[Federal Register Volume 89, Number 61 (Thursday, March 28, 2024)]
[Notices]
[Pages 21484-21485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov. 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 https://www.regulations.gov.

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 
[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 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 (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, 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) 1 2 
be added to the List? If so, would you suggest that AMS use a modifier, 
trade name, variety, etc.?
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    \1\ https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=23.
    \2\ Agricultural Biotechnology Annual-2021-Brazil, https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Brasilia_Brazil_10-20-2021.
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    2. Should Cowpea (Event--AAT709A) 3 4 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, https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Lagos_Nigeria_10-20-2021.
    \4\ https://sciencenigeria.com/pbr-cowpea-revolutionising-nigerias-food-production-nabda-boss/.
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    3. Should Wheat (Event--HB4) 5 6 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, https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Buenos%20Aires_Argentina_10-20-2021.
    \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),7 8 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, https://www.irri.org/news-and-events/news/philippines-approves-golden-rice-direct-use-food-and-feed-or-processing.
    \8\ https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Manila_Philippines_RP2022-0058.pdf.
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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\ https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=NewPlantVarietyConsultations&id=DelRos1-N.
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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\ https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=236.
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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]
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