Pioneer Hi-Bred International, Inc.; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status for Insect Resistant and Herbicide-Tolerant Maize, 21602-21603 [2023-07569]
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21602
Notices
Federal Register
Vol. 88, No. 69
Tuesday, April 11, 2023
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2020–0098]
Pioneer Hi-Bred International, Inc.;
Availability of a Draft Plant Pest Risk
Assessment and Draft Environmental
Assessment for Determination of
Nonregulated Status for Insect
Resistant and Herbicide-Tolerant Maize
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service has prepared a draft
plant pest risk assessment and draft
environmental assessment regarding a
request from Pioneer Hi-Bred
International, Inc., seeking a
determination of nonregulated status for
DP23211 maize (corn), which was
developed using genetic engineering for
insect resistance to western corn
rootworm and contains the gene that
codes for the phosphinothricin
acetyltransferase protein responsible for
tolerance to glufosinate-ammonium
herbicides. DP23211 corn also contains
the gene that encodes for the
phosphomannose isomerase protein,
which is used as a selectable marker.
We are making these documents
available for public review and
comment.
We will consider all comments
that we receive on or before May 11,
2023.
DATES:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
www.regulations.gov. Enter APHIS–
2020–0098 in the Search field. Select
the Documents tab, then select the
Comment button in the list of
documents.
lotter on DSK11XQN23PROD with NOTICES1
VerDate Sep<11>2014
17:45 Apr 10, 2023
Jkt 259001
Dr.
Alan Pearson, Biotechnology Regulatory
Services, APHIS, USDA, 4700 River
Road Unit 147, Riverdale, MD 20737–
1236; (301) 851–3944; email:
alan.pearson@usda.gov.
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, ‘‘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
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 petition for
FOR FURTHER INFORMATION CONTACT:
SUMMARY:
ADDRESSES:
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2020–0098, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The petition, draft environmental
assessment, draft plant pest risk
assessment, 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) 7997039 before coming.
Supporting documents for this
petition are also available on the APHIS
website at https://www.aphis.usda.gov/
aphis/ourfocus/biotechnology/
regulatory-processes/petitions/petitionstatus.
1 To view the final rule, go to
www.regulations.gov and enter APHIS–2018–0034
in the Search field.
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
determination of nonregulated status
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 July 21,
2020.
Pioneer Hi-Bred International
(Pioneer) has submitted a petition
(APHIS Petition Number 20–203–01p)
to APHIS seeking a determination of
nonregulated status for DP23211 maize
(corn), which was developed using
genetic engineering for insect resistance
to western corn rootworm and contains
the gene that codes for the
phosphinothricin acetyltransferase
protein responsible for tolerance to
glufosinate-ammonium herbicides.
DP23211 corn also contains the gene
that encodes for the phosphomannose
isomerase protein, which is used as a
selectable marker. The petition states
that DP23211 corn 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 2 for
soliciting public comment when
considering petitions for determination
of nonregulated status of organisms
developed using genetic engineering,
APHIS accepts written comments
regarding a petition once APHIS deems
the petition complete. On November 3,
2020, APHIS announced in the Federal
Register 3 (85 FR 69564–69566, Docket
No. APHIS–2020–0098) the availability
of the Pioneer petition for public
comment. APHIS solicited comments on
2 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.
3 To view the notice, its supporting documents,
and the comments that we received, go to
www.regulations.gov and enter APHIS–2020–0098
in the Search field.
E:\FR\FM\11APN1.SGM
11APN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 69 / Tuesday, April 11, 2023 / Notices
the petition for 60 days ending January
4, 2021.
APHIS received four comments on the
petition during the comment period.
One comment was from an individual,
which stated opposition to
biotechnology-derived crops in general.
Three comments were received from
industry organizations, which generally
supported approval of the petition.
After public comments are received
on a completed petition, APHIS
evaluates those comments and then
provides a second opportunity for
public involvement in our decisionmaking process. According to our public
review process (see footnote 2), the
second opportunity for public
involvement follows one of two
approaches, as described below.
If APHIS decides, based on its review
of the petition and its evaluation and
analysis of comments received during
the 60-day public comment period on
the petition, that the petition involves
an organism that raises no substantive
new issues, APHIS will follow
Approach 1 for public involvement.
Under Approach 1, APHIS prepares and
announces in the Federal Register the
availability of APHIS’ preliminary
regulatory determination along with its
draft EA, preliminary finding of no
significant impact (FONSI), and its draft
plant pest risk assessment (PPRA) for a
30-day public review period. APHIS
will evaluate any information received
related to the petition and its supporting
documents during the 30-day public
review period. If APHIS determines that
no substantive information has been
received that would warrant APHIS
altering its preliminary regulatory
determination or FONSI, or
substantially change the analysis of
impacts in the EA, our preliminary
regulatory determination will become
final and effective upon notification of
the public through an announcement on
our website. No further Federal Register
notice will be published announcing the
final regulatory determination.
Under Approach 2, if APHIS decides,
based on its review of the petition and
its evaluation and analysis of comments
received during the 60-day public
comment period on the petition, that the
petition involves an organism that raises
substantive new issues, APHIS first
solicits written comments from the
public on a draft EA and draft PPRA for
a 30-day comment period through the
publication of a Federal Register notice.
Then, after reviewing and evaluating the
comments on the draft EA and draft
PPRA and other information, APHIS
will revise the draft PPRA as necessary.
It will then prepare a final EA, and
based on the final EA, a National
VerDate Sep<11>2014
17:45 Apr 10, 2023
Jkt 259001
Environmental Policy Act (NEPA)
decision document (either a FONSI or a
notice of intent to prepare an
environmental impact statement).
For this petition, we will be following
Approach 2.
As part of our decision-making
process regarding an organism’s
regulatory status, APHIS prepared a
PPRA to assess the plant pest risk of the
organism, and an EA to evaluate
potential impacts on the human
environment. This will provide the
Agency and the public with a review
and analysis of any potential
environmental impacts that may result
if the petition request is approved.
APHIS’ draft PPRA compared the pest
risk posed by DP23211 corn with that of
the unmodified variety from which it
was derived. The draft PPRA concluded
that DP23211 corn is unlikely to pose an
increased plant pest risk compared to
the unmodified corn.
The draft EA evaluated potential
impacts that may result from the
commercial production of DP23211
corn, to include potential impacts on
conventional and organic corn
production; the acreage and area
required for U.S. corn production;
agronomic practices and inputs; the
physical environment; biological
resources; human health and worker
safety; animal health and welfare; and
socioeconomic impacts. No significant
impacts were identified with the
production and marketing of DP23211
corn.
The draft EA was prepared in
accordance with (1) NEPA, as amended
(42 U.S.C. 4321 et seq.), (2) regulations
of the Council on Environmental
Quality for implementing the
procedural provisions of NEPA (40 CFR
parts 1500–1508), (3) USDA regulations
implementing NEPA (7 CFR part 1b),
and (4) APHIS’ NEPA Implementing
Procedures (7 CFR part 372).
We are making available for a 30-day
comment period our draft EA and draft
PPRA. These documents are available as
indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
Copies of these documents may also be
obtained from the person listed under
FOR FURTHER INFORMATION CONTACT.
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 5th day of
April 2023.
Michael Watson,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2023–07569 Filed 4–10–23; 8:45 am]
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Frm 00002
Fmt 4703
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21603
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2023–0020]
Notice of Request for Extension of
Approval of an Information Collection;
Imported Seeds and Screening
Animal and Plant Health
Inspection Service, USDA.
ACTION: Extension of approval of an
information collection; comment
request.
AGENCY:
In accordance with the
Paperwork Reduction Act of 1995, this
notice announces the Animal and Plant
Health Inspection Service’s intention to
request an extension of approval of an
information collection associated with
the regulations for the importation of
seeds and screenings from Canada into
the United States.
DATES: We will consider all comments
that we receive on or before June 12,
2023.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
www.regulations.gov. Enter APHIS–
2023–0020 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–2023–0020, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments we receive on this docket
may be viewed at 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: For
information on the regulations related to
the importation of seeds and screenings,
contact Mrs. Heather Coady, Senior
Regulatory Policy Specialist, PPQ,
APHIS, USDA, 4700 River Road Unit
137, Riverdale, MD 20737–1231; (240)
935–1598; heather.s.coady@usda.gov.
For information on the information
collection reporting process, contact Mr.
Joseph Moxey, APHIS’ Paperwork
Reduction Act Coordinator, at (301)
851–2483; joseph.moxey@usda.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21602-21603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07569]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 88, No. 69 / Tuesday, April 11, 2023 /
Notices
[[Page 21602]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0098]
Pioneer Hi-Bred International, Inc.; Availability of a Draft
Plant Pest Risk Assessment and Draft Environmental Assessment for
Determination of Nonregulated Status for Insect Resistant and
Herbicide-Tolerant Maize
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a draft plant pest risk assessment and
draft environmental assessment regarding a request from Pioneer Hi-Bred
International, Inc., seeking a determination of nonregulated status for
DP23211 maize (corn), which was developed using genetic engineering for
insect resistance to western corn rootworm and contains the gene that
codes for the phosphinothricin acetyltransferase protein responsible
for tolerance to glufosinate-ammonium herbicides. DP23211 corn also
contains the gene that encodes for the phosphomannose isomerase
protein, which is used as a selectable marker. We are making these
documents available for public review and comment.
DATES: We will consider all comments that we receive on or before May
11, 2023.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to www.regulations.gov.
Enter APHIS-2020-0098 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-2020-0098, Regulatory Analysis and Development, PPD,
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
The petition, draft environmental assessment, draft plant pest risk
assessment, 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) 7997039 before coming.
Supporting documents for this petition are also available on the
APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/petitions/petition-status.
FOR FURTHER INFORMATION CONTACT: Dr. Alan Pearson, Biotechnology
Regulatory Services, APHIS, USDA, 4700 River Road Unit 147, Riverdale,
MD 20737-1236; (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 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 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 petition for determination of nonregulated status 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 July 21, 2020.
---------------------------------------------------------------------------
\1\ To view the final rule, go to www.regulations.gov and enter
APHIS-2018-0034 in the Search field.
---------------------------------------------------------------------------
Pioneer Hi-Bred International (Pioneer) has submitted a petition
(APHIS Petition Number 20-203-01p) to APHIS seeking a determination of
nonregulated status for DP23211 maize (corn), which was developed using
genetic engineering for insect resistance to western corn rootworm and
contains the gene that codes for the phosphinothricin acetyltransferase
protein responsible for tolerance to glufosinate-ammonium herbicides.
DP23211 corn also contains the gene that encodes for the phosphomannose
isomerase protein, which is used as a selectable marker. The petition
states that DP23211 corn 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 \2\ for soliciting public comment when
considering petitions for determination of nonregulated status of
organisms developed using genetic engineering, APHIS accepts written
comments regarding a petition once APHIS deems the petition complete.
On November 3, 2020, APHIS announced in the Federal Register \3\ (85 FR
69564-69566, Docket No. APHIS-2020-0098) the availability of the
Pioneer petition for public comment. APHIS solicited comments on
[[Page 21603]]
the petition for 60 days ending January 4, 2021.
---------------------------------------------------------------------------
\2\ 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.
\3\ To view the notice, its supporting documents, and the
comments that we received, go to www.regulations.gov and enter
APHIS-2020-0098 in the Search field.
---------------------------------------------------------------------------
APHIS received four comments on the petition during the comment
period. One comment was from an individual, which stated opposition to
biotechnology-derived crops in general. Three comments were received
from industry organizations, which generally supported approval of the
petition.
After public comments are received on a completed petition, APHIS
evaluates those comments and then provides a second opportunity for
public involvement in our decision-making process. According to our
public review process (see footnote 2), the second opportunity for
public involvement follows one of two approaches, as described below.
If APHIS decides, based on its review of the petition and its
evaluation and analysis of comments received during the 60-day public
comment period on the petition, that the petition involves an organism
that raises no substantive new issues, APHIS will follow Approach 1 for
public involvement. Under Approach 1, APHIS prepares and announces in
the Federal Register the availability of APHIS' preliminary regulatory
determination along with its draft EA, preliminary finding of no
significant impact (FONSI), and its draft plant pest risk assessment
(PPRA) for a 30-day public review period. APHIS will evaluate any
information received related to the petition and its supporting
documents during the 30-day public review period. If APHIS determines
that no substantive information has been received that would warrant
APHIS altering its preliminary regulatory determination or FONSI, or
substantially change the analysis of impacts in the EA, our preliminary
regulatory determination will become final and effective upon
notification of the public through an announcement on our website. No
further Federal Register notice will be published announcing the final
regulatory determination.
Under Approach 2, if APHIS decides, based on its review of the
petition and its evaluation and analysis of comments received during
the 60-day public comment period on the petition, that the petition
involves an organism that raises substantive new issues, APHIS first
solicits written comments from the public on a draft EA and draft PPRA
for a 30-day comment period through the publication of a Federal
Register notice. Then, after reviewing and evaluating the comments on
the draft EA and draft PPRA and other information, APHIS will revise
the draft PPRA as necessary. It will then prepare a final EA, and based
on the final EA, a National Environmental Policy Act (NEPA) decision
document (either a FONSI or a notice of intent to prepare an
environmental impact statement).
For this petition, we will be following Approach 2.
As part of our decision-making process regarding an organism's
regulatory status, APHIS prepared a PPRA to assess the plant pest risk
of the organism, and an EA to evaluate potential impacts on the human
environment. This will provide the Agency and the public with a review
and analysis of any potential environmental impacts that may result if
the petition request is approved.
APHIS' draft PPRA compared the pest risk posed by DP23211 corn with
that of the unmodified variety from which it was derived. The draft
PPRA concluded that DP23211 corn is unlikely to pose an increased plant
pest risk compared to the unmodified corn.
The draft EA evaluated potential impacts that may result from the
commercial production of DP23211 corn, to include potential impacts on
conventional and organic corn production; the acreage and area required
for U.S. corn production; agronomic practices and inputs; the physical
environment; biological resources; human health and worker safety;
animal health and welfare; and socioeconomic impacts. No significant
impacts were identified with the production and marketing of DP23211
corn.
The draft EA was prepared in accordance with (1) NEPA, as amended
(42 U.S.C. 4321 et seq.), (2) regulations of the Council on
Environmental Quality for implementing the procedural provisions of
NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR
part 372).
We are making available for a 30-day comment period our draft EA
and draft PPRA. These documents are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. Copies of these
documents may also be obtained from the person listed under FOR FURTHER
INFORMATION CONTACT.
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 5th day of April 2023.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2023-07569 Filed 4-10-23; 8:45 am]
BILLING CODE 3410-34-P
