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Regulation 

Civil Rights Impact Analysis 

Agency: Agricultural Marketing Service

Point of Contact: Krista Dickson

Telephone: (202) 720-3252 

Title of Action: Final Rule; National Bioengineered Food Disclosure Standard (the Standard): 

Updates to the List of Bioengineered Foods (the List)

Background: 

On July 29, 2016, Public Law 114–216 amended the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 

et. seq.) (amended Act) to require USDA to establish a national, mandatory standard for disclosing any 

food that is or may be bioengineered. In accordance with the amended Act, USDA published final 

regulations to implement the Standard on December 21, 2018 (83 FR 65814). The regulations became 

effective on February 19, 2019, with a mandatory compliance date of January 1, 2022. Under 7 CFR 66.1, 

a bioengineered food is a food that, subject to certain factors, conditions, and limitations, contains 

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. 

The 7 CFR 66.6 regulations include the AMS List of Bioengineered Foods (the List), which currently are: 

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), and sugarbeet. 

As stated in the preamble to the final rule, at 83 FR 65852, the List “establishes a presumption about what 

foods might require disclosure under the Standard but does not absolve regulated entities from the 

requirement to disclose the bioengineered status of food and food ingredients produced with foods not on 

the List when the regulated entities have actual knowledge that such foods or food ingredients are 

bioengineered.” As a result, if a regulated entity is using a food or ingredient produced from an item on 

the List, they must make a bioengineered food disclosure unless they have records demonstrating that the 

food or ingredient they are using is not bioengineered. Similarly, even if a food is not on the List, a 

regulated entity must make a bioengineered food disclosure if they have actual knowledge a food or 

ingredient that they are using is a bioengineered food or a bioengineered food ingredient. 

As stated in 7 CFR 66.7(a), AMS will review and consider updates to the List on an annual basis and will 

solicit recommendations regarding updates to the List through notification in the Federal Register and on 

the AMS website. 

On July 22, 2022, AMS published a proposed rule in the Federal Register seeking public comment on 

recommendations to update the List (87 FR 43751). In the proposed rule, AMS sought comments on 

adding “sugarcane (Bt insect-resistant varieties)” to the List and amending “squash (summer)” to “squash 

(summer, mosaic virus-resistant varieties).” Pursuant to 7 CFR 66.7(a)(3), AMS consulted with the 

government agencies responsible for oversight of the products of biotechnology, Animal and Plant Health 

Inspection Service (APHIS), Environmental Protection Agency (EPA), and Food and Drug 

Administration (FDA), on the proposed updates to the List. 
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The comment period for the proposed rule closed on September 20, 2022. AMS received a total of 37 

comments, out of which 36 comments were related to the proposed rule and one comment was unrelated. 

Commenters included individuals, consumer groups, companies, and organizations that represent 

different segments of the food industry. After reviewing the public comments, AMS is proceeding with 

this final rule to add “sugarcane (Bt insect-resistant varieties)” to the List and to amend “squash 

(summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).”

Most commenters supported the updates to the List put forward in the Proposed Rule. Of the 36 

substantive comments received 72% supported adding “sugarcane (Bt insect-resistant varieties)” and 67% 

supported amending “squash (summer)” to “squash (summer, mosaic virus-resistant varieties)”. Only 6% 

were opposed to adding sugarcane, and no commenters were opposed to amending squash. Zero 

commenters addressed AMS questions on squash variety market share, or the Civil Rights Impact 

Analysis (CRIA). Commenters provided insight, questions, and suggestions on other topics including, 

pros and cons of the List Update, the potential burden on regulated entities, the timeliness of the List 

Update process, the AMS List website and supporting materials, education and outreach on 

biotechnology, and other concerns about biotechnology.

Of the commenters supporting the updates, many stated that the changes would help inform consumers 

and provide additional transparency. Most commenters (61%) spoke of the Update providing information 

in some form, and this belief aligned with support for the updates. 

Of particular interest, four commenters identified that adding sugarcane to the List would present a 

burden on the sugar industry and regulated entities. Two of the four (6% of total) believed that this burden 

is high enough to oppose adding sugarcane to the List. These comments state many regulated entities 

using sugarcane or ingredients derived from sugarcane would be impacted, and that current recordkeeping 

practices would not be sufficient to satisfy the requirements of the Standard. In response, AMS does not 

believe that the addition of “sugarcane (Bt insect-resistant varieties)” constitutes an undue burden. AMS 

notes that regulated entities, both domestic and foreign, likely will have customary and reasonable records 

in accordance with the Standard if they are maintaining records in compliance with other laws and 

regulations associated with the food sector. Records would be required to substantiate a decision not to 

label under 7 CFR 66.9. These records could include country of origin records that show a product or 

ingredient is from a country that has not approved a BE variety of the crop for commercial production.

Some commenters suggested that because sugar produced from “sugarcane (Bt insect-resistant varieties)” 

is highly refined, it does not contain detectable modified genetic material, it is not a BE food, and it 

should not be added to the List. In response to some commenters’ statements that sugarcane is likely 

highly refined, AMS notes that the List establishes a presumption about which foods and food ingredients 

are or may be BE. Inclusion on the List does not affirmatively mean an item on the List, or a food

produced from an item on the List, is a BE food. Rather, inclusion on the List establishes a presumption 

and requires a regulated entity to make a BE food disclosure unless it maintains records, in accordance 

with 7 CFR 66.9, to demonstrate that modified genetic material is not detectable. 

Additionally, one commenter asked that AMS use a more descriptive term for squash (summer) than 

“mosaic virus-resistant varieties,” as conventionally bred squash could presumably also be mosaic virusresistant. In response, AMS is amending the List entry to “squash (coat protein-mediated virus-resistant 

varieties)” which provides additional descriptive information to stakeholders, including regulated entities 

and consumers. This change would be consistent with the treatment of other items on the List, where

modifiers are included to describe a trait, as is the case with eggplant, papaya, and pineapple. The “coat 

protein-mediated virus-resistant varieties” modifier is more specific than “mosaic virus-resistant 

varieties” and currently pertains only to mosaic virus resistance achieved in BE squash varieties. 

Therefore, the “coat protein-mediated virus-resistant varieties” modifier encompasses both BE varieties of 
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squash without including any non-BE varieties. AMS believes that this modifier narrows the List entry 

for squash and will amend the List using this modifier. 

In summary, AMS is amending the List to be the following:

1. Alfalfa

2. Apple (ArcticTM varieties)

3. Canola 

4. Corn

5. Cotton 

6. Eggplant (BARI Bt Begun varieties)

7. Papaya (ringspot virus-resistant varieties)

8. Pineapple (pink flesh varieties) 

9. Potato 

10. Salmon (AquAdvantage®) 

11. Soybean 

12. Squash (coat protein-mediated virus-resistant varieties) 

13. Sugarbeet 

14. Sugarcane (Bt insect-resistant varieties) 

The authority for this final rule is under the Administrator, Agricultural Marketing Service. AMS expects 

to publish this final rule updating the List in Summer, 2023. To assist the industry in complying with the 

new regulations for the List, the regulated entities will have 18 months following the effective date of the 

updated List to revise food labels to reflect changes to the List in accordance with the disclosure 

requirements. 

Analysis: 

Race/Ethnicity/Gender Data

The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et. seq.) (amended Act) is a federal law, that 

established a national, mandatory standard for disclosing any food that is or may be bioengineered. The 

law applies generally to all persons conducting business subject to the Standard. Congress declared in the 

amended Act (1621 et. seq.) that it is essential to have a sound, efficient, and privately operated system 

for distributing and marketing agricultural products to a prosperous agriculture and is indispensable to the 

maintenance of full employment and to the welfare, prosperity, and health of the Nation. 

USDA, AMS’ Food Disclosure and Labeling Division (FDLD) administers and enforces the mandatory 

National Bioengineered Food Disclosure Standard and its regulations and is responsible for establishing 

new rules as needed. This final rule will add “sugarcane (Bt insect-resistant varieties)” to the List and 

amend “squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties).

Regulated entities, subject to this final rule, and consumers who benefit from the rule, would not be 

required to apply to any program or opt-in to participate. This final rule is not intended to: 1) opt-in any 

stakeholder to participation under the AMS final rule; and/or 2) recruit any stakeholder including 

consumers, retailers, manufacturers, or importers. The regulation acts as a federal law that would establish 

the requirement for bioengineered food disclosure to consumers; and regulated entities that fail to disclose 

would be subject to an investigation and results reported on the AMS website. 

This final rule affects manufacturers, retailers, and importers. While completing these analyses, the US 

Census, Annual Business Survey 2018 was not designed for the user to select specific retailers and 

importers subject to the Standard such as food and beverage industries listed in the Industry Codes 
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(NAICS). If AMS included all retailers and importers in the data analyses, it may result in an inaccurate 

estimation of impacted groups and non-impacted groups. Therefore, AMS evaluated the data based only 

on the manufacturing sector. 

The 2018 Annual Business Survey provides race, ethnicity, and gender (REG) data for principal operators 

in the US.1 Table 1 shows the proportion of these groups in the manufacturing sector. The final rule does 

not alter the ability for manufacturer of any race, color, national origin, gender, religion, age, disability 

political beliefs, sexual orientation, or marital or family status to participate in the mandatory National 

Bioengineered Food Disclosure Standard or change their protections from discrimination. Any 

requirements for complying with the mandatory National Bioengineered Food Disclosure Standard as a 

manufacturer apply regardless of race, national origin, or gender. As previously mentioned, AMS has 

elected to use data from the manufacturers only to determine the adverse impact rates. The impacts of this 

final rule are predominantly due to required label changes to comply with bioengineered food disclosure 

laws.

Data Analysis

Table 1. Program Participants Race/Ethnicity/Gender Data for Firms With or 

Without Paid Employees as of 2018 

Census Data 2018 for Principal Operators in U.S. (N = 35,499,980)

Hispanic 

or Latino

Non-Hispanic or Latino

Total

White

Black or 

African 

American

Asian 

Native

Hawaiian or 

Other Pacific

Islander

American 

Indian or 

Alaskan 

Native Males Females

4,228,625 25,219,883 3,239,551 2,651,835 46,653 113,433 17,796,959 12,001,410

11.91% 71.04% 9.13% 7.47% 0.13% 0.32% 50.13% 33.81%

Census Data 2018 Impacted Manufacturing Firms (n = 633,478)

Hispanic 

or Latino

Non-Hispanic or Latino

Total

White

Black or 

African 

American

Asian 

Native 

Hawaiian or 

Other Pacific 

Islander

American 

Indian or 

Alaskan 

Native Males Females

57,248 519,051 25,870 28,351 645 2,313 381,278 148,683

9.04% 81.94% 4.08% 4.48% 0.10% 0.37% 60.19% 23.47%

Note: “The total number of males and females above will not add up to the baseline or impacted totals, 

due to some principal operators not specifying a gender.” 

1 US Census ABS, 2018 Annual Business Survey, Statistics for Employer and Nonemployer Firms Demographics series. 

Available online at: AB1800NESD05: Nonemployer ... - Census Bureau Table
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AMS established baseline data using principal operators for all sectors in U.S. Population in 2018 and the 

impact rates of the groups were measured using data from the 2018 Annual Business Survey for the 

United States.

The data shown in Table 1. indicates that in 2018 of the 633,478 impacted manufacturing firms, there 

were 60.19% Males, 23.47% Females, 9.04% Hispanic/Latino, 81.94% White, 4.08% Black or African 

Americans, 4.48% Asians, 0.10% Native Hawaiian or Other Pacific Islanders, and 0.37% American 

Indian/Alaska Natives.2

 

Table 2. Program Participants for Firms, With or Without Paid Employees

Group

Principal 

Operators in 

U.S.

Range 

(10% Variance)

Census 

Data 2018 

Impact 

Rate

Proportionate or 

Disproportionate

Males 50.13% 45.12% - 55.15% 60.19% Disproportionately 

Higher 

Females 33.81% 30.43% - 37.19% 23.47% Disproportionately 

Lower

Hispanic/Latino 11.91% 10.72% - 13.10% 9.04% Disproportionately 

Lower

White 71.04% 63.94% - 78.15% 81.94% Disproportionately 

Higher 

Black or Black or African 

American 9.13% 8.21% - 10.04% 4.08% Disproportionately Lower

Asian 7.47% 6.72% - 8.22% 4.48% Disproportionately 

Lower

Native Hawaiian or Other 

Pacific Islander 0.13% 0.12% - 0.14% 0.10% Disproportionately Lower

American Indian or 

Alaskan Native 0.32% 0.29% - 0.35% 0.37% Disproportionately Higher 

AMS established a baseline using Principal Operators for all sectors in U.S. Population in 2018. The 

Agency measured disparate impact using a 10% variance to determine disproportionate impact. A 10% 

variance was used to determine if the impact rates of the groups from the 2018 Annual Business Survey 

for the United States were proportionate to their respective participation rate with census data from 2018 

shown in Table 2. 

2 US Census ABS, 2018 Annual Business Survey, Statistics for Employer and Nonemployer Firms Demographics series. 

Available online at: AB1800NESD05: Nonemployer ... - Census Bureau Table
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According to Table 2, the impact rate for Females, Hispanics/Latino, Black or African Americans, and 

Asians, and Native Hawaiian or Pacific Islander were disproportionately lower than the participation rate 

for these groups for Principal Operators for all sectors in U.S. Population in 2018. 

The impact rates for Males, Whites, and American Indian/Alaskan Natives were disproportionately higher 

than the participation rate for these groups for Principal Operators for all sectors in U.S. Population in 

2018. 

No data are available for Persons with Disabilities.

Table 3. Program Participants Race/Ethnicity/Gender Data for Firms, With or 

Without Paid Employees

Hispanic or

Latino

Non-Hispanic or Latino

Total

White

Black or 

African 

American

Asian 

Native 

Hawaiian or 

Other Pacific 

Islander

American 

Indian or 

Alaskan 

Native M F

Impacted (Census Data 2018 = 633,478)

9.04% 81.94% 4.08% 4.48% 0.10% 0.37% 60.19% 23.47%

Principal Operators in U.S. = 35,499,980

11.91% 71.04% 9.13% 7.47% 0.13% 0.32% 50.13% 33.81%

Selection (Impact) Rates

75.87% 115.34% 44.75% 59.91% 77.48% 114.27% 120.06% 69.43%

80% Calculation

63.19% 96.07% 37.27% 49.90% 64.53% 95.18% 100.00% 57.83%

An adverse impact is an impact on employees, or a program beneficiary based on their membership in a 

protected group resulting from a regulatory change that meets the quantitative condition for adverse 

impact. An adverse impact is measured using the 80% Rule, 80/20 or “four-fifths” rule. The 80% rule is a 

test of proportions requiring the profile for the impacted group as well as the profile for the relevant 

baseline. Rates of 80% or higher do not meet the condition for having an adverse impact.3

 

A baseline was established using the demographics of Principal Operators for all sectors in U.S. 

Population in the United States from the 2018 Annual Business Survey. In Table 3, an assessment was 

made whether the impact rate for any group met the condition of adverse impact using the 80% Rule. 

The impact rate for Whites, American Indians or Alaskan Natives, and Males are above 80% and does not 

meet the condition for adverse impact. The impact rates for Hispanics/Latinos, Black/African Americans, 

Asians, Native Hawaiians or Other Pacific Islanders, and Females, fall below 80% and meet the condition 

for adverse impact.

3 USDA Departmental Guidebook, Civil Rights Impact Analysis, Office of the Assistant Secretary for Civil Rights, 2020, Section 

3 - Definitions, page 9.
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Impacts on Regulated Entities

USDA estimates that the costs associated with this action would range from $6 million to $37 million for 

the initial year, with no ongoing annual costs and no significant change in benefits. The annualized cost of 

adding sugarcane (Bt insect-resistant varieties) to the List would be between $500,000 and $3.5 million 

(annualized over 20 years using a seven percent discount rate). Cost changes due to this action will be 

limited to the addition of “sugarcane (Bt insect-resistant varieties)” to the List because regulated entities 

have already incurred costs associated with the inclusion of summer squash on the List. Most of the 

estimated costs are related to a one-time deliberation and potential testing by food manufacturers to 

confirm the source of sugar used in their products and to comply with recordkeeping and labeling 

requirements. 

The Standard is not expected to have any benefits to human health or the environment. Any benefits to 

consumers from the provision of reliable information about BE food products are difficult to measure. 

Under some, but not all, potentially informative analytic baselines, a more clear-cut benefit of the 

Standard is that it eliminates costly inefficiencies of a state-level approach to BE disclosure. AMS 

estimates the size of these benefits by focusing on the increased consumer access to bioengineered food 

disclosures. The rule is not considered to be economically significant under Executive Order 12866. Even 

considering only the first year (where all of the costs are expected to occur), the estimated costs do not 

exceed the $200 million threshold to be considered economically significant.

Impacts on Protected Groups

Although the required analysis indicates a disproportionate impact for Hispanics/Latinos, Black/African 

Americans, Asians, Native Hawaiians or Other Pacific Islanders, and Females, because the new 

regulation impacts all industry participants equally, no individual or group would likely be adversely 

impacted differently.

Because the disparate impact analysis identified the potential impact rate for Hispanics/Latinos, 

Black/African Americans, Asians, Native Hawaiians or Other Pacific Islanders, and Females as having 

met the condition for adverse impacts, AMS will institute enhanced efforts to notify these groups as to the 

publication of the final rule. 

Tribal Implications

AMS has assessed the impact of this final rule on Indian tribes and determined that this final rule does 

not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a tribe 

requests consultation, AMS will work with the Office of Tribal Relations to ensure meaningful 

consultation is provided where changes, additions, and modifications identified herein are not expressly 

mandated by Congress. Throughout the rulemaking process, AMS will continue to develop and provide 

outreach and education for all regulated entities.

Barrier Analysis

Background

Barrier analyses are generally conducted to address a policy, procedure, or condition that may or may not 

limit the opportunity for members or participants of a particular race, ethnic group, or gender, or because 

of a disability. AMS conducted a barrier analysis for the final rule to assess potential barriers that may 

prevent any person or group affected by the rule from learning about the rule.
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The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et. seq.) (amended Act) is a federal law that 

grants the Administrator the authority to promulgate regulations that establishes a consistent national, 

mandatory standard for disclosing any food that is or may be bioengineered. The USDA National 

Bioengineered Food Disclosure Standard (NBFDS) imposes labeling requirements for certain human 

foods that are bioengineered (BE) or contain BE food ingredients. The NBFDS covers foods (including 

dietary supplements) and food ingredients that contain genetic material (DNA) that has been modified 

through in vitro recombinant deoxyribonucleic acid techniques. Foods and food ingredients in which 

modified genetic material (rDNA) cannot be detected are excluded from the NBFDS. The law applies 

generally to all persons conducting business subject to the Standard (i.e., regulated entities – importers, 

manufacturers, and retailers). Manufacturers and importers have responsibility for applying the BE label 

on packaged food products. Retailers have responsibility for providing BE signage for food products such 

as fresh produce sold in bulk at grocery stores and similar establishments. The USDA NBFDS 

administers and enforces the Standard and its regulations and is responsible for establishing new rules as 

needed.

The USDA NBFDS label is a mandatory marketing standard for disclosing any food that is or may be 

bioengineered. The USDA NBFDS regulations and this final rule does not require all importers, 

manufacturers, and retailer operations to participate in the NBFDS program, nor does it seek to recruit all 

importers, manufacturers, and retailer operations into the NBFDS Program. This final rule will require 

regulated entities offering any food that is or may be bioengineered which are subject to the Standard and 

provide disclosure on the label. This action is aimed to better align with consumer expectations.

Findings 

As discussed in the Analysis section of this document, there is evidence based on principle operator 

program participants that this final rule will have disproportionate adverse civil rights impact on 

manufacturers. This final rule, however, will not impose any requirements related to eligibility for 

benefits and services on protected classes, nor will the rule have the purpose or effect of treating classes 

of persons differently. This is a mandatory requirement for disclosing any food that is bioengineered. 

Additionally, AMS’s analysis of available data indicates that the impact rates for Hispanics/Latinos, 

Black/African Americans, Asians, Native Hawaiians or Other Pacific Islanders, and Females, fall below 

80% and meet the condition for adverse impact. As such, AMS has re-evaluated its outreach strategy to 

address any potential invisible barrier preventing protected groups from learning about the final rule.

Potential Barriers

AMS has identified several potential barriers that may prevent certain groups or persons from learning 

about the final rule:

• Disproportionate impact analysis. A disproportionate impact analysis reveals that the impact rates 

for Females, Hispanics/Latino, Black or African Americans, and Asians, and Native Hawaiian or 

Pacific Islander were disproportionately lower than the participation rate for these groups for 

Principal Operators for all sectors in U.S. Population in 2018. AMS intends to address this barrier 

as part of its outreach and communication plan for the final rule (see more detail below).

• Limited English proficiency. While the final rule and information about it are approved to be 

provided in English, there may be a potential barrier that information about the rule is not translated 

for limited English-proficient (LEP) stakeholders. AMS would provide translated information about 

the final rule as requested. Translated information about the final rule would be posted on the AMS 

website.
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Mitigation Strategies 

AMS will address the potential barriers above as part of its outreach plan and monitoring mechanisms, 

described below in the Mitigation and Outreach section of this document. Specifically, the outreach plan 

is designed to maximize the reach of information about the final rule, including to persons and groups 

identified in this barrier analysis.

Mitigation: 

The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et. seq.) (amended Act) is a federal law, that 

established a national, mandatory standard for disclosing any food that is or may be bioengineered. The 

law applies generally to all persons conducting business subject to the Standard. Congress declared in the 

amended Act (1621 et. seq.) that it is essential to have a sound, efficient, and privately operated system 

for distributing and marketing agricultural products to a prosperous agriculture and is indispensable to the 

maintenance of full employment and to the welfare, prosperity, and health of the Nation. 

USDA, AMS’ Food Disclosure and Labeling Division administers and enforces the mandatory National 

Bioengineered Food Disclosure Standard and its regulations and is responsible for establishing new rules 

as needed. This final rule will add “sugarcane (Bt insect-resistant varieties)” to the List and amend 

“squash (summer)” to “squash (summer, coat protein-mediated virus-resistant varieties). Regulated 

entities, subject to this final rule, and consumers who benefit from the rule, would not be required to 

apply to any program or opt-in to participate. This final rule is not intended to: 1) opt-in any stakeholder 

to participation under the AMS final rule; and/or 2) recruit any stakeholder including consumers, retailers, 

manufacturers, or importers. The regulation acts as a federal law that would establish the requirement for 

bioengineered food disclosure to consumers; and regulated entities that fail to disclose would be subject 

to an investigation and results reported on the AMS website. 

Difficulties may arise in cases where information on the Standard is difficult to access or understand due 

to language barriers. Other challenges may occur when a small, regulated entity finds it difficult to 

provide the funds to change labels or test the products to comply with the disclosure regulation. As such, 

civil rights implications may occur.

AMS is committed to several strategies to mitigate the potential for civil rights implications on these and 

other affected groups, through 1) 18-month implementation following the effective date of the rule to 

revise food labels, 2) exemptions, 3) multiple disclosure options, and 4) outreach activities for regulated 

entities: 

18 Month Implementation to Revise Labels:

To help regulated entities with preparing for compliance, regulated entities will have 18 months following 

the effective date of the updated List to revise food labels to reflect changes to the List in accordance with 

the disclosure requirements. If a regulated entity from one of the impacted groups is using a food or 

ingredient produced from an item on the List, they must make a bioengineered food disclosure unless they 

have records demonstrating that the food or ingredient they are using is not bioengineered. 

Exempted Manufacturers and Businesses:

• Very small food manufacturers (any food manufacturer with annual receipts of less than 

$2,500,000) are exempt from the Standard, thus mitigating any potential disparate impacts on the 

affected groups who belong to the very small food manufacturers category. 
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• Food served in a restaurant or similar retail food establishment (cafeteria, lunch room, food stand, 

food truck, transportation carrier (such as a train or airplane), saloon, tavern, bar, lounge, other 

similar establishment operated as an enterprise engaged in the business of selling prepared food to 

the public, or salad bars, delicatessens, and other food enterprises located within retail 

establishments that provide ready-to-eat foods that are consumed either on or outside of the 

retailer’s premises) are exempt from the Standard as well, thus mitigating any potential disparate 

impacts on the affected groups who belong to the restaurant or similar retail food establishment 

category. 

Multiple Disclosure Options: 

According to the 2018 Final Rule on the Standard, four disclosure options are available to regulated 

entities, which may mitigate the costs associated with a new label. As mentioned in subpart B of the 

regulations, those four options are (1) on-package text, (2) the bioengineered (BE) symbol, (3) electronic 

or digital link, or (4) text message: 

1. If a regulated entity chooses to use on-package text, as described at 7 CFR 66.102, the language 

must be “Bioengineered food,” “Contains a bioengineered food ingredient,” or if multiple 

bioengineered food ingredients are present, “Contains bioengineered food ingredients.” 

2. The BE symbol, described at 7 CFR 66.104, can be utilized [see https://www.ams.usda.gov/rulesregulations/be/symbols], and may be in either the black and white version or the version provided 

in color. 

3. The electronic or digital link, explained at 7 CFR 66.106, requires an on-package statement that 

says: “Scan here for more food information” and “Call 1-000-000-0000 for more food 

information.” When accessed, the electronic or digital link must include the bioengineered food 

disclosure in either text or symbol form, as described above. 

4. The text message option, described at 7 CFR 66.108, requires an on-package statement that says 

“Text [command word] to [number] for bioengineered food information.” When used, the 

consumer must receive the bioengineered food disclosure using the same language allowed by 

on-package text, as noted above. 

These four disclosure options allow flexibility for regulated entities of the impacted groups to select the 

disclosure option that best suits their product and funding availability. Small food manufacturers, defined 

at 7 CFR 66.1 (any food manufacturer with annual receipts of at least $2,500,000, but less than 

$10,000,000), have additional options for disclosure available to them as described at 7 CFR 66.110. 

Outreach: 

Education and Technical Assistance: 

Through a Notice to Trade and a targeted email, stakeholders of the Standard will be informed upon 

publication of the final rule to the Federal Register. AMS also maintains a website at 

https://www.ams.usda.gov/rules-regulations/be with all current information regarding the List and the 

Standard. Interested persons, including regulated entities and consumers, can find information about the 

Standard. Upon publication of this rule, appropriate changes will be made to the List on the AMS 

Website. Additionally, AMS plans to continue presentations and other outreach as enumerated in the Prior 

Outreach Efforts section below. 

AMS responds on a continuous basis to questions and requests received through the email inbox at 

befooddisclosure@usda.gov. Most questions received are from small to medium sized businesses asking 

for clarification on compliance. The average response time for fiscal year 2022 was 4 days. 
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Prior Outreach Efforts

During Fiscal Year 2022 AMS engaged with stakeholders through several venues and formats to provide 

technical assistance with validation and testing guidance and education on the Standard: 

• Presentation on Bioengineered Overview for FAS Posts/Webinar on 1/19/2022, with unknown 

attendees 

• Presentation on the Overview of the National Bioengineered Food Disclosure Standard for the 

Society of Flavor Chemist, West Coast Meeting on 1/27/2022, with 40 attendees 

• Presentation on How Genetically Engineered Microbes are Regulated by the Standard for the 

Future of Micro-biotechnology: From Research to Regulation workshop on 2/3/2022, with 

unknown attendees

• Participation on a panel about Bioengineered for Registered Dietitians for the FDA’s Agricultural 

Biotechnology continuing professional education (CPE) on 2/22/2022, with unknown attendees 

• Presentation on Overview of Bioengineered for the Q1 Productions 9th Annual Food Labeling: 

Evolving Regulatory Compliance Conference on 2/23/2022, with 75 attendees 

• Presentation on Overview of The National Bioengineered Food Disclosure Standard for the 

Minnesota Department of Agriculture Specialty Crop Biotechnology Forum on 3/10/2022, with 

35 attendees 

• Presentation on Bioengineered Disclosure: Update and Enforcement #1 at Prime Label 

Consultants - Food Label Conference on 4/26/2022, with 200+ attendees 

• Presentation on Bioengineered Disclosure: Update and Enforcement #2 at Prime Label 

Consultants - Food Label Conference on 4/26/2022, with 200+ attendees 

• Presentation on Overview of The National Bioengineered Food Disclosure Standard to State 

Department - Foreign Service Institute on 7/21/2022, with 25 attendees 

• Poster Presentation on Overview of Bioengineered program at Institute of Food Technologists 

Annual Meeting 2022 on 7/22/2022, with over 20,000 attendees 

• Oral Presentation on Overview of Bioengineered program at Institute of Food Technologists 

Annual Meeting 2022 on 7/22/2022, with over 20,000 attendees 

• Presentation on Bioengineered Regulations – specifically microbial products and import impacts 

to FAS - Turkish Cochran Fellows on 7/27/2022, with 15 attendees 

• Presentation on Bioengineered Overview for Regulators to FAS - South American Regulators on 

8/29/2022, with 15 attendees 

• Presentation on the Bioengineered Consumer Complaint Process Overview at the American 

Bakers Association, Food Technical Regulatory Affairs Professional Group virtual meeting on 

11/30/2022, with 50 attendees 

Conclusion: 

The Agricultural Marketing Service proposes to publish a final rule to update the List of Bioengineered 

Foods (the List). Regulated entities using foods on the List must make a bioengineered food disclosure 

related to food ingredient(s). To assist the industry in complying with the new regulations for the List, the 

regulated entities will have 18 months following the effective date of the updated the List to revise food 

labels to reflect changes to the List in accordance with the disclosure requirements.

The final rule has potential to impose adverse and/or disproportionate impacts on protected groups 

((Black/African American-, Hispanic/Latino-, Asian-, American Indian/Alaskan-, and men/womenowned businesses). AMS is committed to mitigating the potential impacts through the very small food 

manufacturer and restaurant/ready-to-eat-style business exemptions, multiple disclosure options, and 
23-AMS-CRIA-FTPP-015

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training and technical assistance offered to regulated entities. Throughout the process of updating the List, 

AMS has and will engage industry stakeholders and consumers to ensure that the final rule accomplishes 

the objective without unduly burdening small entities or erecting barriers that would restrict their ability 

to compete in the marketplace. AMS will also review and consider updates to the List annually and will 

solicit recommendations regarding updates to the List through notification in the Federal Register and on 

the AMS website.

AMS expects to publish this final rule updating the List in Summer, 2023.