Notice2024-06535
National Bioengineered Food Disclosure Standard; Annual Review of the List of Bioengineered Foods
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Published
March 28, 2024
Issuing agencies
Agriculture DepartmentAgricultural Marketing Service
Abstract
The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is soliciting information about potential additions to or subtractions from the List of Bioengineered Foods (List) as it pertains to the National Bioengineered Food Disclosure Standard (Standard).
Full Text
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<title>Federal Register, Volume 89 Issue 61 (Thursday, March 28, 2024)</title>
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[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21484-21485]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-06535]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
[Doc. No. AMS-FTPP-22-0080]
National Bioengineered Food Disclosure Standard; Annual Review of
the List of Bioengineered Foods
ACTION: Notice; request for information.
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SUMMARY: The Agricultural Marketing Service (AMS) of the Department of
Agriculture (USDA) is soliciting information about potential additions
to or subtractions from the List of Bioengineered Foods (List) as it
pertains to the National Bioengineered Food Disclosure Standard
(Standard).
DATES: Comments must be received by April 29, 2024 to be assured of
consideration.
ADDRESSES: Interested parties are invited to submit written comments
via the internet at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Enter ``AMS-FTPP-22-
0080'' in the Search field. Select the Documents tab, then select the
`Comment' button in the list of documents. Comments may also be filed
by mail or by fax with the Docket Clerk, 1400 Independence Ave. SW,
Room 2069--South, Washington, DC 20250; Fax: (202) 260-8369. All
comments submitted in response to this notice, including the identity
of individuals or entities submitting comments, will be made available
to the public on the internet via <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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) 570-3661, Email
<a href="/cdn-cgi/l/email-protection#610a040f0f0415094f0304020a041321141205004f060e17"><span class="__cf_email__" data-cfemail="cba0aea5a5aebfa3e5a9aea8a0aeb98bbeb8afaae5aca4bd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
On July 29, 2016, Public Law 114-216 amended the Agricultural
Marketing Act of 1946 (7 U.S.C. 1621 et. seq.) (amended Act) to require
USDA to establish a national, mandatory standard for disclosing any
food that is or may be bioengineered. In accordance with the amended
Act, USDA published final regulations (2018 final rule) to implement
the Standard on December 21, 2018 (83 FR 65814). The regulations became
effective on February 19, 2019, with a mandatory compliance date of
January 1, 2022. Under 7 CFR 66.1, a bioengineered food is a food
that--subject to certain factors, conditions, and limitations--contains
detectable genetic material that has been modified through in vitro
recombinant deoxyribonucleic acid (rDNA) techniques and for which the
modification could not otherwise be obtained through conventional
breeding or found in nature.
The regulations, at 7 CFR 66.6, provides the List, which currently
includes: alfalfa, apple (Arctic<SUP>TM</SUP> varieties), canola, corn,
cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-
resistant varieties), pineapple (pink flesh varieties), potato, salmon
(AquAdvantage[supreg]), soybean, squash (summer, coat-protein mediated
virus-resistant), sugarbeet, and sugarcane (Bt insect-resistant). Where
practical, the List includes specific information about individual
crops and foods, such as variety descriptions or trade names, to help
distinguish bioengineered versions of those foods from their non-
bioengineered counterparts.
The List attempts to capture bioengineered crops and food that meet
the statutory definition of ``bioengineering,'' based on existing
technology, and that could potentially be offered for sale in the
United States (83 FR 65839). AMS has developed the List to identify the
crops and food that are available in a bioengineered form, and to aid
regulated entities considering whether they may need to make a
bioengineered disclosure (83 FR 65839). Food has a broad definition
under 7 CFR 66.1 and includes raw agricultural commodities, such as
crops and animals; incidental additives; and processed foods. Raw
agricultural commodities, including crops and animals, are candidates
for inclusion on the List. Microbes, such as enzymes, yeasts, and other
similar foods produced in controlled environments, are excluded from
the List, as explained in the preamble to the 2018 Final Rule, and
therefore are not considered for addition to the List (83 FR 65839).
Similarly, ``processed foods'', as defined at 7 CFR 66.1, are excluded
from the List (See 83 FR 65819).
As stated in the preamble to the 2018 final rule, at 83 FR 65852,
the List ``establishes a presumption about what foods might require
disclosure under the Standard but does not absolve regulated entities
from the requirement to disclose the bioengineered status of food and
food ingredients produced with foods not on the List when the regulated
entities have actual knowledge that such foods or food ingredients are
bioengineered.'' As a result, if a regulated entity is using a food or
ingredient produced from an item on the List, they must make a
bioengineered food disclosure unless they have records demonstrating
that the food or ingredient they are using is not bioengineered.
Similarly, even if a food is not on the List, a regulated entity must
make a bioengineered food disclosure if they have actual knowledge a
food or ingredient that they are using is a bioengineered food or a
bioengineered food ingredient.
The regulations at 7 CFR 66.7(a) require AMS to review and consider
updates to the List on an annual basis and solicit comments regarding
recommended updates to the List through notification in the Federal
Register and on the AMS website.
The regulations at 7 CFR 66.7(a) further provide that:
(1) Recommendations regarding additions to and subtractions from
the List may be submitted to AMS at any time or as part of the annual
review process.
(2) Recommendations should be accompanied by data and other
information to support the recommended action.
(3) AMS will post public recommendations on its website, along with
information about other revisions to the List that the agency may be
considering, including input based on consultation with the government
agencies responsible for oversight of the products of biotechnology:
USDA's Animal and Plant Health Inspection Service (USDA-APHIS); the
U.S. Environmental Protection Agency (EPA); the Department of Health
and Human Services' Food and Drug Administration (FDA)' and appropriate
members of the Coordinated Framework for the Regulation of
Biotechnology or a similar successor.
(4) 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.
As stated at 7 CFR 66.7(b), regulated entities will have 18 months
following the effective date of the updated List to revise food labels
to reflect changes to the List in accordance with the disclosure
requirements of 7 CFR part 66.
[[Page 21485]]
II. Request for Information
When considering whether crops and food available in a
bioengineered form should be added to the List, AMS will consider two
criteria: (1) whether the food has been authorized for commercial
production somewhere in the world; and (2) whether the food is
currently in legal commercial production for human food somewhere in
the world. AMS uses resources such as GAIN Agricultural Biotechnology
Annual Reports, information from food manufacturers, and international
governmental information to track such authorizations and the status of
commercial production.
AMS is soliciting comments including data, recommendations, and
other information on the inclusion of several specific crops and foods
it has determined are likely to meet the criteria to be added to the
List. AMS also seeks information from the public on any additional
crops or foods that may meet the criteria to be added to the List, any
crops or foods that no longer meet the criteria and should be
subtracted from the List, and any trade names, varieties or modifiers
that should be considered for addition to or subtraction from the items
currently appearing on the List. After reviewing the recommendations
and information submitted in response to this notice, AMS will use that
information, as well as input based on consultation with other
government agencies responsible for oversight of the products of
biotechnology, to determine whether it should initiate rulemaking to
update the List. Any comments not directly related to updates to the
List will not be considered, nor will recommendations that are not
accompanied by data and other information to support the recommended
action. AMS is providing 30 days for the submission of relevant
information. Any changes to the List would be reflected in an amendment
to 7 CFR part 66.
1. Should Dry Edible Beans (Event--EMB-PV[Oslash]51) <SUP>1 2</SUP>
be added to the List? If so, would you suggest that AMS use a modifier,
trade name, variety, etc.?
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\1\ <a href="https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=23">https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=23</a>.
\2\ Agricultural Biotechnology Annual-2021-Brazil, <a href="https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Brasilia_Brazil_10-20-2021">https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Brasilia_Brazil_10-20-2021</a>.
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2. Should Cowpea (Event--AAT709A) <SUP>3 4</SUP> be added to the
List? If so, would you suggest that AMS use a modifier, trade name,
variety, etc.?
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\3\ Agricultural Biotechnology Annual--2021--Nigeria, <a href="https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Lagos_Nigeria_10-20-2021">https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Lagos_Nigeria_10-20-2021</a>.
\4\ <a href="https://sciencenigeria.com/pbr-cowpea-revolutionising-nigerias-food-production-nabda-boss/">https://sciencenigeria.com/pbr-cowpea-revolutionising-nigerias-food-production-nabda-boss/</a>.
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3. Should Wheat (Event--HB4) <SUP>5 6</SUP> be added to the list?
If so, would you suggest that AMS use a modifier, trade name, variety,
etc.?
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\5\ Argentina: Agricultural Biotechnology--Annual-2021, <a href="https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Buenos%20Aires_Argentina_10-20-2021">https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Buenos%20Aires_Argentina_10-20-2021</a>.
\6\ UPDATE 1--Argentina becomes first country to authorize
planting GMO wheat [verbar] Reuters.
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4. Should Rice (Event--GR2E, Production of provitamin A
carotenoids),<SUP>7 8</SUP> also known as Golden Rice, be added to the
List? If so, would you suggest that AMS use a modifier, trade name,
variety, etc.?
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\7\ Philippines approves Golden Rice for direct use as food and
feed, or for processing, <a href="https://www.irri.org/news-and-events/news/philippines-approves-golden-rice-direct-use-food-and-feed-or-processing">https://www.irri.org/news-and-events/news/philippines-approves-golden-rice-direct-use-food-and-feed-or-processing</a>.
\8\ <a href="https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Manila_Philippines_RP2022-0058.pdf">https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Manila_Philippines_RP2022-0058.pdf</a>.
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5. Should Purple Tomato (Event--Del/Ros1-N) \9\ be added to the
List? If so, would you suggest that AMS use a modifier, trade name,
variety, etc.?
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\9\ <a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=NewPlantVarietyConsultations&id=DelRos1-N">https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=NewPlantVarietyConsultations&id=DelRos1-N</a>.
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6. Should Plums (Honeysweet, Event--ARS-PLMC5-6) \10\ be added to
the List? If so, would you suggest that AMS use a modifier, trade name,
variety, etc.?
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\10\ <a href="https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=236">https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=236</a>.
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7. Are there any other crops or foods that should be considered for
inclusion on the List?
8. Are there any crops or foods currently on the List that should
be considered for subtraction from the List?
9. Should any modifiers be added or changed for any of the crops or
foods already on the List?
Authority: 7 U.S.C. 1621 et seq.
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2024-06535 Filed 3-27-24; 8:45 am]
BILLING CODE P
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