BE Frequently Asked Questions - General

Q. What is the National Bioengineered Food Disclosure Standard?

  • The National Bioengineered Food Disclosure Standard (NBFDS or Standard) requires food manufacturers, importers, and certain retailers to disclose information about whether food offered for retail sale is bioengineered (BE) or uses BE food ingredients. The Standard is designed to provide consumers more information about their food.
  • The Standard defines bioengineered foods as those that contain detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.

Q. What is the difference between the effective, implementation, and compliance dates?

  • The effective, implementation, and compliance dates are as follows:
    • Effective Date: This rule became effective February 19, 2019.
    • Implementation Date: January 1, 2020.
    • Extended Implementation Date (for small food manufacturers): January 1, 2021.
    • Voluntary Compliance Date: Ends on December 31, 2021.
    • Mandatory Compliance Date: January 1, 2022.
  • To comply with the Congressional Review Act, the effective date for this rule was February 19, 2019, which is sixty days after the rule was published in the Federal Register.
  • The implementation date is when regulated entities (except small food manufacturers) should prepare to fully comply with the National Bioengineered Food Disclosure Standard (Standard).  The extended implementation date is when small food manufacturers should prepare to fully comply with the Standard.  Preparation may include identifying the foods that may require a BE disclosure, records necessary to meet the Standard’s recordkeeping requirements, and the types of BE disclosures that will be used on products.
  • The voluntary compliance date is the last date when foods entering commerce may voluntarily comply with the Standard, and the last date that preempted state labels may be put into commerce.
  • The mandatory compliance date is the date when foods entering commerce must be labeled in accordance with the Standard.

Q. When does USDA consider a food as having “entered commerce?”

  • USDA considers food as having entered commerce on the date it is labeled for retail sale.

Q. How long can labels that are not compliant with the Standard remain on grocery store shelves?

  • At 7 CFR 66.13(c), the National Bioengineered Food Disclosure Standard (the Standard) includes a mandatory compliance date of January 1, 2022.  By this date, 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.

Q. Who must comply with the disclosure requirements of the Standard? What is a regulated entity?

  • Regulated entities must comply with the Standard. The Standard defines regulated entities as food manufacturers, importers, and certain retailers who label food for retail sale. 
  • The law does not apply to restaurants and similar retail food establishments (e.g. cafeterias, food trucks, airplanes, etc.) or very small food manufacturers, which are food manufacturers with annual receipts of less than $2,500,000.
  • The law does include dietary supplements in the definition of food covered under the standard, so manufacturers and importers of dietary supplements must comply with the disclosure requirements of the Standard.

Q. A bakery sells sandwiches, soups, salads, breads, muffins, cookies, and many other baked goods.  Some of these items are sold as single servings (e.g. soup and salads), while others are multiple servings (e.g. loaf of bread and bag of dinner rolls).  Which of these foods, if any, are subject to the Standard?

  • As discussed in the exemptions at 7 CFR 66.5(a), restaurants and similar retail food establishments are not required to comply with the National Bioengineered Food Disclosure Standard (the Standard), although they may voluntarily comply with the Standard if they so choose. 
  • All foods sold inside a standalone restaurant or a similar retail food establishment fall under this exemption.
  • 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, such as a single-serving salad, a single muffin, a sandwich, or a single serving of soup, would be considered a restaurant or similar retail food establishment when selling these restaurant-type foods, and such foods would not be subject to the Standard.  Conversely, 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, would be subject to the Standard because they are not considered to be restaurant-type foods sold in a restaurant or similar retail food establishment.

Q. What 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 that contain detectable genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
  • Highly refined foods or ingredients that do not contain detectable modified genetic material are not bioengineered foods.

Q. What is the List of Bioengineered Foods?

  • The List of Bioengineered Foods (List) identifies bioengineered foods that are authorized for commercial production (by the country in which it is produced) and in legal production somewhere in the world. The List tells regulated entities which foods they must keep records for and which foods may require 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 and sugarbeet.
  • When only one company produces a bioengineered food, such as ArcticTM Apples or AquAdvantage® salmon, AMS will include the trade name on the List to simplify compliance for regulated entities.
  • Regulated entities whose records show that a food they are selling or using is bioengineered must make appropriate disclosure of that food, even if that food is not on the List.
  • Additional information about the crops and foods on the List is available on the AMS website. The information will be maintained and updated.
  • The online information will include 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.

Q. I’m using a processed form of a food on the List, do I need to make a bioengineered food disclosure?

  • Whether an ingredient that is derived from a bioengineered food—such as corn, canola, or soybeans—is a bioengineered food depends on whether the ingredient includes detectable modified genetic material. 
  • As defined in 7 CFR 66.1, bioengineered foods must contain detectable modified genetic material.  If the ingredients you use—such as corn starch, canola oil, and soy lecithin—contain detectable modified genetic material, then they are considered bioengineered food ingredients and do require a bioengineered food disclosure. 
  • If these ingredients are highly refined and your records show the modified genetic material is no longer detectable, then they do not require disclosure.

Q. Is an animal product considered a bioengineered food if the animal ate bioengineered feed?

  • At 7 CFR 66.5, the Standard states that food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal ate a bioengineered feed. 
  • For example, the milk from a cow that ate bioengineered alfalfa is not considered a bioengineered food just because the cow ate bioengineered alfalfa.

Q. How will the List be updated?

  • USDA will update the List when necessary to reflect the current availability of bioengineered foods. 
  • Before updating the List, USDA will coordinate with other Federal regulatory agencies who regulate biotechnology. 
  • 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 help determine whether there are certain “factors and conditions” that may exclude certain foods from being considered a bioengineered food. 

Q. How can I tell if my food has detectable modified genetic material?

  • The Standard identifies three different ways that a regulated entity can determine that modified genetic material is not detectable: (1) by using records to verify that a food is sourced from a non-bioengineered crop, (2) by 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) by maintaining certificates of analysis or other testing records appropriate to a specific food that confirm the absence of detectable modified genetic material.

Q. Will the Standard have an impact on foreign trade?

  • The Standard is not intended to, or expected to, disrupt trade. The Standard places the same requirements on domestic and foreign entities.
  • During the rulemaking process, USDA sought comment from all stakeholders regarding any 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.
  • 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.

Q. What is the information that AMS has on its website for each of the items on the List of Bioengineered Foods?

  • The information on the website is designed to help regulated entities understand which varieties of foods on the List of Bioengineered Foods may be bioengineered. The website will include specific information about traits, varieties, and production information (i.e. location) that will help regulated entities determine whether they need to make a BE disclosure.

Q. If I think there is a food that is bioengineered, but it does not include a bioengineered food disclosure, how do I report that?

  • Anybody who suspects a violation may have occurred can file a written complaint with the AMS Administrator by mail or on the AMS website. More detailed instructions will be posted to the AMS website closer to the compliance date.

Q. If a regulated entity supplies product to a distributor who only distributes products to foodservice end users, does the product manufactured by the regulated entity and sold by a distributor exclusively to a foodservice establishment require the BE disclosure?

  • As noted at 7 USC 1639a and 7 CFR 66.3(b), 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 (the Standard).  However, the Standard also excludes certain foods from this labeling requirement.  At 7 USC 1639b and 7 CFR 66.5(a), food served in a restaurant or similar retail food establishment is exempted.  Because the Standard exempts food served in a restaurant or similar retail food establishment, food being supplied to a restaurant or similar retail food establishment is not subject to the Standard so long as that food is being served in a restaurant or similar retail food establishment.

Q. Is there any allowable percentage of recombinant DNA presence that would render a food product exempt from labelling under the law?

  • The Standard includes an exemption at 7 CFR 66.5(c), which 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.  Bioengineered substance is defined at 7 CFR 66.1.
  • For example, if a food manufacturer sources non-bioengineered corn and that non-bioengineered corn has an inadvertent or technically unavoidable amount of a bioengineered substance that is less than 5 percent, then disclosures is not required.  However, if a food manufacturer intends to use a highly refined ingredient produced from a bioengineered food such as 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.  As explained at 83 Fed. Reg. 65848-65849, 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.  This exemption does not apply when a regulated entity intends to use a highly refined bioengineered food ingredient but does not refine it to the point where detectable modified genetic material is no longer present.

Q. We currently have specifications on the ingredients we use stating whether or not they are genetically modified, is that a sufficient record along with the invoice stating that we purchased the product from that company?

  • According to 7 CFR 66.3, disclosure is required for a food that is a bioengineered food or contains a bioengineered food ingredient.  The definition of bioengineered food is included at 7 CFR 66.1.  Regulated entities are required to keep records that demonstrate compliance with the disclosure requirements for bioengineered foods and bioengineered food ingredients, as stated at 7 CFR 66.302.  If the records that you currently keep show whether a food is genetically modified align with the definition of bioengineered food, as stated at 7 CFR 66.1, and you make appropriate disclosures based on those records, then those records should be sufficient to comply with the law.

Questions Added 05/24/19

Q. Will each facility be required to validate a process for highly refined ingredients? Or will facilities that use the same processes be able to rely on results from a process that has already been validated?

  • 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.  As required by the regulation, validation refers to the process, not the facility in which the process occurs.  As such, once a process is validated under the Standard and all recordkeeping requirements are followed, that validated process does not need to be revalidated when completed in a different facility.

Q. Will AMS maintain a list of validated refining processes?

  • No, AMS will not be maintaining a list of validated refining processes.  Given the proprietary nature of food production, AMS believes that regulated entities are in the best position to determine whether the processes they use make modified genetic material undetectable.

Q. For purposes of the threshold, what types of records are required to show that the presence of a bioengineered substance is inadvertent or technically unavoidable?  If a food manufacturer has specification sheets that require ingredient suppliers to provide inputs with less than or equal to 0.9% BE substance, can they assume that such presence is inadvertent or technically unavoidable?

  • 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 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 they 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.  A record that indicates an ingredient has less than or equal to 0.9 percent BE presence, without more, is insufficient because the amount up to or equal to 0.9 percent may have been intentionally included.  A record that indicates an ingredient was sourced from a non-bioengineered crop, reasonable precautions have been taken to keep that non-bioengineered crop and ingredient separate from bioengineered crops and ingredients, and that any presence of a bioengineered substance is less than or equal to 0.9 would be sufficient to demonstrate compliance with the exemption at 7 CFR 66.5(c).

Questions Added 09/24/19

Q. Is documentation required to verify the BE status of enzymes, yeasts, and other micro-organisms, when I do not have definitive knowledge that these ingredients are bioengineered?

  • As required by 7 CFR 66.109, 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.

Q. When a product label has a component ingredient statement (e.g., FILLING:  PORK, ONION, CABBAGE, CORN, SALT, SUGAR. WRAPPER:  WHEAT FLOUR, WATER.), how do I identify the first ingredient?

  • Predominance is defined at 7 CFR 66.1 and what foods are subject to the Standard based on the predominance of certain ingredients is explained at 7 CFR 66.3(b).  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. 
  • In this example, AMS would consider pork to be the first ingredient.  Because pork is subject to the Federal Meat Inspection Act, the food would not be subject to the Standard.

For further questions or if you would like more specific information pertaining to the Standard, please e-mail befooddisclosure@ams.usda.gov