National Bioengineered Food Disclosure Standard; List of Bioengineered Foods, 83305-83311 [2023-26059]
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Rules and Regulations
Federal Register
Vol. 88, No. 228
Wednesday, November 29, 2023
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.
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.
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
SUMMARY:
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.
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TABLE 1—UPDATES TO THE LIST
Crop
Regulation
Final rule action
Sugarcane ..............
Squash (summer) ...
7 CFR 66.6 ............
7 CFR 66.6 ............
Add to the List as ‘‘sugarcane (Bt insect-resistant varieties)’’.
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
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that they thought that the two proposed
List updates would provide the public
with accurate information on the BE
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status of foods. There was, however,
opposition from two commenters about
AMS’s proposal to add ‘‘sugarcane (Bt
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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
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.
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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.
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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
2 National Bioengineered Food Disclosure
Standard, 83 FR 65818 (Dec. 21, 2018).
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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
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.
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.
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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.
7 Martı
´n-Herna´ndez, A.M., & Pico´, 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/11780squash-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/agronomicspotlights/mosaic-virus-diseases-of-squash.html.
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.
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‘‘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
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.
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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
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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 24month enforcement discretion period
for recordkeeping of sugarcane.
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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
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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 60day 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
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.
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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,
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.
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83309
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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Federal Register / Vol. 88, No. 228 / Wednesday, November 29, 2023 / Rules and Regulations
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
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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
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.
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.
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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
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 protein-
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83311
mediated virus-resistant varieties’’ will
not have a significant economic impact
on a substantial number of small
entities.
DEPARTMENT OF THE TREASURY
F. Executive Order 12988
12 CFR Part 34
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.
[Docket No. OCC–2023–0012]
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
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Office of the Comptroller of the
Currency
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
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.
AGENCY:
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
SUMMARY:
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]]>Agencies
[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]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
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.
========================================================================
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:
[email protected].
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[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.
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\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.
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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.
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\2\ National Bioengineered Food Disclosure Standard, 83 FR 65818
(Dec. 21, 2018).
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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.
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\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.
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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.5 6 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.
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\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.
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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.
---------------------------------------------------------------------------
\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.
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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.
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\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.
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``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'' 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 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.
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\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.
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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.
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\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.
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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\
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\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.
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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.
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\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.
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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.
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\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.
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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
