[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Proposed Rules]
[Pages 44791-44792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14933]
[[Page 44791]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 66
[Document No. AMS-FTPP-20-0057]
National Bioengineered Food Disclosure Standard; Updates to the
List of Bioengineered Foods
ACTION: Request for comments.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) of the Department of
Agriculture (USDA) is soliciting comments and feedback on
recommendations to update the List of Bioengineered Foods (List) as it
pertains to the National Bioengineered Food Disclosure Standard
(Standard).
DATES: Comments are due by August 24, 2020.
ADDRESSES: We invite you to submit written comments via the internet at
http://www.regulations.gov. All comments should refer to the date and
page number of this issue of the Federal Register. 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 http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Trevor Findley, Deputy Director, Food
Disclosure and Labeling Division, Fair Trade Practices Program,
Agricultural Marketing Service, U.S. Department of Agriculture,
telephone (202) 690-3460, email [email protected].
SUPPLEMENTARY INFORMATION:
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 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 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, include the AMS List of
Bioengineered Foods (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 final rule, at 83 FR 65852, the List
``establishes a presumption about what foods might require disclosure
under the NBFDS, 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 the List, a regulated entity must make
a bioengineered food disclosure if they have actual knowledge a food or
ingredient they are using is a bioengineered food or a bioengineered
food ingredient.
As stated in 7 CFR 66.7(a), AMS will review and consider updates to
the List on an annual basis and will solicit recommendations regarding
updates to the List through notification in the Federal Register and on
the AMS website. The regulations 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), and 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 proposed 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.
(5) If AMS determines that an update to the List is appropriate
following its review of all relevant information provided, AMS will
modify the List.
In addition to seeking public recommendations generally regarding
the entries on the List, AMS is specifically seeking public comment on
the recommendations listed below.
Additions to the List
As required by 7 CFR 66.7(a)(4), AMS will consider two criteria
when identifying food to add to the List: (1) Whether the food proposed
for inclusion on the List has been authorized for commercial production
somewhere in the world, and (2) whether that food is currently in legal
commercial production for human food somewhere in the world.
For the first criterion, AMS considers a food to have been
authorized for commercial production when it has cleared all the legal
requirements necessary to be produced in that country. If multiple
authorizations are required before a food can be commercially produced,
AMS would not consider that food to have been authorized for commercial
production until it has completed all such authorizations. For the
second criterion, AMS will look to see if the food that has been
authorized for commercial production actually is in legal commercial
production for use as human food.
Based on publicly available information, AMS currently believes
there is at least one crop that meets the dual criteria required by 7
CFR 66.7(a)(4). AMS believes that sugarcane is (1) Authorized for
commercial production somewhere in the world and (2) currently in legal
commercial production for human food somewhere in the world.
1. Sugarcane: AMS believes that Brazil approved bioengineered
sugarcane for commercial release and that bioengineered sugar cane is
currently in legal commercial production.\1\ The sugarcane was
developed using recombinant DNA technology to be insect-resistant to
help control sugarcane borer infestations. Brazil approved the
bioengineered sugarcane for commercial production in
[[Page 44792]]
2018 and planted approximately 4,000 hectares for commercial production
in the 2018/2019 crop year.\2\ As a result, AMS believes that sugarcane
should be added to the List. Consistent with other items on the List,
AMS would initially propose that sugarcane include ``(insect-resistant
\3\)'' because there is currently only one bioengineered trait used in
sugarcane production. As stated in the preamble to the final rule,\4\
if other BE versions of listed foods are authorized and become legally
available, AMS would revise the listing during the annual update
process to be more generic. Therefore, AMS seeks comment on whether it
should undertake rulemaking to add ``Sugarcane (insect-resistant)'' to
the List.
---------------------------------------------------------------------------
\1\ Agricultural Biotechnology Annual--2018, [Brazil--
Agricultural Biotechnology Report] https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Brasilia_Brazil_12-26-2018.
\2\ Agricultural Biotechnology Annual--2019, [Brazil--
Agricultural Biotechnology Report] https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Brasilia_Brazil_10-20-2019.
\3\ Consultations on Food from New Plant Varieties, https://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon&id=CTC175-A.
\4\ 83 FR 65819.
---------------------------------------------------------------------------
Amendments to the List
1. Squash (summer): Squash (summer) is currently included on the
List but AMS proposes to add an additional modifier to reflect that the
only trait for bioengineered summer squash that is currently available
is virus-resistance.\5\ Therefore, AMS would add ``virus-resistant'' to
the existing modifier ``summer,'' so that squash on the list would read
``Squash (summer, virus-resistant).'' This change would be consistent
with the treatment of other items on the list, where modifiers are
included when only one bioengineered trait is available, as is the case
with eggplant, papaya, and pineapple. Therefore, AMS seeks comment on
whether it should add ``virus-resistant'' as a modifier to the existing
entry of ``Squash (summer).''
---------------------------------------------------------------------------
\5\ Consultations on Food from New Plant Varieties, https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=Biocon&id=SEM%2D0CZW3%2D2, Consultations on Food from
New Plant Varieties, https://www.accessdata.fda.gov/scripts/fdcc/index.cfm?set=Biocon&id=SEM%2D0ZW20%2D7.
---------------------------------------------------------------------------
Other Foods Considered for Addition to the List
In its research, AMS identified several bioengineered foods that
are at various stages of authorization or have been authorized for
commercial production but are not yet in legal commercial production
for human food. Although AMS believes these bioengineered foods do not
yet meet the criteria in 7 CFR 66.7(a)(4) to be added to the List, AMS
is seeking public comment to determine if additional information is
publicly available.
1. Cowpea: Nigeria recently authorized the commercial release of
pod-borer resistant cowpea (Event--AAT709A), bioengineered for
lepidopteran insect pest (Maruca vitrata) resistance.\6\ AMS seeks
comment on whether cowpea is in legal commercial production for human
food, or would be in legal commercial production for human food when
AMS initiates the rulemaking process.\7\ If cowpea is added to the
List, AMS also seeks comment on whether the addition should include any
modifiers that would more accurately describe the type of cowpea that
is bioengineered, such as pod-borer resistant cowpea or insect
resistant cowpea.
---------------------------------------------------------------------------
\6\ Agricultural Biotechnology Annual--2019, Nigeria Approves
the Commercial Release of Bt. Pod-Borer Resistant Cowpea https://apps.fas.usda.gov/newgainapi/api/Report/DownloadReportByFileName?fileName=Agricultural%20Biotechnology%20Annual_Lagos_Nigeria_5-21-2019
\7\ Pod-borer Resistant Cowpea Project, https://www.aatf-africa.org/wp-content/uploads/2019/06/Cowpea-Project.pdf, Event Name
AAT709A, https://www.isaaa.org/gmapprovaldatabase/event/default.asp?EventID=543&Event=AAT709A.
---------------------------------------------------------------------------
2. Rice: AMS is aware that the Philippine Department of Agriculture
approved the safety of bioengineered rice (Event--GR2E, Production of
provitamin A carotenoids), also known as golden rice, for use as human
food.\8\ While this approval has to do with the safety of the rice as
human food, the rice is not yet authorized for commercial production.
Because this rice has not yet been authorized for commercial release
and is not in legal commercial production, it does not meet the
criteria identified in 7 CFR 66.7(a)(4) and AMS is not recommending it
be added to the List. AMS seeks comment on its understanding of the
current status of this rice.
---------------------------------------------------------------------------
\8\ 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.
---------------------------------------------------------------------------
After completing its research, AMS has not identified any other
foods that it believes would meet the criteria to be included on the
List. AMS requests public comment on any other foods not mentioned
above that it should consider for addition to the List.
Any comments not directly related to the addition, deletion or
modification of the potential items for the List will not be considered
nor will recommendations that are not accompanied by data and other
information to support the recommended action. After reviewing the
comments on this notice, AMS will determine whether it should initiate
rulemaking to update the List. Any changes to the regulations would be
reflected in an amendment to the regulations found at 7 CFR part 66. As
stated at 7 CFR 66.7(b), regulated entities would 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 7 CFR part 66.
Authority: 7 U.S.C. 1621 et seq.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2020-14933 Filed 7-23-20; 8:45 am]
BILLING CODE P