Bioengineered food ingredients, as explored on FOODS.EDU.VN, are transforming the food industry, and understanding them is crucial for informed consumer choices. Let’s delve into the meaning of bioengineered food ingredients, offering clarity and insights into related aspects such as genetic modification, disclosure standards, and labeling requirements.
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1. Decoding Bioengineered Food Ingredients
What Is the National Bioengineered Food Disclosure Standard?
The National Bioengineered Food Disclosure Standard (NBFDS), as understood by FOODS.EDU.VN users, mandates that food manufacturers, importers, and certain retailers disclose whether food available for retail sale is bioengineered (BE) or contains BE food ingredients. This standard aims to furnish consumers with enhanced insights into their food choices, promoting transparency in the food industry.
What Defines a “Bioengineered Food” Under the Standard?
According to the NBFDS, bioengineered foods encompass those containing detectable genetic material modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques, modifications that could not be achieved through conventional breeding methods or found naturally, highlighting the role of modern biotechnology in food production.
Effective Date vs. Compliance Date: What’s the Distinction?
- Effective Date: This marks when a published Final Rule becomes operative and enforceable.
- Mandatory Compliance Date: On this date, all foods entering commerce must be labeled in accordance with the Standard, and regulated entities using food on the List must maintain records.
At What Point Does USDA Consider a Food to Have “Entered Commerce?”
The USDA considers a food to have “entered commerce” on the date it is labeled for retail sale, directly impacting labeling requirements and compliance timelines.
How Long Can Non-Compliant Labels Remain on Grocery Shelves?
The Standard mandates that all foods entering commerce must adhere to labeling compliance. It does not govern the duration for which foods labeled before the mandatory compliance date can remain in retail environments.
2. Compliance and Regulation of Bioengineered Foods
Who Is Obligated to Comply with the NBFDS Disclosure Requirements?
Regulated entities, including food manufacturers, importers, and select retailers who label food for retail sale, must adhere to the Standard, as they are the primary stakeholders in ensuring accurate food labeling and consumer information.
Are Restaurants and Small Food Manufacturers Exempt?
The law excludes 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, recognizing the diversity of the food industry and aiming to streamline compliance efforts.
Do Dietary Supplements Fall Under the NBFDS?
Yes, dietary supplements are included in the definition of food covered under the standard, requiring their manufacturers and importers to comply with the disclosure requirements, ensuring that consumers have comprehensive information on a wide array of products.
How Does the NBFDS Apply to Bakeries and Similar Establishments?
A bakery or deli within a larger retail establishment selling restaurant-type foods intended for immediate consumption (e.g., single-serving salads, muffins, sandwiches, or soup) is considered a restaurant or similar retail food establishment for those items and is exempt from the Standard. However, foods not intended for immediate consumption, such as multiple muffins, loaves of bread, or bags of dinner rolls, are subject to the Standard.
3. Products Subject to NBFDS Disclosure
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, providing transparency and information to consumers about the ingredients in their food.
What About Highly Refined Foods?
Highly refined foods or ingredients that do not contain detectable modified genetic material are not considered bioengineered foods and do not require disclosure, distinguishing between the presence and absence of modified genetic material in food products.
What Is the List of Bioengineered Foods?
The List of Bioengineered Foods identifies foods authorized for commercial production (by the country in which it is produced) and in legal production globally. This list informs regulated entities about which foods necessitate record-keeping and may require BE disclosures. It 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 and sugarbeet.
Why Are Trade Names Included on the List?
When a single company produces a bioengineered food, such as ArcticTM Apples or AquAdvantage® salmon, AMS includes the trade name on the List to simplify compliance for regulated entities, facilitating easier identification and labeling of bioengineered foods.
What if a Food Is Bioengineered but Not on the List?
Regulated entities whose records indicate a food they are selling or using is bioengineered must disclose that information, even if the food is not on the List, ensuring comprehensive disclosure and consumer awareness.
How Is the List Maintained and Updated?
Additional information about the crops and foods on the List is available on the AMS website. The information is maintained and updated, including details about specific varieties of crops and foods that have been bioengineered, to help regulated entities more easily identify foods for which disclosure may be necessary.
4. Implications for Processed Foods and Animal Products
Do Processed Forms of Foods on the List Require Disclosure?
Whether an ingredient derived from a bioengineered food, such as corn, canola, or soybeans, requires a bioengineered food disclosure depends on whether the ingredient contains 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 records indicate that the modified genetic material is no longer detectable, disclosure is not required.
Is an Animal Product Considered Bioengineered if the Animal Ate Bioengineered Feed?
The Standard specifies that food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal consumed such feed. For example, milk from a cow that ate bioengineered alfalfa is not considered a bioengineered food, distinguishing between direct and indirect impacts of bioengineering in food production.
How Often Will the List Be Updated?
The USDA will update the List as needed to reflect the current availability of bioengineered foods, coordinating with other Federal regulatory agencies that regulate biotechnology. Annual reviews of the List will be conducted, and rulemaking will be initiated as necessary to amend the List, with ongoing invitations for public input on the List’s composition.
5. Determining Detectable Modified Genetic Material
How Can I Tell if My Food Has Detectable Modified Genetic Material?
The Standard outlines three methods for a regulated entity to determine that modified genetic material is not detectable: (1) using records to verify that a food is sourced from a non-bioengineered crop, (2) using records to verify that a food has been subjected to a refinement process that has been validated to render modified genetic material undetectable, or (3) maintaining certificates of analysis or other testing records specific to a food that confirm the absence of detectable modified genetic material.
What Impact Will the Standard Have on Foreign Trade?
The Standard is designed and expected not to disrupt trade, applying the same requirements to both domestic and foreign entities. The USDA sought input from all stakeholders during the rulemaking process regarding any unique issues associated with bioengineered food disclosure for imports, ensuring fair and equitable trade practices.
What Information Does AMS Provide on Its Website for Each Item on the List?
The information on the AMS website is intended to help regulated entities understand which varieties of foods on the List may be bioengineered, including specific information about traits, varieties, and production information (i.e., location) to help determine whether a BE disclosure is necessary.
6. Reporting and Compliance Verification
How Do I Report a Food That I Suspect Is Bioengineered but Does Not Include a Disclosure?
Anyone suspecting a violation can file a written complaint with the AMS Administrator by mail or on the AMS website, promoting vigilance and adherence to the Standard.
What About Products Supplied to Distributors Serving Foodservice End Users?
If a regulated entity supplies a product to a distributor who exclusively distributes to foodservice end users, the product does not require a BE disclosure, provided that the food is served in a restaurant or similar retail food establishment, streamlining the disclosure process for specific distribution channels.
Is There an Allowable Percentage of Recombinant DNA Presence Exempting a Food from Labeling?
The Standard includes an exemption for foods in which no ingredient intentionally contains a bioengineered substance, allowing for an inadvertent or technically unavoidable bioengineered presence of up to five percent for each ingredient, recognizing the complexities of the supply chain and potential commingling of bioengineered and non-bioengineered foods.
Are Existing Specifications on Ingredients Sufficient for Compliance?
According to 7 CFR 66.3, disclosure is required for a food that is a bioengineered food or contains a bioengineered food ingredient. Regulated entities must maintain records that demonstrate compliance with disclosure requirements, as stated in 7 CFR 66.302. If current records align with the definition of bioengineered food and disclosures are made accordingly, those records should suffice for compliance.
7. Validating Processes and Enzyme Documentation
Is Validation Required for Each Facility Processing Highly Refined Ingredients?
The requirements for a validated refining process are detailed in 7 CFR 66.9(b). Once a refining process is 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. Validation refers to the process, not the facility; thus, a validated process does not need revalidation when completed in a different facility.
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 their processes make modified genetic material undetectable.
What Records Are Needed to Show Inadvertent Bioengineered Presence?
At 7 CFR 66.5(c), the Standard exempts from disclosure a food in which no ingredient intentionally contains a bioengineered substance, with an allowance of up to five percent for inadvertent presence. 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.
Is Documentation Required for Enzymes, Yeasts, and Other Micro-organisms?
As required by 7 CFR 66.109, if a regulated entity has actual knowledge that a food is bioengineered or contains a bioengineered food ingredient, disclosure is mandatory. For foods not on the AMS List of Bioengineered Foods, like enzymes, yeasts, and other micro-organisms, if records demonstrate actual knowledge of using a bioengineered version, disclosure is required.
8. Ingredient Statements and Broth Products
How Do I Identify the First Ingredient in a Component Ingredient Statement?
For purposes of applying 7 CFR 66.3(b), AMS will consider the ingredients in the order they appear on the ingredient list of the food label. For example, in “FILLING: PORK, ONION, CABBAGE, CORN, SALT, SUGAR. WRAPPER: WHEAT FLOUR, WATER,” pork would be the first ingredient. If pork is subject to the Federal Meat Inspection Act, the food would not be subject to the Standard.
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. 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.
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.
If Alcohol Derived from a Food on the AMS List Is Used, Is Disclosure Needed?
If the rum cake or other products are subject to the labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDCA), then they are subject to the Standard and must include a bioengineered food disclosure if any bioengineered foods or bioengineered food ingredients are used.
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 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, even if any of the remaining ingredients would, on their own, be considered bioengineered foods and otherwise subject to the Standard.
For food products with 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.
For food products with 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.
Are Meat Pizzas Subject to the Standard?
As stated at 7 CFR 66.3(b) 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.
Here, 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.
9. Additional Regulations and Verifications
Does the SECURE Rule Impact Labeling Requirements Under the NBFDS?
No, the SECURE rule 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.
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 but does not require claims about the absence of bioengineered food ingredients.
Will Each Facility Be Required to Validate a Process for Highly Refined Ingredients?
The requirements for a validated refining process are explained at 7 CFR 66.9(b). Those requirements state that, among other things, once a refining process has been validated to render modified genetical 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, provided that no significant changes are made to the validated process and provided that records are maintained to demonstrate that the refining process has been validated and that the validated refining process is followed.
Does USDA Maintain a List of Approved Laboratories for Testing the Modified Genetic Material?
USDA does not maintain an approved list of labs to test modified genetic material (rDNA). USDA published guidance documents on validation of a refinement process and selection of a test method. These documents can be found on the AMS BE disclosure webpage.
10. FAQs: Bioengineered Food Ingredients
1. What are the main goals of the National Bioengineered Food Disclosure Standard (NBFDS)?
The NBFDS seeks to provide consumers with more information about their food, ensuring transparency and informed choices regarding bioengineered ingredients.
2. How does the NBFDS define 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 could not be obtained through conventional breeding or found in nature.
3. Who is required to comply with the disclosure requirements of the NBFDS?
The Standard applies to regulated entities, including food manufacturers, importers, and certain retailers who label food for retail sale.
4. Are there any exemptions to the NBFDS disclosure requirements?
Yes, restaurants and similar retail food establishments (e.g., cafeterias, food trucks, airplanes, etc.) and very small food manufacturers with annual receipts of less than $2,500,000 are exempt.
5. What types of products are subject to the NBFDS disclosure requirements?
Bioengineered foods or foods that contain bioengineered food ingredients must be labeled with the bioengineered food disclosure.
6. What is the List of Bioengineered Foods, and how is it used?
The List identifies bioengineered foods authorized for commercial production and in legal production globally. Regulated entities use this list to determine which foods require record-keeping and may necessitate BE disclosures.
7. How often is the List of Bioengineered Foods updated?
The USDA updates the List as necessary to reflect the current availability of bioengineered foods, conducting annual reviews and initiating rulemaking to amend the List as needed.
8. What should I do if I suspect a food is bioengineered but does not include a disclosure?
You can file a written complaint with the AMS Administrator by mail or on the AMS website.
9. Does the NBFDS affect international trade?
The Standard is not intended to disrupt trade and applies the same requirements to both domestic and foreign entities.
10. Where can I find more information about the crops and foods on the List of Bioengineered Foods?
Additional information is available on the AMS website, which is regularly maintained and updated with details about specific varieties of crops and foods that have been bioengineered.
For further questions or specific information, please e-mail [email protected].
Understanding bioengineered food ingredients is essential for making informed choices about the food we consume. At FOODS.EDU.VN, we are committed to providing you with the most accurate, up-to-date information on this and many other topics related to food and nutrition.
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