[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