[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Rules and Regulations]
[Pages 83305-83311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26059]



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Rules and Regulations
                                                Federal Register
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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. 

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

[[Page 83305]]



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 virus-resistant 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: 
<a href="/cdn-cgi/l/email-protection#365d53585853425e185453555d5344764345525718515940"><span class="__cf_email__" data-cfemail="81eae4efefe4f5e9afe3e4e2eae4f3c1f4f2e5e0afe6eef7">[email protected]</span></a>.

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 (Arctic<SUP>TM</SUP> varieties), canola, corn, 
cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-
resistant varieties), pineapple (pink flesh varieties), potato, salmon 
(AquAdvantage[supreg]), 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 insect-resistant varieties)'' to the List 
and amend ``squash (summer)'' to ``squash (summer, coat protein-
mediated virus-resistant 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

[[Page 83306]]

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 
insect-resistant 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 multi-ingredient food products.
---------------------------------------------------------------------------

    \1\ USDA 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.
---------------------------------------------------------------------------

    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 insect-
resistant 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 
insect-resistant 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\ National Bioengineered Food Disclosure Standard, 83 FR 65818 
(Dec. 21, 2018).
---------------------------------------------------------------------------

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

[[Page 83307]]

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 non-
bioengineered 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.
---------------------------------------------------------------------------

    \3\ National Bioengineered Food Disclosure Standard, 83 FR 65819 
(Dec. 21, 2018).
    \4\ USDA-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.
---------------------------------------------------------------------------

    The proposed modifier in the request for comments was to amend 
``squash (summer)'' to ``squash (summer, virus-resistant 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.<SUP>5 6</SUP> Both varieties provide resistance to mosaic 
viruses, so the proposed modifier was updated to ``mosaic virus-
resistant 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.
---------------------------------------------------------------------------

    \5\ U.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.
    \6\ U.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.
---------------------------------------------------------------------------

    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.<SUP>5 6</SUP> Non-BE squash varieties 
could be more resistant to viruses naturally \7\ or as a result of 
conventional breeding,<SUP>8 9 10</SUP> 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.
---------------------------------------------------------------------------

    \7\ Mart[iacute]n-Hern[aacute]ndez, A.M., & Pic[oacute], B. 
(2020). Natural resistances to viruses in cucurbits. Agronomy, 
11(1), 23. https://doi.org/10.3390/agronomy11010023.
    \8\ Schultheis, 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.
    \9\ Harris 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.
    \10\ Bayer Group. (2022). Agronomic Spotlight: Mosaic Virus 
Diseases of Squash. https://www.vegetables.bayer.com/us/en-us/resources/growing-tips-and-innovation-articles/agronomic-spotlights/mosaic-virus-diseases-of-squash.html.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \11\ Mueller, 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.
---------------------------------------------------------------------------

    ``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 virus-resistant varieties''. ``Coat 
protein-mediated protection'' \15\ and ``coat protein-mediated virus 
resistance'' <SUP>16 17</SUP> 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 virus-resistant varieties'' and currently pertains only 
to mosaic virus resistance achieved in BE squash varieties.\18\

[[Page 83308]]

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 protein-
mediated virus-resistant variety will no longer be presumed to be a BE 
food.
---------------------------------------------------------------------------

    \13\ Baulcombe, 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/.
    \14\ Canto-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.
    \16\ Beachy, 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.
    \17\ Lindbo, 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.
    \18\ Tricoll, 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.
---------------------------------------------------------------------------

    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 protein-mediated 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 insect-resistant 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

[[Page 83309]]

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.
---------------------------------------------------------------------------

    \19\ USDA-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.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \20\ Agricultural Marketing Act of 1946''. Sec 202. [7 U.S.C. 
1621 note] https://www.govinfo.gov/content/pkg/COMPS-10259/pdf/COMPS-10259.pdf.
---------------------------------------------------------------------------

    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 protein-mediated 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 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 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-to-government 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 insect-resistant 
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.

[[Page 83310]]

    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 protein-mediated 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 protein-mediated 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 insect-resistant 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.
---------------------------------------------------------------------------

    \21\ USDA-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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \22\ USDA-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.
---------------------------------------------------------------------------

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 insect-resistant varieties)'' and 
amendment of ``squash (summer)'' to ``squash (summer, coat protein-
mediated virus-resistant 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

[[Page 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 insect-resistant 
varieties)'' to the List and limiting the varieties of squash listed as 
BE foods to ``summer, coat protein-mediated 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

0
1. The authority citation for part 66 continues to read as follows:

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


0
2. Revise Sec.  66.6 to read as follows:


Sec.  66.6  List of bioengineered foods.

    The List of Bioengineered Foods consists of the following: Alfalfa, 
apple (Arctic\TM\ varieties), canola, corn, cotton, eggplant (BARI Bt 
Begun varieties), papaya (ringspot virus-resistant varieties), 
pineapple (pink flesh varieties), potato, salmon 
(AquAdvantage[supreg]), soybean, squash (summer, coat protein-mediated 
virus-resistant 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


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