Notice2025-10138
Ishihara Sangyo Kaisha, Limited: Availability of a Petition for a Determination of Nonregulated Status, Draft Plant Pest Risk Assessment, and Draft Environmental Assessment for ISK-311NR-4 Phalaenopsis (Moth Orchid)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 4, 2025
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are advising the public that the Animal and Plant Health Inspection Service has received a petition from Ishihara Sangyo Kaisha, Limited seeking a determination of nonregulated status for ISK-311NR-4 Phalaenopsis (moth orchid) which has been developed using genetic engineering to produce a blue-purple flower color. We are making the petition, draft plant pest risk assessment, and draft environmental assessment available for public review and comment.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 106 (Wednesday, June 4, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 106 (Wednesday, June 4, 2025)]
[Notices]
[Pages 23666-23667]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10138]
========================================================================
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.
========================================================================
Federal Register / Vol. 90, No. 106 / Wednesday, June 4, 2025 /
Notices
[[Page 23666]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2025-0005]
Ishihara Sangyo Kaisha, Limited: Availability of a Petition for a
Determination of Nonregulated Status, Draft Plant Pest Risk Assessment,
and Draft Environmental Assessment for ISK-311NR-4 Phalaenopsis (Moth
Orchid)
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has received a petition from Ishihara Sangyo Kaisha,
Limited seeking a determination of nonregulated status for ISK-311NR-4
Phalaenopsis (moth orchid) which has been developed using genetic
engineering to produce a blue-purple flower color. We are making the
petition, 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
August 4, 2025.
ADDRESSES: You may submit comments by either of the following methods:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2025-0005 in the Search field. Select the Documents tab,
then select the Comment button in the list of documents.
<bullet> Postal Mail/Commercial Delivery: Send your comment to
Docket No. APHIS-2025-0005, Regulatory Analysis and Development, PPD,
APHIS, Station 2C-10.16, Unit 25, 4700 River Road Unit 25, Riverdale,
MD 20737-1238.
The petition, draft plant pest risk assessment, draft environmental
assessment, and any comments we receive on this docket may be viewed at
<a href="http://www.regulations.gov">www.regulations.gov</a>, 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 petition, draft plant pest risk assessment, and draft
environmental assessment are also available on the APHIS website at:
<a href="https://www.aphis.usda.gov/biotechnology/legacy-petition-process/petitions">https://www.aphis.usda.gov/biotechnology/legacy-petition-process/petitions</a>. Search for APHIS petition 25-062-01p.
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: <a href="/cdn-cgi/l/email-protection#fd9c919c93d38d989c8f8e9293bd888e999cd39a928b"><span class="__cf_email__" data-cfemail="02636e636c2c72676370716d6c42777166632c656d74">[email protected]</span></a>.
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 25-062-01p)
from Ishihara Sangyo Kaisha, Limited seeking a determination of
nonregulated status for ISK-311NR-4 Phalaenopsis (moth orchid) which
has been developed using genetic engineering to produce blue-purple
flower color. The petition states that the information provided
indicates that ISK-311NR-4 Phalaenopsis 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, and a draft
environmental assessment (EA) to evaluate potential impacts on the
human environment that may result if the petition request is approved.
APHIS' draft PPRA compared the pest risk posed by the ISK-311NR-4
Phalaenopsis with that of the unmodified variety from which it was
derived. The draft PPRA concluded that ISK-311NR-4 Phalaenopsis is
unlikely to pose an increased plant pest risk compared to the
unmodified moth orchid.
The draft EA evaluated potential impacts that may result from the
commercial production of ISK-311NR-4 Phalaenopsis, to include potential
impacts on conventional moth orchid production; the acreage and area
required for U.S. moth orchid production; agronomic practices and
inputs; the physical environment; biological resources; human health
and worker safety; and animal health and welfare. APHIS applied USDA'
regulation at 7 CFR part 1b, and APHIS' National Environmental Policy
Act (NEPA) implementing regulations (7 CFR part 372), when preparing
this draft EA.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment on
petitions for a determination of nonregulated status. In accordance
with Sec. 340.6(d), we are publishing this notice to inform the public
that APHIS will accept written comments regarding the petition, draft
PPRA, and draft EA from interested or affected persons for a period of
60 days from the date of this notice. The petition, 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
[[Page 23667]]
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 28th day of May 2025.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2025-10138 Filed 6-3-25; 8:45 am]
BILLING CODE 3410-34-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 4, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.