Notice2021-17558
BASF Corporation; Availability of a Draft Plant Pest Risk Assessment and Draft Environmental Assessment for Determination of Nonregulated Status of Plant-Parasitic Nematode-Protected and Herbicide Tolerant Soybean
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 17, 2021
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
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 BASF Corporation seeking a determination of nonregulated status for soybean event GMB151, which has been developed using genetic engineering for resistance to the plant-parasitic nematode, soybean cyst nematode (Heterodera glycines), and for tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor herbicides. We are making these documents available for public review and comment.
Full Text
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<title>Federal Register, Volume 86 Issue 156 (Tuesday, August 17, 2021)</title>
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[Federal Register Volume 86, Number 156 (Tuesday, August 17, 2021)]
[Notices]
[Pages 45955-45956]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17558]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0023]
BASF Corporation; Availability of a Draft Plant Pest Risk
Assessment and Draft Environmental Assessment for Determination of
Nonregulated Status of Plant-Parasitic Nematode-Protected and Herbicide
Tolerant Soybean
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service has prepared a draft plant pest risk assessment and
draft environmental assessment regarding a request from BASF
Corporation seeking a determination of nonregulated status for soybean
event GMB151, which has been developed using genetic engineering for
resistance to the plant-parasitic nematode, soybean cyst nematode
(Heterodera glycines), and for tolerance to 4-hydroxyphenylpyruvate
dioxygenase (HPPD-4) inhibitor herbicides. We are making these
documents available for public review and comment.
DATES: We will consider all comments that we receive on or before
September 16, 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-2020-0023 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-2020-0023, 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
<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) 7997039 before coming.
Supporting documents for this petition are also available on the
APHIS website at <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>.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology
Regulatory Services, APHIS, 4700 River Road, Unit 147, Riverdale, MD
20737-1236; (301) 851-3892, email: <a href="/cdn-cgi/l/email-protection#54372d3a203c3d357a357a31373f14212730357a333b22"><span class="__cf_email__" data-cfemail="73100a1d071b1a125d125d16101833060017125d141c05">[email protected]</span></a>.
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 November 13, 2019.
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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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BASF Corporation (BASF) has submitted a petition (APHIS Petition
Number 19-317-01p) to APHIS seeking a determination of nonregulated
status under 7 CFR part 340, for soybean event GMB151 which has been
developed using genetic engineering for resistance to the plant-
parasitic nematode, soybean cyst nematode (Heterodera glycines), and
for tolerance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4) inhibitor
herbicides. The petition states that GMB151 soybean is
[[Page 45956]]
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 May 28, 2020, APHIS announced in the Federal Register \3\ (85 FR
32004-32005, Docket No. APHIS-2020-0023) the availability of the BASF
petition for public comment. APHIS solicited comments on the petition
for 60 days ending July 27, 2020.
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\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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a> and enter
APHIS-2020-0023 in the Search field.
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APHIS received nine comments during the comment period. They were
from the agricultural and private sectors. Five comments generally
supported BASF's petition, while four expressed objections to crops
developed or modified through genetic engineering.
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 soybean event
GMB151 with that of the unmodified variety from which it was derived.
The draft PPRA concluded that soybean event GMB151 is unlikely to pose
an increased plant pest risk compared to the unmodified soybean.
The draft EA evaluated potential impacts that may result from the
commercial production of GMB151 soybean, to include potential impacts
on conventional and organic soybean production; the acreage and area
required for U.S. soybean 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 GMB151 soybean.
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 review 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.
After the 30-day review period closes, APHIS will review and
evaluate any information received during the 30-day review period.
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 11th day of August 2021.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2021-17558 Filed 8-16-21; 8:45 am]
BILLING CODE 3410-34-P
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