[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 http://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