Q. If I am a regulated entity, how must I make the disclosure to show that my food is bioengineered or includes bioengineered food ingredients?
- The disclosure may be made using one of four different methods: (1) text, (2) symbol, (3) electronic or digital link, or (4) text message.
- The text disclosure is: “bioengineered food” or “contains bioengineered food ingredients.”
- The symbol disclosure is:
- The electronic or digital disclosure must include a statement such as “Scan here for more food information” and must be accompanied by a telephone number and the statement “Call [1-000-000-0000] for more food information.” When accessed, the electronic or digital link must include the bioengineered food disclosure (text or symbol) on the first screen a consumer sees on the electronic or digital device.
- The text message disclosure must include the statement “Text [command word] to [number] for bioengineered food information.” When used, the number must immediately send a response to the consumer’s mobile device with the bioengineered food disclosure.
- Small food manufacturers (< $10,000,000 annual receipts) may make the disclosure using a telephone number or URL and the statement “Call/visit [phone number/website] for more food information.”
- The Standard includes reasonable accommodations for disclosure on foods in small and very small packages, including a shortened statement accompanying disclosures made by text message and electronic or digital disclosure.
Q. Where must the bioengineered food disclosure be placed?
- The Standard prescribes three different locations for the disclosure. First, the disclosure can be placed on the information panel directly adjacent to the statement identifying the name and location of the distributor (or similar information). This will frequently be directly below the nutrition fact panel. Second, the disclosure can be placed on the principal display panel, which is typically the front of the package and the panel that consumers will see first when shopping. If there is not enough space on the information panel or the principal display panel, then the disclosure may be made on an alternative panel likely to be seen by the consumer under ordinary shopping conditions.
- Consumers should look in these places for the bioengineered food disclosure, which may be made using (1) text disclosure, (2) symbol disclosure, (3) electronic or digital disclosure, or (4) text message disclosure.
Q. Is there a specific size requirement for the disclosure?
- The Standard does not prescribe a specific size for the disclosure. Regardless of the disclosure option a regulated entity chooses to use, the Standard requires that the disclosure be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions.
Q. When a regulated entity uses the electronic or digital disclosure option, does the number that accompanies the statement “Call [1-000-000-000] for food information.” need to be a different number than one that is already on a food package? Does the number need to be used exclusively for the bioengineered food disclosure?
- As required by 7 CFR 66.106(a)(2), a regulated entity that chooses to use an electronic or digital disclosure must also include a phone number that allows the consumer to access the disclosure by phone.
- Any phone number that provides the bioengineered food disclosure to the consumer when they call the number is sufficient. This includes a phone number that, when called, lists the bioengineered food disclosure as one option in a menu of options.
- There is no requirement that regulated entities use a separate or unique phone number to make the bioengineered food disclosure.
Questions Added 05/24/2019
Q. We are in the process of revising our labels and I was trying to find more information on the disclosure statements. Is there a minimum font size for any of the disclosure options?
- Disclosure requirements, such as the size of disclosure, are explained at 7 CFR 66.100. At 7 CFR 66.100(c), it states that the required disclosure must be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions. Given the variation in package sizes and multiple disclosure options, AMS has not prescribed specific size requirements for the disclosure. Any disclosure that is “of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions” is acceptable.
Questions Added 09/24/19
Q. Does the BE Standard apply to a regulated entity selling food online, in catalogs, or through other remote means?
- The disclosure requirements are discussed at 7 CFR 66.100. There is not a requirement for foods sold online, in catalogs, or through other remote means to include a bioengineered food disclosure other than what is required under 7 CFR 66.100 and the remainder of Subpart B of the Standard.
- AMS notes that although a disclosure is not required online or in a catalog, a regulated entity may choose to voluntarily include the bioengineered food disclosure in the materials included online or in the catalog.
Q. Can a food not subject to the Standard make a claim regarding the absence of bioengineering?
- As stated in 7 USC 1639(c), “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 under this subchapter.”
Question Added 05/18/2021
Q: Will USDA provide BE symbols in Illustrator AI or EPS files or other file formats?
A: USDA does not provide the BE symbols in Illustrator AI or EPS files or other formats other than the PNG format.
Question Added 12/15/2021
Q: If we are to disclose using a sticker, does the sticker have to be directly on the package product label or can it be anywhere on packaging itself, so long as it meets the Standard at 7 CFR 66.100(c)?
A: The Standard requires, at 7 CFR 66.3, that a label for a bioengineered food must bear a disclosure indicating that the food is a bioengineered food or contains a bioengineered food ingredient. The bioengineered food disclosure must be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions. 7 CFR 66.100(c).
In the case that the existing label is too small to fit a sticker bearing a bioengineered disclosure, placing the sticker directly on the package would likely be in compliance provided it meets the requirements of 66.100(c).
Question added 1/3/2022
Q: A food manufacturer uses a substance that meets the definition of “incidental additive” at 21 C.F.R. § 101.100(a)(3). However, the food manufacturer voluntarily includes the incidental additive in a product’s ingredient list. Would this require disclosure?
A: Pursuant to the Standard at 7 CFR 66.1, food is not a bioengineered food if it is, “An incidental additive present in food at an insignificant level and that does not have any technical or functional effect in food, as described in 21 CFR 101.100(a)(3).” If the incidental additive being used meets the definition of an incidental additive as defined by the FDA in 21 CFR 101.100(a)(3) it is not a bioengineered food and does not require a disclosure under the Standard regardless of whether the manufacturer voluntarily labels it, includes it in the ingredient list to comply with the Food Allergen Labeling and Consumer Protection Act of 2004, or references it in a “Contains” statement. A food cannot be mandatorily disclosed as bioengineered based solely on the presence of an incidental additive.
Under 7 CFR 66.116(b), the Standard does not allow a voluntary disclosure for incidental additives (as defined by paragraph (2) of the definition of bioengineered food at 7 CFR 66.1). Thus, regulated entities are not allowed to voluntarily disclose a food as bioengineered based solely on the presence of an incidental additive.
Q. Can an entity voluntarily make disclosures for foods that are derived from bioengineered crops, but do not contain detectable modified genetic material?
- Yes. The Standard acknowledges that consumers want additional information about their food and how it was produced, and that some regulated entities want to provide consumers with this information. To provide consumers with more information, the Standard allows regulated entities to voluntarily disclose the presence of ingredients derived from bioengineering when the modified genetic material is no longer detectable. This voluntary disclosure can be made using any of the disclosure methods available for mandatory disclosures, and by using the phrase “derived from bioengineering” or “ingredient(s) derived from a bioengineered source,” or the symbol:
- Entities electing to make voluntary disclosures must comply with all requirements of the Standard.
Q. Can an entity that is otherwise exempt from disclosure, such as a very small food manufacturer or a restaurant, voluntarily comply with the Standard?
- Yes, exempt entities such as very small food manufacturers, and restaurants or similar retail food establishments who are labeling bioengineered foods for retail sale may voluntarily comply with NBFDS in the same manner as regulated entities including using one of the disclosure methods set forth in the Standard.
- Exempt entities may voluntarily disclose foods that are derived from bioengineered crops, but do not contain detectable modified genetic material, in accordance with the Standard.
Q. If a raw material has processing aids that are not labeled in the ingredient list on our finished product, would that be subject to disclosure under the Standard? For example, we use a vitamin D that has a corn oil carrier. We label the vitamin D on our finished product, but not the corn oil. If we know the vitamin D is not a bioengineered food, does the finished product need a BE disclosure because of the corn oil carrier?
- The definition of bioengineered food, at 7 CFR 66.1, excludes incidental additives that are present in food at an insignificant level and that do not have any technical or functional effect in the food, as described in 21 CFR 101.100(a)(3). Incidental additives, when used in accordance with this definition, are not required to be included on the ingredient list. If the corn oil you are using as a processing aid is considered an incidental additive as defined in 21 CFR 101.100(a)(3), then it does not require a bioengineered food disclosure.
Q. Would it still be acceptable to still use stamps or stickers after January 1, 2022?
- The National Bioengineered Food Disclosure Standard requires, at 7 CFR 66.100(c), the bioengineered food disclosure to be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions. Any stamp or sticker that meets this requirement using one of the allowed disclosure options (e.g. text, symbol, electronic or digital disclosure, text message), and that is in compliance with the requirement concerning placement of such disclosures under 7 CFR 66.100(d), is sufficient to comply with the law.
Question added 11/4/2019
Q. We label our products in both English and Spanish. Can we list the bioengineered disclosure in both languages? Is there a Spanish translation we should use?
- At 7 CFR 66.102(b), the Standard allows food that is distributed solely in a U.S. territory to be labeled with statements equivalent to those required in the Standard, using the predominant language in that territory. Other than this, the Standard only requires that the BE food disclosure appear in English. If a regulated entity chooses to voluntarily include the BE food disclosure in Spanish, the following translations should be used:
Alimento producido con bioingeniería
Contains a bioengineered food ingredient
Contiene un ingrediente producido con bioingeniería
Contains bioengineered food ingredients
Contiene ingredientes producidos con bioingeniería
Derived from bioengineering
Derivado de la bioingeniería
Ingredient derived from a bioengineered source
Ingrediente derivado de un producto producido con bioingeniería
Ingredients derived from a bioengineered source
Ingredientes derivados de un producto producido con bioingeniería
Question added 5/21/2020
Q. If I choose to use the electronic or digital disclosure, can I combine the two required statements?
- AMS will allow the following single statement to be used on product labels as it conveys the required information: “Scan here for more food information or call [1-000-000-0000].” All other requirements remain.