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, 43160-43162 [2021-16771]
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43160
Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices
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required regarding; whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; the accuracy of the
agency’s estimate of burden including
the validity of the methodology and
assumptions used; ways to enhance the
quality, utility and clarity of the
information to be collected; and ways to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Comments regarding this information
collection received by September 7,
2021 will be considered. Written
comments and recommendations for the
proposed information collection should
be submitted within 30 days of the
publication of this notice on the
following website www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
by using the search function.
An agency may not conduct or
sponsor a collection of information
unless the collection of information
displays a currently valid OMB control
number and the agency informs
potential persons who are to respond to
the collection of information that such
persons are not required to respond to
the collection of information unless it
displays a currently valid OMB control
number.
Farm Service Agency
Title: Assignments of Payments and
Joint Payment Authorizations; Request
for Waiver.
OMB Control Number: 0560–0183.
Summary of Collection: The Soil
Conservation and Domestic Allotment
Act (16 U.S.C. 590h(g)) authorizes
producers to assign, in writing, Farm
Service Agency (FSA) conservation
program payments. The statute requires
that any such assignment be signed and
witnessed. The Agricultural Act of 1949,
as amended, extends that authority to
Commodity Credit Corporation (CCC)
programs, including rice, feed grains,
cotton, and wheat. When the recipient
of an FSA, NRCS, or CCC payment
chooses to assign a payment to another
party or have the payment made jointly
with another party, the other party must
be identified. All federal nontax
payments must be made by EFT, unless
a waiver applies which requires certain
criteria to be granted. FSA will collect
information using forms CCC–36, CCC
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19:29 Aug 05, 2021
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37, CCC–251, CCC–252 and FPAC–FM–
12.
Need and Use of the Information: The
information collected on the forms will
be used by FSA and NRCS employees in
order to record the payment or contract
being assigned, the amount of the
assignment, the date of the assignment,
and the name and address of the
assignee and the assignor. This is to
enable FSA employee to pay the proper
party when payments become due. FSA
will also use the information to issue
program payments jointly at the request
of the producer and also terminate joint
payments at the request of both the
producer and joint payee.
Description of Respondent: Farms.
Number of Respondents: 700,491.
Frequency of Responses: Reporting;
On occasion.
Total Burden Hours: 116,687.
Animal and Plant Health
Inspection Service, Agriculture (USDA).
ACTION: Notice of intent to prepare an
environmental impact statement.
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: cynthia.a.eck@
usda.gov.
SUPPLEMENTARY INFORMATION:
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
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
Ruth Brown,
Departmental Information Collection
Clearance Officer.
[FR Doc. 2021–16833 Filed 8–5–21; 8:45 am]
BILLING CODE 3410–05–P
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:
SUMMARY:
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Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices
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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.
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.
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
1 To view the final rule, go to
www.regulations.gov and enter APHIS–2018–0034
in the Search field.
2 To view the petition, go to https://
www.aphis.usda.gov/aphis/ourfocus/biotechnology/
permits-notifications-petitions/petitions/petitionstatus.
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.
VerDate Sep<11>2014
19:29 Aug 05, 2021
Jkt 253001
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, nongovernmental organizations, nonprofit
organizations, industry, Tribes, and
unaffiliated individuals.
Comments in favor of the petition
emphasized the positive environmental
and socio-economic benefits of restoring
American chestnut throughout its preblight 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.
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
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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43161
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.
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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43162
Federal Register / Vol. 86, No. 149 / Friday, August 6, 2021 / Notices
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, nongovernmental 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.
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Schedule for the Decision-Making
Process
19:29 Aug 05, 2021
Jkt 253001
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
DEPARTMENT OF AGRICULTURE
U.S. Codex Office
U.S. Codex Office, USDA.
Notice of public meeting and
request for comments.
ACTION:
The U.S. Codex Office is
sponsoring a public meeting on
September 20, 2021. The objective of the
public meeting is to provide information
and receive public comments on agenda
items and draft United States (U.S.)
positions to be discussed at the 27th
Session of the Codex Committee on Fats
and Oils (CCFO) of the Codex
Alimentarius Commission, which will
convene virtually, October 18–26, 2021.
The U.S. Manager for Codex
Alimentarius and the Acting Deputy
Under Secretary for Trade and Foreign
Agricultural Affairs recognize the
importance of providing interested
parties the opportunity to obtain
background information on the 27th
Session of the CCFO and to address
items on the agenda.
SUMMARY:
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The public meeting is scheduled
for September 20, 2021, from 2:00–4:00
p.m. EDT.
ADDRESSES: The public meeting will
take place via Video Teleconference
only. Documents related to the 27th
Session of the CCFO will be accessible
via the internet at the following address:
https://www.fao.org/fao-whocodexalimentarius/meetings/detail/en/
?meeting=CCFO&session=27. Dr. Paul
South, U.S. Delegate to the 27th Session
of the CCFO, invites U.S. interested
parties to submit their comments
electronically to the following email
address: paul.south@fda.hhs.gov.
REGISTRATION: Attendees must register
to attend the public meeting here:
https://www.zoomgov.com/meeting/
register/vJItdeCspjoiE_
dPA0lHBseYMWHn9UDDhdY. After
registering, you will receive a
confirmation email containing
information about joining the meeting.
FOR FURTHER INFORMATION CONTACT:
For further information about the 27th
Session of the CCFO, contact U.S.
Delegate, Dr. Paul South, paul.south@
fda.hhs.gov, +1 (240) 402–1640.
For further information about the
public meeting contact: U.S. Codex
Office, 1400 Independence Avenue SW,
Room 4861, South Agriculture Building,
Washington, DC 20250. Phone (202)
720–7760, Fax: (202) 720–3157, Email:
uscodex@usda.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Background
Codex Alimentarius Commission:
Meeting of the Codex Committee on
Fats and Oils
AGENCY:
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
VerDate Sep<11>2014
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.
Sfmt 4703
Codex was established in 1963 by two
United Nations organizations, the Food
and Agriculture Organization and the
World Health Organization. Through
adoption of food standards, codes of
practice, and other guidelines
developed by its committees, and by
promoting their adoption and
implementation by governments, Codex
seeks to protect the health of consumers
and ensure fair practices in the food
trade.
The Terms of Reference of the Codex
Committee on Fats and Oils (CCFO) are:
(a) To elaborate worldwide standards
for fats and oils of animal, vegetable and
marine origin including margarine and
olive oil.
The CCFO is hosted by Malaysia. The
United States attends the CCFO as a
member country of Codex.
Issues To Be Discussed at the Public
Meeting
The following items on the Agenda
for the 27th Session of the CCFO will be
discussed during the public meeting:
• Adoption of the Agenda.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\1\ To view the final rule, go to www.regulations.gov and enter
APHIS-2018-0034 in the Search field.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ To view the petition, go to https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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
