Notice2021-16771
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
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Published
August 6, 2021
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 149 (Friday, August 6, 2021)</title>
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[Federal Register Volume 86, Number 149 (Friday, August 6, 2021)]
[Notices]
[Pages 43160-43162]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>.
Enter APHIS-2020-0030 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-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 <a href="http://www.regulations.gov">www.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.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1238; (301) 851-3892, email: <a href="/cdn-cgi/l/email-protection#187b61766c7071793679367d7b73586d6b7c79367f776e"><span class="__cf_email__" data-cfemail="8ceff5e2f8e4e5eda2eda2e9efe7ccf9ffe8eda2ebe3fa">[email protected]</span></a>.
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
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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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status">https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status</a>.
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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 <a href="http://www.regulations.gov">www.regulations.gov</a> and enter
APHIS-2011-0129 in the Search field.
\4\ 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.
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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
<a href="http://www.regulations.gov">www.regulations.gov</a> (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, <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/">https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/</a>.
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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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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
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