BASF Corporation; Petition for a Determination of Nonregulated Status for Plant-Parasitic Nematode-Protected and Herbicide Resistant Soybean, 32004-32005 [2020-11492]
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VerDate Sep<11>2014
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Jkt 250001
public record and may be sent to the
following address:
Bruce Summers,
Administrator.
[FR Doc. 2020–11429 Filed 5–27–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2020–0023]
BASF Corporation; Petition for a
Determination of Nonregulated Status
for Plant-Parasitic Nematode-Protected
and Herbicide Resistant Soybean
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service (APHIS) has received
a petition from BASF Corporation
seeking a determination of nonregulated
status of soybean event GMB151
genetically engineered for resistance to
the plant-parasitic nematode, soybean
cyst nematode (Heterodera glycines),
and for resistance to 4hydroxyphenylpyruvate dioxygenase
(HPPD–4) inhibitor herbicides. The
petition has been submitted in
accordance with our regulations
concerning the introduction of certain
genetically engineered organisms and
products. We are making the petition
available for review and comment to
help us identify potential environmental
and interrelated economic issues and
impacts that APHIS may determine
should be considered in our evaluation
of the petition.
DATES: We will consider all comments
that we receive on or before July 27,
2020.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2020-0023.
• 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 and any comments we
receive on this docket may be viewed at
https://www.regulations.gov/
#!docketDetail;D=APHIS-2020-0023 or
in our reading room, which is located in
room 1141 of the USDA South Building,
14th Street and Independence Avenue
SW, Washington, DC. Normal reading
SUMMARY:
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
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.
The petition is also available on the
APHIS website at: https://
www.aphis.usda.gov/aphis/ourfocus/
biotechnology/permits-notificationspetitions/petitions/petition-status under
APHIS petition 19–317–01p.
FOR FURTHER INFORMATION CONTACT: Ms.
Cindy Eck, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
851–3892, email: cynthia.a.eck@
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, ‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered (GE) organisms
and products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Paragraphs (b) and (c) of § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
APHIS has received a petition (APHIS
Petition Number 19–317–01p) from
BASF Corporation (BASF) seeking a
determination of nonregulated status of
soybean event GMB151 genetically
engineered for resistance to the plantparasitic nematode, soybean cyst
nematode (Heterodera glycines), and for
resistance 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 not likely to be
a plant pest and therefore should not be
a regulated article under APHIS’
regulations in 7 CFR part 340.
As described in the petition, GMB151
soybean was developed through
disarmed Agrobacterium-mediated
transformation using the vector
E:\FR\FM\28MYN1.SGM
28MYN1
jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 103 / Thursday, May 28, 2020 / Notices
pSZ8832 containing the cry14Ab-1.b
and hppdPf-4Pa gene cassettes. GMB151
soybean produces the Cry14Ab-1
protein, a crystal protein derived from
Bacillus thuringiensis, which confers
resistance to the plant-parasitic
nematode, soybean cyst nematode
(Heterodera glycines). GMB151 also
produces a modified 4hydroxyphenylpyruvate dioxygenase
(HPPD–4) derived from Pseudomonas
fluorescens that confers resistance to
HPPD-inhibitor herbicides such as
isoxaflutole. Agronomic performance of
GMB151 was evaluated at 11 field sites
across U.S. soybean growing regions.
The BASF petition states that agronomic
performance of GMB151 soybean is
comparable to the non-genetically
modified conventional counterpart and
reference varieties and that these data
support the conclusion that GMB151
soybean lacks weediness potential and
plant pest risk.
Field tests conducted under APHIS
oversight allowed for evaluation in a
natural agricultural setting while
imposing measures to minimize the
likelihood of persistence in the
environment after completion of the
tests. Data are gathered on multiple
parameters and used by the applicant to
evaluate agronomic characteristics and
product performance. These and other
data are used by APHIS to determine if
the new variety poses a plant pest risk.
Paragraph (d) of § 340.6 provides that
APHIS will publish a notice in the
Federal Register providing 60 days for
public comment for petitions for a
determination of nonregulated status.
On March 6, 2012, we published in the
Federal Register (77 FR 13258–13260,
Docket No. APHIS–2011–0129) a
notice 1 describing our process for
soliciting public comment when
considering petitions for determinations
of nonregulated status for GE organisms.
In that notice we indicated that APHIS
would accept written comments
regarding a petition once APHIS
deemed it complete.
In accordance with § 340.6(d) of the
regulations and our process for
soliciting public input when
considering petitions for determinations
of nonregulated status for GE organisms,
we are publishing this notice to inform
the public that APHIS will accept
written comments regarding the petition
for a determination of nonregulated
status from interested or affected
persons for a period of 60 days from the
date of this notice. The petition is
available for public review and
comment, and copies are available as
indicated under ADDRESSES and FOR
FURTHER INFORMATION CONTACT above.
We are interested in receiving
comments regarding potential
environmental and interrelated
economic issues and impacts that
APHIS may determine should be
considered in our evaluation of the
petition. We are particularly interested
in receiving comments regarding
biological, cultural, or ecological issues,
and we encourage the submission of
scientific data, studies, or research to
support your comments.
After the comment period closes,
APHIS will review all written comments
received during the comment period
and any other relevant information. Any
substantive issues identified by APHIS
based on our review of the petition and
our evaluation and analysis of
comments will be considered in the
development of our decision-making
documents. As part of our decisionmaking process regarding a GE
organism’s regulatory status, APHIS
prepares a plant pest risk assessment to
assess its plant pest risk and the
appropriate environmental
documentation—either an
environmental assessment (EA) or an
environmental impact statement (EIS)—
in accordance with the National
Environmental Policy Act (NEPA), to
provide the Agency with a review and
analysis of any potential environmental
impacts associated with the petition
request. For petitions for which APHIS
prepares an EA, APHIS will follow our
published process for soliciting public
comment (see footnote 1) and publish a
separate notice in the Federal Register
announcing the availability of APHIS’
EA and plant pest risk assessment.
Should APHIS determine that an EIS
is necessary, APHIS will complete the
NEPA EIS process in accordance with
Council on Environmental Quality
regulations (40 CFR part 1500–1508)
and APHIS’ NEPA implementing
regulations (7 CFR part 372).
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.3.
Michael Watson,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2020–11492 Filed 5–27–20; 8:45 am]
BILLING CODE 3410–34–P
1 To view the notice, go to https://
www.regulations.gov/#!docketDetail;D=APHIS2011-0129.
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16:32 May 27, 2020
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32005
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AGENCY:
Notice is hereby given,
pursuant to the provisions of the rules
and regulations of the U.S. Commission
on Civil Rights and the Federal
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2020, for the purpose of hearing
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SUMMARY:
E:\FR\FM\28MYN1.SGM
28MYN1
Agencies
[Federal Register Volume 85, Number 103 (Thursday, May 28, 2020)]
[Notices]
[Pages 32004-32005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11492]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2020-0023]
BASF Corporation; Petition for a Determination of Nonregulated
Status for Plant-Parasitic Nematode-Protected and Herbicide Resistant
Soybean
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: We are advising the public that the Animal and Plant Health
Inspection Service (APHIS) has received a petition from BASF
Corporation seeking a determination of nonregulated status of soybean
event GMB151 genetically engineered for resistance to the plant-
parasitic nematode, soybean cyst nematode (Heterodera glycines), and
for resistance to 4-hydroxyphenylpyruvate dioxygenase (HPPD-4)
inhibitor herbicides. The petition has been submitted in accordance
with our regulations concerning the introduction of certain genetically
engineered organisms and products. We are making the petition available
for review and comment to help us identify potential environmental and
interrelated economic issues and impacts that APHIS may determine
should be considered in our evaluation of the petition.
DATES: We will consider all comments that we receive on or before July
27, 2020.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2020-0023.
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 and any comments we receive on this docket may be
viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2020-0023
or in our reading room, which is located in room 1141 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.
The petition is also available on the APHIS website at: https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status under APHIS petition 19-317-01p.
FOR FURTHER INFORMATION CONTACT: Ms. Cindy Eck, Biotechnology
Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD
20737-1236; (301) 851-3892, 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, ``Introduction of Organisms and Products
Altered or Produced Through Genetic Engineering Which Are Plant Pests
or Which There Is Reason to Believe Are Plant Pests,'' regulate, among
other things, the introduction (importation, interstate movement, or
release into the environment) of organisms and products altered or
produced through genetic engineering that are plant pests or that there
is reason to believe are plant pests. Such genetically engineered (GE)
organisms and products are considered ``regulated articles.''
The regulations in Sec. 340.6(a) provide that any person may
submit a petition to the Animal and Plant Health Inspection Service
(APHIS) seeking a determination that an article should not be regulated
under 7 CFR part 340. Paragraphs (b) and (c) of Sec. 340.6 describe
the form that a petition for a determination of nonregulated status
must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 19-317-01p)
from BASF Corporation (BASF) seeking a determination of nonregulated
status of soybean event GMB151 genetically engineered for resistance to
the plant-parasitic nematode, soybean cyst nematode (Heterodera
glycines), and for resistance 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 not likely to be a plant pest and
therefore should not be a regulated article under APHIS' regulations in
7 CFR part 340.
As described in the petition, GMB151 soybean was developed through
disarmed Agrobacterium-mediated transformation using the vector
[[Page 32005]]
pSZ8832 containing the cry14Ab-1.b and hppdPf-4Pa gene cassettes.
GMB151 soybean produces the Cry14Ab-1 protein, a crystal protein
derived from Bacillus thuringiensis, which confers resistance to the
plant-parasitic nematode, soybean cyst nematode (Heterodera glycines).
GMB151 also produces a modified 4-hydroxyphenylpyruvate dioxygenase
(HPPD-4) derived from Pseudomonas fluorescens that confers resistance
to HPPD-inhibitor herbicides such as isoxaflutole. Agronomic
performance of GMB151 was evaluated at 11 field sites across U.S.
soybean growing regions. The BASF petition states that agronomic
performance of GMB151 soybean is comparable to the non-genetically
modified conventional counterpart and reference varieties and that
these data support the conclusion that GMB151 soybean lacks weediness
potential and plant pest risk.
Field tests conducted under APHIS oversight allowed for evaluation
in a natural agricultural setting while imposing measures to minimize
the likelihood of persistence in the environment after completion of
the tests. Data are gathered on multiple parameters and used by the
applicant to evaluate agronomic characteristics and product
performance. These and other data are used by APHIS to determine if the
new variety poses a plant pest risk.
Paragraph (d) of Sec. 340.6 provides that APHIS will publish a
notice in the Federal Register providing 60 days for public comment for
petitions for a determination of nonregulated status. On March 6, 2012,
we published in the Federal Register (77 FR 13258-13260, Docket No.
APHIS-2011-0129) a notice \1\ describing our process for soliciting
public comment when considering petitions for determinations of
nonregulated status for GE organisms. In that notice we indicated that
APHIS would accept written comments regarding a petition once APHIS
deemed it complete.
---------------------------------------------------------------------------
\1\ To view the notice, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
---------------------------------------------------------------------------
In accordance with Sec. 340.6(d) of the regulations and our
process for soliciting public input when considering petitions for
determinations of nonregulated status for GE organisms, we are
publishing this notice to inform the public that APHIS will accept
written comments regarding the petition for a determination of
nonregulated status from interested or affected persons for a period of
60 days from the date of this notice. The petition is available for
public review and comment, and copies are available as indicated under
ADDRESSES and FOR FURTHER INFORMATION CONTACT above. We are interested
in receiving comments regarding potential environmental and
interrelated economic issues and impacts that APHIS may determine
should be considered in our evaluation of the petition. We are
particularly interested in receiving comments regarding biological,
cultural, or ecological issues, and we encourage the submission of
scientific data, studies, or research to support your comments.
After the comment period closes, APHIS will review all written
comments received during the comment period and any other relevant
information. Any substantive issues identified by APHIS based on our
review of the petition and our evaluation and analysis of comments will
be considered in the development of our decision-making documents. As
part of our decision-making process regarding a GE organism's
regulatory status, APHIS prepares a plant pest risk assessment to
assess its plant pest risk and the appropriate environmental
documentation--either an environmental assessment (EA) or an
environmental impact statement (EIS)--in accordance with the National
Environmental Policy Act (NEPA), to provide the Agency with a review
and analysis of any potential environmental impacts associated with the
petition request. For petitions for which APHIS prepares an EA, APHIS
will follow our published process for soliciting public comment (see
footnote 1) and publish a separate notice in the Federal Register
announcing the availability of APHIS' EA and plant pest risk
assessment.
Should APHIS determine that an EIS is necessary, APHIS will
complete the NEPA EIS process in accordance with Council on
Environmental Quality regulations (40 CFR part 1500-1508) and APHIS'
NEPA implementing regulations (7 CFR part 372).
Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.3.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-11492 Filed 5-27-20; 8:45 am]
BILLING CODE 3410-34-P