[Federal Register Volume 91, Number 166 (Friday, August 28, 2026)]
[Notices]
[Pages 55510-55511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-17596]
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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: Determination of Nonregulated Status for Blight-Tolerant
Darling 54 American Chestnut (Castanea dentata)
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our determination that Darling
54 American Chestnut (Castanea dentata), which was developed using
genetic engineering for tolerance to the fungal pathogen, Cryphonectria
parasitica, is no longer considered regulated. Our determination is
based on our evaluation of information and data submitted by the State
University of New York College of Environmental Science and Forestry in
its petition for a determination of nonregulated status, available
scientific data, a plant pest risk assessment, and public comments
received in response to previous notices 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 August 28,
2026.
ADDRESSES: You may read the petition, our determination referenced in
this notice, and supporting documents by any of the following methods:
Federal eRulemaking Portal: Go to www.regulations.gov.
Enter APHIS-2020-0030 in the Search field.
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 Ave., AP100,
Beltsville, MD
[[Page 55511]]
20705; (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. 7701-7772, 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.''
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.
On January 21, 2020, APHIS received a petition (APHIS Petition
Number 19-309-01p) from the State University of New York College of
Environmental Science and Forestry (ESF) seeking a determination of
nonregulated status for Darling 58, which was developed using genetic
engineering to be tolerant to the fungal pathogen, Cryphonectria
parasitica. The petition provided information in support of
petitioners' position that Darling 58 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.
On August 19, 2020, APHIS published the ESF petition in the Federal
Register seeking public comment for a period of 60 days (85 FR 51008-
51009; Docket No. APHIS-2020-0030). APHIS received 4,337 total comments
on the petition, of which 4,321 were posted to the docket.\1\ APHIS
received comments from the academic sector, farmers, non-governmental
organizations, nonprofit organizations, industry, Tribes, and
unaffiliated individuals. Of the 4,321 comments posted to the docket,
the majority were in favor of deregulation of blight tolerant American
chestnut, many were in opposition to deregulation, and several were out
of scope.
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\1\ Each comment posted on Regulations.gov is assigned a comment
ID. Users have the option to indicate whether their comment includes
multiple comment submissions. If the user answers in the
affirmative, the uploaded comment is given one comment ID but will
count as multiple comments under Regulations.gov's tally of
``Comments Received''. Therefore, Regulations.gov tracks both the
number of comments posted and the total number of ``Comments
Received''.
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On August 6, 2021, APHIS published a Notice of Intent (NOI) to
prepare an Environmental Impact Statement (EIS) in the Federal Register
seeking public comment for a period of 30 days (86 FR 43160-43162;
Docket No. APHIS-2020-0030). APHIS received 3,968 total comments on the
NOI, of which 3,964 were posted to the docket. APHIS received comments
from the academic sector, farmers, non-governmental organizations,
nonprofit organizations, industry, Tribes, and unaffiliated
individuals. Of the 3,964 comments posted to the docket, a large
majority were opposed to the deregulation of blight tolerant American
chestnut, many were in favor of the deregulation, and one was out of
scope.
On November 10, 2022, APHIS published the draft PPRA and draft EIS
in the Federal Register (87 FR 67861-67862; Docket No. APHIS-2020-0030)
and accepted public comments for a period of 45 days. APHIS extended
the comment period for an additional 30 days (87 FR 79273; Docket No.
APHIS-2020-0030). APHIS received 30,455 total comments on the draft
PPRA and draft EIS, of which 9,289 were posted to the docket. APHIS
received comments from the academic sector, farmers, non-governmental
organizations, nonprofit organizations, industry, and unaffiliated
individuals. Of the 9,289 comments posted to the docket, the majority
were in favor of deregulation of blight tolerant American chestnut,
many were in opposition to deregulation, some were out of scope, one
was an extension request, and three were submitted by EPA stating that
``EPA did not identify significant environmental concerns to be
addressed in the Final EIS.''
Subsequently, in August 2024, ESF submitted a revised petition
(APHIS Petition Number 19-309-01p-amended) to provide additional
clarifications and corrections about the chestnut event. ESF's original
January 2020 petition referred 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. Because nearly all of the
phenotypic information in the original petition was generated from
Darling 54 offspring, ESF submitted a revised petition to correct the
line name and provide updates on Darling 54 chestnuts based on data
collected since the original 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.
On June 6, 2025, APHIS published a revised draft EIS and draft PPRA
in the Federal Register, along with the revised petition, seeking
public comment for a period of 45 days (90 FR 24090-24091; Docket No.
APHIS-2020-0030). APHIS received 174,116 total comments on the revised
petition, revised draft EIS, and revised draft PPRA, of which 4,115
were posted to the docket. APHIS received comments from the academic
sector, farmers, non-governmental organizations, nonprofit
organizations, industry, and unaffiliated individuals. Of the 4,115
comments posted to the docket, the large majority were in opposition to
the deregulation of Darling 54 American Chestnut, many supported
deregulation, and several were out of scope.
However, on August 18, 2025, APHIS published a withdrawal of the
NOI (90 FR 40050; Docket No. APHIS-2025-0029). Therefore, consistent
with this August 18, 2025 Federal Register notice, APHIS terminated
work on the EIS.
Based on APHIS' evaluation in the PPRA, of information and data
submitted by ESF in its revised petition, available scientific data,
and public comments received in response to the original and revised
petitions and draft PPRAs, APHIS has determined that Darling 54 is
unlikely to pose a greater plant pest risk than the nonmodified
comparator and therefore is no longer subject to our 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 petitions (original and revised)
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.
Done in Washington, DC, this 24th day of August 2026.
Sarah Helming,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2026-17596 Filed 8-27-26; 8:45 am]
BILLING CODE 3410-34-P