[Federal Register Volume 90, Number 105 (Tuesday, June 3, 2025)]
[Notices]
[Pages 23513-23514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10075]
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Notices
Federal Register
________________________________________________________________________
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
appearing in this section.
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Federal Register / Vol. 90, No. 105 / Tuesday, June 3, 2025 /
Notices
[[Page 23513]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0113]
Bayer U.S.-Crop Science: Availability of a Draft Plant Pest Risk
Assessment and Draft Environmental Assessment for Lepidopteran-
Protected Maize
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a draft plant pest risk assessment and
draft environmental assessment regarding a petition from Bayer U.S.-
Crop Science seeking a determination of nonregulated status for maize
(corn) event MON 95379 which 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
draft plant pest risk assessment, and draft environmental assessment
available for public review and comment.
DATES: We will consider all comments that we receive on or before July
3, 2025.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to www.regulations.gov.
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 2C-10.16, Unit 25, 4700 River Road, Unit 25, Riverdale,
MD 20737-1238.
The draft plant pest risk assessment, draft environmental
assessment, and any comments we receive on this docket may be viewed at
www.regulations.gov, or in our reading room, which is 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.
The draft plant pest risk assessment and draft environmental
assessment are also available on the APHIS website at: https://www.aphis.usda.gov/biotechnology/legacy-petition-process/petitions.
Search for APHIS petition 20-205-01p.
FOR FURTHER INFORMATION CONTACT: Mr. Alan Pearson, Biotechnology
Regulatory Services, APHIS, USDA, 4700 River Road, Unit 78, Riverdale,
MD 20737-1236; (301) 851-3944; 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, ``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,'' regulate, 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.''
The regulations in Sec. 340.6(a) provide 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. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 20-205-01p)
from Bayer U.S.-Crop Science (Bayer) seeking a determination of
nonregulated status for MON 95379 corn which has been developed using
genetic engineering to produce two insecticidal proteins to protect
against feeding damage caused by target lepidopteran pests. The
petition states that the information provided 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.
According to our process for soliciting public comment when
considering petitions for determination of nonregulated status of
organisms developed using genetic engineering, APHIS accepts written
comments regarding a petition once APHIS deems the petition complete.
On March 4, 2024, APHIS announced in the Federal Register (89 FR 15542,
Docket No. APHIS-2020-0113)the availability of the Bayer's petition for
public comment. APHIS solicited comments on the petition for 60 days
ending May 3, 2024.
APHIS received 5 comments during the comment period. They were from
the agricultural, academic, and private sectors. Four comments were
general opposition to deregulating MON 95379 and did not provide any
substantive information that contributed to the development of this
draft Environmental Assessment (EA). One commenter supported the
petition and submitted a recommendation letter.
As part of our decision-making process regarding the organism's
regulatory status, APHIS has prepared a draft plant pest risk
assessment (PPRA) to assess the plant pest risk of the organism and a
draft EA to evaluate potential impacts on the human environment that
may result if the petition request is approved.
APHIS' draft PPRA compared the plant pest risk posed by the MON
95379 corn with that of the unmodified variety from which it was
derived. The draft PPRA concluded that MON 95379 corn is unlikely to
pose an increased plant pest risk compared to the unmodified corn.
The draft EA evaluated potential impacts that may result from the
commercial production of MON 95379 corn, to include potential impacts
on conventional and organic corn production; the acreage and area
required for U.S. corn production; agronomic practices and inputs; the
physical environment; biological resources; human health and worker
safety; and animal health and welfare.
The draft EA also explains that Bayer has registered MON 95379 with
the Environmental Protection Agency
[[Page 23514]]
(EPA). The registration is restricted to breeding and seed increases
only; commercial plantings will not be permitted. Regardless of APHIS'
decision on this petition, EPA registration limits MON 95739 to small-
scale breeding, testing, and seed increase nurseries, in the United
States, to no more than 100 total acres across NE, HI, and IA.
APHIS applied USDA's regulation at 7 CFR part 1b, and APHIS'
National Environmental Policy Act (NEPA) implementing regulations (7
CFR part 372), when preparing this draft EA.
In accordance with Sec. 340.6(d), we are publishing this notice to
inform the public that APHIS will accept written comments regarding the
draft PPRA and draft EA from interested or affected persons for a
period of 30 days from the date of this notice. The draft PPRA and
draft EA are 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 particularly interested in receiving comments regarding biological
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 and evaluate any
information received during the comment period and any other relevant
information. After reviewing and evaluating the comments and other
information, APHIS will prepare a final PPRA and EA. Based on the final
EA, APHIS will prepare a NEPA decision document (either a Finding of No
Significant Impact (FONSI) or a notice of intent to prepare an
environmental impact statement). If a FONSI is reached, APHIS will
furnish a response to the petitioner, either approving or denying the
petition. APHIS will also publish a notice in the Federal Register
announcing the regulatory status of the modified plant and the
availability of APHIS' final EA, PPRA, FONSI, and our regulatory
determination.
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 29th day of May 2025.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2025-10075 Filed 6-2-25; 8:45 am]
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