[Federal Register Volume 86, Number 149 (Friday, August 6, 2021)]
[Notices]
[Pages 43160-43162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16771]


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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; Notice of Intent To Prepare an Environmental Impact Statement 
for Determination of Nonregulated Status for Blight-Tolerant Darling 58 
American Chestnut (Castanea Dentata) Developed Using Genetic 
Engineering

AGENCY: Animal and Plant Health Inspection Service, Agriculture (USDA).

ACTION: Notice of intent to prepare an environmental impact statement.

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SUMMARY: We are announcing to the public that the Animal and Plant 
Health Inspection Service intends to prepare an environmental impact 
statement (EIS) evaluating the impacts that may result from the 
approval of a petition for nonregulated status for blight-tolerant 
Darling 58 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 Darling 58 American chestnut 
tolerant to chestnut blight. Issues to be addressed in the EIS include 
the potential environmental impacts to managed natural and non-
agricultural lands, the physical environment, biological resources, 
human health, socioeconomics, federally listed threatened or endangered 
species, and cultural or historic resources. We are requesting public 
comments to further delineate the scope of the alternatives and 
environmental and interrelated economic issues and impacts to be 
considered in the EIS.

DATES: APHIS will consider all comments received on or before September 
7, 2021.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov. 
Enter APHIS-2020-0030 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-2020-0030, 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 www.regulations.gov 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.

FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology 
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 
20737-1238; (301) 851-3892, email: [email protected].

SUPPLEMENTARY INFORMATION:

Purpose and Need for the Proposed Action

    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, ``Movement of Organisms Modified or Produced Through Genetic 
Engineering,'' regulate, among other things, the importation, 
interstate movement, or release into the environment of organisms 
modified or produced through genetic engineering that are plant pests 
or pose a plausible plant pest risk.
    The petition for nonregulated status described in this notice is 
being evaluated under the version of the regulations effective at the 
time that it was received. The Animal and Plant

[[Page 43161]]

Health Inspection Service (APHIS) issued a final rule, published in the 
Federal Register on May 18, 2020 (85 FR 29790-29838, Docket No. APHIS-
2018-0034),\1\ revising 7 CFR part 340; however, the final rule is 
being implemented in phases. The new Regulatory Status Review (RSR) 
process, which replaces the determination of nonregulated status 
petition process, became effective on April 5, 2021 for corn, soybean, 
cotton, potato, tomato, and alfalfa. The RSR process is effective for 
all crops as of October 1, 2021. However, ``[u]ntil RSR is available 
for a particular crop . . . ., APHIS will continue to receive petitions 
for determination of nonregulated status for the crop in accordance 
with the [legacy] regulations at 7 CFR 340.6.'' (85 FR 29815). This 
petition for a determination of nonregulated status is being evaluated 
in accordance with the regulations at 7 CFR 340.6 (2020) as it was 
received by APHIS on January 21, 2020.
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    \1\ To view the final rule, go to www.regulations.gov and enter 
APHIS-2018-0034 in the Search field.
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    APHIS received a petition from the State University of New York 
College of Environmental Science and Forestry (ESF) (APHIS Petition 
Number 19-309-01p) \2\ seeking a determination of nonregulated status 
for blight-tolerant Darling 58 American chestnut (Castanea dentata). 
The petition states 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.
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    \2\ To view the petition, go to https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.
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    According to our process \3\ 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.\4\ 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.
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    \3\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for organisms developed using genetic 
engineering. To view the notice, go to www.regulations.gov and enter 
APHIS-2011-0129 in the Search field.
    \4\ To view the notice, supporting documents, and the comments 
that we received, go to www.regulations.gov and enter APHIS-2020-
0030 in the Search field.
_____________________________________-

    Comments in favor of the petition emphasized the positive 
environmental and socio-economic benefits of restoring American 
chestnut throughout its pre-blight range. Issues raised in the opposing 
comments included environmental impacts of the unconfined release of a 
forest tree developed using genetic engineering, impacts to native 
communities, human health and safety impacts of using a wheat gene, the 
need for long term studies, the potential for chestnut to be more 
susceptible to chestnut blight as well as other diseases, the potential 
for impacts to organic producers, impacts to trade, and general anti-
biotech sentiments. APHIS evaluated all comments received on the 
petition. A full record of comments received is available online at 
www.regulations.gov (see footnote 4). As part of our evaluation of the 
petition and consideration of public comments, APHIS has determined 
that this proposed action has potential to significantly affect the 
quality of the human environment.\5\ As such, APHIS is deciding to 
prepare an environmental impact statement (EIS) in order to conduct the 
level of detailed and rigorous environmental analysis required to make 
an informed decision about the proposed deregulation of Darling 58 
American chestnut.
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    \5\ 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).
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    The EIS is being prepared in accordance with: (1) National 
Environmental Policy Act (NEPA), as amended (42 U.S.C. 4321 et seq.), 
(2) the Council on Environmental Quality's (CEQ) NEPA-implementing 
regulations (40 CFR parts 1500-1508), (3) USDA's NEPA-implementing 
regulations (7 CFR part 1b), and (4) APHIS' NEPA Implementing 
Procedures (7 CFR part 372).

Proposed Action and Alternative the EIS Will Consider

    The EIS will analyze the preferred alternative, approval of ESF's 
petition for a determination of nonregulated status for Darling 58 
American chestnut, as well as the no action alternative, denial of the 
petition for nonregulated status. Both alternatives will receive APHIS' 
full consideration. APHIS has developed a list of topics for 
consideration in the EIS based on public comments on the petition, 
prior environmental assessments (EAs)/EISs for plants developed using 
genetic engineering, public comments submitted for other EAs/EISs 
evaluating petitions for nonregulated status, scientific literature on 
biotechnology, and issues identified by APHIS specific to American 
chestnut and other Castanea species. The following topics were 
identified as relevant to the scope of analysis: Action Area (Historic, 
Present, and Potential Future Range of American Chestnut); Physical 
Environment (Soil Quality, Water Resources, Air Quality and Climate 
Change); Biological Resources (Animal Communities, Plant Communities, 
Gene Flow and Weediness, Microorganisms, and Biodiversity); Human 
Health Considerations; Animal Health and Welfare; and Socioeconomic 
Considerations (Domestic Economic Environment, International Trade). In 
addition, potential impacts on threatened and endangered species, as 
well as adherence of the Agency's decision to Executive Orders, and 
environmental laws and regulations to which the action may be subject 
will also be examined.

Summary of Potential Impacts

    APHIS anticipates the potential impacts of the proposed action 
could include impacts on the physical environment, biological 
resources, and socioeconomic impacts.

Anticipated Permits and Authorizations

    Darling 58 American chestnut, if deregulated, could be cultivated 
to produce food or animal feed, subject to any Environmental Protection 
Agency's (EPA) and/or U.S. Food and Drug Administration (FDA) 
requirements under the Coordinated Framework.\6\ For example, any human 
food or animal feed derived from Darling 58 American chestnut would be 
subject to the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 
301 et seq.) and FDA requirements. ESF may voluntarily consult with the 
FDA to ensure compliance with the FFDCA.
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    \6\ See Coordinated Framework. U.S. Department of Agriculture, 
Animal and Plant Health Inspection Service, Biotechnology Regulatory 
Services, https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.

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[[Page 43162]]

Public Scoping Process

    As previously discussed, APHIS seeks public comment on petitions 
deemed complete through notices published in the Federal Register. In 
accordance with our process, on August 19, 2020, APHIS solicited 
comments on the petition for 60 days and received 4,320 comments from 
the academic sector, farmers, non-governmental organizations, nonprofit 
organizations, industry, Tribes, and unaffiliated individuals.
    APHIS is seeking additional public comment on this notice of intent 
to prepare an EIS to help identify potential alternatives, as well as 
relevant information, studies, and/or analyses that we should consider 
in evaluating the potential impacts of the proposed action on the 
quality of the human environment. Those who have already submitted 
comments on the ESF petition need not resubmit--we will consider these 
comments in development of the EIS. To promote informed NEPA analysis 
and decisionmaking, comments should be as specific as possible and 
explain why the issues raised are important for consideration in the 
EIS. Comments should include, where possible, references and data 
sources supporting the information provided in the comment. We 
encourage the submission of data, studies, or research to support your 
comments.
    APHIS will accept written comments for a period of 30 days from the 
date of this notice. The petition is available for public review, and 
copies are available as indicated under ADDRESSES and FOR FURTHER 
INFORMATION CONTACT above.

Schedule for the Decision-Making Process

    As part of the decision-making process regarding the petition, we 
are preparing a plant pest risk assessment (PPRA) and the EIS that is 
the subject of this notice. We plan to complete the PPRA within 6 
months, and the EIS and record of decision (ROD) within 2 years of the 
date of this notice. This schedule is tentative and subject to 
extension.
    Once we have reviewed the comments received in response to this 
notice, we will prepare and make available a draft EIS for a review and 
comment for a period of 45 days. A notice for public comment on the 
draft EIS will be provided in the Federal Register, and the draft EIS 
and associated documents will be made available on www.regulations.gov.
    The commenting and review process on the draft EIS will be 
conducted in accordance with CEQ's NEPA regulations. Comments will be 
invited from State, Tribal, and local governments and agencies, 
industry, environmental organizations, academia, and the public. APHIS 
will review all comments received on the draft EIS, provide responses 
to substantive comments, and incorporate relevant issues raised in the 
comments into development of a final EIS.
    We will announce the availability of the final EIS in the Federal 
Register and file the final EIS together with comments and responses 
with the EPA, Office of Federal Activities, consistent with EPA's 
procedures and CEQ's filing requirements. The EPA will publish a notice 
in the Federal Register announcing the final EIS. APHIS will issue a 
ROD on the final EIS and petition 30 days after the EPA notifies the 
public that the final EIS has been completed and submitted. If 
necessary, APHIS may extend these timeframes.
    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 2nd day of August 2021.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-16771 Filed 8-5-21; 8:45 am]
BILLING CODE 3410-34-P