Overview of the 

National Bioengineered Food 

Disclosure Standard

December 2020

www.ams.usda.gov/be
Erin Healy, Director 

USDA AMS Food Disclosure and Labeling 

Division, Research and Rulemaking Branch

Trevor Findley, Deputy Director

Lakshmanan Ramamoorthi, 

Senior Technical Advisor

Anna Waller, 

Marketing Specialist & PMF

Serena Baldwin, 

Marketing Specialist & PMF
1. Who is regulated?

2. What foods are considered bioengineered 

foods?

3. How must bioengineered foods be labeled?

4. What are the recordkeeping requirements?

5. What does enforcement look like?

Presentation Overview

Email questions to: befooddisclosure@usda.gov
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. 
Who is 

regulated?

Please note: all presentation photos are 

intended for visual interest only and may not 

represent actual BE products.
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 Entity
What foods are 

considered 

bioengineered 

foods?

Please note: all presentation photos are 

intended for visual interest only and may not 

represent actual BE products.

Is this food 

subject to 

disclosure?
Is this food 

subject to 

disclosure?
Is this food 

subject to 

disclosure?
Is this food 

subject to 

disclosure?
Bioengineered Food

• 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.

• Foods in which the modified genetic material 

is not detectable are not bioengineered foods.

• Food subject to certain factors and 

conditions are not bioengineered foods (i.e. 

incidental additives).
Found in Nature and Conventional 

Breeding

• USDA did not define either of the terms 

“found in nature” or “conventional breeding.”

• USDA intends to make determinations about 

whether a specific modifications would be 

considered “found in nature” or obtained 

through “conventional breeding” on a caseby-case basis.
List of Bioengineered Foods

• 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
Detectability

• Modified genetic material is not detectable if:

• Records verify the food is made from a nonbioengineered food;

• Records verify that the food has been refined 

using a process validated to render the 

modified genetic material undetectable; or

• Testing records for the specific food confirm 

the absence of detectable modified genetic 

material.
Detectability 

(non-bioengineered food)

• Modified genetic material is not detectable if:

• Records verify the food is made from a 

non-bioengineered food.

• Such records may include:

• Organic certification

• Documentation that ingredient is sourced 

from a country that does not allow 

production of that specific ingredient in a 

bioengineered form 
Detectability (refined food)

• Modified genetic material is not detectable if:

• Records verify that the food has been refined 

using a process validated to render the 

modified genetic material undetectable.

• Such records may include:

• Documentation that a specific process is used 

to refine an ingredient and that process has 

been shown, using the analytical testing that 

meets the NBFDS’s performance standards, to 

render any modified genetic material 

undetectable.
Detectability (refined food)

• Once a process has 

been shown to render 

modified genetic 

material in a specific 

ingredient 

undetectable, no 

additional testing of 

that ingredient is 

necessary unless 

changes are made to 

the refining process.
Guidance to Ensure Acceptable 

Validation of a Refining Process

• AMS published final guidance on refining 

process method validation on July 7, 2020 

• The guidance includes 8 General Steps to 

Validate a Refinement Process
1. Identify raw materials, ingredients, and productcontact materials

2. Define characteristics and intended use of end 

product

3. Define the sequence and interaction of all 

processing steps used to arrive at the end product

4. Identify key step or steps in the refinement process 

that may influence the end product’s characteristics 

and its ability to meet specified requirements

Key Steps to Validate a 

Refinement Process
5. Assemble relevant validation information that 

demonstrates the refinement process operates as 

intended to meet specified requirements (end product 

characteristics), conducting studies as needed

6. Continually verify the refinement process is operating 

as validated

7. Revalidate the refinement process, as applicable, if 

significant changes are made to the process

8. Maintain record(s) of the validation and ongoing 

verification

Key Steps to Validate a 

Refinement Process
Detectability (testing)

• Modified genetic material is not 

detectable if:

• Testing records for the 

specific food confirm the 

absence of detectable 

modified genetic material
Guidance on Testing 

Methods

• AMS published final guidance on testing 

methods on July 7, 2020 

• The guidance includes 5 Key Concepts
1. General considerations in selecting a test 

method

2. DNA-based test methods

3. Emerging technologies and other methods

4. General consideration in selecting a 

laboratory

5. Recordkeeping requirements

Key Steps in Selecting a Test 

Method
Guidance Documents available at: 

https://www.ams.usda.gov/rules-regulations/be/validation-process
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.
Exemptions

1. Threshold: Allows each 

ingredient to contain up to 

five percent of a BE 

substance, as long as it is 

inadvertent or technically 

unavoidable

2. Animals fed bioengineered 

feed

3. Food certified under the 

National Organic Program

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

bioengineered 

foods be 

labeled?
Disclosure Options

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 Accessibility

1. On-package text

2. Symbol

3. Electronic or digital disclosure

4. Text message
For small food manufacturers ($2,500,000 -

$10,000,000 in annual receipts)

• Telephone or website

For small and very small packages

• Shortened statements for electronic or 

digital, text message, and phone number 

disclosures

• Very small packages may use existing URL 

or phone no.

Disclosure for small 

manufacturers/packages
• “Bioengineered food”

• “Contains a bioengineered food 

ingredient” or “Contains bioengineered 

food ingredients”

On-Package Text Disclosure
Disclosure Symbol
• Must include the instructions to “Scan here for more food 

information” or similar language that reflects a change in technology, 

such as “Scan anywhere on package for more food information”

• When accessed, the electronic or digital link must go directly to 

the product information page. The product information page must:

• Be the first screen to appear on an electronic or digital device

• Include the bioengineered food disclosure in text or symbol 

form

• Must not collect information about the consumer or their 

devices

Electronic/Digital Disclosure
Electronic/Digital Disclosure

• The electronic or digital disclosure must also be 

accompanied by a telephone number, in close 

proximity, that includes the statement “Call [1-000-000-

0000] for more food information.”

• The phone number must provide the BE food 

disclosure, regardless of time of day

• The BE food disclosure may be a recorded 

message.
Text Message Disclosure

• “Text [command 

word] to [number] for 

bioengineered food 

information.”

• The number must be 

a number, including 

a short code, that 

sends an immediate 

response to the 

consumer’s mobile 

device.
• Any of the four disclosure options available to all 

regulated entities

• Using the statement “Call for more food information,” 

accompanied by a telephone number that will provide 

the disclosure to the consumer, regardless of the time 

of day

• Using the statement “Visit [URL of the website] for 

more food information” and a website that is 

consistent with the requirements of electronic or 

digital disclosure

Disclosure Options for Small 

Food Manufacturers
Small Packages (less than 40 square inches)

• Using a shortened version of the required 

on-package statements, including “Scan 

for info,” “Text for info,” or “Call for info.”

Disclosure for Small 

Packages
Very Small Packages (less than 12 square in)

• If the label includes a preexisting Uniform 

Resource Locator for a website or a 

telephone number that a consumer can 

use to get more food information, then the 

URL or number may be used for the 

required disclosure

Disclosure for Very Small 

Packages
Foods Sold in Bulk 

Containers

• Retailers are responsible for 

disclosure

• Disclosure can be made using 

any of the four standard options

• Disclosure must be placed on 

signage or other materials on or 

near the bulk food items

Please note: all presentation photos are intended for visual interest only 

and may not represent actual BE products.
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
• For entities that would otherwise be exempt

• May voluntarily disclose using any of the 

disclosure options available to regulated 

entities

• May include very small food manufacturers, 

restaurants, bars, food trucks, etc.

Voluntary Disclosure for 

exempt entities
For foods that do not contain detectable modified 

genetic material but are derived from bioengineering:

• Only applies to highly refined ingredients in which the modified 

genetic material is no longer detectable (e.g. corn syrup 

originating from BE corn, soybean oil)

• Is not allowed for any other foods or ingredients

• Examples that cannot be voluntarily disclosed: food 

produced from animals fed bioengineered feed; soups where 

the first ingredient is meat; incidental additives

Voluntary Disclosure for foods “derived from 

bioengineering”
Voluntary Disclosure for foods “derived from 

bioengineering”

• May use any of the available disclosure options, however, text 

must be “derived from bioengineering” or “ingredients derived 

from a bioengineered source,” or if a symbol is used, it must be 

this symbol:
What are the 

recordkeeping 

requirements?
• For non-disclosure of foods on the List of Bioengineered 

Foods, records need to validate that the food is not 

bioengineered or no longer contains detectable modified 

genetic material pursuant to § 66.9

• For positive disclosure of foods on the List of 

Bioengineered Foods, records would simply identify the 

food or ingredient (e.g. “Canola”)

How Recordkeeping Applies 

to Disclosure
• Everyone subject to mandatory bioengineered food disclosure 

is 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 – no new records or 

forms are required

• 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
Recordkeeping

Regulated entities are able to determine what business records to 

maintain, provided that they demonstrate compliance with the disclosure 

standard. Examples of possible records include:

• Invoices 

• Bills of lading 

• Inventory records

• Supply chain records 

• Country of origin records

• Process verifications 

• Organic certifications

• Laboratory test results
• 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

Recordkeeping
How is the 

Standard 

enforced?
• Failure to make a bioengineered food disclosure as 

required by the NBFDS is prohibited

• Complaints about possible violations of the NBFDS 

will be made to AMS

• 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

Enforcement
• Regulated entities will be able to appeal the 

results of an audit or investigation

• Following an appeals hearing, AMS will notify the 

regulated entity of its final determination in the 

matter

• The summary of the results of the audit or 

investigation will be posted to AMS’s website 

Enforcement
Implementation Date

• January 1, 2020

• Small Food Manufacturers: January 1, 2021

Compliance Date

• The mandatory compliance date for all 

regulated entities is January 1, 2022.

• Regulated entities may voluntarily comply 

before that time and may use existing labels

Compliance Dates
Question 1 

Animal products are exempt, right?
Question 2 

I am using X ingredient, do I need to 

make a disclosure?
Question 3 

I’m using a bioengineered food 

ingredient, but it is less than two 

percent of the entire product. 

Do I need to make a disclosure?
Question 4 

I’m using a food on the AMS List of 

Bioengineered Foods and do not 

want to make a disclosure. My 

supplier sent me a record that says 

non-GMO, is that sufficient?
Question 5 

I’m a copacker. Am I responsible for 

complying with the BE Standard? 
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 an email to

befooddisclosure@usda.gov

Please note: all presentation photos are intended for visual interest only and 

may not represent actual BE products.