Bayer CropScience: Determination of Nonregulated Status of MON 95275 Maize (Corn)
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Issuing agencies
Abstract
We are advising the public of our determination that MON 95275 maize (corn), which was developed using genetic engineering to produce two insecticidal proteins and a double-stranded RNA transcript to provide protection from feeding damage caused by targeted coleopteran (corn rootworm) insect pests, is no longer considered regulated. Our determination is based on our evaluation of information and data Bayer CropScience submitted in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. This notice announces the availability of our written determination and supporting documents.
Full Text
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<title>Federal Register, Volume 91 Issue 59 (Friday, March 27, 2026)</title>
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[Federal Register Volume 91, Number 59 (Friday, March 27, 2026)]
[Notices]
[Pages 14805-14806]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05978]
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Notices
Federal Register
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This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
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Federal Register / Vol. 91, No. 59 / Friday, March 27, 2026 /
Notices
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2025-0021]
Bayer CropScience: Determination of Nonregulated Status of MON
95275 Maize (Corn)
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that MON 95275
maize (corn), which was developed using genetic engineering to produce
two insecticidal proteins and a double-stranded RNA transcript to
provide protection from feeding damage caused by targeted coleopteran
(corn rootworm) insect pests, is no longer considered regulated. Our
determination is based on our evaluation of information and data Bayer
CropScience submitted in its petition for a determination of
nonregulated status, available scientific data, the plant pest risk
assessment, and public comments received in response to a previous
notice announcing the availability of the petition for nonregulated
status and a draft plant pest risk assessment. This notice announces
the availability of our written determination and supporting documents.
DATES: This change in regulatory status is recognized as of March 19,
2026.
ADDRESSES: You may read the petition, our determination referenced in
this notice, and supporting documents by any of the following methods:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2025-0021 in the Search field.
<bullet> Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2025-0021, Regulatory Analysis and Development, PPD,
APHIS, 5601 Sunnyside Ave. #AP760, Beltsville, MD 20705.
<bullet> Our reading room, located in 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.
FOR FURTHER INFORMATION CONTACT: Mr. Alan Pearson, Biotechnology
Regulatory Services, APHIS, USDA, 5601 Sunnyside Avenue, AP100-3-WS-
1151, Beltsville, MD 20705; (301) 851-3944; email:
<a href="/cdn-cgi/l/email-protection#94f5f8f5fabae4f1f5e6e7fbfad4e1e7f0f5baf3fbe2"><span class="__cf_email__" data-cfemail="62030e030c4c12070310110d0c22171106034c050d14">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (7 U.S.C. 7701-7772, 7781-7786)
and the regulations in 7 CFR part 340, ``Introduction of Organisms and
Products Altered or Produced Through Genetic Engineering Which Are
Plant Pests or Which There Is Reason to Believe Are Plant Pests,''
APHIS regulates, among other things, the introduction (importation,
interstate movement, or release into the environment) of organisms and
products altered or produced through genetic engineering that are plant
pests or that there is reason to believe are plant pests. Such
organisms and products are considered ``regulated articles.''
Section 340.6(a) of the regulations provides that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340.
APHIS received a petition (APHIS Petition Number 25-083-01p) from
Bayer CropScience (Bayer) seeking a determination of nonregulated
status for MON 95275 maize (corn), which has been developed using
genetic engineering to produce two insecticidal proteins and a double-
stranded RNA transcript to provide protection from feeding damage
caused by targeted coleopteran (corn rootworm) insect pests. The
petition provides information in support of petitioners' position that
MON 95275 is unlikely to pose a plant pest risk and therefore should
not be regulated under APHIS' regulations in 7 CFR part 340.
As part of our decision-making process regarding the organism's
regulatory status, APHIS prepared a draft plant pest risk assessment
(PPRA) to assess the plant pest risk of the organism.
APHIS published the petition and draft PPRA in the Federal Register
[90 FR 30035, APHIS-2025-0021] and accepted public comments from July
8, 2025, through September 8, 2025. APHIS received 11 comments by the
close of the comment period. No comments addressed the PPRA. Five
comments from individuals stated general opposition to genetic
engineering. These comments are non-substantive and will not be
addressed further. One comment specifically opposed deregulating the
product and also expressed concerns related to deregulation
contributing to carbon dioxide (CO<INF>2</INF>) emissions. This comment
is addressed in our response to comments. One comment remained neutral
regarding the petition, but also expressed concerns related to
deregulation contributing to CO<INF>2</INF> emissions. This comment is
also addressed in our response to comments. The remaining four comments
from non-government organizations expressed support in the deregulation
of the corn. We note the support expressed by these commenters to
deregulate the corn for the record.
Determination
Based on APHIS' evaluation in the PPRA of information and data
submitted by Bayer in its petition, available scientific data, and
public comments received in response to the petition and draft PPRA,
APHIS has determined that MON 95275 is unlikely to pose a greater plant
pest risk than the unmodified comparator and therefore is no longer
subject to the regulations in 7 CFR part 340 governing the introduction
of certain organisms developed using genetic engineering.
Copies of the signed determination, PPRA, and response to comments,
as well as the previously published petition and supporting documents,
are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION
CONTACT sections of this notice.
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR
2.22, 2.80, and 371.3.
[[Page 14806]]
Done in Washington, DC, this 25th day of March 2026.
Kelly Moore,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2026-05978 Filed 3-26-26; 8:45 am]
BILLING CODE 3410-34-P
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