineered foods and bioengineered food ingredients.
If the records currently kept show whether a food is genetically modified in alignment with 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. Will Each Facility Be Required to Validate Processes for Highly Refined Ingredients?
The requirements for a validated refining process are explained at 7 CFR 66.9(b). Once a refining process has been validated to render modified genetic material in a food undetectable, additional testing is not necessary to confirm the absence of detectable modified genetic material in food subsequently refined through that process.
This is provided that no significant changes are made to the validated process and records are maintained to demonstrate that the refining process has been validated and is followed. Validation refers to the process, not the facility, so a validated process does not need to be revalidated when completed in a different facility.
20. Will AMS Maintain a List of Validated Refining Processes?
No, AMS will not maintain a list of validated refining processes. Given the proprietary nature of food production, AMS believes that regulated entities are best positioned to determine whether the processes they use make modified genetic material undetectable.
21. What Records Are Required to Show Inadvertent Presence of a Bioengineered Substance?
The Standard exempts from disclosure a food 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.
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, then AMS may presume that any bioengineered presence below five percent is inadvertent or technically unavoidable.
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, like enzymes, yeasts, and other micro-organisms, 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. For example, in an ingredient list like “FILLING: PORK, ONION, CABBAGE, CORN, SALT, SUGAR. WRAPPER: WHEAT FLOUR, WATER,” AMS would consider pork to be the first ingredient.
24. Does the SECURE Rule Impact Labeling Requirements Under the NBFDS?
No, the final SECURE rule (7 CFR 340) does not impact labeling requirements under the National Bioengineered Food Disclosure Standard (NBFDS). 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 Modified Genetic Material?
No, USDA does not maintain an approved list of labs to test modified genetic material (rDNA). USDA has published guidance documents on the validation of a refinement process and the selection of a test method. These documents can be found on the AMS BE disclosure webpage.
26. Is a Closed-Face Sandwich Exempt if Meat is the First Ingredient?
As stated at 7 CFR 66.3(b), the Standard applies only to a food subject to: (1) the labeling requirements of the Federal, Food, Drug, and Cosmetic Act (“FDCA”); or (2) 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.
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. Does 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 but does not require any claims to be made about the absence of bioengineered food ingredients.
28. Are Alcoholic Beverages 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.
This includes:
- All beverage spirits, malt beverages, and their products regardless of 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. Do I Need to Disclose if I Use Alcohol Derived from a Food on the AMS List?
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. Are Foods Primarily Made of Meat or Poultry Broths Subject to 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) 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.
For food products with meat broth as the first ingredient, if the product is subject to the labeling requirements of the FMIA, that food is not subject to the Standard, even if any of the remaining ingredients would, on their own, be considered bioengineered foods.
For food products with poultry broth as the first ingredient, if the product is subject to the labeling requirements of the PPIA, it is subject to the Standard because poultry broth is independently subject to the labeling requirements of the FDCA.
For food products with vegetable broth as the first ingredient, that food product would only be subject to the Standard if its second ingredient was subject to the labeling requirements of the FDCA.
31. Are 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.
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.
FAQ on Bioengineered Food Ingredients
Here are some frequently asked questions to further clarify the topic:
| Question | Answer |
|---|---|
| What exactly does “bioengineered” mean in the context of food? | “Bioengineered” refers to foods that contain detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, and where such modifications cannot be obtained through conventional breeding or found in nature. |
| Why is there a need for bioengineered food disclosure standards? | The standards aim to provide consumers with more information about their food, allowing them to make informed decisions. It promotes transparency in the food industry and builds trust between consumers and producers. |
| How do bioengineered foods differ from genetically modified organisms (GMOs)? | The terms are often used interchangeably, but “bioengineered” is the term used in the National Bioengineered Food Disclosure Standard. It specifically refers to foods with detectable modified genetic material created through rDNA techniques. |
| Are bioengineered foods safe to eat? | Regulatory bodies such as the USDA and FDA assess the safety of bioengineered foods before they enter the market. These assessments ensure that bioengineered foods are as safe as their non-bioengineered counterparts. |
| Can a food be labeled as “non-GMO” if it doesn’t require a bioengineered disclosure? | No, a food cannot be labeled as “non-GMO” solely because it doesn’t require a bioengineered food disclosure. The USDA clarifies that such a claim may mislead consumers, as the absence of a disclosure doesn’t automatically qualify the food as “non-GMO.” |
| How can consumers identify bioengineered foods in the market? | Consumers can look for specific disclosures on food packaging, including text labels, symbols, or electronic or digital links (like QR codes). These disclosures indicate that the food is bioengineered or contains bioengineered ingredients. |
| What are the benefits of bioengineering in food production? | Bioengineering can lead to increased crop yields, enhanced nutritional value, pest resistance, and reduced pesticide use. These benefits can contribute to more sustainable and efficient food production systems. |
| Are there any environmental concerns associated with bioengineered foods? | Environmental concerns include the potential for cross-pollination with non-bioengineered crops, the development of herbicide-resistant weeds, and impacts on biodiversity. However, these concerns are continuously studied and managed through regulatory oversight and best practices. |
| What role do international standards play in the regulation of bioengineered foods? | International standards, such as those set by the Codex Alimentarius Commission, provide guidelines for the safety assessment and labeling of bioengineered foods. These standards help harmonize regulations across different countries and facilitate international trade. |
| Where can I find more detailed information about the National Bioengineered Food Disclosure Standard? | You can visit the USDA Agricultural Marketing Service (AMS) website for detailed information, including the full text of the standard, the List of Bioengineered Foods, and guidance documents for regulated entities. For further questions, you can also email [email protected]. Additionally, FOODS.EDU.VN provides extensive resources and articles on this topic. |
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