[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Notices]
[Pages 51008-51009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18135]


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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; Petition for Determination of Nonregulated Status for Blight-
Resistant Darling 58 American Chestnut

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 (APHIS) has received a petition from the State 
University of New York College of Environmental Science and Forestry 
(ESF) seeking a determination of nonregulated status for blight-
resistant Darling 58 American chestnut (Castanea dentata). The petition 
has been submitted in accordance with our regulations concerning the 
introduction of certain genetically engineered organisms. We are making 
available for public comment the ESF petition and requesting public 
input regarding potential issues and impacts that APHIS should be 
considering in our evaluation of the petition.

DATES: We will consider all comments that we receive on or before 
October 19, 2020.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0030.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2020-0030, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    The petition and any comments we receive on this docket may be 
viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2020-0030 
or in our reading room, which is located in room 1141 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 is also available on the APHIS website at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS petition 19-309-01p.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1236; (301) 851-3892, 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 plants developed using 
genetic engineering 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 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 American chestnut (Castanea dentata). The ESF petition 
states that Darling 58 American chestnut has been genetically 
engineered for fungal resistance to chestnut blight caused by 
Cryphonectria parasitica and is unlikely to pose a plant pest risk and, 
therefore, should not be a regulated article under APHIS' regulations 
in 7 CFR part 340.
    As described in the petition, resistance to this exotic pathogen in 
Darling 58 American chestnuts was enhanced by adding a gene for an 
enzyme called oxalate oxidase (OxO). This enzyme has no direct 
fungicidal properties, but rather detoxifies oxalic acid (oxalate) 
produced by the fungus, preventing the acid from killing the chestnut's 
tissues, which can lead to lethal cankers on the tree. In the presence 
of OxO, the damage caused by the oxalate is significantly restricted, 
resulting in superficial cankers. For this reason, the tree can coexist 
with the fungus in a manner similar to Asian chestnut species in the 
fungus' natural range.
    Data were gathered on multiple parameters and used by the applicant 
to evaluate agronomic characteristics and product performance. These 
and other data are used by APHIS to determine if the new variety poses 
a plant pest risk.
    Paragraph (d) of Sec.  340.6 provides that APHIS will publish a 
notice in the Federal Register providing 60 days for public comment for 
petitions for a determination of nonregulated status. On March 6, 2012, 
we published in the Federal Register (77 FR 13258-13260, Docket No. 
APHIS-2011-0129) a notice \1\ describing our process for soliciting 
public comment when considering petitions for determinations of 
nonregulated status for organisms developed using genetic engineering. 
In that notice, we indicated that APHIS would accept written comments 
regarding a petition once APHIS deemed it complete.
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    \1\ To view the notice, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
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    In accordance with Sec.  340.6(d) of the regulations and our 
process for soliciting public input when considering petitions for 
determinations of nonregulated status for organisms developed using 
genetic engineering, we are publishing this notice to inform the public 
that APHIS will accept written comments regarding the petition for a 
determination of nonregulated status from interested or affected 
persons for a period of 60 days from the date of this notice. The 
petition is available for public review and comment, and copies are 
available as indicated under ADDRESSES and FOR FURTHER INFORMATION 
CONTACT above. We are interested in receiving comments regarding 
potential environmental and interrelated economic issues and impacts 
that APHIS may determine should be considered in our evaluation of the 
petition. We are particularly interested in receiving comments 
regarding biological, cultural, or ecological issues, and we encourage 
the submission of scientific data, studies, or research to support your 
comments.

[[Page 51009]]

    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. Any substantive issues identified by APHIS based on our 
review of the petition and our evaluation and analysis of comments will 
be considered in the development of our decision-making documents. As 
part of our decision-making process regarding an organism's regulatory 
status, APHIS prepares a plant pest risk assessment to assess its plant 
pest risk and the appropriate environmental documentation--either an 
environmental assessment (EA) or an environmental impact statement 
(EIS)--in accordance with the National Environmental Policy Act (NEPA), 
to provide the Agency with a review and analysis of any potential 
environmental impacts associated with the petition request. For 
petitions for which APHIS prepares an EA, APHIS will follow our 
published process for soliciting public comment (see footnote 1) and 
publish a separate notice in the Federal Register announcing the 
availability of APHIS' EA and plant pest risk assessment.
    Should APHIS determine that an EIS is necessary, APHIS will 
complete the NEPA EIS process in accordance with Council on 
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS' 
NEPA implementing regulations (7 CFR part 372).

    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 13th day of August 2020.
Mark Davidson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-18135 Filed 8-18-20; 8:45 am]
BILLING CODE 3410-34-P