Notice2025-10226

State University of New York College of Environmental Science and Forestry; Availability of a Revised Petition, Draft Environmental Impact Statement, and Draft Plant Pest Risk Assessment for Determination of Nonregulated Status for Blight-Tolerant Darling 54 American Chestnut (Castanea dentata) Developed Using Genetic Engineering

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 6, 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 prepared a revised draft environmental impact statement (EIS) and revised draft plant pest risk assessment (PPRA) evaluating the potential environmental impacts and plant pest risk that may result from the approval of a petition for nonregulated status for blight-tolerant American chestnut (Castanea dentata) from the State University of New York College of Environmental Science and Forestry. The trees have been developed using genetic engineering to express an oxalate oxidase enzyme from wheat as a defense against the fungal pathogen Cryphonectria parasitica, making American chestnut tolerant to chestnut blight. Based on a revised petition submitted by the State University of New York College of Environmental Science and Forestry, we have revised the draft EIS and draft PPRA. We are making the revised petition, revised draft EIS, and revised draft PPRA available for public review and comment.

Full Text

<html>
<head>
<title>Federal Register, Volume 90 Issue 108 (Friday, June 6, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 108 (Friday, June 6, 2025)]
[Notices]
[Pages 24090-24091]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-10226]


========================================================================
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. 108 / Friday, June 6, 2025 / 
Notices

[[Page 24090]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2020-0030]


State University of New York College of Environmental Science and 
Forestry; Availability of a Revised Petition, Draft Environmental 
Impact Statement, and Draft Plant Pest Risk Assessment for 
Determination of Nonregulated Status for Blight-Tolerant Darling 54 
American Chestnut (Castanea dentata) Developed Using Genetic 
Engineering

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability.

-----------------------------------------------------------------------

DATES: We will consider all comments that we receive on or before July 
21, 2025.
SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service has prepared a revised draft environmental impact 
statement (EIS) and revised draft plant pest risk assessment (PPRA) 
evaluating the potential environmental impacts and plant pest risk that 
may result from the approval of a petition for nonregulated status for 
blight-tolerant American chestnut (Castanea dentata) from the State 
University of New York College of Environmental Science and Forestry. 
The trees have been developed using genetic engineering to express an 
oxalate oxidase enzyme from wheat as a defense against the fungal 
pathogen Cryphonectria parasitica, making American chestnut tolerant to 
chestnut blight. Based on a revised petition submitted by the State 
University of New York College of Environmental Science and Forestry, 
we have revised the draft EIS and draft PPRA. We are making the revised 
petition, revised draft EIS, and revised draft PPRA available for 
public review and comment.

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-2020-0030 in the Search field and select the Documents tab.
    <bullet> 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, draft environmental impact statement, and draft plant 
pest risk assessment, and any comments we receive on this docket may be 
viewed at <a href="http://regulations.gov">regulations.gov</a> 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, draft environmental impact statement, and draft plant 
pest risk 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 19-309-01p.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Pearson, Biotechnology 
Regulatory Services, APHIS, USDA, 4700 River Road, Unit 147, Riverdale, 
MD 20737-1236; (301) 851-3944; email: <a href="/cdn-cgi/l/email-protection#e2838e838ccc92878390918d8ca297918683cc858d94"><span class="__cf_email__" data-cfemail="72131e131c5c02171300011d1c32070116135c151d04">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

Background

    Under the authority of the plant pest provisions of the Plant 
Protection Act, as amended (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 altered or produced through genetic 
engineering that are plant pests or that there is reason to believe are 
plant pests.
    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.
    In 2020, APHIS received a petition from the State University of New 
York College of Environmental Science and Forestry (ESF) (APHIS 
Petition Number 19-309-01p) seeking a determination of nonregulated 
status for blight-tolerant Darling 58 American chestnut (Castanea 
dentata). The petition stated that Darling 58 American chestnut 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 
regulated organisms, APHIS accepts written comments regarding a 
petition once APHIS deems it complete. On August 19, 2020, we announced 
in the Federal Register (85 FR 51008-51009, Docket No. APHIS-2020-0030) 
the availability of the blight-tolerant chestnut petition for public 
comment. We solicited comments on the petition for 60 days to help us 
identify potential environmental and interrelated economic issues and 
impacts that APHIS should consider in evaluation of the petition. We 
received 4,320 comments on the petition from the academic sector, 
farmers, non-governmental organizations, nonprofit organizations, 
industry, Tribes, and unaffiliated individuals.
    As part of our evaluation of the petition and consideration of 
public comments, APHIS determined that the proposed determination of 
nonregulated status has the potential to significantly affect the 
quality of the human environment.\1\ In a notice \2\ published in the 
Federal Register on August 6, 2021

[[Page 24091]]

(86 FR 43160-43162, Docket No. APHIS-2020-0030), we announced our 
intention to prepare an environmental impact statement (EIS) to conduct 
a detailed and rigorous environmental analysis to inform its decision 
about the proposed determination of nonregulated status for Darling 58 
American chestnut.
---------------------------------------------------------------------------

    \1\ Human environment means comprehensively the natural and 
physical environment and the relationship of present and future 
generations of Americans with that environment. Impacts/effects 
include ecological (such as effects on natural resources, and on the 
components, structures, and functioning of affected ecosystems), 
aesthetic, historic, cultural, economic (such as the effects on 
employment), social, or health effects (see 40 CFR 1508.1).
    \2\ To view the notice and the comments we received, go to 
<a href="http://www.regulations.gov">www.regulations.gov</a> and enter APHIS-2020-0030 in the Search field.
---------------------------------------------------------------------------

    APHIS solicited public comment on the notice for a period of 30 
days ending September 7, 2021, as part of its scoping process to 
identify issues to address in the draft EIS. We received a total of 
3,964 public comments.
    On November 10, 2022, we published in the Federal Register (87 FR 
67861-67862, Docket No. APHIS-2020-0030) a notice of availability \3\ 
of a draft EIS and draft plant pest risk assessment (PPRA) and made the 
documents available for review and comment for 45 days. A notice of 
availability of the draft EIS was also published by the U.S. 
Environmental Protection Agency (EPA) in the Federal Register on 
November 10, 2022 (87 FR 67901, Docket No. FRL OP-OFA-043).
---------------------------------------------------------------------------

    \3\ To view the notice, supporting documents, and the comments 
that we received, go to <a href="http://www.regulations.gov">www.regulations.gov</a> and enter APHIS-2020-
0030 in the Search field.
---------------------------------------------------------------------------

    Comments on the draft EIS and draft PPRA were required to be 
received on or before December 27, 2022. We extended the comment period 
for an additional 30 days, to January 26, 2023, to allow interested 
persons additional time to prepare and submit comments.
    Subsequently, in August 2024, ESF submitted a revised petition to 
provide additional clarifications and corrections about the chestnut 
event. In January 2020, ESF initially submitted a petition referring to 
Darling 58 instead of Darling 54. These two lines were produced at the 
same time, using the same transgenes in the same genetic background, so 
they express the same protein products. Multiple analyses in 2023 
revealed that essentially all the offspring from the initial crosses 
were derived from Darling 54, due to a labeling error in 2016. Since 
nearly all of the phenotypic information in the original petition was 
generated from Darling 54 offspring, a revised petition was submitted 
to correct the line name and provide updates on Darling 54 chestnuts 
based on data collected since the initial submission. As a result of 
the revised petition, APHIS evaluated the new information provided on 
Darling 54 and revised the draft EIS and draft PPRA.
    The issues discussed in the draft EIS were developed by considering 
the public input from the Federal Register notice announcing the 
intention to draft an EIS. APHIS evaluated these issues to analyze the 
potential environmental impacts of a determination of nonregulated 
status for Darling 54 American chestnut and included a discussion of 
these issues in the draft EIS. In addition, although the comments on 
the original draft EIS were for plants thought to be Darling 58 
American chestnut instead of Darling 54, the issues raised would apply 
to both lines. Therefore, APHIS used the comments on the notice of 
intent and integrated the concerns raised into the revised draft EIS.
    APHIS is making available the revised petition, the revised draft 
EIS, and the draft PPRA, for a 45-day public review and comment period. 
The revised petition, the draft EIS, and the draft PPRA are available 
as indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    The draft EIS was prepared in accordance with: (1) The National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.), (2) USDA regulations implementing NEPA (7 CFR part 1b), and (3) 
APHIS' NEPA Implementing Procedures (7 CFR part 372).
    The EPA will publish a separate notice in the Federal Register that 
announces publication of the revised draft EIS for public review.
    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. 2025-10226 Filed 6-5-25; 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 6, 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.