Bayer U.S.-Crop Science: Availability of a Petition for a Determination of Nonregulated Status for Lepidopteran-Protected Maize, 15542-15543 [2024-04395]
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Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices
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DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
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VerDate Sep<11>2014
17:45 Mar 01, 2024
Jkt 262001
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Acting USDA Committee Management
Officer.
[FR Doc. 2024–04515 Filed 3–1–24; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2020–0113]
Bayer U.S.-Crop Science: Availability
of a Petition for a Determination of
Nonregulated Status for LepidopteranProtected Maize
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has received a
petition from Bayer U.S.-Crop Science
seeking a determination of nonregulated
status for maize (corn) event MON
95379 that has been developed using
genetic engineering to produce two
insecticidal proteins to protect against
feeding damage caused by target
lepidopteran pests. We are making the
petition available for review and
comment to help us identify potential
issues and impacts that we may
SUMMARY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
determine should be considered in our
evaluation of the petition.
DATES: We will consider all comments
that we receive on or before May 3,
2024.
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and enter
APHIS–2020–0113 in the Search field.
Select the Documents tab, then select
the Comment button in the list of
documents.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2020–0113, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road, Unit 118,
Riverdale, MD 20737–1238.
The petition and any comments we
receive on this docket may be viewed at
www.regulations.gov by entering
APHIS–2020–0113 in the Search field,
or in our reading room, which is located
in Room 1620 of the USDA South
Building, 14th Street and Independence
Avenue SW, Washington, DC. Normal
reading room hours are 8 a.m. to 4:30
p.m., Monday through Friday, except
holidays. To be sure someone is there to
help you, please call (202) 799–7039
before coming.
The petition is also available on the
APHIS website at: https://www.aphis.
usda.gov/aphis/ourfocus/biotechnology/
regulatory-processes/petitions/petitionstatus/petitions-table. Search for APHIS
petition 20–205–01p.
FOR FURTHER INFORMATION CONTACT: Mr.
Subray Hegde, Biotechnology
Regulatory Services, APHIS, 4700 River
Road, Unit 147, Riverdale, MD 20737–
1238; (301) 851–3901; email: subray.
hegde@usda.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of the plant pest provisions of
the Plant Protection Act (7 U.S.C. 7701
et seq.), the regulations in 7 CFR part
340, ‘‘Movement of Organisms Modified
or Produced Through Genetic
Engineering,’’ regulate, among other
things, the importation, interstate
movement, or release into the
environment of organisms modified or
produced through genetic engineering
that are plant pests or pose a plausible
plant pest risk.
The petition for nonregulated status
described in this notice is being
evaluated under the version of the
regulations effective at the time that it
was received. The Animal and Plant
Health Inspection Service (APHIS)
issued a final rule, published in the
Federal Register on May 18, 2020 (85
FR 29790–29838, Docket No. APHIS–
ADDRESSES:
E:\FR\FM\04MRN1.SGM
04MRN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 43 / Monday, March 4, 2024 / Notices
2018–0034),1 revising 7 CFR part 340;
however, the final rule was
implemented in phases. The new
Regulatory Status Review (RSR) process,
which replaces the petition for
determination of nonregulated status
process, became effective on April 5,
2021, for corn, soybean, cotton, potato,
tomato, and alfalfa. The RSR process
was effective for all crops as of October
1, 2021. However, ‘‘[u]ntil RSR is
available for a particular crop . . .
APHIS will continue to receive petitions
for determination of nonregulated status
for the crop in accordance with the
[legacy] regulations at 7 CFR 340.6.’’ (85
FR 29815). This petition for a
determination of nonregulated status is
being evaluated in accordance with the
regulations at 7 CFR 340.6 (2020) as it
was originally received by APHIS on
July 23, 2020.
Bayer U.S.-Crop Science (Bayer) has
submitted a petition (APHIS Petition
Number 20–205–01p) to APHIS seeking
a determination of nonregulated status
of maize (corn) designated as MON
95379, which has been developed using
genetic engineering for resistance to
feeding damage caused by target
lepidopteran pests, including fall
armyworm (Spodoptera frugiperda),
sugarcane borer (Diatraea saccharalis),
and corn earworm (Helicoverpa zea).
We are making the Bayer petition
available for public comment and
requesting public input regarding
potential issues and impacts that APHIS
should be considering in our evaluation
of the petition. The Bayer petition states
that information collected during field
trials and laboratory analyses indicates
that MON 95379 corn is unlikely to pose
a plant pest risk and therefore should
not be regulated under APHIS’
regulations in 7 CFR part 340.
As described in the Bayer petition,
MON 95379 corn was developed to
produce two insecticidal proteins,
Cry1B.868 and Cry1Da_7, which protect
against feeding damage caused by
targeted lepidopteran insect pests.
Cry1B.868 is a chimeric protein
comprised of domains I and II from
Cry1Be (Bacillus thuringiensis, Bt),
domain III from Cry1Ca (Bt subsp.
aizawai) and C-terminal protoxin
domain from Cry1Ab (Bt subsp.
kurstaki). Cry1Da_7 is a modified
Cry1Da protein derived from Bt subsp.
aizawai.
MON 95379 corn was developed to
provide growers in South America an
additional tool for controlling target
1 To
view the final rule, go to
www.regulations.gov and enter APHIS–2018–0034
in the Search field.
VerDate Sep<11>2014
17:45 Mar 01, 2024
Jkt 262001
lepidopteran corn pests, including fall
armyworm resistant to current Bt
technologies. MON 95379 corn will be
combined through traditional breeding
with other deregulated traits to provide
protection against both above-ground
and below-ground corn pests, as well as
herbicide tolerance. These nextgeneration, combined-trait corn
products will offer broader grower
choice, improved production efficiency,
increased pest control durability, and
enhanced grower profit potential. MON
95379 corn will not be commercialized
in the United States but is intended to
only be cultivated in small-scale
breeding, testing, and seed increase
nurseries to develop seed of products
that will be sold in other countries,
primarily in South America.
Field tests conducted under APHIS
oversight allowed for evaluation of
MON 95379 corn in a natural
agricultural setting while imposing
measures to minimize the likelihood of
persistence in the environment after
completion of the tests. Data are
gathered on multiple parameters and
used by the applicant to evaluate
agronomic characteristics and product
performance. These and other data are
used by APHIS to determine if the new
variety poses a plant pest risk.
On March 6, 2012, we published in
the Federal Register (77 FR 13258–
13260, Docket No.APHIS–2011–0129) a
notice 2 describing our process for
soliciting public comment when
considering petitions for determinations
of nonregulated status for organisms
developed using genetic engineering. In
that notice, we indicated that APHIS
would accept written comments
regarding a petition once APHIS
deemed it complete.
In accordance with our process for
soliciting public input when
considering petitions for determinations
of nonregulated status for organisms
developed using genetic engineering, we
are publishing this notice to inform the
public that APHIS will accept written
comments regarding the petition for a
determination of nonregulated status
from interested or affected persons for a
period of 60 days from the date of this
notice. The petition is available for
public review and comment, and copies
are available as indicated under
2 On March 6, 2012, APHIS published in the
Federal Register (77 FR 13258–13260, Docket No.
APHIS–2011–0129) a notice describing our public
review process for soliciting public comments and
information when considering petitions for
determinations of nonregulated status for organisms
developed using genetic engineering. To view the
notice, go to www.regulations.gov and enter APHIS–
2011–0129 in the Search field.
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
15543
ADDRESSES and from the individual
listed under the FOR FURTHER
INFORMATION CONTACT section of this
notice. We are interested in receiving
comments regarding potential
environmental and interrelated
economic issues and impacts that
APHIS may determine should be
considered in our evaluation of the
petition. We are particularly interested
in receiving comments regarding
biological, cultural, or ecological issues,
and we encourage the submission of
scientific data, studies, or research to
support your comments.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. Any
substantive issues identified by APHIS
based on our review of the petition and
our evaluation and analysis of
comments will be considered in the
development of our decision-making
documents. As part of our decisionmaking process regarding the regulatory
status of an organism developed using
genetic engineering, APHIS prepares a
plant pest risk assessment to assess its
plant pest risk and the appropriate
environmental documentation—either
an environmental assessment (EA) or an
environmental impact statement (EIS)—
in accordance with the National
Environmental Policy Act (NEPA), to
provide the Agency with a review and
analysis of any potential environmental
impacts associated with the petition
request. For petitions for which APHIS
prepares an EA, APHIS will follow our
published process for soliciting public
comment (see footnote 2) and publish a
separate notice in the Federal Register
announcing the availability of APHIS’
EA and plant pest risk assessment.
Should APHIS determine that an EIS is
necessary, APHIS will complete the
NEPA EIS process in accordance with
Council on Environmental Quality
regulations (40 CFR part 1500–1508)
and APHIS’ NEPA implementing
regulations (7 CFR part 372).
Authority: 7 U.S.C. 7701–7772 and
7781–7786; 31 U.S.C. 9701; 7 CFR 2.22,
2.80, and 371.3.
Done in Washington, DC, this 26th day of
February 2024.
Michael Watson,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2024–04395 Filed 3–1–24; 8:45 am]
BILLING CODE 3410–34–P
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15542-15543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04395]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0113]
Bayer U.S.-Crop Science: Availability of a Petition for a
Determination of Nonregulated Status for Lepidopteran-Protected Maize
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Bayer U.S.-Crop Science
seeking a determination of nonregulated status for maize (corn) event
MON 95379 that has been developed using genetic engineering to produce
two insecticidal proteins to protect against feeding damage caused by
target lepidopteran pests. We are making the petition available for
review and comment to help us identify potential issues and impacts
that we may determine should be considered in our evaluation of the
petition.
DATES: We will consider all comments that we receive on or before May
3, 2024.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov and enter APHIS-2020-0113 in the Search field.
Select the Documents tab, then select the Comment button in the list of
documents.
Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2020-0113, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
The petition and any comments we receive on this docket may be
viewed at www.regulations.gov by entering APHIS-2020-0113 in the Search
field, or in our reading room, which is located in Room 1620 of the
USDA South Building, 14th Street and Independence Avenue SW,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 799-7039 before coming.
The petition is also available on the APHIS website at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status/petitions-table. Search for APHIS petition
20-205-01p.
FOR FURTHER INFORMATION CONTACT: Mr. Subray Hegde, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1238; (301) 851-3901; email: [email protected].
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the
regulations in 7 CFR part 340, ``Movement of Organisms Modified or
Produced Through Genetic Engineering,'' regulate, among other things,
the importation, interstate movement, or release into the environment
of organisms modified or produced through genetic engineering that are
plant pests or pose a plausible plant pest risk.
The petition for nonregulated status described in this notice is
being evaluated under the version of the regulations effective at the
time that it was received. The Animal and Plant Health Inspection
Service (APHIS) issued a final rule, published in the Federal Register
on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-
[[Page 15543]]
2018-0034),\1\ revising 7 CFR part 340; however, the final rule was
implemented in phases. The new Regulatory Status Review (RSR) process,
which replaces the petition for determination of nonregulated status
process, became effective on April 5, 2021, for corn, soybean, cotton,
potato, tomato, and alfalfa. The RSR process was effective for all
crops as of October 1, 2021. However, ``[u]ntil RSR is available for a
particular crop . . . APHIS will continue to receive petitions for
determination of nonregulated status for the crop in accordance with
the [legacy] regulations at 7 CFR 340.6.'' (85 FR 29815). This petition
for a determination of nonregulated status is being evaluated in
accordance with the regulations at 7 CFR 340.6 (2020) as it was
originally received by APHIS on July 23, 2020.
---------------------------------------------------------------------------
\1\ To view the final rule, go to www.regulations.gov and enter
APHIS-2018-0034 in the Search field.
---------------------------------------------------------------------------
Bayer U.S.-Crop Science (Bayer) has submitted a petition (APHIS
Petition Number 20-205-01p) to APHIS seeking a determination of
nonregulated status of maize (corn) designated as MON 95379, which has
been developed using genetic engineering for resistance to feeding
damage caused by target lepidopteran pests, including fall armyworm
(Spodoptera frugiperda), sugarcane borer (Diatraea saccharalis), and
corn earworm (Helicoverpa zea). We are making the Bayer petition
available for public comment and requesting public input regarding
potential issues and impacts that APHIS should be considering in our
evaluation of the petition. The Bayer petition states that information
collected during field trials and laboratory analyses indicates that
MON 95379 corn is unlikely to pose a plant pest risk and therefore
should not be regulated under APHIS' regulations in 7 CFR part 340.
As described in the Bayer petition, MON 95379 corn was developed to
produce two insecticidal proteins, Cry1B.868 and Cry1Da_7, which
protect against feeding damage caused by targeted lepidopteran insect
pests. Cry1B.868 is a chimeric protein comprised of domains I and II
from Cry1Be (Bacillus thuringiensis, Bt), domain III from Cry1Ca (Bt
subsp. aizawai) and C-terminal protoxin domain from Cry1Ab (Bt subsp.
kurstaki). Cry1Da_7 is a modified Cry1Da protein derived from Bt subsp.
aizawai.
MON 95379 corn was developed to provide growers in South America an
additional tool for controlling target lepidopteran corn pests,
including fall armyworm resistant to current Bt technologies. MON 95379
corn will be combined through traditional breeding with other
deregulated traits to provide protection against both above-ground and
below-ground corn pests, as well as herbicide tolerance. These next-
generation, combined-trait corn products will offer broader grower
choice, improved production efficiency, increased pest control
durability, and enhanced grower profit potential. MON 95379 corn will
not be commercialized in the United States but is intended to only be
cultivated in small-scale breeding, testing, and seed increase
nurseries to develop seed of products that will be sold in other
countries, primarily in South America.
Field tests conducted under APHIS oversight allowed for evaluation
of MON 95379 corn in a natural agricultural setting while imposing
measures to minimize the likelihood of persistence in the environment
after completion of the tests. Data are gathered on multiple parameters
and used by the applicant to evaluate agronomic characteristics and
product performance. These and other data are used by APHIS to
determine if the new variety poses a plant pest risk.
On March 6, 2012, we published in the Federal Register (77 FR
13258-13260, Docket No.APHIS-2011-0129) a notice \2\ describing our
process for soliciting public comment when considering petitions for
determinations of nonregulated status for organisms developed using
genetic engineering. In that notice, we indicated that APHIS would
accept written comments regarding a petition once APHIS deemed it
complete.
---------------------------------------------------------------------------
\2\ On March 6, 2012, APHIS published in the Federal Register
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing
our public review process for soliciting public comments and
information when considering petitions for determinations of
nonregulated status for organisms developed using genetic
engineering. To view the notice, go to www.regulations.gov and enter
APHIS-2011-0129 in the Search field.
---------------------------------------------------------------------------
In accordance with our process for soliciting public input when
considering petitions for determinations of nonregulated status for
organisms developed using genetic engineering, we are publishing this
notice to inform the public that APHIS will accept written comments
regarding the petition for a determination of nonregulated status from
interested or affected persons for a period of 60 days from the date of
this notice. The petition is available for public review and comment,
and copies are available as indicated under ADDRESSES and from the
individual listed under the FOR FURTHER INFORMATION CONTACT section of
this notice. We are interested in receiving comments regarding
potential environmental and interrelated economic issues and impacts
that APHIS may determine should be considered in our evaluation of the
petition. We are particularly interested in receiving comments
regarding biological, cultural, or ecological issues, and we encourage
the submission of scientific data, studies, or research to support your
comments.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. Any substantive issues identified by APHIS based on our
review of the petition and our evaluation and analysis of comments will
be considered in the development of our decision-making documents. As
part of our decision-making process regarding the regulatory status of
an organism developed using genetic engineering, APHIS prepares a plant
pest risk assessment to assess its plant pest risk and the appropriate
environmental documentation--either an environmental assessment (EA) or
an environmental impact statement (EIS)--in accordance with the
National Environmental Policy Act (NEPA), to provide the Agency with a
review and analysis of any potential environmental impacts associated
with the petition request. For petitions for which APHIS prepares an
EA, APHIS will follow our published process for soliciting public
comment (see footnote 2) and publish a separate notice in the Federal
Register announcing the availability of APHIS' EA and plant pest risk
assessment. Should APHIS determine that an EIS is necessary, APHIS will
complete the NEPA EIS process in accordance with Council on
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS'
NEPA implementing regulations (7 CFR part 372).
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
Done in Washington, DC, this 26th day of February 2024.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2024-04395 Filed 3-1-24; 8:45 am]
BILLING CODE 3410-34-P
