Overview of the National Bioengineered 

Food Disclosure Standard

Krista Dickson, Director

Food Disclosure and Labeling Division

Fair Trade Practices Program
Public Law 114-216

The law amended the Agricultural Marketing Act of 

1946 and was signed on July 29, 2016. 

The Law directs the Secretary to establish the 

National Bioengineered Food Disclosure Standard for 

disclosing bioengineered food and food that may be 

bioengineered. 
Presentation Outline

I. Regulated Entities

II. Bioengineered Foods

III. Foods Subject to the Standard

IV. Disclosure Options

V. Recordkeeping Requirements

VI. Compliance & Enforcement
Regulated Entities
1. Food Manufacturers

2. Importers

3. Retailers who:

• Package and label food for retail sale or

• Sell bulk food items

Does not include:

• Restaurants and similar retail food establishments

• Very small food manufacturers (< $2,500,000 annual 

receipts)

Regulated Entities
Suppliers are not a regulated entity

• The regulated entities (i.e., retailers, manufacturers) that suppliers 

ship ingredients to may request records from suppliers so that they 

can comply with the law

Any requirements or requests from a regulated entity to their 

supplier are governed by private contracts and relationships that 

are not regulated by the Standard

Suppliers’ Role
Bioengineered Foods
A food that contains genetic material that has been modified through in 

vitro rDNA techniques and for which the modification could not otherwise 

be obtained through conventional breeding or found in nature.

• Food subject to certain factors and conditions are not

bioengineered foods (i.e. incidental additives).

• Foods in which the modified genetic material is not detectable 

are not bioengineered foods.

Bioengineered Food Definition
Factors or Conditions

USDA adopted incidental additives as a factor or condition. 

• Incidental additives, when used in accordance with 21 CFR 

101.100(a)(3), are not bioengineered foods or ingredients and do 

not trigger the need for disclosure.
Modified genetic material is not detectable if:

1) Records verify the food is made from a non-bioengineered food;

2) Records verify that the food has been refined using a process 

validated to render the modified genetic material undetectable; or

3) Testing records for the specific food confirm the absence of 

detectable modified genetic material.

Detectability
Ingredients derived from a food on the List 

• An ingredient that is derived from a food on the List is a bioengineered 

food if the ingredient contains detectable modified genetic material. 

• If the highly refined ingredient (canola oil, soybean oil, etc.) 

contains detectable modified genetic material, then it is 

considered a bioengineered food ingredient and does require a BE 

disclosure. 

• If records show that the highly refined ingredient does not contain 

detectable modified genetic material, then a BE disclosure is not 

required. 

Highly Refined Ingredients
• Alfalfa

• Apple (ArcticTM varieties)

• Canola

• Corn 

• Cotton

• Eggplant (BARI Bt Begun varieties)

• Papaya (ringspot virus-resistant varieties)

• Pineapple (Pink flesh varieties)

• Potato

• Salmon (AquAdvantage®)

• Soybean

• Squash (summer)

• Sugarbeet

List of Bioengineered Foods
Foods 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) Certain foods 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).

Foods Subject to the Standard

Exemptions

Exempt entities

• Restaurants and similar retail food 

establishments

• Very small food manufacturers (< 

$2,500,000 annual receipts)

Exempt products

• Threshold: Allows each ingredient to 

contain up to five percent of a BE 

substance, as long as it is 

inadvertent or technically 

unavoidable

• Animals fed bioengineered feed

• Food certified under the National 

Organic Program

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Disclosure Options
1. On-package text

• Should read “Bioengineered food” or “Contains a 

bioengineered food ingredient” or “Contains bioengineered 

food ingredients”

2. Symbol

3. Electronic or digital disclosure

4. Text message

Disclosure Options
Two types of voluntary disclosures may be made:

1. Entities that are exempt

2. Foods that do not contain detectable modified genetic material but 

are derived from bioengineering

Voluntary Disclosure under the 

Standard
1. Information panel adjacent to the manufacturer/distributor 

information

2. Principal display panel

3. If there is insufficient space on either the information panel or the 

principal display panel, then disclosure may be made on any other 

panel likely to be seen by a consumer under ordinary shopping 

conditions

Disclosure Format 
Foods Sold in Bulk Containers

1. Retailers are responsible for disclosure

2. Disclosure can be made using any of the 

four standard options

3. Disclosure must be placed on signage or 

other materials on or near the bulk food 

items

Disclosure Format 
Recordkeeping 

Requirements
1. A record that indicates the food is produced from a non-bioengineered crop.

2. A record that indicates the food has been subjected to a refinement process 

validated to render modified genetic material undetectable.

3. A record such as a certificate of analysis or other testing record appropriate 

to a specific food that confirm the absence of detectable modified genetic 

material. These would be batch-by-batch testing records to confirm each 

batch does not contain detectable modified genetic material.

Recordkeeping Requirements at 

7 CFR 66.9
• Organic certifications

• Documentation that ingredient is sourced from a country that does not 

allow production of that specific ingredient in a bioengineered form 

• Laboratory test results

• Process verifications 

Examples of Records to Justify 

Non-Disclosure
• Regulated entities subject to mandatory bioengineered food disclosure are 

required to keep sufficient records to establish compliance with the standard

• Must keep customary or reasonable records that would be generated in the 

normal course of business

• Regulated entities may determine which records to maintain, provided they are 

sufficient to demonstrate compliance

• Records may be in any format (hard copy or electronic)

• Records may be stored at any business location 

Recordkeeping
Regulated entities may determine the types of business records to 

maintain, provided that the records demonstrate compliance with the 

disclosure standard. Examples of possible records include:

• Ingredient List

• Invoices 

• Bills of lading 

• Inventory records

• Supply chain records 

Recordkeeping
• Records must be maintained for two years after the food is sold or distributed 

for retail sale

• Some records, such as those verifying a certain manufacturing process or 

testing, may be necessary to retain for longer periods

• When requested by USDA, records need to be produced within five business 

days, unless USDA grants an extension

• If on-site access is necessary, USDA will provide notice at least three business 

days in advance

• Suppliers are not required to maintain records

Recordkeeping
Compliance & Enforcement
Compliance and Enforcement

• The BE Standard is enforced at the retail level, where 

consumers make decisions about their food.

• Failure to make a bioengineered food disclosure as required by 

the BE Standard is prohibited.

• Complaints about possible violations of the BE Standard will be 

made to AMS through the BE complaint Portal on the AMS 

website. 

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Online submission: BE Complaints Portal [https://fdld-complaint-be.ams.usda.gov/] 32
Compliance and Enforcement

• AMS will determine whether further investigation is warranted.

• AMS will conduct a records audit, if appropriate. 

• The regulated entity will be notified about the results of the 

audit or investigation.

• AMS does not have the authority to recall any foods that have 

not properly disclosed BE ingredients or levy any fines.

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BE Complaint Cases

17 - Complaint Cases filed January 1 through April 10, 2023

14 - Closed Complaint Cases – No reasonable Grounds

2 - Investigated Complaint Cases - Closed

1 - Open Complaint Case (current investigation case)

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Thank You!

For additional information, including fact sheets, FAQs, a 

disclosure determination tool, and more please visit the AMS 

webpage at

www.ams.usda.gov/be

or send your questions by email to

befooddisclosure@usda.gov

Please note: All presentation photos are intended for visual interest only and may not represent actual BE products.

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