Notice2022-05444
BASF Corporation; Determination of Nonregulated Status of Plant-Parasitic, Nematode-Protected and Herbicide-Tolerant Soybean
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Published
March 15, 2022
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are advising the public of our determination that soybean designated as 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, is no longer considered regulated. Our determination is based on our evaluation of data submitted by BASF Corporation in its petition for a determination of nonregulated status, our analysis of available scientific data, and public comments received in response to our previous notices announcing the availability of the petition for nonregulated status and its associated draft environmental assessment and draft plant pest risk assessment. This notice also announces the availability of our final environmental assessment, final plant pest risk assessment, written determination, and finding of no significant impact.
Full Text
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<title>Federal Register, Volume 87 Issue 50 (Tuesday, March 15, 2022)</title>
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[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Pages 14440-14441]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05444]
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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.
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Federal Register / Vol. 87, No. 50 / Tuesday, March 15, 2022 /
Notices
[[Page 14440]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0023]
BASF Corporation; 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 of our determination that soybean
designated as 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, is no
longer considered regulated. Our determination is based on our
evaluation of data submitted by BASF Corporation in its petition for a
determination of nonregulated status, our analysis of available
scientific data, and public comments received in response to our
previous notices announcing the availability of the petition for
nonregulated status and its associated draft environmental assessment
and draft plant pest risk assessment. This notice also announces the
availability of our final environmental assessment, final plant pest
risk assessment, written determination, and finding of no significant
impact.
DATES: This change in regulatory status was recognized on March 9,
2022.
ADDRESSES: You may read the documents referenced in this notice and the
comments we received at <a href="http://www.regulations.gov">www.regulations.gov</a> and entering APHIS-2020-
0023 in the Search field. You can also view them 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.
Supporting documents 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> under APHIS Petition
19-317-01p.
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#ceadb7a0baa6a7afe0afe0abada58ebbbdaaafe0a9a1b8"><span class="__cf_email__" data-cfemail="15766c7b617d7c743b743b70767e55606671743b727a63">[email protected]</span></a>. To obtain
copies of the supporting documents for this petition, contact Ms. Cindy
Eck at (301) 851-3892, email: <a href="/cdn-cgi/l/email-protection#6f0c16011b07060e410e410a0c042f1a1c0b0e41080019"><span class="__cf_email__" data-cfemail="7d1e04130915141c531c53181e163d080e191c531a120b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the authority of the plant pest
provisions of the Plant Protection Act (PPA) (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 was
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 has been 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 January 28, 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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The petition (APHIS Petition Number 19-317-01p) \2\ from BASF
Corporation, of Research Triangle Park, NC (BASF), seeks a
determination of nonregulated status of soybean (Glycine max)
designated as 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
BASF petition states that information collected during field trials and
laboratory analyses indicates that GMB151 soybean 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 determinations of nonregulated status of
organisms developed using genetic engineering, APHIS accepts written
comments regarding a petition once APHIS deems it complete. In a notice
published in the Federal Register on May 28, 2020 (85 FR 32004-32005,
Docket No. APHIS-2020-0023),\4\ APHIS announced the availability of the
BASF petition for public comment. APHIS solicited comments on the
petition for 60 days ending on July 27, 2020, in order to help identify
potential environmental and interrelated economic issues and impacts
that APHIS may determine
[[Page 14441]]
should be considered in our evaluation of the petition.
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\3\ On March 6, 2012, we published in the Federal Register (77
FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing our
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">http://www.regulations.gov</a> and enter APHIS-2011-0129 in the
Search field.
\4\ To view the notice, petition, 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 on the petition from agricultural
trade groups, farmers, and members of the public. Five comments
generally supported BASF's petition, while four expressed objections to
crops developed or modified through genetic engineering.
APHIS decided, based on its review of the petition and its
evaluation and analysis of the comments received during the 60-day
public comment period on the petition, that the petition involves an
organism developed using genetic engineering that raises substantive
new issues. According to our public review process for such petitions
(see footnote 3), APHIS is following Approach 2, in which we first
solicit written comments from the public on a draft environmental
assessment (EA) and a draft plant pest risk assessment (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 the draft PPRA and other information, APHIS revises the draft
PPRA as necessary and prepares a final EA. APHIS also publishes a
notice in the Federal Register announcing the regulatory status of the
organism developed using genetic engineering and the availability of
APHIS' final EA, PPRA, finding of no significant impact (FONSI), and
our regulatory determination.
A second opportunity for public involvement was provided on August
17, 2021, with a notice published in the Federal Register (86 FR 45955-
45956) announcing the availability of the draft EA and draft PPRA for
public review and comment. That comment period closed on September 16,
2021. APHIS received 2,743 comments on the petition and supporting
documents. All but eight of the comments consisted of identical and
near-identical copies of a form letter submitted by different
individuals who expressed their general opposition to the concept and
use of genetic engineering for any purpose. Commenters objected to
GMB151 soybean because it expresses a novel protein from Bacillus
thuringiensis, which many stated has not been adequately evaluated for
use as a pesticide. Others objected to deregulation of GMB151 soybean
on grounds that it would contribute to weed resistance. Commenters also
opposed deregulation because it would contribute to an increase in the
use of isoxaflutole, which they stated will jeopardize human health and
safety. The comments are addressed in our final EA.
National Environmental Policy Act
The final EA contains the results of APHIS' review and evaluation
of the comments received during the comment period on the draft EA,
draft PPRA, and the petition. The final EA provides the public with
documentation of APHIS' review and analysis of any potential
environmental impacts associated with the determination of nonregulated
status of GMB151 soybean. The EA was prepared in accordance with: (1)
National Environmental Policy Act (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). Based on our EA,
the response to public comments, and other pertinent scientific data,
APHIS has reached a FONSI with regard to the preferred alternative
identified in the EA (to make a determination of nonregulated status of
GMB151 soybean).
Determination
Based on APHIS' analysis of field and laboratory data submitted by
BASF, references provided in the petition, peer-reviewed publications,
information analyzed in the EA, the PPRA, comments provided by the
public, and information provided in APHIS' response to those public
comments, APHIS has determined that GMB151 soybean is unlikely to pose
a plant pest risk and therefore is no longer subject to our regulations
governing the importation, interstate movement, or release into the
environment of organisms developed using genetic engineering.
Copies of the signed determination document, PPRA, final EA, and
FONSI, as well as the previously published petition and supporting
documents, are available as indicated in the ADDRESSES and FOR FURTHER
INFORMATION CONTACT sections of this notice.
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 10th day of March 2022.
Anthony Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2022-05444 Filed 3-14-22; 8:45 am]
BILLING CODE 3410-34-P
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