This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents.

Rules and Regulations Federal Register

83305 

Vol. 88, No. 228 

Wednesday, November 29, 2023 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

7 CFR Part 66 

[Doc. No. AMS–FTPP–20–0057] 

RIN 0581–AD95 

National Bioengineered Food 

Disclosure Standard; List of 

Bioengineered Foods 

ACTION: Final rule. 

SUMMARY: This final rule updates the 

National Bioengineered Food Disclosure 

Standard’s (the Standard) List of 

Bioengineered (BE) Foods (the List) by 

adding ‘‘sugarcane (Bt insect-resistant 

varieties)’’ to the List and amending 

‘‘squash (summer)’’ to ‘‘squash 

(summer, coat protein-mediated virusresistant varieties).’’ In updating the 

List, this final rule provides consumers 

with information regarding foods that 

may be BE and aids regulated entities in 

determining whether they need to make 

a BE disclosure. 

DATES: 

Effective Date: This rule is effective 

December 29, 2023. 

Compliance Date: June 23, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth Becker, Research and 

Rulemaking Branch Chief, Food 

Disclosure and Labeling Division, Fair 

Trade Practices Program, Agricultural 

Marketing Service, U.S. Department of 

Agriculture, Telephone (202) 720–4486, 

Email: kenneth.becker@usda.gov. 

SUPPLEMENTARY INFORMATION: 

I. 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 BE. 

USDA published a final rule (2018 BE 

final rule) promulgating the regulations 

(7 CFR part 66) 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 BE 

food is a food that, subject to certain 

factors, conditions, and limitations, 

contains 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 regulations, at 7 CFR 66.6, 

contain the List, which currently 

includes: 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 2018 BE 

final rule, at 83 FR 65852, the List 

establishes a presumption about what 

foods require disclosure under the 

Standard. However, a food or food 

ingredient’s absence from the List does 

not absolve regulated entities from the 

requirement to disclose the BE 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 BE. If a regulated entity 

is using a food or ingredient produced 

from an item on the List, it must make 

a BE food disclosure unless it has 

records demonstrating that the food or 

ingredient it is using is not BE. 

Similarly, even if a food is not on the 

List, a regulated entity must make a BE 

food disclosure if it has actual 

knowledge that a food or a food 

ingredient being used is a BE food or a 

BE food ingredient. In accordance with 

7 CFR 66.7(a)(5), this final rule updates 

the List. 

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. 

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 insectresistant varieties)’’ to the List and 

amend ‘‘squash (summer)’’ to ‘‘squash 

(summer, coat protein-mediated virusresistant varieties).’’ Table 1 summarizes 

the final revisions to the List. 

TABLE 1—UPDATES TO THE LIST

Crop Regulation Final rule action 

Sugarcane .............. 7 CFR 66.6 ............ Add to the List as ‘‘sugarcane (Bt insect-resistant varieties)’’. 

Squash (summer) ... 7 CFR 66.6 ............ Add additional modifier to the existing entry on the List to read ‘‘squash (summer, coat protein-mediated virus-resistant varieties)’’. 

II. Comments on the Proposed Rule 

Most commenters supported the 

proposed rule overall, with many stating 

that they thought that the two proposed 

List updates would provide the public 

with accurate information on the BE 

status of foods. There was, however, 

opposition from two commenters about 

AMS’s proposal to add ‘‘sugarcane (Bt 


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83306 Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations 

1USDA Foreign Agriculture Service. (2019). Gain 

Agricultural Information Network: Agricultural 

Biotechnology Annual Report—Brazil https://

apps.fas.usda.gov/newgainapi/api/Report/ 

DownloadReportByFileName?fileName=

Agricultural%20Biotechnology%20Annual_

Brasilia_Brazil_10-20-2019. 

2National Bioengineered Food Disclosure 

Standard, 83 FR 65818 (Dec. 21, 2018). 

insect-resistant varieties)’’ to the List. 

AMS has reviewed and considered the 

issues raised by commenters and 

provides its responses below. 

1. Addition to the List 

AMS requested public comments on 

the proposed addition of ‘‘sugarcane (Bt 

insect-resistant varieties)’’ to the List. 

Comment: Commenters both 

supported and opposed the addition of 

‘‘sugarcane (Bt insect-resistant 

varieties)’’ to the List. Commenters in 

support of the addition of ‘‘sugarcane 

(Bt insect-resistant varieties)’’ expressed 

that it would provide more information 

to consumers. Commenters opposed to 

the addition of ‘‘sugarcane (Bt insectresistant varieties)’’ expressed concern 

that this would place an undue burden 

on regulated industry for a product that 

was unlikely to be sold in the United 

States. Lastly, 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. 

AMS Response: AMS has considered 

all the information provided to the 

agency related to the addition of 

‘‘sugarcane (Bt insect-resistant 

varieties)’’ to the List. AMS has 

determined that the criteria identified in 

7 CFR 66.7(a)(4) are met. ‘‘Sugarcane (Bt 

insect-resistant varieties)’’ has been 

authorized for commercial production 

in Brazil and is currently in legal 

commercial production for human food 

in Brazil.1 There is no statutory or 

regulatory requirement that a BE food 

must be sold or grown in the United 

States for that food to be placed on the 

List. 7 CFR 66.7(a)(4) states that when 

determining if a food will be added to 

the List, ‘‘AMS will consider whether 

foods for inclusion on the List have 

been authorized for commercial 

production somewhere in the world, 

and whether the food is currently in 

legal commercial production for human 

food somewhere in the world.’’ AMS 

notes that the BE sugarcane grown in 

Brazil could be sold in the United States 

as an ingredient in single or multiingredient food products. 

Additionally, AMS requested 

commenters provide any data and 

evidence that would suggest ‘‘sugarcane 

(Bt insect-resistant varieties)’’ is being 

used for seedling bulk up rather than 

human consumption but did not receive 

any information in response to this 

request. 

AMS does not believe that the 

addition of ‘‘sugarcane (Bt insectresistant varieties)’’ constitutes an 

undue burden for regulated entities. 

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 (83 FR 65830). 

Records are required to substantiate a 

decision not to label under 7 CFR 66.9. 

The Standard at 7 CFR 66.302(a)(4) 

includes a non-exhaustive list of records 

that could satisfy the recordkeeping 

requirements. That list includes, but is 

not limited to, supply chain records, 

bills of lading, invoices, supplier 

attestations, contracts, or brokers’ 

statements (such as those used to 

maintain compliance with the 

Perishable Agricultural Commodities 

Act); third party certifications (such as 

organic certifications provided by the 

USDA’s National Organic Program); 

laboratory testing results, and validated 

process verifications. These records 

could also include country of origin 

records that show a product or 

ingredient is from a country that has not 

authorized a BE variety of the crop for 

commercial production. 

In response to some commenters’ 

statements that sugarcane is likely 

highly refined, AMS notes that the List 

establishes a presumption about what 

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 genetic material is not 

detectable, or that the regulated entity or 

food qualifies for an exemption listed at 

7 CFR 66.5. 

Comment: One commenter opposed 

the addition of ‘‘sugarcane (Bt insectresistant varieties)’’ to the List, noting 

that while the regulations require AMS 

to consider whether a food is authorized 

for commercial production somewhere 

in the world, and whether the food is 

currently in legal commercial 

production for human food somewhere 

in the world, AMS retains discretion as 

to its decision. Another commenter 

noted that in light of AMS’s regulatory 

requirement to consider ‘‘all relevant 

information,’’ sugarcane should not be 

added to the List at this time. 

AMS Response: As stated in the 2018 

BE final rule that established the 

Standard, the List captures BE crops or 

foods that meet the statutory definition 

of bioengineering, based on existing 

technology, and that could potentially 

be offered for sale in the United States.2

In addition, Section 66.1 of the Standard 

defines the List as a list, maintained and 

updated by AMS and provided in 7 

CFR 66.6, of foods for which BE versions 

have been developed. Commenters did 

not dispute that there is a BE version of 

sugarcane and that a BE version of 

sugarcane is currently authorized for 

commercial production and is currently 

in legal commercial production for 

human consumption in Brazil. 

2. Update to the List 

AMS requested public comments on 

the proposed List update changing 

‘‘squash (summer)’’ to ‘‘squash 

(summer, mosaic virus-resistant 

varieties).’’ 

Comment: Most commenters 

supported updating ‘‘squash (summer)’’ 

on the List to include a modifier, and no 

commenters opposed the inclusion of a 

modifier. As with the addition of 

‘‘sugarcane (Bt insect-resistant 

varieties),’’ commenters generally 

agreed that updating ‘‘squash (summer)’’ 

to include a modifier would provide 

additional information to consumers. 

Although no commenters were opposed 

to updating ‘‘squash (summer),’’ one 

commenter suggested revising the 

proposed modifier, which is discussed 

in the next comment discussion below. 

No commenters addressed AMS’s 

questions requesting information on the 

market share of BE and non-BE squash. 

AMS Response: AMS proposed to 

update the List entry for ‘‘squash 

(summer)’’ to ‘‘squash (summer, mosaic 

virus-resistant varieties)’’ to provide 

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. AMS believes 

the further revised modifier for squash 

serves these goals as detailed below. 

Comment: A commenter stated that 

the proposed ‘‘mosaic virus-resistant 

varieties’’ modifier is not specific 

enough to provide meaningful 

information to consumers. The 

commenter asked AMS to change the 

proposed ‘‘mosaic virus-resistant 

varieties’’ modifier to a more technical 


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Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations 83307 

3National Bioengineered Food Disclosure 

Standard, 83 FR 65819 (Dec. 21, 2018). 

4USDA–AMS (2022). Public Comments for 

Proposed Rule: National Bioengineered Food 

Disclosure Standard: Updates to the List of 

Bioengineered Foods (Docket AMS–FTPP–20– 

0057). https://www.regulations.gov/document/ 

AMS-FTPP-20-0057-0001. 

5U.S. FDA. (1997). Consultations on Food from 

New Plant Varieties. https://

www.accessdata.fda.gov/scripts/fdcc/ 

index.cfm?set=Biocon&id=SEM%2D0CZW3%2D2. 

6U.S. FDA. (1994). Consultations on Food from 

New Plant Varieties. https://

www.accessdata.fda.gov/scripts/fdcc/ 

index.cfm?set=Biocon&id=SEM%2D0ZW20%2D7. 

7Martı ́n-Herna ́ndez, A.M., & Pico ́, B. (2020). 

Natural resistances to viruses in cucurbits. 

Agronomy, 11(1), 23. https://doi.org/10.3390/ 

agronomy11010023. 

8Schultheis, J.R., & Walters, S.A. (1998). Yield 

and virus resistance of summer squash cultivars 

and breeding lines in North Carolina. 

HortTechnology, 8(1), 31–39. https://doi.org/ 

10.21273/HORTTECH.8.1.31. 

9Harris Seeds Product Page. (n.d.). Squash 

Reward F1 Seed. Product number 11780–00–01– 

012. https://www.harrisseeds.com/products/11780- 

squash-reward-f1?variant=12427665539144. 

10Bayer Group. (2022). Agronomic Spotlight: 

Mosaic Virus Diseases of Squash. https://

www.vegetables.bayer.com/us/en-us/resources/ 

growing-tips-and-innovation-articles/agronomicspotlights/mosaic-virus-diseases-of-squash.html. 

11Mueller, E., Gilbert, J., Davenport, G., Brigneti, 

G., & Baulcombe, D.C. (1995). Homology-dependent 

resistance: transgenic virus resistance in plants 

related to homology-dependent gene silencing. The 

Plant Journal, 7(6), 1001–1013. https://doi.org/ 

10.1046/j.1365-313X.1995.07061001.x. 

12 Grumet, R. (1990). Genetically engineered plant 

virus resistance. HortScience, 25(5), 508–513. 

https://doi.org/10.21273/HORTSCI.25.5.508. 

13Baulcombe, D.C. (1996). Mechanisms of 

pathogen-derived resistance to viruses in transgenic 

plants. The plant cell, 8(10), 1833. https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC161318/. 

14Canto-Pastor, A., Santos, B.A., Valli, A.A., 

Summers, W., Schornack, S., & Baulcombe, D.C. 

(2019). Enhanced resistance to bacterial and 

oomycete pathogens by short tandem target mimic 

RNAs in tomato. Proceedings of the National 

Academy of Sciences, 116(7), 2755–2760. https://

www.jstor.org/stable/26682958. 

15 Gonsalves, D. & Slightom, J.L. (1993). Coat 

protein-mediated protection: analysis of transgenic 

plants for resistance in a variety of crops. Seminars 

in Virology, 4, 397–405. https://doi.org/10.1006/ 

smvy.1993.1039. 

16Beachy, R.N., Loesch-Fries, S., & Tumer, N. 

(1990). Coat protein-mediated resistance against 

virus infection. Annual Review of Phytopathology, 

28, 451–474. https://doi.org/10.1146/ 

annurev.py.28.090190.002315. 

17Lindbo, J.A., & Falk, B.W. (2017). The impact 

of ‘‘coat protein-mediated virus resistance’’ in 

applied plant pathology and basic research. 

Phytopathology, 107(6), 624–634. https://doi.org/ 

10.1094/phyto-12-16-0442-rvw. 

18Tricoll, D.M., Carney, K.J., Russell, P.F., 

McMaster, J.R., Groff, D.W., Hadden, K.C., Himmel, 

P., T., Hubbard, J.P., Boeshore, M.L., & Quemada, 

H.D. (1995). Field evaluation of transgenic squash 

containing single or multiple virus coat protein 

gene constructs for resistance to cucumber mosaic 

virus, watermelon mosaic virus 2, and zucchini 

yellow mosaic virus. Bio/technology, 13(12), 1458– 

1465. https://doi.org/10.1038/nbt1295-1458. 

modifier to provide more meaningful 

information to consumers. 

AMS Response: The goal in adding a 

modifier to the List entry for squash is 

to narrow the presumption of what type 

of squash is considered BE. The 

preamble to the 2018 BE final rule 

states, ‘‘Where practical, the List 

includes specific information about 

individual crops and foods, such as 

descriptions or trade names, to help 

distinguish bioengineered versions of 

those foods from their nonbioengineered counterparts, as 

requested by commenters.’’ 3 Amending 

the modifier for squash to include a 

more specific descriptor would be 

consistent with the treatment of other 

items on the List, where descriptive 

modifiers are included. A request for 

comments published July 24, 2020, 

sought to narrow the scope of the List 

entry for squash to serve this goal.4

AMS received 22 comments on the 

request for comments, and later the 

proposed rule, supporting a modifier as 

it would provide additional information 

to consumers. 

The proposed modifier in the request 

for comments was to amend ‘‘squash 

(summer)’’ to ‘‘squash (summer, virusresistant varieties).’’ Comments on the 

request for comments suggested using a 

trade name; however, as explained in 

the proposed rule, the availability of 

two squash varieties in legal commercial 

production precludes this option.5 6

Both varieties provide resistance to 

mosaic viruses, so the proposed 

modifier was updated to ‘‘mosaic virusresistant varieties’’ in the proposed rule. 

Despite this further refinement, a 

commenter still noted the modifier was 

too broad in a comment on the proposed 

rule. 

In response to the comment on the 

proposed rule, AMS researched whether 

the modifier was still too broad and if 

further refinement was indeed required. 

AMS concluded that further refinement 

was needed to provide more specific 

information to regulated entities and 

consumers on squash varieties requiring 

disclosure. As technology advances and 

new squash varieties are developed, the 

modifier may need further refinement. 

The originally proposed modifier, 

‘‘mosaic virus-resistant varieties’’, 

covers the two BE squash varieties 

mentioned above, it would also cover 

squash varieties that are not BE. 

‘‘Mosaic virus-resistance’’ specifies the 

result of the trait, namely that the 

squash is less susceptible to diseases 

caused by mosaic virus pathogens 7

‘‘mosaic virus resistance’’ to describe 

both BE and non-BE squash that are 

resistant to mosaic viruses. The two BE 

squash varieties mentioned above are 

mosaic virus resistant.5 6 Non-BE squash 

varieties could be more resistant to 

viruses naturally 7 or as a result of 

conventional breeding,8 9 10 the result 

would be a mosaic virus-resistant 

squash that is not BE. AMS believes that 

it should refine the modifier to include 

all BE squash varieties and exclude all 

non-BE squash varieties. 

AMS considered several options for a 

modifier that would accomplish the 

above goals and be narrower than 

‘‘mosaic virus-resistant varieties.’’ Use 

of a trade name was not possible, as 

explained above, because of the 

availability of two BE squash varieties. 

The terms ‘‘transgenic virus 

resistance’’ 11 and ‘‘genetically 

engineered virus resistance’’ 12 would 

narrow the ‘‘mosaic virus-resistant 

varieties’’ modifier. These two modifiers 

describe the process used to achieve the 

virus resistance trait; however, the terms 

‘‘transgenic’’ and ‘‘genetically 

engineered’’ are not defined in the 

Standard. AMS believes that using 

terms like ‘‘transgenic’’ or ‘‘genetically 

engineered’’ may create inconsistency 

with the Standard’s scope of disclosure. 

‘‘Pathogen-derived resistance’’ 13 has 

been used to describe the traits found in 

BE squash. However, this modifier is 

broad and could refer to bacterial or 

fungal resistance,14 not just virus 

resistance. Therefore, it would not be 

wholly accurate and would not narrow 

the proposed modifier, ‘‘mosaic virusresistant varieties’’. ‘‘Coat proteinmediated protection’’ 15 and ‘‘coat 

protein-mediated virus resistance’’ 16 17

refer specifically to the trait found in BE 

squash varieties. Both these terms 

explain a subset of pathogen derived 

resistance in which a gene from a virus 

is added to a plant genome through 

biotechnology. The added viral coat 

protein gene then slows or prevents 

subsequent viral infection. AMS 

determined that ‘‘coat protein-mediated 

virus resistance’’ is the preferred 

terminology as it is more descriptive 

than ‘‘coat protein-mediated 

protection,’’ and it is used by academics 

and the industry. AMS believes the 

preferred term is more helpful to 

regulated entities and consumers. Both 

varieties of BE squash mentioned above 

use coat protein-mediated virus 

resistance to achieve mosaic virus 

resistance. Only BE squash is known to 

have coat protein-mediated virus 

resistance. The ‘‘coat protein-mediated 

virus-resistant varieties’’ modifier is 

more specific than ‘‘mosaic virusresistant varieties’’ and currently 

pertains only to mosaic virus resistance 

achieved in BE squash varieties.18


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Therefore, the ‘‘coat protein-mediated 

virus-resistant varieties’’ modifier 

encompasses both BE varieties of 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. With the 

addition of the modifier, summer 

squash that is not a coat proteinmediated virus-resistant variety will no 

longer be presumed to be a BE food. 

AMS consulted with the government 

agencies responsible for oversight of the 

products of biotechnology, APHIS, EPA, 

and FDA, regarding the two updates to 

the List, including the updated ‘‘coat 

protein-mediated virus-resistant 

varieties’’ modifier. Representatives 

from APHIS and FDA had no comments 

on the use of ‘‘coat protein-mediated 

virus-resistant varieties’’ for the 

modifier used on the List. EPA 

suggested adding ‘‘gene’’ to the 

modifier: ‘‘coat protein gene-mediated 

virus-resistant varieties.’’ EPA’s 

suggestion would clarify that ‘‘coat 

protein’’ is the name of the gene that 

encodes the coat protein of a virus and 

that it is the presence of the gene in BE 

squash that confers resistance to mosaic 

viruses, rather than the protein product 

of the gene. While EPA’s proposed 

modifier may provide more scientific 

clarity, AMS will use ‘‘coat proteinmediated virus-resistant varieties’’ 

without adding ‘‘gene.’’ AMS believes 

adding ‘‘gene’’ to the commonly used, 

AMS-preferred term would not provide 

any additional insight for consumers in 

identifying what foods are presumed to 

be a BE food. 

3. Information Collection and 

Recordkeeping Comment 

Commenters expressed that the 

proposed amendment would create 

burdens in connection with 

recordkeeping for sugarcane. They 

recommended that sources, trade 

names, and modifiers should be 

included on the List to minimize the 

recordkeeping burden of substantiating 

a determination not to disclose. One 

commenter stated that AMS’s economic 

analysis was flawed. The commenter 

stated that AMS miscalculated the costs 

associated with the use of sugarcane in 

products, underestimating the time and 

resources required to comply with the 

recordkeeping requirements. The 

commenter also stated that AMS 

calculated estimated costs by 

erroneously considering only Universal 

Product Codes (UPCs) that use cane 

sugar as an ingredient. The commenter 

contends that this analysis does not 

account for the costs incurred by 

regulated entities with those UPCs that 

contain other ingredients made from BE 

foods and crops in addition to cane 

sugar. The commenter’s position is that 

these regulated entities would incur 

costs associated with their use of cane 

sugar regardless of whether the final 

product contains other BE ingredients or 

ingredients derived from BE sources. 

AMS Response: AMS has considered 

all information provided to the agency 

related to the modifier for sugarcane and 

has determined ‘‘sugarcane (Bt insectresistant varieties)’’ to be the most 

precise naming convention to minimize 

the recordkeeping burden. The List 

includes specific information about 

certain individual crops and foods, such 

as modifiers or trade names, to help 

distinguish BE versions of those foods 

from their non-BE counterparts. The 

specificity of the sugarcane modifier ‘‘Bt 

insect-resistant varieties’’ is intended to 

identify foods for which disclosure may 

be necessary, based on the regulated 

entities’ records. There would be no 

presumption that sugarcane or 

sugarcane-derived ingredients would be 

BE unless they were sourced from Bt 

insect-resistant varieties. Regulated 

entities may refer to the AMS website to 

obtain additional information regarding 

the associated BE events for crops or 

foods they are sourcing and determine 

whether they need to make a disclosure. 

Products with potential BE 

ingredients (other than cane sugar) do 

not need to be added into the 

calculation for recordkeeping costs 

(since the recordkeeping costs 

associated with those ingredients are 

already included in the cost of the 

baseline program). Products that could 

use BE varieties of sugarcane, but list 

only ‘‘sugar’’ as an ingredient already 

require recordkeeping under the 

Standard and thus were not considered 

when estimating costs associated with 

this rule. If a regulated entity was 

already disclosing a BE food, their 

disclosure requirements would not 

change, nor would they incur additional 

costs. 

Customary and reasonable records can 

be used to justify non-disclosure for 

sugarcane-containing products. For 

further details on the economic analysis, 

see Section III.D of this rule. 

Comment: Commenters explained that 

recordkeeping for refined sugars 

typically does not follow standard 

recordkeeping specifications that track 

the sugar back to its source. 

Commenters further stated that 

generating records and coordinating 

with suppliers and laboratories for such 

records is a significant cost. Due to these 

obstacles, commenters requested a 24- 

month enforcement discretion period 

for recordkeeping of sugarcane. 

AMS Response: The final rule at 7 

CFR 66.7(b) states that, ‘‘regulated 

entities will have 18 months following 

the effective date of the updated List of 

Bioengineered Foods to revise food 

labels to reflect changes to the List in 

accordance with the disclosure 

requirements.’’ After considering input 

from commenters and other available 

information when drafting the 2018 BE 

final rule, AMS recognized that 

regulated entities should have sufficient 

time to transition their recordkeeping 

and labeling processes and procedures 

to implement the BE disclosure 

requirements. AMS continues to believe 

that regulated entities will have 

sufficient time to update recordkeeping 

procedures and to revise food labels to 

reflect changes to the List contained in 

this update within the 18-month 

compliance phase-in period. 

4. Outreach and Education 

Comment: Commenters requested 

increased outreach and education to 

consumers on BE foods to include 

definitions for the descriptions of 

resistant varieties. 

AMS Response: AMS intends to 

update the List on its website consistent 

with this final rule. Any definitions for 

the modifiers of resistant varieties 

included in this final rule will be 

reflected on the AMS website. The AMS 

website provides consumers and 

regulated entities with additional 

information including FDA-reviewed BE 

events in the food supply, BE varieties, 

trade names, source, and traits (e.g., 

non-browning, pesticide resistance, 

virus resistance, enhanced growth, etc.) 

for items on the List. While the List 

names each food known to have a BE 

variety, this additional information on 

the website seeks to enumerate each 

available BE variety. Regulated entities 

can use this information, to better 

understand if their products require a 

BE disclosure. Similarly, consumers can 

use this information to understand the 

types of BE products available. AMS 

will continue to update the website and 

corresponding outreach materials as 

new information becomes available. 

III. Required Regulatory Analyses 

A. Paperwork Reduction Act 

In accordance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520), the information collection related 

to the Standard has previously been 

approved by OMB and assigned OMB 

No. 0581–0315—National 

Bioengineered Food Disclosure 

Standard. AMS estimates that changes 

in the recordkeeping burden due to the 


ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations 83309 

19USDA–AMS. (2022). Public Comments for the 

National Bioengineered Food Disclosure Standard 

Information Collection Renewal (Docket AMS–22– 

0005–0001). https://www.regulations.gov/ 

document/AMS-AMS-22-0005-0001. 

20Agricultural Marketing Act of 1946’’. Sec 202. 

[7 U.S.C. 1621 note] https://www.govinfo.gov/ 

content/pkg/COMPS-10259/pdf/COMPS-10259.pdf. 

proposed revisions to the List would be 

minimal. 

Generally, the records necessary to 

substantiate the need for a disclosure 

are customary and reasonable, and 

maintained in the usual course of 

business. The same records would be 

required to substantiate a decision not 

to label under 7 CFR 66.9. Limiting 

reporting to specific varieties of summer 

squash does not impact recordkeeping. 

Entities may still be subject to an 

examination of customary or reasonable 

records for summer squash following a 

BE audit, as outlined in 7 CFR 66.402. 

AMS requested comments with data 

or information on market share or 

proportion of squash of virus-resistant 

varieties and the number of entities that 

might be impacted by this change as 

part of the proposed rule during the 60- 

day comment period. While AMS 

received two comments during the open 

comment period for the Information 

Collection renewal request published in 

2022,19 those comments were not 

substantive and did not include any 

data or comments on market share or 

proportion of virus-resistant varieties of 

squash. 

B. Civil Rights Review 

AMS has considered the potential 

civil rights implications of this final rule 

on minorities, women, or persons with 

disabilities to ensure that no person or 

group shall be discriminated against 

based on race, color, national origin, 

gender, religion, age, disability, sexual 

orientation, marital or family status, 

political beliefs, parental status, or 

protected genetic information. This 

review included persons that are 

employees of the entities that are subject 

to these regulations. 

The 2018 BE final rule offers several 

distinct avenues of compliance for 

regulated entities that can be tailored to 

the needs of their consumers. This final 

rule to update the List of BE Foods does 

not alter those options. No persons or 

groups are denied the benefits of the 

program nor are any persons or groups 

subjected to discrimination by making 

amendments to the List. The amended 

Act is a federal law that established a 

national, mandatory standard for 

disclosing any food that is or may be BE. 

The law applies generally to all persons 

conducting business subject to the 

Standard. Congress declared in the 

amended Act that ‘‘a sound, efficient, 

and privately operated system for 

distributing and marketing agricultural 

products is essential to a prosperous 

agriculture and is indispensable to the 

maintenance of full employment and to 

the welfare, prosperity, and health of 

the Nation’’.20

USDA, AMS’ Food Disclosure and 

Labeling Division administers and 

enforces the Standard and its 

regulations and is responsible for 

establishing new rules as needed. This 

final rule updates the List of BE Foods 

at 7 CFR 66.6 by adding ‘‘sugarcane (Bt 

insect-resistant varieties)’’ to the List 

and amending ‘‘squash (summer)’’ to 

‘‘squash (summer, coat proteinmediated virus-resistant varieties)’’ 

under the Standard. Regulated entities, 

subject to this final rule, and consumers 

who benefit from the rule, would not be 

required to apply to any program or optin 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 BE 

food disclosure to consumers; and 

regulated entities that fail to disclose 

would be subject to an investigation and 

results reported on the AMS website. 

C. Executive Order 13175 

This rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175—Consultation 

and Coordination with Indian Tribal 

Governments. Executive Order 13175 

requires Federal agencies to consult 

with Tribes on a government-togovernment basis on policies that have 

Tribal implications, including 

regulations, legislative comments or 

proposed legislation, and other policy 

statements or actions that have 

substantial direct effects on one or more 

Indian Tribes, on the relationship 

between the Federal Government and 

Indian Tribes or the distribution of 

power and responsibilities between the 

Federal Government and Indian Tribes. 

This final rule may impact individual 

members of Indian Tribes that operate 

as food manufacturers or retailers; 

however, AMS has determined that this 

final rule does not have a direct effect 

on Tribes or the relationship or 

distribution of power and 

responsibilities between the Federal 

Government and Indian Tribes that 

would require consultation. AMS 

continues to engage with Tribes on such 

changes, including through 

teleconference calls on March 11, 2021, 

and July 22, 2021, where AMS provided 

Tribal representatives with an overview 

of the upcoming proposed rule that 

would add ‘‘sugarcane (Bt insectresistant varieties)’’ to the List, amend 

‘‘squash (summer)’’ to include the 

modifier ‘‘mosaic virus-resistant 

varieties’’ and extended the opportunity 

for questions and requests for additional 

information. At that time, AMS received 

no questions or requests from Tribal 

representatives. 

On September 20, 2022, the comment 

period for the proposed rule closed. 

Only one comment out of 37 comments 

received on the proposed rule was 

identified as being submitted from a 

Tribal representative. The commenter 

acknowledged the proposed rule 

provides transparency to the consumer 

about BE foods and stated that the 

Tribal groups have not yet seen if 

certain groups will be affected, but the 

exemptions seem to offer such groups 

with a cushion. AMS will continue to 

extend outreach to ensure Tribe 

members are aware of the requirements 

and benefits under this final rule once 

effective. Where Tribes request 

consultation on relevant matters that are 

not required under legislation, AMS 

will collaborate with the Office of Tribal 

Relations to ensure meaningful 

consultation is provided. 

D. Executive Orders 12866, 14094 and 

13563 

USDA is issuing this final rule in 

conformance with Executive Orders 

12866 and 13563, which direct agencies 

to assess all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits, which include potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity. Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Executive Order 

14094 reaffirms, supplements, and 

updates Executive Order 12866 and 

further directs agencies to solicit and 

consider input from a wide range of 

affected and interested parties through a 

variety of means. This rule has been 

designated ‘‘Significant’’ under 

Executive Order 12866 as amended by 

Executive Order 14094. To provide 

sufficient time to help mitigate impacts 

to regulated entities, pursuant to 7 CFR 

66.7(b), regulated entities have 18 

months following the effective date of 

the updated List of Bioengineered Foods 

to revise food labels to reflect changes 

to the List in accordance with the 

disclosure requirements of this part. 


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83310 Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations 

21USDA–AMS. (2019). Regulatory Impact 

Analysis for the Proposed Rule: National 

Bioengineered Food Disclosure Standard: Updates 

to the List of Bioengineered Foods (Docket AMS– 

TM–17–0050–14035). https://www.regulations.gov/ 

document/AMS-TM-17-0050-14035. 

22USDA–AMS. (2019). Regulatory Impact 

Analysis for the Proposed Rule: National 

Bioengineered Food Disclosure Standard: Updates 

to the List of Bioengineered Foods (Docket AMS– 

TM–17–0050–14035). https://www.regulations.gov/ 

document/AMS-TM-17-0050-14035. 

AMS identified three benefits of this 

rule. First it fulfills the regulatory 

responsibility to update the List 

according to 7 CFR 66.7. Sugarcane has 

satisfied the criteria for inclusion, as 

does the amendment to squash; in 

addition, the amendment to squash was 

initiated by a comment from the 

stakeholder. The updates in this final 

rule inform consumers whether certain 

products are BE, and aid regulated 

entities in determining if their product 

requires disclosure. Second, this rule 

provides specific information to 

consumers about the types of BE foods 

that are or could become available for 

retail sale. Third, this rule removes the 

presumption that all summer squash is 

BE and now only ‘‘coat proteinmediated virus-resistant varieties’’ will 

be presumed to be BE. 

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. 

More specifically, processors and 

retailers of summer squash are already 

required to keep records to justify their 

decision to label or not label their 

product. The addition of a new modifier 

to summer squash does not absolve 

regulated entities of the recordkeeping 

responsibility. The number of BE 

‘‘squash (summer, coat proteinmediated virus-resistant varieties)’’ that 

must be labeled will remain the same as 

the number of BE ‘‘squash (summer)’’ 

that were required to be labelled 

pursuant to the original List in the 2018 

BE final rule. All BE squash still must 

bear a disclosure. With the addition of 

the modifier, summer squash that is not 

a coat protein-mediated virus-resistant 

variety will no longer be presumed BE. 

The record keeping burden for regulated 

entities selling summer squash, or 

products with summer squash 

ingredients will also remain the same, 

since regulated entities are required to 

maintain records demonstrating that 

their product is not BE to satisfy the 

requirements of 7 CFR 66.302. 

The addition of ‘‘sugarcane (Bt insectresistant varieties)’’ to the List would 

not significantly increase the cost of 

compliance with, or enforcement of, the 

BE labeling requirements. To estimate 

the cost of this action, we used the Label 

Insight Database to determine the 

number of products that use sugarcane 

as an ingredient, and which have no 

other ingredients that would otherwise 

require labeling of the product as BE as 

described in the Regulatory Impact 

Analysis for the 2018 BE final rule on 

page 19.21 A total of 10,600 individual 

UPCs were identified using this 

criterion. Products that could use BE 

varieties of sugarcane, but list only 

‘‘sugar’’ as an ingredient already require 

recordkeeping under the Standard and 

thus were not considered when 

estimating costs associated with this 

rule. 

Increased costs associated with this 

rule are analytical costs and testing 

costs. Analytical costs represent the 

administrative costs of determining 

applicability of the Standard to products 

and compiling any records that may be 

required. Testing costs represent the 

costs that regulated entities would incur 

to test their products for detectable 

modified genetic material. The upper 

and lower bounds of the estimate were 

calculated by multiplying 10,600 UPCs 

by the unit cost for testing for 

detectability (unit cost range: $153– 

$431) and for analytical costs (unit cost 

range: $376–$3,084) as described in the 

Regulatory Impact Analysis for the 2018 

BE final rule.22 This is likely an 

overestimate of costs, as a test may be 

used to cover multiple UPCs. For 

example, different sizes of the same 

product would have different UPCs yet 

require only a single test for the 

product. AMS 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 would be 

between $500,000 and $3.5 million 

(annualized over 20 years using a seven 

percent discount rate). 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. 

E. Final Regulatory Flexibility Analysis 

AMS has examined the economic 

implications of this final rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). If a rule has 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act requires 

agencies to analyze regulatory options 

that would lessen the economic effect of 

the rule on small entities, consistent 

with statutory objectives. AMS has 

concluded that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

The addition of ‘‘sugarcane (Bt insectresistant varieties)’’ and amendment of 

‘‘squash (summer)’’ to ‘‘squash 

(summer, coat protein-mediated virusresistant varieties)’’ to the List would 

directly affect three industry sectors: 

manufacturers that process sugarcane, 

processed food manufacturers that use 

sugarcane or summer squash as 

ingredients, and grocery or other 

retailers that sell raw sugarcane or 

summer squash. 

According to the 2017 Study of U.S. 

Business (SUSB) from the U.S. Census, 

there were 37 manufacturers that 

process sugarcane in the United States. 

Approximately 32 of these 

manufacturers would meet the Small 

Business Administration definition of 

small. Of the 32 small firms, 11 would 

also qualify as very small food 

manufacturers under the Standard and 

would be exempt from disclosure 

requirements. Accordingly, those 11 

firms would incur no costs associated 

with the addition of ‘‘sugarcane (Bt 

insect-resistant varieties)’’ to the List. 

The remaining 21 small firms would not 

likely face significant costs as they only 

have one product and are likely to know 

where the cane for their sugar 

originates. At this time ‘‘sugarcane (Bt 

insect-resistant varieties)’’ is grown 

commercially only in Brazil. If 

‘‘sugarcane (Bt insect-resistant 

varieties)’’ becomes more prevalent, 

manufacturers that process sugarcane 

may incur additional costs associated 

with substantiating non-disclosure (e.g., 

maintaining customary and reasonable 

records on the origin of the sugarcane 

processed into sugar, certification costs 

associated with demonstrating that the 

final product has no detectable modified 

genetic material). If the refinement of 

cane sugar, like beet sugar, would 

verifiably not contain detectable 

modified genetic material and therefore 

would not be BE, cane sugar producers 

would face minimal labeling costs. 

Processed food manufacturers that use 

sugarcane as an ingredient will need to 

determine whether the sugar they use is 

BE—assuming sugar made from 

‘‘sugarcane (Bt insect-resistant 

varieties)’’ makes it into the U.S. market. 

Most food manufacturers already face 

costs associated with determining 

whether their ingredients are BE and 

maintaining records to demonstrate that 

determination. The marginal cost 

associated with an additional ingredient 

is expected to be small. As noted in 

section III(D) of this rule, the costs 


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Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations 83311 

associated with this final rule will be 

limited to administrative costs to 

analyze applicability of the rule and 

compliance and validation testing to 

determine the presence of detectable 

modified genetic material in affected 

products. As with beet sugar, it is 

unlikely that refined sugarcane would 

contain detectable levels of modified 

genetic material. As a result, regulated 

entities may not have additional 

labeling costs due to the addition of 

‘‘sugarcane (Bt insect-resistant 

varieties)’’ to the List. 

Food manufacturers whose products 

contain summer squash and retailers 

that sell uncooked summer squash will 

see no change in costs as the 

amendment to the List would reduce the 

varieties of squash that are presumed to 

be a BE food. Food manufacturers 

whose products contain summer squash 

and retailers that sell uncooked summer 

squash are already maintaining records 

or labeling relevant products in 

accordance with the Standard. 

Food manufacturers that use summer 

squash are likely concentrated in Fruit 

and Vegetable Preserving and Specialty 

Food Manufacturing (The North 

American Industry Classification 

System (NAICS) 3114). This industry 

sector had 1,540 firms listed in the 2017 

Statistics of US Businesses. Of these, 

approximately 1,475 would be classified 

as small. Additionally, 904 firms would 

be classified as very small food 

manufacturers by the Standard and are 

therefore exempt. Food manufacturers 

already face the administrative costs 

associated with using a product on the 

List. The final rule would make it easier 

for regulated entities, who are already 

maintaining records in compliance with 

the Standard, to demonstrate that 

labeling is not required if they know 

they are not receiving BE varieties. Costs 

to small food manufacturers using 

summer squash therefore will remain 

unchanged by this proposal. 

Retailers will not see a change in the 

number of labels required as a result of 

the change in the modifier of summer 

squash or by the addition of sugarcane. 

Summer squash that meets the 

requirement for disclosure under the 

2018 BE final rule will also meet the 

requirement for disclosure under this 

amendment. The same number of labels 

are required under the two rules. 

Therefore, the cost to retailers will 

remain unchanged. Therefore, the costs 

to each of the three affected industry 

sectors would not be significant. For 

these reasons, AMS is certifying that 

this rule to add ‘‘sugarcane (Bt insectresistant varieties)’’ to the List and 

limiting the varieties of squash listed as 

BE foods to ‘‘summer, coat proteinmediated virus-resistant varieties’’ will 

not have a significant economic impact 

on a substantial number of small 

entities. 

F. Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. The final rule is not 

intended to have retroactive effect. All 

labeling claims made in conjunction 

with this regulation must be consistent 

with other applicable Federal 

requirements. There are no 

administrative procedures that must be 

exhausted prior to any judicial 

challenge to the provisions of this rule. 

G. Congressional Review Act 

Pursuant to Subtitle E of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (the Congressional 

Review Act), the Office of Information 

and Regulatory Affairs has determined 

that this action does not meet the 

criteria set forth in 5 U.S.C. 804(2). 

List of Subjects in 7 CFR Part 66 

Agricultural commodities, Food 

labeling, Reporting and recordkeeping 

requirements. 

For the reasons stated in the 

preamble, the Agricultural Marketing 

Service amends 7 CFR part 66 as set 

forth below: 

PART 66—NATIONAL 

BIOENGINEERED FOOD DISCLOSURE 

STANDARD 

■ 1. The authority citation for part 66 

continues to read as follows: 

Authority: 7 U.S.C. 1621 et seq. 

■ 2. Revise § 66.6 to read as follows: 

§ 66.6 List of bioengineered foods. 

The List of Bioengineered Foods 

consists of the following: Alfalfa, apple 

(ArcticTM varieties), canola, corn, 

cotton, eggplant (BARI Bt Begun 

varieties), papaya (ringspot virusresistant varieties), pineapple (pink 

flesh varieties), potato, salmon 

(AquAdvantage®), soybean, squash 

(summer, coat protein-mediated virusresistant varieties), sugarbeet, and 

sugarcane (Bt insect-resistant varieties). 

Erin Morris, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2023–26059 Filed 11–28–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF THE TREASURY 

Office of the Comptroller of the 

Currency 

12 CFR Part 34 

[Docket No. OCC–2023–0012] 

RIN 1557–AF23 

FEDERAL RESERVE SYSTEM 

12 CFR Part 226 

[Docket No. R–1819] 

RIN 7100–AG19 

CONSUMER FINANCIAL PROTECTION 

BUREAU 

12 CFR Part 1026 

Appraisals for Higher-Priced Mortgage 

Loans Exemption Threshold 

AGENCY: Office of the Comptroller of the 

Currency, Treasury (OCC); Board of 

Governors of the Federal Reserve 

System (Board); and Consumer 

Financial Protection Bureau (Bureau). 

ACTION: Final rules, official 

interpretations, and commentary. 

SUMMARY: The OCC, the Board, and the 

Bureau are finalizing amendments to the 

official interpretations for their 

regulations that implement section 

129H of the Truth in Lending Act 

(TILA). Section 129H of TILA 

establishes special appraisal 

requirements for ‘‘higher-risk 

mortgages,’’ termed ‘‘higher-priced 

mortgage loans’’ or ‘‘HPMLs’’ in the 

agencies’ regulations. The OCC, the 

Board, the Bureau, the Federal Deposit 

Insurance Corporation (FDIC), the 

National Credit Union Administration 

(NCUA), and the Federal Housing 

Finance Agency (FHFA) (collectively, 

the Agencies) jointly issued final rules 

implementing these requirements, 

effective January 18, 2014. The 

Agencies’ rules exempted, among other 

loan types, transactions of $25,000 or 

less, and required that this loan amount 

be adjusted annually based on any 

annual percentage increase in the 

Consumer Price Index for Urban Wage 

Earners and Clerical Workers (CPI–W). 

If there is no annual percentage increase 

in the CPI–W, the OCC, the Board, and 

the Bureau will not adjust this 

exemption threshold from the prior 

year. Additionally, in years following a 

year in which the exemption threshold 

was not adjusted because the CPI–W 

decreased, the threshold is calculated by 

applying the annual percentage increase 

in the CPI–W to the dollar amount that 


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